chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Convulsion, Drug exposure before pregnancy, Head injury, Resuscitation
Clinical narrative: Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning a female who "a couple of years ago" was vaccinated with completed series dose of GARDASIL. The patient had been having a lot of health problems. Recently, on an unspecified date, the patient had a miscarriage and was put on DEPO-PROVERA. Soon after, the patient had seizure activities. The patient collapsed during a walk with her sister and hit her head and rushed to the hospital. On another occasion, patient was in the hospital for some tests and also collapsed in the cafeteria and code was called for her. At the present time, the patient was admitted in the hospital (location unspecified) for further test. And during hospital stay, the patient experienced at least 3 seizures. Upon the time of the report, the patient's present status was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning a female who "a couple of years ago" was vaccinated with completed series dose of GARDASIL. The patient had been having a lot of health problems. Recently, on an unspecified date, the patient had a miscarriage and was put on DEPO-PROVERA. Soon after, the patient had seizure activities. The patient collapsed during a walk with her sister and hit her head and rushed to the hospital. On another occasion, patient was in the hospital for some tests and also collapsed in the cafeteria and code was called for her. At the present time, the patient was admitted in the hospital (location unspecified) for further test. And during hospital stay, the patient experienced at least 3 seizures. Upon the time of the report, the patient's present status was unknown. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient received the HPV and following 3 minutes later patient complained of lightheadedness. She was escorted to exam table to lie down. Patient stated started to feel better and remained for 10 minutes. BP was taken 113/64. Raised to sitting position, BP 97/75, BP 2 minutes later 116/74. Raised to standing position, walked 5 steps, BP 106/70. Patient stated feeling better and escorted to car. Explained to patient if reocurrance lie down.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness and warmth and tenderness around vaccine injection site on left upper arm
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Headache, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Papule, Pyrexia, Rash macular, Rash pruritic, Scar
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Skin discolouration, Skin lesion
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Biopsy skin abnormal, Generalised vaccinia, Headache, Injection site discolouration, Injection site erythema
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Neck pain, Pain of skin, Pyrexia, Rash macular
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash pruritic, Scar, Skin lesion, Skin oedema
Clinical narrative: This 43 yo AD service member reported receipt of typhoid, AVA#1 and HepB #1 on 3/3/11 with no systemic adverse events. She did c/o nodule formation to her left deltoid lasting about 1 month. It resolved about 1-2 days before receipt of AVA#2 and HepB #2 on 4/4/2011, again to left deltoid. She denied any adverse events other than site tenderness when she received her primary SPV on 4/8/2011 to left deltoid. Approximately day 4-5, she experienced a dull frontal and occipital headache 5/10 self treating with OTC MOTRIN w/relief. She attributed this headache to onset of menses (headache similar to past menstrual headaches). Approximately day 6-7, her SPV site began to redden, swell and itch with skin tenderness under bandage. Day 8 (4/16/11) she c/o of left axillary node swelling and tenderness. On day 11 (4/19/11), while returning from where she was visiting family (4/16-19/11), she c/o scattered red macular spots on left then right forearms, right shoulder, neck and hairline and a mild headache and neck ache which eased by rubbing her neck and use of MOTRIN. She self treated her pruritic red spots with her son's Trimincinalone thinking she has poison ivy (not put on SPV site). She had mowed the lawn 24 hours before with possible exposure to area known to have had poison ivy; however she did not remember seeing any. Day 12 (4/20/2011) she presented to medical clinic complaining of a mild fever (99.2 F) with skin lesions and was transferred to another clinic for further evaluation. She advised she had kept her SPV site covered utilizing large bandaids with resulting skin irritation around SPV site most likely from the bandage adhesive. On day 13 (4/22/2011) her lesions had expanded to her arms, forearms, hands (including hypothenar regions), and 2 papules to left anterior thigh. She c/o tender pinpoint red macules to anterior hairline and behind her left ear. Macules to arms and hands were tender, especially to hypothenar regions. As of 4/25/2011 SM reported skin lesions were almost resolved with dark patch skin discoloration at sites. She continued to experience tenderness along the hypothenar region of the right hand. She denied any headaches, myalgia, fevers, or new symptomatology. She is using Clodetasol cream to sites. 5/5/2011 full resolution of rash with some scaring.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Asthma, Dizziness, Fatigue, Pyrexia
Clinical narrative: Fever 103 degrees, dizziness, lightheadedness, fatigue, asthmatic episode - Mother left message on our service on 4/8/11 describing the symptoms listed on left side. She did not return our calls until 4/11/11 - stating son was fine now. He used inhaler 1 time only. No additional symptoms or problems noted. No treatment.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Patient states dizzy, hot and nausea within a few minutes after getting last shot and lasted about 2 minutes. Laid patient down, checked BP 80/40 and gave juice. Patient improved.
Sex: U
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: 5 hrs after vaccine, tingling noted in (L) hand for about 5 hrs - until patient went to sleep (vaccine in (L) deltoid).
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Activities of daily living impaired, Malaise, Myalgia, Nodule, Pyrexia
Clinical narrative: Mom reports 48 hours post vaccination, pt developed fever, muscle aches & general malaise. Sx lasted x 48 hours - T max 103 degrees F (missed 2 days of school). Then subsided. Had a nickel sized "knot" "in one of his arms".
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site reaction, Local reaction
Clinical narrative: Localized allergic rx at injection site of pneumonia vaccine
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Anxiety, Axillary pain, Chest pain, Electrocardiogram normal, Generalised vaccinia
Clinical narrative: Blistering around smallpox site, armpit swollen and sore, tingling in left hand.  Multiple bumps on back of head, neck, both arms, chest, finger, and back.  Pt presented to the clinic with chest pain 09 May 11.  EKG was performed to r/u myocarditis/pericarditis.  EKG did not show any signs of either condition.  Chest pain may have been due to anxiety related to Dx of generalized vaccinia.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site vesicles, Oedema peripheral, Paraesthesia, Rash
Clinical narrative: Blistering around smallpox site, armpit swollen and sore, tingling in left hand.  Multiple bumps on back of head, neck, both arms, chest, finger, and back.  Pt presented to the clinic with chest pain 09 May 11.  EKG was performed to r/u myocarditis/pericarditis.  EKG did not show any signs of either condition.  Chest pain may have been due to anxiety related to Dx of generalized vaccinia.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Activities of daily living impaired, Adverse reaction, Electrocardiogram normal, Pain in extremity, Rash
Clinical narrative: Blistering around smallpox site, armpit swollen and sore, tingling in left hand.  Multiple bumps on back of head, neck, both arms, chest, finger, and back.  Pt presented to the clinic with chest pain 09 May 11.  EKG was performed to r/u myocarditis/pericarditis.  EKG did not show any signs of either condition.  Chest pain may have been due to anxiety related to Dx of generalized vaccinia.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site vesicles, Local swelling, Paraesthesia, Rash
Clinical narrative: Blistering around smallpox site, armpit swollen and sore, tingling in left hand.  Multiple bumps on back of head, neck, both arms, chest, finger, and back.  Pt presented to the clinic with chest pain 09 May 11.  EKG was performed to r/u myocarditis/pericarditis.  EKG did not show any signs of either condition.  Chest pain may have been due to anxiety related to Dx of generalized vaccinia.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Vaccination site reaction
Clinical narrative: Pimple-like lesion about 3cm proximal to vaccination site about 10 days after smallpox vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Hot, red cellulitis-like area on L upper arm.  5/9/11 red area measures 80 x 30 cm.
Age: 28.0
Sex: F
Vaccine: JEV1, RAB
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site.  Pain would shoot down arm when pressure applied to injection site.  Pain has been present since day vaccine received.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose decreased, Convulsion, Headache, Muscle rigidity, Tremor
Clinical narrative: Seizure - rigid and shaking.  Given glucose gel in mouth and seizure stopped after 6 minutes.  Fingerstick glucose of 62 at that time.  Vomited once and severe headache followed.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Seizure - rigid and shaking.  Given glucose gel in mouth and seizure stopped after 6 minutes.  Fingerstick glucose of 62 at that time.  Vomited once and severe headache followed.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Culture negative, Feeling abnormal, Lethargy, Platelet count normal, Pyrexia
Clinical narrative: Fever that has gotten as high as 105.4, rash that was on his behind and spread up his back. At times appeared lethargic and dazed.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Red blood cell count normal, White blood cell count normal
Clinical narrative: Fever that has gotten as high as 105.4, rash that was on his behind and spread up his back. At times appeared lethargic and dazed.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness, Headache, Immediate post-injection reaction, Respiratory rate increased
Clinical narrative: Prior to vaccination patient was crying and breathing fast.  Immediately after vaccination patient said she felt dizzy.  One hour post vaccination, patient's mother called and said patient had a severe headache.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Blood culture, Blood test, C-reactive protein, Chest X-ray
Clinical narrative: FEVER, FUSSY.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Irritability, Metabolic function test, Pyrexia, Streptococcus test
Clinical narrative: FEVER, FUSSY.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: right arm pain, swelling, erythema, fever to 102 degrees, burning into entire arm
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Dysgeusia, Dysphagia, Throat irritation
Clinical narrative: Throat tender hard to swallow, sour taste crying. Occured 45 minutes to 1 hour after receiving pediatric Hep A vaccine. Duration of event 90 minutes.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Ear pain, Gastroenteritis, Otitis media, Pharyngeal oedema
Clinical narrative: That same evening I received the vaccination I threw up. The next morning I woke up with a tight chest and swollen throat. The next evening I went to the hospital and had a very painful middle ear infection. The next day I could not stop throwing up and was readmitted to hospital.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: That same evening I received the vaccination I threw up. The next morning I woke up with a tight chest and swollen throat. The next evening I went to the hospital and had a very painful middle ear infection. The next day I could not stop throwing up and was readmitted to hospital.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Approx 14 hrs after Varicella injection, client noticed redness & swelling at site - approx 2 1/2" x 3" erythema with some induration. Dx with cellulitis at urgent. Resolved 2-3 d after KEFLEX started 3 -30 -11.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Loss of consciousness
Clinical narrative: Seizure and loss of consciousness 30-45 minutes after Tdap & MCV 4 pt. was taken by ambulance to medical center. CT scan of brain negative.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Parosmia
Clinical narrative: Patient described enhanced ability to smell things that may or may not be there. Described smell as ammonia or burnt smell. Said started around time vaccine given.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood urine present, Chest X-ray normal, Erythema, Full blood count, Pyrexia
Clinical narrative: Red, tender, swollen (L) lateral buttocks after receiving PNEUMOVAX vaccine on 5/5/11. (+) fever 101.3.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness, Urine analysis abnormal, White blood cell count normal
Clinical narrative: Red, tender, swollen (L) lateral buttocks after receiving PNEUMOVAX vaccine on 5/5/11. (+) fever 101.3.
Age: 1.31
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt developed fever a week after receiving MMR & HIB vaccines. Fever went away then developed rash that started on her face & spread throughout her extremities & body on the 10th day.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Flushing, Urticaria, Vision blurred
Clinical narrative: Employee states sitting in class & started feeling flushed, SOB, hives, right eye blurred vision, & dizzy approximately one hour post Hepatitis B #3 vaccine. Employee states went to ED where treated.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain, Skin tightness, Skin warm
Clinical narrative: Soreness next day, tight, knot in arm. On 5/3/11 - woke with red warm area from 3 inches below shoulder to elbow.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Vaccine administered 5/3/11 - seen in clinic 5/5/11 with 12 cm x 8 cm area of warmth and erythema around injection site right leg. - Area was observed. No treatment needed. - Patient had fever of T99 and was fussy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Ring around injection site (medium red color) & pink around the ring. Last night (5/8/11) a little painful.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Hypersensitivity, Swollen tongue
Clinical narrative: Going to car approx. 45 min-1 hr after receiving PPD & Tdap in Employee Health Services and noted tongue swelling & difference in voice - went to ED believing she was having allergic response - copies of records attached.
Age: 1.24
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Condition aggravated, Injection site erythema, Injection site rash, Otitis media, Rash erythematous
Clinical narrative: Small, red - dotted rash on face, torso, thighs. No itching. Also on day 9 of Amoxicillin at this time. Given BENADRYL at home. Rash gone today (5/9/11). On Amoxicillin for (R) otitis media.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Reported being tired on 5/4/11 & diarrhea on 5/5/11.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact, Injection site pain, Papule, Rash generalised
Clinical narrative: Pt was last seen on 4/26/11 for her #2 GARDASIL injection. She comes today complaining of "a rash and sore left arm" since the injection. She describes the rash "all over her lower left arm and a little on her right arm". She is wondering if it is a reaction from the vaccine. Pt denies any SOB, breathing problems, erythema, itch, fever, headache, nausea, environmental exposure or changes, no new medications, food, creams, lotions or soaps. Exam: Slight point tenderness but no erythema or induration at injection site on left upper arm; both lower arms have 1-2 dozen, 1-2 mm skin colored papules scattered on lower arms up to elbows with left arm papules in greater number than right arm, no erythema noted; full ROM in arms, hands and fingers bilaterally, muscle strength 4+ bilaterally in upper extremities. Impression: Mild dermatitis of unknown origin, most likely contact in origin. I reviewed the list of adverse reactions listed for GARDASIL and this presentation was not included. I told her I would report this to the toll free number for GARDASIL recipients. Her #3 GARDASIL will be given in her right deltoid if she decides to complete the vaccine series.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood glucose normal, Computerised tomogram normal, Concussion, Haemoglobin normal, Head injury
Clinical narrative: Patient received below shots, and 5 min later had syncopal event, passed out, hit head on floor. Hemoglobin, glucose, BP all normal. Patient had large lump on head, observed in ED, CT scan negative and had headache days later. Dx concussion.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Headache, Loss of consciousness, Mass, Syncope
Clinical narrative: Patient received below shots, and 5 min later had syncopal event, passed out, hit head on floor. Hemoglobin, glucose, BP all normal. Patient had large lump on head, observed in ED, CT scan negative and had headache days later. Dx concussion.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: 24 hrs -> local allergic rxn; redness, swelling -> seen by provider -> HC cream 1% & BENADRYL prn & ice packs, f/u as necessary.
Age: 1.52
Sex: F
Vaccine: HEPA, HIBV, TDAP
Symptoms: No adverse event
Clinical narrative: Given Tdap instead of DTaP. No adverse reaction to immunization.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: (L) upper arm with 7 cm area of erythema and edema; no other sx.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash: red, warm, tender to right deltoid, redness appeared within minutes of receiving shots. Redness worsened the next day with tenderness and swelling beginning this AM. Showed erythema & swelling approx. 4 x 4 in size. Showed erythema localized to a lesion. Prescribed ZYRTEC 1mg/mL syrup po - 2.5 mL qd for 30 days.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Injection site warmth, Skin lesion
Clinical narrative: Rash: red, warm, tender to right deltoid, redness appeared within minutes of receiving shots. Redness worsened the next day with tenderness and swelling beginning this AM. Showed erythema & swelling approx. 4 x 4 in size. Showed erythema localized to a lesion. Prescribed ZYRTEC 1mg/mL syrup po - 2.5 mL qd for 30 days.
Age: 1.19
Sex: M
Vaccine: MMR
Symptoms: Mumps, Pyrexia, Swelling face
Clinical narrative: Child noted to have cheek swelling and low grade fevers over past 18 hrs, initially left cheek & then right side without redness or pain noted. This is 6-7 days post-vaccination w/MMR. Symptomatic case recommended at this time for suspected mumps infection.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Large red mark on arm - 3 inches long and an inch wide. After 3 months it has not gotten any lighter in color, still very red.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Noted 3cm x 3cm induration with slight redness around inj site.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local swelling increased heat redness (Rt) deltoid.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Injection site erythema, Vomiting
Clinical narrative: Left forearm diffuse erythematous area deltoid to elbow with diarrhea & vomiting.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 15 cm x 12 cm area erythema, tenderness and mild swelling Rt upper arm. Fever 101.5. Treatment: cool compresses, TYLENOL or ibuprofen.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cyanosis, Flushing, Malaise, Nausea
Clinical narrative: Several hours after injection - feeling malaise, chills, nausea. Husband states face became flushed and slightly blue in color - sx mostly resolved by the time patient present to emergency room.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at site of injection accompanied by nausea, headache, and irregular breathing pattern (possibly due to anxiety per father) 05/01/11 at approx. 10:00 am soreness at injection site 04/30/11 at approx. 3 hrs after injection.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Respiration abnormal
Clinical narrative: Redness, swelling, warmth at site of injection accompanied by nausea, headache, and irregular breathing pattern (possibly due to anxiety per father) 05/01/11 at approx. 10:00 am soreness at injection site 04/30/11 at approx. 3 hrs after injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Vaccination complication
Clinical narrative: Reaction to shot DTAP. (R) arm red, painful per pt. Tx: KEFLEX & triamcinolone 0.1% oint given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discharge, Oedema peripheral, Rash, Skin irritation
Clinical narrative: Patient came to the pharmacy on 4/18/11 to report a reaction to ZOSTAVAX. Patient's left arm was very swollen, red, and irritated. It appeared to be forming a rash and discharge was coming from the injection site. Patient had contacted her primary care doctor and was taking Ibuprofen OTC. Patient was called 24 hrs later by pharmacist for follow-up. Patient said arm appeared to be getting better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching around site of injection.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Condition aggravated, Contusion, Head injury, Syncope
Clinical narrative: Pt fainted, hit head. (+) contusion. Pt observed in office - sent home.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Incident ID# 492523. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documentsheld by sender: None.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Incident ID# 492523. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documentsheld by sender: None.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Incident ID# 492523. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documentsheld by sender: None.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old male patient with asthma and no allergies or drug reactions who on 27-APR-2011 was intramuscularly vaccinated with a dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). Concomitant therapy included albuterol. On 27-APR-2011 after 10 minutes of receiving GARDASIL the patient experienced felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given but the patient continued to not feel well and thus the patient was transferred to the emergency department. No laboratories were performed. On 27-APR-2011 the patient recovered. Upon internal review the events were considered to be other important medical event because the patient was treated with epinephrine. This one of two reports from the same source. Follow up information has been received from a licensed practical nurse concerning a 15 year old male patient on 29-NOV-2011 was vaccinated with the first dose of GARDASIL (Lot# 666598/0786Z, expiration: 18-OCT-2012) and on 27-APR-2011 was intramuscularly vaccinated with the second dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). It was reported that the patient received the second dose and did not received any concomitant vaccinations at that time. The patient expressed that he was "afraid of needles". About 10 minutes after receiving the GARDASIL the patient began having symptoms (as previously reported). The patient received epinephrine IM. The patient was sent to the emergency room but was not admitted to the hospital. The patient was diagnosed with vasovagal syncope. The patient recovered. Additional information has been requested.