chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Neurological examination, Pain in extremity, Pallor, Pyrexia, Seizure
Clinical narrative: This is a spontaneous report from a contactable pediatrician and nurse via a Pfizer sales representative. A 13-year-old male patient received first dose (three dose series) of TRUMENBA (Lot# J29203, Exp date 01Jun2016), intramuscular in right arm, on 27Apr2015 at approximately 03:15 pm, at 0.5ml single. He left the reporter's office at 3:30 pm feeling fine. The patient was otherwise healthy, no other medical conditions. Concomitant medication included first dose (three dose series) of HPV vaccine (Lot# L004601, Exp date 04Nov2016), intramuscular in the left arm, on 27Apr2015 at approximately 03:15 pm, at unspecified dose and frequency. On 27Apr2015 the patient experienced pain at the injection site, headache, fatigue, nausea, extreme dizziness, right arm feeling sore or painful, pallor and chills. The patient came back to see the doctor on 28Apr2015 at 11:45 am for extreme dizziness and other side effects. At doctor's visit he could barely lift his right arm. The patient was running into corners of the wall when he had the dizziness. Patient stated he felt like blood rushing through him fast (Apr2015). On 29Apr2015 the patient experienced trouble walking: needed to go down stairs on his back, and could not walk down the stairs because of weakness in legs. On an unspecified date the patient experienced fever. The patient was completely checked out and examined at hospital and was diagnosed with convulsion disorder, for which received treatment. He was brought to the emergency room (ER), where full neurological work up was performed. Outcome of events trouble walking, weakness in legs and extreme dizziness was not recovered at the time of this report. Outcome of the other mentioned events was unknown. The reporting physician did not think side effects had anything to do with the HPV vaccine, he thought they were from TRUMENBA. Follow-up (05May2015): new information received from a contactable pediatrician via a Pfizer sales representative includes: event "Convulsion disorder" added, lab data added.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Fatigue, Malaise
Clinical narrative: Patient states symptoms of general malaise began 3/8/15. By morning of 4/9/15 patient was experiencing severe abdominal pain and diarrhea, which lasted five days. Patient also reports experiencing muscle aches, fatigue, and loss of appetite during this time.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Patient states symptoms of general malaise began 3/8/15. By morning of 4/9/15 patient was experiencing severe abdominal pain and diarrhea, which lasted five days. Patient also reports experiencing muscle aches, fatigue, and loss of appetite during this time.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Electroencephalogram abnormal, Epilepsy, Hypometabolism, Nausea
Clinical narrative: After last HPV had ongoing nausea and vomiting for over 6 months. Had 1st seizure May 2013. Seizures have continued. Normal development milestones with above avg intelligence.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Positron emission tomogram, Seizure, Vomiting
Clinical narrative: After last HPV had ongoing nausea and vomiting for over 6 months. Had 1st seizure May 2013. Seizures have continued. Normal development milestones with above avg intelligence.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored (Merck) VARIVAX (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005209 and 1505USA004053). Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Client developed a rash on back arms and chest.  Client stated there was over 50 dots on the child's back alone.  They are not raised, but flat purple color dots that are nearly the size of a dime the mother explained.  The client has also been itching for 2 days previous to this rash but child has history of eczema. Client has no fever and is behaving as normal otherwise.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, IPV
Symptoms: Wrong drug administered
Clinical narrative: Incorrect immunization given. Given DTaP. Td should have been given. Received Tdap on 09/05/2014.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. There was no pertinent medical history, drug reactions/allergies and concomitant medication provided. On 20-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route were not reported, lot # K018175, expiration date 10-JAN-2016). On 26-APR-2015, the patient experienced nausea and diarrhea. The patient's outcome was not recovered/not resolved (reported as the symptoms had not resolved). The patient was scheduled to see an unspecified physician on 01-MAY-2015 for an evaluation. The relatedness between the events and therapy with ZOSTAVAX was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored ZOSTAVAX (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005209 and 1505USA005210). Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a male patient of unknown age. There was no medical history, drug reactions/allergies and concomitant medication provided. On 06-MAY-2015, the patient was vaccinated with a improperly stored dose of (Merck) PROQUAD (route subcutaneous, dose was not reported, lot # reported as K020740, expiration date 30-APR-2016) as patient's second dose in the series. There was no adverse event reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Large 2.5" x 3" raised, warm, reddened area under right arm.  Area is also somewhat bruised.   She stated that the same thing happened w/first varicella inj on 4/7/15, but we didn't see this. Instructed her to use ibuprofen and Benadryl and if not better was going to contact us.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient administered Zostavax 0.65mL SQ instead of Varivax. Parents informed of event. No reactions at time of administration or yet reported.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 1 year old patient of unknown gender. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported) instead of first dose of (Merck) VARIVAX. No adverse symptoms were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Erythema, Full blood count, Metabolic function test, Pain in extremity
Clinical narrative: Rash to whole body except for face and top of arms, red, itching and burning. Swelling and pain in her feet and hands.  Onset of symptoms 7 days after MMR #2 administered.  Sent to an Occupational Med physician for evaluation.  CBC, sed rate, and CMP obtained.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate, Swelling
Clinical narrative: Rash to whole body except for face and top of arms, red, itching and burning. Swelling and pain in her feet and hands.  Onset of symptoms 7 days after MMR #2 administered.  Sent to an Occupational Med physician for evaluation.  CBC, sed rate, and CMP obtained.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis viral, Blood test abnormal, Lymphadenopathy, Sjogren's syndrome
Clinical narrative: Swollen glands, tenderness in neck and chest.  Extensive joint pain, became noticeable in early September.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Swollen glands, tenderness in neck and chest.  Extensive joint pain, became noticeable in early September.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Apnoea, Hypotension, Pallor
Clinical narrative: Initial unsolicited report received from a physician on 01 May 2015. A 02-month-old male (reported as 2.5 month old) patient, whose concomitant medications were not reported, had received a first dose of PENTACEL (batch number C4876AA, expiry date 12-Sep-2015, dose, site of administration were not reported) intramuscularly on an unspecified date. It was reported that, patient had no previous dose. Reporter denied any illness at the time vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, patient had experienced apnea, hypotension and paleness after seven days post vaccination. Patient required an emergency room visit and was subsequently hospitalized on an unspecified date. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was not reported. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Apnoea, Blood electrolytes normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Initial unsolicited report received from a physician on 01 May 2015. A 02-month-old male (reported as 2.5 month old) patient, whose concomitant medications were not reported, had received a first dose of PENTACEL (batch number C4876AA, expiry date 12-Sep-2015, dose, site of administration were not reported) intramuscularly on an unspecified date. It was reported that, patient had no previous dose. Reporter denied any illness at the time vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, patient had experienced apnea, hypotension and paleness after seven days post vaccination. Patient required an emergency room visit and was subsequently hospitalized on an unspecified date. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was not reported. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Hypotonia, Pallor, Urine analysis normal
Clinical narrative: Initial unsolicited report received from a physician on 01 May 2015. A 02-month-old male (reported as 2.5 month old) patient, whose concomitant medications were not reported, had received a first dose of PENTACEL (batch number C4876AA, expiry date 12-Sep-2015, dose, site of administration were not reported) intramuscularly on an unspecified date. It was reported that, patient had no previous dose. Reporter denied any illness at the time vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, patient had experienced apnea, hypotension and paleness after seven days post vaccination. Patient required an emergency room visit and was subsequently hospitalized on an unspecified date. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was not reported. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Malaise, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 62 year old female patient. No pertinent medical history was reported. Last Tuesday on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # were not reported). Within two days on an unknown date, the patient contacted the office to report that she had what she believed was a Shingles like rash starting from two inches from the injection site distributed down to her elbow. The patient reported that the area was painful, burning and she experienced malaise. The physician had not seen the patient in the office and cannot confirmed this was a case of Shingles. Office visit was pending. The physician had only prescribed that the patient could take BENADRYL and ibuprofen or TYLENOL (dosages unknown) if she develops fever, until she visits the office and the diagnosis is confirmed. Action taken was not applicable. The outcome of events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Areflexia, Balance disorder, Gait disturbance, Muscular weakness
Clinical narrative: 9 hrs. post vaccine, pt developed fever 39.2 R, tachycardia, abdominal pain, huge emesis, P.E.-absent reflexes LLE. Treatment-fever mgt, elevated IV lipids. 1/18/15 AM balance off, absent (R) patellar reflex. 1/27/15 abnormal gait, (R) upper/lower weakness of extremity.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Tachycardia, Vomiting
Clinical narrative: 9 hrs. post vaccine, pt developed fever 39.2 R, tachycardia, abdominal pain, huge emesis, P.E.-absent reflexes LLE. Treatment-fever mgt, elevated IV lipids. 1/18/15 AM balance off, absent (R) patellar reflex. 1/27/15 abnormal gait, (R) upper/lower weakness of extremity.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history and drug allergies or reactions were reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports form the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous, Skin warm
Clinical narrative: PATIENT REPORTED DEVELOPMENT OF RASH AT SITE OF INJECTION AND EXTENDING 2-3 INCHES DOWN BACK OF ARM. RASH IS RED AND WARM TO THE TOUCH.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Pain, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Pt noticed burning sensation in feet upon awakening.  Then had similar sensation in hands with red dots appearing on palm and fingers thoughout the morning with TTP and swelling in hands and feet and worsening of pain.  Pt treated with Zyrtec and tramadol for pain and given SIQ for 24 hours.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Tenderness
Clinical narrative: Pt noticed burning sensation in feet upon awakening.  Then had similar sensation in hands with red dots appearing on palm and fingers thoughout the morning with TTP and swelling in hands and feet and worsening of pain.  Pt treated with Zyrtec and tramadol for pain and given SIQ for 24 hours.
Sex: F
Vaccine: HEP
Symptoms: Band neutrophil percentage, Eosinophil percentage increased, Erythema, Eyelid oedema, Haematocrit normal
Clinical narrative: Rash and Erythema; spots on face, arms, arm pits, torso (front and back), buttock and legs.  Face of baby swelled up slightly in cheeks and around the eyes.  No temperature.
Sex: F
Vaccine: HEP
Symptoms: Haemoglobin normal, Lymphocyte percentage decreased, Neutrophil percentage, Rash, Red blood cell count normal
Clinical narrative: Rash and Erythema; spots on face, arms, arm pits, torso (front and back), buttock and legs.  Face of baby swelled up slightly in cheeks and around the eyes.  No temperature.
Sex: F
Vaccine: HEP
Symptoms: Red cell distribution width increased, Swelling face
Clinical narrative: Rash and Erythema; spots on face, arms, arm pits, torso (front and back), buttock and legs.  Face of baby swelled up slightly in cheeks and around the eyes.  No temperature.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and itching of left deltoid, where he was given the injection. Was very itchy and red the night before he came into the clinic. When he presented to the clinic Friday morning there was no itching and only mild redness and swelling the are did feel hot to the touch. Advised to ice the area and given hydrocortisone cream to put on the site.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. Patient's medical history was not reported. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On the same day, after vaccination, the patient experienced tingling down arm. The patient sought medical attention and spoke with the pharmacist. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This one of two reports received form the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Patient's medical history was not reported. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On the same day, after vaccination, the patient experienced tingling down arm. The patient sought medical attention and spoke with the pharmacist. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history and drug allergies or reactions were reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored (Merck) PROQUAD (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005210, 1505USA004053). Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 65 year old patient of unknown gender. On 12-MAY-2015, the patient was vaccinated with an expired PNEUMOVAX 23 (dose, route of administration were not reported, lot number: J013555, expiry date: 02-MAY-2015). No adverse effect was reported. 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 physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of oral, ROTATEQ (doses, routes and lot numbers were not reported). The doses of oral ROTATEQ were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On 07-MAY-2015, according to the reporter, the patient was inadvertently vaccinated with MMR II (LOT # J003002), (strength not reported), subcutaneously injection, 0.5 ml; that had expired on 14-MAR-2015. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receive from a physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of GARDASIL (doses, routes and lot numbers were not reported). The doses of GARDASIL were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 22 year old male patient. The patient's relevant medical history, concurrent condition, and relevant past drug history were unknown. On 18-APR-2015, 22 year old patient was accidentally vaccinated with ZOSTAVAX, .65 ml (The lot number and expiration date - unknown). The pharmacist was concerned because ZOSTAVAX was not indicated for patients under the age of 50. It was also reported that the pharmacist was 99% certain that the patient did not receive ZOSTAVAX. There is no relevant lab data. As of 19-APR-2015, the patient was not on ZOSTAVAX. The outcome of a 22 year old possible being administered ZOSTAVAX accidentally was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored (Merck) PROQUAD (lot#, expiration date, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from the nurse practitioner refers to a  50 year old male patient. Concomitant medications, medical history, concurrent conditions, drug allergies were not reported. On 27-MAR-2015, the patient was vaccinated with ZOSTAVAX (lot # K020186 with the expiration date of 27-JAN-2016), 0.65 milliliter (ml), 1 dose, subcutaneous. On 28-MAR-2015, 2 days after onset of therapy the patient experienced a large red spot at the site of vaccine administration. The large spot became stiff and began to itch. The patient emailed nurse and sought medical attention. No treatment was given. No product quality complaint involved. The outcome of events was reported as recovered/resolved on 06-APR-2015. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an other health professional referring to unspecified number of unspecified patients. No concurrent condition or medical history was reported. On unspecified dates since 09-MAR-2015, the patients were vaccinated with doses of (Merck) PROQUAD (dose and route were unknown, lot# was reported as K008579 exp 13-DEC-2015, K019100 exp 15-APR-2016). No adverse effects reported. This is one of several reports from the same reporter (1505USA005155, 1505USA003305). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Fungal infection, Injection site cellulitis
Clinical narrative: Information has been received for a healthcare worker via a field representative referring to a 22 year old female patient. No relevant medical history or concurrent conditions were reported. On 27-APR-2015 the patient was vaccinated with a dose of (Merck) VARIVAX (dose, frequency and route not reported; lot# L000455, expiration date 06-JAN-2017) in her left deltoid region for vaccination. Concomitant therapies included meningococcal vaccine (unspecified) in her opposite arm. On an unknown date in April 2015 after receiving the vaccines, the patient developed an injection site reaction in her left deltoid (Merck) VARIVAX injection site, which was diagnosed as cellulitis at the injection site on 29-APR-2015 by a nurse practitioner. Also on 29-APR-2015, the patient was diagnosed with a yeast infection (onset date of the yeast infection unspecified), approximately in April 2015. The nurse practitioner prescribed AUGMENTIN and BENADRYL to treat the cellulitis and DIFLUCAN to treat the yeast infection. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). No co-suspect or concomitant medications were reported. On an unknown date the patient reported experiencing shingles after receiving ZOSTAVAX. The patient did not seek any medical attention. The outcome of shingles was reported as not recovered. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with (Merck) VARIVAX INJ, dose 1, subcutaneous (dose and lot # unspecified). On 21-APR-2015 the patient was again vaccinated with (Merck) VARIVAX INJ, dose 2, subcutaneous (dose and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on 17-APR-2015 and 21-APR-2015 was an inappropriate schedule of vaccine, as the doses of vaccine was spaced four days apart. No adverse experience was reported. The outcome of inappropriate schedule was unknown. The reporter considered inappropriate schedule of vaccine administered to be not related to the vaccine. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 67 year old female patient with diabetes mellitus. No drug allergies or reactions were reported. On 27-APR-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (subcutaneous, dose, anatomical location was unknown, lot# L003217, expiration date: April 2016 (reported as 31-APR-2016). Concomitant therapies included lisinopril (manufacturer unknown) metformin, aspirin and hydrochlorothiazide (reported as HCTZ baby aspirin). On 29-APR-2015, the patient experienced redness and swelling at injection site. On 29-APR-2015, the patient consulted the physician and was prescribed with antibiotics as treatment fo5r the events. No Lab diagnostics or studies were performed. The outcome of the events was reported as recovered/resolved on treatment (reported as on therapy). The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist via the field employee refers to a female patient of unknown age. No medical history, concurrent condition and concomitant medication was reported. On an unknown date in December 2014, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot number, dose, unit and route was not reported). On the same day of vaccination, later she noticed her lips were tingling. Patient sought medical attention and contacted the pharmacist. The patient was treated with BENADRYL. A few days later (approximately in December 2014), the patient recovered. No product quality complaint involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 53 year old female patient. Patient medical history and current condition was not reported. On 22-APR-2015 the patient was vaccinated with ZOSTAVAX single dose (Lot # K020802 and expiry date 31-01-2016) via subcutaneous route in the right arm. Other co-suspects and concomitant medication were not reported. On 22-APR-2015 (reported as on the same day) the patient developed a small red, itchy, swollen area on her right shoulder. The pharmacist states it looks like a bug bite. The patient sought medical attention, reported as visited pharmacy. Cancer and overdose was not reported. The outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. 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 Registered Nurse refers to unknown number of patients of unknown age and gender. Since 26-APR-2015, the patients were vaccinated with (Merck) PROQUAD (subcutaneous; dosage, lot # not provided) which had undergone supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 19-MAR-2015 the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit (PFU) (dose and route not reported; lot# K015311, expiration date 17-DEC-2015). On an unknown date in 2015 the patient experienced an unspecified adverse event due to which the patient was prescribed BACTRIM (unspecified manufacturer). BACTRIM was not started by the patient yet. The outcome of the event was unknown. 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 physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of RECOMBIVAX HB (doses, routes and lot numbers were not reported). The doses of RECOMBIVAX HB were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Vaccination complication
Clinical narrative: According to mother, patient had very fine bumps/rash from head to toe. Noted to have red spots on arms, legs, and trunk. 5/8/15 patient presented to Health Department and informed by PHN to see Dr.  8/8/15 @ 10:30 a.m. mom states Dr. told her this was an adverse reaction to the shots patient was given. Gave steroids.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Red, indurated, spherical-shaped, vesicular area at injection site.
Age: 58.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Tingling and swelling of tongue for 24 hours. Took Benadryl.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: LOCAL IRRITATION AND REDNESS AT INJECTION SITE, APPROXIMATELY 2.5 INCHES IN DIAMETER.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.  Approx. 6 inch diameter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash erythematous
Clinical narrative: PT REPORTS HE NOTICED RED PAINFUL SPOTS ON HIS ARMPITS, CHEST, ARMS, AND LEGS.  AT FIRST HE THOUGHT THEY WERE PIMPLES BUT HAD THEM CHECKED OUT BY HIS PHYSICIAN AND IT WAS DIAGNOSED AS SHINGLES.
Age: 1.7
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Polymerase chain reaction, Skin lesion, Varicella virus test
Clinical narrative: Several lesions on left arm and thumb.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Headache, Vomiting
Clinical narrative: C/o HA, mid abd pain, vomited X 1. Advised rest, fluids and supportive care.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Myalgia, Neuropathy peripheral
Clinical narrative: Sore muscles, joints, and neuropathy, from the waist down to toes. Patient is an athlete and runner, and his running has been severely compromised beginning the day after the vaccine was administered. This started 4.5 weeks ago on the morning after the injection and has not resolved at all, so far.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Large red area measured 2" by 4" at site of injection hot with hard lump, next day became 2 1/2 by 4 1/2" redder and hotter. Next day grew to 3" by 5". Used ice pack Benadryl and cortisone cream starting on the  8th. It is now the 13th of May and still have the show of redness about the size of 3 x 5. Itched and stung as well as hot. No fever no respiratory problems. Druggist said I should report.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site bruising, Rash, Rash vesicular
Clinical narrative: Patient came in to pharmacy on 5/13/2015 to report adverse effects from Zostavax administered on 5/8/2015: she said her arm developed blisters and a shingles-like rash on her arm, which had resolved, but today she had a bruise (about the size of two quarters) on the back of her arm, at the site of injection. She didn't report any other symptoms and was in good spirits at the time of her visit.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Either night of 5-8-15 or 5-9-15 started redness of left arm, warmth, and soreness.  Redness progressed to 2.5 inch in diameter 5-12-15 then to approximately 3.5 in diameter 5-13-15.
Age: 11.0
Sex: F
Vaccine: MMR, MNQ, TDAP
Symptoms: Complex regional pain syndrome, Pain
Clinical narrative: My daughter starting complaining of pain in the area of her injury that she had not felt the two months prior.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema, Injection site warmth, Swelling, Tachycardia
Clinical narrative: Patient describes redness and warmth at the site of injection (reaction similar to bug bite). Potentially she had tachycardia and increased blood pressure. She iced the area. The swelling lasted about 2 days.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Activities of daily living impaired, Ageusia, Asthenia, Balance disorder, Blood test
Clinical narrative: The first symptom started approximately 2 weeks after the Tetanus shot.  Loss taste of food and tingling/numbness of tongue.  Approx 4-7 days later my fingers and toes started numbing and tingling like "pins and needles" and progressively got worse and spread into my hands and balls of my feet.  Next symptom I lost my stamina, I became weak in the legs and muscles in my body, like my body was shutting down.  I could not walk to the end of the driveway without becoming severly weak and out of breath. Also I was having some balancing problems. My quality of life went from 100% down to less than 10%. I worked in severe pain and discomfort due to the heighten sensitivity of my hands and feet.  I am an aircraft mechanic planning to work for at least another 8-10 years but wasn't sure I could make it another year 4 weeks ago, build a new house, fix anything anymore, or even enjoy fishing. I was having my wife drive. I depend on my hands for my livelihood.  About 3 weeks ago, the symptoms started reversing and getting better each week. I went to my doctor twice when things weren't getting better. I went to the neurologist today.  I am about at 85-90% back to normal.  I still have some numbness and tingling in some of my fingers and toes, but not in my whole hands or feet.  I also have my energy back.  I'm just not sure if this is permanent, but I can now live and work with this minor discomfort if I have too.  The neurologist says I more than likely had a case of Guillain-Barre Syndrome and the Tetanus is what triggered it.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Discomfort, Dyspnoea, Guillain-Barre syndrome, Hyperaesthesia, Hypoaesthesia
Clinical narrative: The first symptom started approximately 2 weeks after the Tetanus shot.  Loss taste of food and tingling/numbness of tongue.  Approx 4-7 days later my fingers and toes started numbing and tingling like "pins and needles" and progressively got worse and spread into my hands and balls of my feet.  Next symptom I lost my stamina, I became weak in the legs and muscles in my body, like my body was shutting down.  I could not walk to the end of the driveway without becoming severly weak and out of breath. Also I was having some balancing problems. My quality of life went from 100% down to less than 10%. I worked in severe pain and discomfort due to the heighten sensitivity of my hands and feet.  I am an aircraft mechanic planning to work for at least another 8-10 years but wasn't sure I could make it another year 4 weeks ago, build a new house, fix anything anymore, or even enjoy fishing. I was having my wife drive. I depend on my hands for my livelihood.  About 3 weeks ago, the symptoms started reversing and getting better each week. I went to my doctor twice when things weren't getting better. I went to the neurologist today.  I am about at 85-90% back to normal.  I still have some numbness and tingling in some of my fingers and toes, but not in my whole hands or feet.  I also have my energy back.  I'm just not sure if this is permanent, but I can now live and work with this minor discomfort if I have too.  The neurologist says I more than likely had a case of Guillain-Barre Syndrome and the Tetanus is what triggered it.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia oral, Laboratory test, Muscular weakness, Pain, Paraesthesia
Clinical narrative: The first symptom started approximately 2 weeks after the Tetanus shot.  Loss taste of food and tingling/numbness of tongue.  Approx 4-7 days later my fingers and toes started numbing and tingling like "pins and needles" and progressively got worse and spread into my hands and balls of my feet.  Next symptom I lost my stamina, I became weak in the legs and muscles in my body, like my body was shutting down.  I could not walk to the end of the driveway without becoming severly weak and out of breath. Also I was having some balancing problems. My quality of life went from 100% down to less than 10%. I worked in severe pain and discomfort due to the heighten sensitivity of my hands and feet.  I am an aircraft mechanic planning to work for at least another 8-10 years but wasn't sure I could make it another year 4 weeks ago, build a new house, fix anything anymore, or even enjoy fishing. I was having my wife drive. I depend on my hands for my livelihood.  About 3 weeks ago, the symptoms started reversing and getting better each week. I went to my doctor twice when things weren't getting better. I went to the neurologist today.  I am about at 85-90% back to normal.  I still have some numbness and tingling in some of my fingers and toes, but not in my whole hands or feet.  I also have my energy back.  I'm just not sure if this is permanent, but I can now live and work with this minor discomfort if I have too.  The neurologist says I more than likely had a case of Guillain-Barre Syndrome and the Tetanus is what triggered it.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia oral, Quality of life decreased
Clinical narrative: The first symptom started approximately 2 weeks after the Tetanus shot.  Loss taste of food and tingling/numbness of tongue.  Approx 4-7 days later my fingers and toes started numbing and tingling like "pins and needles" and progressively got worse and spread into my hands and balls of my feet.  Next symptom I lost my stamina, I became weak in the legs and muscles in my body, like my body was shutting down.  I could not walk to the end of the driveway without becoming severly weak and out of breath. Also I was having some balancing problems. My quality of life went from 100% down to less than 10%. I worked in severe pain and discomfort due to the heighten sensitivity of my hands and feet.  I am an aircraft mechanic planning to work for at least another 8-10 years but wasn't sure I could make it another year 4 weeks ago, build a new house, fix anything anymore, or even enjoy fishing. I was having my wife drive. I depend on my hands for my livelihood.  About 3 weeks ago, the symptoms started reversing and getting better each week. I went to my doctor twice when things weren't getting better. I went to the neurologist today.  I am about at 85-90% back to normal.  I still have some numbness and tingling in some of my fingers and toes, but not in my whole hands or feet.  I also have my energy back.  I'm just not sure if this is permanent, but I can now live and work with this minor discomfort if I have too.  The neurologist says I more than likely had a case of Guillain-Barre Syndrome and the Tetanus is what triggered it.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Decreased appetite, Lethargy, Pallor, Pyrexia, Vomiting
Clinical narrative: Vomiting multiple times, loss of color, low-grade fever, loss of appetite, lethargic.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Dehydration, Dyspnoea, Malaise
Clinical narrative: Developed trouble breathing - dehydration and general malaise requiring hospitalization.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an other health professional referring to unspecified number of unspecified patients. No concurrent condition or medical history was reported. On unspecified dates since 09-MAR-2015, the patients were vaccinated with doses of improperly stored ZOSTAVAX (dose and route were unknown, Lot# was reported as K00885 exp 20-SEP-2015, K020802 Exp 31-JAN-2016, L000461 exp 08-MAR-2016). No adverse effects reported. No adverse effects reported. This is one of several reports from the same reporter (1505USA005155, 1505USA005156). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date these patients were vaccinated with improperly stored (Merck) VARIVAX (lot#, expiration date, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dysphagia, Dyspnoea, Hyperhidrosis
Clinical narrative: PT c/o difficulty breathing/swallowing approximately 15 min post PNP vaccine. Pt given 50mg IM BENADRYL and placed on 2L O2. EMS called. Pt with HR 150's, Resp rate 30's, pt c/o dizzines and pt was diaphoretic. Pt sent to ER via EMS.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Fall, Injection site pain, Nausea, Syncope
Clinical narrative: Patient experienced pain at the site of injection. The morning following the administration of the vaccine, patient felt nauseated. She fainted and fell from her chair. No symptoms since this event (1 week ago).
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patients arm is sore, and inflammed at injection site some redness.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Immediate rash all over trunk and both arms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: He has had recurrent urticaria only at the site of injection (L) arm off and on for 4 weeks.
Sex: U
Vaccine: PNC, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of PREVNAR (manufacturer unspecified) (strength, dose, route, lot# and expiration date unknown) and then "3 days later" received a dose of PNEUMOVAX 23 (strength, dose, route, lot# and expiration date unknown). The company representative stated "this occurred in November". No adverse effects reported. Additional information has been requested.