chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Axillary pain, Brachial plexopathy, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable physician's assistant. A 57 year-old male patient received PREVNAR 13 (lot J67646, expiry date 01Mar2016) intramuscular in the left deltoid and MENOMUNE (lot UH537AA, expiry date 20May2016) subcutaneous in the right deltoid, both on 30Jan2015 at 1:20 pm at 0.5 ml single. The patient was HIV positive since 2009 and he has been on anti-viral therapy for a long time, other relevant medical histories included ongoing hepatitis C since 2012, ongoing allergy to latex, ongoing syphilis diagnosed on 30Jan2015. The patient underwent laboratory tests and procedures which included syphilis test: 1-4 on 11Feb2015 and for that on 17Feb2015 he received BICILLIN LA. The patient's concomitant medications were not reported. The patient had previously taken KEFLEX and had experienced blood pressure fluctuations and heart rate abnormal, meperidine and he had experienced hiccups. On 02Mar2015 the patient experienced brachial plexitis from which he was not recovered, right shoulder pain and numbness in right middle fingers, deep pain in right scapula and pain persisted in right hand because of weakness and numbness, all with unknown outcome. Due to the events the patient had seen a neurologist at a tertiary care center, he had a phone call with a specialist neurologist on 06Mar2015 and he visited him on 27Mar2015. On 27Mar2015 pain moved into this right armpit and inside of right arm; pain was right subscapular and he still had right hand weakness especially right index finger, from which he was not recovered. The neurologist believed that the adverse reactions were from either one of the vaccines. The patient was on anti-viral therapy but it was a stable regimen and the reporter did not think the above was due to that.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Musculoskeletal pain, Pain in extremity, Treponema test positive
Clinical narrative: This is a spontaneous report from a contactable physician's assistant. A 57 year-old male patient received PREVNAR 13 (lot J67646, expiry date 01Mar2016) intramuscular in the left deltoid and MENOMUNE (lot UH537AA, expiry date 20May2016) subcutaneous in the right deltoid, both on 30Jan2015 at 1:20 pm at 0.5 ml single. The patient was HIV positive since 2009 and he has been on anti-viral therapy for a long time, other relevant medical histories included ongoing hepatitis C since 2012, ongoing allergy to latex, ongoing syphilis diagnosed on 30Jan2015. The patient underwent laboratory tests and procedures which included syphilis test: 1-4 on 11Feb2015 and for that on 17Feb2015 he received BICILLIN LA. The patient's concomitant medications were not reported. The patient had previously taken KEFLEX and had experienced blood pressure fluctuations and heart rate abnormal, meperidine and he had experienced hiccups. On 02Mar2015 the patient experienced brachial plexitis from which he was not recovered, right shoulder pain and numbness in right middle fingers, deep pain in right scapula and pain persisted in right hand because of weakness and numbness, all with unknown outcome. Due to the events the patient had seen a neurologist at a tertiary care center, he had a phone call with a specialist neurologist on 06Mar2015 and he visited him on 27Mar2015. On 27Mar2015 pain moved into this right armpit and inside of right arm; pain was right subscapular and he still had right hand weakness especially right index finger, from which he was not recovered. The neurologist believed that the adverse reactions were from either one of the vaccines. The patient was on anti-viral therapy but it was a stable regimen and the reporter did not think the above was due to that.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: No adverse event
Clinical narrative: No adverse reaction occurred after vaccine was given.
Age: 53.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chills, Delusion, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: States she had fever, did not take temp but reports chills and felt she had fever. Heat swelling redness to area. Pain at site. Flu like symptoms felt delusional.  Symptoms started in evening.
Age: 53.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: States she had fever, did not take temp but reports chills and felt she had fever. Heat swelling redness to area. Pain at site. Flu like symptoms felt delusional.  Symptoms started in evening.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Amylase normal, Asthenia, Blood HIV RNA, Cytomegalovirus test negative, Differential white blood cell count normal
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus antibody negative, Full blood count normal, HIV test, HIV test negative, Lymph node pain
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mumps antibody test negative, Myalgia, Night sweats, Oral discomfort, Parotid gland enlargement
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Polymerase chain reaction, Pyrexia, Swelling face
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Amylase normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Cytomegalovirus test negative, Epstein-Barr virus test negative
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Full blood count normal, HIV test negative, Inappropriate schedule of drug administration, Malaise
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 24.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mumps antibody test negative, Parotid gland enlargement, Pyrexia, Serology negative
Clinical narrative: Patient c/o vague myalgias and mild fevers on 3/24, the following day he noted left cheek swelling associated w/ fevers and that night he had nightsweats. On 03/25/2015 morning he awoke w/ both cheeks swollen and noted discomfort chewing, but was able to eat and swallow w/o throat pain. On 3/27 when he came into office he reported feeling a little better, now it no longer hurts to bite down and clinch teeth. Fevers and nightswetas persist. Energy level is mildly depressed.  Patient presented to office with fever of 103 degrees and Bilateral swelling of the parotid glands, firm and tender to palpation. Non toxic appearing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site joint movement impairment, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh was red, warm to the touch, and swollen from upper thigh to knee.  The child would not bend his knee no fever. Mom iced the leg and gave Motrin.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE IS STILL SORE AND PAINFUL AFTER FIVE WEEKS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Arm very sore, small red rash at the site of shot, warm to touch, palpable area about the size of a quarter, cheeks red and possibly a low fever; mother called about 4pm on 4/8/15 to report symptoms. Instructed to apply ice to the area and give pain medications if felt needed per recommendations in appendix D of pink book; instructed mother to seek medical attention if symptoms worsened; Mother did call pediatrician and was instructed to give Benadryl and she did administer to child; follow up call on 4/9/15 mother reported area a little bigger and still somewhat red with soreness being the same and she reported that her left arm is swollen and warm with no redness or pain where Kinrix was administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Arm very sore, small red rash at the site of shot, warm to touch, palpable area about the size of a quarter, cheeks red and possibly a low fever; mother called about 4pm on 4/8/15 to report symptoms. Instructed to apply ice to the area and give pain medications if felt needed per recommendations in appendix D of pink book; instructed mother to seek medical attention if symptoms worsened; Mother did call pediatrician and was instructed to give Benadryl and she did administer to child; follow up call on 4/9/15 mother reported area a little bigger and still somewhat red with soreness being the same and she reported that her left arm is swollen and warm with no redness or pain where Kinrix was administered.
Age: 1.88
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: When speaking with mother about sister's adverse reaction she reported that patient had some redness, swelling and pain to both of her thighs when immunizations were given. She administered Benadryl and Motrin as recommended per her pediatrician.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Musculoskeletal pain, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Had flu shot, morning of 9-22-2014. That evening body aches, chills, runny nose. About one month later the pain in arm, shoulder and shoulder blade. Dec. went to Dr. was given Rx for MOBIC. Still the pain there. Back to Dr. Jan. 2015 more of same rx after X-ray. March 2015 saw item in paper about shots checked web. Still have pain. Ice used.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb normal
Clinical narrative: Had flu shot, morning of 9-22-2014. That evening body aches, chills, runny nose. About one month later the pain in arm, shoulder and shoulder blade. Dec. went to Dr. was given Rx for MOBIC. Still the pain there. Back to Dr. Jan. 2015 more of same rx after X-ray. March 2015 saw item in paper about shots checked web. Still have pain. Ice used.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy-developed 24-48 hours after vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Lip swelling, Oral herpes, Swelling face
Clinical narrative: On Mar 19, 2015, at 8:43 AM, patient wrote: I just wanted to inform you of an adverse reaction I had that began the evening after I received the flu vaccine. My lips began swelling and got progressively worse over the next few days. I took BENADRYL every 8 hours in the hopes of decreasing the reaction but by day 2, other parts of my face began swelling, lip swelling increased and I broke out with cold sores all over my lips. I went to see Dr. on Friday and he began me on VALTREX for the cold sores. By Friday night it was much worse and today is the first time I have been able to come back to work.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously, (lot # J014810, expiration date: 21-FEB-2015), (strength and anatomical location was not reported) which was expired. No adverse events were reported and product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Vaccine 4/7/15-small area of redness right thigh. 4/8/15 AM mom noticed more redness right thigh. Worsening 4/9/15 0945 apparent right thigh w/ local reaction approximately 6cm diameter and most consistent w/ reaction to DTaP #4. Mildly tender. Ambulating. Afebrile.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 58 years old female patient who did not have pertinent medical history, drug reactions or allergies. On 16-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route and anatomical location were not reported), (lot # K015312, expiration date: 17-DEC-2015). The patient was not taken concomitant medications. On an unspecified date in March 2015, the patient experienced a 3 inch raised, reddened area around the injection site, no rash was presented and due this the patient went to the pharmacy on 19-MAR-2015. It was not given treatment for the adverse event and no lab diagnostics studies were performed. Product quality complaint (PQC) was not involved. The outcome of 3 inch raised, reddened area around the injection site was reported as not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. The healthcare professional reported that beginning on 04-FEB-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information is not expected, since there was no consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. On 08-APR-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot# and expiration date were not reported) instead of VARIVAX (Merck). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 02-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, lot reported as: H33604, expiry date: March 2015, route of administration were not reported) or PREVNAR 13. It was documented by the administering nurse just as a pneumonia vaccine. It was intended for the patient to receive PREVENAR 13, but the clinic also had PNEUMOVAX 23 in stock. Concomitant therapy was unknown. Relevant tests were unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient with congestive cardiac failure. The patient had no drug reactions nor allergies. On 17-JAN-2015, he was vaccinated with a dose of PNEUMOVAX23 intramuscularly 0.5 ml, once, in his arm (lot # K009876, expiration date: 19-MAR-2016). Concomitant therapies included ZANTAC, XANAX, TOPROL, CYMBALTA, LIPITOR, NITROSTAT, DIOVAN, allopurinol, ZYLOTAN and LOMOTIL. On the same day, the patient experienced arm pain and soreness in the muscle at the injection site. It was unspecified by the reporter whether any treatment was given for adverse event. No laboratory test was perform. The patient sought medical attention by visiting the pharmacist (date was unknown). No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Redness on inj site, raised and red lesions, itchy, feels hot, mild pain. TX: diphenhydramine 12.5mg/5ml oral liquid directions 8mL PO TID.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Skin lesion
Clinical narrative: Redness on inj site, raised and red lesions, itchy, feels hot, mild pain. TX: diphenhydramine 12.5mg/5ml oral liquid directions 8mL PO TID.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site oedema, Injection site pain
Clinical narrative: Edema, pain at injection site that extended to (L) axilla. TX=BENADRYL and NSAIDS and ice.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's daughter and refers to a female patient of unknown age. In approximately March 2013, two years ago, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiry date were not reported). In approximately March 2015, recently, the patient developed shingles. The patient's outcome was not reported. The relatedness between the therapy with ZOSTAVAX and the adverse event was not reported. Additional information is not expected because there is no contact information with reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to her currently 60 year old sister. The patient's concurrent conditions included breast cancer and penicillin allergy (reported as upper respiratory distress). On 27-MAR-2015, the patient was vaccinated at unspecified pharmacy with ZOSTAVAX, lot # K007986, expiration date 03-SEP-2015, (dose, route and site of administration were not reported). Concomitant therapies included tamoxifen, propranolol, CITRACAL, ZYRTEC. On 30-MAR-2015, the patient broke out with red raised area near her ear. No lab tests were done. Attention via making appointment with her physician. During the visit, the patient was diagnosed with shingles. VALTREX was suggested as a treatment for the event. The outcome of herpes zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a currently 3 years old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The reporting nurse stated that on unspecified dates, the patient was vaccinated with three doses of VAQTA 20/0.5 (units not reported), 0.5 ml, intramuscular (lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information is not expected, since there was no consent to follow up.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Blood test normal, Cardiac stress test normal, Dizziness
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to an approximately 13 year old female patient, who was also a school athlete. The patient's pertinent medical history included asthma and drug allergies were none. On an unknown date in August 2014, the patient was vaccinated with first dose of GARDASIL. Concomitant medications were none. On an unknown date in 2014 since 1 week after the administration of 1st dose of vaccine, the patient experienced episodes of stomach pian, nausea, paleness, weakness and dizziness. These episodes are associated with exercise and resolve with food and rest, without requiring medical intervention. The patient was evaluated by an unspecified provider at medical Center. An unspecified blood work was negative. The patient was referred to an unspecified cardiologist. A cardiac stress test and electrocardiogram were normal. The second dose of GARDASIL was administered an unknown date in October 2014. The outcome of the events, stomach pain, nausea, paleness, weakness and dizziness was reported as recovered/resolved. The relatedness of the events with GARDASIL was not reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Nausea, Pallor
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to an approximately 13 year old female patient, who was also a school athlete. The patient's pertinent medical history included asthma and drug allergies were none. On an unknown date in August 2014, the patient was vaccinated with first dose of GARDASIL. Concomitant medications were none. On an unknown date in 2014 since 1 week after the administration of 1st dose of vaccine, the patient experienced episodes of stomach pian, nausea, paleness, weakness and dizziness. These episodes are associated with exercise and resolve with food and rest, without requiring medical intervention. The patient was evaluated by an unspecified provider at medical Center. An unspecified blood work was negative. The patient was referred to an unspecified cardiologist. A cardiac stress test and electrocardiogram were normal. The second dose of GARDASIL was administered an unknown date in October 2014. The outcome of the events, stomach pain, nausea, paleness, weakness and dizziness was reported as recovered/resolved. The relatedness of the events with GARDASIL was not reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacy manager via company representative refers to a patient of unknown age and gender. The patient's medical history was not reported. In 2015 (reported as about middle of last week, near 01-APR-2015), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route of administration were not reported) in arm. No concomitant medication was reported. On 05-PAR-2015 (reported as 3 days ago), the patient returned to the pharmacy with tingling in arm at the injection site. There was no redness. No treatment was given and pharmacy had not heard back from patient at the time of report. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 06-APR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K003601, expiry date: 19-MAR-2015, 0.65 ml, subcutaneous). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients. No medical history, concurrent conditions, concomitant medications and drug allergies were reported. On unknown dates, between 03-MAR-2015 and 20-MAR-2015, the unspecified patients were vaccinated with improperly stored VARIVAX (Merck), lot# K007784, expiration date 28-MAY-2016 or lot# K002925, expiration date 26-FEB-2016, (dose, administration route and site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Rash
Clinical narrative: Rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Erythema, Flushing, Generalised erythema, Injection site erythema
Clinical narrative: Patient reported to me 6 hours after vaccine feeling flushed, generalized skin redness (not just at site of inj.). Felt throat closing up/cough-sxs resolved quickly. Then persistent red rash at injection site no vesicles with surrounding swelling, erythema arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Throat tightness
Clinical narrative: Patient reported to me 6 hours after vaccine feeling flushed, generalized skin redness (not just at site of inj.). Felt throat closing up/cough-sxs resolved quickly. Then persistent red rash at injection site no vesicles with surrounding swelling, erythema arm.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Injection site erythema, Tremor
Clinical narrative: 9/20/2012 - Patient states he got a flu shot and the pnu shot in the same arm, 2 days ago, states the first night he was cold, shaking like a leaf, sweating but cold, states that the next day he felt bad, but did not have the shakes. Today he feels better but he has noticed that below where he got the injections he has redness. No pain. No swelling. Just a bug red place. About the size of a saucer . No fever.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 month old patient. The patient's medical history and current conditions were not provided. On 06-APR-2015, the patient was vaccinated with RECOMBIVAX HB lot # K023863, expiration date 03-APR-2016, intramuscular in the leg. Secondary suspects and concomitant therapies were not reported. On 06-APR-2015, during vaccination the Luer Lok broke off of the barrel of the prefilled syringe after the needle was inserted intramuscularly in the child's unspecified leg. Product quality complaint (PQC) was involved. The patient did not experience any adverse effects. There was no treatment given for adverse event. There was no lab diagnostics studies performed. Patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age who refers herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration not reported). On an unknown date the patient experienced developed redness and swelling at the injection site after administration of ZOSTAVAX. The outcome of injection site swelling and injection site erythema was unknown. The relatedness was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Type 1 diabetes mellitus
Clinical narrative: New onset Diabetes Mellitis type I.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Child complained to parent when came home from school.  Arm swollen, hot and bright red down to elbow. No fever.  Dr. treated as skin infection with 7 day course of antibiotics, but wasn't sure if it was a shot reaction, so also prescribed Benadryl and ibuprofen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin infection
Clinical narrative: Child complained to parent when came home from school.  Arm swollen, hot and bright red down to elbow. No fever.  Dr. treated as skin infection with 7 day course of antibiotics, but wasn't sure if it was a shot reaction, so also prescribed Benadryl and ibuprofen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site infection, Pain in extremity, Peripheral swelling
Clinical narrative: Per the father, son stated his right arm hurt and looked red and swollen.  Father then transported pt to the local emergency dept for evaluation.  Father stated the diagnosis at discharge was a local infection at the injection site and a Rx for amoxicillin was written.  After speaking with the father on 4/8/15 he stated the arm looked better and his son was feeling better as well.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rash, Rash macular
Clinical narrative: Macular rash on wrists and hands requiring the administration of Benadryl, as well as complaints of "a headache in the back of my head".
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after gave vaccination 1:30 pm. Pt awake and oriented x3 and vital signs normal. Pt went home with Father. Called Home Father states "she is doing fine. She went to shopping with Mother.
Age: 27.0
Sex: F
Vaccine: TYP, YF
Symptoms: Exposure during pregnancy
Clinical narrative: Potential adverse event to fetus: vaccines administered before patient knew she was pregnant. Was approximately 6 weeks of gestation on 3/27. Tdap and MENACTRA were administered at the office and Typhoid/Yellow Fever at pharmacy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an 18 year old female patient. On unknown date, the patient was vaccinated with the 1st, 2nd and 3rd doses of GARDASIL (route, lot number and expiration date not reported) and on 26-MAR-2015, the patient was inadvertently administered a fourth dose. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to 3 patients who were over 13 years. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot# and dose not reported), subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: RED HOT SWOLLEN LEFT ARM.  PT DESCRIBES AS PAINFUL.
Age: 0.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Screaming
Clinical narrative: Screaming and high pitched for hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a pharmacist referring to a 71 year old male patient. Concurrent conditions, pertinent medical history of the patient were not reported. The patient had no drug reactions/allergies. On an unspecified date in 2013 (reported as "2 years ago") the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified). After receiving ZOSTAVAX, the patient had multiple outbreaks of shingles, accompanied by nerve pain. The patient sought medical attention via visit the pharmacy and was treated with gabapentin 300 mg. At the time of this report, the outcome of shingles and nerve pain was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist refers to a 59 year old female patient with no drug reactions/allergies. Pharmacist reporting that the patient believed that she received a dose of ZOSTAVAX (lot # K020185, EXP date 27-JAN-2016) intramuscularly in her left arm on 23-MAR-2015. The pharmacist confirmed that the patient believed that the injection needle was inserted into her muscle. On 25-MAR-2015, the patient contacted the pharmacist because she was concerned that she has redness and swelling of approximately 4 inches in diameter around her injection site on her left upper arm. The pharmacist did not clarify with the patient when the redness and swelling began, and the pharmacist recommended that the patient take ibuprofen for the discomfort and the swelling. She did not know if the patient has taken any ibuprofen, and if the patient has contacted her healthcare provider. She also did not think the patient was experiencing a rash. Follow-up AE Information was received on 26-MAR-2015 from the primary pharmacist. The pharmacist reported that the ZOSTAVAX was administered via the subcutaneous route not via the intramuscular route, as previously reported. The pharmacist stated, "the patient gave me wrong information, the ZOSTAVAX was given subcutaneous as it should have been". The patient sought medical attention by notifying pharmacist. There was none lab diagnostics studies performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Left thigh approximately 8cm area marked w/ erythema approximately 6cm. Tender to palpation. Ambulating. No fever. Local reaction.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1504USA003189, 1503USA005652 and 1504USA003190) from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse via company representative, refers to a seven patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed that on an unknown date in March 2015, the patients were vaccinated with M-M-R II HSA (strength, dosage and route were not reported) lot# K020188, expiration date 22-OCT-2016, that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, and the temperature was unspecified. No adverse effects were reported. The licensed vocational nurse also informed that the shipment were 20 doses of M-M-R II HSA, however just 7 doses were administered. Additional information has been requested.
Age: 1.46
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Febrile seizure.
Age: 1.28
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Patient with hives face, ears, neck, chest, trunk. Vomited x1. BENADRYL 12.5mg/5ml, 5ml PO x1 hives responding within 5-10 min.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On 07-APR-2015 the patients were vaccinated subcutaneously with PROQUAD (Merck) (dose, lot# and expiration date were not reported) which underwent a supported temperature excursion. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Numbness in right hand, can't move control fingers 8 days later. Feels burning, down back of arm, down the hand.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On an unknown date the patients received improperly stored M-M-R II (incorrect product storage). No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered product the event to be not related to M-M-R II. This is one of several reports from the same reporter (MARRS # 1504USA004227 and MARRS # 1504USA004065). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, office manager and medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 18-MAR-2015, the patient was vaccinated with a expired dose of ZOSTAVAX lot number K000996, expiry date 13-MAR-2015 (dose and route were not reported). No adverse effect had been observed or reported. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of PNEUMOVAX23, (lot #, series and route of administration not reported). On an unknown date, the patient experienced hypersensitivity to PNEUMOVAX23. The outcome of hypersensitivity was unknown. The patient then after, on an unknown date was vaccinated with a dose of PREVNAR 13. The healthcare professional inquired if the patient could receive PREVNAR13 even if the patient has the hypersensitivity history with PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Acne, Diarrhoea, Insomnia, Oropharyngeal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female (non-pregnant) patient of unknown age. No concurrent conditions or medical history were provided. On 28-MAR-2015, the patient was vaccinated with a dose of M-M-R II injection, administered 0.5 ml subcutaneously in the right arm (lot # K001231 with expiry date 27-JAN-2016 and albumin status: HSA). No concomitant medications were reported. On 30-MAR-2015, the patient developed a pimple on her neck, pain in her throat, pain in the arm that was vaccinated ("painful right arm"), diarrhea, fever of 99F, itchy tummy and behind, restlessness and also the patient could not sleep. The patient sought medical attention, she called pharmacy and the pharmacist advised her to go to an urgent care clinic. The patient did not go to urgent care but did take 500 mg of acetaminophen as treatment. The pharmacist stated that all symptoms resolved on 31-MAR-2015, except the diarrhea. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Restlessness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female (non-pregnant) patient of unknown age. No concurrent conditions or medical history were provided. On 28-MAR-2015, the patient was vaccinated with a dose of M-M-R II injection, administered 0.5 ml subcutaneously in the right arm (lot # K001231 with expiry date 27-JAN-2016 and albumin status: HSA). No concomitant medications were reported. On 30-MAR-2015, the patient developed a pimple on her neck, pain in her throat, pain in the arm that was vaccinated ("painful right arm"), diarrhea, fever of 99F, itchy tummy and behind, restlessness and also the patient could not sleep. The patient sought medical attention, she called pharmacy and the pharmacist advised her to go to an urgent care clinic. The patient did not go to urgent care but did take 500 mg of acetaminophen as treatment. The pharmacist stated that all symptoms resolved on 31-MAR-2015, except the diarrhea. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 4-year-old female patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). Previously administered products included INFANRIX with an associated reaction of no adverse event (Series) and PEDIARIX with an associated reaction of no adverse event (Series). Concomitant products included PROQUAD. On 27th March 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 28th March 2015, 1 days after receiving KINRIX, the patient experienced hives and allergic reaction. The patient was treated with BENADRYL ALLERGY. On an unknown date, the outcome of the hives and allergic reaction were recovering/resolving. The reporter considered the hives and allergic reaction to be possibly related to KINRIX. Additional information was provided as follow: The patient had KINRIX along with PROQUAD in her left leg. Next day, she had hives on left leg from thigh down to knee and corresponding hives right thigh where there was no injection. PROQUAD given SQ back of left thigh and KINRIX given IM left AL thigh. Mother finally took child to ED on 2 April 2015 because hives were not resolving. No other local injection site reactions or systemic reactions. ED said it was an allergic reaction and she should not receive KINRIX again.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients. No medical history, concurrent conditions, concomitant medications and drug allergies or reactions were reported. On unknown dates, between 03-MAR-2015 and 20-MAR-2015, the unspecified patients were vaccinated with improperly stored GARDASIL, dose 0.5 ml, intramuscular, (lot#, expiration date and administration site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash, Rash macular
Clinical narrative: On 4/2/15 3 months old infant male was vaccinated by PCV, HBV, PENTACEL, oral ROTATEQ-and 45 minute after # shot in office, by parent reported on 4/6/15 when, later had chest, abdomen macular rash.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On an unknown date the patients received improperly stored PEDVAXHIB (incorrect product storage). No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered product the event to be not related to PEDVAXHIB. This is one of several reports from the same reporter (MARRS # 1504USA004228 and MARRS # 1504USA004065). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. On an unspecified date in 2014 (reported as one year ago), patient received the first dose of GARDASIL (dose/frequency and route unspecified). The patient received second dose of GARDASIL on 02-APR-2015. No adverse effects were reported. Outcome of the event, inappropriate schedule of drug administration was unknown. Reporting health professional considered product the event to be not related to GARDASIL. Causality assessment was not provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchospasm, Dyspnoea, Vomiting
Clinical narrative: No erythema or tenderness at site. 3/24/15 Vaccine Tdap administered. 3/27/15 Vomiting immediate care. 3/29/15 Acute bronchospasm immediate care prednisone, albuterol. 3/31/15 ZPAK given for cough, SOB, patchy opacity left lunch back. ER to R/O clot. 4/5/15 ER R/O clot.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information about patient's current condition or medical history was not reported. "2 years ago", in April 2013 the patient got her first dose of VARIVAX (Merck) (lot#, dose, route not reported). Concomitant medications were not provided. The pharmacist reported that the patient was found to fail to seroconvert on an unknown date and the patient was getting another dose of VARIVAX (Merck) (0.5ml subcutaneous, left arm) "today", on 07-APR-2015. Outcome of "fail to seroconvert" was not reported. The causality was not provided. Additional information is not expected as the reporter did not want to be contacted.