chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Erythema, Headache, Hyperhidrosis, Malaise
Clinical narrative: 5/16/2015: Saturday had hives and itching on hands/feet and abdomen. Hives, mostly on feet and hands, some on upper abdomen. Hands and feet are red and slightly swollen. 05/17/2015: Saturday, throat red, raw, sore, malaise, headache, body aches. Sunday, temp up to 101-102. 5/18/2015: Woke today very diaphoretic, sheets were soaked.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Peripheral swelling, Pharyngeal erythema, Pruritus
Clinical narrative: 5/16/2015: Saturday had hives and itching on hands/feet and abdomen. Hives, mostly on feet and hands, some on upper abdomen. Hands and feet are red and slightly swollen. 05/17/2015: Saturday, throat red, raw, sore, malaise, headache, body aches. Sunday, temp up to 101-102. 5/18/2015: Woke today very diaphoretic, sheets were soaked.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: 5/16/2015: Saturday had hives and itching on hands/feet and abdomen. Hives, mostly on feet and hands, some on upper abdomen. Hands and feet are red and slightly swollen. 05/17/2015: Saturday, throat red, raw, sore, malaise, headache, body aches. Sunday, temp up to 101-102. 5/18/2015: Woke today very diaphoretic, sheets were soaked.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Heart rate increased, Injection site pain, Myalgia
Clinical narrative: Far more than expected ache/pain in right arm (injection site), right leg, right foot, left arm muscles, and all joints. Severe fatigue. Some elevated heart rate. 36 hours duration.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Far more than expected ache/pain in right arm (injection site), right leg, right foot, left arm muscles, and all joints. Severe fatigue. Some elevated heart rate. 36 hours duration.
Age: 48.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Pruritus, Rash
Clinical narrative: The day after shots, started out itching on both shoulders, then both arms. Two days after shots, bumps appreared on forearms with itching. The itching spread to my hand, also with bumps forming. Now forearms and hands itch with bumps.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt felt faint, was pale and diaphoretic, no seizure like movements per father, was observed 20 min post incident pt felt fine, parents took her home.
Age: 43.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Fatigue, Malaise, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Symptom of sore throat began the evening of vaccination on 05/13/15 then by mid-day 05/14/15 employee developed symptoms of low grade fever, malaise, muscle aches, and fatigue.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Chills, shaking, high fever, nausea, body aches, severe fatigue, pain at injection site, redness and swelling at injection site....injection site and about 5 inches around it was hard and hot.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Chills, shaking, high fever, nausea, body aches, severe fatigue, pain at injection site, redness and swelling at injection site....injection site and about 5 inches around it was hard and hot.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Chills, shaking, high fever, nausea, body aches, severe fatigue, pain at injection site, redness and swelling at injection site....injection site and about 5 inches around it was hard and hot.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Patient received immunization, reported feeling a little dizzy and became pale. Client then leaned forward, was supported by vaccine administrator, experienced syncope for approximately 1 minute and aroused on own and was alert to time and place. Placed cool towel on neck and observed client for 15 minutes. At that time, client's color returned to normal, lips returned to pink color. Client expressed desire to leave and was ok.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Laboratory test, Rash
Clinical narrative: Severe R Flank pain.
Age: 24.0
Sex: M
Vaccine: HEP, HPV4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Rash appeared at the localized injection site on right deltoid area (size of palm of hand).  Patient states she experienced some itch, redness, and that the area feels hot to the touch.  Patient also reports a fever and sore arm and that Tylenol provided relief.
Age: 24.0
Sex: M
Vaccine: HEP, HPV4, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Rash appeared at the localized injection site on right deltoid area (size of palm of hand).  Patient states she experienced some itch, redness, and that the area feels hot to the touch.  Patient also reports a fever and sore arm and that Tylenol provided relief.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Amenorrhoea, Dysmenorrhoea, Menorrhagia
Clinical narrative: Menstruation began not long after vaccine. Bleeding was heavy and cramping was very painful. This went on for over a year. Her periods then stopped completly. She now has to take hormones for her period to begin. I feel she will have problems conceiving when she decides to so. This is something that is going to effect her for the rest of her life.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness at site, swollen, low grade fever, headache and mentioned some heart issue.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient in office, received 4 month old vaccines. Twenty minutes after receiving Rotateq vaccine, patient vomited. Patient vomited a total of 7 times.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Headache, Pyrexia, Rash
Clinical narrative: Pt notices he had night chills, headache and a low fever the night of onset. Pt had headache and chills the next day when he woke up fever was still present. Pt was waiting for a flight, on the plane he notices his face got red and started noticing bumps on his face. When he arrived he took a shower and felt shivering and a really bad headache and he noticed more bumps on his face and his neck. That same day at 1630 he spoke with a medical provider.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Renal failure
Clinical narrative: Skin itching and progressive renal failure.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Dry skin, Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: 14:00 hours: bilateral foot/toe itching and discomfort; bilateral swelling of upper feet and toes; slight stiffness of tarsals; slight skin discoloration along arch lines and upper feet near the toes. 16:00 hours: Treatment of feet with Lotrimin AF spray [believing onset of tinea pedis]. 15:30 hours: No reversal of bilateral swelling of the feet and toes after antifungal application. Swelling continues, pustules populate upper feet, and rough/sticky skin starts to arise along top and bottom of feet. 20:00 hours: Feet and toes covered with pustules. Sought treatment from primary physician and frequent urgent care visits.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash pustular, Skin discolouration
Clinical narrative: 14:00 hours: bilateral foot/toe itching and discomfort; bilateral swelling of upper feet and toes; slight stiffness of tarsals; slight skin discoloration along arch lines and upper feet near the toes. 16:00 hours: Treatment of feet with Lotrimin AF spray [believing onset of tinea pedis]. 15:30 hours: No reversal of bilateral swelling of the feet and toes after antifungal application. Swelling continues, pustules populate upper feet, and rough/sticky skin starts to arise along top and bottom of feet. 20:00 hours: Feet and toes covered with pustules. Sought treatment from primary physician and frequent urgent care visits.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pt stated he received a rash in the hip area at least 1 week after vaccination.  Pt stated the rash cleared on its own without seeking medical attention.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Large, hard inflammatory skin response around injection site continued 3 days after injection; size/shape approx that of a slice of cheese, red, hard, warm, painful reported to pharmacy afternoon of 5/16. Patient instructed to use cool compresses, anti-inflammatory med, and diphenhydramine, and she was instructed to follow-up with dr with it continued.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist on behalf of a nurse via company representative refers to a 60 year old female patient. No pertinent medical history was reported. On 11-MAY-2015, the patient was vaccinated with PNEUMOVAX 23 of lot number: K012424 and expiry date: 05-JUN-2016 (dose and route of administration was not reported) in unspecified arm. No concomitant medications were reported. On 12-MAY-2015, the patient sought medical attention at the office of physician as the arm in which PNEUMOVAX 23 was administered was swollen, red and puffy from shoulder to elbow. The patient was advised to seek additional medical treatment at the emergency room on 12-MAY-2015 and she was admitted. The outcome of the reported events was unknown. The causality was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site injury, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site injury in a 58-year-old male patient who received FLUARIX. Concomitant products included CRESTOR. In November 2014, the patient received FLUARIX (intramuscular). In November 2014, less than a month after receiving FLUARIX, the patient experienced injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain. The patient was treated with NAPROSYN. On an unknown date, the outcome of the injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain were recovering/resolving. The reporter considered the injection site injury, injection site inflammation, muscle weakness upper limb and muscle pain to be almost certainly related to FLUARIX. Additional details provided as follows: The patient reported that he now knows that since receiving FLUARIX he has developed a chronic problem with his left deltoid. He clarified this problem as an injury. He often lifts weights vigorously and the FLUARIX has caused him not to be able to lift like he normally can. The injured area was inflamed and it has been hurting. The patient in particular has problem lifting weights that involves overhead movements. He has been seeing a physical therapist at least three times a week, has been self-medicating with NAPROSYN, and has been stretching. It does now seem better since beginning physical therapy. They have told him that the injury was with the middle deltoid tendon and a little bit of the interior. The reporting physician was wondering if there was an alternative route of administration because he does not plan on receiving in the deltoid again.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician via field representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL, (intramuscular, strength, dose number, lot# and dose were unknown). On an unknown date the patient experienced facial numbness after GARDASIL injection. The patient sought medical attention via phone call. The outcome of facial numbness was unknown. The relationship of facial numbness and GARDASIL was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy on 5/14/15 at 5:45 pm and said she has a rash on arm where I had injected ZOSTAVAX 2 days earlier. There is a small rash about 2" x 1" around injection site. Little warm to touch but not hard or swollen. I had her buy BENADRYL and told her to take one capsule every 6 hours and to call me in the morning and let me know if that helped the rash.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site cellulitis, Skin discolouration
Clinical narrative: Mother first noticed mild erythema and duration 5-06-15 and does not recall the time she became concerned 5-09-15 when it increased in size, duration and became purple in color. Pt was seen 5-10-15 by Dr who prescribed ABX x 10 days. Dx of cellulitis in (L) lateral thigh mid.
Age: 46.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Urticaria
Clinical narrative: Pt with urticarial rash to face progressed to body in 2 days given Pred taper, ZYRTEC and ZANTAC.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Anxiety, Disorientation, Dizziness, Dyspnoea, Eating disorder
Clinical narrative: 12pm - felt disoriented, didn't feel well, dizzy and had not eaten well. 9pm - trouble breathing, anxiety, and felt throat closing. Was taken to ER. At ER fluids were given. Also, medication to relax him and BENADRYL.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Malaise, Throat tightness
Clinical narrative: 12pm - felt disoriented, didn't feel well, dizzy and had not eaten well. 9pm - trouble breathing, anxiety, and felt throat closing. Was taken to ER. At ER fluids were given. Also, medication to relax him and BENADRYL.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash erythematous
Clinical narrative: 3 cm area of induration and erythema surrounding right thigh injection site with faint reticular non blanching erythematous rash behind ears, cheeks, trunk, arms, no vesicle, no crusting.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Full blood count normal, Headache
Clinical narrative: Fatigue. Dizziness. Myalgia, headache, weakness next day of receiving MENACTRA.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Metabolic function test normal, Myalgia, Thyroid function test normal
Clinical narrative: Fatigue. Dizziness. Myalgia, headache, weakness next day of receiving MENACTRA.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practioner referring to six unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (strength, lot#, route and dose were unknown). No adverse events were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient had a fainting episode for few sec right after the immunizations Tdap - MENACTRA with sweats and pallor. He recovered immediately but was tired with dizziness for 1 hour after fainting.
Age: 54.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Muscle tightness
Clinical narrative: Redness at injection sites, pain from injection sites down to elbow and muscle tightness.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Circumferential redness and pain and swelling in the upper arm - both shots given in left arm.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M decreased
Clinical narrative: Information has been received from a 25 year old female healthcare student referring to herself. There were no pertinent medical history and drug reactions or allergies. Because the patient was enrolling in the medical school, on 04-FEB-2015, she was vaccinated with the first dose of (Merck) VARIVAX (dose and route were unknown). On 09-MAR-2015 the patient was vaccinated with the second dose of (Merck) VARIVAX (dose and route were unknown). There were no concomitant medications. On 21-APR-2015, her titers were drawn, and the values of her immunoglobulin m (IgM) and immunoglobulin g (IgG) were both "less than 135)". The outcome and causality between (Merck) VARIVAX and the events were unknown. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Pain
Clinical narrative: Pt woke up in middle of night on 5/14/15 with temp to 102 and severe body aches.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site bruising
Clinical narrative: Bruising (L) deltoid. Localized rxn. 4 days after vaccine. No abx needed - to date - will follow.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Face injury, Fall, Syncope, Tremor
Clinical narrative: Fainted (syncope) after received vaccines walked out to parking lot fell and hit face on concrete per mother was shaking. Brought into office was alert.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration
Clinical narrative: Had large area of erythema and induration over left arm.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bone pain, Injection site reaction, Myalgia
Clinical narrative: Information has been received from a pharmacist referring to a 56 year old female patient with fibromyalgia, lumbosacral disk degeneration and no drug allergies. On 30-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009809, expiration date 16-MAY-2015, intramuscular; dose not reported). Concomitant therapies included AFLURIA which was vaccinated in the other arm on the same day, potassium, CYMBALTA, PERCOCET, FIORICET, LUNESTA, VALIUM, FLEXERIL, LASIX, PRILOSEC, ropinirole, LIPITOR, LYRICA, pilocarpine and ZESTRIL. Later the same day (30-SEP-2014) the patient began to have "throbbing pain down through the muscle and bone" at the injection site of PNEUMOVAX 23. The patient sought medical attention by calling the pharmacist. No treatment was given for the event and no lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bone pain, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to a 56 year old female patient with fibromyalgia, lumbosacral disk degeneration and no drug allergies. On 30-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K009809, expiration date 16-MAY-2015, intramuscular; dose not reported). Concomitant therapies included AFLURIA which was vaccinated in the other arm on the same day, potassium, CYMBALTA, PERCOCET, FIORICET, LUNESTA, VALIUM, FLEXERIL, LASIX, PRILOSEC, ropinirole, LIPITOR, LYRICA, pilocarpine and ZESTRIL. Later the same day (30-SEP-2014) the patient began to have "throbbing pain down through the muscle and bone" at the injection site of PNEUMOVAX 23. The patient sought medical attention by calling the pharmacist. No treatment was given for the event and no lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Discomfort, Impaired work ability, Inflammation, Injection site bruising, Injection site erythema
Clinical narrative: Pt called to let us know yesterday 5/14/15 she noticed her right thigh where she got the Pneumococcal vaccine was swollen. Pt states she left work early due to her leg feeling stiff/swollen. Pt got home and her temperature was 101. Pt followed up with her PCP and was given a antibiotic injection. Pt states she is unable to put weight on her leg at all due to pain. Pt is taking ibuprofen PRN for pain and ZYRTEC for inflammation. Pt is concerned due to the high fever she has been experiencing and the diameter of the swollen spot from the vaccine. Spoke with Dr and he is going to call the pt to FU. Called patient to check on her status this morning. She is on AVONEX in the Vaccine Study. Reviewed the sequence of events with patient. On 5/13/15 noted mild pain and redness the size of a dime at the PNEUMOVAX injection site on right lateral thigh. She reports the pain increased and she was very uncomfortable sitting down at work, so went home. She took her temperature and it was 101 degrees and at that time the area was greater than a quarter size. She took ADVIL, TYLENOL and hydrated. She was evaluated by her PCP on 5/15/15 and the injection reaction area grew to 3-4 inches in diameter. Her PCP told her to take BENADRYL 50mg and continue ADVIL and elevate the right leg. She was advised if the area grew larger to call back. She started KEFLEX 500mg po BID for 10 days. Her fever then went up to 102.6 and grew larger. Then 2 hours later went back to PCP and was given ROCEPHIN IM (5/15/15). The next day (5/16/15) the injection site area grew larger, increasing in redness, swelling and pain. She noted ecchymosis in the center of the reaction and her PCP advised  her to go to ER. She was given Vancomycin IV 350 over 2 hours. She reports labs were done and WBC were slightly elevated. She started a Rx of BACTRIM DS one po bid(5/16/15) and then discharged home. Spoke to her this AM and she reports it has grown a bit larger with a "funky bruise" color; however, no fever, less painful and mildly swollen. Advised to follow up with PCP for evaluation and follow up with me afterwards.
Age: 34.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt called to let us know yesterday 5/14/15 she noticed her right thigh where she got the Pneumococcal vaccine was swollen. Pt states she left work early due to her leg feeling stiff/swollen. Pt got home and her temperature was 101. Pt followed up with her PCP and was given a antibiotic injection. Pt states she is unable to put weight on her leg at all due to pain. Pt is taking ibuprofen PRN for pain and ZYRTEC for inflammation. Pt is concerned due to the high fever she has been experiencing and the diameter of the swollen spot from the vaccine. Spoke with Dr and he is going to call the pt to FU. Called patient to check on her status this morning. She is on AVONEX in the Vaccine Study. Reviewed the sequence of events with patient. On 5/13/15 noted mild pain and redness the size of a dime at the PNEUMOVAX injection site on right lateral thigh. She reports the pain increased and she was very uncomfortable sitting down at work, so went home. She took her temperature and it was 101 degrees and at that time the area was greater than a quarter size. She took ADVIL, TYLENOL and hydrated. She was evaluated by her PCP on 5/15/15 and the injection reaction area grew to 3-4 inches in diameter. Her PCP told her to take BENADRYL 50mg and continue ADVIL and elevate the right leg. She was advised if the area grew larger to call back. She started KEFLEX 500mg po BID for 10 days. Her fever then went up to 102.6 and grew larger. Then 2 hours later went back to PCP and was given ROCEPHIN IM (5/15/15). The next day (5/16/15) the injection site area grew larger, increasing in redness, swelling and pain. She noted ecchymosis in the center of the reaction and her PCP advised  her to go to ER. She was given Vancomycin IV 350 over 2 hours. She reports labs were done and WBC were slightly elevated. She started a Rx of BACTRIM DS one po bid(5/16/15) and then discharged home. Spoke to her this AM and she reports it has grown a bit larger with a "funky bruise" color; however, no fever, less painful and mildly swollen. Advised to follow up with PCP for evaluation and follow up with me afterwards.
Age: 34.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Peripheral swelling, Pyrexia, Weight bearing difficulty, White blood cell count increased
Clinical narrative: Pt called to let us know yesterday 5/14/15 she noticed her right thigh where she got the Pneumococcal vaccine was swollen. Pt states she left work early due to her leg feeling stiff/swollen. Pt got home and her temperature was 101. Pt followed up with her PCP and was given a antibiotic injection. Pt states she is unable to put weight on her leg at all due to pain. Pt is taking ibuprofen PRN for pain and ZYRTEC for inflammation. Pt is concerned due to the high fever she has been experiencing and the diameter of the swollen spot from the vaccine. Spoke with Dr and he is going to call the pt to FU. Called patient to check on her status this morning. She is on AVONEX in the Vaccine Study. Reviewed the sequence of events with patient. On 5/13/15 noted mild pain and redness the size of a dime at the PNEUMOVAX injection site on right lateral thigh. She reports the pain increased and she was very uncomfortable sitting down at work, so went home. She took her temperature and it was 101 degrees and at that time the area was greater than a quarter size. She took ADVIL, TYLENOL and hydrated. She was evaluated by her PCP on 5/15/15 and the injection reaction area grew to 3-4 inches in diameter. Her PCP told her to take BENADRYL 50mg and continue ADVIL and elevate the right leg. She was advised if the area grew larger to call back. She started KEFLEX 500mg po BID for 10 days. Her fever then went up to 102.6 and grew larger. Then 2 hours later went back to PCP and was given ROCEPHIN IM (5/15/15). The next day (5/16/15) the injection site area grew larger, increasing in redness, swelling and pain. She noted ecchymosis in the center of the reaction and her PCP advised  her to go to ER. She was given Vancomycin IV 350 over 2 hours. She reports labs were done and WBC were slightly elevated. She started a Rx of BACTRIM DS one po bid(5/16/15) and then discharged home. Spoke to her this AM and she reports it has grown a bit larger with a "funky bruise" color; however, no fever, less painful and mildly swollen. Advised to follow up with PCP for evaluation and follow up with me afterwards.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) referring to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 05-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, lot # K012874, expiration date 09-JUN-2016 (dose not provided), intramsucularly, which underwent a supported temperature excursion. The patient sat for 15 minutes following vaccination. Co-suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Syncope
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. This spontaneous report was received from a registered nurse and concerns a 47 year old female; Local case ID: 98-008. The subject's weight, height and medical history were not reported. The subject received VIVOTIF (typhoid vaccine oral ty21a) (capsule, hard, oral, batch 0150511A) on 21-JUL-1998 prior to dinner as prophylactic vaccination. Concomitant medications included hepatitis A vaccine and diphtheria/tetanus vaccine for prophylactic vaccination. On 22-JUL-1998, 1 day after starting typhoid vaccine oral ty21a the subject fainted and was taken to the emergency room. Action taken with typhoid vaccine oral ty21a was not reported. The subject had recovered from faint on an unspecified date. The reporter considered the subject's faint to be not related to vaccine. This report was serious (hospitalization). This case follow up information was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. Additional information was received on 23-JUL-1998. Additional reference numbers VIV-9827, SBV020 and Regulatory authority number 119296 were added to the case.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye inflammation, Sudden visual loss
Clinical narrative: Case number PHEH2015US009021 is a combined initial and follow spontaneous report from a health care professional and patient's mother (who is also a pediatrician) via medical information received on 07 May 2015. This report refers to a 15-year-old male patient. His medical history did not include any eye problems. He had no known allergies. Child lives in a area with increased risk for infectious causes. No concomitant medications were taken by the patient. The patient was vaccinated with first dose of BEXSERO (batch number: 1461010) intramuscularly in left deltoid on 09 Apr 2015. On 04 May 2015 at 06:00 am, 4 weeks after vaccination he woke up and was unable to see from the left eye. The eye specialist stated that the patient had complete loss of vision out of the left eye. The patient was diagnosed with optic neuritis/ left neuroretinitis. The patient was currently hospitalized. Diagnosis was done by retinal specialist with supporting nMRI studies. Extensive work-up for infectious or immune-mediated cause was negative but most of the serology results were pending. Child received intravenous steroids with some mild improvement in vision on 07 May 2015. Medical records need to be provided. The patient's mother (who is also a physician) stated that a similar case of optic neuritis was found post-BEXSERO administration and believed that the events in the patient was caused by BEXSERO.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Blindness unilateral, Immunology test normal, Laboratory test normal, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: Case number PHEH2015US009021 is a combined initial and follow spontaneous report from a health care professional and patient's mother (who is also a pediatrician) via medical information received on 07 May 2015. This report refers to a 15-year-old male patient. His medical history did not include any eye problems. He had no known allergies. Child lives in a area with increased risk for infectious causes. No concomitant medications were taken by the patient. The patient was vaccinated with first dose of BEXSERO (batch number: 1461010) intramuscularly in left deltoid on 09 Apr 2015. On 04 May 2015 at 06:00 am, 4 weeks after vaccination he woke up and was unable to see from the left eye. The eye specialist stated that the patient had complete loss of vision out of the left eye. The patient was diagnosed with optic neuritis/ left neuroretinitis. The patient was currently hospitalized. Diagnosis was done by retinal specialist with supporting nMRI studies. Extensive work-up for infectious or immune-mediated cause was negative but most of the serology results were pending. Child received intravenous steroids with some mild improvement in vision on 07 May 2015. Medical records need to be provided. The patient's mother (who is also a physician) stated that a similar case of optic neuritis was found post-BEXSERO administration and believed that the events in the patient was caused by BEXSERO.
Age: 15.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Serology test
Clinical narrative: Case number PHEH2015US009021 is a combined initial and follow spontaneous report from a health care professional and patient's mother (who is also a pediatrician) via medical information received on 07 May 2015. This report refers to a 15-year-old male patient. His medical history did not include any eye problems. He had no known allergies. Child lives in a area with increased risk for infectious causes. No concomitant medications were taken by the patient. The patient was vaccinated with first dose of BEXSERO (batch number: 1461010) intramuscularly in left deltoid on 09 Apr 2015. On 04 May 2015 at 06:00 am, 4 weeks after vaccination he woke up and was unable to see from the left eye. The eye specialist stated that the patient had complete loss of vision out of the left eye. The patient was diagnosed with optic neuritis/ left neuroretinitis. The patient was currently hospitalized. Diagnosis was done by retinal specialist with supporting nMRI studies. Extensive work-up for infectious or immune-mediated cause was negative but most of the serology results were pending. Child received intravenous steroids with some mild improvement in vision on 07 May 2015. Medical records need to be provided. The patient's mother (who is also a physician) stated that a similar case of optic neuritis was found post-BEXSERO administration and believed that the events in the patient was caused by BEXSERO.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not provided. On 15-MAY-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX lot # J005693, expiration date 07-MAY-2015, 0.5 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered nurse refers to a patient of unknown age. Patient medical history and current condition was not reported. On 08-MAY-2015 the patient was vaccinated with MMR II (lot # K009192 and expiry date reported as 27-JUN-2016) which underwent an unsupported temperature excursion via intramuscular route. No adverse effects reported. The outcome of the event was unknown. This is one of the three reports received 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 as received from a registered nurse refers to an unspecified number of patient of unknown gender and age. It was reported that since 24-JUL-2014, improperly stored doses of (Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) were administered to unknown number of patients in approximately 2014. No adverse effects were noted. No product quality complaint (PQC) involved. Follow up was received on 09-SEP-2014. The reporter stated that she does not have any additional information available at the time of reporting. Follow up information has been received from the nurse on 07-MAY-2015. The nurse reported doses of (Merck) VARIVAX (dose, dose number, route, lot/batch number, expiration date were not reported) which had been exposed to temperatures above the recommended range, had been administered to unspecified patients of unspecified dates. This is one of several reports from the same source. Additional information has been requested. Narrative was updated.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a 37 year old female consumer concerning herself with thyroid issue and no drug reactions. On 28-APR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX, (strength, dose, lot number, expire date and route were not provided) for prevention of chickenpox. She also vaccinated with MMR II (strength, dose, lot number, expire date and route were not reported) concomitant. Concomitant therapies included a thyroid medication (unspecified name, dose/frequency and manufacturer). On an unknown date the patient had a pregnancy test which showed she became pregnant on 14-APR-2015. Her Last Menstrual Period (LMP) was 31-MAR-2015 and the Estimated Date of Delivery (EDD) was 05-JAN-2016. Initial exposure to (Oka/Merck) VARIVAX and MMR II was at 4 weeks. The pregnancy outcome was pending. The patient didn's seek medical attention. No treatment was given for adverse event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a female patient of unknown age. On an unknown date in 2015 (reported as "within the past 2 weeks) the patient was vaccinated with an improperly stored dose of GARDASIL (strength, dosage and frequency unspecified) lot # K006117, expiration date: 14-JAN-2017, intramuscularly as her third dose in the series. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. The patients were administered improperly stored doses of (Oka-Merck) PROQUAD (dose and route were not reported, lot# K007801, expiry on 30-NOV-2015 and lot# K011316, expiry on 14-FEB-2016) on 06-JAN-2015, 12-JAN-2015, 23-JAN-2015, 26-JAN-2015, 28-JAN-2015, 29-JAN-2015, 30-JAN-2015, 03-FEB-2015, 04-FEB-2015, 05-FEB-2015, 06-FEB-2015, 03-MAR-2015, 06-MAR-2015, 11-MAR-2015, 20-MAR-2015, 09-APR-2015, 16-APR-2015, 17-APR-2015 and on 22-APR-2015. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 35 year old female patient. On 23-APR-2015, the patient was vaccinated with an expired dose of GARDASIL lot # H018019, expiry date 03-APR-2015. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness approx 10 cm around injection site.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Mom reports that patient has a mild red rash from shoulders extended to buttocks.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Brief episode of fainting and dizziness. Reclined in chair and recovered completely.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Headache, Pain, Pain of skin, Pyrexia
Clinical narrative: Fever (101.0)/chills, headache, body aches, snuffy/runny nose - signs of improvement on 05/18/2015. Skin sore to touch increased on 05/17/2015 and has not improved yet.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea
Clinical narrative: Fever (101.0)/chills, headache, body aches, snuffy/runny nose - signs of improvement on 05/18/2015. Skin sore to touch increased on 05/17/2015 and has not improved yet.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and unknown gender. Medical history and drug allergy were not reported. On 14-MAY-2015 the patient was vaccinated with one dose of improperly stored (Merck) VARIVAX (dose, strength, route, lot# and expire date were not reported). Concomitant drug were not reported. No adverse effects were reported. It was unspecified if the patient sought any medical attention. 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 refers to unspecified number of patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. The patient were administered improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were not reported) on 06-JAN-2015, 12-JAN-2015, 23-JAN-2015, 26-JAN-2015, 28-JAN-2015, 29-JAN-2015, 30-JAN-2015, 03-FEB-2015, 04-FEB-2015, 05-FEB-2015, 06-FEB-2015, 03-MAR-2015, 06-MAR-2015, 11-MAR-2015, 20-MAR-2015, 25-MAR-2015, 09-APR-2015, 16-APR-2015, 17-APR-2015 and on 22-APR-2015. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Within 24 hours of vaccination,patient developed full body rash that mimics chicken pox. Patient complained of itching but no other symptoms.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure like phenomena
Clinical narrative: GARDASIL 9 Lot no. L001312 had seizure like activity only on (L) side lasting 20 sec. No prior reactions noted on any vaccines.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: I woke up with flat red patches on my upper arm for about an 8" radius around the site of the injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, and itchy around injection site on arm.  Patient describes area of inflammation as a welt and to be 5" long and 3" wide.  Patient called MD and MD instructed her to take Benadryl, in which she has been doing.
Age: 1.53
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 102.2, pain in leg, 2 days.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling. Told to give Benadryl and Zantac.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: In drawing up the Pentacel DTap/IPV/Hib I did not reconstitute he Hib portion into the the DTap/IPV so the Hib was not administered.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Seizure
Clinical narrative: Approx 5 minutes after receiving HPV patient stated he needed to go to the rest room. Patient found in the bathroom having a seizure, stated by the front desk staff.  Patient found leaning against wall complaining that stomach hurt.  Patient was laid down and cool packs were placed on forehead and gatorade was given.  Patient waited 20 minutes without further symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Started to develop a red rash under abdomen fold. Over the last months this has continuous spread to now it covers my body up to my face. It itches and then hurts when I scratch it. I have been to the Dr 3 times over this. My Dr prescribed a lotion, then prednisone and now Allegra. Nothing has worked.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: The Hib portion of the DTap/IPV/Hib was not reconstituted into the Dtap/IPV. Hence Hib was not administered. It is uncertain if it was with this patient or another so reports are filed on both.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness and swelling; fever 102.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of an unknown age and gender. It was reported that on unknown dates, the patients may had been administered improperly stored doses of (Merck) VARIVAX (lot# reported as # K015933, expiration date 23-SEP-2016, dose and frequency were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On 28-APR-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX lot # J003703, expiration date 27-MAR-2015 (dose and route of administration were not reported). No information on patient's concomitant medication was provided. No adverse events were reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative, Injury associated with device, No therapeutic response
Clinical narrative: Information has been received from a nurse referring to a currently 36 year old female patient. The patient's medical history or concurrent condition were not provided. It was reported that the patient received 6 doses (confirmed the patient received a three dose series two times) of hepatitis b vaccine (manufacturer unknown) (strength, formulation, lot#, expired date, dose, route, duration were unspecified) and had not seroconverted. It could not be determined if the unspecified hepatitis b vaccine was a Merck product. The patient has sought medical attention via office visit. Unspecified blood work was performed with no result provided. The nurse also mentioned the patient was stuck by a needle today (15-MAY-2015). The patient's present status was reported as not recovered. Additional information has been requested.
Age: 0.32
Sex: M
Vaccine: RV5
Symptoms: Base excess decreased, Base excess increased, Blood bicarbonate decreased, Blood potassium decreased, C-reactive protein increased
Clinical narrative: Information has been received from Sanofi Pasteur MSD (MFR # DE-1577272925-E2015-05044) on 13-MAY-2015. Case was received from a physician on 12-MAY-2015. Case is medically confirmed. A male patient received the complete immunisations series with three doses of ROTATEQ orally starting at the age of seven weeks on 09-APR-2013 (D1, lot#. J000051, expiry: 30-SEP-2014), on 10-MAY-2013 (D2, lot # J000051, expiry: 30-SEP-2014) and on 14-JUN-2013 (D3, lot #. J000554, expiry: 30-SEP-2014). One and a half year later at the age of 2 years, on 01-MAY-2015, the patient developed diarrhea. On 03-MAY-2015 during the night he additionally developed recurrent vomiting. On the next day, on 04-MAY-2015, he was presented to emergency room due to vomiting and reduced general condition. He was hospitalised on that day. On admission physical investigation revealed slightly reduced turgor, dry mucous membranes and slightly reddened pharynx. Laboratory test results: 04-MAY-2015: pH: 7.32, Carbon dioxide partial pressure (pCO2): 3.59 Hydrogencarbonate (HCO3): 16.1, Base excess: 11.2, CRP: 32.4. Urine- acetone: +++ (positive) (check up showed normal results), blood gases analysis: pH: 7.38, Base excess: -8.6, potassium: 2.7, potassium (serum): 2.68. Check up on 05-MAY-2015: pH: 7.38, Base excess: -5.9, potassium: 3.21. Check up on 05-MAY-2015, 06:00 pm: potassium: normal. The patient was treated with infusion therapy consisting of sodium chloride 0.9% and glucose-electrolytes mixture with potassium supplementary. Stool test was positive for rotavirus. Following diagnoses were established: rotavirus gastroenteritis, hypokalaemia, food refusal, vomiting and acetonuria. On 07-MAY-2015 the patient was discharged in good general condition.