chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 55 years old female patient with current condition included hepatitis c, hypertension, hyperthyroidism, vitamin d deficiency and diabetes mellitus and with no known "allergies". On 16-JAN-2013, the patient was vaccinated with PNEUMOVAX23(lot# and expiration date unspecified by the reported) (0.2ml single dose vaccination, intramuscular injection, site was unspecified). No other co-suspects were reported. Concomitant medications included insulin. The registered nurse reported that the patient reports that one day following the vaccination with PNEUMOVAX23, on 17-JAN-2013, her arm was sore, two days following the vaccination on18-JAN-2013 her arm additionally became red and swollen, it was mentioned that symptoms have improved since 18-JAN-2013. The patient sought medical attention at office visit and treatment was given with Nonsteroidal anti-inflammatory drugs (NSAIDS) and compressions. The patient's arm remains stiff and sore at the time of the report. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Cellulitis at 10 days post immunization. Tx. PO KEFLEX 8ml/TID 4.0 cm x 2.5 cm well demarcated erythematous rxn, possible developing abscess.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL, VARZOS, DTAPIPV, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: ZOSTAVAX given in error to 4 year old in addition to VARIVAX. Should have received MMR and varicella. No unusual side effects reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL, VARZOS, DTAPIPV, VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ZOSTAVAX given in error to 4 year old in addition to VARIVAX. Should have received MMR and varicella. No unusual side effects reported.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Left upper arm with approximately 7 cm area of erythema or swelling. Area with itching. Treatment of CLARITIN and ATARAX given. Advised to ice as needed and return if symptoms persist.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Welts around her eyes, mouth, and on her neck. Throat is swollen. Tongue numb, scalp is itchy, lips are numb and tingling - onset occurred 4 days after receiving the immunization. Still symptomatic as of Jan 28, 2013.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Redness (4 inch diameter), swelling, pain, muscle ache, elevated temperature around injection site. Pt was given KEFLEX 500mg -> DC due side effects. MD changed to BACTRIM DS.
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Cough, Influenza like illness, Irritability, Pyrexia
Clinical narrative: Low grade fever, fussiness, cough within 24hrs of vaccine. Appears to be influenza-like illness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: 1/28/13 - Approx 2.5 x 1.5 in. raised red area with clear margins. Per pt - PCP started abx for cellulitis.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: On 1/23/13, patient reported muscle pain from the arm where shot was administered. Patient described it as "ache that comes and goes". On a scale of 1-10, patient stated pain is 5. Patient denied any induration, inflammation / swelling on the arm. Patient denied having pain in other body parts. Patient did warm compress and took Ibuprofen on 1/24/13.
Age: 1.45
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 months old patient. The patient was vaccinated with first dose of M-M-R II (lot number 671686/1874AA, exp 30-NOV-2013) subsequently in thigh on 22-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The reporter said that during the injection, the patient moved the leg, and only half of the 0.5ml dose of vaccine was administered. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Neck injury, Syncope
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female "teenager" patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (lot # unspecified) 0.5 ml on 21-JAN-2013. It was not unknown when the first dose of GARDASIL was given. No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (manufacturer unspecified). On 21-JAN-2013, as the patient was walking towards the exit, she fainted, falling on the ground and hurting her neck. The patient was allowed to rest at the office, and by the time the patient left the office later that day, she was "fine". The doctor did not specify if the patient still had neck pain or not. No treatment information was given. The patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. On unspecified dates, the patients were vaccinated intramuscularly with RECOMBIVAX HB (lot number unspecified) doses that were improperly stored at a low temperatures of 29 because of a refrigerator malfunction. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unknown if the patients had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. The medical assistant reported that an unknown number of patients may have been vaccinated with VARIVAX (Merck) (lot # and exp date were unspecified) (dose, route frequency of administration were unspecified) stored in the refrigerator for a unknown period of time. No adverse event was reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, HIBV, MMRV, PPV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old female patient. On 21-JAN-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # reported as H06327, Exp. Date: 30-AUG-2014) into right thigh, and a dose of PROQUAD (lot # reported as H015644, Exp, Date: 23-FEB-2014) into left thigh (reported as "MMRV", verbally described as MMR plus varicella). Concomitant medications included vitamins (unspecified), HIBV (unspecified carrier),Hep A (unspecified) , PNEUMOVAX 23 (Pediatric PNEUMOVAX) and influenza virus vaccine (unspecified). On 21-JAN-2013, the 12 month old patient received 6 total vaccines. Two of the vaccines, VARIVAX (Merck) and "MMRV" contained the varicella component. The patient's medical history included a "well baby visit" on 21-JAN-2013. There is no relevant laboratory data. As of 21-JAN-2013, it was unknown if the patient continued to take VARIVAX or "MMRV" and the outcome of the two doses of varicella 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 Nurse Practitioner refers to a patient of unknown age (gender unspecified). The patient was vaccinated with the first dose of 0.5 ml GARDASIL intramuscularly on an unspecified date 6 years ago in approximately 2007. The patient was in the office on 24-JAN-2013 to received the second dose of GARDASIL. No adverse effects reported. No lot # was provided. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Tenderness
Clinical narrative: This spontaneous report was received from a consumer of unknown age and gender reporting on him/herself with no written record of ever having chicken pox who 2 years ago, around Christmas time (approximately on 28-DEC-2010, on Tuesday) was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. Concomitant medications included: OXYCONTIN. 2 years ago (approximately in December 2010), Christmas, the patient was visiting one of his daughters, it was the day before Christmas eve (23-DEC-2010) and he developed an unbelievable pain on the left side of his scalp. It became so disconcerting that the patient asked his/her daughter to take him/her to the local hospital emergency room. The doctors asked a million questions and took blood, did an MRI, finally said the patient probably was suffering from a migraine. The patient have never had a migraine in his/her entire life- besides, the pain was on my scalp not in his/her head. They sent him/her home with a prescription for pain. That night the was in such agony that the patient again asked his/her daughter to take him back to the hospital. The patient was asked the same questions and given the same physical, sent home with prescription for OXYCONTIN. Needless to say the patient was out for Christmas eve day and the following day. The pain was still there even though the patient was not. The finally said no more pain killers! Still had the pain but had to get home... so on Monday (approximately on 27-DEC-2010) the patient drove home. Tuesday (approximately on 28-DEC-2010) some of the pain had diminished, so the patient decided to take a shower and wash his hair. As soon as the patient started to wash his/her hair, the patient felt all the little bumps and said "I know what I have .... Shingles". The patient went to the local emergency clinic- was put on the right medication, and went in and had the shingles shot. To this day (on 18-JAN-2012), the patient still have tenderness in the area where the shingles blossomed, sometimes when combing his hair the patient suffer residual pain. This was the worse pain the patient had ever suffered, the patient cannot say enough to anyone- go and get the shingles shot today. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient (age and gender unknown) with hemophilia. On 17-DEC-1999, the patient was vaccinated with first dose of RECOMBIVAX HB subcutaneously (lot number and dose not reported). On 04-MAY-2000, the patient was vaccinated with second dose of RECOMBIVAX HB subcutaneously (lot number and dose not reported). On 27-AUG-2002, the patient was vaccinated with third dose of RECOMBIVAX HB subcutaneously (lot number and dose not reported). Other suspect therapies included on 07-NOV-2001, the patient was vaccinated with first dose of VAQTA subcutaneously (lot number and dose not provided). On 15-MAY-2002, the patient was vaccinated with second dose of VAQTA (lot number and dose not provided). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Guillain-Barre syndrome, Nervousness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Jan-2013) concerns a male patient. On an unknown date several years ago, the patient developed Guillain Barre syndrome after receiving influenza vaccine (batch and manufacturer unspecified). The patient felt like he (had) pressure in his heart and felt shaky and weak. The patient was hospitalised for an unspecified period of time. The event outcome was recovered. Reporter's comments: The reporter considered events serious due to hospitalisation.
Age: 43.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aura, Diarrhoea, Headache, Pain, Photophobia
Clinical narrative: This spontaneous report was received from a physician refers to a 43 years old male patient with no Pertinent Medical History of Drug Reactions/Allergies. On 22-JAN-2013, the patient was vaccinated intramuscularly with an only dose of GARDASIL VIAL (Lot # H017758, Exp date : 28-NOV-2014, dose not reported). No other co-suspects were reported. Concomitant medications included EFEXOR and mirtazapine. On 23-JAN-2013, the patient experienced "severe headache with a bit of aura and light sensitivity"; the patient also experienced diarrhea. The patient went home that day (23-JAN-2013) from work and went to bed. The headache lasted 12 to 16 hours and then ended but the diarrhea still persisted. Treatment was no given to the patient. No lab tests were performed. The patient sought Medical attention. The outcome of a bit of aura and light sensitivity was unknown. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aura, Diarrhoea, Headache, Photophobia
Clinical narrative: This spontaneous report was received from a physician refers to a 43 years old male patient with no Pertinent Medical History of Drug Reactions/Allergies. On 22-JAN-2013, the patient was vaccinated intramuscularly with an only dose of GARDASIL VIAL (Lot # H017758, Exp date : 28-NOV-2014, dose not reported). No other co-suspects were reported. Concomitant medications included EFEXOR and mirtazapine. On 23-JAN-2013, the patient experienced "severe headache with a bit of aura and light sensitivity"; the patient also experienced diarrhea. The patient went home that day (23-JAN-2013) from work and went to bed. The headache lasted 12 to 16 hours and then ended but the diarrhea still persisted. Treatment was no given to the patient. No lab tests were performed. The patient sought Medical attention. The outcome of a bit of aura and light sensitivity was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Dyspnoea, Loss of consciousness, Swollen tongue, Throat tightness, Urticaria
Clinical narrative: Pt states she had a rash first and was itchy took OTC BENADRYL. Then throat and tongue started to swell and had wheezing. Then pt broke out in a cold sweat and went to ER. They gave her 2 EPIPENS, BENADRYL IV, 2 bags IV drip and steroids per pt. Pt also states she passed out shortly after receiving vaccine.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Cold sweat, Loss of consciousness, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: Pt states she had a rash first and was itchy took OTC BENADRYL. Then throat and tongue started to swell and had wheezing. Then pt broke out in a cold sweat and went to ER. They gave her 2 EPIPENS, BENADRYL IV, 2 bags IV drip and steroids per pt. Pt also states she passed out shortly after receiving vaccine.
Age: 32.0
Sex: F
Vaccine: HEPAB, TD, HEPAB, TDAP
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Pt states she had a rash first and was itchy took OTC BENADRYL. Then throat and tongue started to swell and had wheezing. Then pt broke out in a cold sweat and went to ER. They gave her 2 EPIPENS, BENADRYL IV, 2 bags IV drip and steroids per pt. Pt also states she passed out shortly after receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL, VARZOS, DTAPIPV, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4 years old female patient with seasonal allergies. The patient has no relevant medical history. The patient has a family history of cardiovascular disease and no drug allergies. On 25-JAN-2013, the patient was accidentally vaccinated with a dose of live ZOSTAVAX (lot # H018091, expiry: 04-JAN-2014) injection by an unknown route. Concomitant medications included varicella virus vaccine live (manufacturer unknown). Her past drug history was unknown. There was no relevant laboratory data. As of 25-JAN-2013, it was unknown if the patient will receive live ZOSTAVAX again and the outcome of accidentally receiving live ZOSTAVAX was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL, VARZOS, DTAPIPV, VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4 years old female patient with seasonal allergies. The patient has no relevant medical history. The patient has a family history of cardiovascular disease and no drug allergies. On 25-JAN-2013, the patient was accidentally vaccinated with a dose of live ZOSTAVAX (lot # H018091, expiry: 04-JAN-2014) injection by an unknown route. Concomitant medications included varicella virus vaccine live (manufacturer unknown). Her past drug history was unknown. There was no relevant laboratory data. As of 25-JAN-2013, it was unknown if the patient will receive live ZOSTAVAX again and the outcome of accidentally receiving live ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with an expired dose of 0.5 ml (Merck) VARIVAX (lot# 668256/0903Z, exp 09-JUL-2012) subsequently on 23-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unspecified date the patient was vaccinated with live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, while on live ZOSTAVAX, the patient had an unspecified anaphylactic reaction. She was admitted to an unspecified emergency room on an unspecified date for an unspecified length of time. Patient was given EPIPEN injection for treatment. The status of the patient was unknown at the time of reporting. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This spontaneous report was received from a 72 year old female patient regarding herself. Medical history of the patient included a bypass surgery on an unknown date approximately in January 2008 (5 years). On 30-NOV-2012, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date and dose unspecified) subcutaneously. Concomitant medications included simvastatin, metoprolol, PLAVIX, NORVASC and aspirin. On 09-DEC-2012 (9 days after receiving live ZOSTAVAX), the patient experienced severe shingles like rash and post herpetic neuralgia. The patient sought medical attention (patient visited doctor at outbreak of shingles) and she was treated with hydrocodone. No lab tests were completed. The outcome of severe shingles like rash and post herpetic neuralgia was reported as not resolved as the patient was still suffering with pain and mild rash at the time of reporting. The relatedness for severe shingles like rash and post herpetic neuralgia was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B core antibody negative, Hepatitis B e antigen positive, Hepatitis B surface antigen positive, Hepatitis B virus test positive
Clinical narrative: The information has been received from a literature article below which stating as: We identified a male surgeon with HBV infection and a high viral load (HBeAg positive) during evaluation of a needle-stick injury. Herein we report the results of an investigation of patients who had undergone operative procedures by the surgeon to evaluate potential provider-to-patient HBV transmission. In 2009, a surgeon was identified as being unknowingly and asymptomatically infected with HBV following baseline evaluation during an exposure workup. Laboratory results included a positive B surface antigen (HBsAg), positive HBeAg, negative immunoglobulin M (IgM) anti-hepatitis B core antibody (anti-HBc), and normal liver enzymes. The source patient of the exposure had negative HBV serology (HBsAg and antiHBc) results. The surgeon was removed from performing operative procedures after testing revealed a viral load of > 17.9 million IU/mL (Versant HBV bDNA 3.0 assay, Siemens Healthcare Diagnostics) while an investigation of potentially exposed patients was conducted. The surgeon completed orthopedic residency training before being employed by Facility A. Having previously completed 2 hepatitis B (manufacturer unknown) vaccination series without achieving a protective level of hepatitis B surface antibody (anti-HBs >= 10 IU/L), the provider declined further vaccination upon hire at Facility A. No additional evaluation of nonresponder status (ie, testing for the presence of HBsAg) had been performed prior to the tome of the needle-stick injury. A retrospective cohort study was conducted to Facility A to determine whether the surgeon had transmitted HBV to patients. On the basis of all available evidence, surgeon-to-patient transmission of HBV appears to be a rare event. However, our understanding of the epidemiology is limited owing tot the lack of a systematic surveillance and reporting systems. Therefore, healthcare facilities should assess their employee vaccination, blood and body fluid exposure, and infected provider oversight programs to ensure that they are sufficiently robust to identify healthcare workers with chronic HBV infection and that HBV-infected healthcare workers are evaluated and monitored appropriately. These measures are crucial to minimize the risk of HBV transmission to patients and help prevent the serious sequelae of chronic liver disease. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Injury associated with device, Laboratory test normal, No therapeutic response
Clinical narrative: The information has been received from a literature article below which stating as: We identified a male surgeon with HBV infection and a high viral load (HBeAg positive) during evaluation of a needle-stick injury. Herein we report the results of an investigation of patients who had undergone operative procedures by the surgeon to evaluate potential provider-to-patient HBV transmission. In 2009, a surgeon was identified as being unknowingly and asymptomatically infected with HBV following baseline evaluation during an exposure workup. Laboratory results included a positive B surface antigen (HBsAg), positive HBeAg, negative immunoglobulin M (IgM) anti-hepatitis B core antibody (anti-HBc), and normal liver enzymes. The source patient of the exposure had negative HBV serology (HBsAg and antiHBc) results. The surgeon was removed from performing operative procedures after testing revealed a viral load of > 17.9 million IU/mL (Versant HBV bDNA 3.0 assay, Siemens Healthcare Diagnostics) while an investigation of potentially exposed patients was conducted. The surgeon completed orthopedic residency training before being employed by Facility A. Having previously completed 2 hepatitis B (manufacturer unknown) vaccination series without achieving a protective level of hepatitis B surface antibody (anti-HBs >= 10 IU/L), the provider declined further vaccination upon hire at Facility A. No additional evaluation of nonresponder status (ie, testing for the presence of HBsAg) had been performed prior to the tome of the needle-stick injury. A retrospective cohort study was conducted to Facility A to determine whether the surgeon had transmitted HBV to patients. On the basis of all available evidence, surgeon-to-patient transmission of HBV appears to be a rare event. However, our understanding of the epidemiology is limited owing tot the lack of a systematic surveillance and reporting systems. Therefore, healthcare facilities should assess their employee vaccination, blood and body fluid exposure, and infected provider oversight programs to ensure that they are sufficiently robust to identify healthcare workers with chronic HBV infection and that HBV-infected healthcare workers are evaluated and monitored appropriately. These measures are crucial to minimize the risk of HBV transmission to patients and help prevent the serious sequelae of chronic liver disease. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 years old male patient. The patient had no history of drug reactions/allergies. He never had chickenpox. The patient was vaccinated with a dose of ZOSTAVAX (lot number not specified) on 08-OCT-2012. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed an injection site reaction after vaccination with ZOSTAVAX. The patient had a quarter size area which was inflamed at the injection site and had burning and itching. No treatment was given for the events. The patient had sought medical attention by contacting the pharmacist. At the time of report the patient had not recovered. The reporter did not provide a causality assessment. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Speech disorder, Swelling face, Swollen tongue
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated with live ZOSTAVAX on 21-JAN-2013. Patient route of administration and lot no. were not provided. No other co-suspects were reported. No concomitant medications were reported. On 28-JAN-2013 the patient experienced swelling of the jaw region, 8 days after onset of therapy, and swelling of tongue. It is effecting his speech No treatment information was reported. The outcome of swelling of the jaw region, swelling of tongue and it is effecting his speech was reported as not recovered/not resolved. The relatedness for swelling of the jaw region, it is effecting his speech and swelling of tongue is unknown for live ZOSTAVAX. Additional information is not expected, because consumer declined to answer any further AE questions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a 67 years old female patient regarding herself. The patient was allergic to penicillin. The patient had no medical history. On 07-DEC-2012, the patient was vaccinated with first dose of ZOSTAVAX (lot number, expiry date and dose were not reported) subcutaneously on her left arm. Concomitant medications were none. On 07-DEC-2012, the patient experienced pain at the site on her left arm. Later on 12-DEC-2012, the patient developed a rash type symptom on her trunk, on her hip and back not on one side of her body. She described it as diffused and as red spots. The patient sought no medical attention and no treatment was provided. The outcome of all the reported events was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Abscess sterile
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on unspecific date. The patient developed a sterile abscess after being administered ZOSTAVAX. The pharmacy has a Registered Nurse (RN) that came in to administer the vaccines. The patient's physician informed the pharmacy of this event and questioned the administration of the vaccine. It was unknown whether the patient sought medical attention. The outcome of event was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: This spontaneous report as received from a 51 years old female patient with no medical history and no drug reactions. The patient was vaccinated with a dose of ZOSTAVAX on 23-JAN-2013 in left arm for shingle prevention. There was no concomitant medications. On 24-JAN-2013 48 hours after getting the vaccine the patient's arm was tender to the touch and had a red mark the size of a penny. The patient sought unspecified medical attention and no treatment was given to the adverse events and no lab diagnostics was performed. The outcome of the adverse events was unknown. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G abnormal, Blood immunoglobulin M abnormal, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 months old female patient with no pertinent medical history and no drug reactions or allergies. On 04-DEC-2012 the patient was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (lot # 0692AE, exp. date: 02-APR-2014) for immunization. There was no concomitant medication. The patient was seen in the office on 27-DEC-2012 with vesicular rash. The Physician recommended oatmeal baths and calamine lotion. A Varicella Zoster IgG, IgM was drawn at that time. On 07-JAN-2013 the results for that blood work returned positive, and a diagnosis of chicken pox was made. The patient's mother reported that the rash and infection has resolved at this time. The relatedness for the events were unknown for VARIVAX. 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 physician refers to a patient of unknown age and gender. The patient was vaccinated with GARDASIL for the first time in 2007 and received a second dose in 2009. This is considered an inappropriate schedule of drug administration. No adverse effect was reported. Patient route of administration and lot no. information were not reported. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed nurse practitioner refers to a female patient of unknown age. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 (lot number 0841AA, expiry date 08-APR-2013) and 2 (lot number 1291AA, expiry date 12-APR-2014) of GARDASIL, both on unknown dates. The anatomical location and route of administration were not reported for the doses. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant. The LMP and EDD is not known. The amount of weeks at which initial exposure to GARDASIL took place was unknown. It was reported that the patient delivered a baby, without further details. No treatment information was reported. The reported relatedness for the fact that the patient received the first and second dose of GARDASIL and then got pregnant is unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. On an unknown date, the patient experienced redness at the injection site after administration of ZOSTAVAX. The outcome of redness at the injection site after administration of ZOSTAVAX was unknown. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Full blood count normal, Nausea, Urine analysis normal
Clinical narrative: Receive shot on 11/6/12 first one ever was made to take or no job got shot around 10AM - felt fine (no problems till that night 10:15PM it hit nausea, room spinning couldn't walk dizziness.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Receive shot on 11/6/12 first one ever was made to take or no job got shot around 10AM - felt fine (no problems till that night 10:15PM it hit nausea, room spinning couldn't walk dizziness.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Neck pain, Throat tightness
Clinical narrative: Employee returned to Employee Health office after 5 mins. of mumps (MMR) administration complaining of throat feeling "tight", sharp pain on (L) side of neck and nausea. Vitals were obtained, BENADRYL was administered and physician made aware.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an approximately 75 years old female patient with hypothyroidism, high cholesterol and depression refers to herself. The patient had no drug allergy. The patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) one injection subdermally in the upper arm about a year after the shot came out in approximately 2007. No other co-suspects were reported. Concomitant medications included SYNTHROID, ZETIA and PAXIL. The patient stated that she had shingles two times since she had received ZOSTAVAX. She experienced shingles and went to the doctor "this past Saturday" on 22-DEC-2012 and was given some pills she had to take 5 times a day for 7 days. She also stated that she got the shingles a couple of months after getting the vaccine (in approximately 2007). She said she did go to the doctor. She was prescribed a pill but could not tolerate it. The outcome of shingles was unknown. No lab test was performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Rash
Clinical narrative: Hard lump at site of injection. Rough raised area on surface of skin. Almost feels like shingles in area of vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Dyskinesia, Erythema, Eye movement disorder, Hypotonia
Clinical narrative: Initially after receiving his 2 month immunizations, he cried immediately then became red, eyes stared straight ahead, stopped crying, normal muscle tone then resumed crying and color normalized within 15 seconds.  Fine afterwards. At 3 pm same day, mother reported infant in her lap moving about, normal color and tone.  Suddenly became red in the face, not crying but eyes staring straight ahead and loss of tone in arms and legs.  Arms flopped to side.  Was supine in mother's lap and so unable to tell what legs were doing.  No twitching or unusual muscle movements. No crying afterwards.  Total event lasted less than 30 seconds.  Then resumed normal eye movements and extremity movements.  Was afebrile and was breastfeeding well throughout the day. At 9 pm again while suppine in mother's lap, noted again to be calm and not fussy.  Face became red, eyes staring straight ahead without focusing and arms flopped to side of body.  Slight regurgitation of breastmilk out of side of mouth.  No other unusual movements.  No stooling noted.  Again lasted around 30 seconds with then immediate resumption of normal eye movements and extremity tone and movement.  Was breathing throughout. Slept well last night and appears well this morning without further episodes experienced at this time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Regurgitation, Staring
Clinical narrative: Initially after receiving his 2 month immunizations, he cried immediately then became red, eyes stared straight ahead, stopped crying, normal muscle tone then resumed crying and color normalized within 15 seconds.  Fine afterwards. At 3 pm same day, mother reported infant in her lap moving about, normal color and tone.  Suddenly became red in the face, not crying but eyes staring straight ahead and loss of tone in arms and legs.  Arms flopped to side.  Was supine in mother's lap and so unable to tell what legs were doing.  No twitching or unusual muscle movements. No crying afterwards.  Total event lasted less than 30 seconds.  Then resumed normal eye movements and extremity movements.  Was afebrile and was breastfeeding well throughout the day. At 9 pm again while suppine in mother's lap, noted again to be calm and not fussy.  Face became red, eyes staring straight ahead without focusing and arms flopped to side of body.  Slight regurgitation of breastmilk out of side of mouth.  No other unusual movements.  No stooling noted.  Again lasted around 30 seconds with then immediate resumption of normal eye movements and extremity tone and movement.  Was breathing throughout. Slept well last night and appears well this morning without further episodes experienced at this time.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Fall, Headache, Hemiparesis, Injection site pain, Injection site reaction
Clinical narrative: Mother notified public health of symptoms at 08:50 on 01/23/2013. Approx 1 hour following immunization reports client experienced left side to "give out" causing client to fall to the floor for no reason. After fall, client continued through her day. Mother reports raised welt like area at site of injection that is tender. No other welt-like/rash reported. Reports a more severe headache than usual the evening of receiving the shot. 01/23/2012: symptoms are not any worse. Advised to notify MD suggested ibuprofen, Benadryl and ice pack to site.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Mother notified public health of symptoms at 08:50 on 01/23/2013. Approx 1 hour following immunization reports client experienced left side to "give out" causing client to fall to the floor for no reason. After fall, client continued through her day. Mother reports raised welt like area at site of injection that is tender. No other welt-like/rash reported. Reports a more severe headache than usual the evening of receiving the shot. 01/23/2012: symptoms are not any worse. Advised to notify MD suggested ibuprofen, Benadryl and ice pack to site.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Localised oedema, Tenderness
Clinical narrative: 3cm, localized erythema, edema, induration, tenderness to palpation. Treated with Motrin.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient complained of pain at the injection site. There was a red area with a 2.5 inch circumference observed with a small hardened area at the center of the injection site.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Activities of daily living impaired, Arthralgia, Borrelia test, C-reactive protein, Full blood count
Clinical narrative: 1 Day after vaccines, pt developed nausea. 2 Days later left wrist soreness. 3 Days later red eyes and pain in other wrist. 4 Days later both wrists swollen & left ankle pain. Monday decr. use of hands & swelling of elbows. Blotchy, rash.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Joint swelling, Nausea, Ocular hyperaemia, Rash macular, Red blood cell sedimentation rate
Clinical narrative: 1 Day after vaccines, pt developed nausea. 2 Days later left wrist soreness. 3 Days later red eyes and pain in other wrist. 4 Days later both wrists swollen & left ankle pain. Monday decr. use of hands & swelling of elbows. Blotchy, rash.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Rheumatoid factor
Clinical narrative: 1 Day after vaccines, pt developed nausea. 2 Days later left wrist soreness. 3 Days later red eyes and pain in other wrist. 4 Days later both wrists swollen & left ankle pain. Monday decr. use of hands & swelling of elbows. Blotchy, rash.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Pain, Pyrexia
Clinical narrative: Patient woke at 2 AM on 1/30/13 with swelling beneath tongue, aching, low grade temp. She is feeling better this morning. She did not seek medical attention.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via company representative, who refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of live ZOSTAVAX (dose, route and lot# not reported). No adverse event reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: MMR
Symptoms: Tinnitus
Clinical narrative: Information has been received from a Physician Assistant who received a call from a 59 year old male patient who was new to his practice complaining of experiencing tinnitus since receiving a 0.5 ml dose of M-M-R II, live (lot # not reported) intramuscularly on 09-JAN-2013. At the time of reporting, the outcome of tinnitus was unknown. The physician assistant reported that he had not seen the patient yet, and so had little medical history and very little patient specific information. The patient was not given treatment for the event. The patient sought medical attention via office visit. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Not exactly sure the onset but in retrospect the adverse event "symptoms" occurred during the two or so weeks following the vaccination date and on 6/17/12 patient was diagnosed with Type 1 Diabetes.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient became pale and experienced syncope.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Left shoulder pain and weakness.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of glands in the neck near the ear.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired Rotarix vaccine administered orally during routine well visit - no problems, no adverse outcome, no treatment needed.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Malaise, Migraine, Pain in extremity, Sensitivity of teeth
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Jan-2013) concerns a 45 year old female patient with a medical history of chronic pain, low back pain, headache, fibromyalgia, and paresthesia. Concomitant medications included gabapentin, hydrocodone and sumatriptan. On 10-Jan-2013, the patient received AFLURIA (batch: 07849211A) in the right upper arm. On the same day, the patient developed a sore arm and afterwards experienced feeling of malaise and a migraine headache for 5 days. The patient was hypersensitive to the vaccine serum. The patient's upper and lower teeth were sensitive on one side only, which was her left side. The patient was treated with ketorolac. The event outcome was unknown. Reporter's comments: The reporter considered events serious due to significant disability or incapacity (bad headache).
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Depressed mood, Emotional disorder, Hallucination, auditory, Thinking abnormal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 18 January 2013. A 25-year-old male patient had received an injection of INFLUENZA VACCINE, Sanofi Pasteur, (lot number, route and site of administration not reported) on 16 January 2013 in the emergency room and "had a reaction to it". On 17 January 2013, when the patient woke up, he noticed his thinking was not normal, had no anger, felt like he could not stand up for himself, was depressed and could not cry. His emotions were not right and asked if there was a medication to take the vaccine out of him. He used to hear voices in his head and now he does not and he does not want to be angry. The patient had no illness at the time of vaccination and a medical history of Hepatitis C. Outcome was not recovered. Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: Initial report was received from a consumer on 18 January 2013. A male patient (age and date of birth not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route, site and date not reported) and an unspecified amount of time later fainted. No additional information was provided. Outcome was not reported. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, DTAPIPVHIB, FLUX, PNC13
Symptoms: Asthenia, Blood creatinine normal, Blood culture, Blood glucose increased, Blood potassium normal
Clinical narrative: Initial report was received from a healthcare professional on 18 January 2013. A six-month-old male patient had received the following injections of 07 January 2013: a dose one intramuscular injection in the right thigh of FLUZONE, lot number U4483BA, a dose one intramuscular injection in the left thigh of PENTACEL, lot number C4270AA and a dose one intramuscular injection in the right thigh of PREVNAR, Wyeth, lot number 166401. On 08 January 2013, the patient was weak and had a weak cry. The patient was taken to the emergency room (ER) and discharged. The patient returned to the ER on 09 January 2013 and was admitted for weakness, dehydration and was on a ventilator with a diagnosis of transverse myelitis. Laboratory results from 09 January 2013 included: sodium 130, potassium 4.9, glucose 96, BUN 9, creatinine 0.4, WBC 12.7, hemoglobin 11.8, platelets 422, differential no shift to left, RSV and Flu negative, and "BC pending". The patient was hospitalized for 10 days. The patient had no illness at the time of vaccination but might have had a viral illness earlier. The patient had no known allergies (NKA). Outcome was not recovered. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, DTAPIPVHIB, FLUX, PNC13
Symptoms: Blood sodium decreased, Blood urea normal, Crying, Dehydration, Haemoglobin normal
Clinical narrative: Initial report was received from a healthcare professional on 18 January 2013. A six-month-old male patient had received the following injections of 07 January 2013: a dose one intramuscular injection in the right thigh of FLUZONE, lot number U4483BA, a dose one intramuscular injection in the left thigh of PENTACEL, lot number C4270AA and a dose one intramuscular injection in the right thigh of PREVNAR, Wyeth, lot number 166401. On 08 January 2013, the patient was weak and had a weak cry. The patient was taken to the emergency room (ER) and discharged. The patient returned to the ER on 09 January 2013 and was admitted for weakness, dehydration and was on a ventilator with a diagnosis of transverse myelitis. Laboratory results from 09 January 2013 included: sodium 130, potassium 4.9, glucose 96, BUN 9, creatinine 0.4, WBC 12.7, hemoglobin 11.8, platelets 422, differential no shift to left, RSV and Flu negative, and "BC pending". The patient was hospitalized for 10 days. The patient had no illness at the time of vaccination but might have had a viral illness earlier. The patient had no known allergies (NKA). Outcome was not recovered. Documents held by sender: None.