chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Cellulitis, Induration, Pain, Skin lesion
Clinical narrative: Upraised lesions/chickenpox lesions/blisters in a cluster at the vaccination site (approx 4 cm in diameter) with surrounding cellulitis which extends from upper deltoid to above the elbow - warm, tender, painful with localized induration.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Tenderness, Varicella post vaccine
Clinical narrative: Upraised lesions/chickenpox lesions/blisters in a cluster at the vaccination site (approx 4 cm in diameter) with surrounding cellulitis which extends from upper deltoid to above the elbow - warm, tender, painful with localized induration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swelling (slightly raised) at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 17 year old female patient. on 22-JUL-2008, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose route unspecified) at an unspecified facility. On 04-JUN-2010, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose route unspecified) at another unspecified facility. On an unknown date in August 2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose route unspecified). On 30-APR-2013 (reported as today), the patient was vaccinated with the fourth dose of 0.5 milliliter (ml) of intramuscularly. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 30-MAY-2012 the patient was vaccinated with the first dose of GARDASIL (lot # unspecified). It was reported that the patient received the second dose on 26-FEB-2013 which was late. No symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Site swollen up immediately after IM injection. Observed approximately 3 minutes. Asked to patient to monitor for additional swelling, itching or anything unusual or painful. It looked as if some of the swelling went down before he left.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Cough, Decreased appetite, Irritability, Pyrexia, Restlessness
Clinical narrative: After receiving 6 mo shots, pt had fever > 102, fussy, decreased appetite, restless sleep. At exam next day exam benign and non focal. Possible vaccine reaction versus virus or bacterial infection. Spoke with mother on 4/28/13 who reported fever lasted 1.5 days along with decreased appetite x 3 days, slight runny nose, cough also developed within 1 day after fever gone.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rhinorrhoea
Clinical narrative: After receiving 6 mo shots, pt had fever > 102, fussy, decreased appetite, restless sleep. At exam next day exam benign and non focal. Possible vaccine reaction versus virus or bacterial infection. Spoke with mother on 4/28/13 who reported fever lasted 1.5 days along with decreased appetite x 3 days, slight runny nose, cough also developed within 1 day after fever gone.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Culture, Erythema infectiosum, Rash, Streptococcus test, Varicella post vaccine
Clinical narrative: Pt. received vaccine on 4-9-13 then presented with rash 4-13-13, then ER 4-20-13 dx with fifth disease. Pt. eval. by PCP on 4-22-13 dx with varicella.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 25 April 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL: dose one, lot number C3896AA, received on 01 August 2011; dose two, C3954AB, received on 23 September 2011; and dose three, lot number C4192AA received on 02 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 March 2013, approximately six months after the last dose. On 15 March 2013, the subject developed a cough and paroxysmal cough on 16 March 2013 with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 20 March 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 March 2013 for five days. The subject was not hospitalized. At time of final contact on 10 April 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 196 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 25 April 2013. These 196 cases represent children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 25 April 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL: dose one, lot number C3896AA, received on 01 August 2011; dose two, C3954AB, received on 23 September 2011; and dose three, lot number C4192AA received on 02 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 March 2013, approximately six months after the last dose. On 15 March 2013, the subject developed a cough and paroxysmal cough on 16 March 2013 with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 20 March 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 March 2013 for five days. The subject was not hospitalized. At time of final contact on 10 April 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 196 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 25 April 2013. These 196 cases represent children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chest pain, Cough, Diarrhoea, Dizziness, Influenza
Clinical narrative: 5-3-13 Friday at 230 got shots, within an hour felt sore throat and cough cold sx flu h/a felt faint and dizzy achiness heart palpitations felt feverish drank lots water and laid down took BENADRYL and ROBITUSSIN did not eat Fri night or Saturday also was nauseated and having diarrhea. Sunday went to church still sx persist not eating. Monday feeling a little better less feverish feeling did not take temp had palpitations injection site sore - neck sore chest sore, over weekend did not see a medical provider managed to do so.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Nasopharyngitis, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: 5-3-13 Friday at 230 got shots, within an hour felt sore throat and cough cold sx flu h/a felt faint and dizzy achiness heart palpitations felt feverish drank lots water and laid down took BENADRYL and ROBITUSSIN did not eat Fri night or Saturday also was nauseated and having diarrhea. Sunday went to church still sx persist not eating. Monday feeling a little better less feverish feeling did not take temp had palpitations injection site sore - neck sore chest sore, over weekend did not see a medical provider managed to do so.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: 5-3-13 Friday at 230 got shots, within an hour felt sore throat and cough cold sx flu h/a felt faint and dizzy achiness heart palpitations felt feverish drank lots water and laid down took BENADRYL and ROBITUSSIN did not eat Fri night or Saturday also was nauseated and having diarrhea. Sunday went to church still sx persist not eating. Monday feeling a little better less feverish feeling did not take temp had palpitations injection site sore - neck sore chest sore, over weekend did not see a medical provider managed to do so.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Pt. in HD for Tdap. After administration Pt. had syncopal episode. Pt. did not hit floor but was assisted to floor by staff. Cold rag applied to forehead, Pt. fanned and feet elevated. Pt. immediately responded and answered questions appropriately. Sprite given to patient and Pt. remained in HD until she could walk without complaint. Mother present.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Localized swelling and erythema approx. 3x5cm left upper arm. Arm was red and warm to touch 48 hrs post injection.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) Deltoid redness and swelling (Localized).
Age: 1.53
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Pt developed fever/generalized fine red rash 2 weeks after receiving MMR.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Patient noticed itching Sunday (5/5/13) afternoon; Monday (5/6/13) red rash the size of an egg around injection site, very itchy. Pt is using ice/BENADRYL to treat.
Age: 1.39
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Pt to clinic with c/o redness, warmth, swelling to site and increased irritability.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of "in his 60s". On an unknown date in 2013 ("couple of months ago") the patient was vaccinated with ZOSTAVAX. Dosing information was not provided. There was no concomitant medication and no pertinent medical history. On an unknown date in 2013 the patient experienced zoster-like rash, after receiving ZOSTAVAX. The location of the rash is unspecified. The patient sought medical attention by a visit to the physician's office. The physician treated the patient with acyclovir (manufacturer unknown) and the rash "went away within a month after it started". The outcome of zoster-like rash was reported as recovered. The relatedness of the event was not reported for ZOSTAVAX. Additional information has been requested.
Age: 0.43
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: 5 months old female excessive irritability and unconsolable crying more than 5 hours after DTaP was given. Pt. developed fever 102 x 24 hours; mother described high pitched cry; Irritability persisted x 48-72 hrs.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a consumer refers to his 66 year old wife (female patient) with penicillin allergy. No medical history was reported. On 25-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Concomitant medications included some unspecified sleeping medication (manufacturer unknown). On 26-APR-2013, one day after getting the injection the patient suffered from a large red lump that was hard at the injection site. She also felt knocked out. She put ice on the site all day Friday and Saturday and was feeling much better by Saturday evening. No treatment was received. No laboratory diagnostic tests were performed. No medical attention was sought. The injection site was still red. The patient was recovering from the events. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site swelling, Local swelling, Pruritus, Skin discolouration
Clinical narrative: ADACEL given IM (L) delt. on 4-26-13. Pt noticed redness, bumpy areas to LUA starting 5-2-13. Skin appears pink from below the injection site to the elbow. Area is warm to touch and swollen but soft to touch. Pt c/o itching. Pt seen by doctor on 5-3-13. See attached note.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Skin warm
Clinical narrative: ADACEL given IM (L) delt. on 4-26-13. Pt noticed redness, bumpy areas to LUA starting 5-2-13. Skin appears pink from below the injection site to the elbow. Area is warm to touch and swollen but soft to touch. Pt c/o itching. Pt seen by doctor on 5-3-13. See attached note.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Immunization given 5/3/13 10 AM. Pt reported inj site on 5/4/13 reaction of raised, red, warm about 5 inches by 3 inches around site. 5/5/13 symptoms remained with addition of itchiness. 5/6 pt consulted physician who stated to contact if worsens, otherwise the symptoms were improving. Pt purchased cetirizine 10 mg to take 5/6/13.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Patient came to clinic 2 days after administration of vaccine with complaint of redness, swelling warm sensation and tender. Patient was prescribed KEFLEX to take 1 capsule (500 mg) by mouth every 8 hours for 7 days.
Age: 0.24
Sex: M
Vaccine: HIBV, RV5
Symptoms: Expired drug administered
Clinical narrative: None noted. 2 mth. old baby received ROTATEQ #1 dose on April 30, 2013 and it was noted to have expired April 25, 2013, was informed by Merck not to repeat.
Age: 0.22
Sex: M
Vaccine: IPV, PNC13
Symptoms: Eczema
Clinical narrative: Pt was breastfeeding and doing very well. On 7/20/12 received Hep B #2, Hib #1 and DTaP #1. Developed a small patch of eczema on face (very clear skin prior to that). On 8/16/12 received IPV #1 and PREVNAR #1. Since 3 days after has had very extensive eczema.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling, Urticaria
Clinical narrative: Pneumonia vcc. given in upper lft arm, following A.M, a welt appeared w/pain, swelling, redness, warmth, slowly spreading. Returned back to clinic, was told to go to urgent care, was given antibiotics.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Mom called doctor (on called M.D.) 4/7/13 stating Pt has a rash.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Urticaria, Varicella virus test
Clinical narrative: According to the mother on April 26,2013 patient woke up with hives all over body and the right arm swollen and red.  She applied ice in the vaccine site.  This happened after receiving the MENVEO and varicella vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 48 hrs after vaccine, pt presented with bruising at site which was surrounded by about a 3" diameter area of erythema, which was hot to touch. Also with low grade fever -> CLARITIN and KEFLEX prescribed.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Myalgias of neck, arthralgias of jaw, (L) MB+, (R) ankle. Pain (L) upper arm. No erythema. Rx: BENADRYL 25 Q 6 hours or ZYRTEC 10mg QD, ALEVE BID.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm noted to be quite red, hot, swollen at site of varicella injection - worsened over a 2-3 day period -> improved with ice, BENADRYL.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Left upper arm pain, severe, 8/10 pain. No redness, heat, or swelling in arm.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Left upper arm pain, severe, 8/10 pain. No redness, heat, or swelling in arm.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Insomnia
Clinical narrative: Left upper arm pain, severe, 8/10 pain. No redness, heat, or swelling in arm.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The patient was given MMRV vaccine that had been stored in a refrigerator instead of freezer.  The patient had no symptoms of an adverse event.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Cough, Gastroenteritis, Headache, Nausea
Clinical narrative: Patient seen in ED this past weekend, at MC for gastroenteritis symptoms, he had headache, and fever symptoms, and abdominal cramping, nausea and vomiting, he also had a cough, he was treated with IV fluids, and supportive medicines, no antibiotics were prescribed, he states that he feels much better day, without any abdominal cramping, no nausea or vomiting, no diarrhea, no fever, no headache, no sore throat, his cough has also improved, he did notice a non-itching rash on his forearms this morning. His symptoms started after he took his second dose of oral typhoid immunization pills.  His symptoms are consistent with adverse reaction to oral vaccine.
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia, Rash, Vaccination complication, Vomiting
Clinical narrative: Patient seen in ED this past weekend, at MC for gastroenteritis symptoms, he had headache, and fever symptoms, and abdominal cramping, nausea and vomiting, he also had a cough, he was treated with IV fluids, and supportive medicines, no antibiotics were prescribed, he states that he feels much better day, without any abdominal cramping, no nausea or vomiting, no diarrhea, no fever, no headache, no sore throat, his cough has also improved, he did notice a non-itching rash on his forearms this morning. His symptoms started after he took his second dose of oral typhoid immunization pills.  His symptoms are consistent with adverse reaction to oral vaccine.
Age: 22.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP, YF
Symptoms: Activities of daily living impaired, Rash generalised
Clinical narrative: Patient went to ER on 4/29/12 for rash all over his body and was treated with Benadryl and steroid. Patient states did not take steroid meds. Follow up with PCM on 4/30/12. Returned to duty but restricted from flying duties. Had active orders for Zantac & prednisone.
Age: 54.0
Sex: F
Vaccine: IPV, MNQ, TDAP, TYP, YF
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Malaise
Clinical narrative: Phone call from patient on morning of 05/01/2013. She had received several travelers vaccinations on 04/30/2013 including oral typhoid which she took her first dose of that date about 10:20 PM. Pt says she slept fine, but after breakfast had onset of illness. Pt reports 8-9 episodes of watery diarrhea over 3-5 hours with waves of abdominal pain reaching intensity of 8/10 on 0-10 pain scale. By 12:00 noon diarrhea had resolved and waves of abd pain were much less frequent and less intense, about 4-6/10 on 0-10 pain scale. Pt denied any fever, chills, rash, itching, breathing changes, nausea or vomiting. She did feel a little weak and fatigued. She was recommended to contact PMD, rest, fluids (clear liquids). If any diarrhea continued next day, she was told not to continue second dose, or if PMD recommended to stop. I followed up with patient on 05/06/2013 and she states all symptoms had resolved and she was feeling "normal" so she took second dose as scheduled, had two loose stools and some mild cramping, resolved quickly. She took third dose as scheduled and had one mild loose stool with mild cramping, resolved quickly. She plans to take final dose as scheduled on evening of 05/06/2013.
Age: 54.0
Sex: F
Vaccine: IPV, MNQ, TDAP, TYP, YF
Symptoms: Migraine, Muscle spasms
Clinical narrative: Phone call from patient on morning of 05/01/2013. She had received several travelers vaccinations on 04/30/2013 including oral typhoid which she took her first dose of that date about 10:20 PM. Pt says she slept fine, but after breakfast had onset of illness. Pt reports 8-9 episodes of watery diarrhea over 3-5 hours with waves of abdominal pain reaching intensity of 8/10 on 0-10 pain scale. By 12:00 noon diarrhea had resolved and waves of abd pain were much less frequent and less intense, about 4-6/10 on 0-10 pain scale. Pt denied any fever, chills, rash, itching, breathing changes, nausea or vomiting. She did feel a little weak and fatigued. She was recommended to contact PMD, rest, fluids (clear liquids). If any diarrhea continued next day, she was told not to continue second dose, or if PMD recommended to stop. I followed up with patient on 05/06/2013 and she states all symptoms had resolved and she was feeling "normal" so she took second dose as scheduled, had two loose stools and some mild cramping, resolved quickly. She took third dose as scheduled and had one mild loose stool with mild cramping, resolved quickly. She plans to take final dose as scheduled on evening of 05/06/2013.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: She states she had a mild fever the first 2 days then developed diarrhea for many days after this.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted within minutes of receiving Hep. A and HPV vaccine. Lasted a few seconds. Placed patient on floor with legs elevated while she sipped on sweet tea.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Clostridium test positive, Culture stool positive, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: On the morning of 5/1/2013, patient began vomiting through the day and had diarrhea.  She was admitted to hospital where the stool culture was positive for rotavirus.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Mother reports hypopigmentation to right upper arm in the shape of the bandaid applied to the vaccination site.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Patient developed hives on both wrists, biceps, in between fingers, buttocks -- took Benadryl & Claritin -- resolved.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: That same evening of the vaccine administration date, the patient experienced a red, 2in x 1&1/2 in circle at the injection site. The color has lightened to a pink color but the diameter has stayed the same. Patient brought this to Pharmacist attention on 6th day after administration. Patient has not taken any medication or applied any medication to site.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Fever for 2 days then rash starting on neck & groin area and spreading; Mother describes as flat, red blotches.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Broke out in varicella zoster rash over the left leg (same as vaccine). Seen at PCP on 4/29 and then Dermatology on 5/2 with confirmed PCR of VZV and with rash occurring in S1 dermatome.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Muscle tightness
Clinical narrative: Initial patient complained of itching.  Swelling and rash around the injection site.  Three days after shot there is a half dollar sized red circle and a lighter circle about 5 inches in diameter around the injection site.  Patient is also complaining of headache, nausea, and tightness in her arm.  She said it looked a little better today.  She has been taking Benadryl at least since yesterday.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus
Clinical narrative: Initial patient complained of itching.  Swelling and rash around the injection site.  Three days after shot there is a half dollar sized red circle and a lighter circle about 5 inches in diameter around the injection site.  Patient is also complaining of headache, nausea, and tightness in her arm.  She said it looked a little better today.  She has been taking Benadryl at least since yesterday.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Back pain, Chest discomfort, Chest pain, Feeling abnormal, Muscle tightness
Clinical narrative: 3 days of right jaw swelling and 2 days of chest/back pain/tightness. Reported feeling as if a "rope was tied around him".
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Swelling
Clinical narrative: 3 days of right jaw swelling and 2 days of chest/back pain/tightness. Reported feeling as if a "rope was tied around him".
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: 3 days of right jaw swelling and 2 days of chest/back pain/tightness. Reported feeling as if a "rope was tied around him".
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Chills, fever of 103F, swelling and redness at the injection site (ca. 2 inch diameter), headaches, light-headedness, dizziness, tendency to vomit.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, fever of 103F, swelling and redness at the injection site (ca. 2 inch diameter), headaches, light-headedness, dizziness, tendency to vomit.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Biopsy, Blood bilirubin increased, Chest pain, Chromaturia
Clinical narrative: This spontaneous report as received from a consumer son refers to a 85 year old male patient with none drug reactions or allergies or patient medical history. On 03-APR-2013 the patient was vaccinated with a standard dose (0.5 mL) of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014 (route not specified). There were no concomitant medication. The patient's son explained that his father after received the dose of PNEUMOVAX 23 on 05-APR-2013, developed pain and redness at the injection site followed by an overall feeling of malaise. The patient's son explained that on 05-APR-2013 the patient's urine turned dark amber color and he developed severe abdominal pain. The patient then developed chest pains and continued to have dark urine through 07-APR-2013 and went to his local urgent care for treatment. At the urgent care facility a liver bilirubin test showed level 8. The patient began to show signs of jaundice on the 09-APR-2013 and was admitted to the hospital. The patient was discharged on 12-APR-2013 when the chest pain went away. The patient followed up with his primary care physician where a blood test showed his bilirubin levels had gone up to 14. Additional test were ordered and the patient continued to have dark amber urine and jaundice symptoms including yellow-itchy skin. The blood test results ordered from the follow up visit were received on 25-APR-2013 and showed bilirubin level of 21-22. The patient was hospitalized again on 26-APR-2013 and was still admitted for treatment of the event. The patient's son explained that bilirubin levels have maintained at 21-22 currently and he was still experiencing Jaundice symptoms. The patient has had a biopsy conducted on Monday morning and an magnetic resonance (MRI) prior to the biopsy and was awaiting those results. The patient's treating physician believes that the reaction was drug induced. It was reported that the patient did not receive treatment for his experience. The outcome of jaundice, developed severe abdominal pain, urine turned a dark amber color, overall feeling of malaise and pain and redness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Jaundice, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a consumer son refers to a 85 year old male patient with none drug reactions or allergies or patient medical history. On 03-APR-2013 the patient was vaccinated with a standard dose (0.5 mL) of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014 (route not specified). There were no concomitant medication. The patient's son explained that his father after received the dose of PNEUMOVAX 23 on 05-APR-2013, developed pain and redness at the injection site followed by an overall feeling of malaise. The patient's son explained that on 05-APR-2013 the patient's urine turned dark amber color and he developed severe abdominal pain. The patient then developed chest pains and continued to have dark urine through 07-APR-2013 and went to his local urgent care for treatment. At the urgent care facility a liver bilirubin test showed level 8. The patient began to show signs of jaundice on the 09-APR-2013 and was admitted to the hospital. The patient was discharged on 12-APR-2013 when the chest pain went away. The patient followed up with his primary care physician where a blood test showed his bilirubin levels had gone up to 14. Additional test were ordered and the patient continued to have dark amber urine and jaundice symptoms including yellow-itchy skin. The blood test results ordered from the follow up visit were received on 25-APR-2013 and showed bilirubin level of 21-22. The patient was hospitalized again on 26-APR-2013 and was still admitted for treatment of the event. The patient's son explained that bilirubin levels have maintained at 21-22 currently and he was still experiencing Jaundice symptoms. The patient has had a biopsy conducted on Monday morning and an magnetic resonance (MRI) prior to the biopsy and was awaiting those results. The patient's treating physician believes that the reaction was drug induced. It was reported that the patient did not receive treatment for his experience. The outcome of jaundice, developed severe abdominal pain, urine turned a dark amber color, overall feeling of malaise and pain and redness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Yellow skin
Clinical narrative: This spontaneous report as received from a consumer son refers to a 85 year old male patient with none drug reactions or allergies or patient medical history. On 03-APR-2013 the patient was vaccinated with a standard dose (0.5 mL) of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014 (route not specified). There were no concomitant medication. The patient's son explained that his father after received the dose of PNEUMOVAX 23 on 05-APR-2013, developed pain and redness at the injection site followed by an overall feeling of malaise. The patient's son explained that on 05-APR-2013 the patient's urine turned dark amber color and he developed severe abdominal pain. The patient then developed chest pains and continued to have dark urine through 07-APR-2013 and went to his local urgent care for treatment. At the urgent care facility a liver bilirubin test showed level 8. The patient began to show signs of jaundice on the 09-APR-2013 and was admitted to the hospital. The patient was discharged on 12-APR-2013 when the chest pain went away. The patient followed up with his primary care physician where a blood test showed his bilirubin levels had gone up to 14. Additional test were ordered and the patient continued to have dark amber urine and jaundice symptoms including yellow-itchy skin. The blood test results ordered from the follow up visit were received on 25-APR-2013 and showed bilirubin level of 21-22. The patient was hospitalized again on 26-APR-2013 and was still admitted for treatment of the event. The patient's son explained that bilirubin levels have maintained at 21-22 currently and he was still experiencing Jaundice symptoms. The patient has had a biopsy conducted on Monday morning and an magnetic resonance (MRI) prior to the biopsy and was awaiting those results. The patient's treating physician believes that the reaction was drug induced. It was reported that the patient did not receive treatment for his experience. The outcome of jaundice, developed severe abdominal pain, urine turned a dark amber color, overall feeling of malaise and pain and redness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot number was reported as 444, Expiration date, dose and route were not reported). Concomitant medications were unspecified by the reporter. The pharmacist reported that she received a phone call from another pharmacy and was told that two patients had a bad reaction to the ZOSTAVAX and developed softball-sized injection site reactions that resulted in hospitalization (length of stay unspecified). Treatment was not reported. The outcome of softball-sized injection site reactions was unknown. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Skin lesion
Clinical narrative: This case was reported by a pharmacist and described the occurrence of itching in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included NIACIN. On 8 April 2013 at 15:45 the subject received 1st dose of TWINRIX (1 ml, intramuscular, left deltoid). On 10 April 2013, 2 days after vaccination with TWINRIX (described as "a couple of days later"), the subject experienced itching and lesion on back (described as "described as lesions on his back and butt cheeks"). Per the pharmacist, the subject "described the lesions as not pustules but looking more like mosquito bites or chicken pox." Per the pharmacist, the subject "thought these may be from his Niacin so he discontinued it. When the itching and lesions did not go away, the [subject] thought it was from the TWINRIX." The pharmacist considered the events were clinically significant (or requiring intervention). The subject was treated with steroid. On an unknown date, the subject returned to the medical center and was given an unknown steroid injection and an unknown steroid dose pack. At the time of reporting the events were improved. The itching and lesions both improved after receiving the steroid treatment. Per the pharmacist, as of 1 May 2013, the subject still experienced some itching and still has a couple lesions. The pharmacist stated that the medical center was considering whether to administer the second dose in the TWINRIX series "next week." The pharmacist considered the events were possibly related to vaccination with TWINRIX.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Induration, Nausea, Oedema peripheral
Clinical narrative: Friday night headache, fever 102, nauseated, dizzy swollen (L) arm 7 cm x 5.5 cm induration 2 x 2.5 cm.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Friday night headache, fever 102, nauseated, dizzy swollen (L) arm 7 cm x 5.5 cm induration 2 x 2.5 cm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, tender 5-6" around injection site. Heat. No nausea, vomiting, diarrhea. Currently still having symptoms.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: 2 day hx of left deltoid pain and hyperemia, fever. Exam: 6 cm hyperemic and edematous patch of skin with sharp edematous demarcation. Plan supportive care, ice compresses, MOTRIN.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Urticaria
Clinical narrative: Urticaria with blisters to face then large patches of urticaria to trunk et extremities. Face - 4/19/13 at 6pm; body - 4/20/13 morning. Went to ER 4/19/13 at 7pm. Received steroid injection.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Within 24 hours local reaction of induration, pain, itching, erythema approximately 12 cm diam. Started antihistamine; Abx., cold pack.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Papule, Tenderness
Clinical narrative: Left arm with development of 3cm x 5cm patch of edematous and hyperemic skin patch with sharply delineated borders. Mild tenderness and papular texture. Plan: Reassure, apply ice, MOTRIN prn.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On 25-APR-2013 the patient was vaccinated with PROQUAD (Lot # not provided) (dose and route not reported). Other suspect therapies included VARIVAX (Merck) (Lot # not reported) (dose and route not reported). No concomitant therapy was reported. On 25-APR-2013, the patient was vaccinated with PROQUAD (Merck) and VARIVAX (Merck): no adverse effects reported at this time. Additional information is not expected.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 25-APR-2013 the patient was vaccinated with PROQUAD (Merck) (Lot # not provided) (dose and route not reported). Other suspect therapies included VARIVAX (Merck) (Lot # not reported) (dose and route not reported). No concomitant therapy was reported. On 25-APR-2013, the patient was vaccinated with PROQUAD (Merck) and VARIVAX (Merck): no adverse effects reported at this time. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Rash erythematous, Rash macular, Rash pruritic, Throat irritation
Clinical narrative: Client received Tdap vaccine at school event 5-2-13. States she awoke this AM 5-3-13 with a red, itchy rash under both breast and on abdomen at panty line. States top lip feels swollen and throat feels itchy - client walked into Health Dept. today 5-3-13 at 8:30AM. She was talking and walking and breathing without difficulty. RN noted light red, round, macular diffused rash measuring 1/4-1/2mm, under both breast and on abdomen around front panty line. No other rashes noted. She stated her top lip felt funny and throat was "itchy". She was walking, talking and showing RN rash. RN offered to call rescue squad to take her to ER but she declined. RN recommended she go to ER of choice for evaluation for possible vaccine reaction. Stated she would go to ER now. PHN called ER to inform client on her way and that Tdap had been given 5-2-13 at 1:30pm. Event witnessed per RN and other staff.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 80 year old male patient. No medical history was reported. On an unknown date in December 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). No concomitant medications were reported. On an unknown date, the patient experienced shingles. Patient sought medical attention (unspecified). The outcome of shingles was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis on upper left arm. Treatment clindamycin 150mg 3 caps three times daily.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Pt complaint severe dizziness for 3 days. Felt 1/2 as bad on the 4th day, and 1/4 as bad on the 5th day.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Febrile convulsion, Influenza virus test negative
Clinical narrative: Patient had seizure 10 days after MMR vaccine - seen in ER - diagnosed with febrile seizure, had 2nd seizure next day, and now is seeing neurology.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Mass
Clinical narrative: On 01/23/13, we administered a FLUZONE INTRADERMAL. Patient came back on 05/01/13 and informed me that there is a lump which is 3-4 mm wide which comes and goes and also associated with flu like symptoms.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Nausea
Clinical narrative: Swelling, redness, heat at site 4 x 4.5 size, rash, nausea, fever, muscle ache.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Swelling, redness, heat at site 4 x 4.5 size, rash, nausea, fever, muscle ache.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Full blood count abnormal, Pain, Pyrexia
Clinical narrative: On 5/4/13 pt c/o fever in am, some swelling body aches. Seen in ER - c/o SOB on 5/6/13 pt seen in clinic - 102 and hot red arm.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling, White blood cell count increased
Clinical narrative: On 5/4/13 pt c/o fever in am, some swelling body aches. Seen in ER - c/o SOB on 5/6/13 pt seen in clinic - 102 and hot red arm.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Small dime size knot on injection site with redness.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Rt arm swollen, hot to touch, redness & fine bumps to rt arm.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt c/o pain, redness, warmth and swelling at injection site which progressed to a cellulitis and abscess. She was started on KEFLEX.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt c/o pain, redness, warmth and swelling at injection site which progressed to a cellulitis and abscess. She was started on KEFLEX.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt developed swelling, redness with warmth to touch the day after injection with progression to larger area by day #3.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a consumer reporting on her 17 year old male son who in July 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The patient's mother stated that her son had not received doses 2 or 3 of the GARDASIL series until this time. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unidentified patient of unknown age and gender. It was reported that on an unknown date the patient was vaccinated with an improperly stored PEDVAXHIB (lot number and expiration date not reported) (dose and route not reported), that were stored as low as 30F on multiple occasions. Concomitant therapy was not reported. No adverse effect reported. This report is linked to MARRS 1305USA001150. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two unidentified patients of unknown age and gender. It was reported that on an unknown date the patients were vaccinated with an improperly stored VAQTA (lot number and expiration date not reported) (dose and route not reported), that were stored as low as 30F on multiple occasions. Concomitant therapy was not reported. No adverse effect reported. This report is linked to MARRS 1305USA002431. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 13 year old male patient who on 14-FEB-2013 was vaccinated with the first dose of GARDASIL lot # H020910 expiration date 18-JUN-2015. No other co-suspect or concomitant medications were reported. The physician reported that on 14-FEB-2013, the patient broke out in hives after receiving his first dose of GARDASIL. The patient was given BENDARYL as treatment for the event. On an unknown date, the patient had recovered from the event and the physician stated that he would not be completing the series of GARDASIL. Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that the patient receive the first dose of GARDASIL (dose and route not reported) series on an unspecified date in May-2012 and the second dose in the series "about a week ago", approximately on 18-APR-2013 (dose and route not reported). No adverse effect was reported. No further information is available. Additional information has been requested.