chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Muscle tightness
Clinical narrative: Patient was instructed by her immunologist (followed for allergies and asthma) to have a Pneumovax vaccine (23 valent pneumococcal vaccine) due to low antibody levels against pneumococcus. Mom brought in patient to the clinic and vaccine given. Was encouraged to massage and move arm around after vaccine administration. 30 minutes after vaccine administration, patient started to complain local injection pain and warm. Once when patient and family returned home, patient took Tylenol for the pain. The next morning, patient woke up with localized swelling approx 10 cm around the injection area on left deltoid, redness, warmth and tightness to muscle with pain and decreased ROM. No fevers, no swelling outside of area mentioned above. Patient with out prior vaccine reactions. No other skin lesions. no difficulty breathing, no vomiting.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site was itching, warm to touch and was red.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Irritability, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Mom states "He was very irritable had a fever of 104, Tylenol did not reduce fever. Ibuprofen did help with the fever he had swollen glands in the back of his neck, he broke out in a rash on 5/04/2013.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, IPV, PPV, RVX
Symptoms: Crying
Clinical narrative: Child cried, inconsolably, for 7 hours starting approximately 45min after administration of the vaccination.  Child returned to doctor's office and was re-evaluated by another physician.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Chills, Headache, Tremor
Clinical narrative: Severe chills, severe uncontrollable shaking, headache, upset stomach.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Amyotrophic lateral sclerosis, Dysarthria, Fall, Fatigue, Gait disturbance
Clinical narrative: Trouble speaking slurred speech, twitching in arms and legs, muscle weakness, fatigue, and irritable bowel, and walking. Doctor thought stroke, but test came back negative,  Weak muscles and falling.  Seeing a neurologist they suspect ALS. Appt. 5/15/13 for official diagnoses.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Irritable bowel syndrome, Laboratory test, Lumbar puncture, Muscle twitching, Muscular weakness
Clinical narrative: Trouble speaking slurred speech, twitching in arms and legs, muscle weakness, fatigue, and irritable bowel, and walking. Doctor thought stroke, but test came back negative,  Weak muscles and falling.  Seeing a neurologist they suspect ALS. Appt. 5/15/13 for official diagnoses.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Speech disorder
Clinical narrative: Trouble speaking slurred speech, twitching in arms and legs, muscle weakness, fatigue, and irritable bowel, and walking. Doctor thought stroke, but test came back negative,  Weak muscles and falling.  Seeing a neurologist they suspect ALS. Appt. 5/15/13 for official diagnoses.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Fatigue
Clinical narrative: Trouble speaking slurred speech, twitching in arms and legs, muscle weakness, fatigue, and irritable bowel, and walking. Doctor thought stroke, but test came back negative,  Weak muscles and falling.  Seeing a neurologist they suspect ALS. Appt. 5/15/13 for official diagnoses.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Headache, huge stomach ache, vomiting whole meal and this occurred 5 times over 3 days, temperature between 99 and 101, wheezing and very pale, around the injection site (3 inches in diameter) was red, raised and hot, during the course of events she blacked out 2x, injection site was also extremely itchy.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Loss of consciousness, Pallor, Vomiting, Wheezing
Clinical narrative: Headache, huge stomach ache, vomiting whole meal and this occurred 5 times over 3 days, temperature between 99 and 101, wheezing and very pale, around the injection site (3 inches in diameter) was red, raised and hot, during the course of events she blacked out 2x, injection site was also extremely itchy.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling, bruising at site and itchiness down my arm.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pyrexia, Rash, Vomiting
Clinical narrative: Was given a Hepatitis A in left upper arm and HPV injection in rt upper arm on April 19, 2013 Friday. On Sunday she developed a rash on right arm, fever 102 degrees, vomiting, sore throat, swollen gland rt side of neck.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Pt reports onset of vomiting/nausea approximately (5/1/13) 3AM after receiving vaccine earlier in day. Also c/o arm soreness. Pt states much improved by 11AM 5/1/13 able to keep liquids down.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from two pharmacists refers to an "approximately 61 years old" female patient with celiac disease, wheat allergy and previous anaphylaxis to lidocaine (date unspecified), and "101 others". On 24-APR-2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot # H019996, expiration date unspecified) single dose, 0.65 ml, subcutaneously (anatomical location unspecified). The pharmacists reported that on 24-APR-2013, the patient had an immediate anaphylactic reaction after receiving ZOSTAVAX involving chest pain and shortness of breath. The pharmacist reported that the patient had a previous anaphylactic reaction to lidocaine that was very similar to the reaction that occurred with the administration of ZOSTAVAX. The patient was taken to emergency room and was admitted overnight for chest pain and decreased respiratory quality, she received treatment with epinephrine (manufacturer unknown), IV drugs unspecified. At the time of the report the outcome of immediate anaphylactic reaction was reported as recovering. Immediate anaphylactic reaction was considered to be serious due to hospitalization, medically significant and life threatening by the reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Immediate post-injection reaction, Respiratory depression
Clinical narrative: This spontaneous report as received from two pharmacists refers to an "approximately 61 years old" female patient with celiac disease, wheat allergy and previous anaphylaxis to lidocaine (date unspecified), and "101 others". On 24-APR-2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot # H019996, expiration date unspecified) single dose, 0.65 ml, subcutaneously (anatomical location unspecified). The pharmacists reported that on 24-APR-2013, the patient had an immediate anaphylactic reaction after receiving ZOSTAVAX involving chest pain and shortness of breath. The pharmacist reported that the patient had a previous anaphylactic reaction to lidocaine that was very similar to the reaction that occurred with the administration of ZOSTAVAX. The patient was taken to emergency room and was admitted overnight for chest pain and decreased respiratory quality, she received treatment with epinephrine (manufacturer unknown), IV drugs unspecified. At the time of the report the outcome of immediate anaphylactic reaction was reported as recovering. Immediate anaphylactic reaction was considered to be serious due to hospitalization, medically significant and life threatening by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from two pharmacists refers to an "approximately 61 years old" female patient with celiac disease, wheat allergy and previous anaphylaxis to lidocaine (date unspecified), and "101 others". On 24-APR-2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot # H019996, expiration date unspecified) single dose, 0.65 ml, subcutaneously (anatomical location unspecified). The pharmacists reported that on 24-APR-2013, the patient had an immediate anaphylactic reaction after receiving ZOSTAVAX involving chest pain and shortness of breath. The pharmacist reported that the patient had a previous anaphylactic reaction to lidocaine that was very similar to the reaction that occurred with the administration of ZOSTAVAX. The patient was taken to emergency room and was admitted overnight for chest pain and decreased respiratory quality, he received treatment with epinephrine (manufacturer unknown), IV drugs unspecified. At the time of the report the outcome of immediate anaphylactic reaction was reported as recovering. Immediate anaphylactic reaction was considered to be serious due to hospitalization, medically significant and life threatening by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Immediate post-injection reaction, Respiratory depression
Clinical narrative: This spontaneous report as received from two pharmacists refers to an "approximately 61 years old" female patient with celiac disease, wheat allergy and previous anaphylaxis to lidocaine (date unspecified), and "101 others". On 24-APR-2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot # H019996, expiration date unspecified) single dose, 0.65 ml, subcutaneously (anatomical location unspecified). The pharmacists reported that on 24-APR-2013, the patient had an immediate anaphylactic reaction after receiving ZOSTAVAX involving chest pain and shortness of breath. The pharmacist reported that the patient had a previous anaphylactic reaction to lidocaine that was very similar to the reaction that occurred with the administration of ZOSTAVAX. The patient was taken to emergency room and was admitted overnight for chest pain and decreased respiratory quality, he received treatment with epinephrine (manufacturer unknown), IV drugs unspecified. At the time of the report the outcome of immediate anaphylactic reaction was reported as recovering. Immediate anaphylactic reaction was considered to be serious due to hospitalization, medically significant and life threatening by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Skin warm, Swelling
Clinical narrative: Swelling, hot to touch. Patient got a reaction to Rt arm.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site induration, Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 49 year old female patient. On 29-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # H015780, expiration date 11-JUN-2014, 0.5 ml in the left deltoid for pneumococcal challenge. The physician assistant did not specify reason for challenge. On 30-APR-2013, 2 days after onset of therapy, the patient experienced cellulitis and on an unknown date, the patient was admitted to the hospital with cellulitis, fever of 102 degrees F and induration at injection site after receiving PNEUMOVAX 23. Unspecified lab test resulted in white blood cell count of 26000 (unspecified unit of measurement). Physician assistant stated the patient could not use that arm. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Sharp pain at the arm that she got shot at. Started 1 day after she has received the shot; pain has been constant since. Saw Dr approximately 2 months ago; got ibuprofen 600mg & steroids (?), ibuprofen did not work, steroids worked but pain return after discontinuation of therapy. Pt has not seen MD since, as she has no insurance.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection red hot swollen and tender.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Diarrhoea, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Runny nose, sneezing, diarrhea. The area was swelling, pain, cellulitis.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Runny nose, sneezing, diarrhea. The area was swelling, pain, cellulitis.
Age: 1.6
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Local reaction, Pyrexia
Clinical narrative: Given PREVNAR 13 on 5/6/13. 1 day developed low grade fever, local site reaction size of a quarter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: Mother called and stated on the day of vaccination the site was red and hot. The next night there was a raised rash that extended to just above elbow. Mother gave BENADRYL on own.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a register nurse concerning a 27 year old female patient with no pertinent medical history or drug reactions/allergies who on 25-APR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (lot number H01419G, expiration date 19-MAR-2014). No co-suspect or concomitant medications were reported. Nurse stated that the patient reported that the site was sore after receiving vaccination then on that evening, patient that her arm "felt heavy" and patient reported she was unable to lift her arm. Nurse stated additionally patient reported that the side of her body where PNEUMOVAX23 was administered was painful, her breast was painful to touch, her armpit was painful to touch. Nurse stated that the patient reported no bruising, and that the area where vaccine was give was not swollen but the site was hot and red.. Nurse states patient called an unspecified doctor's office who advised taking an un unspecified antihistamine which patient did take. Nurse stated that from patient that doctor offered to provide patient a cortisone shot yet patient declined cortisone shot. No laboratory tests were performed. Nurse states patient reports issues slowly resolved by Monday, 29-APR-2013. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a register nurse concerning a 27 year old female patient with no pertinent medical history or drug reactions/allergies who on 25-APR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (lot number H01419G, expiration date 19-MAR-2014). No co-suspect or concomitant medications were reported. Nurse stated that the patient reported that the site was sore after receiving vaccination then on that evening, patient that her arm "felt heavy" and patient reported she was unable to lift her arm. Nurse stated additionally patient reported that the side of her body where PNEUMOVAX23 was administered was painful, her breast was painful to touch, her armpit was painful to touch. Nurse stated that the patient reported no bruising, and that the area where vaccine was give was not swollen but the site was hot and red.. Nurse states patient called an unspecified doctor's office who advised taking an un unspecified antihistamine which patient did take. Nurse stated that from patient that doctor offered to provide patient a cortisone shot yet patient declined cortisone shot. No laboratory tests were performed. Nurse states patient reports issues slowly resolved by Monday, 29-APR-2013. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Streptococcus test negative
Clinical narrative: Vaccines given 5-6-13. Fever 5-7-13, up to 103.3. Nausea, vomited 5-7-13 AM, and c/o headache. Also had diarrhea 5-6-13 evening.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Vaccines given 5-6-13. Fever 5-7-13, up to 103.3. Nausea, vomited 5-7-13 AM, and c/o headache. Also had diarrhea 5-6-13 evening.
Age: 35.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from another refers to a 35 year old patient (gender unknown). On 03-MAY-2013 the patient was inadvertently vaccinated with ZOSTAVAX 5 ml, subcutaneous (lot # J000432, exp date: 10-APR-2013) 5 ml, subcutaneous. The patient was supposed to receive another unspecified vaccine. No adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494 and expiration date 14-APR-2014), 0.65 ml, subcutaneous in the left arm. There was no concomitant medication. The pharmacist reported that the patient experienced an adverse event after receiving ZOSTAVAX. The pharmacist reported the patient's wife also experienced an adverse event (MARRS 1305USA002193). At the time of the report the patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On 01-MAY-2013 the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot number H010515) 0.1 ml, intradermal in the forearm. On 01-MAY-2013, the are became reddened and raised, but not swollen and measured 3.5 inches by 2.5 inches. No treatment has been given at this time. The patient called to office. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-MAY-2013, the patient was vaccinated with a unspecified series of GARDASIL (Lot number # 669308/0636AA, expiry date 11-AUG-2013, route and dose were not reported) was that was exposed to an unsupported temperature excursion. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date in 2011, the patient was vaccinated with a dose of ZOSTAVAX,(lot number, expiry date and route was injection). Concomitant medications were not reported. On an unknown date, the patient had shingles twice since the administration of the vaccine. The outcome of the event was unknown. The patient medical attention (saw the doctor). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The nurse reported that another office was improperly storing RECOMBIVAX HB during the months of February 2013, March 2013 and April 2013. It was reported that there was a possibility that the vaccine was administered to an unspecified number of patients. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The nurse reported that another office was improperly storing M-M-R II during the months of February 2013, March 2013 and April 2013. It was reported that there was a possibility that the vaccine was administered to an unspecified number of patients. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from claims management service refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced adverse reaction. The outcome of adverse reaction was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for vaccinatin. Lot # was unspecified. The physician assistant mentioned that she heard that a patient affiliated with another unspecified practice developed shingles afater receiving ZOSTAVAX. The outcome of shingles was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Rash papular
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 83 year old male patient with allergic to vancomycin. The patient's medical history included heart condition. On 02-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000495, 14-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included fluticasone propionate, ADVAIR and SPIRIVA. On 02-MAY-2013, "within an hour" after vaccination, the patient experienced "raised spots on her face and experienced chills". No treatment was given. No lab was performed. The reporter called patient during the time of call and the patient's daughter reported that the patient's symptoms were "subsiding". The patient did not seek medical attention. The outcome of chills and raised spots on her face was reported as recovering/resolving. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Influenza like illness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with DEMEROL reaction (sick stomach) and IgA deficiency. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494 and expiration date 14-APR-2014), 0.65 ml, subcutaneous in the left arm for immunization. There was no concomitant medication. The pharmacist stated that later in the day on 29-APR-2013, the patient experienced flu like symptoms, a temperature of 101 degrees F, and joint pain in her shoulders and fingers after receiving ZOSTAVAX earlier that day. The patient took an unspecified dose of TYLENOL at 7:00 pm and again at 9:00 pm on 29-APR-2013. By 10:00 pm on 29-APR-2013, the patient was beginning to feel better. Patient sought medical attention by went back in to pharmacy on 03-MAY-2013. Laboratory tests were not performed. At the time of the report the outcome of flu like symptoms, joint pain in her shoulder and fingers and temperature of 101 degrees F was reported as recovering. This is one of two reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTAP, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 year old female with no pertinent medical history and no drug reaction or allergy who on 12-SEP-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # 670099/0410AA). Concomitant therapy included MENVEO, BOOSTRIX and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid on 12-SEP-2011. Urine pregnancy test was performed on12-SEP-2011. It was learned "later that day" that the patient was pregnant (positive 5 weeks gestation). Last menstrual date was on 03-AUG-2011 and estimated delivery date was on 09-MAY-2012. The patient did not seek medical attention. At the time of the report, no adverse effects were seen. Follow up information has been received from registered nurse. She reported that the Health Department had no information regarding the patient or her pregnancy outcome. She stated that the patient had only came in for her immunizations and had no forwarding medical provider information to give to follow up regarding her pregnancy care. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Joint swelling
Clinical narrative: This spontaneous report was received from a physician assistant concerning an 11 year old male patient with slightly overweight. "Within the last week" on approximately 22-APR-2013 the patient was vaccinated in one arm with GARDASIL (Lot # not provided), 0.5 ml, intramuscular. On the same date (approximately on 22-APR-2013), the patient was also vaccinated in the other arm with ADACEL and MENACTRA. The physician assistant reported that the patient developed "redness and swelling" on the arm in which he received ADACEL and MENACTRA (approximately on 22-APR-2013). The patient was administered BENADRYL (manufacturer unknown) and ibuprofen (manufacturer unknown) as treatment for the adverse events. The outcome of redness and swelling was reported as recovered/resolved (approximately in April 2013). The patient was seen in physician assistant's office. This is one of several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Nausea, Pain, Rash pustular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had no drug allergies. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm (LOT # reported as J00443, which is not a valid lot number for ZOSTAVAX, expiry date was reported as 11-APR-2014). Concomitant therapies included ALLOPURINOL, METFORMIN, ZOCOR, ALDACTONE TABLETS and TRICOR. Approximately on 14-APR-2013 (within 48 hours of receiving ZOSTAVAX), the patient developed nausea, diarrhea, pain all over her body, and redness and pustules on the left side of her body. The patient had sought medical attention. She was evaluated at a medical center. It was unknown if the patient was seen in the emergency room and then discharged or if she was admitted as an in-patient. The patient received FAMVIR, hydrocodone and ZOVIRAX cream as treatment. Patient outcome was not reported. Reporter did not assess relationship between the events and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 24-APR-2013 the patient was vaccinated subcutaneously with an expired single dose of ZOSTAVAX (Lot # 672676/0069AE, expired on 03-APR-2013). No adverse effects reported. It was not reported if the patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report was received from a Physician assistant concerning an 11 year old male patient with slightly overweight. Within the last week on approximately 22-APR-2013 the patient was vaccinated in one arm with GARDASIL (Lot # not provided), 0.5 ml, intramuscular. On the same date (approximately on 22-APR-2013), the patient was also vaccinated in the other arm with ADACEL and MENACTRA. The physician assistant reported that the patient developed redness and swelling on the arm in which he received ADACEL and MENACTRA (approximately on 22-APR-2013). The patient was administered BENADRYL (manufacturer unknown) and ibuprofen (manufacturer unknown) as treatment for the adverse events. The outcome of redness and swelling was reported as recovered/resolved (approximately in April 2013). The patient was seen in physician assistant's office. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report was received from a Physician assistant concerning an 11 year old male patient with slightly overweight. Within the last week on approximately 22-APR-2013 the patient was vaccinated in one arm with GARDASIL (Lot # not provided), 0.5 ml, intramuscular. On the same date (approximately on 22-APR-2013), the patient was also vaccinated in the other arm with ADACEL and MENACTRA. The physician assistant reported that the patient developed redness and swelling on the arm in which he received ADACEL and MENACTRA (approximately 22-APR-2013). The patient was administered BENADRYL (manufacturer unknown) and ibuprofen (manufacturer unknown) as treatment for the adverse events. The outcome of redness and swelling was reported as recovered/resolved (approximately in April 2013). The patient was seen in physician assistant's office. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 16 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAY-2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in an unspecified arm. Concomitant therapy included MENACTRA (lot number, expiry date, dose and route unspecified) injected at the same office visit on 01-MAY-2013 with GARDASIL. On 01-MAY-2013, the patient experienced a seizure in the car, five minutes after leaving the office. It was reported by the mother of the patient, ten minutes after having left the office with her two sons. It was unspecified if the patient sought any medical attention. It was unspecified if the patient was treated or if any laboratory tests were performed. The mother of the patient was instructed by an unspecified healthcare worker at the physician office to go to the emergency room of an unspecified hospital. When the physician office later contacted the unspecified hospital to see if the patient had sought treatment, there was no record that the patient had been to the hospital. It was reported that approximately on an unknown date in May 2013, the seizure had ended (duration unspecified). Upon internal review, seizure was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 02-MAY-2012 the patient was vaccinated with VARIVAX (Merck) (dose, route and application site were unspecified) (lot # reported as H01551, exp date: 16-AUG-2013) instead of ZOSTAVAX. The physician reported that the patient will be notified that day that the incorrect vaccine had been administered, along with the time period in which follow up is required for the administration of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Case number PHHY2012US099087 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 463396) web site on 01 Nov 2012, with a follow-up received from a Quality Assurance department (reference number: 209182) on 06 May 2013. This report refers to an 18 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11051), intramuscular, into the right arm, on 22 Aug 2012. Patient passed out after receiving vaccine, revived after 1-2 minutes, threw up, passed out again, and revived again after 1-2 minutes. 20 minutes later patient was feeling better and left the store. Outcome of the event was recovered. Seriousness and causality assessment was not reported. Based on the review performed, it was concluded that this batch (M11051) was manufactured in accordance with the approved internal procedures and it was in compliance with cGMP requirements. Follow-up was received on 06 May 2013: Batch review was updated (batch number was corrected from A11051 to M11051).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Case number PHHY2012US111726, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469384) website on 04 Dec 2012, with a follow up received from the QA department on 06 May 2013. This report refers to 11-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11051) intramuscularly in the left arm, GARDASIL vaccine (other manufacture, batch number: 0636AE) intramuscularly in the left arm, BOOSTRIX vaccine (other manufacture, batch number: AC52B093BA), intramuscularly in the right arm, VARIVAX vaccine (other manufacture, batch number: H011232) subcutaneously in the right arm 12 Oct 2012. After vaccination on the same day, she passed-out. Based on the batch review report, it was stated that the concerned MENVEO batch number M11051 was manufactured in accordance with Approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The outcome of the events was reported as completely recovered. The causality of the events was not reported. Follow up report received from the QA department on 06 May 2013: Updated batch review report.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Case number PHHY2013US032593 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 482030) on 04 Apr 2013, and a follow up received from the quality assurance department (quality reference number 221743) on 06 May 2013: This report refers to a 18-year-old female patient. The patient's medical history was not reported. Concomitant medications included LEVOXYL and ORTHO TRI-CYCLEN. She was vaccinated with MENVEO (batch number: A11077) intramuscularly in left arm and GARDASIL (batch number: H015859) intramuscularly in right arm both on 15 Jan 2013. On the same day, after the vaccinations, the patient became lightheaded and passed out. The outcome of events was reported as complete recovery. The causality and seriousness of events was not reported. Based on the batch review performed, it was concluded that the MENVEO batch A11077 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up information received from the quality assurance department on 06 May 2013: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Asthenia, Chest pain, Death, Gait disturbance
Clinical narrative: Case number PHHY2013US032667 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482371) on 04 Apr 2013 with a non-significant follow-up received from a Quality Assurance Department (QA reference number: 220428) on 04 Apr 2013 with the follow-up received from a Quality Assurance Department on 02 May 2013: This report refers to a 65-year-old male patient. His medical history included chronic kidney disease, hypertension, gout and increasing edema in hands and feet for 'six months'. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206101) intramuscularly in to the left arm on 24 Oct 2012. The patient was hospitalized from 12 Dec 2012 to 22 Dec 2012 for increasing edema in hands and feet and also had unsteady gait (at that time) decreased strength from unknown dates. On an undetermined date, he was diagnosed with Guillain-Barre Syndrome. On 03 Jan 2013, he was readmitted to another medical center for the complaints of worsening weakness, chest pain and dysphasia. On 05 Jan 2013, the patient expired due to unknown cause during ambulance transportation and the death was confirmed on arrival at the community hospital. Myocardial infarction was ruled out at that time. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN vaccine (batch number: 1206101) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department on 04 Apr 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Oedema peripheral
Clinical narrative: Case number PHHY2013US032667 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482371) on 04 Apr 2013 with a non-significant follow-up received from a Quality Assurance Department (QA reference number: 220428) on 04 Apr 2013 with the follow-up received from a Quality Assurance Department on 02 May 2013: This report refers to a 65-year-old male patient. His medical history included chronic kidney disease, hypertension, gout and increasing edema in hands and feet for 'six months'. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206101) intramuscularly in to the left arm on 24 Oct 2012. The patient was hospitalized from 12 Dec 2012 to 22 Dec 2012 for increasing edema in hands and feet and also had unsteady gait (at that time) decreased strength from unknown dates. On an undetermined date, he was diagnosed with Guillain-Barre Syndrome. On 03 Jan 2013, he was readmitted to another medical center for the complaints of worsening weakness, chest pain and dysphasia. On 05 Jan 2013, the patient expired due to unknown cause during ambulance transportation and the death was confirmed on arrival at the community hospital. Myocardial infarction was ruled out at that time. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN vaccine (batch number: 1206101) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department on 04 Apr 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Asthenia, Chest pain, Condition aggravated, Death
Clinical narrative: Case number PHHY2013US032667 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482371) on 04 Apr 2013 with a non-significant follow-up received from a Quality Assurance Department (QA reference number: 220428) on 04 Apr 2013 with the follow-up received from a Quality Assurance Department on 02 May 2013: This report refers to a 65-year-old male patient. His medical history included chronic kidney disease, hypertension, gout and increasing edema in hands and feet for 'six months'. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206101) intramuscularly in to the left arm on 24 Oct 2012. The patient was hospitalized from 12 Dec 2012 to 22 Dec 2012 for increasing edema in hands and feet and also had unsteady gait (at that time) decreased strength from unknown dates. On an undetermined date, he was diagnosed with Guillain-Barre Syndrome. On 03 Jan 2013, he was readmitted to another medical center for the complaints of worsening weakness, chest pain and dysphasia. On 05 Jan 2013, the patient expired due to unknown cause during ambulance transportation and the death was confirmed on arrival at the community hospital. Myocardial infarction was ruled out at that time. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN vaccine (batch number: 1206101) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department on 04 Apr 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Oedema peripheral
Clinical narrative: Case number PHHY2013US032667 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482371) on 04 Apr 2013 with a non-significant follow-up received from a Quality Assurance Department (QA reference number: 220428) on 04 Apr 2013 with the follow-up received from a Quality Assurance Department on 02 May 2013: This report refers to a 65-year-old male patient. His medical history included chronic kidney disease, hypertension, gout and increasing edema in hands and feet for 'six months'. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206101) intramuscularly in to the left arm on 24 Oct 2012. The patient was hospitalized from 12 Dec 2012 to 22 Dec 2012 for increasing edema in hands and feet and also had unsteady gait (at that time) decreased strength from unknown dates. On an undetermined date, he was diagnosed with Guillain-Barre Syndrome. On 03 Jan 2013, he was readmitted to another medical center for the complaints of worsening weakness, chest pain and dysphasia. On 05 Jan 2013, the patient expired due to unknown cause during ambulance transportation and the death was confirmed on arrival at the community hospital. Myocardial infarction was ruled out at that time. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN vaccine (batch number: 1206101) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department on 04 Apr 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department on 02 May 2013: Updated batch review report.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, Headache, Injection site pain, Optic neuritis
Clinical narrative: Case number PHHY2013US032571 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 483130) on 04 Apr 2013, with a follow-up received on 06 May 2013. This is also a quality complaint report (reference number: 221526). This report refers to a 50-year-old male patient. The patient's preexisting condition included anxiety and hypertension. Concomitant medications included lisinopril and escitalopram. He was vaccinated with FLUVIRIN (batch number: 1206501) on left arm on 14 Jan 2013. The day of vaccine patient developed headache and soreness at site. Two days after vaccine he started to lose sight in right eye. Four days after vaccine he had nearly complete loss of vision in right eye and severe headache. Finally he was diagnosed with optic neuritis. The patient had a visit to emergency room. Outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported. On follow-up, it was reported that the patient received FLUARIX (batch number: AFLUA708AB), which is a non Novartis vaccine. Hence this case will be deactivated. Follow-up was received on 06 May 2013: Case deactivation information was updated.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Activities of daily living impaired, Hypersomnia, Impaired driving ability, Sleep study, Somnolence
Clinical narrative: Case number PHHY2013US032587 is an initial spontaneous report from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 483236) on 04 Apr 2013, with a follow-up received on 06 May 2013. This report refers to a 32-year-old female patient. The patient's preexisting conditions included asthma, migraines and seasonal allergies (not at the time of vaccination). Concomitant medications included SINGULAIR, LEXAPRO, TOPAMAX, VENTOLIN and imipramine. The patient received pandemic H1N1 vaccine (batch number: unknown) on 05 Nov 2009. On 08 Nov 2009, four days after receiving the H1N1 vaccination, she just could not get enough sleep. But later, "she began sleeping through her alarm at 5:00 am" and was unable to get out of bed until 12:00 or 1:00pm. She would nod off while driving to work, even though it was only a 30 minute drive and she had only been awake less than 2.5 hours. She actually drove her car off the side of the road once, when she woke up, she was just sitting in her car. She would fall asleep at the light at the exit ramp of the freeway to work. She would be so overcome with the need to sleep; she would shut her office door and sleep on the floor at 9am. She would sleep in her car instead of eating lunch. She came home from work and took 3-4 hour naps. On the weekends, she would sleep 15-19 hours a day. She tried to drink caffeine (she usually don't) but it did help her to stay awake. In mid-Dec, she went to see her gynecologist, thinking maybe she was anemic. Gynecologist woke her up (she fell asleep in the exam chair) and told her that there was no way the extreme sleepiness was caused by her cycle. She ordered a multiple sleep latency test and blood work. She averaged 5 minutes to fall asleep for each nap. Since then she had been to doctor's offices, trying a variety of pills, lifestyle changes, anything to get her life back. Since Nov 2009, she was not able to function daily. Events were assessed as life threatening and disability. Outcome of the events was reported as condition unchanged. Causality of the events were not reported. No further information was available. Follow-up was received on 06 May 2013: The patient was vaccinated with monovalent influenza vaccine of other manufacturer (batch number: 500751P). As no Novartis vaccine was involved, this case will be deactivated.