chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of ROTATEQ Lot # K010221, expiry date 12-MAY-2016; Lot # K011952, expiry date 17-JUN-2016, oral route (dose was not reported), were given to unspecified patients on unspecified dates, between 22-JUL-2015 and 31-DEC-2015. No adverse effects were reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 and PNEUMOVAX 23 were included on the list of questionable stability vaccines, but no doses were administered. This is one of three reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a 66 year old female patient reporting on herself. The patient's medical history included hypotension and drug reaction hypersensitivity to vancomycin. In June 2011, the patient was vaccinated with ZOSTAVAX (lot number reported as 0358AA) (strength, dose and frequency were not provided). Concomitant therapies included NEURONTIN. On 05-JAN-2016, the patient developed a very severe massive shingles all over her back. The shingles are located on her "whole back on each side of her spine", they are very severe and she cannot go to work or put clothes on because of this. Treatment for the event according to her doctor included Acyclovir, famciclovir, DEMEROL and an unspecified shingles gel. The patient sought medical attention, she contacted her physician. At the time of the report the outcome of herpes zoster was reported as not recovered and the relatedness between the events and the ZOSTAVAX was not reported. 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 referring to a 6 patients of unknown ages and genders. The concurrent conditions and medical histories were not provided. Since 13-JAN-2016, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (route and dose were not provided) lot # L013067, expiration date on 14-APR-2017. Concomitant therapies were not provided. Names of vaccines involved (including lot/exp): VARIVAX (Merck), lot # L013067/ Exp. 04/14/2017 - Temperature 7F - Time frame: 10 minutes - Previous temperature excursion? Yes, supported defrost cycles. No doses of ZOSTAVAX were administered. M-M-R II remained in recommended storage range. No adverse events were reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of VAQTA Lot # J007800, expiry date 15-JAN-2016, (dose and route were not reported), were given to unspecified patients on unspecified dates, between 22-JUL-2015 and 31-DEC-2015. No adverse effects were reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 and PNEUMOVAX 23 were included on the list of questionable temperature stability vaccines, but no doses were administered. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of RECOMBIVAX HB, lot # L044917, expiry date 05-OCT-2018; lot # L044707, expiry 06-OCT-2018 (dose and route were not reported), that had been exposed to 34.4 F during 2 hours and then back in range, were given to multiple unspecified patients on unspecified dates. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L044917 and L044707 have been verified to be valid lot numbers for RECOMBIVAX HB. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Pruritus, Urticaria
Clinical narrative: Hives on UE and scalp. Itchiness. Anxiety. Received flu shot. Present 5 minutes later with hives, itching and anxiety. Throughout UE. Vitals increased on presentation (2:30 pm vitals 140/86 P-75) no difficulty breathing. Pt was given 50 mg BENADRYL PO. Hives and itchiness decreased slightly 15 minutes later. Vitals after 15 minutes have returned to normal. Stable. Pt given 50 mg BENADRYL to take 6 hours later. Advised to see PCP.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Pt. rec'd vaccinations at WCE; s/s began next AM -> itchy, red rash to (Lt) arm and transient spreading to trunk. (Lt) deltoid area with approximately 5 cm diameter area erythema and warm confluent raised welts to inner (Lt) arm and (Lt) thigh. Tx- BENADRYL PRN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Pt. rec'd vaccinations at WCE; s/s began next AM -> itchy, red rash to (Lt) arm and transient spreading to trunk. (Lt) deltoid area with approximately 5 cm diameter area erythema and warm confluent raised welts to inner (Lt) arm and (Lt) thigh. Tx- BENADRYL PRN.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cardiac arrest, Dizziness, Loss of consciousness, Pulse absent, Respiratory arrest
Clinical narrative: Initial unsolicited report received from a pharmacist on 11-Jan-2016. This case involves a 66-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (batch number: UI481AA expiration date: 15-May-2016) via intramuscular route in right upper arm and also received 0.5 ml dose of PREVENAR 13 (manufacturer: Pfizer, batch number: MI3067 expiration date: Apr-2017) via intramuscular route in left upper arm on 20-Oct-2015 at 10:30 A.M. The patient's medical history was not reported and patient's concomitant medications included Atorvastatin calcium 20 mg one tablet by mouth at bed time, Hydrochlorothiazide 25 mg one tablet by mouth every day, atenolol 25 mg one tablet by mouth every day and Lisinopril 5 mg one tablet by mouth every day on 07-Aug-2015. Hydrocodone-acetaminophen 5-325 two tablets orally for every 6 hours as needed for aches and pain and ciprofloxacin Hcl 500mg one tablet by mouth every 12 hours for seven days on 08-May-2015. FLUVIRIN Injection 2014-15 on 09-Oct-2014. Atorvastatin calcium 20 mg one tablet by mouth at bed time, Hydrochlorothiazide 25 mg one tablet by mouth every day, atenolol 25 mg one tablet by mouth every day and Lisinopril 5 mg one tablet by mouth every day on 07-Feb-2014. Amoxicillin 500mg one capsule 3 times daily as concomitant medications. On 20-Oct-2015, one minute post vaccination, the patient passed out, was unresponsive, his heart stopped, had stopped breathing, no respirations, had no pulse and felt dizzy. It was reported that the adverse events required an emergency room or physician visit. The patient was not hospitalized. It was reported that no laboratory investigation and corrective treatments were required. On 20-Oct-2015, patient recovered from all the events. Upon internal review, the case was considered to be serious due to important medical events: passed out/no pulse, unresponsive, heart stopped, stopped breathing and no respirations. The event dizzy considered serious in relation to other events. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a pharmacist on 11-Jan-2016. This case involves a 66-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (batch number: UI481AA expiration date: 15-May-2016) via intramuscular route in right upper arm and also received 0.5 ml dose of PREVENAR 13 (manufacturer: Pfizer, batch number: MI3067 expiration date: Apr-2017) via intramuscular route in left upper arm on 20-Oct-2015 at 10:30 A.M. The patient's medical history was not reported and patient's concomitant medications included Atorvastatin calcium 20 mg one tablet by mouth at bed time, Hydrochlorothiazide 25 mg one tablet by mouth every day, atenolol 25 mg one tablet by mouth every day and Lisinopril 5 mg one tablet by mouth every day on 07-Aug-2015. Hydrocodone-acetaminophen 5-325 two tablets orally for every 6 hours as needed for aches and pain and ciprofloxacin Hcl 500mg one tablet by mouth every 12 hours for seven days on 08-May-2015. FLUVIRIN Injection 2014-15 on 09-Oct-2014. Atorvastatin calcium 20 mg one tablet by mouth at bed time, Hydrochlorothiazide 25 mg one tablet by mouth every day, atenolol 25 mg one tablet by mouth every day and Lisinopril 5 mg one tablet by mouth every day on 07-Feb-2014. Amoxicillin 500mg one capsule 3 times daily as concomitant medications. On 20-Oct-2015, one minute post vaccination, the patient passed out, was unresponsive, his heart stopped, had stopped breathing, no respirations, had no pulse and felt dizzy. It was reported that the adverse events required an emergency room or physician visit. The patient was not hospitalized. It was reported that no laboratory investigation and corrective treatments were required. On 20-Oct-2015, patient recovered from all the events. Upon internal review, the case was considered to be serious due to important medical events: passed out/no pulse, unresponsive, heart stopped, stopped breathing and no respirations. The event dizzy considered serious in relation to other events. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Heart rate increased, Seizure like phenomena
Clinical narrative: Case number PHHY2016US006875 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609033) on 18 Jan 2016. This report refers to an 11 year old male patient. He had no medical history or current conditions. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 158301) intramuscularly in the left arm on 11 Nov 2015. On the same day after administering the shot, the patient closed his eyes and went into symptoms what seemed to be seizure for about 10 to 15 seconds. The patient slid on to the floor and then opened his eyes and said that he had a dream. It seemed like his heart rate was high and hence ambulance was immediately called. They came over within 10 minutes and the patient seemed to be fine. The patient went to emergency room. The final outcome of events was reported as condition unchanged. The seriousness of the events was not reported, but the event seizure like phenomena was upgraded as medically significant based on the NVS-IME list and the event fall was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US006920 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609276) on 18 Jan 2016. This report refers to a 57 year old male patient. His medical history included depression and current conditions were blacking out and fainting. His concomitant medications were ZYPREXA, sertraline, diphenhydramine and lorazepam. He was vaccinated with FLUVIRIN (batch number: 158902) in the left arm on 05 Nov 2015 at 9:15 am. On the same day, 10 minutes after vaccination, he walked to his car with his son, but blacked out and fainted. He stated that he drove himself to hospital across the street. He went to emergency room and was hospitalized for 2 days. He would not provide details of treatment, but stated that he received a blood thinner. The final outcome of events was reported as complete recovery. The causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Syncope
Clinical narrative: Information  has been received from a physician via a company representative referring to a 25 year old female patient. On 08-JUN-2015 the patient was vaccinated first dose of regiment with original GARDASIL (lot # K023432, dose and route unknown). No adverse event occurred for the first dose. On 29-DEC-2015, during the second dose of regimen, the patient was administered with GARADASIL 9 (lot # L014415, 1 shot) intramuscularly with no other vaccines administered (interchange of vaccine products). Approximately  on 05-JAN-2016, about a week after the dose of GARDASIL 9 the patient was out at a bar and had a few drinks. She had experienced "black vision" and became sweaty, went outside to get some air and fainted. She had two fainting episodes back to back. They called emergency medical technicians (EMTs) and was told that they checked vitals, were normal. The patient went home and visited student health center at her college, and everything appeared normal. She was referred to family physician and visited them on 18-JAN-2016. Upon inspected of patient, she also developed a 2 cm lump in arm  near injection site, but inferior to the upper deltoid w here shot was given. The patient also had a rash over the injection site, which was macular, red and discrete. No prescription medications were given, she was told to ice site and if needed to use Over-The-Counter (OTC) medications for swelling. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperhidrosis, Injection site mass, Injection site reaction, Rash macular, Syncope
Clinical narrative: Information  has been received from a physician via a company representative referring to a 25 year old female patient. On 08-JUN-2015 the patient was vaccinated first dose of regiment with original GARDASIL (lot # K023432, dose and route unknown). No adverse event occurred for the first dose. On 29-DEC-2015, during the second dose of regimen, the patient was administered with GARADASIL 9 (lot # L014415, 1 shot) intramuscularly with no other vaccines administered (interchange of vaccine products). Approximately  on 05-JAN-2016, about a week after the dose of GARDASIL 9 the patient was out at a bar and had a few drinks. She had experienced "black vision" and became sweaty, went outside to get some air and fainted. She had two fainting episodes back to back. They called emergency medical technicians (EMTs) and was told that they checked vitals, were normal. The patient went home and visited student health center at her college, and everything appeared normal. She was referred to family physician and visited them on 18-JAN-2016. Upon inspected of patient, she also developed a 2 cm lump in arm  near injection site, but inferior to the upper deltoid w here shot was given. The patient also had a rash over the injection site, which was macular, red and discrete. No prescription medications were given, she was told to ice site and if needed to use Over-The-Counter (OTC) medications for swelling. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Visual impairment
Clinical narrative: Information  has been received from a physician via a company representative referring to a 25 year old female patient. On 08-JUN-2015 the patient was vaccinated first dose of regiment with original GARDASIL (lot # K023432, dose and route unknown). No adverse event occurred for the first dose. On 29-DEC-2015, during the second dose of regimen, the patient was administered with GARADASIL 9 (lot # L014415, 1 shot) intramuscularly with no other vaccines administered (interchange of vaccine products). Approximately  on 05-JAN-2016, about a week after the dose of GARDASIL 9 the patient was out at a bar and had a few drinks. She had experienced "black vision" and became sweaty, went outside to get some air and fainted. She had two fainting episodes back to back. They called emergency medical technicians (EMTs) and was told that they checked vitals, were normal. The patient went home and visited student health center at her college, and everything appeared normal. She was referred to family physician and visited them on 18-JAN-2016. Upon inspected of patient, she also developed a 2 cm lump in arm  near injection site, but inferior to the upper deltoid w here shot was given. The patient also had a rash over the injection site, which was macular, red and discrete. No prescription medications were given, she was told to ice site and if needed to use Over-The-Counter (OTC) medications for swelling. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Severe pain in deltoid muscle where vaccine was administered.  Lasting til now, Jan 22, 2016. Pain is constant and worse at night. Treated with menthol pack, Celebrex, Ibuprofen, tramadol.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Tachycardia
Clinical narrative: Starting approximately 3hrs after vaccine administration pt began to experience significant diarrhea. Mom states pt has not had any fevers, sick contacts, difficulty breathing, decreased level of activity, or increased sleep. Pt experienced ~30 diarrhea stools after vaccination before presentation to ED. ~30 hours persistent diarrhea & dry mucus membranes, tachycardic, concerning for dehydration. Pt given 20ml/kg NS bolus, electrolytes wnl, pt improved clinically, had wet diaper w/o diarrhea during stay. Pt brother required hospitalization for same after he received his rotavirus vaccination several years ago.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Induration, Skin warm
Clinical narrative: Induration of skin (12 cm x 12 cm); warmth of skin.  Patient received Ibuprofen/Ice education.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Lethargy
Clinical narrative: The patient developed lethargy and a cough that has persisted greater than 2 weeks.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Fatigue, Headache, Hypersensitivity, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 13-Jan-2016) concerns a 60 year old female patient. The patient has a medical history of GERD, globus hystericus (reported as 'globus'), diphenhydramine allergy, amoxicillin allergy, hypertension and anxiety.  Prior vaccination with Afluria in Nov or Dec 2014 resulted in hives.  This reaction was treated with diphenhydramine to which she experienced an allergic reaction and was placed on prednisone which helped.  Concomitant medications include nebivolol, ranitidine, alprazolam, pravastatin and vitamin D. On 01-Dec-2015 at 09:30, the patient received Afluria (influenza virus vaccine polyvalent, batch number: unknown) via the intramuscular route for protection against the influenza virus.  On 01-Dec-2015 following influenza vaccination, the patient experienced headache and tiredness.  At 02:00 on 02-Dec-2015, the patient experienced pain in the back of her right leg and tingling on the right side of her face (also reported as occurring on 01-Dec-2015).  That same day, she went into work, was sent to ER/OT and was admitted to hospital for a mild/moderate allergic reaction.  Treatment comprised of prednisone (20 mg for 4 days) due to her diphenhydramine (Benadryl) allergy.  On 05-Dec-2015, the patient woke up with heart palpitations and called the ER doctor who told her to stop prednisone and take her alprazolam (Xanax).  On 11-Dec-2015, the patient returned to the ER for a rash that developed and palpitations.  The patient described it as hives.  The ER discharge noted acute anxiety and told her to continue alprazolam (Xanax).  She was also provided with an epinephrine which she has not used.  The patient stated white marks on her face and stomach but rash comes and goes.  The patient stated headache, tingling in face and leg pain comes and goes as well. The outcome was reported as not recovered. Linked case: 2016057877 (same patient). Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness criterion/criteria: Hospitalisation. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, acute anxiety and all other events are unlisted. Paraesthesia, headache rash and hives are listed. Causality: Possible. Time to onset is same day for headache and tiredness and next day for other events and 11 day for rash. Although the patient was treated with antihistamine and steroids events are not typical of type 1 allergic reaction. The case did not meet Brighton collaboration group definition for anaphylaxis due to delayed onset for rash and urticaria. History of anxiety was a probable factor in causation of palpitation rash and or events. Causality with vaccination cannot be completely excluded due to temporal association.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia, Rash, Skin discolouration, Urticaria
Clinical narrative: This spontaneous consumer report (initial receipt 13-Jan-2016) concerns a 60 year old female patient. The patient has a medical history of GERD, globus hystericus (reported as 'globus'), diphenhydramine allergy, amoxicillin allergy, hypertension and anxiety.  Prior vaccination with Afluria in Nov or Dec 2014 resulted in hives.  This reaction was treated with diphenhydramine to which she experienced an allergic reaction and was placed on prednisone which helped.  Concomitant medications include nebivolol, ranitidine, alprazolam, pravastatin and vitamin D. On 01-Dec-2015 at 09:30, the patient received Afluria (influenza virus vaccine polyvalent, batch number: unknown) via the intramuscular route for protection against the influenza virus.  On 01-Dec-2015 following influenza vaccination, the patient experienced headache and tiredness.  At 02:00 on 02-Dec-2015, the patient experienced pain in the back of her right leg and tingling on the right side of her face (also reported as occurring on 01-Dec-2015).  That same day, she went into work, was sent to ER/OT and was admitted to hospital for a mild/moderate allergic reaction.  Treatment comprised of prednisone (20 mg for 4 days) due to her diphenhydramine (Benadryl) allergy.  On 05-Dec-2015, the patient woke up with heart palpitations and called the ER doctor who told her to stop prednisone and take her alprazolam (Xanax).  On 11-Dec-2015, the patient returned to the ER for a rash that developed and palpitations.  The patient described it as hives.  The ER discharge noted acute anxiety and told her to continue alprazolam (Xanax).  She was also provided with an epinephrine which she has not used.  The patient stated white marks on her face and stomach but rash comes and goes.  The patient stated headache, tingling in face and leg pain comes and goes as well. The outcome was reported as not recovered. Linked case: 2016057877 (same patient). Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness criterion/criteria: Hospitalisation. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, acute anxiety and all other events are unlisted. Paraesthesia, headache rash and hives are listed. Causality: Possible. Time to onset is same day for headache and tiredness and next day for other events and 11 day for rash. Although the patient was treated with antihistamine and steroids events are not typical of type 1 allergic reaction. The case did not meet Brighton collaboration group definition for anaphylaxis due to delayed onset for rash and urticaria. History of anxiety was a probable factor in causation of palpitation rash and or events. Causality with vaccination cannot be completely excluded due to temporal association.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blood test, Exposure during pregnancy, No adverse event, Tuberculin test, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report was received from a 22 year old female patient, who was reporting on herself. The patient's pertinent medical history included nothing relevant. The patient had none drug reactions or allergies. On 16-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported) in the right arm, prior to learn that she was pregnant. Concomitant therapies included prenatal vitamins, unspecified tetanus booster and Flu vaccine. No adverse event was reported. No product quality complaint (PQC) was involved. Lab diagnostic studies included: tuberculosis skin test, blood test and intravaginal ultrasound, all performed on unknown dates. The patient received prenatal vitamins as a treatment. On 01-NOV-2015 (also reported as about two months and 10 days), the patient had last menstrual period (LMP). The date of conception was calculated as 15-NOV-2015. On 28-DEC-2015, the patient found out she was pregnant. The patient sought medical attention by speaking with physician and obstetrician. 07-AUG-2016, was the estimated date of delivery (EDD). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blood test, Exposure during pregnancy, Tuberculin test, Ultrasound scan vagina
Clinical narrative: This spontaneous prospective pregnancy report was received from a 22 year old female patient, who was reporting on herself. The patient's pertinent medical history included nothing relevant. The patient had none drug reactions or allergies. On 16-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported) in the right arm, prior to learn that she was pregnant. Concomitant therapies included prenatal vitamins, unspecified tetanus booster and Flu vaccine. No adverse event was reported. No product quality complaint (PQC) was involved. Lab diagnostic studies included: tuberculosis skin test, blood test and intravaginal ultrasound, all performed on unknown dates. The patient received prenatal vitamins as a treatment. On 01-NOV-2015 (also reported as about two months and 10 days), the patient had last menstrual period (LMP). The date of conception was calculated as 15-NOV-2015. On 28-DEC-2015, the patient found out she was pregnant. The patient sought medical attention by speaking with physician and obstetrician. 07-AUG-2016, was the estimated date of delivery (EDD). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Patient had a fever of 100.8 with headache and body aches.  Fever spiked to 102.8 by 2:00 PM. He was given ibuprofen and fluids.  His fever was 99.5 by 11/04/2015 at 7:00 AM but he still felt unwell.  By 11/04/2015 at 7:00 PM he had no fever.  By 11/05/2015 at 7:00 AM he felt fine.
Sex: F
Vaccine: PPV
Symptoms: Ear infection, Extra dose administered, Injection site erythema, Swelling
Clinical narrative: Information has been received from a nurse practitioner referring to a female patient (age and race unspecified). The patient was considered as a high risk patient as she had a history of asthma, hepatitis C with liver damage and was a smoker. No concomitant medication was reported. In April 2014 (reported as "In April, the year before last"), the patient was administered the first dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date unspecified). In December 2014 (reported as "In December, the year before last"), the patient was then admitted to a hospital for an ear infection where she received a second dose of PNEUMOVAX 23 (the vaccinated date, strength, dose, route, lot # and expiation date were unspecified). On an unknown date, after receiving the second dose, the patient had an injection site reaction described as redness and swelling in an unspecified area of the body. The outcome of the events was not provided. The relationship between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of un an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 14-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (dose, lot#, expiration date and route of administration were not reported), PROQUAD (Merck) (dose, lot#, expiration date and route of administration were not reported) and HAVRIX (dose and route of administration were not reported). There were no adverse symptoms reported. There were no adverse symptoms reported. Product quality complaint was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Rash, Rash pruritic, Skin burning sensation
Clinical narrative: This spontaneous report was received from a physician referring to a 68 year old male patient with diabetes mellitus, hyperlipidemia, gastroesophageal reflux disease, benign prostatic hyperplasia, unspecified knee surgery, unspecified shoulder surgery, cataract surgery, unspecified back surgery and unspecified hand surgery. The patient did not present drug reaction/allergy. On an unknown day in July 2012, the patient was vaccinated with ZOSTAVAX (route, strength, dose, frequency and lot number were not reported). No concomitant medications were reported. Fall 2012, the patient developed red, painful, burning, tingling and itchy rash over his trunk and face in intermittent intervals. The patient sought medical attention via visiting an allergist, rheumatologist and dermatologist and treatment was received as a physician prescribed ZYRTEC and another unspecified allergy medication which the patient stated did not help. No product quality complaint was involved. The outcome of the adverse events was reported as not recovered. The relatedness of the adverse events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (reported as lot # L041627 with expiry date: 20-APR-2017). No concomitant medication was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: On 1/19/16 returned to office complaining of left upper arm pain from deltoid down to elbow. No redness or edema. Strength equal - complains of weakness left arm started on naproxen to see will help with pain.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K008824, 19-JUN-2016, lot # L026410 with expiry 15-FEB-2017). No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning her mother, a female patient of unknown age. The patient's pertinent medical history, drug reactions and concomitant medications were not reported. On an unspecified date, the patient had an injection site reaction with redness and swelling on an unspecified area of the body after receiving a dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date unspecified). The outcome of the event was not provided. The relationship between the event and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received form a 64 year old female registered nurse, who was reported on herself. The patient's concurrent conditions included hypothyroidism, allergy to sulfa and penicillin. The reaction for these medications was rash and hives. On 28-DEC-2015, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included SYNTHROID. On 31-DEC-2015, the patient experienced headache, redness and tenderness at the injection site of ZOSTAVAX. The patient did not seek medical attention. No lab diagnostics studies were performed. The headache was treated with ibuprofen and resolved on an unknown date. At the time of report, the patient was still recovering from the redness and tenderness at the injection site. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse refers to a 45 year old female patient. The concurrent condition included allergy to sulfa and DEMEROL. No medical history was reported. On an unknown dates in 2003, the patient was vaccinated with 2 doses of VARIVAX (Merck), one month apart. No concomitant therapy was reported. On an unknown date, after vaccination the patient had an unspecified blood test performed to determine the patient's varicella immunity. The test determined the patient was seronegative for varicella immunity. The patient sought medical attention. No treatment was given for the events. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 68 year old male patient regarding himself. The concurrent condition of the patient included prostate cancer, high blood pressure, chronic obstructive pulmonary disease (COPD), diabetes mellitus and allergy to ZOCOR and PERCOCET. On 31-DEC-2015, the patient was vaccinated with ZOSTAVAX (subcutaneous, dose not provided). The concomitant therapy included unspecified medications for treatment of diabetes, high blood pressure, COPD and prostate cancer. On 31-DEC-2015, after 30 minutes of vaccination, the patient experienced pain and swelling in his left arm and in his neck. The patient sought medical attention and called pharmacist. No treatment was given for the events. No lab studies were performed. On 12-JAN-2016, the patient contacted unspecified physician. The patient was waiting to hear back from his physician. The outcome of the events was not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a 55 year old male patient. On an unknown date the patient was vaccinated with GARDASIL with unspecified doses (dosing regimen unspecified). No concomitant medications were reported. The reporter reports that the 55 year old male patient received unspecified doses of GARDASIL on unspecified dates. No adverse effects reported. No product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. On 24-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not provided). On 04-DEC-2015, the patient inadvertently received second dose of ZOSTAVAX (extra dose administered) (dose, and route not provided). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Rash
Clinical narrative: This spontaneous report was received from a male pharmacist of unknown age concerning himself via a company representative. No pertinent medical history was reported. No drug reaction or allergies were reported. It was reported that, on an unspecified date while he was reconstituting ZOSTAVAX (dose, route and frequency was unknown), some of the vaccine squirted out onto his hand (unspecified hand) (accidental exposure to product) and on an unspecified date after this incident, he developed an unspecified rash in the same area on his hand where he came in contact with the vaccine. The pharmacist reported that the rash lasted for a duration of 2 weeks. No other concomitant therapy was reported. Outcome of the event rash was reported as recovered/resolved. Outcome of accidental exposure to product was unknown. The causality of the event rash was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 13 month old male patient. The patient's concurrent conditions and drug reactions/allergies were not reported. Before vaccination, there was no adverse event. It was reported that vaccine was verified viable at time of the call. On 02-NOV-2015, the patient was vaccinated with improperly stored doses of PROQUAD (Merck), lot # L023114, expiration date 24-DEC-2016, (dose was not provided). On the same day the patient was vaccinated with Hep A vaccine (strength, dosage, frequency and route unspecified) and pneumococcal conj vaccine (unspecified) (manufacturer unknown, strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Back pain, Blood pressure decreased, Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report derives from an internet website, where a patient's mother reported on her approximately 14-year-old daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-OCT-2013 and 02-DEC-2013, the patient was vaccinated the first and the second dose of GARDASIL (exact dose, route, lot # and expiration date were not reported), respectively. Since 02-DEC-2013 (the second shot), the patient had never been the same and the symptoms started. Within a week, she went to the pediatrician's office with reports of constant dizziness and not feeling right. Symptoms were subtle at first, but then there were more and they were more severe. The patient was seen by a neurologist who believed that the vaccine caused an autoimmune "avalanche that triggered the Lyme disease front and center". The reporter stated that many of the symptoms of Lyme disease were the same for autoimmune issues and GARDASIL. The patient had legs, arms, back and neck pain. She also experienced blood pressure drop when standing and tachycardia. The reporter stated it was getting to be postural orthostatic tachycardia syndrome (POTS). The patient also developed Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). The patient was not in school but in homebound program at that moment. The reporter also mentioned that her daughter was treated in the emergency room (ER) on 07-FEB-2015 with an intravenous (IV) "cocktail" to relieve the pain and nausea. They were considering the IV immunoglobulin therapy. Therapy with GARDASIL was discontinued (the patient did not receive the third dose). Outcome of the events was not reported. The patient's mother felt that the events were related to the therapy with GARDASIL. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease, Nausea, Neck pain, Neuropsychiatric syndrome, Pain in extremity
Clinical narrative: This spontaneous report derives from an internet website, where a patient's mother reported on her approximately 14-year-old daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-OCT-2013 and 02-DEC-2013, the patient was vaccinated the first and the second dose of GARDASIL (exact dose, route, lot # and expiration date were not reported), respectively. Since 02-DEC-2013 (the second shot), the patient had never been the same and the symptoms started. Within a week, she went to the pediatrician's office with reports of constant dizziness and not feeling right. Symptoms were subtle at first, but then there were more and they were more severe. The patient was seen by a neurologist who believed that the vaccine caused an autoimmune "avalanche that triggered the Lyme disease front and center". The reporter stated that many of the symptoms of Lyme disease were the same for autoimmune issues and GARDASIL. The patient had legs, arms, back and neck pain. She also experienced blood pressure drop when standing and tachycardia. The reporter stated it was getting to be postural orthostatic tachycardia syndrome (POTS). The patient also developed Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). The patient was not in school but in homebound program at that moment. The reporter also mentioned that her daughter was treated in the emergency room (ER) on 07-FEB-2015 with an intravenous (IV) "cocktail" to relieve the pain and nausea. They were considering the IV immunoglobulin therapy. Therapy with GARDASIL was discontinued (the patient did not receive the third dose). Outcome of the events was not reported. The patient's mother felt that the events were related to the therapy with GARDASIL. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: This spontaneous report derives from an internet website, where a patient's mother reported on her approximately 14-year-old daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-OCT-2013 and 02-DEC-2013, the patient was vaccinated the first and the second dose of GARDASIL (exact dose, route, lot # and expiration date were not reported), respectively. Since 02-DEC-2013 (the second shot), the patient had never been the same and the symptoms started. Within a week, she went to the pediatrician's office with reports of constant dizziness and not feeling right. Symptoms were subtle at first, but then there were more and they were more severe. The patient was seen by a neurologist who believed that the vaccine caused an autoimmune "avalanche that triggered the Lyme disease front and center". The reporter stated that many of the symptoms of Lyme disease were the same for autoimmune issues and GARDASIL. The patient had legs, arms, back and neck pain. She also experienced blood pressure drop when standing and tachycardia. The reporter stated it was getting to be postural orthostatic tachycardia syndrome (POTS). The patient also developed Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). The patient was not in school but in homebound program at that moment. The reporter also mentioned that her daughter was treated in the emergency room (ER) on 07-FEB-2015 with an intravenous (IV) "cocktail" to relieve the pain and nausea. They were considering the IV immunoglobulin therapy. Therapy with GARDASIL was discontinued (the patient did not receive the third dose). Outcome of the events was not reported. The patient's mother felt that the events were related to the therapy with GARDASIL. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician assistant refers to an adult female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced swelling of the whole arm. The patient was in Emergency Room, where she was told that the reaction was probably due to latex in PNEUMOVAX 23. The reporter wanted to know if the vaccine actually contained latex. The outcome of the event was reported as recovered/resolved on an unknown date (reported as "the patient was fine now"). The relatedness between the events and PNEUMOVAX 23 was not assessed by the reporter. Additional information has been requested.
Age: 0.97
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Tdap instead of DTaP.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Local reaction, Swelling, Tenderness
Clinical narrative: Localized reaction. Redness, swelling and tenderness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Fatigue, Seizure
Clinical narrative: In office seizure. Patient had seizure while Mom was carrying him at the check out window. Seizure happened six minutes after vaccination and instead about five seconds. The patient was examined by the doctor and received oxygen for 15 minutes for comfort, Pt was tired but back to baseline. Oxygen 93%. Pt temp after seizure 97.4.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 0.25 flu shot given at 2 months instead of at 6 months.
Age: 16.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Headache, Hypoaesthesia, Intervertebral disc disorder, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Patient awoke with headache, numbness and tingling of lower extremities and fingers both hands. Seen in PCP office that morning and admitted to hospital for evaluation.
Age: 16.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Paraesthesia, Spinal osteoarthritis
Clinical narrative: Patient awoke with headache, numbness and tingling of lower extremities and fingers both hands. Seen in PCP office that morning and admitted to hospital for evaluation.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Golf ball size lump at injection site.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Experienced syncope right after vaccine administered.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Mobility decreased, Myalgia
Clinical narrative: Injection site reaction with limited limb mobility and myalgia.