chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K023432 and expiry date: 18-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports 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 as received from a healthcare worker refers to a patient of unknown age and gender. On 04-MAY-2015 the patient was vaccinated with a dose of improperly stored MMR II, 0.5 ml, subcutaneously (lot number was not reported). No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 4 year old male patient. He had no pertinent medical history and no drug reactions or allergies. On 21-APR-2015, the patient was vaccinated with (Oka-Merck) PROQUAD subcutaneous (lot # reported as: K007157, dose not provided). There was no concomitant medication. On 26-APR-2015, the patient developed a rash and swelling at the injection site. Therefore the patient was seen at the unspecified physician's office on 28-APR-2015. No treatment was given and no lab diagnostic studies were performed. By the time of the report, the patient did not recovered from the events. Relatedness between the events and suspect product was not specified. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of unspecified patients. Patients medical history and current conditions were not reported. On an unknown date since 2-JAN-2015, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K006960 and expiry date 19-FEB-2017) via intramusucular route. No adverse effect reported. Product quality complaint was not reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of unspecified patients. Patients medical history and current conditions were not reported. On unspecified dates since 2-JAN-2015, the patients were vaccinated with unspecified number of improperly stored doses of COMVAX (lot # J013884 and expiry date 19-AUG-2016) via intramuscular route. No adverse effect reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, RECOMBIVAX HB of lot # J007943, expiry date 05-FEB-2016 and lot number J007946, with expiry date 24-MAR-2016 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored RECOMBIVAX HB. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, GARDASIL of lot # K004205, expiry date 12-JAN-2017 and lot number K005881, with expiry date 14-JAN-2017 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored GARDASIL. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. 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 registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with improperly stored doses (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 29-APR-2015, the patient were vaccinated with an improperly stored dose of PROQUAD (dose, route, lot # and expiration date were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unspecified date, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 (lot # K004930 and expiry date: 16-MAR-2015, reported as 06-MAR-2015) after the labeled expiration date. No adverse effects reported. No product quality complaint was reported for PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old female patient with drug allergies to codeine and tramadol hydrochloride. No concurrent or historical conditions were reported. On 21-APR-2015 the patient was vaccinated with ZOSTAVAX subcutaneously (strength and dose unknown, lot # K023621, expiration date: 19-FEB-2015). There the patient did not take any concomitant medication. On 22-APR-2015, the patient experienced injection site reaction to ZOSTAVAX. The patient noticed injection site tenderness and redness. The patient initiated the use of hydrocortisone as treatment but the pharmacist advised her to stop. The pharmacist saw the patient on 30-APR-2015 and noted the redness had faded to a "pinkish color" and reduced in size to "about the size of a half dollar" at the injection site. The outcome of the events were recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 63 year old female patient with a pertinent medical history of high blood pressure. Drug reactions or allergies and concomitant medications were not specified. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot number were not reported) to prevent shingles. The patient received the vaccine from an unspecified pharmacy. A week later, the patient developed shingles. The patient sought medical attention via a doctor visit. The outcome of herpes zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Nodule, Oral herpes, Pruritus
Clinical narrative: This spontaneous report as received from a 70 year old female patient who is also a healthcare worker and who was reporting on herself. The patient's pertinent medical history included hypertension and benign breast mass. The patient had an allergy to ampicillin, penicillin and KEFLEX. Concomitant therapies included ramipril, MOTRIN and simvastatin (manufacturer unknown). On 24-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and route were not reported, lot # K018172, expiration date 02-DEC-2015). On an approximately 24-MAR-2015 (reported as approximately 4 weeks after), the patient experienced fever blisters, itching, nodules in back of head and side of her face and swelling on her lips. The patient did not seek a medical attention and did not receive any treatment. There was no lab diagnostics and studies performed. The patient's outcome was not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Information has been received from a physician via practice manager referring to a 52 year old female patient. Her medical history and past drug history are unknown. On 08-MAY-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015) dose 1, 0.5 ml, intramuscular in the left arm. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL TABLETS, fluticasone propionate, ADVAIR, albuterol, SEROQUEL. There was no relevant laboratory data or tests. As of 08-MAY-2015, she no longer took PNEUMOVAX 23 and the outcome of being administered an expired vaccine was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient. She had no pertinent medical history and no known allergies. On 24-APR-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous in the left arm, lot # K020185 and expiry: 27-JAN-2016. There was no concomitant medication. On an unknown date in April 2015, the patient experiened redness and itchiness at the injection site of her left arm. Apart from that, the patient was in the sun on approximately 25-APR-2015 (reported as "on Saturday afternoon") and suspected that due to sun exposure she was also experiencing tingling of her finer (in April 2015). The patient sought medical attention and called the pharmacy. There was no treatment given and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. Relatedness between the events and suspect vaccine was not specified. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 18-year-old patient of unknown gender. On 24-APR-2015, the patient was vaccinated with one dose of (Oka/Merck) PROQUAD 0.5 ml, subcutaneously (lot number and expiration date was unknown) instead of the intended single dose each of MMR II and (Oka/Merck) VARIVAX. No adverse effects were reported. Additional information is not expected as there was no permission to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. Since unknown dates from 01-APR-2015, the patients were vaccinated with (Oka/Merck) VARIVAX (route, dose, Lot# and expiration date not reported), the vaccines were exposed to temperatures outside of the recommended range on 01-APR-2015. No adverse effect has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Patient describes arm red, swollen and itchy with hives down to elbow.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Large circular surrounding rash (15cm), warmth, extreme tenderness, palpable mass at injection site, arthralgia, myalgia, fatigue.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Large circular surrounding rash (15cm), warmth, extreme tenderness, palpable mass at injection site, arthralgia, myalgia, fatigue.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a few patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K006960, expiration date 19-FEB-2017, dose and route were unknown). No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected because the reporter does not want to be contacted further.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 01-MAY-2015, the patient was inadvertently administered an expired dose of GARDASIL, expiration date 13-OCT-2013 (lot #, dose and route not provided. The patient had not reported any adverse effects. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Cough, Flushing, Urticaria, Wheezing
Clinical narrative: Urticaria, facial flushing, wheezing, coughing. Prednisolone and BENADRYL 6 mL also given. Gave 0.2 mL of 1/1000 Epinephrine injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient report fever, rigors, severe muscle pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm became hot, red and swollen over area that extended beyond deltoid according to mother and pain lasted for over 3 days. Pt. had to be given pain meds.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Skin warm
Clinical narrative: 5/4/15 developed quarter size area of induration with warmness, applied ice and took NSAID/ 5/5/15 increased to baseball size area of induration with warmness sent to PCP.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Computerised tomogram head normal, Diarrhoea, Enema administration, Haematochezia, Intussusception
Clinical narrative: Patient developed vomiting and loose stools on 4/ /15. Admitted on 4/12/15 to hospital for vomiting. Developed bloody stools and lethargy. Had evaluation for head trauma and intussusception on 4/12. Negative initial U/S but symptoms persisted. Review of initial ultrasound w/ possible intussusception and U/S repeated confirming this. Reduced by air contrast enema w/ surgery team.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Lethargy, Ultrasound abdomen abnormal, Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: Patient developed vomiting and loose stools on 4/ /15. Admitted on 4/12/15 to hospital for vomiting. Developed bloody stools and lethargy. Had evaluation for head trauma and intussusception on 4/12. Negative initial U/S but symptoms persisted. Review of initial ultrasound w/ possible intussusception and U/S repeated confirming this. Reduced by air contrast enema w/ surgery team.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warmth
Age: 0.67
Sex: F
Vaccine: MNQHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave pt. MENHIBRIX instead of missing PREVNAR dose. Looked at chart wrong. No adverse reaction.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Developed ITP - given steroid boost and will F/U with blood work to make sure platelets recover back to a normal level.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Smallpox
Clinical narrative: This spontaneous report was received from a 65 year old female patient referring to herself. The patient reported that she had gotten prior case of shingles 3 to 5 years ago. The patient's concurrent conditions and concomitant mediations were not reported. On an unknown day, reported as "six months after her first case of shingles", the patient was vaccinated with ZOSTAVAX, (dose, lot# and route of administration not reported, in the right arm). On 10-APR-2015 (also reported as this past Friday), the patient experienced "small pox" on both arms and sought medical attention. The physician who attended her, advised that she was having another case of shingles. The outcome of the adverse event was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurser refers to unspecified number of patients of unknown age and gender. Information about the patient's relevant medical history or concomitant medications was not reported. Since May 2015 (for both vaccines reported as since 08-MAY-2015), the patients were vaccinated with improperly stored doses of GARDASILL (route, dose, lot# and expiration date were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-APR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (INJ N/A 10 VIALS OF 1) (lot # K005957 and expiration date 08-MAR-2015) 0.5 ml, intramuscular. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Scrotal swelling
Clinical narrative: This spontaneous report was received from a consumer refers to her son as a male patient of unknown age. On 07-APR-2015, the patient was vaccinated with MMR II INJ initial dose (dose and lot# were not reported). On 18-APR-2015, the patient experienced mild fever, rash and scrotal swelling. It was not specified if the patient will receive the subsequent doses. On an unknown date, the patient sought medical attention by an office visit. Action taken was not applicable. The outcome of reported events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Induration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling & itching around the injection site on the left anterolateral arm. Area of erythema and induration at office visit on 5/11/2015 was 10 cm x 8 cm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient experienced itching raised rash red to touch. Came into doctor on 5/11/15 had spread down to pash elbow. Started on antibiotic Keflex bid for 10 days at this time.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Musculoskeletal stiffness
Clinical narrative: Stiff neck, body ache, severe headache, fever 102, vertigo, extreme fatigue. Stiff neck, body ache (extreme in joints) and fever resolved in 4 days, vertigo and fatigue took 6 weeks to resolve and I still don't feel "normal".
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Vertigo
Clinical narrative: Stiff neck, body ache, severe headache, fever 102, vertigo, extreme fatigue. Stiff neck, body ache (extreme in joints) and fever resolved in 4 days, vertigo and fatigue took 6 weeks to resolve and I still don't feel "normal".
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Bacterial test, Headache, Lethargy, Malaise, Pyrexia
Clinical narrative: Fever 103.6, headache, lethargy, malaise, skin sores, pustules.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Rash pustular, Skin ulcer, Viral test
Clinical narrative: Fever 103.6, headache, lethargy, malaise, skin sores, pustules.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 08-MAY-2015 the patient was vaccinated with an improperly stored dose of MMR II, 0.5 ml, subcutaneous (dose number, lot number and expiration date were unspecified. No concomitant therapies were reported. No adverse experience reported. The outcome of the event was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt describes swelling, redness and pain, fever the day following vaccine. Pt seen on 4/17 by MD urgently. Right upper arm with non blanchable, slightly swollen, warm erythema measuring 19 cm w/superior width 11 cm and posterior 16 cm. Treated w/doxycycline monohydrate 100 mg oral tabs by mouth 2x day x 10 days - F/U with provider.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt describes swelling, redness and pain, fever the day following vaccine. Pt seen on 4/17 by MD urgently. Right upper arm with non blanchable, slightly swollen, warm erythema measuring 19 cm w/superior width 11 cm and posterior 16 cm. Treated w/doxycycline monohydrate 100 mg oral tabs by mouth 2x day x 10 days - F/U with provider.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Unsure of actual time of onset. Patient's wife reported that redness at injection site has moved down past his elbow. (Pt got SubQ Pneumovax 23).  Red area is sore and hot. Patient is contacting physician. At this time has not seen doctor, but we recommended he call/see physician.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives on Face.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient's last menses was 4 April, she was vaccinated on 16 April and came in on 11 May with a positive pregnancy test.  This is to report in case any tracking is needed.  Patient has no adverse event at this time and was notified of the theoretical concern.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: The LVN was giving Pentacel, she gave the DTaP, and Polio antigens with the ActHib component. The child received the correct antigens, but they were mixed incorrectly.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: LVN giving Pentacel, used the blue bottle containing Polio and DTap and mixed with ActHib, the child received the correct components, although the vaccine was mixed incorrectly.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Diet refusal, Laboratory test, Mobility decreased, X-ray
Clinical narrative: After day of vaccination, all of sudden he started giving up on feeding and stop turning on side. That never happen before vaccinations. His growth percentile was perfect at his 2 months pediatric visit (the day he got his 2 months vaccines).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: RED RAISED QUARTER SIZED REACTION ON ARM SHORTLY AFTER INJECTION WAS GIVEN. PHARMACIST INFORMED PT TO USE ICE PACK, TAKE IBUPROFEN AND/OR TYLENOL AS DIRECTED. PT CALLED BACK 5/12/15 AND SAID THERE WRE RED STRIATIONS FROM INJECTION SITE DOWN BACK OF ARM. UPPER ARM SORE AND PAINFUL AND NECK PAIN. PAIN HAS SUBSIDED SINCE THE INJECTION WAS GIVEN BUT STILL HAS THE ROUND AREA RAISED AND RED STRIATIONS DOWN ARM. WARM TO TOUCH IS STILL THERE.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: RED RAISED QUARTER SIZED REACTION ON ARM SHORTLY AFTER INJECTION WAS GIVEN. PHARMACIST INFORMED PT TO USE ICE PACK, TAKE IBUPROFEN AND/OR TYLENOL AS DIRECTED. PT CALLED BACK 5/12/15 AND SAID THERE WRE RED STRIATIONS FROM INJECTION SITE DOWN BACK OF ARM. UPPER ARM SORE AND PAINFUL AND NECK PAIN. PAIN HAS SUBSIDED SINCE THE INJECTION WAS GIVEN BUT STILL HAS THE ROUND AREA RAISED AND RED STRIATIONS DOWN ARM. WARM TO TOUCH IS STILL THERE.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction developed after Zostavax administered. Patient was instructed by MD to monitor size and to take hydrocortisone or Benadryl if itching.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on abdomen, neck and rt temple area. ER evaluation. Possible chicken pox post vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with a first dose of GARDASIL dose, route and lot# were not reported. On 08-MAY-2015, the patient received a second dose of GARDASIL dose, route, and lot# were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-MAY-2015 the patient was vaccinated with PNEUMOVAX 23, administered intramuscularly. The patient received a 1.5 mL dose of PNEUMOVAX 23 instead of the recommended 0.5 mL dose. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Night sweats, Pain in extremity
Clinical narrative: Soreness in arm, shortness of breath, and headache. Night sweats.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Discomfort, Febrile convulsion, Pyrexia
Clinical narrative: Child displayed slight fever and uncomfort, the days after the 12 months vaccines were administered. Then, he underwent a febrile seizure on Sunday morning. No other symptoms showed except for fever during these days. He finally was fever-free on Tuesday, May 12th.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Contusion, Pruritus, Rash, Urticaria
Clinical narrative: Woke up itching and noticed hives, bumps and bruising and was given Benadryl.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Dental operation, Device failure, Electromyogram
Clinical narrative: Over the course of a few days, loss function of legs, arms, and hands. Unable to control bowel movements and bodily functions. Unable to walk; wheelchair bound for life. Unable to bathe or dress myself. Numerous dental teeth implants fell out. Treatments included medicines, IVig treatments, Plasmapharesis, extensive Physical Therapy, Dental Surgery, among other treatments.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Faecal incontinence, Immunoglobulin therapy, Musculoskeletal disorder, Nerve conduction studies, Plasmapheresis
Clinical narrative: Over the course of a few days, loss function of legs, arms, and hands. Unable to control bowel movements and bodily functions. Unable to walk; wheelchair bound for life. Unable to bathe or dress myself. Numerous dental teeth implants fell out. Treatments included medicines, IVig treatments, Plasmapharesis, extensive Physical Therapy, Dental Surgery, among other treatments.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Wheelchair user
Clinical narrative: Over the course of a few days, loss function of legs, arms, and hands. Unable to control bowel movements and bodily functions. Unable to walk; wheelchair bound for life. Unable to bathe or dress myself. Numerous dental teeth implants fell out. Treatments included medicines, IVig treatments, Plasmapharesis, extensive Physical Therapy, Dental Surgery, among other treatments.
Age: 1.51
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: High Fever over 101.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Pain, Polymerase chain reaction
Clinical narrative: Patient began having severe lateral torso pain 24-48 hours post vaccine that then radiated to back and scapula.  The pain persisted and he saw a physician on May 8, 2015.  She noted the zoster rash (that the patient had not seen) and diagnosed him with shingles.  He was started on antivirals on that day for 7 days.  He was seen in the research clinic on May 12, 2015; samples were taken from the zoster vesicles and sent to the CDC for PCR/genotyping. This patient is participating in a clinical trial.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient began having severe lateral torso pain 24-48 hours post vaccine that then radiated to back and scapula.  The pain persisted and he saw a physician on May 8, 2015.  She noted the zoster rash (that the patient had not seen) and diagnosed him with shingles.  He was started on antivirals on that day for 7 days.  He was seen in the research clinic on May 12, 2015; samples were taken from the zoster vesicles and sent to the CDC for PCR/genotyping. This patient is participating in a clinical trial.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Haematochezia, Intussusception, Vomiting
Clinical narrative: Patient had large emesis around 0730 on 4-16-2015 after am feeding. Patient was taken to daycare and reported to the patient's mother that he was very tired and did not want any bottles for that day. Mother took infant to local ER who transferred to hospital. Patient did have a bloody stool while admitted to ER. Patient was admitted to the hospital as inpatient and later diagnosed with intussusception.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Burning sensation, Erythema
Clinical narrative: Intense erythema circumferentially around entire upper arm in 3 inch wide band with burning sensation.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Blood electrolytes, Blood glucose, Cardiac function test, Cardiac stress test, Chills
Clinical narrative: Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Coagulation test, Diarrhoea, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Hypertension, Laboratory test, Nausea, Palpitations
Clinical narrative: Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Tachycardia, Ultrasound abdomen, Urine analysis, Vertigo, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count
Clinical narrative: Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient reported tenderness/firmness at the injection site which had continued at day 3 post vaccine administration.
Age: 0.41
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Injection site erythema, Injection site nodule, Screaming
Clinical narrative: Redness at injection site, high pitched scream that evening for about 1 hour off and on and was inconsolable. Knot under skin where vaccine for given for about a month.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dysaesthesia, Injection site dysaesthesia, Muscle spasms, Tension
Clinical narrative: Tension and spasm of left trapezius and dysesthesia into deltoid area and lateral forearm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site swelling, Screaming
Clinical narrative: Patient received Pentacel immunization at 9:35 AM, and according to Mom the patient was screaming for several hours after getting the vaccine. Patient's left leg (where the vaccine was given) also swelled up. Tylenol dose was administered by Mom after talking to the nurses around 2:20 pm, and baby did eventually stop crying and fall asleep. Patient called back a couple hours later and baby was doing much better.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Arthralgia, Myalgia
Clinical narrative: Miscarriage, muscle pain, joint pain.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyskinesia, Eye movement disorder, Pallor, Unresponsive to stimuli
Clinical narrative: Student turned pale, pasty eyes rolled to back of head and started jerking movement or upper arms, non responsive to verbal stimuli. EMS activated and student taken to hospital for further evaluation.
Age: 0.87
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Aggression, Antisocial behaviour, Decreased appetite, Developmental delay, Emotional distress
Clinical narrative: He started a high pitch constant scream that lasted for several hours. He was inconsolable. Arching neck and back. He was very rigid. Hard to hold onto. Then lethargic, irritable. Screamed constantly. Didn't sleep well. Had fever for 15 days of 103-104 degrees. I called pediatrician immediately. I brought son in to see, the next day. They checked him. said no sign of any illness. Probably a virus and to bring back in 3 days if still have fever. I did every 3 business days. My son has never been the same. He banged his head on the floor, wall, toy box, ect. Has frequent meltdowns. Sensory and auditory processing concerns. Very aggresive with peers. Antisocial. Sever social anxiety and parental attachment. Hard time self soothing. Doesn't eat well or sleep. Has milestone delays. He receives treatment from an Early Interventionist and speech therapist once a week. He has been sent to an Occupational Therapist. The insurance and few available in our area prevent him from benefiting from treatment.
Age: 0.87
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Head banging, Hearing impaired, Irritability, Lethargy, Muscle rigidity
Clinical narrative: He started a high pitch constant scream that lasted for several hours. He was inconsolable. Arching neck and back. He was very rigid. Hard to hold onto. Then lethargic, irritable. Screamed constantly. Didn't sleep well. Had fever for 15 days of 103-104 degrees. I called pediatrician immediately. I brought son in to see, the next day. They checked him. said no sign of any illness. Probably a virus and to bring back in 3 days if still have fever. I did every 3 business days. My son has never been the same. He banged his head on the floor, wall, toy box, ect. Has frequent meltdowns. Sensory and auditory processing concerns. Very aggresive with peers. Antisocial. Sever social anxiety and parental attachment. Hard time self soothing. Doesn't eat well or sleep. Has milestone delays. He receives treatment from an Early Interventionist and speech therapist once a week. He has been sent to an Occupational Therapist. The insurance and few available in our area prevent him from benefiting from treatment.
Age: 0.87
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Opisthotonus, Poor quality sleep, Pyrexia, Screaming, Sensory disturbance
Clinical narrative: He started a high pitch constant scream that lasted for several hours. He was inconsolable. Arching neck and back. He was very rigid. Hard to hold onto. Then lethargic, irritable. Screamed constantly. Didn't sleep well. Had fever for 15 days of 103-104 degrees. I called pediatrician immediately. I brought son in to see, the next day. They checked him. said no sign of any illness. Probably a virus and to bring back in 3 days if still have fever. I did every 3 business days. My son has never been the same. He banged his head on the floor, wall, toy box, ect. Has frequent meltdowns. Sensory and auditory processing concerns. Very aggresive with peers. Antisocial. Sever social anxiety and parental attachment. Hard time self soothing. Doesn't eat well or sleep. Has milestone delays. He receives treatment from an Early Interventionist and speech therapist once a week. He has been sent to an Occupational Therapist. The insurance and few available in our area prevent him from benefiting from treatment.
Age: 0.87
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Social phobia, Viral infection
Clinical narrative: He started a high pitch constant scream that lasted for several hours. He was inconsolable. Arching neck and back. He was very rigid. Hard to hold onto. Then lethargic, irritable. Screamed constantly. Didn't sleep well. Had fever for 15 days of 103-104 degrees. I called pediatrician immediately. I brought son in to see, the next day. They checked him. said no sign of any illness. Probably a virus and to bring back in 3 days if still have fever. I did every 3 business days. My son has never been the same. He banged his head on the floor, wall, toy box, ect. Has frequent meltdowns. Sensory and auditory processing concerns. Very aggresive with peers. Antisocial. Sever social anxiety and parental attachment. Hard time self soothing. Doesn't eat well or sleep. Has milestone delays. He receives treatment from an Early Interventionist and speech therapist once a week. He has been sent to an Occupational Therapist. The insurance and few available in our area prevent him from benefiting from treatment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: Passed out while leaving the mass vaccination for meningitis B (Trumenba Vaccine).
Age: 0.24
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swelling with lump at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2015US008637, is an initial spontaneous report from a nurse received on 30 Apr 2015. This report refers to an 18-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient does not have any known allergies and had tolerated vaccines in the past. The patient was vaccinated with MENVEO (batch number: M14075) intramuscularly into the deltoid on 29 Apr 2015. On the same day after vaccination, the patient experienced swelling, warmth and hardness across the arm from the deltoid to elbow of the arm of MENVEO administration. The reporter insisted that the warmth, hardness and swelling was approximately three inches away from the injection site and does not incorporate the injection site. The patient did not receive any vaccine concomitantly. On 30 Apr 2015, the patient went to a clinic and was being treated for cellulitis in the arm. The final outcome of the events was unknown. Seriousness and causality was not reported. Seriousness of the event cellulitis in the arm was upgraded based on NVS-IME list.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Epstein-Barr virus infection
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a patient of unknown age and gender. The patient's medical history included an unspecified lymphoma and bone marrow transplant (date was not provided). On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously (anatomical location, dose, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. On an unknown date, after receiving ZOSTAVAX, the patient died of possible complications of Epstein Barr Syndrome, it was unknown if an autopsy was performed. The patient sought medical attention through an office visit. No product quality complaint was involved. At the time of the report, the outcome of Epstein-Barr virus infection was fatal. the causal relationship between Epstein-Barr virus infection/death and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Autoimmune disorder, Visual acuity reduced
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to an 11 year old female patient. Patient's current conditions and pertinent medical history were not provided. In around 2010 the patient was vaccinated with her first dose of GARDASIL (lot#, dose and route were unspecified). Concomitant therapies included MENACTRA and Tdap, which were given at the same time as GARDASIL. Within a few days the patient became partially blind; this was diagnosed as autoimmune in nature. The patient was seen by ophthalmologists. Diagnostic tests information was unknown. Her vision resolved within a few weeks, but it was a scary few weeks. The physician believed it was probably a coincidence (i.e., not caused by the vaccines), but could not be certain. Because the physician couldn't be certain she preferred now not to give GARDASIL and MENACTRA at the same time. Upon internal review, the event of autoimmune partial blindness was considered to be medical significant. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Contusion, Skin disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of contusion in a 66-year-old male patient who received Influenza vaccine. Co-suspect products included VOTRIENT tablet for lung disorder. Concurrent medical conditions included sleeve gastrectomy, diabetes mellitus, blood pressure high, artificial cardiac pacemaker user and renal cancer. Concomitant products included ACTOS, lisinopril and NORVASC. In October 2014, the patient received Influenza vaccine. In May 2014, the patient started VOTRIENT (oral) 800 mg once daily. In October 2014, less than a month after receiving Influenza vaccine and several months after starting VOTRIENT, the patient experienced contusion and skin disorder. On an unknown date, the outcome of the contusion and skin disorder were not recovered/not resolved. The reporter considered the contusion to be almost certainly related to Influenza vaccine and VOTRIENT. The reporter considered the skin disorder to be probably related to Influenza vaccine and VOTRIENT. Additional information: The patient reported that he had a flu shot (unknown manufacturer) in October 2014 and experienced bruising on his arms and hands. The patient also reported that he experienced bruising on his arms and hands after taking VOTRIENT. The patient planned to continue follow-up with his physician on an unknown date.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of therapy non-responder in a patient who received ENGERIX B. Previously administered products included ENGERIX B (in series in 2002). Concurrent medical conditions included hepatitis c. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional information received: Nurse reported that a patient received Hepatitis B vaccine in series in 2002 on unspecified dates and started that the patient was non responder. The nurse also reported that she was aware a lot (unspecified amount) of patients that were non responders to ENGERIX. No further information was provided.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Skin reaction
Clinical narrative: Red, indurated area (L) arm 5x7 cm
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Systemic rash on face, torso, arms, legs, plantar surface of hands/feet.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt states she noticed swelling/redness of injection site later in the evening of the day vaccine was administered which lasted 5-6 days. She states the area of injection was very "firm". Later that same night she felt very fatigued and weak. She states that she has been "tired" and "not regained all her strength back" yet, ever since the evening of the vaccination. Patient never called office to tell us this and never reported event to anyone until 05/05/15.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chest X-ray normal, Chest pain, Urinary system X-ray, Urine output decreased
Clinical narrative: PT. received HPV dose #1 on 04/16/14 approximately 3 wks after developed s/s of back/chest pain and decreased urination as reported to dr on 7/14/14 at OV for same S/s approximately 3 weeks after HPV #2 was given. Pt. sent for CXR and AXR (KUB). All WNL. Dr suspects reaction to HPV vaccines.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: PT. received HPV dose #1 on 04/16/14 approximately 3 wks after developed s/s of back/chest pain and decreased urination as reported to dr on 7/14/14 at OV for same S/s approximately 3 weeks after HPV #2 was given. Pt. sent for CXR and AXR (KUB). All WNL. Dr suspects reaction to HPV vaccines.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: Local redness. Numb up his neck and down back.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash
Clinical narrative: Local redness. Rash size of pancake on arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R upper arm became red and swollen, redness about baseball size. R upper arm swollen lasted approx 2 days. Used ice therapy ibuprofen and loratadine/BENADRYL.
Age: 0.8
Sex: F
Vaccine: MMR
Symptoms: Epinephrine, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to her 10 month old daughter. The patient's medical history included familial risk factor of autoimmune disorders. The patient concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (route, lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient experienced pyrexia described as a fever of 105 degrees and pain in extremity. The patient sought medical attention by an office visit. On an unknown date, the epinephrine levels were measured but the results were not provided. At the time of the report, the outcome of pain in extremity and pyrexia was unknown. Additional information is not expected. There was no consumer information to contact for follow-up.