chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain lower, Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Sudden onset of severe upper abdominal pain with nausea and vomiting until about 1PM when it turned into lower abdominal pain with diarrhea. No evidence of anyone I came in contact with had a virus within weeks preceding vaccine.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered at inappropriate site, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Headache, low grade fever on the first evening. 2nd day until present Redness and extensive swelling at the injection site in Left arm, Headache, fever at injection site. Has been taking Benadryl and Tylenol for reaction. Still on present treatment. As a RN, it looks to me that the injection was not given in the correct site. I am not sure that it has anything to do with the reaction.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Headache, low grade fever on the first evening. 2nd day until present Redness and extensive swelling at the injection site in Left arm, Headache, fever at injection site. Has been taking Benadryl and Tylenol for reaction. Still on present treatment. As a RN, it looks to me that the injection was not given in the correct site. I am not sure that it has anything to do with the reaction.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Pt reports to the clinic c/o L arm swelling, hot to touch x 2 days.  Denies pain/touble breathing/signs of anaphylaxis. No hx of reactions with vaccinations in past. NKDA. Tx'd with Benadryl, Ice Packs and Tylenol. Pt verbalized understanding to RTC if s/s worsen.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chest pain, Costochondritis, Musculoskeletal pain, Neck pain
Clinical narrative: Neck, back, shoulder entire arm and chest pain all on the other side of body from shot.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Neck, back, shoulder entire arm and chest pain all on the other side of body from shot.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab
Clinical narrative: She received Zoster Vaccine 09/20/2007. She contracted shingles 7/3/2012. She went to hospital clinic. She took antiviral pill for > 20 days. Lesions are around middle of abdomen. They have scabbed over at present and bumping has decreased.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hallucination
Clinical narrative: C/O hallucinating about 12 hrs after receiving vaccine. Had taken TYLENOL w/codeine x 2 in past 48 hrs. Parent feels like reaction was not related to medication (?).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: The patient's arm swelled about 1 inch high and SA 4x7 inch approx. ED physician prescribed Vicodin and prednisone.
Age: 1.05
Sex: M
Vaccine: HEP, HEPA, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 26.0
Sex: M
Vaccine: IPV, MMR, MNQ
Symptoms: Abnormal sensation in eye, Aphasia, Depressed level of consciousness, Disturbance in attention, Fatigue
Clinical narrative: On 28 JUN 2012, patient, who was in his usual state of good health, received IPV and MMR vaccines in right upper arm, and on 26 JUN 2012, had received MGC vaccine in his left upper arm. He does not recall any significant local reactions at his vaccination sites. He denies any systemic symptoms during the first week after vaccine receipt. At the time of vaccine receipt, patient was attending Officer Development School (ODS). [Attended ODS from period of 10 JUN through 13 July]. During the last week of ODS (6 through 13 JUL), patient was sleep deprived as a result of intensive training, so when he noted fatigue, difficulty concentrating, and decreased mental alertness, he attributed theses symptoms to lack of sleep. However, following ODS, after patient was getting sufficient sleep and on TAD status, he noted ongoing symptoms such as "mental fatigue", difficulty comprehending materials he read, forgetfulness, difficulty finding appropriate words during conversations, and decrease in his attention span. Denies significant mood changes. No difficulty in comprehending typical conversations and no disorientation. No history of recent head trauma. Denies associated headaches or dizziness. Awakens feeling physically rested; when he wakes up, he feels awake (not sleepy), but he is not alert, and the remainder of the day, he does not feel alert or attentive. Patient used to run 2-4 miles several times per week. He has tried to run since symptom onset, but says although he feels his body is able, he cannot push himself mentally to complete the run. His physician training over the last couple of weeks has primarily been 20 minutes of weight training several days per week. No snoring or apneic episodes reported. (Patient had normal sleep studies in 2007 after surgery.) Around 2-3 weeks ago, Patient also noted onset pressure behind eyes bilaterally with photophobia and visual changes. Intensity of pressure behind eyes is rated as 3/10 most of time, but worsens when focusing visually or concentrating. Closing eyes for several minutes seems to help. Patient describes experiencing mild blurring of words appearing on TV screen, while watching TV, sees "afterimages" after he looks at an illuminated object or light, and sees "superimposed" images following words on his Kindle screen. Denies double vision or flashes of light. Patient does not wear contacts or glasses. Denies sinus pressure, nasal congestion or PND. Able to function in his current status, but is often frustrated with limitations. Relying on smartphone as memory aide. Concerned, as he will be starting his first year of Prosthodontics Residency next week. Patient denies recent acute infections prior to symptom onset. At the time of vaccine receipt, the only medication he was taking was a daily multivitamin. Denies history of previous adverse events following immunizations. Patient received HPV (1) vaccine on 19 JUL without noting exacerbation of symptoms.
Age: 26.0
Sex: M
Vaccine: IPV, MMR, MNQ
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin normal, Mean cell haemoglobin concentration increased, Mean cell haemoglobin normal
Clinical narrative: On 28 JUN 2012, patient, who was in his usual state of good health, received IPV and MMR vaccines in right upper arm, and on 26 JUN 2012, had received MGC vaccine in his left upper arm. He does not recall any significant local reactions at his vaccination sites. He denies any systemic symptoms during the first week after vaccine receipt. At the time of vaccine receipt, patient was attending Officer Development School (ODS). [Attended ODS from period of 10 JUN through 13 July]. During the last week of ODS (6 through 13 JUL), patient was sleep deprived as a result of intensive training, so when he noted fatigue, difficulty concentrating, and decreased mental alertness, he attributed theses symptoms to lack of sleep. However, following ODS, after patient was getting sufficient sleep and on TAD status, he noted ongoing symptoms such as "mental fatigue", difficulty comprehending materials he read, forgetfulness, difficulty finding appropriate words during conversations, and decrease in his attention span. Denies significant mood changes. No difficulty in comprehending typical conversations and no disorientation. No history of recent head trauma. Denies associated headaches or dizziness. Awakens feeling physically rested; when he wakes up, he feels awake (not sleepy), but he is not alert, and the remainder of the day, he does not feel alert or attentive. Patient used to run 2-4 miles several times per week. He has tried to run since symptom onset, but says although he feels his body is able, he cannot push himself mentally to complete the run. His physician training over the last couple of weeks has primarily been 20 minutes of weight training several days per week. No snoring or apneic episodes reported. (Patient had normal sleep studies in 2007 after surgery.) Around 2-3 weeks ago, Patient also noted onset pressure behind eyes bilaterally with photophobia and visual changes. Intensity of pressure behind eyes is rated as 3/10 most of time, but worsens when focusing visually or concentrating. Closing eyes for several minutes seems to help. Patient describes experiencing mild blurring of words appearing on TV screen, while watching TV, sees "afterimages" after he looks at an illuminated object or light, and sees "superimposed" images following words on his Kindle screen. Denies double vision or flashes of light. Patient does not wear contacts or glasses. Denies sinus pressure, nasal congestion or PND. Able to function in his current status, but is often frustrated with limitations. Relying on smartphone as memory aide. Concerned, as he will be starting his first year of Prosthodontics Residency next week. Patient denies recent acute infections prior to symptom onset. At the time of vaccine receipt, the only medication he was taking was a daily multivitamin. Denies history of previous adverse events following immunizations. Patient received HPV (1) vaccine on 19 JUL without noting exacerbation of symptoms.
Age: 26.0
Sex: M
Vaccine: IPV, MMR, MNQ
Symptoms: Mean cell volume normal, Memory impairment, Photophobia, Platelet count normal, Red blood cell count normal
Clinical narrative: On 28 JUN 2012, patient, who was in his usual state of good health, received IPV and MMR vaccines in right upper arm, and on 26 JUN 2012, had received MGC vaccine in his left upper arm. He does not recall any significant local reactions at his vaccination sites. He denies any systemic symptoms during the first week after vaccine receipt. At the time of vaccine receipt, patient was attending Officer Development School (ODS). [Attended ODS from period of 10 JUN through 13 July]. During the last week of ODS (6 through 13 JUL), patient was sleep deprived as a result of intensive training, so when he noted fatigue, difficulty concentrating, and decreased mental alertness, he attributed theses symptoms to lack of sleep. However, following ODS, after patient was getting sufficient sleep and on TAD status, he noted ongoing symptoms such as "mental fatigue", difficulty comprehending materials he read, forgetfulness, difficulty finding appropriate words during conversations, and decrease in his attention span. Denies significant mood changes. No difficulty in comprehending typical conversations and no disorientation. No history of recent head trauma. Denies associated headaches or dizziness. Awakens feeling physically rested; when he wakes up, he feels awake (not sleepy), but he is not alert, and the remainder of the day, he does not feel alert or attentive. Patient used to run 2-4 miles several times per week. He has tried to run since symptom onset, but says although he feels his body is able, he cannot push himself mentally to complete the run. His physician training over the last couple of weeks has primarily been 20 minutes of weight training several days per week. No snoring or apneic episodes reported. (Patient had normal sleep studies in 2007 after surgery.) Around 2-3 weeks ago, Patient also noted onset pressure behind eyes bilaterally with photophobia and visual changes. Intensity of pressure behind eyes is rated as 3/10 most of time, but worsens when focusing visually or concentrating. Closing eyes for several minutes seems to help. Patient describes experiencing mild blurring of words appearing on TV screen, while watching TV, sees "afterimages" after he looks at an illuminated object or light, and sees "superimposed" images following words on his Kindle screen. Denies double vision or flashes of light. Patient does not wear contacts or glasses. Denies sinus pressure, nasal congestion or PND. Able to function in his current status, but is often frustrated with limitations. Relying on smartphone as memory aide. Concerned, as he will be starting his first year of Prosthodontics Residency next week. Patient denies recent acute infections prior to symptom onset. At the time of vaccine receipt, the only medication he was taking was a daily multivitamin. Denies history of previous adverse events following immunizations. Patient received HPV (1) vaccine on 19 JUL without noting exacerbation of symptoms.
Age: 26.0
Sex: M
Vaccine: IPV, MMR, MNQ
Symptoms: Red cell distribution width, Vision blurred, Visual impairment, White blood cell count decreased
Clinical narrative: On 28 JUN 2012, patient, who was in his usual state of good health, received IPV and MMR vaccines in right upper arm, and on 26 JUN 2012, had received MGC vaccine in his left upper arm. He does not recall any significant local reactions at his vaccination sites. He denies any systemic symptoms during the first week after vaccine receipt. At the time of vaccine receipt, patient was attending Officer Development School (ODS). [Attended ODS from period of 10 JUN through 13 July]. During the last week of ODS (6 through 13 JUL), patient was sleep deprived as a result of intensive training, so when he noted fatigue, difficulty concentrating, and decreased mental alertness, he attributed theses symptoms to lack of sleep. However, following ODS, after patient was getting sufficient sleep and on TAD status, he noted ongoing symptoms such as "mental fatigue", difficulty comprehending materials he read, forgetfulness, difficulty finding appropriate words during conversations, and decrease in his attention span. Denies significant mood changes. No difficulty in comprehending typical conversations and no disorientation. No history of recent head trauma. Denies associated headaches or dizziness. Awakens feeling physically rested; when he wakes up, he feels awake (not sleepy), but he is not alert, and the remainder of the day, he does not feel alert or attentive. Patient used to run 2-4 miles several times per week. He has tried to run since symptom onset, but says although he feels his body is able, he cannot push himself mentally to complete the run. His physician training over the last couple of weeks has primarily been 20 minutes of weight training several days per week. No snoring or apneic episodes reported. (Patient had normal sleep studies in 2007 after surgery.) Around 2-3 weeks ago, Patient also noted onset pressure behind eyes bilaterally with photophobia and visual changes. Intensity of pressure behind eyes is rated as 3/10 most of time, but worsens when focusing visually or concentrating. Closing eyes for several minutes seems to help. Patient describes experiencing mild blurring of words appearing on TV screen, while watching TV, sees "afterimages" after he looks at an illuminated object or light, and sees "superimposed" images following words on his Kindle screen. Denies double vision or flashes of light. Patient does not wear contacts or glasses. Denies sinus pressure, nasal congestion or PND. Able to function in his current status, but is often frustrated with limitations. Relying on smartphone as memory aide. Concerned, as he will be starting his first year of Prosthodontics Residency next week. Patient denies recent acute infections prior to symptom onset. At the time of vaccine receipt, the only medication he was taking was a daily multivitamin. Denies history of previous adverse events following immunizations. Patient received HPV (1) vaccine on 19 JUL without noting exacerbation of symptoms.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Mbr. had (L) shoulder pain approx. 2 wks after vaccine. No trauma/overused syndrome or sports injury. Mbr. continues to have decreased flexion/abduction of shoulder. (+) painful arc, (+) Neer, (+) Hawkins; (-) fever, (-) sepsis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt. developed local hive-like reaction at injection site about the diameter of a tennis ball. Was given Rx for BACTRIM and Hydrocortisone cream 2.5% and steroids.
Sex: F
Vaccine: HPV2
Symptoms: Head injury, Hypotension, Syncope
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of fainting in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included hepatitis A inactivated and hepatitis B recombinant vaccine; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received unspecified dose of CERVARIX (details unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced fainting, hit head and low blood pressure. The subject hit her head while fainting. The subject was seen in the emergency room. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Severe swelling at injection site, Pediatric down past elbow, very hot and red. Saw MD 8-6-12, Rx's- Prednisone; KEFLEX; Hydroxyzine and VICODIN.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Developed severe headache and dizziness approx 8 hours after vaccine received. Relief with TYLENOL. Also in context of sinusitis.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, swollen and itching.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Diaphoresis pale, dizzy. Placed in supine position, BP 86/54. Cool compress. Improvement in 5 mins. BP 110/ 60 after 25 minutes.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: V. painful (L) arm, difficulty raising arm over her head.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema, edema, mild tenderness and mild itching to (R) anterior thigh/knee; afebrile; treated with BENADRYL and ZYRTEC.
Age: 30.0
Sex: M
Vaccine: IPV, JEV1, RAB, TYP
Symptoms: Pruritus generalised, Rash generalised, Rash maculo-papular
Clinical narrative: Pt received 4 vaccines on 8/1/12 Polio, TYPHIM Vi, J.E. (IXIARO), Rabies, (IMOVAX), pt reports that the next day (8/2/12) pt developed rash behind ear, ear itchy, spread to body, arms, & legs, slight improvement with CLARITIN - rash: macular & papular.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Pharyngeal oedema
Clinical narrative: Patient loss color in face, throat, felt swollen, past out for a couple of seconds, administered Epipen. All occurred over 5 minutes. EMS responded.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Burning, itching, tiny pimples on scalp, red bumps on face.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: (L) arm rash/redness 6cm X 6 cm.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse and an administering healthcare professional concerning a 13 year old male patient with a history of meningitis, group B Streptococci, wet lung and seizures who on 21-DEC-2011 at 14:19 was vaccinated with the second dose of GARDASIL (lot number 670050/1229AA), I.M., right deltoid (dose not reported) at private doctor's office/hospital. The immunization with GARDASIL was reported due to out of temperature range, fridge temperature fell below 32 degrees F (it was also reported as 30 degrees F) over 16 day period. It was reported that no adverse reaction occurred. On 11-FEB-2012, the patient was revaccinated with GARDASIL (dose, route and lot number not reported). Follow up information has been received from a registered nurse concerning a 13 year old male patient, who received his first dose of GARDASIL on 20-OCT-2011, second dose on 21-DEC-2011, and this dose was exposed to altered temperatures, third dose on 11-FEB-2012 and fourth dose on 23-APR-2012. There were no adverse event reported. This is one of several reports received from the same source. Follow up information has been received from an other health professional refers to the 13 years old male patient. The patient's medical history included spinal meningitis, streptococcus, group b, wet lung and seizures (resolved). The reporter stated that no adverse event, immunization being reported due to out of temperature range. Fridge temperature fell below 32 degrees F. Patient was re-vaccinated for 0.5 ml GARDASIL (lot # 670050/1229AA) on 11-FEB-2012 at 14:19, IM right deltoid. No relevant diagnostic test and laboratory data performed. No prior vaccination adverse events. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 58 year old female who on 22-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# 672868/0239AE, Exp26-APR-2012) (0.65mL, subcutaneously). On 24-JUN-2012 the patient experienced redness and swelling around her injection site. On 25-JUN-2012, she went to see her physician which diagnosed her with cellulitis and prescribed KEFLEX for her. At the time of reporting, the patient was recovering. Follow-up information has been received from physician who stated that the patient's injection was given at local pharmacy and an office was unaware of any adverse event. It was also reported that the patient was not seen after vaccination. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow-up information has been received from a registered nurse and an administering healthcare professional concerning a 11 year old female patient with allergy induced asthma who on 27-DEC-2011 at 12:14 was vaccinated with the third dose of GARDASIL, (lot number 670050/1229AA), I.M. right deltoid (dose not reported) at private doctor's office/hospital. The immunization with GARDASIL was reported due to out of temperature range, fridge temperature fell below 32 degrees F (it was also reported as 30 degrees F) over 16 day period. It was reported that no adverse reaction occurred. This is one of several reports received from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pain in extremity, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with hypothyroidism. The patient was vaccinated with dose 3 GARDASIL on 14-JUN-2012. No other co-suspects were reported. Concomitant medications included: SYNTHROID. On 22-JUN-2012 the patient experienced pain in extremity, 9 days after onset of therapy, rash and injection site swelling. No treatment information was reported. The outcome of pain in extremity, rash and injection site swelling is unknown. The relatedness for pain in extremity, rash and injection site swelling is unknown for GARDASIL. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot # 1174Z; exp. date 10-MAR-2012) (dose and route not reported) on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular, Scab, Skin lesion
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with lot # (671452/1124AA expiration date 12-OCT-2012), with a 0.65 ml dose of ZOSTAVAX on 15-NOV-2011. No other co-suspects were reported. Concomitant medications included bupropion hydrochloride, magnesium oxide, potassium (unspecified), naproxen, trazodone hydrochloride, multivitamins, simvastatin (manufacturer unknown), gabapentin, vitamin D (unspecified), docusate sodium, CETRIZIN and ropinirole. The pharmacist reported that on approximately 28-JUN-2012, "about 2 - 4 weeks ago", the patient developed varicella - like rash. The patient had about 20-30 lesions, raised rash on his back and legs, which would blister, then form scabs and fell off over the time. No treatment information was given. There were no Lab diagnosis or studies performed. The patient sought unspecified medical attention. The outcome of varicella - like rash was reported as not recovered/not resolved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female smoker patient, with rheumatoid arthritis, asthma, Gastrooesophageal reflux disease (GERD), diverticulosis, hypertension, osteopenia, obesity, panic attacks, allergy to PROCARDIA and allergy to citalopram hydrobromide. The patient was vaccinated with a first dose of PNEUMOVAX23 (Lot # not reported) in 2001, a second dose of PNEUMOVAX23 (Lot # not reported) in 2006, a third dose of PNEUMOVAX23 (Lot # not reported) on 29-FEB-2012 and a fourth dose of PNEUMOVAX23 (Lot # not reported) on 13-JUL-2012. No other co-suspects were reported. Concomitant medications included DIOVAN, ZANTAC, albuterol, methotrexate, folic acid, SIMPONI, lansoprazole, ADVAIR, MIRALAX, senna, LEUCOVORIN, ibuprofen, prednisone, CARAFATE, alprazolam, VICODIN, calcium supplement, calcium-magnesium-zinc supplement, nystatin and triamcinolone. The nurse reported that on 13-JUL-2012, the patient developed severe joint, shoulder and hip pain after she was vaccinated on 13-JUL-2012. The patient did not receive treatment for the adverse events. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 63 year old female patient with sulfa allergy and high blood pressure who on 23-MAY-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose not provided) (lot # 670816/0693AA, expiration date). The pharmacist reported that the patient developed a raised area at the injection site spreading 1.5 inches, soreness and itching after vaccination with ZOSTAVAX (Merck). Onset dates not provided. At the time of the report, the patient had not recovered from the events. The patient contacted the pharmacist. Follow up information has been received from the pharmacist concerning the patient with no illness at time of vaccination and no drug reactions or allergies (previously reported as sulfa allergy and high blood pressure), who on 23-MAY-2012 at 14:00, was vaccinated with a first dose of ZOSTAVAX (Merck) (dose not provided) subcutaneously in the upper left arm. The pharmacist reported that on 24-MAY-2012, the patient experienced swelling, itching, redness, pain and rash. There were no Lab diagnosis/studies performed. At the time of the report, the patient's outcome regarding redness, swelling, itching and rash was unknown. Follow-up information has been received from the pharmacist concerning female patient with none of pre-existing medical conditions. It was reported that on 24-MAY-2012, the patient experienced redness, swelling, looked like a "rash" at the injection site. It was also reported that the patient thought she was getting shingles. At the time of report the patient's outcome regarding to redness, swelling, looked like a "rash" at the injection site, "thought she was getting shingles" was recovered (date unspecified). The relatedness for the patient's events was not provided for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL (Lot number, dose and route not reported) in January 2012. In February 2012, a month later, the patient received dose 3 of GARDASIL (Lot number, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received the third dose outside of the recommended dosing schedule. No adverse reaction reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a claims examiner for a pharmacy regarding a female who was vaccinated with ZOSTAVAX (lot number 672608/1715AA, expiration date 02-FEB-2013). The patient's medical history and concomitant medications were not provided. It was reported that the patient developed a localized site reaction after the vaccine was administered. The outcome of the event was not provided. A lot check has been requested. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 35 month old patient who on 16-JUN-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 666344/1657Y). The nurse mentioned that on 12-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow up information has been received from a registered nurse refers to a 3 years old male patient. The patient's medical history included contact dermatitis and bronchiolitis and none illness at time of vaccination. The patient was vaccinated subcutaneously in right leg with a first dose of VARIVAX (Merck) (dose not reported, lot # (666344/1657Y) on 16-JUN-2010. It was reported that the patient came to the clinic on 12-JUN-2012 with rash described as "erythematous papules some with vesicles on arm, legs, buttocks, few on face. Lesions appearing in different stages and some had crusted over becoming confluent on left forearm". Patient was diagnosed with varicella. No lab diagnostic tests were performed. At the time of the report the patient's status was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Muscle spasms, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning herself a 73 year old female with hypercholesterolaemia and temporal arteritis and with no known drug allergies who in June 2006 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#, dose and route not reported). On 10-MAY-2012 the patient was diagnosed with a mild case of shingles. The shingles was located at the left knee in a horseshoe shape, and also a patch on the arch of her left foot. The pain would travel down from the left knee to the left calf to the left toes. The patient sought for unspecified medical attention. The patient stated the pain was managed with TYLENOL, and when the pain occurred she would get up and walk too. The patient was treated with an antiviral medication for one week's time and fluocinonide cream. The patient was recovering. Now all that remains on the leg was some small scars. The patient stated that she knew the shingles would have been much worse if she had not gotten the vaccine. Follow up information was received from the nurse practitioner reporting on herself with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no adverse events following prior vaccination, who on an unspecified date was participant in a study of ZOSTAVAX. Then she found to had been on placebo. After FDA approval in June 2006 the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX (dose and lot number not reported). It was stated that on 14-MAY-2012 (previously reported as 10-MAY-2012) the patient developed a mild case of shingles, however left leg lesion, plus 5 m lesion left arch of foot for three days. Atypical rash-looked like mosquito bites-slight itch. Not really sign of pain. The patient did not experience other systemic symptoms. Severe cramps started from knee then calf then ankle to toes. Relief from very few doses of TYLENOL. The patient recovered on 11-JUN-2012. The patient did not seek medical attention. It was reported that the patient was not recently exposed to chicken pox or herpes zoster. Fluorescent antibody or specimen collected for PCR were not performed. Relationship between shingles and muscle cramps and ZOSTAVAX was unknown. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a nurse practitioner concerning herself a 73 year old female with hypercholesterolaemia and temporal arteritis and with no known drug allergies who in June 2006 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#, dose and route not reported). On 10-MAY-2012 the patient was diagnosed with a mild case of shingles. The shingles was located at the left knee in a horseshoe shape, and also a patch on the arch of her left foot. The pain would travel down from the left knee to the left calf to the left toes. The patient sought for unspecified medical attention. The patient stated the pain was managed with TYLENOL, and when the pain occurred she would get up and walk too. The patient was treated with an antiviral medication for one week's time and fluocinonide cream. The patient was recovering. Now all that remains on the leg was some small scars. The patient stated that she knew the shingles would have been much worse if she had not gotten the vaccine. Follow up information was received from the nurse practitioner reporting on herself with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no adverse events following prior vaccination, who on an unspecified date was participant in a study of ZOSTAVAX. Then she found to had been on placebo. After FDA approval in June 2006 the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX (dose and lot number not reported). It was stated that on 14-MAY-2012 (previously reported as 10-MAY-2012) the patient developed a mild case of shingles, however left leg lesion, plus 5 m lesion left arch of foot for three days. Atypical rash-looked like mosquito bites-slight itch. Not really sign of pain. The patient did not experience other systemic symptoms. Severe cramps started from knee then calf then ankle to toes. Relief from very few doses of TYLENOL. The patient recovered on 11-JUN-2012. The patient did not seek medical attention. It was reported that the patient was not recently exposed to chicken pox or herpes zoster. Fluorescent antibody or specimen collected for PCR were not performed. Relationship between shingles and muscle cramps and ZOSTAVAX was unknown. Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 23 month old patient who on 26-JUL-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 669684/0088AA). The nurse mentioned that on 05-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow up information has been received from a registered nurse refers to a 2 year old female patient. The patient's medical history included wheezing and none illness at time of vaccination. The patient was vaccinated subcutaneously in left leg with a first dose of VARIVAX (Merck), (dose not reported, lot # (669684/0088AA) on 26-JUL-2011. It was reported that the patient came to the clinic on 05-JUL-2012 with a rash described as "vesicles noted on trunk upper extremities. Patient had some crusted lesions in the popliteal area of both legs." The patient was diagnosed with varicella. No lab diagnostic tests were performed. At the time of the report the patient's status was recovered (recovery date was reported as 22-JUN-2012, when patient was seen without rash). This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from an office manager refers to 2 unspecified patients of unknown age. On unspecified date the patients were vaccinated with dose of PNEUMOVAX 23 (Lot# 672962/0025AE, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On unknown date the patients experienced unspecified injection site reaction after vaccination with PNEUMOVAX 23. It was not known if the patients sought for medical attention. The statuses of the two patients were unknown. This is one of several reports received from a same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with high blood pressure. The patient was vaccinated with a dose of ZOSTAVAX on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. In July 2012 date the patient developed a little bump, a burning sensation and a larger area around the injection site after vaccination. The reporter said the red area was the size of her palm. The patient had visited the office for medical attention and was treated with KEFLEX. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Cervical dysplasia, Colposcopy abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no medical history and no drug reactions/allergies. The patient was vaccinated with 2 doses of GARDASIL at another unspecified practice 6 years ago (in 2006). No other co-suspects were reported. There was no concomitant therapy. In June 2012, the patient had an abnormal PAP smear and colposcopy reveled CIN1 (cervical intraepithelial neoplasia) and condyloma due to HPV. The patient will be monitored with PAP smears every 6 months. The patient sought medical attention by office visit and was given no treatment for AEs. The outcome of adverse events was reported as recovered/resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) refers to a female patient of unknown. The patient was vaccinated with the first dose of GARDASIL (lot # not reported) in 2007 and the second dose of GARDASIL (lot # not reported) in the reporter's office on 30-JUL-2012. Whether the patient sought for medical attention was not reported. No adverse effect was reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # 665215/1172Y, Exp 14-FEB-2011, dose unspecified) on 31-JUL-2012. No other co-suspects were reported. No concomitant medications were ported. Reporter noted that the patient was administered an expired dose of ZOSTAVAX on 31-JUL-2012. No adverse effect reported. It was unspecified the patient had sought medical attention or not. NO treatment information was reported. The outcome was unknown. 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 pharmacist refers to a patient of unknown age. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot #, dose and route not reported) respectively on 05-AUG-2010, 29-SEP-2010 and 30-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was not known if the patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 18 years old male patient with no known drug allergies. The patient was vaccinated IM with a dose of GARDASIL, 0.5 ml, on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012, minutes after receiving the GARDASIL, the patient felt faint. The patient did not lose consciousness, but he felt lousy for better than an hour. No treatment information was reported. No lab diagnostic studies were performed. The patient was observed for one hour. The patient will not receive any more doses of GARDASIL. The patient was recovered on 11--JUL-2012. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an 18 years old male patient with no known drug allergies. The patient was vaccinated IM with a dose of GARDASIL, 0.5 ml, on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012, minutes after receiving the GARDASIL, the patient felt faint. The patient did not lose consciousness, but he felt lousy for better than an hour. No treatment information was reported. No lab diagnostic studies were performed. The patient was observed for one hour. The patient will not receive any more doses of GARDASIL. The patient was recovered on 11--JUL-2012. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was respectively vaccinated IM with the first and second dose of GARDASIL on 30-JUN-2011 and 31-JUL-2012. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from an office manager refers to a male patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 672962/0025AE, dose and route not reported) on 26-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced local injection site reaction after vaccination with PNEUMOVAX 23. The site was hot, swollen and raised. The treatment was TYLENOL and ice. The patient called to office for medical attention. The outcome of local injection site reaction was unknown. This is one of several reports received from a same source. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Blister, Genital pain, Malaise, Oropharyngeal blistering, Oropharyngeal pain
Clinical narrative: Information has been received from a physician concerning a 54 year old female patient with high blood pressure, high cholesterol, lupus, diabetes, low thyroid activity, allergy to adhesive bandage, iodinated contrast dye and avocado and with a drug allergy to COMPAZINE who on 18-MAY-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 672867/0241AE). Concomitant therapy included diphtheria toxoid (+)( pertussis acellular vaccine (unspecified) (+) tetanus toxoid, GLUMETZA, BYSTOLIC, MAXZIDE, levothyroxine Na, CRESTOR, cholecalciferol, ALLEGRA and multivitamins. It was reported that, on 05-JUN-2012 a patient developed chickenpox-like blisters on her body. She had a clear painful blister on her genital area. She also had a clear painful blister on her right thumb and a clear blister on her right pharynx. The patient developed a low grade fever which lasted until 10-JUN-2012. The patient sought medical attention via calling physician. No lab diagnostic studies were performed. There was no treatment given for AE. By 11-JUN-2012 fever had resolved and blisters were gone. Follow up information has been received from a physician refers to a 54 years old female patient with, hypertension, dyslipidemia, II diabetes and hypothyroidism with none illness at the time of vaccination. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported), (lot # 672867/0241AE) on 18-MAY-2012. It was reported that on 05-JUN-2012 the patient reported a clear painful blister developed in the genital area. It was very important. She then developed a similar blister on the pad of her right thumb, very painful. On 08-JUN-2012 she developed a low grade fever, diffuse body aches, malaise, sore throat. She noted a sore blister on the throat, painful. It was reported that fever resolved on 10-JUN-2012 and blister on 19-JUN-2012 (generally patient was resolved from adverse event between 06 and 19 of June 2012). Additional information is not expected.