chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt states received vaccine 11/11/13. She went camping that day and was camping for few days. Her arm hurt night of 11/11/13. Then starting 11/13 - arm hurts, goes up into shoulder and numbness in thumb. Area around vaccine site not red, hot, no sign of infection. Counseled her to see MD, states will wait another week. She is not sure if vaccine related or something from.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Moderate swelling on right side leg from thigh to knee; and mild swelling from knee to foot. Slight red rash on thigh.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Local injection site reaction: erythema, swelling, and induration occurred approx. 6-8 hours following administration of PNEUMOVAX.
Age: 35.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Local injection site reaction: erythema, swelling, and induration occurred approx. 6-8 hours following administration of PNEUMOVAX.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Joint range of motion decreased, Myalgia
Clinical narrative: Muscle ached later the day of shot. Limited ability to raise arms. Taken ibuprofen does not help. Family doctor gave pain medicine for back pain, and it is helping.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: (L) arm (site of the injection) (+) localized erythema, swelling - large wheals - (-) lymph nodes. RRR. ENT: normal. LCTA.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 3 vaccines given too early. Var., MMR, Hep A 12 mon. vaccines given to a 6 mon patient.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Patient was given pneumonia vaccine on 2nd shift. Patient complained of pain in deltoid. Swelling was noted. No redness or heat.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Limited mobility in arm, can't lift above shoulder level at side, or across body. And pain in arm in shoulder. Feels it was given in shoulder. Taken ibuprofen, currently in physical therapy.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Local swelling
Clinical narrative: Day after injection, arm started to swell and burn. Swelling moved to extremities and she was seen by P.A.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site right arm, hard to move arm for first day (5 hours after injection).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Immediate pain at (L) mid deltoid site of injection. Pain has diminished somewhat but is still significant and has caused decreased ROM/pain on ROM.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Evaluated at health care clinic localized reaction to influenza vaccine; site to be recheck tomorrow apply ice intermittently.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Swelling and redness at injection site. Nurse Practitioner determined it was infected, ordered Keflex 500 mg 3 times for 10 days beginning 11/19/13.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pneumococcal 23-valent vaccine 0.5 ml and influenza virus vaccine 0.5 ml documented given 10/8/13, both in the (R) upper arm 10/8/13 1400 area of redness and swelling ID'd as area of the vaccine administration 10/8 1228 BENADRYL 50mg IV, 10/8 1630 BENADRYL 50mg IV, 10/8 1754 BENADRYL 40mg IV.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Tremor
Clinical narrative: 3hrs after vaccination, pt had shaking, chills, and vomiting since  (1 month) pt has had arthralgia, fatigue, weakness.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 3hrs after vaccination, pt had shaking, chills, and vomiting since  (1 month) pt has had arthralgia, fatigue, weakness.
Age: 1.45
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Antinuclear antibody negative, Body temperature increased, Erythema multiforme, Full blood count abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Hives, temp of 100.3. Dx with erythema multiforme on 11/18/13.
Age: 1.45
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rheumatoid factor negative, Streptococcus test negative, Urticaria
Clinical narrative: Hives, temp of 100.3. Dx with erythema multiforme on 11/18/13.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Influenza virus test negative, Injection site erythema, Injection site irritation, Local swelling
Clinical narrative: PNEUMOVAX 23 adult vac given in her left arm on 11-12-2013 - pt's (L) arm started swelling, site erythema and irritated fever 102.8, flu-like symptoms.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: PNEUMOVAX 23 adult vac given in her left arm on 11-12-2013 - pt's (L) arm started swelling, site erythema and irritated fever 102.8, flu-like symptoms.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Tinnitus, Tonic clonic movements
Clinical narrative: This spontaneous report as received from healthcare student refers to a 17 year old female patient. On 11-NOV-2013, the patient was vaccinated with a first dose of GARDASIL (lot # and expiration date not reported), 0.5 ml, subcutaneous. There was no concomitant medication, pertinent medical history, drug reactions or allergies. On 11-NOV-2013, immediately after administering GARDASIL, the patient began to have ringing in her ears and then experienced tonic clonic jerking and syncope. She was assisted to lie down and her head was lowered. These adverse events were occurred when she was at physician's office. The patient recovered immediately and was able to walk out of the physician's office on her own. No treatment was given for adverse event. None lab diagnostics studies were performed. Upon internal review, tonic clonic jerking was considered as medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Malaise
Clinical narrative: I received the flu shot from a pharmacist and almost immediately felt sick and blacked out. I proceeded to lay down on the ground.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a newspaper via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, frequency and indication not reported). The representative reported that there was an article on the front page of the newspaper "today"(07-NOV-2013). She reported that the article talked about how GARDASIL caused two sisters to have premature ovarian failure. The outcome of the event was unknown. The case captured one of the two sisters, the other sister was captured in the case(1311USA007452). This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a newspaper via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot#, dose, frequency and indication not reported). The representative reported that there was an article on the front page of the newspaper "today"(07-NOV-2013). She reported that the article talked about how GARDASIL caused two sisters to have premature ovarian failure. The outcome of the event was unknown. The case captured one of the two sisters, the other sister was captured in the case(1311USA003897). This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a pharmacist refers to a female patient of unknown age. On 31-OCT-2013 the patient ws vaccinated with ZOSTAVAX (dose and route not reported). The reporter stated that the patient was being prescribed prednisone on 15-NOV-2013 for an unspecified reason. It was unknown whether the patient sought medical attention or not. The outcome was unknown. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: This spontaneous report as received from a 28 year old male patient reporting on himself. The patient had no pertinent medical history nor drug reactions/allergies. On 28-OCT-2013 the patient was vaccinated with VAQTA disposable syringe injection (dose no, dosage and route unknown; lot # J005680 Exp 02-AUG-2015). No concomitant medications were reported. On 28-OCT-2013 the patient reported that he experienced rapid heart beat and dizziness after receiving VAQTA. The patient then stated he was sent to the ER (duration, location and demographics unknown) because he was feeling "foggy" and light headed. The patient sought medical attention (saw the doctor), but received no treatment. No lab diagnostic studies were performed. The patient was reported as recovering from the events. This case is related to MARRS case no. 1310USA014886 (same reporter link). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of age 66 years and 9 months. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On 23-OCT-2013 the patient number 2 was vaccinated with PNEUMOVAX23 lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown) received in same administration session in the opposite arm. On 24-OCT-2013, following day of vaccination, the patient had experienced arm soreness. By 02-NOV-2013, her discomfort had resolved. The patient's physician was notified of the event. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 2 of 3 reports from same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Discomfort, Injection site reaction, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of age 66 years and 9 months. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On 23-OCT-2013 the patient number 2 was vaccinated with PNEUMOVAX23 lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown) received in same administration session in the opposite arm. On 24-OCT-2013, following day of vaccination, the patient had experienced arm soreness. By 02-NOV-2013, her discomfort had resolved. The patient's physician was notified of the event. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 2 of 3 reports from same reporter. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Cellulitis, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a 75 year old female patient with high blood pressure, who on 24-OCT-2013 at 3:20 was vaccinated with ZOSTAVAX (lot # J008802, expiration date 19OCT2013), SQ, right arm. Prior to the patient's vaccination with ZOSTAVAX, she was vaccinated with both PENUMOVAX (lot # J006242) IM, right deltoid and FLUZONE (lot # U4765AA) IM, left deltoid on 07OCT2013. On 25OCT2013, the patient sustained on her right arm: redness, swellings, pain, and arm felt hot, diarrhea and stomach pain. The patient was diagnosed with cellulitis of her right arm. The patient required emergency room/doctor visit. The patient denied illness at the time of her vaccination. Treatment and outcome of the adverse events were unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a 75 year old female patient with high blood pressure, who on 24-OCT-2013 at 3:20 was vaccinated with ZOSTAVAX (lot # J008802, expiration date 19OCT2013), SQ, right arm. Prior to the patient's vaccination with ZOSTAVAX, she was vaccinated with both PENUMOVAX (lot # J006242) IM, right deltoid and FLUZONE (lot # U4765AA) IM, left deltoid on 07OCT2013. On 25OCT2013, the patient sustained on her right arm: redness, swellings, pain, and arm felt hot, diarrhea and stomach pain. The patient was diagnosed with cellulitis of her right arm. The patient required emergency room/doctor visit. The patient denied illness at the time of her vaccination. Treatment and outcome of the adverse events were unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Cellulitis, Diarrhoea, Erythema, Local swelling
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a 75 year old female patient with high blood pressure, who on 24-OCT-2013 at 3:20 was vaccinated with ZOSTAVAX (lot # J008802, expiration date 19OCT2013), SQ, right arm. Prior to the patient's vaccination with ZOSTAVAX, she was vaccinated with both PENUMOVAX (lot # J006242) IM, right deltoid and FLUZONE (lot # U4765AA) IM, left deltoid on 07OCT2013. On 25OCT2013, the patient sustained on her right arm: redness, swellings, pain, and arm felt hot, diarrhea and stomach pain. The patient was diagnosed with cellulitis of her right arm. The patient required emergency room/doctor visit. The patient denied illness at the time of her vaccination. Treatment and outcome of the adverse events were unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a 75 year old female patient with high blood pressure, who on 24-OCT-2013 at 3:20 was vaccinated with ZOSTAVAX (lot # J008802, expiration date 19OCT2013), SQ, right arm. Prior to the patient's vaccination with ZOSTAVAX, she was vaccinated with both PENUMOVAX (lot # J006242) IM, right deltoid and FLUZONE (lot # U4765AA) IM, left deltoid on 07OCT2013. On 25OCT2013, the patient sustained on her right arm: redness, swellings, pain, and arm felt hot, diarrhea and stomach pain. The patient was diagnosed with cellulitis of her right arm. The patient required emergency room/doctor visit. The patient denied illness at the time of her vaccination. Treatment and outcome of the adverse events were unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Permanent red, itchy, inflamed bump immediately after influenza vaccine at injection sight. A year and a half later it spread on skin an inch away from first location. Seen doctor and was given steroid shot to decrease inflammation and itchiness. Did not see any results or follow ups.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Musculoskeletal discomfort, Rhinorrhoea, Swelling
Clinical narrative: Red swelling, joint discomfort, NONstop runny nose.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea began 10 hrs after vaccine, lasted 24 hr.
Age: 35.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a health care worker refers to a 35 year old patient of unknown gender. On 18-JUL-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. On 19-NOV-2013, the patient was administered with another dose of 0.5 ml of PNEUMOVAX23. No adverse effect was reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 35 year old patient of unknown gender. On 18-JUL-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. On 19-NOV-2013, the patient was administered with another dose of 0.5 ml of PNEUMOVAX23. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse practitioner, via a company representative, refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number and expiry date not provided) intramuscular. On an unknown date, the patient had received a dose of ZOSTZVAX administered intramuscularly rather than subcutaneously and that the patient had developed an injection site reaction, recently (date unspecified). The dose of ZOSTAVAX was not administered by the nurse practitioner, but at an unspecified Walgreens Pharmacy. The outcome of injections site reaction and a dose of ZOSTAVAX administered intramuscularly rather than subcutaneously was unknown. The reporter did not assess the relatedness between the injections site reaction and ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Anaphylactic reaction, Immediate post-injection reaction, White blood cell count decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL. On an unknown date, the patient experienced anaphylactic reaction immediately after receiving first dose of GARDASIL (hospitalization). On an unspecified date, the patient's white blood count dropped experienced anemia. The patient sought medical attention and was treated by an unspecified hematologist at the hospital. The company representative was unsure if the patient was hospitalized or if treatment was done in an outpatient setting. The outcome of the events were reported as recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural, Dysphonia, Headache, Heart rate increased
Clinical narrative: This spontaneous report refers to a 68 year old female patient with no medical history or drug allergies/reactions. On 15-OCT-2013 (reported as one month ago), the patient was vaccinated with ZOSTAVAX refrigerated vial lot # J004600 and expiry date 18-JUL-2014, standard dose (0.65 ml), subcutaneous injections for prevention of shingles. Concomitant therapies included unspecified medication for acid reflux, Synthyroid and Lipitor started around the time of vaccination. On an unknown date in October 2013 (reported as within 1 week of vaccination), the patient developed headaches that occurred every day, dizziness when she stand, lightheadedness, hoarseness and fast heart rate. The outcome of events was reported as resolving. No lab tests were performed. Motrin was given as treatment for events. The patient sought medical attention, by speaking to her physician. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Herpes zoster, Hypersensitivity, Migraine
Clinical narrative: This spontaneous report as received from an unknown age female patient refers to herself. The patient had taken LIDODERM ointment and acyclovir for shingles outbreaks in the past. The patient had a history of unspecified thyroid issues and had had a coma. The patient had shingles outbreaks when she was in her 20's (years). On 09-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported, "standard", subcutaneously). Concomitant therapies included levothyroxine sodium(manufacturer unknown), metoprolol, KLONOPIN and EFFEXOR. The patient still experienced shingles outbreaks after having the vaccine, however the outbreaks had been less severe lasting between 1-2 days and included very mild headaches, rash and sore throat. The patient explained that she had had 4 of there outbreaks in a row within this past year and felt that the outbreaks do occur more frequently than before she received the vaccine. Approximately on 28-OCT-2013 ("two weeks ago"), the patient developed a more severe shingles outbreak that included a rash on her left hip, hyper sensitivity, migraine, pain and sore throat, this reaction lasted for a longer timeframe and that on the 02-NOV-2013 or 03-NOV-2013 ("4th-5th day of this outbreak") the rash spread to her right hip. The severe reaction occurred after an unspecified thyroid issue. The patient sought medical attention via talking to the doctor. The patient took TYLENOL for treating the event. The outcome of the events was reported as recovered on 08-NOV-2013 ("three days ago"). Follow-up information was received which reported the patient's birthdate year was unable to be confirmed at this point. The patient was within the indicated age range to received the vaccine according to current prescribing information for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Rash, Thyroid disorder
Clinical narrative: This spontaneous report as received from an unknown age female patient refers to herself. The patient had taken LIDODERM ointment and acyclovir for shingles outbreaks in the past. The patient had a history of unspecified thyroid issues and had had a coma. The patient had shingles outbreaks when she was in her 20's (years). On 09-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported, "standard", subcutaneously). Concomitant therapies included levothyroxine sodium(manufacturer unknown), metoprolol, KLONOPIN and EFFEXOR. The patient still experienced shingles outbreaks after having the vaccine, however the outbreaks had been less severe lasting between 1-2 days and included very mild headaches, rash and sore throat. The patient explained that she had had 4 of there outbreaks in a row within this past year and felt that the outbreaks do occur more frequently than before she received the vaccine. Approximately on 28-OCT-2013 ("two weeks ago"), the patient developed a more severe shingles outbreak that included a rash on her left hip, hyper sensitivity, migraine, pain and sore throat, this reaction lasted for a longer timeframe and that on the 02-NOV-2013 or 03-NOV-2013 ("4th-5th day of this outbreak") the rash spread to her right hip. The severe reaction occurred after an unspecified thyroid issue. The patient sought medical attention via talking to the doctor. The patient took TYLENOL for treating the event. The outcome of the events was reported as recovered on 08-NOV-2013 ("three days ago"). Follow-up information was received which reported the patient's birthdate year was unable to be confirmed at this point. The patient was within the indicated age range to received the vaccine according to current prescribing information for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: pt returned to pharmacy day after shots left arm red and swollen and warm to touch. Top side of upper arm.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: pt returned to pharmacy day after shots left arm red and swollen and warm to touch. Top side of upper arm.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximately 0900, patient called to state she had hives on arms and legs. No respiratory symptoms. Patient saw her personal physician who treated her with steroids. Spoke with patient at 0930 11/15/13 - hives gone itching continued.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 12 month old child patient. On 08-OCT-2013, the patients were inadvertently vaccinated with a dose of MMR II HSA, (lot # 009784, expiry date 15-MAY-2014) which was improperly stored. No adverse effects reported. This is 2 of 2 cases from same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Paraesthesia
Clinical narrative: Pt. felt dizziness, fingers tingling, became pale, elevated his feet, all symptoms resolved within 45 minutes.
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 11-NOV-2013 the patient was vaccinated with ZOSTAVAX (dose unknown). Lot number was reported as J001729 and expiry date was 20-OCT-2013. The patient was administered an expired dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of under the age of 50. The pharmacist reported that an unknown number of patients under the age of 50 were administered ZOSTAVAX (lot# unspecified) (dose, route and locations unspecified) (administration of ZOSTAVAX to the patients occurred at another unspecified site). No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On 16-NOV-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose 0.65 ml, subcutaneous) (lot number H012575 and expiry date 28-DEP-2013). No concomitant therapy was administered. No adverse effects were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a 21 year old female consumer reporting on herself for HPV rL1 6 11 16 18 VLP, a Pregnancy Registry product, who on 26-JAN-2012 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP (dose, route and lot # not reported). Concomitant therapy included "prenatal vitamins". The patient received a dose of HPV rL 1 6 11 16 18 VLP while she was pregnant. (LMP on an approximately 24-FEB-2011; EDD 24-NOV-2012). At the time of reporting, the patient had had no adverse event symptoms. Follow up information has been received from the certified nurse midwife via a pregnancy questionnaire concerning the patient with a history of genital wart, who on 26-JAN-2012 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP lot # 670048/0963AA). The patient's last menstrual period was on 17-FEB-2012 and her EDD would be on 23-NOV-2012. On 23-APR-2012, the patient underwent an ultrasound that was consistent with dates. It was reported that the patient did not have previous pregnancies full term deliveries, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Product reconstitution issue, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding an unknown number of patients (also reported as one or two patients) of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and dosing regimen unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, Pharmacist mentioned to representative that an unknown umber of patients may have received less than the recommended dose of ZOSTAVAX because the pharmacist was not able to withdraw the complete amount of the reconstituted ZOSTAVAX from the vial. When the pharmacist worked at other pharmacies about a month ago (names not provided), she stated she may have had one or two patients (names not provided) that may have received ZOSTAVAX vaccine that was slightly underfilled. A PQC (product quality complaint) was filed. No Adverse events symptoms were reported. The outcome of the underdose was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 74 year old male patient with cholesterol regarding himself. On an unknown date in May 2009 the patient was vaccinated with ZOSTAVAX (lot number and expiry date not reported) (dosing regimen unknown) 1 time vaccine. Concomitant therapies included PLAVIX, ECOTRIN, EDARBI, metoprolol (Manufacturer unknown), LESCOL XL, ZETIA, pantoprazole (Manufacturer unknown) ZANTAC, tamsulosin hydrochloride (Manufacturer unknown) and levomefolate calcium, mecobalamin, METANX. On an unknown date in August 2013 the patient experienced shingles. The patient sought medical attention. The patient was treated with Valacyclovir (VALTREX) by his clinician. The outcome of shingles was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient who was administered an expired dose of PNEUMOVAX 23 (Lot # 672781/1706AA and expiration date 03-OCT-2013) on 06-NOV-2013. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient, also a registered nurse, of unknown age with herpes simplex. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot number J006150/ 08/30/2014) dose 1, 0.65 ml, subcutaneous. No other suspect therapy was reported. Concomitant therapies included VALTREX. The pharmacist reported that the patient reported that on 06-NOV-2013 she began developing a rash on an unspecified location on her body, and she believes that she has shingles. The patient called to provide follow up information. She stated that since she received the ZOSTAVAX she has experienced a headache. She stated that after receiving the ZOSTAVAX she developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation. She states that she has a history of herpes simplex and that this lesion feels like a herpes simplex lesion. She stated that she was not taking her VALTREX at the time of the ZOSTAVAX injection, and has not taken any doses since she got the ZOSTAVAX. She stated that she has not seen her physician, but she has emailed her physician with a picture of the lesion. No treatment information was reported. The outcome of shingles, developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation, headache and lesion feels like a herpes simplex lesion is unknown. The reporters relatedness of shingles, developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation, headache and lesion feels like a herpes simplex lesion to ZOSTAVAX is unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient, also a registered nurse, of unknown age with herpes simplex. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot number J006150/ 08/30/2014) dose 1, 0.65 ml, subcutaneous. No other suspect therapy was reported. Concomitant therapies included VALTREX. The pharmacist reported that the patient reported that on 06-NOV-2013 she began developing a rash on an unspecified location on her body, and she believes that she has shingles. The patient called to provide follow up information. She stated that since she received the ZOSTAVAX she has experienced a headache. She stated that after receiving the ZOSTAVAX she developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation. She states that she has a history of herpes simplex and that this lesion feels like a herpes simplex lesion. She stated that she was not taking her VALTREX at the time of the ZOSTAVAX injection, and has not taken any doses since she got the ZOSTAVAX. She stated that she has not seen her physician, but she has emailed her physician with a picture of the lesion. No treatment information was reported. The outcome of shingles, developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation, headache and lesion feels like a herpes simplex lesion is unknown. The reporters relatedness of shingles, developed a wheal on her upper arm that is red, hot, itchy, painful and with a slight demarcation, headache and lesion feels like a herpes simplex lesion to ZOSTAVAX is 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 healthcare worker refers to an unknown number of patients of unknown ages and genders who might have been received improperly stored GARDASIL on unknown dates (dose, lot#, expiration date and route unknown). The vaccine were exposed to negative 2 centigrade for 30minutes on 01-NOV-2013. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number unspecified). The patient experienced syncopal episode after received GARDASIL and passed out immediately. The patient had not recovered after 25mins. An ambulance was called and the patient was taken to a local emergency room(ER). The physician did not hear any follow up information from the hospital or the patient. The outcome of the patient was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX lot # H021519, expiry date: 09-OCT-2013. On 21-OCT-2013 the patient received expired was vaccinated with ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX lot# J006831 expiry date 14-SEP-2013, 0.65 ml, subcutaneously. After vaccination, on 16-NOV-2013, the patient experienced at the injection site redness, pain, some swelling, itching, warm to the touch and the size of the affected area was 2x3 inches in diameter. The outcome of the events was reported as not resolved. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On an unknown date in late August or early September 2013, the patient was vaccinated with PNEUMOVAX23 (lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza (manufacturer unknown) received in same administration session in the opposite arm. On an unknown date in 2013, the patient experienced similar events (reported as adverse effects fit the same description) as the other 2 patients, namely arm soreness and difficulty moving her arm. The outcome of events was reported as resolved. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 3 of 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown demographics. The nurse reported that an expired dose of VARIVAX (0.5 ml, subcutaneous) (lot number reported as 1632AA/expiry date: 18-OCT-2013) was administered to a patient on 04-NOV-2013. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On 14-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose, route, strength and indication not reported). In July 2013, the patient experienced joint and muscle pain. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding children (patients) of unknown demographics. On an unknown date the patients were vaccinated with M-M-R II injection (lot number and dosing regimen unspecified). No concomitant medications were reported. On an unknown date the nurse practitioner reported that the children may have been vaccinated with improperly M-M-R II vaccine. No adverse effects reported. There was no product quality complaint involved. The outcome of th medication error was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The pharmacist reported regarding three patients who have received doses of PNEUMOVAX23 of lot number 0709AE, expiry date 04-JAN-2014, have experienced injection site reactions in the injection arm. On 30-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # 0709AE, expiry date 04-JAN-2014, dose 0.5 ml, via intramuscular route in deltoid muscle of the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown) received in same administration session in the opposite arm. The same day she received the dose, the patient began to experience pain in her arm and difficulty moving her arm. The patient reports feeling eighty percent better on 03-NOV-2013 when the pharmacist followed up with her. The outcome of pain in her arm and difficulty moving her arm was reported as recovering/resolving. The pharmacist requested a lot check for 0709AE, expiry date 04-JAN-2014. This is 1 of 3 reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-NOV-2013 the patient received a dose of VARIVAX (Merck) (lot number, dose, route and site of administration were not reported) and a dose of PROQUAD (Merck) (lot number, does, route and site of administration were not reported) during the same visit. No symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot #, exp date were not reported). The pharmacist reported that after an unspecified patient was administered a dose of ZOSTAVAX on an unspecified date, the patient developed redness and swelling at the injection site on an unspecified date. These adverse symptoms lasted for 4 to 5 days and the patient recovered on an unspecified date.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # was reported as J004271, Exp date 12-JUL-2013) (dose unknown) subcutaneous. On 05-NOV-2013, the patient received improperly stored ZOSTAVAX which exposed to refrigeration for 2 weeks. No known adverse effects. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Swollen right arm. Interior arm opposite to injection site red and swollen down to inside (toward body) elbow area.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness in left deltoid area. Treatment - local ice, OTC pain relief.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles, Rash
Clinical narrative: Large rash on back of arm. Could see injection site. Unusual blister about 2 inches below injection site. Rash occurred night of injection, but had gotten bigger 2 days later.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Childhood disintegrative disorder, Decreased eye contact
Clinical narrative: Mom states that since pt last vaccine administration, pt has been less verbal, sits up less steadily, no longer rolls from belly to back (will roll from back to belly) and she does not hold eye contact as long as she did before.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Right anterior thigh with 10.0 x 10.5 cm area of erythema, induration, some tenderness to palpation noted by mom on morning of 11-7-13.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vibratory sense increased
Clinical narrative: This spontaneous report was received from the consumer, a 70 year old female patient with drug allergy to Cevita, insulin, Januvia (MARRS#1311USA009049), Novak, penicillin, percocet, sulfa and Zocor (MARRS # 1311USA009050). The patient's medical history included polio in childhood and rheumatic fever in childhood. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX single injection in the left arm. Dosage was not reported. Concomitant therapies included fenofibrate, quinapril, COREG, DOXIMYCIN, LANTUS, and VICTOZA. ON 15-NOV-2013, in the evening on the date of administration, the patient experienced overall feeling of vibration (without break-outs) which she described as bunch of bees coming from top of the shoulder, through the neck into the jaw area. The patient did not seek for medical attention and no treatment was given. The outcome was reported as not recovered/not resolved. No causality assessment was provided. The case was linked to MARRS # 1311USA009049 and #1311USA009050 (same patient). Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 53 year old male patient with anemia, appendectomy, benign positional vertigo, congestive heart failure, carpal tunnel syndrome, cataracts, chronic back pain, recent aortic coronary bypass, deaf in left ear, diabetes, end stage renal disease, gastroesophageal reflux disease, gastroparesis, hypertension, neuropathy, sleep apnea, diastolic dysfunction, hyperlipidemia and defibrillator. On 15-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # H015749, 0.5 ml, intradermal. Concomitant therapies included amiodarone, HUMALOG, NORVASC, LIPITOR, EPOGEN, PERCOCET, CYMBALTQA, PHOSLO, PROTONIX and ramipril. The patient was supposed to received purified protein derivative (PPD) for tuberculin test but instated received PNEUNOVAX23. Several hours later, on 15-NOV-2013, the patient experienced an injection site reaction of redness, inflammation and pain. The affected area was hot. The nurse practitioner would be prescribing KEFLEX and BENADRYL at the day of reporting (18-NOV-2013). She might order an ultrasound of the patient's arm. On 18-NOV-2013, the patient stated that his arm was improving. The relatedness was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included no drug reactions or allergies. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, administration site not provided., lot J011211, expiration date 21-JUL-2014. Concomitant medication included blood pressure and cholesterol medication. In November 2013 the patient experienced local reaction on back side of the arm, the patient's arm appeared to have a "welt the size of 2 golf balls next to each other; the arm was red, warm and blistering like water blisters". "The patient did not have fever, there was no pain, just a little itching, almost an allergic reaction of shingles". The patient had not sought treatment yet. The outcome and relatedness of the events were not provided. Additional information has been requested.