chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) in 2008. The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) in 2009. The patient was vaccinated with the third dose of GARDASIL (dose, route and lot not reported) in 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received form pharmacist considering a 63 years old patient of unknown gender, who on 21-NOV-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005679, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received form pharmacist considering a 63 years old patient of unknown gender, who on 29-NOV-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005679, 1212USA005681, 1212USA005680). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age (gender unspecified). On 30-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number 1193AA, route not reported), which had expired on 25-OCT-2012. No concomitant medications were reported. There was no adverse event report. It was, unspecified if patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to a person (patient) of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient experienced light case of shingles after vaccination with ZOSTAVAX. The outcome of light case of shingles was unknown. This is one of the several reports from the same reporter. Additional information is not expected.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information ahs been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received from pharmacist considering a 63 years old patient of unknown gender, who on 22-OCT-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005680, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information has been requested.
Age: 1.7
Sex: U
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a company representative via physician refers to a 19 month old patient (gender unspecified). On 03-Dec-2012, the patient was vaccinated with VARIVAX, Lot number was reported as 11011416, expiration date and route not reported). No concomitant medications were reported. On 03-DEC-2012, the patient developed 2 to 3 vesicles on the thigh a few hours later after the administration of VARIVAX. It was unspecified if laboratory studies were performed. Treatment rendered for the event was TYLENOL. The outcome of the event was unknown. The patient sought medical attention (went to the hospital). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Acne cystic
Clinical narrative: This spontaneous report as received from a certified nurse midwife refers to a 19 years old female patient with irregular period, diagnosed with polycystic ovary syndrome in 2010 and with no pertinent medical history. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # H011350, expiration sate 21-FEB-2011) IM on 05-SEP-2012 and received a second 0.5 ml dose of GARDASIL (Lot # not reported) IM on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that 24 hours after receiving the second dose of GARDASIL, on 05-DEC-2012, the patient started developing cystic acne on her upper neck and face. The nurse noted that the patient did not immediately seek medical attention but eventually contacted the office and was seen on 19-DEC-2012 when cystic acne would not resolve. The patient was treated with erythromycin and ZYRTEC. There were no Lab diagnosis or studies perform. At the time of the report, the patient was recovering. The relatedness for cystic acne on her upper neck and face was unknown for GARDASIL. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cyanosis, Oxygen saturation decreased, Tremor
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 90 years old female patient with arthritis and coronary artery disease (CAD). The patient's medical history included breast cancer, transient ischaemic attack (TIA), cerebrovascular accident (CVA), hysterectomy, cholecystectomy and appendicetomy. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) IM on 08-DEC-2012. No other co-suspects were reported. Concomitant medications included hydrocodone, acetaminophen and vitamin E. The pharmacist reported that on 08-DEC-2012 the patient started shaking, got chills, and her nail beds turned blue. Her blood oxygen saturation dropped and the health care providers present called 911. The pharmacist did not know if the patient was hospitalized or if any life sustaining measures were performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Scab
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 56 year old female patient. The patient had no drug reactions or allergies. Current conditions included diabetes and shingles. ON 07-NOV-2012, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX, (lot number, expiry date not reported) while having shingles and while on VALTREX. Concomitant medications included acetaminophen, ENDOCET and VALTREX. Soon after the vaccination with ZOSTAVAX the lesions crusted over. But now approximately on an unknown date in December 2012, the patient developed shingles again on face, mouth, throat, sides and arms. It was unspecified if laboratory studies were performed. The outcome of the event was reported as not recovered. The patient sought medical attention (unspecified). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from an approximately 77 year old male patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified). Concomitant medication included hydrocortisone. On an unknown date, after receiving ZOSTAVAX, the patient experienced itchyness and rashes on both legs and arms. On his right side of the waist, he developed white bumps. The patient did not seek any medical attention. No treatment was provided. No laboratory diagnostic tests were performed. The outcomes of all the events were unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist refers to an approximately 75 years old female patient with none medical history, drug reactions or allergies. In 2009, the patient was vaccinated with first dose, 0.5 ml PNEUMOVAX23 (lot number not provided) intramuscularly, right upper arm. On 01-DEC-2012, the patient was vaccinated with 0.5 ml PNEUMOVAX23 intramuscularly, right upper arm (lot number H013394; exp: 05-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed pain and a red, itchy rash at the injection site that lasted for 4 days. No treatment information was reported. The patient seeks medical attention, she called the pharmacy. Laboratory test diagnostic were not performed. The outcome of pain and a red, itchy rash at the injection site was reported as recovered. The relatedness for pain and a red, itchy rash at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a receptionist (health care worker) refers to a patient of unknown age and gender. On 11-DEC-2012, the patient was vaccinated with a expired dose of 0.65 milliliter (ml) of ZOSTAVAX) (lot number 671075/1197AA, expiry date 25-OCT-2012) subcutaneously. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 64 year old female patient with no drug reactions or allergies. On 04-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified) at a pharmacy. No concomitant medications were reported. On 04-NOV-2012, her injection site became swollen, red and soar to the touch. The patient did nor seek any medication attention. No treatment was provided. No laboratory diagnostic tests were performed. At the time of report, all the events had subsided with the exception of the redness. The relatedness for all the events was unknown for ZOSTAVAX. Additional information is no expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Scab
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old female patient. The patient had no pertinent medical history. On n03-DEC-2012, the patient was vaccinated with ZOSTAVAX, (lot number reported as H018091, expiration date 04-JAN-2014, route not reported). No concomitant medications were reported. On 06-DEC-2012, the patient developed blisters on her back which started to crust over in 2 days. On 08-DEC-2012, the patient developed more new blisters. On an unknown date, the patient was diagnosed as having shingles. The healthcare professional was interested in information regarding Varicella zoster virus (VZV) analysis by polymerase chain reaction. Treatment rendered for the event is VALTREX. There were no laboratory diagnostics performed. At the time of this report the patient was recovering from the reported event. The patient sought medical attention (called physician). Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Crying, Fatigue
Clinical narrative: Inconsolable crying ceasing for brief periods only when the baby passed out from exhaustion. The crying lasted 5 hours.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Discomfort, Injection site pain, Insomnia, Musculoskeletal pain
Clinical narrative: I experienced a sore and stiff neck on shoulder on my left side.  This did not go away and after 10 days it moved to my right side.  Then after several days moved back to my left side again while slowly fading away from my right side.  It lasted over 6 weeks until the end of November 2012.  I had difficulty working and sleeping due to the discomfort.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: I experienced a sore and stiff neck on shoulder on my left side.  This did not go away and after 10 days it moved to my right side.  Then after several days moved back to my left side again while slowly fading away from my right side.  It lasted over 6 weeks until the end of November 2012.  I had difficulty working and sleeping due to the discomfort.
Age: 28.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: DIZZINESS, NAUSEA, VOMITING, HEADACHE, VERY TIRED, LETHARGIC. THIS LASTED FOR FOUR DAYS HITTING ME REALLY HARD. I STILL GET NAUSEOUS NOW AND DIZZY BUT ITS FADING. I HAVE A HUGE LUMP ON MY ARM STILL THAT'S VERY PAINFUL.
Age: 28.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pain, Upper extremity mass, Vomiting
Clinical narrative: DIZZINESS, NAUSEA, VOMITING, HEADACHE, VERY TIRED, LETHARGIC. THIS LASTED FOR FOUR DAYS HITTING ME REALLY HARD. I STILL GET NAUSEOUS NOW AND DIZZY BUT ITS FADING. I HAVE A HUGE LUMP ON MY ARM STILL THAT'S VERY PAINFUL.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Localized hives on site of injection. 6:00 PM - 6:00 AM hives spread from arm across chest, neck, back. 12/21/2012 6:00 AM -2:00 PM hives, nausea, chills; 2:00 PM - 11:00 AM. 12/22/2012 hives have gone down, still itch, nausea, vomiting, chills accompanied by slight fever, headache, dull ache in legs, arms, neck, and back, fatigue, dizziness. Spoke to nurse advice line, was told if lymph nodes become swollen to visit ER. No sign of swollen glands as of yet. Aspirin taken as needed.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Nausea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Localized hives on site of injection. 6:00 PM - 6:00 AM hives spread from arm across chest, neck, back. 12/21/2012 6:00 AM -2:00 PM hives, nausea, chills; 2:00 PM - 11:00 AM. 12/22/2012 hives have gone down, still itch, nausea, vomiting, chills accompanied by slight fever, headache, dull ache in legs, arms, neck, and back, fatigue, dizziness. Spoke to nurse advice line, was told if lymph nodes become swollen to visit ER. No sign of swollen glands as of yet. Aspirin taken as needed.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Localized hives on site of injection. 6:00 PM - 6:00 AM hives spread from arm across chest, neck, back. 12/21/2012 6:00 AM -2:00 PM hives, nausea, chills; 2:00 PM - 11:00 AM. 12/22/2012 hives have gone down, still itch, nausea, vomiting, chills accompanied by slight fever, headache, dull ache in legs, arms, neck, and back, fatigue, dizziness. Spoke to nurse advice line, was told if lymph nodes become swollen to visit ER. No sign of swollen glands as of yet. Aspirin taken as needed.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Headache, dizziness and weakness.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: PATIENT REPORTED FEELING DIZZINESS AFTER VACCINATION.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Mass, Nausea, Pain
Clinical narrative: Redness, swelling, itching 40 minute intense itching and then went down hand, finally subsided, still hard, painful and 2 inch lump and hot to touch.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product taste abnormal, Skin warm, Swelling
Clinical narrative: Redness, swelling, itching 40 minute intense itching and then went down hand, finally subsided, still hard, painful and 2 inch lump and hot to touch.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: High fever uncontrollable chills, vomiting, aches in arms and legs, headache dizziness and sleepy for 15 hours.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Somnolence, Vomiting
Clinical narrative: High fever uncontrollable chills, vomiting, aches in arms and legs, headache dizziness and sleepy for 15 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: Pain in upper arm, but no swelling or heat at site of injection.  Some tingling in fingers of left hand. Shot was given in very upper right arm, very close to shoulder.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Pyrexia, Wheezing
Clinical narrative: Barky cough, wheezing, fever, hoarseness - gave 3 puffs of Albuterol inhaler to settle the cough and wheezing.  Tried to give Nyquil for cough and fever but the strong cough prevented it from staying down.  We are on the third day after and the cough persists.  The fevers lasted 2 days.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Oral pruritus
Clinical narrative: Patient experienced itching in mouth and lips. He had already taken two 25 mg BENADRYL and 10 ml BENADRYL Elixir before returning to pharmacy.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Drug label confusion, No adverse event
Clinical narrative: This spontaneous report was received from an Office Administrator. The reporter stated that MMR II and (Merck) PROQUAD boxes look too much alike and may cause confusion. There was no note of any patient involvement. No adverse effect reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, warmth at injection site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site abscess, Injection site joint swelling, Pain in extremity, Pyrexia
Clinical narrative: This sponatenous report as received from a consumer refers to her mother, a 69 years old female patient with high cholesterol and amoxicillin and ampicillin allergy. The patient was vaccinated in the left arm with dose 1 of PNEUMOVAX23 (lot number unspecified) on 26-JUN-2012. On 17-DEC-2012 the patient was vaccinated in the left arm with a second dose of PNEUMOVAX (lot number unspecified). Route was not reported. No other co-suspects were reported. Concomitant medications included: CRESTOR. The patient was vaccinated with 2 doses of PNEUMOVAX 23 with in 6 months time. After the first dose the patient had no adverse event. Post vaccination of the second dose on 17-DEC-2012, the patient went home and developed soreness, 3 inch diameter circumference around the left arm, and swelling down to the left elbow, and fever of 100.5. The reporter called her mother's physician on 18-DEC-2012 and TYLENOL and cold compress for left arm were recommended. The patient did not take the TYLENOL. The patient was seen by the doctor and as told that she may have an abscess at the injection site. The physician recommended ciprofloxacin, but the reporter stated she does not think her mother should take the medicine, as she does not need it. The reporter stated that her mother's left arm still hurt, the swelling was going down, but it looked like she was getting better. The reporter did not provided a causality assessment. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date the patient might have received less than a full dose of ZOSTAVAX (lot# not reported) due to excessive foaming of the vaccine following reconstitution, and dues to leaking of the vaccine vial during withdrawal of the vaccine. No adverse effect was reported. It was unknown if the patient sought medical attention. The outcome of adverse events was unknown. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Sleep disorder
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to an approximately 86-year-old female patient with no drug reaction/allergies. Current conditions included diabetes, breast cancer and high cholesterol. The patient's history included heart failure. On 05-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H01258, expiration date 09-OCT-2013 and route not reported) Concomitant medications included atorvastatin, spironolactone, carvedilol phosphate (COREG CR), warfin, furosemide, anastrozole, alendronate sodium (manufacturer unknown), glyburide, APIDRA, levothyroxine sodium and losartan potassium (manufacturer unknown). Approximately on an unknown date in December 2012, patient developed a large red flat area at the injection site after vaccination with ZOSTAVAX. The area also itched and the itching kept her up at night. The area was slightly bigger than half dollar coin. an unspecified cream was given as a treatment for the events. The patient sought medical attention by contacting the pharmacist. At the time of the report the events did not resolve. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Computerised tomogram, Diet refusal, Fall
Clinical narrative: This spontaneous report was received from a consumer refers to a 87-year-old female patient. Current conditions included colitis, anemia, low blood cells and allergy to penicillin. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Concomitant medications included ASACOL, chlordiazepoxided, clidinium bromide and prednisone. The consumer stated that his wife (patient) was administered ZOSTAVAX and on 09-DEC-2012 had extreme weakness, trouble walking, a fever of 103 degrees, her legs and neck hurt and she won't eat. the consumer also indicated that the patient fell. treatment was given for the events, intravenous (IV) at the emergency room. lab tests were performed on 09-DEC-2012. Blood work, X-rays, catscan and urine test were done, results were unknown. The events did not resolve at the time of this report. The patient sought medical attention for the events, Emergency room visit not overnight. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Neck pain, Pain in extremity, Pyrexia, Urine analysis
Clinical narrative: This spontaneous report was received from a consumer refers to a 87-year-old female patient. Current conditions included colitis, anemia, low blood cells and allergy to penicillin. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Concomitant medications included ASACOL, chlordiazepoxided, clidinium bromide and prednisone. The consumer stated that his wife (patient) was administered ZOSTAVAX and on 09-DEC-2012 had extreme weakness, trouble walking, a fever of 103 degrees, her legs and neck hurt and she won't eat. the consumer also indicated that the patient fell. treatment was given for the events, intravenous (IV) at the emergency room. lab tests were performed on 09-DEC-2012. Blood work, X-rays, catscan and urine test were done, results were unknown. The events did not resolve at the time of this report. The patient sought medical attention for the events, Emergency room visit not overnight. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a consumer refers to a 87-year-old female patient. Current conditions included colitis, anemia, low blood cells and allergy to penicillin. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Concomitant medications included ASACOL, chlordiazepoxided, clidinium bromide and prednisone. The consumer stated that his wife (patient) was administered ZOSTAVAX and on 09-DEC-2012 had extreme weakness, trouble walking, a fever of 103 degrees, her legs and neck hurt and she won't eat. the consumer also indicated that the patient fell. treatment was given for the events, intravenous (IV) at the emergency room. lab tests were performed on 09-DEC-2012. Blood work, X-rays, catscan and urine test were done, results were unknown. The events did not resolve at the time of this report. The patient sought medical attention for the events, Emergency room visit not overnight. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Headache, Myalgia, Rhinorrhoea
Clinical narrative: Lightheadedness, runny nose, muscle aches, headache, cough.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal discomfort, Asthenia, Blood test normal, Computerised tomogram, Computerised tomogram normal
Clinical narrative: Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Condition aggravated, Crying, Depressed level of consciousness, Diarrhoea, Diet refusal
Clinical narrative: Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Fatigue, Hypotonia, Intensive care, Irritability, Laboratory test
Clinical narrative: Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Pallor, Scan brain, Somnolence, Staring
Clinical narrative: Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Ultrasound scan normal, Unresponsive to stimuli, Vaccination complication
Clinical narrative: Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Erythema, Induration, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Red, hard itchy blisters appeared on hands and feet. Hives on arms, trunk and legs.  Unable to lift arm that received injection above head due to pain; one week later muscle weakness and twitching in left deltoid where injection was received.  Red, hot, round, itchy rash appeared around injection site, approximately 4 inches across.  The area later peeled like a sunburn.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site exfoliation, Injection site pruritus, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Red, hard itchy blisters appeared on hands and feet. Hives on arms, trunk and legs.  Unable to lift arm that received injection above head due to pain; one week later muscle weakness and twitching in left deltoid where injection was received.  Red, hot, round, itchy rash appeared around injection site, approximately 4 inches across.  The area later peeled like a sunburn.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle twitching, Muscular weakness, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Red, hard itchy blisters appeared on hands and feet. Hives on arms, trunk and legs.  Unable to lift arm that received injection above head due to pain; one week later muscle weakness and twitching in left deltoid where injection was received.  Red, hot, round, itchy rash appeared around injection site, approximately 4 inches across.  The area later peeled like a sunburn.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Erythema, Hypersensitivity, Irritability, Lethargy
Clinical narrative: Started as a low grade fever, sluggish and lethargic after waking from afternoon nap-gave Motrin and he seemed much better. Then, during his bath 8:00 PM that evening, we noticed red circles about half in I diameter on his torso. They blanched when touched and were not raised but rather flush with his skin. Called dr; he said could be viral, allergic reaction or combination. No fever at this time. Recommended Benadryl. Did not have any, and child did not seem bothered, so we chose not to give meds. Next morning, 12/21/2011, tons more spots and they've changed in appearance. Some are still small red dots, se have tripled in size and joined together. Child again lethargic and clingy unlike himself. Gave Benadryl. He soon fell asleep. When he woke, he was still whiny and cranky. Gave Motrin and soon was playing and acting normal. Next morning, 12/22/2012, child covered in spots head to toe. Child very irritated and itchy now. Spots on back of head and neck and ears are bothersome to child. Ears dark red. Many of the spots on sides and underarm are raised and look like welts. They also appear to be more of a red raised ring instead of the whole spot being red as they had started. Chose to go to ER. Diagnosed with allergic reaction probably to vaccine.  Ran fever again through that night. Ongoing as this reaction is still active in my son.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Pyrexia, Rash erythematous, Rash generalised, Sluggishness
Clinical narrative: Started as a low grade fever, sluggish and lethargic after waking from afternoon nap-gave Motrin and he seemed much better. Then, during his bath 8:00 PM that evening, we noticed red circles about half in I diameter on his torso. They blanched when touched and were not raised but rather flush with his skin. Called dr; he said could be viral, allergic reaction or combination. No fever at this time. Recommended Benadryl. Did not have any, and child did not seem bothered, so we chose not to give meds. Next morning, 12/21/2011, tons more spots and they've changed in appearance. Some are still small red dots, se have tripled in size and joined together. Child again lethargic and clingy unlike himself. Gave Benadryl. He soon fell asleep. When he woke, he was still whiny and cranky. Gave Motrin and soon was playing and acting normal. Next morning, 12/22/2012, child covered in spots head to toe. Child very irritated and itchy now. Spots on back of head and neck and ears are bothersome to child. Ears dark red. Many of the spots on sides and underarm are raised and look like welts. They also appear to be more of a red raised ring instead of the whole spot being red as they had started. Chose to go to ER. Diagnosed with allergic reaction probably to vaccine.  Ran fever again through that night. Ongoing as this reaction is still active in my son.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Started as a low grade fever, sluggish and lethargic after waking from afternoon nap-gave Motrin and he seemed much better. Then, during his bath 8:00 PM that evening, we noticed red circles about half in I diameter on his torso. They blanched when touched and were not raised but rather flush with his skin. Called dr; he said could be viral, allergic reaction or combination. No fever at this time. Recommended Benadryl. Did not have any, and child did not seem bothered, so we chose not to give meds. Next morning, 12/21/2011, tons more spots and they've changed in appearance. Some are still small red dots, se have tripled in size and joined together. Child again lethargic and clingy unlike himself. Gave Benadryl. He soon fell asleep. When he woke, he was still whiny and cranky. Gave Motrin and soon was playing and acting normal. Next morning, 12/22/2012, child covered in spots head to toe. Child very irritated and itchy now. Spots on back of head and neck and ears are bothersome to child. Ears dark red. Many of the spots on sides and underarm are raised and look like welts. They also appear to be more of a red raised ring instead of the whole spot being red as they had started. Chose to go to ER. Diagnosed with allergic reaction probably to vaccine.  Ran fever again through that night. Ongoing as this reaction is still active in my son.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Cough, Discomfort, Eye pain
Clinical narrative: I am only providing this information to help HHS help other citizens who receive the vaccine. I am slowly recovering from the following: 1. Extreme tiredness-sleep 12-14 hours or more 2. Dry infrequent cough 3. Increased upper respiratory secretions 4. Sneezing 5. Chills 6. Muscle and joint aches 7. Injection site tenderness 8. Stuffy nose 9. Very uncomfortable frontal headache 10. It is painful to open my eyes 11. Neck ache
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hypersomnia, Increased upper airway secretion, Injection site pain
Clinical narrative: I am only providing this information to help HHS help other citizens who receive the vaccine. I am slowly recovering from the following: 1. Extreme tiredness-sleep 12-14 hours or more 2. Dry infrequent cough 3. Increased upper respiratory secretions 4. Sneezing 5. Chills 6. Muscle and joint aches 7. Injection site tenderness 8. Stuffy nose 9. Very uncomfortable frontal headache 10. It is painful to open my eyes 11. Neck ache
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nasal congestion, Neck pain, Sneezing
Clinical narrative: I am only providing this information to help HHS help other citizens who receive the vaccine. I am slowly recovering from the following: 1. Extreme tiredness-sleep 12-14 hours or more 2. Dry infrequent cough 3. Increased upper respiratory secretions 4. Sneezing 5. Chills 6. Muscle and joint aches 7. Injection site tenderness 8. Stuffy nose 9. Very uncomfortable frontal headache 10. It is painful to open my eyes 11. Neck ache
Age: 1.69
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever (101.5), and rapid heart rate (180 bpm).
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: 4 days after immunizations, patient developed fever, chills, swelling of the arm, & muscle aches. Was seen in the hospital and was treated for cellulitis.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 years old female patient. On 02-OCT-2012 the patient was vaccinated with dose 1 GARDASIL and on 13-DEC-2012 the patient was vaccinated with dose 2 GARDASIL intramuscular in her right arm. "Lot not reported as H014231, expiry date 21-NOV-2014, not valid for the product). No other co-suspects were reported. Concomitant medication included unspecified birth control pill. Five minutes after vaccination, the medical assistant noticed swelling at the injection site. The patient told her that the injection site was hot and burning. She then had tingling through her whole injection arm including her hand and wrist. About 15 minutes after vaccination, the hand felt better except for her little finger on her right hand. Ice was used as treatment. The outcome of the events was reported as recovering/resolving. The relatedness for the events is unknown for GARDASIL. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a physician refers to her 15 months old female baby. The physician stated that her baby had been administered an additional dose of M-M-R II (Lot#, dose/frequency, route unspecified) and PROQUAD (Merck) (Lot#, dose/frequency, route unspecified) accidentally on 11-DEC-2012. Other suspect therapies included PROQUAD (Merck) on 11-DEC-2012. The patient did not seek medical attention. No treatment was given for the event. The outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received from pharmacist considering a 61 year old patient of unknown gender, who on 11-OCT-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-Sept-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005680, 1212USA005679, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Extreme pain when injection administered. Arm and shoulder pain noticed next morning. Progressively worse each day. Pain and range of motion issues. Physical therapy and pain rx provided no relief. MRI shows tear in bursa lining, per Dr.
Age: 50.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Bursa injury, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Extreme pain when injection administered. Arm and shoulder pain noticed next morning. Progressively worse each day. Pain and range of motion issues. Physical therapy and pain rx provided no relief. MRI shows tear in bursa lining, per Dr.
Age: 50.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, X-ray
Clinical narrative: Extreme pain when injection administered. Arm and shoulder pain noticed next morning. Progressively worse each day. Pain and range of motion issues. Physical therapy and pain rx provided no relief. MRI shows tear in bursa lining, per Dr.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: See original online report for full details.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Irritability, Nausea, Pain, Pyrexia
Clinical narrative: See original online report for full details.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: See original online report for full details.
Age: 65.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haemorrhage, Infection, Pruritus, Scar
Clinical narrative: Scar seemed to become infected & kept getting larger. Now approx. 3" x 4". This is 17 yrs after it started.
Age: 65.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Scar, Skin infection
Clinical narrative: Scar seemed to become infected & kept getting larger. Now approx. 3" x 4". This is 17 yrs after it started.
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Arthralgia, Gait disturbance, Henoch-Schonlein purpura, Joint swelling, Oedema peripheral
Clinical narrative: Case number PHHY2012US117700 is an initial spontaneous report received from a pharmacist on 13 Dec 2012: This report refers to a 9-year-old male patient. He was vaccinated with the third dose of RABAVERT on 14 Apr 2012 following which she experienced fever (see related case: PHEH2012US024846). He was further on vaccinated with the fourth dose of RABAVERT (batch number: 473011C) intramuscularly on 24 Apr 2012 (the fourth dose was postponed due to the reaction after the third injection).  24 hours after the vaccination, he reported pain in joints and knees. Swelling developed in his feet and knees on 27 Apr 2012 (which the reporter initially thought was because of soccer). On 28 Apr 2012, swelling spread to the elbows. The swelling became so severe that he was unable to walk. On 29 Apr 2012,  he was brought to the emergency room with a rash of small dots on his legs and he was then diagnosed with Henoch-Schonlein purpura.  The child was doing well at the time of this report. However final outcome of the events was reported as unknown. No further information about seriousness and causality was provided.
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Case number PHHY2012US117700 is an initial spontaneous report received from a pharmacist on 13 Dec 2012: This report refers to a 9-year-old male patient. He was vaccinated with the third dose of RABAVERT on 14 Apr 2012 following which she experienced fever (see related case: PHEH2012US024846). He was further on vaccinated with the fourth dose of RABAVERT (batch number: 473011C) intramuscularly on 24 Apr 2012 (the fourth dose was postponed due to the reaction after the third injection).  24 hours after the vaccination, he reported pain in joints and knees. Swelling developed in his feet and knees on 27 Apr 2012 (which the reporter initially thought was because of soccer). On 28 Apr 2012, swelling spread to the elbows. The swelling became so severe that he was unable to walk. On 29 Apr 2012,  he was brought to the emergency room with a rash of small dots on his legs and he was then diagnosed with Henoch-Schonlein purpura.  The child was doing well at the time of this report. However final outcome of the events was reported as unknown. No further information about seriousness and causality was provided.
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abasia, Arthralgia, Henoch-Schonlein purpura, Joint swelling, Oedema peripheral
Clinical narrative: Case number PHHY2012US117700 is an initial spontaneous report received from a pharmacist on 13 Dec 2012: This report refers to a 9-year-old male patient. He was vaccinated with the third dose of RABAVERT on 14 Apr 2012 following which she experienced fever (see related case: PHEH2012US024846). He was further on vaccinated with the fourth dose of RABAVERT (batch number: 473011C) intramuscularly on 24 Apr 2012 (the fourth dose was postponed due to the reaction after the third injection).  24 hours after the vaccination, he reported pain in joints and knees. Swelling developed in his feet and knees on 27 Apr 2012 (which the reporter initially thought was because of soccer). On 28 Apr 2012, swelling spread to the elbows. The swelling became so severe that he was unable to walk. On 29 Apr 2012,  he was brought to the emergency room with a rash of small dots on his legs and he was then diagnosed with Henoch-Schonlein purpura.  The child was doing well at the time of this report. However final outcome of the events was reported as unknown. No further information about seriousness and causality was provided.