chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral (dose and frequency were not reported). No adverse events were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 60 year old female patient. On 28-JUL-2014 the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX 1 single shot, lot # J000783 (expiration date 30-APR-2014) no adverse effects were reported. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash
Clinical narrative: Patient received routine, CDC recommended, vaccines for 12 month old child. Immediately after injections, a red flat rash developed at each injection site. BENADRYL given. Pt observed. Discharge condition.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: Severe allergic reaction after receiving immunizations. Presented with swelling of lips. Hives on face, arms and chest. Administered 50 mg BENADRYL, 0.3 mg epipen. 911 called pt transported for observation to hospital.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age reporting of himself. Pertinent medical history, drug reactions or allergies were not reported. On 05-MAY-2014, the patient was vaccinated with RECOMBIVAX HB dose 1 (route and lot # were not reported). On 05-AUG-2014, the patient was vaccinated with RECOMBIVAX HB dose 2 (route and lot # were not reported). The patient stated that this was outside the dosing schedule. No side effects reported. Additional information is not expected because the reporter details were not provided.
Age: 1.02
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling/redness/induration 12 x 6 cm at left thigh - PREVNAR site. No sig. pain, no fever; will treat with cephalexin course.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Varicella vaccine given IM instead of SQ. No adverse event.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Passed out.
Age: 1.1
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site erythema, Injection site inflammation, Injection site urticaria
Clinical narrative: Large hive at site 20 min later 3" dia area red, inflamed.
Age: 1.1
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site urticaria
Clinical narrative: Large hive at site 20 min later 3" dia area red, inflamed.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Bump and rash on arms in area of shot.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right upper arm with well circumscribed area of induration, mild erythema and warmth, tense, tender to palpation.
Age: 35.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 35 year old patient (gender unknown). Pertinent medical history, drug reactions or allergies were not reported. On 28-JUL-2014, the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous (lot # was not reported). On 05-AUG-2014, the patient was inadvertently administered another dose of VARIVAX, (dose, route and lot # were not reported). No adverse effects reported. Additional information is not expected because the reporter refused further follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pruritus, Rash generalised
Clinical narrative: Per nurse practitioner ar dr office called re informed about this incident: Patient developed rash all over the body-sides right after the vaccination. No blisters. Itching is there. She is going to give him BENADRYL and SOLUMEDROL xfer him to primary care.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unkonwn age who was a nurse in his office. On an unknown date the patient completed 3-dose HepB (manufacturer unknown) 10 MCG/ML series (lot#, frequency and route unspecified) on unspecified dates in the past but when she was tested for Hepatitis B antibody titer, result was negative. The patient received another series of 3-dose HepB (manufacturer unknown) 10 MCG/ML series (lot#, frequency and route unspecified) on unspecified dates and second titer for Hepatitis B antibody was done but her result was yet again negative. The patient sought medical attention and no treatment was given for the events. Physician could not confirm that Hepatitis B series nurse received was RECOMBIVAX HB. The outcome of the events was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 28 year old female patient. On 23-MAY-2014 the patient was vaccinated with VARIVAX (dose 1, subcutaneous, dosage and lot number unknown) for she has no titer. On 18-JUL-2014 the patient was vaccinated with VARIVAX (dose 2, subcutaneous, dosage and lot number unknown) for she had no titer. The patient reported that she was one month pregnant with LMP of 02-JUL-2014 and EDD of 08-APR-2015. Initial exposure to VARIVAX was at 2 week(s). The pregnancy outcome was outcome pending. The patient did not seek medical attention and did not receive treatment. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three unspecified patients of unknown age. On 04-AUG-2014 the three patient was inadvertently vaccinated with expired doses of RECOMBIVAX HB intramuscular. Lot# was 1741AA, and the vaccine was expired on 27-JUN-2014. No adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse refers to a 20 year old female patient. Patient medical history was not reported. On 04-AUG-2014 the patient who was 34 weeks pregnant was inadvertently vaccinated with GARDASIL (strength, dose number, frequency, route, lot number and expiry date unknown) instead of BOOSTRIX. No concomitant medications were reported. The patient became pregnant with last menstrual period (LMP) of 09-DEC-2013 and estimated delivery date (EDD) of 15-SEP-2014. Patients date of conception was on 23-DEC-2013. Initial exposure of GARDASIL was at 34 week(s). The pregnancy outcome was outcome pending. No adverse effect was reported. The outcome of 34 weeks pregnant, was inadvertently administered a dose of GARDASIL instead of BOOSTRIX and no adverse effect was unknown. No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 31-JUL-2014 the patient was administered with an expired dose of M-M-R II HSA (dose, route not reported), lot # H013042, expiration date 17-JUL-2014 (reported as 15-JUL-2014). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. None drug reactions or allergies reported. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX lot # K007177, expiry date: 21-AUG-2015, single dose, subcutaneous in the left arm. Concomitant therapies included aspirin. On 03-AUG-2014, the patient experienced a sore, hard knot at the injection site. The knot was initially the "size of the bottom of a glass", but was now getting smaller and less sore. No treatment was given. The patient sought medical attention by calling the pharmacy. None lab studies were performed. The patient present status was reported as recovering. Causality was not reported. Additional information is not expected because the reporter refused further follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient. In 2009 the patient was vaccinated with ZOSTAVAX, (route and dose unknown). On 11-JUL-2014 the patient was diagnosed with shingles after receiving ZOSTAVAX. The outcome of shingles was reported as recovered/resolved on an unknown date. The patient was treated with unspecified treatment. The patient sought medical attention by an office visit on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. On an unknown date unspecified patients were vaccinated with several doses (reported as about 4 doses) of improperly stored VARIVAX (Merck) (0.5 ml, lot# was unknown) subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with VAQTA (lot#, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster
Clinical narrative: This spontaneous report was received from other health professional refers to a 76 year old female patient. Patient's concurrent conditions included hypertension, hyperlipidemia, diabetes and asthma. On 29-JAN-2009, the patient was vaccinated with ZOSTAVAX, 0.65 ml in the right upper arm (lot # reported as 1561X; expiration date; 28-APR-2010). Concomitant therapies included Gabapentin (manufacturer unknown), FLOVENT, Diltiazem hydrochloride, Lovastatin (manufacturer unknown), Metformin (manufacturer unknown), Duloxetine hydrochloride (manufacturer unknown), Montelukast sodium (manufacturer unknown) and Oxybutynin (manufacturer unknown). On 29-JUL-2014 (reported as "a week ago"), the patient experienced pain in her left flank "a week ago" and the patient consulted a physician and she was diagnosed with shingles on an unspecified date in 2014. The physician ordered for her "maintenance dose" of Gabapentin to be increased and he also prescribed Valacyclovir for her. On an unspecified date, the patient sought medical attention. No lab diagnostics studies were performed. The outcome of experienced pain in her left flank "a week ago" and she was diagnosed with shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report as received via a website from a 14 year old (currently 20 y.o.) patient refers to herself. In approximately 2008 (reported as "at 14 years old"), the patient was supposed to received the 3-series GARDASIL that was recommended to her by her doctor but she was vaccinated with two doses of GARDASIL (dose, route of administration, indication, lot# and expiry date unspecified). Therapy with GARDASIL was discontinued after her second dose. No concomitant medications were reported. In approximately 2008 (reported as "it was the next night"), the patient started having symptoms immediately: she had bad pain in her hips, and her legs, in her pelvic and in her back. She stated it was only the start to a very painful next 6 years and the Human Papilloma Virus, HPV vaccination ruined her life. The patient went through extreme fatigue, she slept 20 out of 24 hours a day. She had probably 10 different kinds of rashes. She had joint pain probably every single day and it was very stressful for her because nobody knew how to fix her. She couldn't do anything normal 20-years old wanted to do. She was wearing a back brace and leg braces. Even getting up in the morning was a struggle for her. After medically withdrawing from college, she said her friendships and relationships started to crumble. She wasn't able to hang out with friends, and she started to feel like it was her fault. She was put on several different medicines all through high school. She said she would go to see the doctors, but no one could figure out what was wrong with her. Other doctors didn't even try to help her, instead they told her it was all in her head, but she knew it wasn't. The outcome of all the events was unknown. She said she started researching her symptoms and they all started to line up with side effects from the GARDASIL she received in 8th grade. The patient reported she was never warned about these possible side effects. She wanted to warn out others about her adverse reaction to the vaccine because she was never warned. The reporter considered those events to be related to GARDASIL. This case is serious as the aforementioned events caused disability of patient. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Incomplete course of vaccination, Orthosis user, Pain in extremity, Pelvic pain
Clinical narrative: This spontaneous report as received via a website from a 14 year old (currently 20 y.o.) patient refers to herself. In approximately 2008 (reported as "at 14 years old"), the patient was supposed to received the 3-series GARDASIL that was recommended to her by her doctor but she was vaccinated with two doses of GARDASIL (dose, route of administration, indication, lot# and expiry date unspecified). Therapy with GARDASIL was discontinued after her second dose. No concomitant medications were reported. In approximately 2008 (reported as "it was the next night"), the patient started having symptoms immediately: she had bad pain in her hips, and her legs, in her pelvic and in her back. She stated it was only the start to a very painful next 6 years and the Human Papilloma Virus, HPV vaccination ruined her life. The patient went through extreme fatigue, she slept 20 out of 24 hours a day. She had probably 10 different kinds of rashes. She had joint pain probably every single day and it was very stressful for her because nobody knew how to fix her. She couldn't do anything normal 20-years old wanted to do. She was wearing a back brace and leg braces. Even getting up in the morning was a struggle for her. After medically withdrawing from college, she said her friendships and relationships started to crumble. She wasn't able to hang out with friends, and she started to feel like it was her fault. She was put on several different medicines all through high school. She said she would go to see the doctors, but no one could figure out what was wrong with her. Other doctors didn't even try to help her, instead they told her it was all in her head, but she knew it wasn't. The outcome of all the events was unknown. She said she started researching her symptoms and they all started to line up with side effects from the GARDASIL she received in 8th grade. The patient reported she was never warned about these possible side effects. She wanted to warn out others about her adverse reaction to the vaccine because she was never warned. The reporter considered those events to be related to GARDASIL. This case is serious as the aforementioned events caused disability of patient. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Social problem, Stress
Clinical narrative: This spontaneous report as received via a website from a 14 year old (currently 20 y.o.) patient refers to herself. In approximately 2008 (reported as "at 14 years old"), the patient was supposed to received the 3-series GARDASIL that was recommended to her by her doctor but she was vaccinated with two doses of GARDASIL (dose, route of administration, indication, lot# and expiry date unspecified). Therapy with GARDASIL was discontinued after her second dose. No concomitant medications were reported. In approximately 2008 (reported as "it was the next night"), the patient started having symptoms immediately: she had bad pain in her hips, and her legs, in her pelvic and in her back. She stated it was only the start to a very painful next 6 years and the Human Papilloma Virus, HPV vaccination ruined her life. The patient went through extreme fatigue, she slept 20 out of 24 hours a day. She had probably 10 different kinds of rashes. She had joint pain probably every single day and it was very stressful for her because nobody knew how to fix her. She couldn't do anything normal 20-years old wanted to do. She was wearing a back brace and leg braces. Even getting up in the morning was a struggle for her. After medically withdrawing from college, she said her friendships and relationships started to crumble. She wasn't able to hang out with friends, and she started to feel like it was her fault. She was put on several different medicines all through high school. She said she would go to see the doctors, but no one could figure out what was wrong with her. Other doctors didn't even try to help her, instead they told her it was all in her head, but she knew it wasn't. The outcome of all the events was unknown. She said she started researching her symptoms and they all started to line up with side effects from the GARDASIL she received in 8th grade. The patient reported she was never warned about these possible side effects. She wanted to warn out others about her adverse reaction to the vaccine because she was never warned. The reporter considered those events to be related to GARDASIL. This case is serious as the aforementioned events caused disability of patient. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Inflammation, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Vaccine administered in January 2014. Left shoulder pain within 24 hours and never went away then pain progressed to legs and feet.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: Vaccine administered in January 2014. Left shoulder pain within 24 hours and never went away then pain progressed to legs and feet.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Cystitis, Death, Dysstasia, Wheelchair user
Clinical narrative: Case number PHHY2014US081208, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 529028) received on 01 Jul 2014, and with a follow-up information received from Quality Assurance Department (reference number: 310063) on 30 Jul 2014. This report refers to a 70 year old female patient. Her medical history included diabetes and congestive heart failure. Concomitant medications included Insulin; COLCRYS; ULORIC; Carvedilol; Bumetanide; NEURONTIN; Clopidogrel; Losartan and Tramadol. She was vaccinated with FLUVIRIN (batch number: 1203901, expiry date: 31 May 2013) intramuscular into left arm on 23 Jan 2013. The next day on 24 Jan 2013, she could not walk and stand. She went to the hospital and was told about bladder infection. She never walked again and was in hospital 7 times in 12 months. She was in a wheelchair until her death on 02 Jan 2014. The cause of death was not reported. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1203901) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 310063) on 02 Jul 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 310063) on 30 Jul 2014: Updated batch review report.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Cystitis, Death, Dysstasia
Clinical narrative: Case number PHHY2014US081208, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 529028) received on 01 Jul 2014, and with a follow-up information received from Quality Assurance Department (reference number: 310063) on 30 Jul 2014. This report refers to a 70 year old female patient. Her medical history included diabetes and congestive heart failure. Concomitant medications included Insulin; COLCRYS; ULORIC; Carvedilol; Bumetanide; NEURONTIN; Clopidogrel; Losartan and Tramadol. She was vaccinated with FLUVIRIN (batch number: 1203901, expiry date: 31 May 2013) intramuscular into left arm on 23 Jan 2013. The next day on 24 Jan 2013, she could not walk and stand. She went to the hospital and was told about bladder infection. She never walked again and was in hospital 7 times in 12 months. She was in a wheelchair until her death on 02 Jan 2014. The cause of death was not reported. Causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1203901) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from Quality Assurance Department (reference number: 310063) on 02 Jul 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 310063) on 30 Jul 2014: Updated batch review report.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. Follow up information has been received from the certified medical assistant. The CMA stated that she did not have additional information at this time. She would provide additional information when available. Follow up information was received from medical assistant refers to a 5 year old female patient. No concurrent conditions or medical were provided. On 15-MAY-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injected in the right arm (lot# J001176, expiry date: 31-JAN-2015; dose, route of administration and indication unspecified), that was stored outside of the temperature ranges. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because all correspondence has been received.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. Follow up information has been received from the certified medical assistant. The CMA stated that she did not have additional information at this time. She would provide additional information when available. Follow up information was received from medical assistant refers to a 5 year old female patient. No concurrent conditions or medical were provided. On 15-MAY-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injected in the right arm (lot# J001176, expiry date: 31-JAN-2015; dose, route of administration and indication unspecified), that was stored outside of the temperature ranges. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because all correspondence has been received.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Swelling, chest pain, No SOB, red, itchy.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Erythema, Pruritus, Swelling
Clinical narrative: Swelling, chest pain, No SOB, red, itchy.
Age: 2.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Developed fever 5 hours after shots.  Fever on 7/31/14 to 102.  Rash on 8/1/14.
Age: 2.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: Developed fever 5 hours after getting immunizations.  Febrile seizure on 7/30/14.  Seen at Emergency Department.  Developed rash on 8/1/14.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Pt developed uticaria, and macular erythematous rash to R arm and across anterior/posterior thorax. Denies pruritis or other symptomology.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Rash papular
Clinical narrative: Tender papular-vesicular rash on bilat fingers and toe.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Tremor
Clinical narrative: After patient received immunization with Gardasil, the patient began to shake and passed out for about 10 seconds.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test normal, Borrelia test, Colonoscopy normal
Clinical narrative: 10/7/13: Patient received the FLUMIST vaccination at her school. By 7:00 PM, patient complained of a headache and went to sleep. 10/8/13: She began complaining that she still had headache, now followed by stomach pain. 10/9/13: She was sent home from school due to headache, dizziness, and stomach pain. My daughter did not return to school until January 2014. Visited ER 10/12 for symptoms and was told that it was FLUMIST side effects and that they should go away. Was told to take laxatives (probably MIRALAX) to help with stomach. The problem did not go away. She had numerous trips to her family doctor and to the ER for her symptoms. X-rays showed mild to moderate constipation but blood work showed nothing. She was told to take more laxatives, have more enemas, etc. to help. Patient began having difficulty speaking and eating. At the end of October, she saw a GI physician. Right off the bat, this doctor diagnosed it as a reaction to the FLUMIST based on dates of illness and side effects. She attempted two clean out methods for patient. My daughter now had enough MIRALAX and laxatives in her to kill a horse. The problem was still not solved. Patient was admitted to hospital on November 7 and was there until November 12. They used an NG tube to clean her out, and she had an endoscopy, colonoscopy, and stomach ultrasound. No results popped from these tests. She also saw a neurologist for the headaches. She passed the basic neurological exam.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Constipation, Dizziness, Eating disorder, Electrocardiogram, Endoscopy normal
Clinical narrative: 10/7/13: Patient received the FLUMIST vaccination at her school. By 7:00 PM, patient complained of a headache and went to sleep. 10/8/13: She began complaining that she still had headache, now followed by stomach pain. 10/9/13: She was sent home from school due to headache, dizziness, and stomach pain. My daughter did not return to school until January 2014. Visited ER 10/12 for symptoms and was told that it was FLUMIST side effects and that they should go away. Was told to take laxatives (probably MIRALAX) to help with stomach. The problem did not go away. She had numerous trips to her family doctor and to the ER for her symptoms. X-rays showed mild to moderate constipation but blood work showed nothing. She was told to take more laxatives, have more enemas, etc. to help. Patient began having difficulty speaking and eating. At the end of October, she saw a GI physician. Right off the bat, this doctor diagnosed it as a reaction to the FLUMIST based on dates of illness and side effects. She attempted two clean out methods for patient. My daughter now had enough MIRALAX and laxatives in her to kill a horse. The problem was still not solved. Patient was admitted to hospital on November 7 and was there until November 12. They used an NG tube to clean her out, and she had an endoscopy, colonoscopy, and stomach ultrasound. No results popped from these tests. She also saw a neurologist for the headaches. She passed the basic neurological exam.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Gastrointestinal tube insertion, Headache, Neurological examination normal, Nuclear magnetic resonance imaging brain, Speech disorder
Clinical narrative: 10/7/13: Patient received the FLUMIST vaccination at her school. By 7:00 PM, patient complained of a headache and went to sleep. 10/8/13: She began complaining that she still had headache, now followed by stomach pain. 10/9/13: She was sent home from school due to headache, dizziness, and stomach pain. My daughter did not return to school until January 2014. Visited ER 10/12 for symptoms and was told that it was FLUMIST side effects and that they should go away. Was told to take laxatives (probably MIRALAX) to help with stomach. The problem did not go away. She had numerous trips to her family doctor and to the ER for her symptoms. X-rays showed mild to moderate constipation but blood work showed nothing. She was told to take more laxatives, have more enemas, etc. to help. Patient began having difficulty speaking and eating. At the end of October, she saw a GI physician. Right off the bat, this doctor diagnosed it as a reaction to the FLUMIST based on dates of illness and side effects. She attempted two clean out methods for patient. My daughter now had enough MIRALAX and laxatives in her to kill a horse. The problem was still not solved. Patient was admitted to hospital on November 7 and was there until November 12. They used an NG tube to clean her out, and she had an endoscopy, colonoscopy, and stomach ultrasound. No results popped from these tests. She also saw a neurologist for the headaches. She passed the basic neurological exam.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Ultrasound abdomen normal, Vaccination complication, X-ray abnormal
Clinical narrative: 10/7/13: Patient received the FLUMIST vaccination at her school. By 7:00 PM, patient complained of a headache and went to sleep. 10/8/13: She began complaining that she still had headache, now followed by stomach pain. 10/9/13: She was sent home from school due to headache, dizziness, and stomach pain. My daughter did not return to school until January 2014. Visited ER 10/12 for symptoms and was told that it was FLUMIST side effects and that they should go away. Was told to take laxatives (probably MIRALAX) to help with stomach. The problem did not go away. She had numerous trips to her family doctor and to the ER for her symptoms. X-rays showed mild to moderate constipation but blood work showed nothing. She was told to take more laxatives, have more enemas, etc. to help. Patient began having difficulty speaking and eating. At the end of October, she saw a GI physician. Right off the bat, this doctor diagnosed it as a reaction to the FLUMIST based on dates of illness and side effects. She attempted two clean out methods for patient. My daughter now had enough MIRALAX and laxatives in her to kill a horse. The problem was still not solved. Patient was admitted to hospital on November 7 and was there until November 12. They used an NG tube to clean her out, and she had an endoscopy, colonoscopy, and stomach ultrasound. No results popped from these tests. She also saw a neurologist for the headaches. She passed the basic neurological exam.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient. There was no pertinent medical history and no drug reactions/allergies. On 28-JAN-2013, the patient was vaccinated with GARDASIL, via wet SD (lot # H016960, expired date: 02-DEC-2013) and also on 24-JUN-2014 (lot # H020901, expired date: 05-JUL-2015), intramuscular (dose not provided). There was no concomitant therapy. The patient became pregnant with last menstrual period (LMP) of 21-JUN-2014 and expected delivery date (EDD) of 28-MAR-2015. On 23-JUL-2014, a urine pregnancy test was performed that was positive for pregnancy. No known adverse effects. The outcome of pregnancy was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: 5-6 min. after administration of vaccines pt had syncopal episode, was "out" for less than 30 seconds. Given juice and observed for 15-25 minutes before allowing pt to leave office.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: PATIENT HAVING FEVER, DIARRHEA, SWELLING AND REDNESS AT INJECTION SITE.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Confusional state, Hyperhidrosis, Loss of consciousness, Malaise, Pallor
Clinical narrative: Before the injection, the patient was very apprehensive asking me if this was going to hurt several times. I used a calming tone and reassured the patient that it was a benefit to his health and that his school was requiring it, I also told him it would be quick and that he would feel a little prick. After the injection the patient was his baseline self, until aprox 3 minutes after the injection he turned pale white and very diaphoretic. He stated he did not feel well and thought he was going to pass out. I went to his side to prevent him from falling out of the chair and called for help. Two RNs and one LPN came to the room. He lost conciousness as the other nurses were coming in the room. He had a fixed stare / gaze on his face and was unresponsive to any stimuli. We applied ice packs to his forehead and nape of neck in an attempt to cool him down. We also directed a room fan on him and made sure he was maintaining a open patent airway. We took vitals, BP 102/70, p 96, R19 and his O2 was 95-99%. He was unresponsive for aprox 3 minutes. When he came to, he was at first very confused. He had a couple juice boxes and called his mother for a ride home to not drive.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Before the injection, the patient was very apprehensive asking me if this was going to hurt several times. I used a calming tone and reassured the patient that it was a benefit to his health and that his school was requiring it, I also told him it would be quick and that he would feel a little prick. After the injection the patient was his baseline self, until aprox 3 minutes after the injection he turned pale white and very diaphoretic. He stated he did not feel well and thought he was going to pass out. I went to his side to prevent him from falling out of the chair and called for help. Two RNs and one LPN came to the room. He lost conciousness as the other nurses were coming in the room. He had a fixed stare / gaze on his face and was unresponsive to any stimuli. We applied ice packs to his forehead and nape of neck in an attempt to cool him down. We also directed a room fan on him and made sure he was maintaining a open patent airway. We took vitals, BP 102/70, p 96, R19 and his O2 was 95-99%. He was unresponsive for aprox 3 minutes. When he came to, he was at first very confused. He had a couple juice boxes and called his mother for a ride home to not drive.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding unspecified patients of unknown age and gender. The reporter stated that on an unknown date unspecified patients might have vaccinated with ZOSTAVAX (dose, route, product lot# not reported) that was exposed to 21F on multiple occasions for an unknown time frame. No adverse effects were reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-APR-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot# not reported). No concomitant medications reported. On an unknown date of August-2014 the patient is currently in the office for her second dose of vaccine, which was inappropriate schedule of vaccine administration. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. No pertinent medical history or drug reactions/allergies were reported. On 23-NOV-2010 the patient was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml, intramuscular. The patient received her second dose of GARDASIL (lot#, dose and route not reported) on 30-JUL-2014. The physician stated that the patient also received a "hepatitis A vaccine" (manufacturer unknown). No concomitant medication was reported. She stated that the patient's urine was tested for HCG, and the patient was found to be pregnant after receiving the GARDASIL. The patient sought medical attention via office visit. The physician stated that the patient had not yet seen the OB/GYN and gestation had not yet been determined. No adverse effects reported. The Menstrual Period and Estimated date of delivery were not known. The outcome of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. No pertinent medical history or drug reactions/allergies were reported. On 23-NOV-2010 the patient was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml, intramuscular. The patient received her second dose of GARDASIL (lot#, dose and route not reported) on 30-JUL-2014. The physician stated that the patient also received a "hepatitis A vaccine" (manufacturer unknown). No concomitant medication was reported. She stated that the patient's urine was tested for HCG, and the patient was found to be pregnant after receiving the GARDASIL. The patient sought medical attention via office visit. The physician stated that the patient had not yet seen the OB/GYN and gestation had not yet been determined. No adverse effects reported. The Menstrual Period and Estimated date of delivery were not known. The outcome of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. No pertinent medical history or drug reactions/allergies were reported. On 23-NOV-2010 the patient was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml, intramuscular. The patient received her second dose of GARDASIL (lot#, dose and route not reported) on 30-JUL-2014. The physician stated that the patient also received a "hepatitis A vaccine" (manufacturer unknown). No concomitant medication was reported. She stated that the patient's urine was tested for HCG, and the patient was found to be pregnant after receiving the GARDASIL. The patient sought medical attention via office visit. The physician stated that the patient had not yet seen the OB/GYN and gestation had not yet been determined. No adverse effects reported. The Menstrual Period and Estimated date of delivery were not known. The outcome of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. No pertinent medical history or drug reactions/allergies were reported. On 23-NOV-2010 the patient was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5 ml, intramuscular. The patient received her second dose of GARDASIL (lot#, dose and route not reported) on 30-JUL-2014. The physician stated that the patient also received a "hepatitis A vaccine" (manufacturer unknown). No concomitant medication was reported. She stated that the patient's urine was tested for HCG, and the patient was found to be pregnant after receiving the GARDASIL. The patient sought medical attention via office visit. The physician stated that the patient had not yet seen the OB/GYN and gestation had not yet been determined. No adverse effects reported. The Menstrual Period and Estimated date of delivery were not known. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from company representative from a physician refers to a female patient of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# not reported). No concomitant medications reported. On an unknown date the patient was not able to get a dose with GARDASIL on the date she was scheduled to receive it because of a shipping problem resulting in an NCD# mismatch according to the documentation of the company vaccine assistance program. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Computerised tomogram normal, Urine analysis
Clinical narrative: Sudden band of back pain all across lower back, very painful. Pain transitioned after about 30 minutes to waves of pain concentrated over right kidney. Waves of pain came approximately every 20 seconds and continued for approximately 4 hours.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Urine analysis normal
Clinical narrative: Sudden band of back pain all across lower back, very painful. Pain transitioned after about 30 minutes to waves of pain concentrated over right kidney. Waves of pain came approximately every 20 seconds and continued for approximately 4 hours.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Heart rate increased, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: PT c/o scratchy throat, mild swelling of tongue. No SOB, no rash. PT took oral diphenhydramine, monitored in office until 7:30 PM. PT reported improvement before leaving office and at telephone F/U @9:00 PM, but did report welts on back. Phone F/U 8/7/2014:1130, PT reports welts on back still present and feels elevated heart rate.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Streptococcus test
Clinical narrative: Given PNEUMONIA 23 immunization, 8-5-14 started having fever of 101.9 in the evening of 8-6-14, Left arm sore with some redness, treated with TYLENOL.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, PNC13
Symptoms: Syncope
Clinical narrative: Pt stood up from exam table and fainted.
Age: 29.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer (patient's husband) refers to his 29 year old wife. On 27-JUN-2014, the patient was vaccinated with VARIVAX, (1 injection, subcutaneous). On the same day, the patient was vaccinated with three other vaccines, one of which was flu vaccine (name unspecified). On 22-JUL-2014, the patient went to her physician who performed blood work and found out that she was pregnant. Patient's husband estimated that his wife was approximately four months pregnant, but he did not know if the estimate was exact. Her husband also stated that it was not explained to husband and wife that they should not conceive until after three months of receiving the vaccines. It was reported that the patient sought medical attention. Action taken, outcome and causality were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 30-JUN-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 08-JUN-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reproter. Additional information has been requested.