chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-OCT-2015 08:59, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.0 and 2.8 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015 04:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.8 and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-OCT-2015 16:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.4 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-NOV-2015 14:17, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.7 and 2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-NOV-2015 00:38, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.7 and 2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015 10:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 02:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.1 (30 mins) and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-NOV-2015 18:03, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.7 and 2.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015 18:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 06:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 16:33, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.1 and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015 11:05, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.1 and 2.0 respectively. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015 14:02, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.8 and 2.0 respectively. There were no product quality complaints (PQC) involved.  No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-NOV-2015 00:12, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. NO adverse effects were reported. The high temperature and low temperature were 10.8 (1 hour 31 mins) and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Red, hard rash, three inch circumference (approx.), warm to touch.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: About a month after first vaccine, started developing fast heart rate, shortness of breath and dizziness. Symptoms have continued to get worse over time. Recently diagnosed with POTS.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Pulmonary function test, Tilt table test
Clinical narrative: About a month after first vaccine, started developing fast heart rate, shortness of breath and dizziness. Symptoms have continued to get worse over time. Recently diagnosed with POTS.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Pt is a 24 y/o otherwise healthy presented to the ER with complaint of 12 hours of chest pain. He was in his usual state of health until he started experiencing diffuse "numbness", which is how he feels when he is getting sick. Throughout the day the numbness became more like myalgias and he developed a non focal HA. He went to bed at his normal time then woke early morning with chest pressure that radiated to his back. He tried multiple times to fall back asleep. However he was never able to sleep longer than 45min 2/2 pain. Chest pain is worse when lying flat. He presetned to the ER today after he started to feel SOB in addition  to the chest pain. He denies URI symptoms. He traveled on 15JAN16 then returned 15FEB16. He received smallpox vaccine (right shoulder) 2wks prior.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myalgia, Sleep disorder
Clinical narrative: Pt is a 24 y/o otherwise healthy presented to the ER with complaint of 12 hours of chest pain. He was in his usual state of health until he started experiencing diffuse "numbness", which is how he feels when he is getting sick. Throughout the day the numbness became more like myalgias and he developed a non focal HA. He went to bed at his normal time then woke early morning with chest pressure that radiated to his back. He tried multiple times to fall back asleep. However he was never able to sleep longer than 45min 2/2 pain. Chest pain is worse when lying flat. He presetned to the ER today after he started to feel SOB in addition  to the chest pain. He denies URI symptoms. He traveled on 15JAN16 then returned 15FEB16. He received smallpox vaccine (right shoulder) 2wks prior.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This medically confirmed literature report (initial receipt 23-Feb-2016) concerns a male patient. On an unknown date, the patient received an influenza vaccine (brand, batch number and route unspecified) for indication not provided. On an unknown date following vaccination, the patient developed GB syndrome from which he died. The outcome was reported as fatal. Linked to case: 2016059460 (same reporter). Reporter's Comments: Reporter comments: n/a. Sender's Comments: Company's evaluation and comment: Seriousness criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not provided. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and the Afluria Product Information, GBS is unlisted due to the fatal outcome. Company Causality: Unassessable. Temporal relationship could not be established. GBS is a known class effect of Influenza vaccine in general and is mediated by immune attack on peripheral nerve myelin. Risk factors include upper respiratory, infections, (40% of cases) and or preceding diarrheal illness due to campylobacter infection (20%). The outcome is usually complete recovery over weeks to months however fatal outcome is due to autonomic disturbances resulting in cardiac arrest being the most common cause, in 20-30% of deaths. Due to missing information causality is unassessable.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Influenza B virus test positive, Rhinorrhoea, Sinusitis
Clinical narrative: Initial unsolicited report received from consumer on 24 February 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number and route of administration not reported) in the left deltoid on 26 October 2015. The patient was unsure about previous vaccination with FLUZONE HD vaccine, illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies was reported as seasonal allergy. Birth defects, medical conditions was not reported. The patient's concomitant medications were not provided. On 24 January 2016, two months following the vaccination, the patient had experienced cough, runny nose. The patient was diagnosed with sinusitis and diarrhea. On 25 January 2016, she was tested positive for Influenza B. It was a case of suspected vaccination failure. The patient required ER/doctor visit. Laboratory test included flu swab (unspecified). The patient's received treatment (unspecified). On an unspecified date, the patient recovered from events. Upon internal review the case was considered as serious because of important medical events: suspected vaccination failure and influenza B virus test positive. List of documents held by sender: none. Sender's Comments: This is a case of possible vaccination failure (tested positive for Influenza B) in a 79-year-old female patient after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. As with any vaccine, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE may not protect a 100% of susceptible individuals. The patient was also diagnosed with Sinusitis and Diarrhea. Laboratory test (Flu swab) was unspecified. Additional information on the tests performed to confirm H1N1 infection would be helpful to further assess this case.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination failure
Clinical narrative: Initial unsolicited report received from consumer on 24 February 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number and route of administration not reported) in the left deltoid on 26 October 2015. The patient was unsure about previous vaccination with FLUZONE HD vaccine, illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies was reported as seasonal allergy. Birth defects, medical conditions was not reported. The patient's concomitant medications were not provided. On 24 January 2016, two months following the vaccination, the patient had experienced cough, runny nose. The patient was diagnosed with sinusitis and diarrhea. On 25 January 2016, she was tested positive for Influenza B. It was a case of suspected vaccination failure. The patient required ER/doctor visit. Laboratory test included flu swab (unspecified). The patient's received treatment (unspecified). On an unspecified date, the patient recovered from events. Upon internal review the case was considered as serious because of important medical events: suspected vaccination failure and influenza B virus test positive. List of documents held by sender: none. Sender's Comments: This is a case of possible vaccination failure (tested positive for Influenza B) in a 79-year-old female patient after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. As with any vaccine, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE may not protect a 100% of susceptible individuals. The patient was also diagnosed with Sinusitis and Diarrhea. Laboratory test (Flu swab) was unspecified. Additional information on the tests performed to confirm H1N1 infection would be helpful to further assess this case.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: The patient developed fever and hives about two hours after the administration of the vaccines.
Age: 29.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Respiration abnormal, Throat tightness
Clinical narrative: Light headed, weakness, and mild feeling as if breathing was becoming affected.  No shortness of breath, but a little tightness in throat area.
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 45.0
Sex: M
Vaccine: MENHIB, MMR, TYP, YF
Symptoms: Cough, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Pain at injection site. Body aches, headache, fever (102.1 at peak), nausea, and severe cough without production. Most symptoms lasted 6 days. The cough is persistent.
Age: 45.0
Sex: M
Vaccine: MENHIB, MMR, TYP, YF
Symptoms: Pyrexia
Clinical narrative: Pain at injection site. Body aches, headache, fever (102.1 at peak), nausea, and severe cough without production. Most symptoms lasted 6 days. The cough is persistent.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: HIVES, SOLU MEDROL.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypersomnia, Hypotonia, Muscle twitching, Pallor, Staring
Clinical narrative: Initial unsolicited report received from a physician on 10 November 2015. This case involves a two-month-old male patient who was vaccinated with a intramuscular dose of PENTACEL (batch number C4877AA, expiration date 19 August 2016, dose was not reported) in left thigh, a dose of PREVNAR (batch number L87117, manufacturer- Pfizer, dose, dose in series, route of administration was not reported) in right thigh and an oral dose of ROTATEQ) (batch number L002041, dose, dose in series was not reported) all on 10 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 September 2015, same day following the vaccination, the patient experienced sleeping more, looked a little pale, minor hand twitching, seemed limp when picked up, was staring and had crossed eye contact, no LOC (loss of consciousness). It was reported that the patient was not evaluated by the physician. Lab data and corrective treatments were not reported. Patient was recovered from events (as reported events lasted a few minutes). List of documents held by sender: none. Follow up information received from Physician on 22 February 2016. No additional information provided.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Strabismus
Clinical narrative: Initial unsolicited report received from a physician on 10 November 2015. This case involves a two-month-old male patient who was vaccinated with a intramuscular dose of PENTACEL (batch number C4877AA, expiration date 19 August 2016, dose was not reported) in left thigh, a dose of PREVNAR (batch number L87117, manufacturer- Pfizer, dose, dose in series, route of administration was not reported) in right thigh and an oral dose of ROTATEQ) (batch number L002041, dose, dose in series was not reported) all on 10 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 10 September 2015, same day following the vaccination, the patient experienced sleeping more, looked a little pale, minor hand twitching, seemed limp when picked up, was staring and had crossed eye contact, no LOC (loss of consciousness). It was reported that the patient was not evaluated by the physician. Lab data and corrective treatments were not reported. Patient was recovered from events (as reported events lasted a few minutes). List of documents held by sender: none. Follow up information received from Physician on 22 February 2016. No additional information provided.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Lymphadenopathy, Rash, Rash erythematous
Clinical narrative: Swollen lymph nodes in groin area, rash at injection site 2" in diameter, then grew to 4" diameter within 24 hours. Rash, red spots covering legs, arms and scalp.
Age: 6.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Fatigue, Full blood count, Hypersomnia, Laboratory test
Clinical narrative: Became lethargic and slept for 18 hours. Then continued to go down hill and experienced diarrhea lethargy and extreme fatigue lasting 12 months. Numerous doctors visits, including returning to the clinic where it was given, my pcp and naturopathic MD.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Lethargy
Clinical narrative: Became lethargic and slept for 18 hours. Then continued to go down hill and experienced diarrhea lethargy and extreme fatigue lasting 12 months. Numerous doctors visits, including returning to the clinic where it was given, my pcp and naturopathic MD.
Age: 3.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUCELVAX GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, C-reactive protein, Chills, Dizziness
Clinical narrative: 12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Dry mouth, Eye pain, Full blood count, Headache
Clinical narrative: 12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hyperhidrosis, Joint vibration, Metabolic function test, Myalgia
Clinical narrative: 12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Nausea, Neck pain, Pain in jaw, Paraesthesia
Clinical narrative: 12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation, Tinnitus, Toothache
Clinical narrative: 12:30 am: fast heart beat, palpitations, ringing in ears, itching, dry mouth/eyes. Then more symptoms developed as time went on over 96 hrs +: scratchy throat, stuffy nose, headaches, nausea, neck ache, L foot tingle/vibration, eye pain, prickles all over body, muscle/joint pain, chills, dizzy, sweating, teeth/jaw pain, low back pain.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching and macular rash over trunk, extremities and head.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on chest abdomen and arms.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Mild cellulitis (R) arm low grade fever. Tx with cephalexin and BACTRIM.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Both feet turned red and mildly swollen. The left foot more than the right.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Injection site pain, Neuralgia, Pain in extremity, X-ray limb
Clinical narrative: My Left Shoulder and entire arm was filled with intense pain and shooting nerve pain.  I massaged and iced the areas.   I have seen several doctors and am currently in physical therapy.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3, FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: Initial unsolicited report received from a consumer on 23-Feb-2016. This case involves a 66-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (Influenza virus vaccine whole) (batch number, dose, dose in series, route and administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient experienced neuropathy. Laboratory investigations were not reported. Patient had received LYRICA as a corrective treatment. At the time of this report patient was not recovered from the event. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: 3/6/16 noticed soreness... looked at area and noticed a reddened area around injection site.  3/7/16 noticed the reddened area had grown.  12:20pm 3/7/16 area is red about 2 inches by 3 inches and feels swollen. No treatment has been attempted at this time.
Age: 3.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient presented with fever less than 2 hours after being injected with vaccine.  At 3 hours patient started vomiting.  Fever continued for 36hrs ranging from 100-103 degrees.  Vomiting occurred 7 times for 24 hrs (since 12:30pm on 3/4/2015).  Patient was given oral fluids, Tylenol Children's (160mg/5ml), FeverAll (120 mg of acetaminophen)
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: She developed pneumonia 7 days after being given the PREVNAR vaccine (13). She is the 4th of 4 cases I am submitting within 1 month of vaccination.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Culture, Laboratory test, Pneumonia staphylococcal, X-ray
Clinical narrative: PREVNAR 13. The patient developed MRSA pneumonia within 1 month of the vaccine. He is the 1st of 4 cases I am submitting with the same complication (others not MRSA).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Eye swelling, Hypersensitivity, Mouth swelling, Rhinorrhoea
Clinical narrative: ALLERGIC REACTION = HIVES ALL OVER BODY, SWOLLEN EYES, MOUTH & FACE, RUNNY NOSE, NO APPETITE.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Swelling face, Urticaria
Clinical narrative: ALLERGIC REACTION = HIVES ALL OVER BODY, SWOLLEN EYES, MOUTH & FACE, RUNNY NOSE, NO APPETITE.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in all 4 extremities.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site nodule, Lymphadenopathy, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling of left arm, knot at injection site, Lymph node swelling down the arm, tingling/numbess of left arm fingers.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Laboratory test, Pneumonia
Clinical narrative: PREVNAR 13. Given PREVNAR vaccine 1/5/16 and developed pneumonia 2/5/16. Recovered with antibiotics. This is my 3rd patient to develop pneumonia within 4 weeks of the vaccine.
Age: 0.21
Sex: F
Vaccine: RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of intussusception in a 3-month-old female patient who received ROTARIX (batch number A41CB508A, expiry date 4th February 2017). On 20th October 2015, the patient received the 1st dose of ROTARIX (oral). On 6th December 2015, 47 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). The patient was treated with Enema (Nos). On an unknown date, the outcome of the intussusception was recovered/resolved. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were received as follows: On 6th December 2015, the patient was hospitalized for intussusception and was treated with an air enema. On 8th December 2015, the patient recovered and was discharged. On 10th December 2015, the patient received 2nd dose of ROTARIX (batch number A41CB524A, expiry date 13th February 2017) and the symptoms which occurred after the 1st dose, did not return.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site nodule, Malaise
Clinical narrative: Patient reports feeling "sick and drained (Tired)".  Also reports redness at site and a hard knot at the injection site.  It has been a week.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Diarrhoea, Malaise, Pyrexia, Respiratory symptom
Clinical narrative: Diarrhea next day lasting about a day. Two days after vaccine, asthma like symptoms reported, on 2/21/16 general malaise, and hives. 2/22/16 fever and respiratory symptoms. 2/26 sinus infection, 3/2 sinus infection, antibiotic change by PMD.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Sinusitis, Urticaria
Clinical narrative: Diarrhea next day lasting about a day. Two days after vaccine, asthma like symptoms reported, on 2/21/16 general malaise, and hives. 2/22/16 fever and respiratory symptoms. 2/26 sinus infection, 3/2 sinus infection, antibiotic change by PMD.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash vesicular, Viral rash
Clinical narrative: Appearance of small red spots began, continued into the following day, spreading to most of patient's body. Most spots looked like chicken pox, but some spread and became a larger contiguous rash. Determined to be viral exanthem on March 7th.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Client's mother called on 02/26/2016 at 3:00 PM to report that the day before she had picked up client from school since he was vomiting and had a fever of 102 degrees F. Client's mother reported that Tylenol was not helping to relieve fever. Client's mother was instructed to seek medical attention. I spoke on the phone with client's mom on 3/7/2016 and she reports that they did not seek medical attention, but client is now feeling better. Illness lasted 4-5 days total. Vomiting and fever were the only symptoms reported.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood heavy metal test, Blood test, Delivery, Exposure during pregnancy, Foetal disorder
Clinical narrative: Unborn child started moving less frequently. Baby measured normal at 20 week ultrasound but then growth slowed. Was born at 40 weeks at only 6.4 lbs and had meconium. Baby was born with a neuromuscular disorder and hypertonia. Child is now 3 years old and is barely growing. He is now 24 lbs and 34 inches tall. He cannot was unassisted and has developmental, gross and fine motor delays due to his condition.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal growth restriction, Foetal hypokinesia, Hypotonia, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Unborn child started moving less frequently. Baby measured normal at 20 week ultrasound but then growth slowed. Was born at 40 weeks at only 6.4 lbs and had meconium. Baby was born with a neuromuscular disorder and hypertonia. Child is now 3 years old and is barely growing. He is now 24 lbs and 34 inches tall. He cannot was unassisted and has developmental, gross and fine motor delays due to his condition.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Unborn child started moving less frequently. Baby measured normal at 20 week ultrasound but then growth slowed. Was born at 40 weeks at only 6.4 lbs and had meconium. Baby was born with a neuromuscular disorder and hypertonia. Child is now 3 years old and is barely growing. He is now 24 lbs and 34 inches tall. He cannot was unassisted and has developmental, gross and fine motor delays due to his condition.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: Swelling in left arm, redness, lethargy, severe chills, severe pain in left bicep, inability to lift left arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling in left arm, redness, lethargy, severe chills, severe pain in left bicep, inability to lift left arm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Emotional disorder, Feeling abnormal, Headache, Malaise
Clinical narrative: There was no treatment. The vaccine made me sick to my stomach that I could not stand up while I was at work. I had to sit for about 10 minutes before I had to get back to work. It gave me headaches and made me very emotional (I am not an emotional person.) This lasted for a few days of continuous headaches and that suck feeling, along with bruising and the inability to raise my arm above my head for a few days due to the soreness. The headaches still continue now. (03/07/2016)
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased
Clinical narrative: There was no treatment. The vaccine made me sick to my stomach that I could not stand up while I was at work. I had to sit for about 10 minutes before I had to get back to work. It gave me headaches and made me very emotional (I am not an emotional person.) This lasted for a few days of continuous headaches and that suck feeling, along with bruising and the inability to raise my arm above my head for a few days due to the soreness. The headaches still continue now. (03/07/2016)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Pt developed shingles and post herpetic neuralgia after receiving vaccine.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: Joint and muscle pain. Limited arm motion.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, soreness, and swelling of the arm for one week.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Blood potassium decreased, Body temperature increased, Chest X-ray, Eye swelling, Full blood count
Clinical narrative: Pt developed a itchy rash on arms, neck, and back of head. Eyes and head were swelling with temp of 99.8.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Local swelling, Metabolic function test, Rash, Rash pruritic, White blood cell count increased
Clinical narrative: Pt developed a itchy rash on arms, neck, and back of head. Eyes and head were swelling with temp of 99.8.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bursitis, Joint swelling
Clinical narrative: Bursitis- Swollen arm around elbow.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on neck, face and upper body on back and front.  Blood Pressure at 180/82.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal mass, Abdominal pain, Abdominal pain lower, Adnexal torsion, Computerised tomogram abdomen abnormal
Clinical narrative: Started with abdominal pain 1/20/16 RLQ pain. Had U/S and CT which showed large cystic mass. Had diagnostic laparoscopy which showed (R) paratubal cyst and fallopian tube torsion. Had detorsion of fallopian tube and excision of cyst.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst removal, Fallopian tube cyst, Laparoscopy abnormal, Therapeutic procedure, Ultrasound abdomen abnormal
Clinical narrative: Started with abdominal pain 1/20/16 RLQ pain. Had U/S and CT which showed large cystic mass. Had diagnostic laparoscopy which showed (R) paratubal cyst and fallopian tube torsion. Had detorsion of fallopian tube and excision of cyst.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Paralysis
Clinical narrative: Patient chief complaint is not able to raise arm higher than shoulder. She is feeling "paralysis".
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Cellulitis, Erythema, Pyrexia
Clinical narrative: The patient called the pharmacy to inform that she had to go to the doctor because she had some fever and redness on the arm. The diagnosis was cellulitis and was treated with Loratadine and Cefadroxil.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling in arm from shoulder to elbow (L). Neck and both shoulders stiffness. All started 2/27/16.
Age: 81.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt reports that he developed a rash on both arms going to his back approximately 2 days after receiving the influenza vaccine. Started w/small red spots, then become bigger, inflamed, bumpy too. Methylprednisolone take by mouth as directed.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Tremor
Clinical narrative: Per physician's note: Had flu shot, fb one week of cough, chills and shakes which kept him home for a week.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 101 fever x 24 hours 3-5-16 headache, body aches.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-DEC-2015 at 18:11, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 7.4 and 6.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-ols female patient who received FLUARIX QUADRIVALENT (batch number 7A54E, expiry date 30th June 2016). Concurrent medial conditions included diabetes (no more details were provided). Concomitant products included PREVENAR. On 27th December 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb decreased were unknown. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a consumer via a pharmacy via a pharmacy claims management company. The patient received the FLUARIX QUADRIVALENT vaccine in the left deltoid and the PREVENAR vaccine in the right deltoid. The patient experienced pain the entire left arm and limited movement on it.
Sex: U
Vaccine: FLU4
Symptoms: Bursitis, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shoulder pain in unspecified number of patients who received FLUARIX. On an unknown date, the patients received FLUARIX (intramuscular). On an unknown date, an unknown time after receiving FLUARIX season, the patients experienced shoulder pain, rotator cuff injury and bursitis. On an unknown date, the outcome of the shoulder pain, rotator cuff injury and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, rotator cuff injury and bursitis to be related to FLUARIX season. Additional details were provided as follows: This case was previously reported to a doctor. The reporter reported that they had more than 1 patient who experienced shoulder pain, bursitis, and rotator cuff injuries after receiving the FLUARIX vaccine. The field representative was unable to provide any further details but he stated that the nurse would like to be contacted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash vesicular
Clinical narrative: Developed vesicular eruption in crops one day after 2nd dose of VZV. No sick contacts. No complications.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Differential white blood cell count abnormal, Full blood count abnormal, Gait disturbance, Pyrexia, Ultrasound scan normal
Clinical narrative: Pt. received Hep A #2 at visit on 02-18-16. Developed fever (99 degrees-104.3 degrees max) and (Lt) leg limp on 03/02/16. No other s/s illness. TX = X-ray (Bi) Hip, AP Pelvic and (Lt) knee; hip U.S. (all normal). Labs - mildly elevated. To tx fever with OTC; recheck if s/s worsen or progress.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: Pt. received Hep A #2 at visit on 02-18-16. Developed fever (99 degrees-104.3 degrees max) and (Lt) leg limp on 03/02/16. No other s/s illness. TX = X-ray (Bi) Hip, AP Pelvic and (Lt) knee; hip U.S. (all normal). Labs - mildly elevated. To tx fever with OTC; recheck if s/s worsen or progress.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015 at 07:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 11.2 (5hours and 7mins) and 1.6 (2hours 37mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 07:51, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 03:34, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter.