chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Pain in extremity
Clinical narrative: Severe low back and leg pain down both legs to ankles resolved in 2-3 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Hyperhidrosis, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Stiff, weak arm. Faint, sweating, pain radiated to shoulder, neck, chest.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Neck pain, Syncope
Clinical narrative: Stiff, weak arm. Faint, sweating, pain radiated to shoulder, neck, chest.
Age: 23.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain, Dizziness, Muscle spasms, Nausea
Clinical narrative: Muscle spasms of right forearm (extensor tendons), mid back (between scapulae), and low back; nausea; abdominal pain, and dizziness.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Joint pain, chills, fatigue.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Cough, Ear infection, Injection site erythema, Injection site induration
Clinical narrative: Patient went into urgent care with fever, cough, and rash on right arm legs, and body.  She had been on amoxicillin since 1/8/15 for ear infection.  Lesion noted on right arm where varicella vaccine administerd.  Dr described as a cyst like lesion on posterior right arm.  Rash on Right Posterior Arm: 2.5cm X 1cm. Erythematous. Indurated. No vesicles, pustules or crusts. No red streaks. No discharge. No obvious breaks in skin. Mildly tender to palpation. She was diagnosed with cellulitis and given oral Clindamycin.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Pyrexia, Rash
Clinical narrative: Patient went into urgent care with fever, cough, and rash on right arm legs, and body.  She had been on amoxicillin since 1/8/15 for ear infection.  Lesion noted on right arm where varicella vaccine administerd.  Dr described as a cyst like lesion on posterior right arm.  Rash on Right Posterior Arm: 2.5cm X 1cm. Erythematous. Indurated. No vesicles, pustules or crusts. No red streaks. No discharge. No obvious breaks in skin. Mildly tender to palpation. She was diagnosed with cellulitis and given oral Clindamycin.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient went into urgent care with fever, cough, and rash on right arm legs, and body.  She had been on amoxicillin since 1/8/15 for ear infection.  Lesion noted on right arm where varicella vaccine administerd.  Dr described as a cyst like lesion on posterior right arm.  Rash on Right Posterior Arm: 2.5cm X 1cm. Erythematous. Indurated. No vesicles, pustules or crusts. No red streaks. No discharge. No obvious breaks in skin. Mildly tender to palpation. She was diagnosed with cellulitis and given oral Clindamycin.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Malaise, Pallor
Clinical narrative: At pharmacy, Customer received the shingles vaccine per her prescription. No contraindications existed. She was given VIS statement, had no questions, I counseled her to stay 20 minutes, she said she would leave with her husband. Vaccine given at 11:20 at about 11:30 husband said she was sitting on bench at entrance and was very pale and dizzy. I called a code white (customer accident page) and rushed to her. She said she did not feel well, got hot feeling and was dizzy. She refused emergency treatment. She quickly sat up and I asked to check her BP, it came up 56/41 which was very concerning, I asked her to call 911 she again refused. She said she was ok and laid back down. 5 minutes later I checked her BP and it was up to 102/72, color looked much better, she then decided she felt well enough to leave. I again offered to call for emergency help she refused. I told her I would follow up with her this evening. I spoke to Dr office and they are aware of the reaction and have documented it.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Chapped lips, Dry mouth, Influenza, Nasal congestion, Onychoclasis
Clinical narrative: Initial unsolicited report was received from a consumer, who is also the patient. This case is related to case ID 2014SA099610 (same patient). A 62 year-old female patient with a history of MS, hair loss and tired had received on an unspecified date an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed "the flu twice this season with chapped lips". The patient also experienced 2 episodes of nails shredding down to the quick, dry mouth, plugged nose and tearful. Concomitant medication included AUBAGIO. The patient has arm surgery scheduled for March 2015. No further information was received at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Tearfulness
Clinical narrative: Initial unsolicited report was received from a consumer, who is also the patient. This case is related to case ID 2014SA099610 (same patient). A 62 year-old female patient with a history of MS, hair loss and tired had received on an unspecified date an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed "the flu twice this season with chapped lips". The patient also experienced 2 episodes of nails shredding down to the quick, dry mouth, plugged nose and tearful. Concomitant medication included AUBAGIO. The patient has arm surgery scheduled for March 2015. No further information was received at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pharyngeal oedema, Pyrexia
Clinical narrative: Initial unsolicited case received from an office manager in a physician's office on 06 January 2015. A female patient with no reported medical history received FLUZONE HIGH DOSE (lot number U5022BA, expiration date 29-APR-2015) on 25 September 2014. Three hours after vaccination, the patient experienced throat swelling and a fever of 101 degrees. She reported feeling sick for three days afterwards. She did not notify her physician or go to the emergency room. Outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of queasy in a female patient who received FLUARIX. Co-suspect products included ADVAIR Diskus inhalation powder for chronic obstructive pulmonary disease. On an unknown date, the patient received FLUARIX at an unknown dose. In August 2002, the patient started ADVAIR Diskus at an unknown dose and frequency. On an unknown date, an unknown time after receiving FLUARIX and ADVAIR Diskus, the patient experienced queasy. On an unknown date, the outcome of the queasy was unknown. It was unknown if the reporter considered the queasy to be related to FLUARIX and ADVAIR Diskus. Additional information received: The patient said she had a lung infection and then said no she just felt a little queasy from the flu shot, which she got a few days ago. She stated she is fine, and did not want to answer any other questions.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Dehydration, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: Nausea, Loose Stools, Chills, Sweating, Body Aches.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Nausea, Loose Stools, Chills, Sweating, Body Aches.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Severe swelling of arm at injection site, fever.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: Agitation, Crying, Lethargy, Screaming, Somnolence
Clinical narrative: Normally a very happy baby who rarely napped very long (but did sleep through the night), he became VERY lethargic and difficult to wake; when he was awake, and also sometimes during sleep, he cried a high pitched cry/scream. He was agitated and very lethargic for about 3 days, then returned to normal.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Swelling and inflammation at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Syncope
Clinical narrative: Within 5 minutes of getting her immunization shots she fainted. She recovered immediately after laying her down.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Food allergy, Rash, Rash erythematous, Rash generalised
Clinical narrative: Dry, flat, red rash to face, neck, ears and chest. No other symptoms present. Rash remained visible 7-8 minutes. Pt states she ate sunflower seeds moments before the rash appeared and stated "I always get this when I eat sunflower seeds".
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Injection site urticaria, Peripheral swelling, Skin tightness
Clinical narrative: Itchiness and hives around area of pneumonia vaccine.  Left arm was swelling and constricting. By approx. 10 PM there was redness just below the elbow to the shoulder. As of 01/14/2015 arm is still swollen and red though not as bad.  At the hospital, Benadryl was given to me and Benadryl cream was applied to location.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Received my flu shot on Tuesday. Tuesday night began having numbness, tinling in legs, feet, pain in back, hands, and shoulders.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Patient described a knot under the band aid where vaccine was administered.  She removed band aid and noticed area was red and slightly swollen.  Patient returned to pharmacy on 01/14/2015 and noticed vaccine was given in deltoid region of arm and was red.  Then told patient to continue to observe the area and if got any worse to call pharmacy or doctor.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC
Symptoms: Aggression, Diarrhoea, Dyskinesia, Dyspnoea, Injection site rash
Clinical narrative: Extreme aggression, jerking in sleep, diarrhea and rash all over the leg and point of injection. High pitch scream in sleep and gasps.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC
Symptoms: Screaming
Clinical narrative: Extreme aggression, jerking in sleep, diarrhea and rash all over the leg and point of injection. High pitch scream in sleep and gasps.
Age: 73.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, tender to touch area around injection site left deltoid. Benadryl OTC x 3 days ordered and Betamethasone Depropionate ointment 0.05% to area twice/day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Slight swelling at injection site. Painful when touched. No general fever, or general symptoms, all local to the site. Patient took Advil and iced the injection site.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood culture negative, Blood test normal, Chills, Culture urine negative
Clinical narrative: Severe chills, body aches, sweats. Spine feels icy cold. Symptoms were originally almost constant and have gradually become a bit less frequent but are still, as of this date, debilitating. Loss of weight and appetite have continued. Headaches.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Feeling cold, Headache, Hyperhidrosis, Pain
Clinical narrative: Severe chills, body aches, sweats. Spine feels icy cold. Symptoms were originally almost constant and have gradually become a bit less frequent but are still, as of this date, debilitating. Loss of weight and appetite have continued. Headaches.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Urine analysis normal, Weight decreased
Clinical narrative: Severe chills, body aches, sweats. Spine feels icy cold. Symptoms were originally almost constant and have gradually become a bit less frequent but are still, as of this date, debilitating. Loss of weight and appetite have continued. Headaches.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted 10 seconds after injection.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Numbness, weakness in hands, feet, arms, legs, fingers, toes. Fatigue/exhaustion. Guillain-Barre syndrome. IVIG infusions given.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea - not severe treated with oral fluids.
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of shoulder pain in a adult unk patient who received FLUARIX. On 4th September 2014, the patient received FLUARIX (unknown). On an unknown date, less than a year after receiving FLUARIX, the patient experienced shoulder pain, pain in arm, back pain, neck pain and stiffness. On an unknown date, the outcome of the shoulder pain, pain in arm, back pain, neck pain and stiffness were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, back pain, neck pain and stiffness to be related to FLUARIX. Additional information received: This case was one of the 8 cases reported after vaccination with FLUARIX (see case US2014GSK005295).
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Bloody stools.
Sex: U
Vaccine: RV1
Symptoms: Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016) and (batch number A41CB4464, expiry date unknown). On 14th October 2014, the patient received ROTARIX (oral). On an unknown date, the dose was an unknown dose. On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. ROTARIX was continued with no change. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information: 2 of 5 reports. Nurse reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician's office that day to receive the vaccine and diluent product. No AEs were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over vaccine manufacturers.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pruritus, Urticaria
Clinical narrative: Pt rec'd flu vaccine 12/22/14. She was feeling fine. Says that within 1 hour she was covered head to toe with itchy hives and had chills and aches but no fever. Pt had same reaction with TAMIFLU last year she has no allergies to egg. She's never had flu shot before. We told her that future flu shots should be at MD office.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Anterior interosseous syndrome
Clinical narrative: (Lt) anterior interosseous neuropathy developing after influenza vaccination.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Had flu shot 1/5/2015. 2 days later noted sore lymph node same arm as shot. Node increased pain and size. Said fever 101.2 on 1/8/15. 1/9/15 saw doctor - was told "caused by shot". Given prednisone.
Sex: U
Vaccine: HPV4, PPV, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a registered nurse concerning an unspecified number of patients (ages and genders not specified). The nurse reported that the unspecified number of patients were administered GARDASIL, ROTATEQ, PNEUMOVAX 23 and (Merck) VARIVAX that were improperly stored. There were no adverse effects. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a Registered Nurse who stated that the refrigerator temperature rose to 16C time of excursion 67 hours (worse case), affecting ROTATEQ (dose, site and duration not reported) "(not supported)". The reporter stated that vaccines had experienced  previous temperature excursion of 14C for 12 hours. Temperature ranged and time frame: 16C for 67 hours and 14C for 12 hours. This is one of several reports received from the same reporter. Additional information is not expected because the registered nurse stated she did not want to receive any further follow up letters.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (also reported as registered nurse) refers to an unknown number of patients of unknown age and gender. Since 02-JAN-2015, an unknown number of doses of ROTATEQ (dose, route, anatomical location, lot # and expiration date were not reported), which underwent supported temperature excursions, have been administered to an unknown number of patients. No adverse effect reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neuralgia, Neuritis
Clinical narrative: Neuralgia/neuritis in (R) shoulder and arm.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 11 cm x 7 cm area of erythema w/o induration surrounding injection site.
Sex: U
Vaccine: RVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients (age and gender not specified). The nurse stated an unspecified number of patients received improperly stored Rotavirus Vaccine. No adverse effects were reported. Additional information is not expected as the nurse declined to be contacted for follow-up.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Rash generalised
Clinical narrative: This is a prospective pregnancy case. This 30-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV (unknown) .5 ml on 25th August 2014. The subject's past medical history included no adverse event (The patient was not allergic to eggs). Previously administered products included flu vaccine with an associated reaction of no adverse event (It was unknown if the patient already received FLUARIX/FLULAVAL shots but she had no reactions following previous flu shots vaccinations). The subject's last menstrual period was on 7th February 2014 and estimated date of delivery was 14th November 2014. The subject received Flu Seasonal QIV at week 28 of the pregnancy and during the second trimester of pregnancy. On an unknown date, several days after receiving Flu Seasonal QIV the subject developed generalized rash (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of generalized rash was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the generalized rash to be related to Flu Seasonal QIV. Additional information received on 26 September 2014: The patient was not sick the day of vaccination. The patient reported that after the vaccination, she got a fine rash down both of her arms and her chest for a few days after injection was given. The rash ended up spreading to her left leg at some point. The rash was resolved without symptoms. The last menstrual period was not reported but was calculated with the due date.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Left arm swelling from injection site (deltoid) to elbow. Also pain and redness. Started same day ended after two days. Arm was itchy afterwards for two more days.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Nausea
Clinical narrative: Pt states to have experienced a blister formation to injection site. (+) redness/swelling/pain, fever and nausea. Symptoms lasted approximately 4-5 days. Pt did not seek medical attention at the time.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt states to have experienced a blister formation to injection site. (+) redness/swelling/pain, fever and nausea. Symptoms lasted approximately 4-5 days. Pt did not seek medical attention at the time.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of arm sore in a 56-year=old male patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). On 20th October 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 21st October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced arm sore and erythema. On an unknown date, the outcome of the arm sore and erythema were recovered/resolved. The reporter considered the arm sore and erythema to be related to FLUARIX QUADRIVALENT. Additional information received: A patient received the FLUARIX QUADRIVALENT, and experienced arm soreness and redness the day after receiving his flu shot. The issues resolved at an unknown time after the injection. The exact dosage was unknown by the sales representative.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number: UNKNOWN, expiry date unknown). On 20th October 2014, the patient received FLUARIX QUADRIVALENT. On 21st October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and localized erythema. On an unknown date, the outcome of the pain in arm and localized erythema were recovered/resolved. The reporter considered the pain in arm and localized erythema to be related to FLUARIX QUADRIVALENT. Additional information: Sales representative was made aware today by the Chief Operating Officer4 of an Account office, who had received the FLUARIX QUADRIVALENT, experience arm soreness and redness the day after receiving his flu shot. The issues resolved at an unknown time after the injection. The exact dosage was unknown by the sales representative.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Malaise
Clinical narrative: This is a prospective pregnancy case. This 42-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV (unknown) .5 ml on 29th September 2014. The subject's past medical history included no adverse event. Previously experienced adverse reactions included malaise (The patient always experienced malaise after vaccinations). Previously administered products included Tdap with an associated reaction of no adverse event. Concomitant products included Prenatal Vitamins. Th subject's last menstrual period was on 15th January 2014 and estimated date of delivery was 22nd October 2014. The subject received Flu Seasonal QIV at week 36 of the pregnancy and during the third trimester of pregnancy. On 30th September 2014, 1 days after receiving Flu Seasonal QIV the subject developed malaise (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of malaise was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the malaise to be possibly related to Flu Seasonal QIV. Additional information received on 07 October 2014: The patient received a Tdap vaccine about one week before the FLUARIX Quadrivalent vaccine. She had no adverse events.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug  in several patients who received FLUARIX Quadrivalent 2013-2014 season.  On an unknown date, the patient received FLUARIX Quadrivalent 2013-2014 season at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2013-2014 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional  information: Per the nurse, FLUARIX QIX was stored at 30.6 degrees F and administered to several patients in torsed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On 11/19/14 pt was administered the flu shot. Patient informed me on 1/13/15 that her arm was still sore when she moved it. I recommended she see her MD.
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of shoulder pain in a adult unk patient who received FLUARIX Quadrivalent. On 4th September 2014, the patient received FLUARIX Quadrivalent (unknown). On an unknown date, an unkown time after receiving FLUARIX Quadrivalent, the patient experienced shoulder pain, pain in arm, back pain, neck pain and stiffness. On an unknown date, the outcome of the shoulder pain, pain in arm, back pain, neck pain and stiffness were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, back pain, neck pain and stiffness to be related to FLUARIX Quadrivalent. Additional information received: This case was one of the 8 cases reported after vaccination with FLUARIX Quadrivalent (see case US2014GSK005295).
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Employee reported, on Jan. 14, 2015, that on 10/23/14, a few hours after receiving her flu shot at work, she noticed a red, bumpy, itchy rash on her left arm and left side of her chest. Rash lasted < 24 hours and resolved without treatment. She denies any known allergies. Flu shot was given in left arm.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US021520 is an initial spontaneous report received from a consumer on 06 Nov 2013 with a follow-up received on 02 Oct 2014. This report refers to a 29-year-old pregnant female patient. Two weeks ago (possible 23 Oct 2013), she was vaccinated with FLUVIRIN (batch number: no provided) intramuscularly at her village obstetrics and gynecology clinic. No adverse event was reported following this administration error. Multiple attempts have been made to obtain follow-up information and outcome of pregnancy without success. Hence this case is considered lost to follow-up. Follow-up received on 02 Oct 2014: Lost to follow-up information updated.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Case number PHEH2013US022850 is an initial spontaneous report received from a pharmacist on 29 Oct 2013 with a follow up information received from the pharmacist on 19 Nov 2013. This report refers to a 58-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in the left arm deltoid at a dose of 0.5 ml on 26 Oct 2013. On 27 Oct 2013, he develo9ped blisters that appeared around the injection site. Outcome was reported as complete recovery on 04 Nov 2013. No seriousness and causality was reported. Follow up information received from the pharmacist on 19 Nov 2013: Site and dose of vaccination, event onset date and stop date and outcome updated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US022526 is an initial spontaneous report from nurse received on 24 Oct 2013. This case refers to 64-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1308101, expiry date: Mar 2014) 0.5 ml intramuscularly on 15 Oct 2013. On the same date of vaccination, the patient developed softball size red, raised and hot reaction at injection site. She came back on 17 Oct 2013 with soccer or football size reaction area. She was treated with SOLUMEDROL 40 mg for the events. The outcome of the events was reported as resolved. The seriousness and causality of events was not reported. Following internal review, for the information received on 24 Oct 2013, the following correction was done. The event verbatim was updated as "soccer or football size reaction area" and coded to extensive swelling of vaccinated limb.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Cough, Diarrhoea, Malaise
Clinical narrative: Case number PHEH2013US022627 is an initial spontaneous report from  health care professional received on 25 OCT 2013 with a follow-up received on 13 JAN 2014. This case refers to 61-year-old male patient. His medical history included allergies and concomitant medications included NSAID's. His vaccination history included administration of a seasonal influenza vaccine (manufacturer and batch number: unknown) on 13 OCT 2012, following which no adverse events were reported. He was vaccinated with FLUVRIN 2013/2014 (batch number: 1309601) intramuscularly at a dose of 0.5 ml into the left deltoid on 22 OCT 2013. On 23 OCT 2013, he experienced body aches,  nonproductive cough, diarrhea, fever with a body temperature of 100 degree. Fahrenheit and malaise. Number of stools was reported as five daily. Forty eight hours after the vaccination, the patient developed abdominal cramps. Seventy two hours after FLUVIRIN administration, he developed joint pain, muscle pain and loose stools. Outcome of the events, body aches, nonproductive cough, diarrhea, fever and malaise was reported as complete recovery on an unspecified date. Outcome of the other events was not reported. The serious ness of events were not reported.  Follow-up received from the health care professional on 13 JAN 2014: Updated patient demographics, medical history and concomitant medications, vaccination history, dose and site of FLUVIRIN, events (body aches, non-productive cough, fever and malaise) body temperature and outcome.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Case number PHEH2013US022627 is an initial spontaneous report from  health care professional received on 25 OCT 2013 with a follow-up received on 13 JAN 2014. This case refers to 61-year-old male patient. His medical history included allergies and concomitant medications included NSAID's. His vaccination history included administration of a seasonal influenza vaccine (manufacturer and batch number: unknown) on 13 OCT 2012, following which no adverse events were reported. He was vaccinated with FLUVRIN 2013/2014 (batch number: 1309601) intramuscularly at a dose of 0.5 ml into the left deltoid on 22 OCT 2013. On 23 OCT 2013, he experienced body aches,  nonproductive cough, diarrhea, fever with a body temperature of 100 degree. Fahrenheit and malaise. Number of stools was reported as five daily. Forty eight hours after the vaccination, the patient developed abdominal cramps. Seventy two hours after FLUVIRIN administration, he developed joint pain, muscle pain and loose stools. Outcome of the events, body aches, nonproductive cough, diarrhea, fever and malaise was reported as complete recovery on an unspecified date. Outcome of the other events was not reported. The serious ness of events were not reported.  Follow-up received from the health care professional on 13 JAN 2014: Updated patient demographics, medical history and concomitant medications, vaccination history, dose and site of FLUVIRIN, events (body aches, non-productive cough, fever and malaise) body temperature and outcome.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013U S022427 is an initial spontaneous report from nurse received on 23 Oct 2013 with a follow up received from nurse on 06 Dec 2013. This case refers to a female patient of an unknown age. The pregnant patient received a shot of FLUVIRIN (batch number: not reported) on 10 Oct 2013. No adverse event was reported following this vaccine exposure during pregnancy. Follow up received from nurse on 06 Dec 2013. It was confirmed that patient didn't receive second FLUVIRIN injection as initially reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Case number PHEH2013US021885 is an initial spontaneous report received from a consumer on 18 OCT 2013, with a follow-up received on 13 NOV 2013. This report refers to a 50-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly on 16 OCT 2013. On the same day after vaccination, she experienced swollen lymph nodes under her left arm. She had not consulted a physician at this time, but a nurse recommended placing warm packs under the arm to help with the swelling. Consumer stated that the swelling bothered her day before, but it worsened the next morning with some pain and was getting worse. Consumer added that she had received flu vaccines in the past, and this experience had never happened previously. Outcome was reported as condition worsening. No further information about seriousness and causality was mentioned. Treating physician stated that the patient had not received the vaccine at their clinic and had not seen the patient since Feb 2013.  Follow-up was received on 13 NOV 2013. Treating physician statement was updated.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US021520 is an initial spontaneous report received from a pharmacist on 15 Oct 2013. This report refers to a female patient of an unknown age. On 14 Oct 2013, while she was pregnant, she was administered with FLUVIRIN (batch number: unknown) intramuscularly from a multidose vial. No adverse event was reported following vaccine exposure during pregnancy. Follow up information received on 15 Oct 2013: This case is lost to follow up because the reporter was anonymous.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US021461 is an initial spontaneous report received from a pharmacist on 11 Oct 2013 with a follow up information received from the pharmacist on 29 Sep 2014. This report refers to a 35-years-old female patient. On 08 Oct 2013, while she was pregnant, she was vaccinated with FLUVIRIN (batch number: 13382P, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly. No adverse event was reported following vaccination. Upon follow up information received on 29 Sep 2014, the reporter stated that the patient received prepackaged FLUVIRIN vaccine and not a multidose vial and as per their headquarters, it was okay to administer this vaccine to patients who were pregnant. Reporter stated that patient was doing fine and the reporter would like to close this case. No further information was provided. Follow up information received from the pharmacist on 29 Sep 2014: Reporter's comment and lost follow-up updated. Following internal review on 20 Oct 2014 of the data received on 29 Sep 2014: It was identified that the birth type was erroneously updated as outcome pending and the birth type correctly updated as lost to follow-up.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHEH2013US021243 is an initial spontaneous report received from a health care professional on 09 Oct 2013 with a follow-up received on 11 Nov 2013: This report refers to a 45-year-old female patient. Her medical history was unknown. Her concomitant medication included Estradiol at 1mg orally QD. She was vaccinated with FLUVIRIN (batch number: 1308901 and expiry date: Apr 2014) intramuscularly at 0.5 ml in to the left deltoid on 07 Oct 2013. Immediately after vaccination, she complained of 4 to 5 inches itching, redness, soreness, swelling and induration at the injection site. The events resolved on 09 Oct 2013. No further information about seriousness and causality were reported. Follow-up received from the health care professional on 11 Nov 2013: Updated patient demographics, concomitant medication, site and date of application of FLUVIRIN, onset and end dates of events and outcome of the events.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2013US021243 is an initial spontaneous report received from a health care professional on 09 Oct 2013 with a follow-up received on 11 Nov 2013: This report refers to a 45-year-old female patient. Her medical history was unknown. Her concomitant medication included Estradiol at 1mg orally QD. She was vaccinated with FLUVIRIN (batch number: 1308901 and expiry date: Apr 2014) intramuscularly at 0.5 ml in to the left deltoid on 07 Oct 2013. Immediately after vaccination, she complained of 4 to 5 inches itching, redness, soreness, swelling and induration at the injection site. The events resolved on 09 Oct 2013. No further information about seriousness and causality were reported. Follow-up received from the health care professional on 11 Nov 2013: Updated patient demographics, concomitant medication, site and date of application of FLUVIRIN, onset and end dates of events and outcome of the events.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHEH2013US0211241 is an initial spontaneous report received from a health care professional on 09 OCT 2013 and a follow up information received on 18 NOV 2013. This refers to a 39-year-old female patient. Her medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308901, expiry date: Apr 2014) intramuscularly in the left deltoid at 0.5 ml on 07 OCT 2013. Immediately after vaccination on the same date, she complained of 4 to 5 inches itching, redness, soreness, swelling and induration at the injection site. The outcome was reported as complete recovery on 09 OCT 2013. No seriousness and causality were reported.   Follow up information received on 18 NOV 2013. Patient demographics (date of birth, height and weight), site of vaccination , vaccination date, onset date, stop date and outcome of the event updated.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2013US0211241 is an initial spontaneous report received from a health care professional on 09 OCT 2013 and a follow up information received on 18 NOV 2013. This refers to a 39-year-old female patient. Her medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308901, expiry date: Apr 2014) intramuscularly in the left deltoid at 0.5 ml on 07 OCT 2013. Immediately after vaccination on the same date, she complained of 4 to 5 inches itching, redness, soreness, swelling and induration at the injection site. The outcome was reported as complete recovery on 09 OCT 2013. No seriousness and causality were reported.   Follow up information received on 18 NOV 2013. Patient demographics (date of birth, height and weight), site of vaccination , vaccination date, onset date, stop date and outcome of the event updated.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US019374, is an initial spontaneous report from the health care professional received on 13 Sep 2013, and with a follow up report received on 18 Aug 2014. This report refers to a 24-year-old female pregnant patient. Her last menstrual date was not provided. This pregnant patient was vaccinated with FLUVIRIN (batch number: 13394P) via intramuscular route on 12 Sep 2013. No adverse event reported following FLUVIRIN vaccination. Multiple attempts were made to obtain follow-up information and outcome of pregnancy event but it was without success. This case was considered lost to follow-up. Follow up report received on 18 Aug 2014. Lost to follow up updated.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2013US021457 is an initial spontaneous report from the pharmacist received on 11 OCT 2013 and with a follow up information received 28 AUG 2014. This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13382P, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly on 07 OCT 2013. She was also on treatment with Clozaril (batch number: not reported) for unspecified indication. It was reported that she was pregnant during vaccination with FLUVIRIN and treatment with Clozaril. No adverse events reported after the maladministration . It was reported that patient is fine now. No more information available.   Follow up information received from the pharmacist on 26 AUG 2014: New suspect product (Clozaril) was added and reporter's comment updated.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 62 year old female patient, regarding herself. Patient's pertinent medical history was not reported. Patient was reported as allergic to penicillin, sulfa and many antibiotics. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and expiry date not specified). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after she received ZOSTAVAX) patient developed adverse experiences at the injection site. The patient said her arm was swollen, red, and hot to the touch at the injection site. Patient stated that even though these adverse experiences have subsided, she still had a lump at the injection site. On the night of 22-DEC-2014, the patient started to have symptoms on shingles on her rear end. The symptom she experienced was a red blistering rash. No laboratory diagnostic studies were performed. On an unknown date, patient sought medical attention and spoke to pharmacist because she had received the ZOSTAVAX vaccine there. Outcome of the events were reported as not recovered. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: This spontaneous report was received from a 62 year old female patient, regarding herself. Patient's pertinent medical history was not reported. Patient was reported as allergic to penicillin, sulfa and many antibiotics. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and expiry date not specified). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after she received ZOSTAVAX) patient developed adverse experiences at the injection site. The patient said her arm was swollen, red, and hot to the touch at the injection site. Patient stated that even though these adverse experiences have subsided, she still had a lump at the injection site. On the night of 22-DEC-2014, the patient started to have symptoms on shingles on her rear end. The symptom she experienced was a red blistering rash. No laboratory diagnostic studies were performed. On an unknown date, patient sought medical attention and spoke to pharmacist because she had received the ZOSTAVAX vaccine there. Outcome of the events were reported as not recovered. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report was received from a 62 year old female patient, regarding herself. Patient's pertinent medical history was not reported. Patient was reported as allergic to penicillin, sulfa and many antibiotics. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # and expiry date not specified). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after she received ZOSTAVAX) patient developed adverse experiences at the injection site. The patient said her arm was swollen, red, and hot to the touch at the injection site. Patient stated that even though these adverse experiences have subsided, she still had a lump at the injection site. On the night of 22-DEC-2014, the patient started to have symptoms on shingles on her rear end. The symptom she experienced was a red blistering rash. No laboratory diagnostic studies were performed. On an unknown date, patient sought medical attention and spoke to pharmacist because she had received the ZOSTAVAX vaccine there. Outcome of the events were reported as not recovered. No product quality complaint was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage in a patient who received HAVRIX. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: HAVRIX, ENGERIX and TWINRIX were shipped to clinic by wholesaler, but wholesaler states they had a refrigerator failure of their own causing higher than recommended storage temps. Clinic administered 6 doses of HAVRIX and TWINRIX and 2 doses of ENGERIX-B to various patients. Follow-up information received on 8 December 2014: Lot number added. Additional information:This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range has not been established. This product was administered to several patients, ages and genders are not known at this time. Once additional information regarding the ages and genders of the patients involved is received it will be submitted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information was received from a 58 year old female patient, who on 01-DEC-2014, was vaccinated with ZOSTAVAX "1 single shot" (route of administration not provided). The patient reported that on 01-DEC-2014, after receiving ZOSTAVAX, "I developed a red spot on my arm that has since doubled in size and has traveled down my arm." The patient sought medical attention and was treated with BENADRYL. The outcome of the event was reported as not recovered. No further information was provided. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was reporting on himself. On approximately 04-JAN-2015, reported as last Sunday, the patient was vaccinated with ZOSTAVAX (injection dose, route of administration, lot number and expiration date were not reported) (reported as shingles). On approximately 04-JAN-2015, last Sunday (also reported: the following day), the patient experienced pins and needles feeling throughout his entire body. The outcome of pins and needles feeling throughout his entire body was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected, because there is no patient's and physician's contact information.