chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Shoulder pain around injection site, starting approx 11/22/15 still sore on 12/2/15.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from the director of nursing regarding 5 unspecified patients of unknown demographics. There was no information about concurrent condition. Sometime between 18-APR-2015 and 23-OCT-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expired date as 18-NOV-2016, route, dose, dose number and strength were unspecified). On 18-NOV-2015 and 19-NOV-2015, unspecified patients were revaccinated with PNEUMOVAX 23 lot # L017406, expiration date 20-FEB-2017, 0.5ml intramuscularly. On an unknown date in November 2015, the patient developed cellulitis at the injection site. The outcome of cellulitis at the injection site was unknown. Causality between cellulitis at the injection site and PNEUMOVAX 23 was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Got shot on 11/14, but arm was very sore. Went to urgent care on 11/30, and diagnosed with adhesive capsulitis.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site reaction
Clinical narrative: On 11/15/15, patient got the Flu and Pneumonia shots. He slept ok but a week later he had a reaction to the shots and he went to the ER.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Induration, Injection site pruritus, Peripheral swelling
Clinical narrative: (R) arm swollen, red, hot and indurated about the size of a 1/2 dollar. States that the site of injection is very itchy and has caused her increased fatigue. Will have follow up in office tomorrow 12/4/2015.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: (R) arm swollen, red, hot and indurated about the size of a 1/2 dollar. States that the site of injection is very itchy and has caused her increased fatigue. Will have follow up in office tomorrow 12/4/2015.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm at inj site tender to touch sl. swelling.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm at inj site tender to touch sl. swelling.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm at inj site tender to touch sl. swelling.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient presented to Emergency Room with was believed to be a reaction to medication. Patient had a redness at site of band aid that was applied to vaccine site as well as what appeared to be as hives per Emergency Room Physician.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Patient presented to Emergency Room with was believed to be a reaction to medication. Patient had a redness at site of band aid that was applied to vaccine site as well as what appeared to be as hives per Emergency Room Physician.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Condition aggravated, Congenital cystic kidney disease, Hepatobiliary scan, Ultrasound abdomen abnormal
Clinical narrative: This 73-year-old male subject was enrolled in a study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) on 8th April 2015. The subject received the 1st dose of Tdap vaccine (intramuscular) on 17th December 2014. Concurrent medical conditions included polycystic kidney. In May 2015, 30 days after receiving Zoster VZV-gE-AS01B and 152 days after receiving Tdap vaccine, the subject developed severe - grade 3 polycystic kidney. Serious criteria included hospitalization and GSK medically significant. The subject was treated with Acetaminophen-Oxycodone and fentanyl. The outcome of polycystic kidney was recovered/resolved on 2nd July 2015. The investigator considered that there was no reasonable possibility that the polycystic kidney may have been caused by Zoster VZV-gE-AS01B and Tdap vaccine. Relevant Tests: No relevant diagnostic tests. Investigator comment: Patient was admitted on 30 Jun 2015 for evaluation of possible acute cholecystitis. Patient was made NPO with intravenous fluids. Abdominal ultrasound imaging showed cholelithiasis and necessitated follow-up HIDA scan, which showed no acute cystic obstruction. Patient's diet was slowly advanced, which he tolerated well. Upon discharge on 02 Jul 2015 he no longer had any abdominal pain. The likely cause of his pain is due to his known polycystic kidney disease. No, discharged diagnosis is worsening of pain from polycystic kidney disease and acute cholelithiasis was ruled out for this admission.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: I got the new vaccine on October 13th and have numbness and tingle on hands and feet.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, pain, swelling to right deltoid area.
Age: 56.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 9/23 1:30 Pain / small lump size of a quarter at site. 9/23 7:30 increased pain / larger lump / redness (used ice). 9/24 6 am increasing pain / lump about the size of a baseball / hot to touch / red / slight fever / blood pressure elevated  145/90 (ice compresses regularly). 9/24 3 PM same symptoms / fever 100.4. 9/24 2 am same symptoms / fever 102.9 / BP 170/110. 9/24 same symptoms / diagnosed with cellulitis at injection site / blood cultures drawn at 2 sites / Vancomycin IV started. 9/26 or 9/27 blood cultures came back positive for staph and elevated WBC (14000), diagnosed with Sepsis, switched to Augmentin.
Age: 56.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site warmth, Pyrexia, Sepsis, Staphylococcus test positive, White blood cell count increased
Clinical narrative: 9/23 1:30 Pain / small lump size of a quarter at site. 9/23 7:30 increased pain / larger lump / redness (used ice). 9/24 6 am increasing pain / lump about the size of a baseball / hot to touch / red / slight fever / blood pressure elevated  145/90 (ice compresses regularly). 9/24 3 PM same symptoms / fever 100.4. 9/24 2 am same symptoms / fever 102.9 / BP 170/110. 9/24 same symptoms / diagnosed with cellulitis at injection site / blood cultures drawn at 2 sites / Vancomycin IV started. 9/26 or 9/27 blood cultures came back positive for staph and elevated WBC (14000), diagnosed with Sepsis, switched to Augmentin.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Haematochezia
Clinical narrative: 1 HOUR AFTER FLUMIST WAS RECEIVED SHE HAD AN URGENT SOFT BOWEL MOVEMENT WITH 2 PEA SIZED BLOOD CLOTS PRESENT AND WATER IN TOILET WAS RED WITH BLOOD AS DESCRIBED BY MOTHER.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash over abdomen, arms, and legs.  Rash was not itchy and was not raised. Patient was seen by a physician the next day and was given a steroid shots and cream. Patient stated that it took about a week for the rash to subside.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Pt reported sore spot and and rash on left arm and received rx prednisone and Famvir on 9/18. Rash spread to right inner arm and back. Pt also started Toprol xl 25mg on 8/11 2015. Dermatoligist felt rash was not shingles. Toprol stopped and rash subsided as of last report.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a female pharmacist referring to herself. The pharmacist was 27 weeks and 4 days pregnant (date of Last Menstrual Period (LMP): 04-MAY-2015), reported that while administering ZOSTAVAX (dose and lot# not reported) to an unspecified patient on 13-NOV-2015, some of the reconstituted product leaked onto her own skin. The pharmacist stated that she did not experience any adverse symptoms due to this exposure. This is two of reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Haematoma, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a 22 year old female patient. The patient's medical history, drug allergies/reactions and concurrent conditions were not reported. The patient was not pregnant. Approximately in October 2015 (reported as 1 month ago), the patient was vaccinated with one shot of GARDASIL in the left deltoid region. No information on concomitant medications was provided. Approximately in October 2015 (reported as 1 month ago), the patient experienced soreness around the injection site after receiving the shot. The patient received medical attention at the nurse practitioner's office and the patient continues to have soreness (3cm) and hematoma (or spot) was identified. No treatment was given for the events. The patient stated that it was very painful when she rolled on it and she gets a pain in her left arm. The patient had full range of motion. The outcome of the events was reported as not recovered/not resolved. The relatedness of the events with GARDASIL was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Burning sensation, Generalised erythema, Hypersensitivity, Pruritus generalised, Rash generalised
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic reaction in a 25-year-old male patient who received MENVEO (batch number M14071, expiry date unknown). On 22nd January 2015 14:40, the patient received MENVEO (intramuscular) .5 ml. In January 2015, 15 hrs 20 min after receiving MENVEO, the patient experienced allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria. The patient was treated with SOLU MEDROL and BENADRYL (nos). On 23rd January 2015, the outcome of the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalizes urticaria were recovered/resolved. It was unknown if the reporter considered the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria to be related to MENVEO. Additional details were received as follows: On 22nd January 2015, at 2:40 pm, the patient received a dose of MENVEO. On 23rd January 2015, at 6 am, the patient wake up with allergy, all over body rash, itching, burning sensation, urticaria when he scratch his skin and specially when he had contact with cold water. On 23rd January 2015, at 11:30. 5 hours and 30 minutes after starting the events, the patient was recovered. The patient visited to emergency room but was not admitted for prolonged time. On 23rd January 2015, at 11:30 the patient was recovered.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic reaction in a 25-year-old male patient who received MENVEO (batch number M14071, expiry date unknown). On 22nd January 2015 14:40, the patient received MENVEO (intramuscular) .5 ml. In January 2015, 15 hrs 20 min after receiving MENVEO, the patient experienced allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria. The patient was treated with SOLU MEDROL and BENADRYL (nos). On 23rd January 2015, the outcome of the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalizes urticaria were recovered/resolved. It was unknown if the reporter considered the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria to be related to MENVEO. Additional details were received as follows: On 22nd January 2015, at 2:40 pm, the patient received a dose of MENVEO. On 23rd January 2015, at 6 am, the patient wake up with allergy, all over body rash, itching, burning sensation, urticaria when he scratch his skin and specially when he had contact with cold water. On 23rd January 2015, at 11:30. 5 hours and 30 minutes after starting the events, the patient was recovered. The patient visited to emergency room but was not admitted for prolonged time. On 23rd January 2015, at 11:30 the patient was recovered.
Sex: F
Vaccine: RAB
Symptoms: Adverse reaction, Nervousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced adverse reaction and nervous. On an unknown date, the outcome of the adverse reaction and nervous were unknown. It was unknown if the reporter considered the adverse reaction and nervous to be related to RABAVERT. Additional details were provided as follows: After vaccination with RABAVERT, the patient experienced strange reactions (adverse reaction) and the vaccines was making her very nervous. The patient refused to provide any clarification regarding the reported events. No additional information was obtained including lot number and expiration date as the patient refused to provide information for the report.
Age: 67.0
Sex: F
Vaccine: PNC, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received BOOSTRIX (batch number JT494, expiry date 3rd April 2016). Concomitant products included PREVNAR. On 20th November 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In November 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site pain, injected limb mobility decreased and stiffness. On an unknown date, the outcome of the injection site pain and stiffness were recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the injection site pain, injected limb mobility decreased and stiffness to be related to BOOSTRIX. Additional details provided were as follows: On 20th November 2015, at 11:47 am, the patient received a dose of BOOSTRIX in her left deltoid. In November 2015, less than a week after vaccination, the patient complained of soreness, stiffness and decreased range of motion in her left arm. Also the patient was not able to dress properly due to the events. On the same day, the patient also concomitantly received a dose of PREVENAR in her right deltoid.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 30-NOV-2015, the patient was vaccinated with one dose of improperly stored PNEUMOVAX 23 (lot # K020215, expiry date: 15-MAY-2016) (dose, route unknown). No adverse effects were reported. Product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding multiple, unspecified patients of unknown demographics. There was no information about concurrent condition. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L006386, expiration date- 25-FEB-2017, lot # L018002, expiration date- 19-MAY-2017 and lot # L021215, expiration date- 10-JUN-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after receiving 4th vaccine which was the HPV, patient fainted.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 30 min post vaccine - itchiness at vaccine site & headache.  1hr post - tennis ball size swelling at vaccine site. Hot to the touch. Administered Prednisone 10mg and Aleve. 12/2 swelling still present. Cold packed. 12/3/15 golf ball size swelling at vaccine site still hot to the touch.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient (reporter's wife) of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 24-NOV-2015, the patient was administered with a dose of ZOSTAVAX (lot, expiry date unknown, dose unknown) intramuscular rather than subcutaneously in the arm. Concomitant medications were not reported. On an unknown date in November 2015, the patient's arm became very sore. No treatment was rendered for the event. The action taken with the vaccine was not applicable. The outcome of the event pain in arm was resolving (reported as pain has begun to subside). Product quality complaint was not filed. Causality assessment was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis infective, Surgery
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. No information on patient's medical history or concurrent conditions was provided. On 19-JUN-2015 and 20-JUL-2015, the patient was respectively vaccinated with dose 1 and 2 of RECOMBIVAX HB injection, 10 microgram/ml, adult formulation, lot # L000717, intramuscularly (dose and expiration date were not reported). On 20-OCT-2015 (reported as "approximately six weeks ago"), the patient had an unspecified surgery for unspecified reason and afterwards developed a hip infection (in 2015, dates and details unspecified). The patient was on intravenous ANCEF (manufacturer unknown) therapy from her treating physician and would start BACTRIM (also reported as manufacturer unknown) in about two weeks from the time of the report. The outcome of the adverse events was reported as not recovered. The causality between the adverse events and RECOMBIVAX HB was not provided. Upon internal review, unspecified surgery was determined to be medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Dizziness, Heart rate abnormal, Heart rate increased, Skin warm
Clinical narrative: Rapid and heavy heart beat, tight chest, dizziness, no fever but incredibly hot to the touch.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Fatigue, malaise, low fever (100+), frontal headache for 36 hours.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain from elbow to shoulder, hurt to move it.  No redness or swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Rash
Clinical narrative: Rash, severe myalgia.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Malaise, Pyrexia, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Became ill several hours after the Flumist with fever to 105.2, rhinorrhea, cough, vomiting, mild tonsillitis.  Lasted four days.  Seen twice by me (PCP) during that time.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Tonsillitis, Vomiting
Clinical narrative: Became ill several hours after the Flumist with fever to 105.2, rhinorrhea, cough, vomiting, mild tonsillitis.  Lasted four days.  Seen twice by me (PCP) during that time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Patient's husband states she has itchy sores on her back that look like chicken pox.  They are not getting any worse but not getting any better.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Vomited within 5 minutes after receiving FluMist.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse symptoms.
Age: 19.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Eye swelling, Injection site pain
Clinical narrative: Had swelling to left eye and severe pain at injection site. Was sent to ER and received epinephrine. Sent home with Zantac, prednisone, and Benadryl. Doing much better.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Top of the right hand swelled, severe pain top of hand, small hard bumps on chest and back.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Limb discomfort, Pain
Clinical narrative: Deep (L) deltoid muscle pain with increase on elevation of arm - feels heavy at times in muscle area. Pain when reaching to pick up items.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Culture throat negative, Cytomegalovirus test negative, Decreased appetite, Epstein-Barr virus antibody negative
Clinical narrative: Headache 11/23-25. Sore throat 11/25-27. Fever 11/25, none 11/26 but fever 11/27-11/30. Malaise, loss of appetite, cough (minimal). ER 11/27 and 11/28. Office visits 11/27, 11/30.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza virus test negative, Malaise, Mononucleosis heterophile test negative, Mycoplasma test
Clinical narrative: Headache 11/23-25. Sore throat 11/25-27. Fever 11/25, none 11/26 but fever 11/27-11/30. Malaise, loss of appetite, cough (minimal). ER 11/27 and 11/28. Office visits 11/27, 11/30.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Headache 11/23-25. Sore throat 11/25-27. Fever 11/25, none 11/26 but fever 11/27-11/30. Malaise, loss of appetite, cough (minimal). ER 11/27 and 11/28. Office visits 11/27, 11/30.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt given HPV #2, Hep A 2nd dose, pt. gradually laid down displaying brief syncope episode. PT was assisted down, vitals taken every 10 min. All V/S were within normal limits. Patient was left alone 1 hr after episode. Monitored frequently by dr. Patient was doing well.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: After flu vaccine given, patient complained of itching at the injection site approx 10 min after injection. Pt was given an ice pack.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Nausea, Pyrexia, Tremor
Clinical narrative: Nausea. Mild fever like sx. Shaky, clammy, dizzy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient developed increased sweating and dizziness.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: H.D. FLUZONE admin 9-17-15, pt states "didn't feel that at all" aware of soreness up to 2-3 days post vaccination. As of 12-2-15; pt comes to clinic reports "flu shot still hurts my arm" states "like a toothache in that "spot" "no where else, no problems, no numbness, no weakness, no bruising, no knots, just aches off and on for days at anytime, awoke me lip and chins at 3 am. Took ADVIL. Very localized pain to spot where hot given. Been 2 1/2 months aching so thought I'd tell someone.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 58 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Asthenia, Back pain, Cold sweat, Decreased appetite, Diarrhoea
Clinical narrative: After last appt, about 12 hours later, starting with room spinning vertigo. Laid down and slept for 24 hours. Got up, drank some water and then vomited. Has had very poor appetite, low back started hurting, feeling chilled, clammy then started with diarrhea. Has no strength. Has been able to keep down water today and a little diet pepsi.
Age: 56.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Feeling cold, Vertigo, Vomiting
Clinical narrative: After last appt, about 12 hours later, starting with room spinning vertigo. Laid down and slept for 24 hours. Got up, drank some water and then vomited. Has had very poor appetite, low back started hurting, feeling chilled, clammy then started with diarrhea. Has no strength. Has been able to keep down water today and a little diet pepsi.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Acne, Immediate post-injection reaction, Pruritus
Clinical narrative: Consistant break out of puss filled pimple type rash that itches unbearably for over a year since original outbreak immediately after vaccination of November 7th, 2014 administered by Dr at Clinic - Referred to another clinic for triamcinolone treatment with limited results - Currently suffering with condition a year later.
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a female patient who received Seasonal Influenza vaccine. Previously administered products included Seasonal influenza vaccine with an associated reaction of cough (experienced every year after receiving flu vaccine) and Seasonal influenza vaccine with an associated reaction of bronchitis (experienced every year after receiving flu vaccine). On an unknown date, the patient received Seasonal influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced bronchitis and cold. On an unknown date, the outcome of the bronchitis and cold were unknown. It was unknown if the reporter considered the bronchitis and cold to be related to Seasonal Influenza vaccine. Additional details were received as follows: The reporter was a friend or caregiver of the patient. Every year the patient received Flu vaccine and experienced cold and bronchitis. The patient recently received an annual dose of Flu vaccine and experienced cold and bronchitis. The reporter declined to provide any further details. This case was linked with case US2015GSK170888, reported for VENTOLIN HFA for the same patient.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to approximately 25 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose and route were not reported, lot # K019560, expiration date: 02-JUN-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # J013729, expiry date: 30-OCT-2015) (dose, route unknown). No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-NOV-2015, the patient was inadvertently administered an expired dose of PROQUAD (Merck) (exact dose and route were not reported, lot # K007797, expiration date: 29-NOV-2015). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 06-NOV-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2015) that was improperly stored. No adverse effects was reported. The primary reporter reported that these doses were administered following an excursion of 14F from 28-AUG-2015 through 17-NOV-2015. This is one of 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 29-SEP-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L019130, expiration date 27-MAY-2015) that was improperly stored. No adverse effects were reported. The primary reporter reported that these doses were administered following an excursion of 14F from 28-AUG-2015 through 17-NOV-2015. This is one of 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 03-SEP-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX with (lot # K021935, expiration date 10-NOV-2015 or lot # L019130, expiration date 27-MAY-2015) that was improperly stored. The reporter could not specify the lot number of (Oka/Merck) VARIVAX was administered additionally to the patient. It was reported that these dose were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple, unspecified patients of unknown demographics. There was no information about concurrent condition. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L005293, expiration date- 17-AUG-2016, lot # L014401, expiration date- 23-OCT-2016 and lot # L024122, expiration date- 30-DEC-2016. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple, unspecified patients of unknown demographics. There was no information about concurrent condition. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX lot # L013546, expiration date- 17-JUL-2016, lot # L016283, expiration date- 07-AUG-2016 and lot # L016284, expiration date- 07-AUG-2016 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a vaccine coordinator via field representative refers to an unknown number of patients. On an unknown date, the unknown number of patients was vaccinated with MMR II (dose and frequency were unknown). It was reported that the MMR II vaccine shot was more painful that the PROQUAD (Oka-Merck). It was not specified what she meant by more painful. It was reported that the patients completed the dosing regimen. The reporter did not specify when she noticed the pain on the specified patients. The patient sought medical attention and no treatment was provided for the event. The outcome of event was reported as recovered/resolved. The causality of the event was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Headache, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report received from a nurse, refers to a 14 years old female patient. The patient had no pertinent medical history or drug allergies. On 28-JUL-2014, the patient received the first dose of GARDASIL (0.5ml, once), intramuscularly. The patient received the second dose of GARDASIL on 06-JUL-2015 (reported as 'did not receive the second dose until 06-JUL-2015'). The patient did not experience any adverse events to the first two doses of the series. On 14-NOV-2015 the patient was vaccinated with the third dose of GARDASIL, (lot # J007850), Expiry: 07-APR-1016) in the right arm. Concomitant therapy included CLARITIN. On the same day, the patient experienced 5 cm swelling in the deltoid muscle of the right arm around the injection site. On 17-NOV-2015, the patient went to the physician's office with the event. The area was found to be flushed and was very tender to palpation. There were no hives or flushing on any other area of the body. On an unknown date in November 2015 the patient also experienced low grade fever and headache. No lab tests were performed. The physician advised the patient to apply ice packs in the affected area and to take ADVIL or TYLENOL as needed for pain and if the symptoms did not improved. The action taken with the vaccine was not applicable. The outcome of all events were unknown. No product quality issue was involved. The causality of the events were not assessed by the reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a nurse, refers to a 14 years old female patient. The patient had no pertinent medical history or drug allergies. On 28-JUL-2014, the patient received the first dose of GARDASIL (0.5ml, once), intramuscularly. The patient received the second dose of GARDASIL on 06-JUL-2015 (reported as 'did not receive the second dose until 06-JUL-2015'). The patient did not experience any adverse events to the first two doses of the series. On 14-NOV-2015 the patient was vaccinated with the third dose of GARDASIL, (lot # J007850), Expiry: 07-APR-1016) in the right arm. Concomitant therapy included CLARITIN. On the same day, the patient experienced 5 cm swelling in the deltoid muscle of the right arm around the injection site. On 17-NOV-2015, the patient went to the physician's office with the event. The area was found to be flushed and was very tender to palpation. There were no hives or flushing on any other area of the body. On an unknown date in November 2015 the patient also experienced low grade fever and headache. No lab tests were performed. The physician advised the patient to apply ice packs in the affected area and to take ADVIL or TYLENOL as needed for pain and if the symptoms did not improved. The action taken with the vaccine was not applicable. The outcome of all events were unknown. No product quality issue was involved. The causality of the events were not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown dates, the unspecified number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# L026411, expiry date: 15-FEB-2017; lot# L015047, expiry date: 29-APR-2017; lot# L010144, expiry date: 24-MAR-2017). No adverse effects were reported. It was also reported that MMR II appears on the product list because stability questions were asked about this product but no doses of improperly stored MMR II were administered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2015, the patient accidentally received a dose of VARIVAX (Merck) (dose, route, therapy type, lot number unknown) instead of ZOSTAVAX. No adverse effects were reported. No product quality complaint was filled. Additional information has been accidentally.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pruritus generalised, Throat irritation, Urticaria
Clinical narrative: Night of vaccine administration - client reports hives; itching all over, eyes, throat itching.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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. Since 11-OCT-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (lot # L001329 and expiration date 13-JAN-2017, exact doses and route of administration were not reported). No adverse effects 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: 40.0
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Pt complains of numbness and tingling in arm with limited range of motion. Still warm. Pt reports arm hurt for 2 weeks.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 102 after imms.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L016283, expiry date: 07-AUG-2016) (incorrect product storage). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1512USA001180 (same reporter link). 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 nurse and refers to approximately 25 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (exact dose and route were not reported, lot # K016314, expiration date: 05-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 83 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Erythema, Local reaction, Pain, Pyrexia
Clinical narrative: Local rxn - redness, warm and pain. Systemic rxn - fever and chills.
Age: 51.0
Sex: U
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Local rxn - redness, warm and pain. Systemic rxn - fever and chills.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 25 year old patient of unknown gender. On 10-AUG-2015 and 13-OCT-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # L010596, expiration date; 06-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Presented 24 hours later with red rash at injection site - was told to monitor - if worsened to seek medical attention. MD called 48 hours later to say the patient had a fever and cellulitis. Prescribed the appropriate medications.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX on 19-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report wad received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 0-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 26-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset and were narrative updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX on 20-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX on 06-AUG-2015. This was one of several reports received from the same reporter. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.