chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a female nurse, of an unknown age, reporting on herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (manufacturer unknown) (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that she received an hepatitis B vaccine (manufacturer unknown) vaccine on unspecified dates years ago. The nurse reported that on an unspecified date she had titers drawn for  hepatitis B and results were negative. The nurse reported that because of this she received another series of unspecified hepatitis B vaccine (manufacturer unknown). At the time of the report the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2014, an expired PNEUMOVAX23 was inadvertently administered to a patient. No adverse effect reported. The outcome of expired PNEUMOVAX23 was inadvertently administered to a patient was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Erythema, Induration, Mass, Pruritus
Clinical narrative: Pt had KINRIX and MMR administered on 8/19/14 in Lt. leg. Mom called on 8/20/14 stating that area was red, hard lump, itchy to child. Advised cook pack, anti-itch cream to area and if got any worse needs to be seen.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Irritability, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Very fussy. Crying non-stop. Fever 101.3. Macular rash over entire body.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: Hep B and TST were administered. Shortly after, client began with c/o tingling in both arms and hands, he was diaphoretic and dizzy. Vital signs normal BP: 113/76 P: 68 Glucose 101. Provided water to client. Sx resolved within 30-40 minutes. Client able to leave facility on his own.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Redness and swelling upper left arm and went below elbow (swelling).
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction
Clinical narrative: Local reaction large and red about 5 in x 6 in round upper arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Pt developed rash at site of injection. Pt complaining of dizziness and pain in extremity; pain at site of rash.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Feeling hot, Malaise, Syncope
Clinical narrative: After getting last vaccine, (Varicella) pt stated feeling sick and hot. BP 83/38. Pt laid on floor with legs propped at 45 degrees. Stated felt better after 5 mins. BP 115/63. Pt able to sit in chair after 10 mins. she was able to walk out of clinic. Stated feeling fine. Mom states has been having freq fainting episodes lately.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Nausea
Clinical narrative: Lightheaded about 10 minutes after had Hepatitis A. Then got nauseated about 1/2 hour after vaccine. Nausea continued presently 8/20/14. 8/17 thought she was going to throw up, but did not. 8/13 had diarrhea. Has had chills; states: like adrenalin chills not fever chills. Does not feel like eating normally. Not getting worse but still nauseated. These symptoms happened also with first Hepatitis A 9/4/14 but still having nausea. Patient did not report until 8/12/13 when for 2nd Hepatitis A.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Vaccine positive rechallenge
Clinical narrative: Lightheaded about 10 minutes after had Hepatitis A. Then got nauseated about 1/2 hour after vaccine. Nausea continued presently 8/20/14. 8/17 thought she was going to throw up, but did not. 8/13 had diarrhea. Has had chills; states: like adrenalin chills not fever chills. Does not feel like eating normally. Not getting worse but still nauseated. These symptoms happened also with first Hepatitis A 9/4/14 but still having nausea. Patient did not report until 8/12/13 when for 2nd Hepatitis A.
Age: 4.0
Sex: M
Vaccine: IPV, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Tdap was given instead of Dtap.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: 11 year old male with right arm localized reaction (redness, swelling) 1 inch of erythema surrounding injection site (+) Induration. No fever, spread of rash, difficulty breathing.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: Per mother, patient had swelling of eyes, lips, nose, face x 1 day. Resolved spontaneously. Mother brought pictures on phone - difficult to ascertain. No swelling today. Mother insists I make a report.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Hypersensitivity, Injection site pruritus, Injection site rash
Clinical narrative: Skin rash to left posterior upper arm. Moderate in severity. Duration is 1 day. Associated symptoms are erythema, and raised above the skin. Patient's temperature at visit was 97 degrees F. Patient received varicella vaccine to left posterior upper arm, subcutaneously. Patient states there was slight itching to site on 8-14-14 but states on 8-15-14 there is no itching. Treated for allergic reaction and was prescribed Prednisone and Hydroxyzine. Mother advised to purchase OTC Hydrocortisone 1% cream.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MMR
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MMR
Symptoms: Antibody test negative, Expired drug administered, Incorrect dose administered
Clinical narrative: None.
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, strength, route and lot numbers were not reported). Pharmacist reported that on an unknown date, the patient developed a plantar's wart on an unspecified foot after receiving his first dose of GARDASIL. Pharmacist stated that she "thinks" that the patient had two doses of GARDASIL already on unspecified date. Pharmacist also reported that the patient had been using over the counter salicylic acids pads for the plantar's wart on unspecified dates but the pads had not been helping. Pharmacist reported that patient was seen by his physician on an unknown date. The outcome of plantar wart was reported as not recovered. The pharmacist also stated that the plantar's wart has made it "difficult" for the patient to run and walk. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report ws received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 19-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 injection, 10 vials of 1, 0.5 ml, intramuscular, lot # J009827, expiration date 10-AUG-2014. No adverse effects were reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Exposure via direct contact, Eye irrigation, No adverse event
Clinical narrative: This spontaneous report was received from a 30 year old female pharmacist who is also the patient regarding on herself. On 20-AUG-2014 one drop of ZOSTAVAX (lot # reported as K007548; expiration date: 23-AUG-2015) splashed in her left eye and she ws 35 weeks pregnant. Pharmacist stated she was wearing her contacts and gloves at the time of administration. Pharmacist stated she flushed her ye with water after incident. She was not experiencing any symptoms and her eye was not red. The patient was 35 weeks pregnant on 21-AUG-2014 with last menstrual period (LMP) of 19 DEC-2013 and Estimated Date of Delivery (EDD) of 25-SEP-2014. The pregnancy outcome was pending.  The outcome of one drop of ZOSTAVAX splashed in her left eye when she was administering the vaccine to the patient, she was not experiencing any symptoms and she was 35 weeks pregnant and drop of ZOSTAVAX splashed in her eye was unknown. This case was related to the patient who also experienced adverse events MARRS1408USA013266. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 31 year old female patient with obese and hypothyroid without history of drug reactions or allergies. On an unknown date, while she was pregnant, the patient was vaccinated with GARDASIL, 0.5 ml, once, intramuscular, lot #J012438 and RHOGAM. Concomitant therapies included LEVOTHYROXINE SODIUM and some prenatal vitamins (manufacturer unknown). The doctor meant to give the patient RHOGAM, but mistakenly gave her GARDASIL. Patient did not seek medical attention or receive any treatment. No laboratories were performed. The patient got her LMP on 16-JAN-2014 (reported as 29 weeks and five days") and EDD of 23-OCT-2014. At the time of report the pregnancy outcome was pending.  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 registered nurse refers to 9 unspecified patients of unknown age and gender. The nurse reported that on unspecified dates in June 2014, the 9 patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous. Strength, lot #, expiration date and anatomical location not reported, that was improperly stored at a maximum of 9F for up to 28 hours. No adverse effects reported. This is one of several reports from the same source. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported, that on unspecified dates in July 2014 and August 2014, the unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5F for up to 11 hours. No adverse effects reported. Thi sis one of 2 reports from the same source. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 6 year old patient. On 19-AUG-2014 the patient was vaccinated with an expired PNEUMOVAX23 (strength and route not reported) lot# H020684. No adverse effects reported. Additional information is not expected because the reported refused additional contact.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Flushing, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old male patient with no pertinent medical history and no drug reactions or allergies. On 18-AUG-2014, the patient was vaccinated with the first dose of VAQTA (lot # reported as K004856, expiration date 04-DEC-2016) intramuscularly. The medical assistant reported that on 18-AUG-2014, the patient experienced a local reaction of about 2 or 3 inches of swelling on the arm around the injection site. The patient experienced redness and flushing on the face, neck and chest. The patient did not receive  treatment for the adverse events. There were no lab diagnosis or studies performed. The patient had recovered on 18-AUG-2014. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 17 month old male patient. On 06-JUN-2014 the patient was vaccinated with M-M-R II. Past medical history included eczema after vaccine. Concomitant medications were not reported. The patient was scheduled to receive his M-M-R II vaccine on 04-JUN-2014 in the allergist's office. The healthcare worker stated that they reconstituted the M-M-R II vaccine in the primary care office, then transported it to the allergist's office, that it was then stored in the refrigerator and administered to the patient two days later. No adverse effects were reported. The outcome of did not receive vaccine on scheduled date is unknown. No adverse effects were reported. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Eczema, Erythema, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 17 month old male patient. On an unknown date the patient was vaccinated with RECOMBIVAX HB via an unknown route of administration. Pat medical history and concomitant medications were not reported. On an unknown date the patient was seen in the office for this "two month vaccines". He received PENTACEL, PREVNAR, ROTATEQ and an unspecified hepatitis B vaccine, could not rule out RECOMBIVAX. She stated that after the doses were given that the patient experienced rash, erythema and fever. The patient was seen by an unspecified allergist and was diagnosed with "eczema after vaccine", but was determined not to be caused by the vaccines. The outcome of rash, eczema after vaccine, fever and erythema was reported as recovered/resolved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Acne, Burning sensation, Cheilitis, Eczema, Headache
Clinical narrative: Within 12-48 hrs I experienced the following ailments. I am not a Dr. I do not know which are from the vaccine and which may be from childbirth. Additionally this list only covers things I was not experiencing immediately prior to vaccination or were unique to the situation: -ringing in ears -blurred vision -headache (not migraine) -severely swollen feet -congestion/respiratory problems -itching all over body -eczema/acne -raised white spots on lips -burning sensation in feet (peripheral nerve damage) -jaw/neck/throat pain Vaccines were given after delivering my child. Easy pregnancy. Full term child. Was induced a couple days early due to my blood pressure being a little high and because my dr said she would be out of town on his due date. Was GBS positive and given antibiotics during labor. Epidural catheter was placed 3 times but test dose was ineffective. There was no time for pain medication during delivery. An hr or less after he was born I was walking around (with escorts) and then moved to a new room. Everything was fine. When it was time to leave it was strongly suggested I be vaccinated for Pneumonia, TDap, and Flu. I fought with them and 100% denied the Flu vaccine as both times in the past I took it I was diagnosed with the flu within 24-48 hrs following. I allowed the Pneumococcal vaccine. I DO NOT know which manufacturer it was. I also allowed the TDaP vaccine. I was told they were very important due to my history of asthma and since I was breast feeding to pass immunity to my son. The nurse still showed up with and almost gave me the flu vaccine even though I did not sign for it. I had to send her out to recheck which ones I'd agreed to.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Local swelling, Neck pain, Nerve injury, Oropharyngeal pain, Pain in jaw
Clinical narrative: Within 12-48 hrs I experienced the following ailments. I am not a Dr. I do not know which are from the vaccine and which may be from childbirth. Additionally this list only covers things I was not experiencing immediately prior to vaccination or were unique to the situation: -ringing in ears -blurred vision -headache (not migraine) -severely swollen feet -congestion/respiratory problems -itching all over body -eczema/acne -raised white spots on lips -burning sensation in feet (peripheral nerve damage) -jaw/neck/throat pain Vaccines were given after delivering my child. Easy pregnancy. Full term child. Was induced a couple days early due to my blood pressure being a little high and because my dr said she would be out of town on his due date. Was GBS positive and given antibiotics during labor. Epidural catheter was placed 3 times but test dose was ineffective. There was no time for pain medication during delivery. An hr or less after he was born I was walking around (with escorts) and then moved to a new room. Everything was fine. When it was time to leave it was strongly suggested I be vaccinated for Pneumonia, TDap, and Flu. I fought with them and 100% denied the Flu vaccine as both times in the past I took it I was diagnosed with the flu within 24-48 hrs following. I allowed the Pneumococcal vaccine. I DO NOT know which manufacturer it was. I also allowed the TDaP vaccine. I was told they were very important due to my history of asthma and since I was breast feeding to pass immunity to my son. The nurse still showed up with and almost gave me the flu vaccine even though I did not sign for it. I had to send her out to recheck which ones I'd agreed to.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus generalised, Respiratory disorder, Respiratory tract congestion, Tinnitus, Vision blurred
Clinical narrative: Within 12-48 hrs I experienced the following ailments. I am not a Dr. I do not know which are from the vaccine and which may be from childbirth. Additionally this list only covers things I was not experiencing immediately prior to vaccination or were unique to the situation: -ringing in ears -blurred vision -headache (not migraine) -severely swollen feet -congestion/respiratory problems -itching all over body -eczema/acne -raised white spots on lips -burning sensation in feet (peripheral nerve damage) -jaw/neck/throat pain Vaccines were given after delivering my child. Easy pregnancy. Full term child. Was induced a couple days early due to my blood pressure being a little high and because my dr said she would be out of town on his due date. Was GBS positive and given antibiotics during labor. Epidural catheter was placed 3 times but test dose was ineffective. There was no time for pain medication during delivery. An hr or less after he was born I was walking around (with escorts) and then moved to a new room. Everything was fine. When it was time to leave it was strongly suggested I be vaccinated for Pneumonia, TDap, and Flu. I fought with them and 100% denied the Flu vaccine as both times in the past I took it I was diagnosed with the flu within 24-48 hrs following. I allowed the Pneumococcal vaccine. I DO NOT know which manufacturer it was. I also allowed the TDaP vaccine. I was told they were very important due to my history of asthma and since I was breast feeding to pass immunity to my son. The nurse still showed up with and almost gave me the flu vaccine even though I did not sign for it. I had to send her out to recheck which ones I'd agreed to.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site of injection.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Convulsion, Injection site haemorrhage, Loss of consciousness
Clinical narrative: Vigorous bleeding from injection site in the arm and then a seizure lasting approximately 10 to 15 seconds and passed out unconscious for another 15 seconds. Taken to exam room, given apple juice, took temperature and blood pressure and stayed at the office 30 minutes to be sure there were no more adverse reactions.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Paraesthesia, Swelling
Clinical narrative: Throbbing, tngling, redness and swelling. Benadryl, Claritin and ibuprofen given in the office.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Swelling, pain, low-grade fever.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea
Clinical narrative: I had nausea/stomach aches, followed by diarrhea for two days.  I was also extremely tired for 3-4 days.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pruritus
Clinical narrative: Erythema and pruritus at injection site, area affected increasing in diameter over 2 days, now the size "of a baseball".
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient reported red rash at injection site (about 4" diameter - visually reviewed by pharmacist). Described as mildly painful. Felt tired and had a headache as well.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site vesicles
Clinical narrative: Blister at injection site.  Red and inflamed.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Red rash about the size of 4 quarters, itchy, swollen, looks small raised bump where shot was injected, area warm to touch.
Age: 78.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported sharp pain in his left arm shooting toward his heart.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Band neutrophil percentage, Blood potassium decreased, Chills, Decreased appetite
Clinical narrative: Fever to 102, myalgia, nausea, headache, chills and mild abd. pain overnight after vaccine was given. Decreased appetite -> IV fluids.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Lymphocyte percentage decreased, Myalgia, Nausea, Neutrophil percentage increased
Clinical narrative: Fever to 102, myalgia, nausea, headache, chills and mild abd. pain overnight after vaccine was given. Decreased appetite -> IV fluids.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: Fever to 102, myalgia, nausea, headache, chills and mild abd. pain overnight after vaccine was given. Decreased appetite -> IV fluids.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt. began feeling dizzy and was instructed to sit down. She then turned pale yellow color and "blacked out". The patient was not treated with anything. She awakened about 10-15 seconds later.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Aphthous stomatitis, Blister, Body temperature increased, Chills, Decreased appetite
Clinical narrative: Symptoms occurred starting about 3 hrs after flu shot. Severe shivering, temperature 105 degrees, difficulty breathing, nausea, diarrhea, fever. Blisters developed next day on mouth and nose/canker sores in mouth, loss of appetite.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Nausea, Oral mucosal blistering, Pyrexia
Clinical narrative: Symptoms occurred starting about 3 hrs after flu shot. Severe shivering, temperature 105 degrees, difficulty breathing, nausea, diarrhea, fever. Blisters developed next day on mouth and nose/canker sores in mouth, loss of appetite.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Injection site reaction, Joint range of motion decreased, Malaise
Clinical narrative: Low grade fever (100 degrees) for 3 days. Aches in hips and knees. Chills and malaise. Local reaction at injection site resulting in difficulty of lifting right arm.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Low grade fever (100 degrees) for 3 days. Aches in hips and knees. Chills and malaise. Local reaction at injection site resulting in difficulty of lifting right arm.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling of left deltoid at vaccination site. Cool compresses and Ibuprofen or TYLENOL.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin lesion
Clinical narrative: Redness of the (L) arm started at 10 hrs after vaccination, ass. pain, no swelling. Diameter at 4 inches. Also: fever (T max 38.2 C) x 1 day. Skin lesion resolved after 4 days.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was not reported. ON an unknown date in August 2014 (reported as two weeks ago), the patient was vaccinated with a expired dose of PNEUMOVAX23 (INJ 25/0.5 Y) (Dose/frequency were not reported, lot # unknown and expiry date: 03-AUG-2014) intramuscular. No adverse events were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. 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 certified medical assistant refers to an patient of unknown age and gender. On an unknown date in 2014 (also reported as since 24-JUN-2014), was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot # J012380 expiration date not reported), does and route not reported which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to 1408USA009333, 1408USA013367, and 1408USA013368 as same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Pruritus
Clinical narrative: This spontaneous report as received from registered nurse via company representative refers to a female patient of unknown age. The patient's medical history and current condition are not reported. On 13-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot # and expiry date not provided) of unknown strength and dose. Other co-suspects and concomitant medication are not reported. On an unknown date the patient experienced several blisters around the injection site and had an itchy arm after receiving ZOSTAVAX shot. Cancer, overdose and product quality complaint was not reported. The outcome of the events was reported as not recovered. Causality was unspecified by the reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an adolescent male patient of unknown age. The patient's medical history and current condition is not reported. On an unknown date the patient was vaccinated with GARDASIL (lot # and expiry date not provided) of unknown strength and dose. Other co-suspects and current condition are not reported. Approximately on an unknown date in AUG0-2014 the patient fainted after receiving GARDASIL. Also reported as the patient still seated in the office when this occurred, cancer, overdose and product quality complaint are not reported. The outcome of adolescent patient fainted after receiving GARDASIL was reported as recovered. Causality was unspecified by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that improperly stored doses of PROQUAD (dose, strength, lot#, expiration date and route  not reported) were administered to unspecified number of patients. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that improperly stored doses of (Oka/Merck) VARIVAX (dose, strength, lot #, expiration date and route not reported) were administered to unspecified number of patients. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information is not expected.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 year old patient. On 08-AUG-2014 the patient was inadvertently vaccinated with RECOMBIVAX HB 40 (unspecified in series), lot # H010965, Expiration Date 01-JUN-2014, 1 ml, once, intramuscularly. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient had drug reaction/allergy to codeine. Approximately on an unknown date in 2014 (also reported as recently), the patient was vaccinated with ZOSTAVAX  vial (lot # unknown, expiry date unknown), subcutaneous. Concomitant medications were unspecified. Approximately on an unknown date in 2014, pharmacist reported that the patient called and stated that she had a red area by the injection site. Pharmacist stated that she informed the patient that this was most likely an injection site reaction. There was no PQC. The outcome of injection site reaction was reported as not recovered/not resolved. Causality of the reported event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with (Oka/Merck) PROQUAD, lot # reported as K006771, expiration date 07-NOV-2015, and lot# J014236, expiration date 07-MAY-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting (Oka/Merck) PROQUAD. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concomitant conditions were not reported.  On an unknown date the patients were vaccinated with M-M-R II, lot # J015503, expiration date 05-DEC-2014, lot # J000154, expiration date 04-JAN-2015, lot J004204, Exp 12-APR-2014, lot J007929, Exp 28-JUN-2015 and lot J0109993, Exp 06-SEP-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting M-M-R II. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention. This is one of several reports from the same source. 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 nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, lot # reported as K002929, expiration date 26-FEB-2016 and Lot # J013900, expiration date 30-OCT-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting (Oka/Merck) VARIVAX. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention.  This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.   Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24 minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M.A.  it was reported that a patient with 11 years old received a dose of GARDASIL with lot # J0133324 exp date 12-FEB-2014, on 09-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route, and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.   Follow up information was received from the medical assistant  on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M.A.  It was reported that a patient with 14 years old received a dose of GARDASIL with lot # as J09788, exp. date 17-MAR-2016, on 09-JUL-2014.  This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a dose of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016, and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.  Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M.A.  It was reported that a patient with 16 years old received a dose of GARDASIL with lot# J013324, exp date 12-FEB-2016, on 23-JUL-2014.  This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site pain, Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient (also a hospital employee), who was currently in her 40's. The patient had no pertinent medical history or drug reactions/allergies. There was no concomitant medication. The patient stated that she had been vaccinated with a dose of M-M-R II (injection, lot #, dose and frequency were not provided) intramuscularly on an unspecified date as a child. The patient had titers for measles, mumps and rubella drawn on either 04-AUG-2014 or 05-AUG-2014 and the results were negative (also reported as no lab diagnostics study was performed). As treatment, the nurse reported that she administered a dose of M-M-R II (dose and lot # were not provided) to the patient on 19-AUG-2014 intramuscularly rather than subcutaneously (also reported as no treatment was given for the adverse events). The patient stated that the injection "burned" as it was administered. Patient's present status was reported as recovered on 19-AUG-2014. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient (also a hospital employee), who was currently in her 40's. The patient had no pertinent medical history or drug reactions/allergies. There was no concomitant medication. The patient stated that she had been vaccinated with a dose of M-M-R II (injection, lot #, dose and frequency were not provided) intramuscularly on an unspecified date as a child. The patient had titers for measles, mumps and rubella drawn on either 04-AUG-2014 or 05-AUG-2014 and the results were negative (also reported as no lab diagnostics study was performed). As treatment, the nurse reported that she administered a dose of M-M-R II (dose and lot # were not provided) to the patient on 19-AUG-2014 intramuscularly rather than subcutaneously (also reported as no treatment was given for the adverse events). The patient stated that the injection "burned" as it was administered. Patient's present status was reported as recovered on 19-AUG-2014. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 31 year old female patient. Medical  history and concurrent conditions were not reported. Approximately in 1988 "around the age of 6 years old", the patient was vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not provided. No co-suspect and concomitant therapies were reported. The physician reports that the patient had titers drawn and the result was negative. The patient stated that she was unsure if she received one does or  two doses. She reports that she had titers drawn "around 01-JUN-2014". The outcome of the titers drawn and the result was negative was unknown. No treatment was given for adverse event. The patient did not seek medical attention. Additional information is not expected (no allowed to contact physician).
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported.  On an unknown date the patient missed a dose of RECOMBIVAX  HB lot # J007946, expiration date 24-MAR-2015 and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a dose of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016 and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported PQC involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a dose of RECOMBIVAXHB lot # J007946, expiration date 24-MAR-2016 and lot J012567 expiration date 30-JAN-201, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a does of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016 and lot J012567 expiration date 30-JAN-2016, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports form the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified.   Follow up information was received from the medical assistant on 06-AUG-2014. The M. A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24 minutes. The M. A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time.   Follow up information has been received from M. A.  It was reported that a patient with 18 years old received a dose of GARDASIL with lot # J010668, exp date 29-APR-2016, on 10-JUN-2014. This is one of several reports received from the same reporter. Additional information is not expected, since all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On 25-JUL-2014, the patient was vaccinated with ZOSTAVAX (lot # J004266, Expiration date: 12-JUL-2014) (dose and route was unspecified). On 25-JUL-2014 (also reported as expired by one week), the patient was administered with expired ZOSTAVAX. No product quality complaint was reported. This report is linked to the MARRS#1408USA011772 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown demographics. On 19-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (lot # J006921, expiration date: 09-AUG-2014) 0.5ml (route of administration unspecified). On 19-AUG-2014, the patient was inadvertently administered with expired PNEUMOVAX23. It was reported that dose was supported. No adverse experience reported. The outcome of event was unknown. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On 22-JUL-2014, the patient was vaccinated with ZOSTAVAX (lot # J004256, Expiration date: 12-JUL-2014) (dose and route was unspecified). On 22-JUL-2014 (also reported as expired by one week), the patient was administered with expired ZOSTAVAX. No product quality complaint was reported. This report is linked to the MARRS#1408USA013399 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a certified medical assistant refers to an patient of unknown age and gender. On an unknown date in 2014 (also reported as since 24-JUN-2014) was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot # J013903) expiration date not reported), dose and route not reported which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to 1407USA009333, 1408USA013366 and 1408USA013368 as same reporter link. Additional information has been requested.