chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: FLUN3, TDAP, TYP, YF
Symptoms: Rhinorrhoea, Sneezing, Speech disorder, Swelling, Throat tightness
Clinical narrative: This 35 year old reported receipt of Tdap (ac52b094ba SK), YF (uh287aa SP), FLUMIST (AH2193 Medimmune), and Typhoid Vi (g1541 SP) on 9/10/2012 at 10:00 am. Approximately 1 hour later after eating lunch he began to sneeze and had a runny nose. Lunch consisted of 2 slices of pizza bought day before from a family owned pizzeria which had red sauce, ground beef, oil, green peppers, onions and olives. He also advised eating hard boiled eggs with protein shake for breakfast 4 hours before getting vaccinations with no adverse reaction (eats frequently). Approximately 1 hour after eating but 2 hours since vaccinations, he complained of swelling, itching to face, lips, eyes, ears and itching to bilateral arms, difficulty speaking with tingling to mouth, lips and surrounding facial tissue and oral cavity (especially gums, but no tongue swelling), his throat felt tight and full "as if closing off", had difficulty swallowing water and he could only speak in whispers, he had a dull midsternal chest ache-tightness worse with breathing in/out. He denied any use or contact with new detergents, soaps, deodorants, shaving cream, clothing, etc. He took daily Lisinopril, but his was not a new prescription or new bottle. He returned to medical at 1431 hours (4 hours since vaccinated) with chest tightness, wheezing and throat swelling. He was treated for an anaphylactic reaction with IM BENADRYL, Albuterol neb, and EPIPEN with resolution of symptoms about 30 min later. He was released with MEDROL dose pak x 6 day, CLARITIN and ZANTAC with prn BENADRYL. Patient advised he completed all medications (MEDROL/CLARITIN/ZANTAX but no BENADRYL) without difficulty. he reported it took 2 days before he felt "normal" and remains asymptomatic since completion of medication on 9/16/12. He experienced a similar reaction in 2006 after eating falafel - Middle Eastern dish with chickpea's, parsley, tomatoes, and other ingredients: had hives with redness and swelling to hands/feet with some SOB but not as severe as 9/10/2012 event. He advised he routinely eats/uses oil, vinegar, mayo, mustard, ketchup, parsley, basil, regular peas, pita bread, etc with no adverse reaction. He has not eaten chick peas since 2006. He presented to the clinic on 9/19/2012 with no symptoms.
Age: 35.0
Sex: M
Vaccine: FLUN3, TDAP, TYP, YF
Symptoms: Wheezing
Clinical narrative: This 35 year old reported receipt of Tdap (ac52b094ba SK), YF (uh287aa SP), FLUMIST (AH2193 Medimmune), and Typhoid Vi (g1541 SP) on 9/10/2012 at 10:00 am. Approximately 1 hour later after eating lunch he began to sneeze and had a runny nose. Lunch consisted of 2 slices of pizza bought day before from a family owned pizzeria which had red sauce, ground beef, oil, green peppers, onions and olives. He also advised eating hard boiled eggs with protein shake for breakfast 4 hours before getting vaccinations with no adverse reaction (eats frequently). Approximately 1 hour after eating but 2 hours since vaccinations, he complained of swelling, itching to face, lips, eyes, ears and itching to bilateral arms, difficulty speaking with tingling to mouth, lips and surrounding facial tissue and oral cavity (especially gums, but no tongue swelling), his throat felt tight and full "as if closing off", had difficulty swallowing water and he could only speak in whispers, he had a dull midsternal chest ache-tightness worse with breathing in/out. He denied any use or contact with new detergents, soaps, deodorants, shaving cream, clothing, etc. He took daily Lisinopril, but his was not a new prescription or new bottle. He returned to medical at 1431 hours (4 hours since vaccinated) with chest tightness, wheezing and throat swelling. He was treated for an anaphylactic reaction with IM BENADRYL, Albuterol neb, and EPIPEN with resolution of symptoms about 30 min later. He was released with MEDROL dose pak x 6 day, CLARITIN and ZANTAC with prn BENADRYL. Patient advised he completed all medications (MEDROL/CLARITIN/ZANTAX but no BENADRYL) without difficulty. he reported it took 2 days before he felt "normal" and remains asymptomatic since completion of medication on 9/16/12. He experienced a similar reaction in 2006 after eating falafel - Middle Eastern dish with chickpea's, parsley, tomatoes, and other ingredients: had hives with redness and swelling to hands/feet with some SOB but not as severe as 9/10/2012 event. He advised he routinely eats/uses oil, vinegar, mayo, mustard, ketchup, parsley, basil, regular peas, pita bread, etc with no adverse reaction. He has not eaten chick peas since 2006. He presented to the clinic on 9/19/2012 with no symptoms.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage, Induration, Local swelling
Clinical narrative: Pt received flu shot. Bled a bit (but pt on blood thinner). Noticed area appeared to swell almost immediately after vaccination. Pt didn't report any issues (RPh noticed swelling). No s/sx of SOB or altered consciousness. Spoke to pt's PCP who wanted pt to get BENADRYL (which was given to him) & proceed to ER. Pt did not want 911 called or ambulance to take him to ER. Swelling of area a nickel to quarter sized and firm to touch.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Swelling, pain, not able to move arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) & (L) arm red swollen.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Injection site erythema, Pyrexia
Clinical narrative: Redness at site, fever, clammy, sweaty, no tx.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Activated partial thromboplastin time normal, Blood lactic acid normal, Blood thyroid stimulating hormone normal, Cardiolipin antibody negative, Chlamydia test negative
Clinical narrative: Patient received Tdap vaccine at 14 6/7 weeks estimated gestational age with a viable pregnancy. Returned at 18 5/7 weeks with a fetal demise diagnosed. Head diameter consistent with 14 week sized fetus.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal death, Laboratory test normal, Maternal exposure during pregnancy, Parvovirus B19 test negative, Prothrombin level normal
Clinical narrative: Patient received Tdap vaccine at 14 6/7 weeks estimated gestational age with a viable pregnancy. Returned at 18 5/7 weeks with a fetal demise diagnosed. Head diameter consistent with 14 week sized fetus.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Treponema test negative
Clinical narrative: Patient received Tdap vaccine at 14 6/7 weeks estimated gestational age with a viable pregnancy. Returned at 18 5/7 weeks with a fetal demise diagnosed. Head diameter consistent with 14 week sized fetus.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site induration, Lip swelling, Oral herpes, Pyrexia
Clinical narrative: 7 x 15 cm erythema; induration (L) deltoid c/o fever, but (R) lower lip swelling onset 12/3/12 C/W herpes labialis mild erythema (R) deltoid 2 x 4 cm.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Movement disorder, Pain
Clinical narrative: Sharp, shooting pain down front of right shoulder. Arm movement very limited. OTC pain meds & heating pad.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Back pain, Chest pain, Dyspnoea, Erythema
Clinical narrative: Pt. verified. Flushed face & body. Weakness. Shortness of breath. Chest & back pain. Redness to neck, chest, and arms, nausea.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Flushing, Nausea
Clinical narrative: Pt. verified. Flushed face & body. Weakness. Shortness of breath. Chest & back pain. Redness to neck, chest, and arms, nausea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash, Psoriasis, Pyrexia, Rash macular
Clinical narrative: Pt. developed rash (blotchy) at injection site (4 x 2 inches). Rash was warm, swollen. MD states pt had cellulitis. Worsened psoriasis. Low grade fever 99.9. Hives on face also.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Pt. developed rash (blotchy) at injection site (4 x 2 inches). Rash was warm, swollen. MD states pt had cellulitis. Worsened psoriasis. Low grade fever 99.9. Hives on face also.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chromaturia, Headache, Malaise, Muscle spasms, Swelling
Clinical narrative: Severe malaise, muscle spasms, H/a, dark urine, swelling from deltoid to elbow and (R) axilla x 7 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: (1) On 11-14-2012 5:00 pm patient noticed 6" long welt, red raise and hot. (2) Went to MD on 11-15-12 9:00 AM nurse local reaction from shot. (3) At 2:30 on 11-15-12 returned to MD office. Patient was feverish, chilled, sore arm, red. MD thought maybe infection prescribed OMNICEF.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: (1) On 11-14-2012 5:00 pm patient noticed 6" long welt, red raise and hot. (2) Went to MD on 11-15-12 9:00 AM nurse local reaction from shot. (3) At 2:30 on 11-15-12 returned to MD office. Patient was feverish, chilled, sore arm, red. MD thought maybe infection prescribed OMNICEF.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediately following injection of MMR 2 small hives appeared on (L) thigh at site and then 2 small hives on Rt thigh near varicella vaccine BENADRYL po given & resolved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives all over her body and itching on Nov 21. Took BENADRYL 50 mg BID, on Nov 22-24. It helped. No other symptoms. Mom did not seek medical care. Mom told me today (Nov 27).
Age: 17.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Diarrhoea, Erythema, Full blood count normal, Headache, Injection site swelling
Clinical narrative: Fever, headache, vomiting, diarrhea, red, swelling at site, achy all over. Tx: ADVIL, TYLENOL, rest.
Age: 17.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever, headache, vomiting, diarrhea, red, swelling at site, achy all over. Tx: ADVIL, TYLENOL, rest.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 4.5 cm indurated tender swelling at site began 2 days after shot, 2 cm redness persists at site as well.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Several minute after injection 2 small hives appeared at site enlarging into a single large hive BENADRYL given po.
Age: 25.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Dizziness, Gaze palsy, Pallor
Clinical narrative: RN administered Hep B vaccine to patient in (L) arm without problems. RN administered MMR to (L) arm, less than 1 minute later, patient reported he was "going to faint". RN called for assist, patient did not loose consciousness, but did appear pale an eyes rolled back. Patient assisted to floor, then assisted to sitting in chair, walked out of clinic w/escort.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Patient reported red, swollen, painful area from shoulder to fingers. She noticed it right after the shot & it has gotten worse. I left a message with doctor & doctor will follow up with patient. The shot was sold on 11/27 at 13:29.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Lip swelling
Clinical narrative: Client received vaccines at clinic. Client left the clinic showing no signs of swelling. Approx 3-3.5 hours later client noticed swelling on right side of lips. The swelling progressed to left side. Client went to the ER. Per her report she received BENADRYL & "a steroid."
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Activities of daily living impaired, Injection site reaction, Myalgia
Clinical narrative: Patient experienced extreme muscle soreness in the tricep muscle near injection site. Lasted 1 month, still bothers her, has missed work as a result.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Oedema peripheral, Pain
Clinical narrative: Pt received vaccine in left arm (sub-q, triceps area) and complained of warmth & pain next day. The arm then swelled down to finger tips. He visited his doctor the next day and was prescribed BACTRIM DS. twice daily x 5 days.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Rash (red, raised, small) started 4 hours after administration. On abdomen & legs, buttocks. Took BENADRYL that night. Rash on legs & buttocks resolved next AM but several on left elbow & still on abdomen 11/21/12 spread to her back & very itchy.
Age: 40.0
Sex: F
Vaccine: JEV1
Symptoms: Headache
Clinical narrative: C/O HA most of the day after injection. Pt has hx of migraine HA's & also minor viral illness coincidentally. Pt advised to f/u with PMD if sx worsen or do not improve.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, axillary pain and adenopathy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test, Chills, Dysgeusia, Erythema
Clinical narrative: Headache, stomach cramping, nausea, metallic taste, fever, chills, tricep red and sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, stomach cramping, nausea, metallic taste, fever, chills, tricep red and sore.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red, swollen, tender at site of vaccination(s).
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Evening after receiving vaccine - chest pain, dizziness, short of breath.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Induration, Insomnia, Oedema peripheral, Pain
Clinical narrative: Afternoon of shot arm got more & more swollen so went to ER & got shot of morphine & told to go home & ice it. Called in morning complained of area 4"x6" hard hot & extremely painful prevented sleep even with morphine. Saw Dr & had X-ray of site which was Neg. also did blood cultures that were negative. Spoke to her 11-29-12 said she remains on BENADRYL, PEPCID and NORCO but it is getting better.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, X-ray limb normal
Clinical narrative: Afternoon of shot arm got more & more swollen so went to ER & got shot of morphine & told to go home & ice it. Called in morning complained of area 4"x6" hard hot & extremely painful prevented sleep even with morphine. Saw Dr & had X-ray of site which was Neg. also did blood cultures that were negative. Spoke to her 11-29-12 said she remains on BENADRYL, PEPCID and NORCO but it is getting better.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Bacterial test negative, Borrelia test positive, Dizziness, Full blood count, Immunology test
Clinical narrative: Increasing dizziness, pallor, right sided neck pain marked right sided neck pain, (L) arm pain, presyncopal unable to sit independently. Symptoms noted the next day. Pt was sent to the ED. Received IV fluids. Was discharged home. Had symptoms for several days. Lyme test was positive and pt was treated for Lyme.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity, Pallor, Presyncope, Streptococcus test negative
Clinical narrative: Increasing dizziness, pallor, right sided neck pain marked right sided neck pain, (L) arm pain, presyncopal unable to sit independently. Symptoms noted the next day. Pt was sent to the ED. Received IV fluids. Was discharged home. Had symptoms for several days. Lyme test was positive and pt was treated for Lyme.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: 15 y.o. male with "whole head" headache that started last night, a few hours after receiving his 1st HPV vaccine. Pt. says he has not taken anything for his pain. Given 1000mg TYLENOL in office.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Breath holding, Convulsion, Gaze palsy, Immediate post-injection reaction
Clinical narrative: Patient was administered vaccines. Immediately after began holding breath and eyes rolled back, appeared to be having a seizure. Child was observed during seizure which lasted about 1 min then Dr. was called to check him. Per Dr. heart (+) lungs sound good and perfusion good. Patient was observed in clinic for 15 min after seizure. No further reaction noted.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling cold, Headache, Hyperaesthesia, Pain of skin
Clinical narrative: High fever, freezing, skin hurt to touch, headache, dizzy. Started within 1 hour of getting flu shot and lasted around 24 hours.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: High fever, freezing, skin hurt to touch, headache, dizzy. Started within 1 hour of getting flu shot and lasted around 24 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Poor quality sleep
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 72 years old female patient. The patient current condition included osteoporosis and hypothyroidism and no drug reactions or allergies. On 16-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H016766, expiry date and dose were not provided) subcutaneously. Concomitant medications included levothyroxine sodium and ATELVIA. On 17-NOV-2012, the patient experienced soreness and radiating pain up to her shoulder in her left arm and she had trouble sleeping. It was unspecified whether lab studies were performed. The patient sought unspecified medical attention and was treated with TYLENOL 500 mg one tablet orally every 6 hours. On an unknown date in November 2012, the reported events were recovered. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 72 years old female patient. The patient current condition included osteoporosis and hypothyroidism and no drug reactions or allergies. On 16-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H016766, expiry date and dose were not provided) subcutaneously. Concomitant medications included levothyroxine sodium and ATELVIA. On 17-NOV-2012, the patient experienced soreness and radiating pain up to her shoulder in her left arm and she had trouble sleeping. It was unspecified whether lab studies were performed. The patient sought unspecified medical attention and was treated with TYLENOL 500 mg one tablet orally every 6 hours. On an unknown date in November 2012, the reported events were recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 13 years old female patient with celiac disease. The patient did not have drug reaction or allergies. The patient was vaccinated with 0.5 ml GARDASIL (lot number not provided) intramuscularly on 15-OCT-2012. No other co-suspects were reported. There were no concomitant medications. The patient developed an enlarged lymph node above her clavicle on approximately 18-OCT-2012, 3 days after she was given the GARDASIL injection. No treatment information was given for adverse event. Blood labs were performed and results were unknown. The parent of patient contacted physician assistant for seeking medical attention. The outcome of adverse event was unknown. Additional information is not expected.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of patients received doses of GARDASIL (dose, route and indication not reported) and PEDVAXHIB (dose, route and indication not reported) that were stored improperly. No concomitant medications were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 72 years old male patient with orthopedic unspecified issues, allergic rhinitis, hypertension, allergy to eggplant and penicillin. The patient was vaccinated with ZOSTAVAX (lot # (672675/0068AE), expiration date was 03-APR-2013, 0.65 ml, subcutaneous, left arm) on 15-MAY-2012. No other co-suspects were reported. Concomitant medications included: ASPIRIN one daily and AMBIEN for sleep PRN. The patient was seen in the office 15-NOV-2012 and complained of left arm swelling, lump, soreness at the injection site. The patient had been experiencing the effects for approximately 3 months or more (approximately in August 2012). The nodule/lump did not appear initially but appeared later, at least 2 months ago(approximately in September 2012). Treatment with BETAMETHASONE two times daily for 7 days. The patient had follow up visit at the doctor office tomorrow(on 16-NOV-2012). If he had not improved he will be referred to a infectious disease physician. The patient was seen in July 2012, but did not complain of any adverse effects at that time; only when he came in on 15-NOV-2012. The outcome of events were unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 12:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 06:03 the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 01:25, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 10:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 at 00:02, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age with immunization. The patient was vaccinated with ZOSTAVAX 3 years ago. No other co-suspects were reported. No concomitant medications were reported. On an unknown date 2 weeks ago the patient was diagnosed with shingles. She has lesions on her back and user th bra area and it is very painful. The patient was treated with pain medication. The outcome of shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 24-OCT-2012 at 17:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 22:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 03:22, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Malaise, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to her nephew who was a male patient of unknown age. The nurse reported that the patient became ill after receiving live, oral, ROTATEQ (Lot#, dose, route and duration unspecified) on an unknown date. The patient received two out of the three doses of the vaccine and became ill after each administration. The patient was seen by unspecified physician and an unspecified "GI Specialist". The "GI Specialist" did "blood work" and found that the patient contracted rotavirus. The "GI Specialist" recommended that the patient should not receive the third dose of the live, oral, ROTATEQ series. No treatment information was reported. The outcome was reported as recovering/resolving. Additional information is not expected.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40F for 30 days. There were no adverse effects. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 22-OCT-2012 03:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 years old female patient. The patient was vaccinated with, .5 ml VARIVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient experienced fever of 104.5 degrees fahrhenheit, 2 days after onset of therapy and small red dots on back. The patient received ADVIL as treatment. The outcome of fever of 104.5 degrees fahrenheit and small red dots on back was reported as recovered/resolved. The relatedness for fever of 104.5 degrees fahrenheit and small red dots on back is unknown for VARIVAX (Merck). 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 an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 10-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA012758, 1212USA000924 and 1212USA000925 (same reporter). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 29-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA011055, 1211USA012758 and 1212USA000925 (same reporter). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA011055, 1211USA012758 and 1212USA000924 (same reporter). Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiry, dose and route not reported). No concomitant medications were reported. On an unknown date, the patient developed a headache after taking ZOSTAVAX. No treatment information was reported. The outcome of headache was unknown. The relatedness for headache was unknown for ZOSTAVAX. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route were unspecified). Concomitant medications were unspecified. On an unknown date, the patient developed rash around the injection site after receiving ZOSTAVAX. The rash went away after an unspecified amount of time. The outcome of the event was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 68 years old female patient with penicillin allergy and no pertinent medical history. On 07-NOV-2012 the patient was vaccinated with ZOSTAVAX subcutaneously to prevent shingles. Dose was not provided. Product lot # was reported as H011050 (with expiry date of 05-SEP-2013). No other co-suspects were reported. Concomitant medications included atenolol, ZETIA, lisinopril, hydrochlorothiazide, glucosamine, metformin and diltiazem hydrochloride, all for unknown indications. In November 2012, 2 weeks after vaccination, the patient developed itchy rash all over her body and sought for medical attention. The rash started at the injection site of the patient's left arm and processed to both sides of the patient's body, from the neck down to the toes. It was noted that the rash was worse at the injection site compared to the rest of the patient's body. The patient received treatment with VALTREX and BENADRYL. The outcome of itchy rash all over the body was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Irritability
Clinical narrative: This spontaneous report as received from a physician refers to a 5 weeks old patient. Relevant medical history and past drug history was unknown. On 26-NOV-2012, the patient was vaccinated with a dose of ROTATEQ (lot number, expiry date, route and dose were not reported). Concomitant medications were unknown. The physician was told by the patient's mother that on 26-NOV-2012, the patient had the vaccine at 5 weeks rather than 6 weeks and was fussy. It was unknown if there were any relevant laboratory data. At the time of this report it was unknown if the patient would get the rest of the series of ROTATEQ. No treatment information was reported. The outcome of the event Fussy was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Infectious mononucleosis, Mononucleosis heterophile test positive, Oropharyngeal pain, Throat irritation
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 19 years old female patient with penicillin allergy and no pertinent medical history. On 26-NOV-2012 the patient was vaccinated with dose 2 of 0.5 ml VARIVAX (Merck) subcutaneously. No other co-suspects were reported. Concomitant medications included: oral hormonal contraceptive (unspecified). At time of vaccination, the patient experienced a scratchy throat. In the night she experienced increased throat pain. The next day, on 27-NOV-2012, the patient came back to the health department and was examined by the nurse practitioner. A monospot test was positive and the patient was diagnosed with mononucleosis. At time of this report the patient did not receive treatment medication. The outcome was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-OCT-2012 at 10:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 20:02, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 30-OCT-2012 at 13:23, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-OCT-2012 at 12:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 13-OCT-2012 at 23:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 03-NOV-2012 at 09:49, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 20:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 12:05, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 21-OCT-2012 16:10, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.