chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to three unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose and frequency were not provided). On an unknown date, the patients experienced mild shingles after receiving ZOSTAVAX. No concomitant therapies were reported. The outcome of mild shingles was unknown. The causality of ZOSTAVAX regarding the event mild shingles was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ, (lot #, exp. date, strength and dose were not provided). No adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly dose of GARDASIL (lot # K009482, exp. date on 06-MAR-2017), (strength, route of administration and dose were not provided). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 15-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot # L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified)(incorrect product storage). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored LIQUID PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following AEQIR review, it was determined that the report did not meet criteria for a quality investigations. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and rout unspecified)(incorrect product storage). No adverse effects were reported. thi sis one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified)(incorrect product storage). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose, frequency and route were not provided). The physician was contacted by the patient's mother who reported that after receiving the second intramuscularly dose of GARDASIL (lot # K026247, expiration date 29-JAN-2017) administered on 06-JUL-2015, the patient experienced a flakey scalp (skin exfoliation). There was not treatment given for the adverse event. The patient did not sought medical attention. The outcome of skin exfoliation was unknown. The causality of GARDASIL regarding the event skin exfoliation was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K009482, exp. date on 06-MAR-2017), (strength, route of administration and dose were not provided). No adverse symptoms reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown ages and genders. Since 20-MAY-2015 on unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L00456, Expiration date 06-JAN-2017 (dose and route not provided). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On a unspecified date, the patients were vaccinated with (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were not provided) and with MMR II (lot #, expiration date, dose and route were not provided). No concomitant therapies were reported. On an unspecified date, the patients' antibody titers to measles, mumps, rubella and varicella were negative. The outcome of varicella virus test negative, mumps antibody test negative, rubella antibody negative and measles antibody negative was unknown. The causality between the events and (Oka/Merck) VARIVAX and MMR II was not provided. This is one of two reports from the same source (MARRS# 1507USA001668). Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This unsolicited case was received on 13-JUL-2015 via a third party query tool search on the VAERS database, under reference number 568572. A 34-year-old male patient received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route on 08-Feb-2015. The medical history and current illnesses was reported as none. The prior vaccination details, laboratory data and other medications were not reported. On 18-Feb-2015, 10 days post-vaccination, the patient developed swelling and redness (Cellulitis) on the left arm. He sought care on both 18-Feb-2015 and 19-Feb-2015. He was treated with antibiotics without incident and had no further problems. The patient required an emergency visit. At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. Upon internal review the case was considered serious due to important medical events: cellulitis, erythema and peripheral swelling. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 66 year old male patient. No concurrent condition or medical history was reported. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX, (subcutaneous in the right arm, dose not provided). On an unknown date in July 2015, the patient experienced unspecified rash around the injection site and a vesicle about 1 inch from the injection site, which was posterior tricep area of patient's right arm. The patient visited the pharmacy on 16-JUL-2015 at which time the rash appeared to have faded but the vesicle was still present. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 66 year old male patient. No concurrent condition or medical history was reported. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX, (subcutaneous in the right arm, dose not provided). On an unknown date in July 2015, the patient experienced unspecified rash around the injection site and a vesicle about 1 inch from the injection site, which was posterior tricep area of patient's right arm. The patient visited the pharmacy on 16-JUL-2015 at which time the rash appeared to have faded but the vesicle was still present. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: REDNESS AT SITE (LEFT ARM) NOTED BY PARENT AFTER PATIENT GOT OUT OF SHOWER.
Age: 9.0
Sex: M
Vaccine: HPVX
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, increased fatigue within hours of vaccine for 1 day in PM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Infusion site pain, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. The patient had no known drug reactions or allergies. On 29-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number and expiration date were not provided). There was no concomitant medication. In 2015, following the administration of ZOSTAVAX, the patient experienced injection site erythema, infusion site pain and injection site pruritus described as redness, itching and burning at the injection site. The pharmacist stated that treatment was given in the form of an ice application to the injection site applied by the patient. There were no laboratory diagnostics studies performed. The patient sought medical attention when she was seen in the pharmacy. The outcome of infusion site pain, injection site pruritus and injection site erythema was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-JUL-2015 the patient was vaccinated with improperly stored PROQUAD lot # L002213, expiration date 21-JUL-2016 (dose strength, route unspecified). No adverse effects reported. The outcome of events reported was unknown. No product quality was involved. This case is linked to the case 1507USA009788 via same reporter link. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Lipase increased, Ultrasound abdomen normal
Clinical narrative: Onset of acute epigastric abdominal pain, mild to moderate pain constantly with intermittent severe colicky pain lasting 30-60 minutes.  Presented to our office for evaluation on 7/16, ultrasound done was normal but pain still severe. Evaluated in the ED at hospital where labs done, lipase found to be elevated to 2479, patient admitted for treatment.  Lipase decreased over the next 2 days, discharged home and continues to decrease, most recent level on 7/21 was 572. Abdominal pain improved.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Tremor
Clinical narrative: Mom stated patient started with shaking of the extremities.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of currently 58 years old. The pharmacist reported that he was informed by the patient itself. No information about medical history, concurrent conditions was reported for the patient. On 13-MAR-2015 the patient was vaccinated with ZOSTAVAX lot # K020802, expiration date 31-JAN-2016, dose 0.65 ml, subcutaneously. No concomitant therapy was reported. Approximately on an unknown date in 2015 the patient experienced unspecified reaction after receiving ZOSTAVAX. The patient was not treated for the event reported. The patient had sought medical attention. The outcome of event reported was unknown. No product quality complaint was involved. This case is linked to the case 1507USA009493 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 12-JUN-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported). It could not be determined whether the patient received the product with lot # L007531 with expiration date: 04-NOV-2016 or lot # K007264 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 15-JUN-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route of administration were not reported). It could not be determined whether the patient received the product with lot # L007531 with expiration date: 04-NOV-2016 or lot # K007264 with expiration date 02-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 28-MAY-2015, the patient was vaccinated with improperly stored ROTATEQ, 2 ml, oral. No concomitant medication was reported. Temperature excursion was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Given DTaP on RVL-reaction area bigger than 50 cent-red-swollen given PROQUAD on left thigh Sub Q area larger than 50 cent, red, swollen.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Blister
Clinical narrative: Developed blisters after receiving Tdap on the 3rd day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 7-4-15, said they had apparent itching and swelling at site of shot. Patient came in on 7-15-15. Area looked red at and around site of injection and felt warm. Referred to her physician.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Patient screamed more than four hours after receiving vaccines in 05/04/15.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Red circle 7.5 cm x 7.5 cm, warm to touch, swollen, itchy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dizziness, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red circle 6 cm x 6 cm, warm to touch, swollen, itchy, dizziness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Injection site cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Given Tdap 7-1-15. Seen by occupational medicine 7-10-15 after arm with redness, swelling, temp 100.6. Had superficial redness 7-8-15. Had put VICKS VAPORUB after shower to area. 7-7-15 had soreness in arm prior, temp 98.8-7-8-15. Antibiotics given have made improvement in arm.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient had first Hep B vaccine 06-16-2015. Presented to clinic for second one with a rash over the initial injection site. She states it appeared within 3 days of injection and it is still present. Rash is red with about 8-10 raised bumps. No illness or fever.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: Pt's mother states that patient was up in the night around 10:30 PM with body aches, Head ache and upset stomach. She states that he took some ibuprofen in the morning and was feeling a little better but still achy and with a slight head ache.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site inflammation, Injection site pruritus
Clinical narrative: ARMED SITE INFLAMED, ITCHY, HARD & SIZE OF A GOLF BALL, STILL EXISTS SIZE OF A NICKEL 2 WEEKS LATER HARD, & ITCHY.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted after shot was given.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Anaphylactic reaction, Anxiety, Cerebrovascular accident, Chest pain
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 9 July 2015. An adult female patient (age not reported), whose medical history includes bee sting for which EPIPEN was taken by the patient as she suffered from reaction anaphylaxis in 1990, ovarian cyst for which oophorectomy of right ovary was carried out in 1988, appendicitis for which appendectomy was carried out in 1977 and concomitant medications were not reported had received a dose of Tetanus vaccine (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date in 1995, after the vaccination the patient had experienced hives and reactions (allergy to tetanus vaccine). It was reported that the patient also experienced the following adverse events: AUGMENTIN allergy (reaction- anaphylaxis) in the year 2000 dates not specified, cephalosporins allergy (reaction anaphylaxis) in the year 2000 dates not specified, osteoarthritis in 2003 dates not specified, hyperlipidemia in 2006 dates not specified, coronary artery disease 2006 for which stent placement was carried out in 2006, 2013 and January 2015, dates not specified, depression in 2010 dates not specified, chronic obstructive pulmonary disease (COPD) in 2011 dates not specified and was also hospitalized on unspecified dates, hypothyroidism in 2013 dates not specified, cerebrovascular accident (CVA) in 19 February 2013, hypertension in 2014 dates not specified, anxiety in January 2015 dates not specified and also COPD exacerbation on 19 June 2015. Then on 6 July 2015 the patient experienced chest pain and was hospitalized on the same day. Laboratory investigations were not reported. Corrective treatments includes Metoprolol, LASIX (2014) for hypertension, Isosorbide, PLAVIX (2013) for coronary artery disease (CAD), Lisinopril (2014) for kidney protection, Atorvastatin (2013) for hyperlipidemia, ASA (2006) for heart health, oxygen (2014), SYMBICORT and Albuterol inhaler (2011), Albuterol Nebulizer (2011) for chronic obstructive pulmonary disease (COPD), ALEVE (2010) for osteoarthritis, DEPAKOTE and ZOLOFT (2010) for depression, Lorazepam (Jan 2015) for anxiety, Levothyroxine (2013) for hyperthyroidism, Nitroglycerin (2013) for chest pain. At the time of this report the event outcome for COPD exacerbation was recovered on 23 June 2015, for Cerebrovascular accident was recovered on 19 February 2013, for chest pain was not recovered, for allergy to vaccine and other events was not reported. Reasonable relation of the events to concomitant medications and to clinical trials was reported as no. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Coronary arterial stent insertion, Coronary artery disease, Depression
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 9 July 2015. An adult female patient (age not reported), whose medical history includes bee sting for which EPIPEN was taken by the patient as she suffered from reaction anaphylaxis in 1990, ovarian cyst for which oophorectomy of right ovary was carried out in 1988, appendicitis for which appendectomy was carried out in 1977 and concomitant medications were not reported had received a dose of Tetanus vaccine (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date in 1995, after the vaccination the patient had experienced hives and reactions (allergy to tetanus vaccine). It was reported that the patient also experienced the following adverse events: AUGMENTIN allergy (reaction- anaphylaxis) in the year 2000 dates not specified, cephalosporins allergy (reaction anaphylaxis) in the year 2000 dates not specified, osteoarthritis in 2003 dates not specified, hyperlipidemia in 2006 dates not specified, coronary artery disease 2006 for which stent placement was carried out in 2006, 2013 and January 2015, dates not specified, depression in 2010 dates not specified, chronic obstructive pulmonary disease (COPD) in 2011 dates not specified and was also hospitalized on unspecified dates, hypothyroidism in 2013 dates not specified, cerebrovascular accident (CVA) in 19 February 2013, hypertension in 2014 dates not specified, anxiety in January 2015 dates not specified and also COPD exacerbation on 19 June 2015. Then on 6 July 2015 the patient experienced chest pain and was hospitalized on the same day. Laboratory investigations were not reported. Corrective treatments includes Metoprolol, LASIX (2014) for hypertension, Isosorbide, PLAVIX (2013) for coronary artery disease (CAD), Lisinopril (2014) for kidney protection, Atorvastatin (2013) for hyperlipidemia, ASA (2006) for heart health, oxygen (2014), SYMBICORT and Albuterol inhaler (2011), Albuterol Nebulizer (2011) for chronic obstructive pulmonary disease (COPD), ALEVE (2010) for osteoarthritis, DEPAKOTE and ZOLOFT (2010) for depression, Lorazepam (Jan 2015) for anxiety, Levothyroxine (2013) for hyperthyroidism, Nitroglycerin (2013) for chest pain. At the time of this report the event outcome for COPD exacerbation was recovered on 23 June 2015, for Cerebrovascular accident was recovered on 19 February 2013, for chest pain was not recovered, for allergy to vaccine and other events was not reported. Reasonable relation of the events to concomitant medications and to clinical trials was reported as no. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Drug hypersensitivity, Hyperlipidaemia, Hypertension, Hypothyroidism, Osteoarthritis
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 9 July 2015. An adult female patient (age not reported), whose medical history includes bee sting for which EPIPEN was taken by the patient as she suffered from reaction anaphylaxis in 1990, ovarian cyst for which oophorectomy of right ovary was carried out in 1988, appendicitis for which appendectomy was carried out in 1977 and concomitant medications were not reported had received a dose of Tetanus vaccine (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date in 1995, after the vaccination the patient had experienced hives and reactions (allergy to tetanus vaccine). It was reported that the patient also experienced the following adverse events: AUGMENTIN allergy (reaction- anaphylaxis) in the year 2000 dates not specified, cephalosporins allergy (reaction anaphylaxis) in the year 2000 dates not specified, osteoarthritis in 2003 dates not specified, hyperlipidemia in 2006 dates not specified, coronary artery disease 2006 for which stent placement was carried out in 2006, 2013 and January 2015, dates not specified, depression in 2010 dates not specified, chronic obstructive pulmonary disease (COPD) in 2011 dates not specified and was also hospitalized on unspecified dates, hypothyroidism in 2013 dates not specified, cerebrovascular accident (CVA) in 19 February 2013, hypertension in 2014 dates not specified, anxiety in January 2015 dates not specified and also COPD exacerbation on 19 June 2015. Then on 6 July 2015 the patient experienced chest pain and was hospitalized on the same day. Laboratory investigations were not reported. Corrective treatments includes Metoprolol, LASIX (2014) for hypertension, Isosorbide, PLAVIX (2013) for coronary artery disease (CAD), Lisinopril (2014) for kidney protection, Atorvastatin (2013) for hyperlipidemia, ASA (2006) for heart health, oxygen (2014), SYMBICORT and Albuterol inhaler (2011), Albuterol Nebulizer (2011) for chronic obstructive pulmonary disease (COPD), ALEVE (2010) for osteoarthritis, DEPAKOTE and ZOLOFT (2010) for depression, Lorazepam (Jan 2015) for anxiety, Levothyroxine (2013) for hyperthyroidism, Nitroglycerin (2013) for chest pain. At the time of this report the event outcome for COPD exacerbation was recovered on 23 June 2015, for Cerebrovascular accident was recovered on 19 February 2013, for chest pain was not recovered, for allergy to vaccine and other events was not reported. Reasonable relation of the events to concomitant medications and to clinical trials was reported as no. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 9 July 2015. An adult female patient (age not reported), whose medical history includes bee sting for which EPIPEN was taken by the patient as she suffered from reaction anaphylaxis in 1990, ovarian cyst for which oophorectomy of right ovary was carried out in 1988, appendicitis for which appendectomy was carried out in 1977 and concomitant medications were not reported had received a dose of Tetanus vaccine (batch number, route and site of administration not reported) on an unspecified date. On an unspecified date in 1995, after the vaccination the patient had experienced hives and reactions (allergy to tetanus vaccine). It was reported that the patient also experienced the following adverse events: AUGMENTIN allergy (reaction- anaphylaxis) in the year 2000 dates not specified, cephalosporins allergy (reaction anaphylaxis) in the year 2000 dates not specified, osteoarthritis in 2003 dates not specified, hyperlipidemia in 2006 dates not specified, coronary artery disease 2006 for which stent placement was carried out in 2006, 2013 and January 2015, dates not specified, depression in 2010 dates not specified, chronic obstructive pulmonary disease (COPD) in 2011 dates not specified and was also hospitalized on unspecified dates, hypothyroidism in 2013 dates not specified, cerebrovascular accident (CVA) in 19 February 2013, hypertension in 2014 dates not specified, anxiety in January 2015 dates not specified and also COPD exacerbation on 19 June 2015. Then on 6 July 2015 the patient experienced chest pain and was hospitalized on the same day. Laboratory investigations were not reported. Corrective treatments includes Metoprolol, LASIX (2014) for hypertension, Isosorbide, PLAVIX (2013) for coronary artery disease (CAD), Lisinopril (2014) for kidney protection, Atorvastatin (2013) for hyperlipidemia, ASA (2006) for heart health, oxygen (2014), SYMBICORT and Albuterol inhaler (2011), Albuterol Nebulizer (2011) for chronic obstructive pulmonary disease (COPD), ALEVE (2010) for osteoarthritis, DEPAKOTE and ZOLOFT (2010) for depression, Lorazepam (Jan 2015) for anxiety, Levothyroxine (2013) for hyperthyroidism, Nitroglycerin (2013) for chest pain. At the time of this report the event outcome for COPD exacerbation was recovered on 23 June 2015, for Cerebrovascular accident was recovered on 19 February 2013, for chest pain was not recovered, for allergy to vaccine and other events was not reported. Reasonable relation of the events to concomitant medications and to clinical trials was reported as no. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Nurse administered a Varicella vaccine with the expiration of 07/10/2015.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a physician (pediatrics) on 13 July 2015 and follow-up information received from a physician (pediatrics) on 14 July 2015. A six-months-old patient (gender not reported), whose medical history and concomitant medication were not reported, had received a dose of PENTACEL (batch number, expiration date, dose, dose number, route and site of administration were not reported), with a dose of Rota (batch number, expiration date, dose, dose number, route and site of administration were not reported) and also received a dose of Pneumococcal (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced seizure. It was reported that, the patient experienced a seizure that did not occur in the office or witnessed by medical staff after Rota, Pneumococcal and PENTACEL were administered. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported. Upon internal review, company assessed the event of seizure as serious and important medical event. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 04-JUN-2015 to 07-JUL-2015, the patients received (Oka/Merck) VARIVAX (lot # L004652 and expiry date of 11-FEB-2017; lot # L006386 and expiry date of 25-FEB-2017 and lot # L005299 and expiry date of 17-FEB-2017) (unknown strength, route and dose), which was improperly exposed to -10.5 degree centigrade for 23 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN2015 to 07-JUL-2015, the patients received GARDASIL (lot # K023432 and expiry date of 18-JUN-2016 and lot # K010574 and expiry date of 08-APR-2017) (unkonwn strength, route and dose), which was improperly exposed to 10.9 degree centigrade for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received VAQTA (Lot # L008665 and expiry date of 10-FEB-2017) (unknown strength, route and dose), which was improperly exposed to 10.9C for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received ROTATEQ (lot # K023532 and expiry date of 21-JUN-2016) (oral, unknown strength and dose), which was improperly exposed to 10.9 degree centigrade for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received RECOMBIVAX HB (lot # K0214444 and expiry date of 17-SEP-2016) (unknown strength, route and dose), which was improperly exposed to 10.9 degrees centigrade for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. 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 healthcare worker refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. On 23-JUN-2015 (two weeks ago), the patients were vaccinated with first dose of GARDASIL (unknown strength, route and dose). The patients were administered second dose of GARDASIL was administered second dose of GARDASIL was administered today, on 07-JUL-2015. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not provide consent for further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 17-JUL-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L007228, expired date 03-SEP-2016, dose and route were unknown). No concomitant medication was reported. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received three doses of PNEUMOVAX23 on an unspecified dates in 2003, 2009 and 2013 respectively. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. None drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). On an unknown date, the patient developed a knot in her arm (unspecified which one) after receiving ZOSTAVAX. The outcome of knot in arm was unknown. The relatedness between the knot in arm and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Asthenia, Discomfort, Erythema, Headache, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The past medical history includes stage 0 leukemia; had lying been outside near wooded area, fully clothed, for hours; no new lotions or soaps; exposed multiple times to chicken pox from his kids. His past drug history was unknown. On 20-JUN-2015 the patient was vaccinated with ZOSTAVAX, lot# 6006380 with expiry date 25-MAY-2016, .5 ml, subcutaneous in the arm. Concomitant therapies included SIMVASTATIN TABLETS, USP, PLAVIX and PREVNAR. On 22-JUN-2015, the patient had one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm, unknown if right or left arm. The patient wondered if it was an allergic reaction. The pharmacist advised hydrocortisone cream. On 26-JUN-2015, the patient had raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center. On 26-JUN-2015, the patient experienced not feeling well, headache, no energy, being uncomfortable from itchy pustules. The pharmacist did not believe it was shingles and thought that the patient was having an allergic reaction. The pharmacist referred the patient to his physician, as concerned that he could possibly have a tick bite. On an unknown date in June 2015, the patient was seen at a clinic and started on acyclovir 800mg five times a day for a vaccine reaction, not chicken pox or zoster. On27-JUN-2015, the patient experienced worsening of not feeling well, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back. The patient had no relevant laboratory data. As of 27-JUN-2015, the patient no longer continues on with ZOSTAVAX and continues to experience vaccine reaction and worsening of not feeling unwell, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back, and the outcome of one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm and raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center was unknown. The reporter did not provide the causality between with ZOSTAVAX and the events. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Pruritus, Rash, Rash macular, Rash pustular, Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The past medical history includes stage 0 leukemia; had lying been outside near wooded area, fully clothed, for hours; no new lotions or soaps; exposed multiple times to chicken pox from his kids. His past drug history was unknown. On 20-JUN-2015 the patient was vaccinated with ZOSTAVAX, lot# 6006380 with expiry date 25-MAY-2016, .5 ml, subcutaneous in the arm. Concomitant therapies included SIMVASTATIN TABLETS, USP, PLAVIX and PREVNAR. On 22-JUN-2015, the patient had one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm, unknown if right or left arm. The patient wondered if it was an allergic reaction. The pharmacist advised hydrocortisone cream. On 26-JUN-2015, the patient had raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center. On 26-JUN-2015, the patient experienced not feeling well, headache, no energy, being uncomfortable from itchy pustules. The pharmacist did not believe it was shingles and thought that the patient was having an allergic reaction. The pharmacist referred the patient to his physician, as concerned that he could possibly have a tick bite. On an unknown date in June 2015, the patient was seen at a clinic and started on acyclovir 800mg five times a day for a vaccine reaction, not chicken pox or zoster. On27-JUN-2015, the patient experienced worsening of not feeling well, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back. The patient had no relevant laboratory data. As of 27-JUN-2015, the patient no longer continues on with ZOSTAVAX and continues to experience vaccine reaction and worsening of not feeling unwell, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back, and the outcome of one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm and raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center was unknown. The reporter did not provide the causality between with ZOSTAVAX and the events. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, PNC13, VARZOS
Symptoms: Rash pustular, Skin reaction, Viral infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The past medical history includes stage 0 leukemia; had lying been outside near wooded area, fully clothed, for hours; no new lotions or soaps; exposed multiple times to chicken pox from his kids. His past drug history was unknown. On 20-JUN-2015 the patient was vaccinated with ZOSTAVAX, lot# 6006380 with expiry date 25-MAY-2016, .5 ml, subcutaneous in the arm. Concomitant therapies included SIMVASTATIN TABLETS, USP, PLAVIX and PREVNAR. On 22-JUN-2015, the patient had one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm, unknown if right or left arm. The patient wondered if it was an allergic reaction. The pharmacist advised hydrocortisone cream. On 26-JUN-2015, the patient had raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center. On 26-JUN-2015, the patient experienced not feeling well, headache, no energy, being uncomfortable from itchy pustules. The pharmacist did not believe it was shingles and thought that the patient was having an allergic reaction. The pharmacist referred the patient to his physician, as concerned that he could possibly have a tick bite. On an unknown date in June 2015, the patient was seen at a clinic and started on acyclovir 800mg five times a day for a vaccine reaction, not chicken pox or zoster. On27-JUN-2015, the patient experienced worsening of not feeling well, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back. The patient had no relevant laboratory data. As of 27-JUN-2015, the patient no longer continues on with ZOSTAVAX and continues to experience vaccine reaction and worsening of not feeling unwell, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back, and the outcome of one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm and raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center was unknown. The reporter did not provide the causality between with ZOSTAVAX and the events. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Incorrect product storage, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker referring to a 24 year old female patient with unspecified drug reaction to CECLOR and VICKS NYQUIL. There was no pertinent medical history reported. 08-MAY-2015 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot  #K005181, expired date 10-APR-2016, dose was unknown) subcutaneously. On 10-JUL-2015, the patient received the second dose of VARIVAX (Merck) (lot # K005181, expired date 10-APR-2016, dose was unknown) subcutaneously which was improperly stored along with TWINRIX. Concomitant medication included JUNEL FE. On 11-JUL-2015, one day after receiving the vaccinations, the patient experienced injection site itching and swelling, and the injection site was "hot to the touch". The patient did not seek medical attention. No lab test was performed and no treatment was given to the patient. The outcome of the events and causality were not provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Medication error, Pneumonia
Clinical narrative: This spontaneous report as received from healthcare worker regarding male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received three doses of PNEUMOVAX 23 on an unspecified dates in 2003, 2009 and 2013 respectively. On an unknown date in 2008 the patient experienced pneumonia. The outcome of pneumonia was unknown. The reporter did not provide the relatedness of PNEUMOVAX 23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.