chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Malaise, Nausea, Tremor
Clinical narrative: Patient c/o not feeling well, was shaky, nauseous with HA.  Once she got home 30 minutes later she ate dinner and threw-up, c/o headache and was sweaty.  Next morning c/o severe headache that lasted throughout day.  Today still has headache.  Encouraged Mom to give daughter Ibuprofen or Tylenol and have her drink plenty of water.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Patient c/o not feeling well, was shaky, nauseous with HA.  Once she got home 30 minutes later she ate dinner and threw-up, c/o headache and was sweaty.  Next morning c/o severe headache that lasted throughout day.  Today still has headache.  Encouraged Mom to give daughter Ibuprofen or Tylenol and have her drink plenty of water.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Condition aggravated, Convulsion, Postictal state, Unresponsive to stimuli, Vomiting
Clinical narrative: Seizure: unresponsive, lasting for approximately 5 minutes. Vomiting immediately following seizure and post-ictal state thereafter.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Documented hypersensitivity to administered drug, Rash
Clinical narrative: Pt received Hep A vaccine, dose #2, on 4/23/13. Started with a rash on arms on 4/25/13. Mom states he has an allergy to Neomycin, component in Hep A vaccine (Havrix). No reaction to first dose of Hep A. Pt seen in office on 4/29/13, treated with hydroxizine and ranitidine. School nurse also put Neosporin in an open wound same week as vaccine, she was not aware of allergy.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Dyspnoea, Eye swelling, Hypersensitivity, Rash
Clinical narrative: 15-30mins after Yellow Fever vaccine given, Pt experienced difficulty breathing and wheezing, rash around his right side of his neck, eye swollen and dizzy/lightheaded. Pt went to the Hospital around 5pm and was given EPI, Benadryl, Prednisone and Zantac told to follow up with Doctor next day. Pt told to take medications as directed, and excused from taking YF vacceine in the future, and never to take it again, placed on allergy list.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Wheezing
Clinical narrative: 15-30mins after Yellow Fever vaccine given, Pt experienced difficulty breathing and wheezing, rash around his right side of his neck, eye swollen and dizzy/lightheaded. Pt went to the Hospital around 5pm and was given EPI, Benadryl, Prednisone and Zantac told to follow up with Doctor next day. Pt told to take medications as directed, and excused from taking YF vacceine in the future, and never to take it again, placed on allergy list.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Left arm swollen, red, hard, itchy, and warm to the touch, given Benadryl and Keflex 250mg qid x 10 days.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Nodule, Oedema peripheral, Pain
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Condition aggravated, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: 38y/o female with vaccine reaction to typhoid and anthrax. Pt had 3 previous Anthrax vaccines and 4 Typhoid vaccines without any complications or adverse reactions.  On 19Apr13, pt received both anthrax and typhoid vaccines placed in left deltoid.  Day of vaccine, pt reported pain at site of shot, with pain down to her left hand.  +erythema.  +swelling of left deltoid area. +malaise, no documented fever. 21Apr13: pt was feeling pain of her left scapula and shoulder region, with resolution of lower left arm/hand pain.  Still had erythema/swelling of left deltoid.   Pt also reported having headaches and nausea, slightly worse than her usual migraines.  Pt was treating with Celexa and Motrin 800mg.  23Apr13: pt reports she feels like there is a band over her left deltoid, with obvious swelling.  Erythema is only noticeable on the lower/distal aspect of the induration of her deltoid and upper arm.  Pt reports throbbing pain of left deltoid, but no longer having shoulder/scapula pain. Pain is present with and without arm movement.  Pt says she can't raise her arm above her head secondary to pain.  No lymphadenopathy of left axilla compared to right but pt was tender in axilla area.  Site of injection was not erythematous.  Did not have any pustules/edema/abscess/fluid.   Symptoms have improved gradually since day of shot.  Treated with NSAIDs with not much improvement in the pain, despite gradual resolution of induration/erythema. Today (1May13), pt reports resolution of erythema and swelling of left deltoid.  No longer having any scapula, chest, lower arm/hand pain.  Very mild residual pain of deltoid, but pt has full function of arm.  Pt reports having headache that has waxed/waned since vaccines but is gone today.  Treated with Motrin 800mg yesterday.  Pt has been applying ice packs to arm in addition to taking NSAIDs.  On 23Apr13, Placed a medical temporary exemption for typhoid/anthrax until pt could be evaluated by Allergy clinic and HC.  1May13, pt was eval by Allergy fellow and NP.  Discussed reaction was large local to anthrax.  Medical reactive exemption to anthrax given, noted in ASIMS.  Exemptions to typhoid removed.  Discussed 2yr protection after this vaccination, and tx with anthrax vaccine and antibiotics if exposed.  Recommend pretreat with antihistamine and NSAIDs prior to vaccine to help with large Local reaction.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Malaise, Migraine
Clinical narrative: 38y/o female with vaccine reaction to typhoid and anthrax. Pt had 3 previous Anthrax vaccines and 4 Typhoid vaccines without any complications or adverse reactions.  On 19Apr13, pt received both anthrax and typhoid vaccines placed in left deltoid.  Day of vaccine, pt reported pain at site of shot, with pain down to her left hand.  +erythema.  +swelling of left deltoid area. +malaise, no documented fever. 21Apr13: pt was feeling pain of her left scapula and shoulder region, with resolution of lower left arm/hand pain.  Still had erythema/swelling of left deltoid.   Pt also reported having headaches and nausea, slightly worse than her usual migraines.  Pt was treating with Celexa and Motrin 800mg.  23Apr13: pt reports she feels like there is a band over her left deltoid, with obvious swelling.  Erythema is only noticeable on the lower/distal aspect of the induration of her deltoid and upper arm.  Pt reports throbbing pain of left deltoid, but no longer having shoulder/scapula pain. Pain is present with and without arm movement.  Pt says she can't raise her arm above her head secondary to pain.  No lymphadenopathy of left axilla compared to right but pt was tender in axilla area.  Site of injection was not erythematous.  Did not have any pustules/edema/abscess/fluid.   Symptoms have improved gradually since day of shot.  Treated with NSAIDs with not much improvement in the pain, despite gradual resolution of induration/erythema. Today (1May13), pt reports resolution of erythema and swelling of left deltoid.  No longer having any scapula, chest, lower arm/hand pain.  Very mild residual pain of deltoid, but pt has full function of arm.  Pt reports having headache that has waxed/waned since vaccines but is gone today.  Treated with Motrin 800mg yesterday.  Pt has been applying ice packs to arm in addition to taking NSAIDs.  On 23Apr13, Placed a medical temporary exemption for typhoid/anthrax until pt could be evaluated by Allergy clinic and HC.  1May13, pt was eval by Allergy fellow and NP.  Discussed reaction was large local to anthrax.  Medical reactive exemption to anthrax given, noted in ASIMS.  Exemptions to typhoid removed.  Discussed 2yr protection after this vaccination, and tx with anthrax vaccine and antibiotics if exposed.  Recommend pretreat with antihistamine and NSAIDs prior to vaccine to help with large Local reaction.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: 38y/o female with vaccine reaction to typhoid and anthrax. Pt had 3 previous Anthrax vaccines and 4 Typhoid vaccines without any complications or adverse reactions.  On 19Apr13, pt received both anthrax and typhoid vaccines placed in left deltoid.  Day of vaccine, pt reported pain at site of shot, with pain down to her left hand.  +erythema.  +swelling of left deltoid area. +malaise, no documented fever. 21Apr13: pt was feeling pain of her left scapula and shoulder region, with resolution of lower left arm/hand pain.  Still had erythema/swelling of left deltoid.   Pt also reported having headaches and nausea, slightly worse than her usual migraines.  Pt was treating with Celexa and Motrin 800mg.  23Apr13: pt reports she feels like there is a band over her left deltoid, with obvious swelling.  Erythema is only noticeable on the lower/distal aspect of the induration of her deltoid and upper arm.  Pt reports throbbing pain of left deltoid, but no longer having shoulder/scapula pain. Pain is present with and without arm movement.  Pt says she can't raise her arm above her head secondary to pain.  No lymphadenopathy of left axilla compared to right but pt was tender in axilla area.  Site of injection was not erythematous.  Did not have any pustules/edema/abscess/fluid.   Symptoms have improved gradually since day of shot.  Treated with NSAIDs with not much improvement in the pain, despite gradual resolution of induration/erythema. Today (1May13), pt reports resolution of erythema and swelling of left deltoid.  No longer having any scapula, chest, lower arm/hand pain.  Very mild residual pain of deltoid, but pt has full function of arm.  Pt reports having headache that has waxed/waned since vaccines but is gone today.  Treated with Motrin 800mg yesterday.  Pt has been applying ice packs to arm in addition to taking NSAIDs.  On 23Apr13, Placed a medical temporary exemption for typhoid/anthrax until pt could be evaluated by Allergy clinic and HC.  1May13, pt was eval by Allergy fellow and NP.  Discussed reaction was large local to anthrax.  Medical reactive exemption to anthrax given, noted in ASIMS.  Exemptions to typhoid removed.  Discussed 2yr protection after this vaccination, and tx with anthrax vaccine and antibiotics if exposed.  Recommend pretreat with antihistamine and NSAIDs prior to vaccine to help with large Local reaction.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness, Blood test, Guillain-Barre syndrome, Monoplegia, Visual acuity tests
Clinical narrative: Paralysis - right leg - ascending; 1/15/13 awoke with partial blindness (right eye); 1/19/13 awoke with total blindness (left eye); Hospitalized for extreme illness from 1/23/13-1/26/13.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antineutrophil cytoplasmic antibody negative, Blindness, Cerebrovascular accident, Computerised tomogram head abnormal, Embolism
Clinical narrative: Paralysis - right leg - ascending; 1/15/13 awoke with partial blindness (right eye); 1/19/13 awoke with total blindness (left eye); Hospitalized for extreme illness from 1/23/13-1/26/13.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pain, Nuclear magnetic resonance imaging normal, Ophthalmological examination, Optic neuropathy, Vision blurred
Clinical narrative: Paralysis - right leg - ascending; 1/15/13 awoke with partial blindness (right eye); 1/19/13 awoke with total blindness (left eye); Hospitalized for extreme illness from 1/23/13-1/26/13.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling tenderness from injection site to surrounding area approximately 5 inches in diameter.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
Clinical narrative: 8 days after MMR vaccine, spiked a 103.4 fever that will not break even with Tylenol and Motrin. My son has the chills and is shaking from being cold, even though fever is high.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Decreased appetite, Dizziness, Headache
Clinical narrative: 1. Pain at vaccine site (severe) within 15 minutes 2. Nausea 3. Loss of appetite that evening 4. Stomach ache all night 5. Nausea and light-headedness 6:00AM waking up 6. Nausea and VOMIT and headache at school 7. Sent home early from school by nurse 2PM 8. Severe painful abdominal cramps all day
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: 1. Pain at vaccine site (severe) within 15 minutes 2. Nausea 3. Loss of appetite that evening 4. Stomach ache all night 5. Nausea and light-headedness 6:00AM waking up 6. Nausea and VOMIT and headache at school 7. Sent home early from school by nurse 2PM 8. Severe painful abdominal cramps all day
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was inadvertently vaccinated with an expired PEDVAXHIB (dose 0.5 ml, intramuscular route) (lot number 0437AA) vaccine that has expired on 09-APR-2013. No concomitant medications were reported. No adverse effects reported. This case is linked to MARRS 1304USA015547 and 1305USA000264. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Very swollen arm. Fever 103. Severe weakness and malaise for 2-3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Blisters on Wed (approx 2 days after inj) at injection site (1 large, 1 med, several small) redness, radiating heat, swelling of injection site and surrounding area. Pt used hydrocortisone cream on surrounding area and symptoms resolved (blisters gone) by 5/1/13 at 6:30 pm.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at site. Fever since 4/30/13. Location in (L) deltoid.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Fatigue, Injection site pain
Clinical narrative: Pt c/o's dizziness, migraine, abd cramping, nausea, diarrhea, increased fatigue am after receiving injection. Symptoms continued Sat and Sunday. Painful inj site. Denied SOB, wheeze, throat swelling or fevers.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Nausea
Clinical narrative: Pt c/o's dizziness, migraine, abd cramping, nausea, diarrhea, increased fatigue am after receiving injection. Symptoms continued Sat and Sunday. Painful inj site. Denied SOB, wheeze, throat swelling or fevers.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Provider notified, patient notified.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: 3/27/13. Stated shortly after receiving vaccine she felt weak. Weakness lasted one week but 1st day was the worst. Had rash, hives like, fine red rash to arms, face and chest. Also had itching, took BENADRYL and it helped.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling and pain at site. Fever chills headache - could not hold urine not sleeping.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pyrexia, Urinary incontinence
Clinical narrative: Redness and swelling and pain at site. Fever chills headache - could not hold urine not sleeping.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was inadvertently vaccinated with an expired PEDVAXHIB (dose 0.5 ml, intramuscular route) (lot number 0437AA) vaccine that has expired on 09-APR-2013. No concomitant medications were reported. No adverse effects reported. This case is linked to MARRS 1304USA015547 and 1305USA000265. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was inadvertently vaccinated with an expired PEDVAXHIB (dose 0.5 ml, intramuscular route) (lot number 0437AA) vaccine that has expired on 09-APR-2013. No concomitant medications were reported. No adverse effects reported. This case is linked to MARRS 1305USA000264 and 1305USA000265. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial information has been received from a registered nurse concerning a 27 year old patient with an unspecified age, pertinent medical history or drug reactions/allergies. On 19-OCT-2012 the patient was vaccinated with the first dose of GARDASIL intramuscular (dose, frequency lot number were not reported). On 20-DEC-2012, the patient was vaccinated with the second dose of GARDASIL intramuscular (dose, frequency lot number were not reported). On 19-APR-2013, the patient received the third dose of GARDASIL intramuscular (dose, frequency lot number were not reported). No other co-suspect medications were reported. No concomitant medications were reported. The patient was vaccinated with the first and second doses of GARDASIL when the patient was 26 years of age. On 19-APR-2013, the patient was administered the third dose of GARDASIL when the patient was 27 years of age. No adverse effect reported. Action taken was not applicable. The events were not related to GARDASIL. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from an 81 year old female consumer refers to herself with no pertinent medical history and no drug reactions/allergies. On 16-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, strength, dose, route and site not reported). Concomitant medication included blood pressure medications and baby aspirin (also reported as treatment). On 16-APR-2013, the patient experienced redness, swelling, tenderness and 2 pin sized brown "spots" at the site of the injection after receiving the dose of ZOSTAVAX. The swelling was about 2 inches in diameter. Aspirin was given for treatment. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The patient saw a pharmacist for medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 51 year old female patient. On an unknown date the patient was vaccinated with MMR II (lot # and expiration date unspecified) one shot, subcutaneous (dose and anatomical location unspecified). On an unknown date the patient developed a high fever of 104 or 105 degrees Fahrenheit five days after she received the MMR II. The patient was fully recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 27-MAR-2013, the patient was vaccinated with a dose of improperly stored PROQUAD (Lot number was H020140, expiry date was 07-MAY-2014, route and dose were not reported) at around 10-11 am. No adverse effect was reported. This is one of the three reports received from the same reporter. Follow up information has been received from the medical assistant refers to a 4 years old male patient. The patient was vaccinated with PROQUAD (lot # H020140, subcutaneously) on 27-MAR-2013. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy normal, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 21 year old female patient. In approximately 2005, at approximately 14 years of age, the patient was vaccinated with the complete series of GARDASIL (route and lot # not reported). The nurse reported that on 01-MAR-2013, the patient had abnormal PAP smear test. The patient underwent a colposcopy with a negative result. The patient did not seek medical attention. The outcome of abnormal PAP smear test was unknown. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practitioner Nurse referred to a 4 month old male patient who on 17-APR-2013 was accidentally vaccinated with a dose of PNEUMOVAX 23 (dose not reported). No adverse effects were reported. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This spontaneous report as received from a nurse refers to a 43 year old female patient with asthma, Demerol allergy, pyridium allergy, sudafed allergy and amoxicillin allergy. The patient's medical history included shortness of breath. On 22-APR-2013 the patient was vaccinated with PNEUMOVAX 23 (Lot # reported as H022064, Exp date 25-JAN-2014, route and dose not reported). Concomitant therapies included PROTONIX, meloxicam, cetirizine hydrochloride, unspecified "inhalers for asthma" and SINGULAIR. On 23-APR-2013 the patient experienced the patient developed a "50 cent piece" size area around the injection site that was, red, raised, swollen and sore after receiving the vaccine. The nurse reported on 24-APR-2013, this area "was bigger and was all over the patient's arm" and the patient experienced feeling lightheaded and "an overall feeling of not feeling well". The patient was sent to the emergency department for treatment. The outcome was recovering. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 13 year old female patient with no pertinent history, or drug reactions or allergies reported. On an unknown date when the patient was 9 years old, was vaccinated with GARDASIL (lot number and expiration date not specified) (dose, route and anatomical location not specified). No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient returned on 25-APR-2013 (reported as "today") to receive her second dose of GARDASIL. The patient is now 13 years old. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an immunizing pharmacist via company representative refers to a 79 year old female patient. On 19-OCT-2011, the patient was vaccinated with ZOSTAVAX (dose and therapy route unspecified) for prevention of shingles. The pharmacist reported that the patient on three separate occasions, after receiving ZOSTAVAX, the patient developed shingles. The first case was on 10-MAY-2012, the second case on 26-SEP-2012 and the third case on 02-MAR-2013. On an unspecified case, the patient developed shingles on her trunk, leg and back. On third case of shingles the patient developed shingles lingering pain. The patient saw an unspecified physician after each use. Unspecified antiviral and pain medication was given to the patient on an unspecified date. The patient was treated at unspecified hospital emergency room on an unspecified date. No PQC was involved. At the time of the report, relationship between ZOSTAVAX and events were unknown. The patient's outcome regarding events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report as received from an immunization official via a company representative refers to 7 patients of unknown gender and ages. On an unknown date the patients were vaccinated with an unknown dose number of MMR II (route, dose, anatomical location and lot number unknown). The immunization official stated that she did not know if the 7 people had received MMR II in the past, concomitant medications were not reported. On an unknown date the 7 patients developed measles. The outcome of measles was unknown. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture positive, Confusional state, Hypoxia, Myalgia, Nausea
Clinical narrative: Case number PHHY2011US114906 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 416124) website on 01 Apr 2011, and with a follow-up received from QA department on 30 Apr 2013. This is also a quality complaint (216459) report. This report refers to a 60-year-old male patient. His medical history included allergies to gentamycin, myelodysplasia. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to unspecified site on 04 Oct 2010. On the same day, he developed fever up to 102 F, took APAP at home, but no effect, and next day his temperature was 103.8 (units not reported). He went to emergency room. He was hypoxic with oxygen saturation level of 82% in room air. He was confused and nauseated due to which he got admitted to CCU with the diagnosis of neutropenic sepsis. He was hospitalized for 6 days. He also complained of myalgia. Lab test for blood culture yielded methicillin resistant staphylococcus aureus (MRSA). The final outcome was reported as condition unchanged on 01 Feb 2011. Causality assessment was not reported. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the complaint production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up report received from QA department on 30 Apr 2013. Investigational summary updated.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neutropenic sepsis, Pyrexia, Staphylococcus test positive
Clinical narrative: Case number PHHY2011US114906 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 416124) website on 01 Apr 2011, and with a follow-up received from QA department on 30 Apr 2013. This is also a quality complaint (216459) report. This report refers to a 60-year-old male patient. His medical history included allergies to gentamycin, myelodysplasia. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on to unspecified site on 04 Oct 2010. On the same day, he developed fever up to 102 F, took APAP at home, but no effect, and next day his temperature was 103.8 (units not reported). He went to emergency room. He was hypoxic with oxygen saturation level of 82% in room air. He was confused and nauseated due to which he got admitted to CCU with the diagnosis of neutropenic sepsis. He was hospitalized for 6 days. He also complained of myalgia. Lab test for blood culture yielded methicillin resistant staphylococcus aureus (MRSA). The final outcome was reported as condition unchanged on 01 Feb 2011. Causality assessment was not reported. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the complaint production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up report received from QA department on 30 Apr 2013. Investigational summary updated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2012US111777, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469662) website on 04 Dec 2012 with a non-significant follow-up received from a Quality Assurance department (reference number: 199066) on 11 Dec 2012, with a follow up received from the QA department on 01 May 2013: This report refers to a 48-year-old female patient. Her historical conditions and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205501) intramuscularly to her left arm on 02 Oct 2012. On 04 Oct 2012 patient returned with redness, pain and heat at injection site. She was referred for medical treatment for cellulitis and was given antibiotics. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 1205501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The event outcome was reported as complete recovery. No further information was available. Non-significant follow-up received from a Quality Assurance department on 11 Dec 2012: Updated QA reference number only and batch review is in progress. Follow up received from the QA department on 01 May 2013: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US012349 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 471136) web site on 08 Feb 2013 with a follow up information received from the quality assurance department (reference number: 210826) on 30 Apr 2013. This report refers to a 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly on to left arm and PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly on to right arm on 09 Oct 2012. On 10 Oct 2012, she developed redness and swelling at injection site that spread all over upper arm. She went to emergency room and visited physician. She was given KEFLEX due to infection. The outcome of the events was reported as complete recovery. The quality assurance department registered a complaint with reference number 210826. Based on the review performed, the FLUVIRIN batch 1207201 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from quality assurance department on 30 Apr 2013: Batch summary updated.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Case number PHHY2013US012394 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473021) on 08 Feb 2013, and a follow up received from the quality assurance department (quality reference number: 211288) on 01 May 2013: This report refers to a 66-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205501) intramuscularly (administration site unspecified) on 11 Oct 2012. The patient also received PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly in to the right arm on 11 Oct 2012. On the same day after vaccinations, he reported feeling feverish and experienced hardness, pain and redness at site of injection on right arm where he had received pneumonia vaccination. Patient physician confirmed that it was cellulitis. Patient was prescribed antibiotic, Clindamycin on 12 Oct 2012. Final outcome was reported as condition unchanged as on 12 Oct 2012. No further information about causality and seriousness was provided. Based on the batch review performed, it was confirmed that FLUVIRIN batch number 1205501 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up received from the quality assurance department on 01 May 2013: updated batch review report.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Rash
Clinical narrative: Case number PHHY2013US012000, is a spontaneous report received initially from the Vaccine Adverse Event Reporting System (VAERS reference number: 474466) website on 08 Feb 2013 with the follow-up received from Quality Assurance Department (reference number: 210327) on 24 Apr 2013: This report refers to a 09-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly into right arm on 13 Nov 2012. On 14 Nov 2012, within 24 hours of vaccination, his mother noticed rash. He visited the emergency room (fast care) and was diagnosed with cellulitis. He was prescribed with KEFLEX as a treatment drug. The outcome of the event was reported as not recovered at the time of reporting. The event seriousness and causality was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1206901) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 24 Apr 2013: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Injection site pain, Muscular weakness
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 65 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies or reactions. On 16-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route was not reported, right arm). Other suspect therapies included ZOSTAVAX (lot number, expiry date and route was not reported, right arm) on 16-JAN-2013. Concomitant therapies included ADVIL and VITAMINS (Unspecified). The reporter stated that her husband had received PNEUMOVAX 23 and ZOSTAVAX during the same office visit in the same arm. The patient had not felt right ever since receiving the vaccines and has not been the same functionally. The first symptoms that presented initially were fever and chills and severe pain in his right shoulder. (vaccines given in right arm) to the point of being immobile. The patient was treated with 10 days of prednisone and these symptoms resolved however following this systemic symptoms including muscle tightness and muscle jitteriness began that have been intermittent and persistent lasting now for approximately 3 months. The patient had almost lost 15 pounds since receiving the vaccines. The reporter also stated that the patient was currently experienced generalized muscle stiffness, muscle jitteriness and shakiness of his hands and legs. The patient saw an endocrinologist who ruled out Addisons disease. He has seen a gastroenterologist who ruled out H. Pylori and saw a rheumatologist who had ordered a creatine phosphokinase (CPK test) results not available. The patient was experiencing anxiety and depression because of his physical symptoms. The patient was not hospitalized. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Night sweats, Pyrexia, Weight decreased
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 65 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies or reactions. On 16-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route was not reported, right arm). Other suspect therapies included ZOSTAVAX (lot number, expiry date and route was not reported, right arm) on 16-JAN-2013. Concomitant therapies included ADVIL and VITAMINS (Unspecified). The reporter stated that her husband had received PNEUMOVAX 23 and ZOSTAVAX during the same office visit in the same arm. The patient had not felt right ever since receiving the vaccines and has not been the same functionally. The first symptoms that presented initially were fever and chills and severe pain in his right shoulder. (vaccines given in right arm) to the point of being immobile. The patient was treated with 10 days of prednisone and these symptoms resolved however following this systemic symptoms including muscle tightness and muscle jitteriness began that have been intermittent and persistent lasting now for approximately 3 months. The patient had almost lost 15 pounds since receiving the vaccines. The reporter also stated that the patient was currently experienced generalized muscle stiffness, muscle jitteriness and shakiness of his hands and legs. The patient saw an endocrinologist who ruled out Addisons disease. He has seen a gastroenterologist who ruled out H. Pylori and saw a rheumatologist who had ordered a creatine phosphokinase (CPK test) results not available. The patient was experiencing anxiety and depression because of his physical symptoms. The patient was not hospitalized. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Anxiety, Blood creatine phosphokinase, Chills, Depression, Feeling abnormal
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 65 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies or reactions. On 16-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route was not reported, right arm). Other suspect therapies included ZOSTAVAX (lot number, expiry date and route was not reported, right arm) on 16-JAN-2013. Concomitant therapies included ADVIL and VITAMINS (Unspecified). The reporter stated that her husband had received PNEUMOVAX 23 and ZOSTAVAX during the same office visit in the same arm. The patient had not felt right ever since receiving the vaccines and has not been the same functionally. The first symptoms that presented initially were fever and chills and severe pain in his right shoulder. (vaccines given in right arm) to the point of being immobile. The patient was treated with 10 days of prednisone and these symptoms resolved however following this systemic symptoms including muscle tightness and muscle jitteriness began that have been intermittent and persistent lasting now for approximately 3 months. The patient had almost lost 15 pounds since receiving the vaccines. The reporter also stated that the patient was currently experienced generalized muscle stiffness, muscle jitteriness and shakiness of his hands and legs. The patient saw an endocrinologist who ruled out Addisons disease. He has seen a gastroenterologist who ruled out H. Pylori and saw a rheumatologist who had ordered a creatine phosphokinase (CPK test) results not available. The patient was experiencing anxiety and depression because of his physical symptoms. The patient was not hospitalized. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Feeling jittery, Muscle tightness, Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 65 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies or reactions. On 16-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route was not reported, right arm). Other suspect therapies included ZOSTAVAX (lot number, expiry date and route was not reported, right arm) on 16-JAN-2013. Concomitant therapies included ADVIL and VITAMINS (Unspecified). The reporter stated that her husband had received PNEUMOVAX 23 and ZOSTAVAX during the same office visit in the same arm. The patient had not felt right ever since receiving the vaccines and has not been the same functionally. The first symptoms that presented initially were fever and chills and severe pain in his right shoulder. (vaccines given in right arm) to the point of being immobile. The patient was treated with 10 days of prednisone and these symptoms resolved however following this systemic symptoms including muscle tightness and muscle jitteriness began that have been intermittent and persistent lasting now for approximately 3 months. The patient had almost lost 15 pounds since receiving the vaccines. The reporter also stated that the patient was currently experienced generalized muscle stiffness, muscle jitteriness and shakiness of his hands and legs. The patient saw an endocrinologist who ruled out Addisons disease. He has seen a gastroenterologist who ruled out H. Pylori and saw a rheumatologist who had ordered a creatine phosphokinase (CPK test) results not available. The patient was experiencing anxiety and depression because of his physical symptoms. The patient was not hospitalized. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Tremor, Weight decreased
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 65 year old husband (who is the patient). The patient had no pertinent medical history or drug allergies or reactions. On 16-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date and route was not reported, right arm). Other suspect therapies included ZOSTAVAX (lot number, expiry date and route was not reported, right arm) on 16-JAN-2013. Concomitant therapies included ADVIL and VITAMINS (Unspecified). The reporter stated that her husband had received PNEUMOVAX 23 and ZOSTAVAX during the same office visit in the same arm. The patient had not felt right ever since receiving the vaccines and has not been the same functionally. The first symptoms that presented initially were fever and chills and severe pain in his right shoulder. (vaccines given in right arm) to the point of being immobile. The patient was treated with 10 days of prednisone and these symptoms resolved however following this systemic symptoms including muscle tightness and muscle jitteriness began that have been intermittent and persistent lasting now for approximately 3 months. The patient had almost lost 15 pounds since receiving the vaccines. The reporter also stated that the patient was currently experienced generalized muscle stiffness, muscle jitteriness and shakiness of his hands and legs. The patient saw an endocrinologist who ruled out Addisons disease. He has seen a gastroenterologist who ruled out H. Pylori and saw a rheumatologist who had ordered a creatine phosphokinase (CPK test) results not available. The patient was experiencing anxiety and depression because of his physical symptoms. The patient was not hospitalized. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Secondary transmission, Vaccination complication
Clinical narrative: This is a follow-up VAERS for VAERS # 487142-1 (possible contact transmission). Patient received smallpox vaccination on 1 Mar 2013. His wife assisted with dressing changes. On 7 Mar 13 the wife noted a "blister-like" lesion her her upper left eyelid. Lesion was tested for vaccinia: PCR neg for vaccinia.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Polymerase chain reaction, Viral test negative
Clinical narrative: This is a follow-up VAERS for VAERS # 487142-1 (possible contact transmission). Patient received smallpox vaccination on 1 Mar 2013. His wife assisted with dressing changes. On 7 Mar 13 the wife noted a "blister-like" lesion her her upper left eyelid. Lesion was tested for vaccinia: PCR neg for vaccinia.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness, Blood test, Guillain-Barre syndrome, Monoplegia, Visual acuity tests
Clinical narrative: Eye Exam 1/16/2013, grey fog center right eye and pain left eye. Optic neuropathy. Partial vision loss. On 1/20/2013 vision loss of left eye with complete visual loss. Admit to hospital 1/23/13 to bilateral vision loss of unknown etiology, MRI unremarkable for ischemia. Discharge 1/26/2013. Thromboembolic CVA.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antineutrophil cytoplasmic antibody negative, Blindness, Cerebrovascular accident, Computerised tomogram head abnormal, Embolism
Clinical narrative: Eye Exam 1/16/2013, grey fog center right eye and pain left eye. Optic neuropathy. Partial vision loss. On 1/20/2013 vision loss of left eye with complete visual loss. Admit to hospital 1/23/13 to bilateral vision loss of unknown etiology, MRI unremarkable for ischemia. Discharge 1/26/2013. Thromboembolic CVA.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye pain, Nuclear magnetic resonance imaging normal, Ophthalmological examination, Optic neuropathy, Vision blurred
Clinical narrative: Eye Exam 1/16/2013, grey fog center right eye and pain left eye. Optic neuropathy. Partial vision loss. On 1/20/2013 vision loss of left eye with complete visual loss. Admit to hospital 1/23/13 to bilateral vision loss of unknown etiology, MRI unremarkable for ischemia. Discharge 1/26/2013. Thromboembolic CVA.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Inflammation, Pain in extremity, Rash, Skin warm, Swelling
Clinical narrative: Small welt started out dime size and was warm, by 10PM rash spread to the size of an egg. The next morning a good portion of triceps and arm were inflamed. By the evening on May 1st the rash spread and was inflamed with shooting pains down my arm and swelling into my armpit.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Small welt started out dime size and was warm, by 10PM rash spread to the size of an egg. The next morning a good portion of triceps and arm were inflamed. By the evening on May 1st the rash spread and was inflamed with shooting pains down my arm and swelling into my armpit.
Age: 1.71
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site rash, Joint swelling, Rash generalised
Clinical narrative: Her mother states that she developed a rash around the injection site. The rash continued to spread over the following days to the rest of her body. On 31 March she developed swelling in both arms at her elbows. Her mother states that it was at that time that she called the ambulance and was admitted to the hospital. Her mother states that she was given IV cortisone which made the rash and swelling go away.