chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Chapped lips, Electroencephalogram normal, Local reaction, Rash
Clinical narrative: Case number# PHEH2015US023424, is a report initially received from a consumer (patient's mother) via a Patient Oriented Program on 09 Nov 2015. This report refers to a child female patient. Historical condition was not reported. Current condition included tuberous sclerosis. Concomitant medications included levocarnitine, DEPAKOTE and Vitamin D. The patient received AFINITOR for the treatment for brain and spinal cord frontal ganglioglioma from 19 Jul 2014 at a dose of 5 mg, QD (route: oral). On an unknown date, the patient received Influenza Virus Vaccine Unknown Inn from an unknown date and dose (route: unknown). It was stated that, the patient's treatment with AFINITOR discontinued for the 2 weeks prior and 2 weeks after the flu shot. On an unknown date, the patient developed local reaction. It was stated that, it was not as severe as she had after previous year's flu shot. The patient restarted her AFINITOR (2 weeks after the flu shot) and not missed any doses since then. The AFINITOR stopped on 05 Jul 2015. Patient's mother reported that on 10 Feb 2016, the patient had rash on patient's face, around her lip area that caused her lips to crack and chafe (chapped lips). The local doctor gave her some Mupirocin cream and the patient used this for about 3 days and it cleared up and had not returned. The patient's AFINITOR was held on 02 Oct (year unknown) and 02 Nov (year unknown). She resumed therapy on 02 Dec (year unknown) with no reappearance of the rash. Last month, patient had an EEG that showed no seizure activity so the doctor did not believed that the DEPAKOTE being increased was a help to the patient. So he decreased it back to her regular dose. Treatment with AFINITOR was temporarily interrupted. On an unknown date, the patient was completely recovered from the events. The seriousness and causality of the events was not reported. Follow up report received from a consumer (patient's mother) via a Patient Oriented Program on 11 Mar 2016: Added new events (rash) (chapped lips), treatment medication, and action taken of suspect AFINITOR and updated narrative accordingly.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024362, is an initial spontaneous report received from a nurse on 18 Nov 2015. This report refers to a patient of unknown demographics. Medical history and concomitant medication were not reported. The patient was vaccinated with a high dose influenza vaccine (manufacturer and batch number: not reported) intramuscularly on an unknown date. It was reported that before administration the vaccine was out of temperature range. No adverse event was reported following this maladministration.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection was painful. My arm hurt within 5 mins. A red area appeared within an hour, it was approx. 2 x 3 inches in size, hot, and hard, and painful, to touch stayed that way for about 11 days.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Injection was painful. My arm hurt within 5 mins. A red area appeared within an hour, it was approx. 2 x 3 inches in size, hot, and hard, and painful, to touch stayed that way for about 11 days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Blood magnesium decreased, Diarrhoea, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: Rc'd vaccine 10/7/16 on 10/9/16 developed SOB and fever-lethargic and had diarrhea 10/9/16 to 10/14/16 went to emergency room and found to have low mag level. Main complaint after vaccine was lethargy and sleepy all day. Patient feels vaccine cause lethargy and fever for longer than expected.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: Rc'd vaccine 10/7/16 on 10/9/16 developed SOB and fever-lethargic and had diarrhea 10/9/16 to 10/14/16 went to emergency room and found to have low mag level. Main complaint after vaccine was lethargy and sleepy all day. Patient feels vaccine cause lethargy and fever for longer than expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Dizziness, Malaise
Clinical narrative: Patient reported dizziness and not feeling well. Blood pressure taken at 9:27am 102/56 Pulse 48. 911 called at 9:30am Blood pressure monitored until 911 arrived at 9:41am. Patient transported to ER.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Erythema, Joint range of motion decreased, Peripheral swelling, Pyrexia
Clinical narrative: Arm was red and swollen with a loss in range of motion. (left arm) Patient had mild fever.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Influenza like illness, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of face, eyes, throat evening of shot flu like symptoms also.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness and swelling at site, nausea and dizziness on day one.
Age: 1.08
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Stomatitis
Clinical narrative: 1 week after receiving vaccines, diagnosed with gingivostomatitis. BMX mouthwash prescribed.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous, Skin test
Clinical narrative: Itching with red rash on all four extremities.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site pain
Clinical narrative: Soreness in area of injection lasting for 3 months, and continuing (left arm following PREVNAR 13 immunization).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Enlarged swelled at injection site, 3-4 inches. No warmth or redness, not tender to touch.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Amylase, Blood lactic acid, Blood magnesium, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: Pt. explains feels like symptoms started on 10/30/16 light headed, no sleep, no appetite, arm numbness (left).
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram pelvis, Decreased appetite, Dizziness, Hypoaesthesia
Clinical narrative: Pt. explains feels like symptoms started on 10/30/16 light headed, no sleep, no appetite, arm numbness (left).
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Laboratory test, Thyroid function test, Urine analysis, X-ray limb
Clinical narrative: Pt. explains feels like symptoms started on 10/30/16 light headed, no sleep, no appetite, arm numbness (left).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Pt. had fever in evening after immunization given, and was given Ibuprofen. Pt. no longer has fever. Pt. also has local redness at injection site. L. thigh: 10x8, R. thigh 3x3 cm. Advised ice and antihistamines. Informed to f/u w/any more fever.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt. received Varicella vaccine 11-29-16. Within 24 hrs. vaccine became itchy, red "erythematous non-indurated area on upper right arm with TTP, no warmth of area" per Dr.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: 7x7 cm red, circular, warm and tender to touch reaction on (R) deltoid. Swelling noted.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Injection site rash
Clinical narrative: Rash at injection site, then increase heart beat. Call 911 Paramedic, patient still alert. Took patient to ER and release patient couple hours later.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Prior to Imm mom reported with last 2 sets of shots and recent venous lead draw, child got red bumps around sites beyond bandaid and used non - alcohol wipe. About 5 minutes after shots MMR - VAR sites; red rash at site and bandaid partly applied BENADRYL topically, rash decreased and resolved 15 minutes. Given po BENADRYL before left.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Pain, Rash, Rash erythematous
Clinical narrative: Erythema indurated area at injection site 4 cm x 3 cm - pain with palpation and with walking. Diffuse maculopapular erythema rash on abdomen, chest, back and spreading to arms.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Rash maculo-papular, Tenderness
Clinical narrative: Erythema indurated area at injection site 4 cm x 3 cm - pain with palpation and with walking. Diffuse maculopapular erythema rash on abdomen, chest, back and spreading to arms.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: light head, pale, vomiting.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Burning at injection site (R upper arm). For 2 days unable to raise arm. Severe pain to raise arm 2 months later - As of today hurts when raising 1/2 up hurts badly at shoulder level (stiffness). The injection has been 2 months - as of today I can hardly move my arm.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client given Hep A #2 dose to soon.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Erythema multiforme, Rash
Clinical narrative: Pt developed systemic rash the same day as receiving vaccine. Pt was diagnosed with erythema multiforme.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, HEPA, MMRV
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: Approx 1 hour after receiving vaccines, mom called. Reports vomiting x 2 and sweating.
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Temp 100 after immunizations. Vomiting.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Monoplegia, Pain
Clinical narrative: Case number PHHY2016US178864 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 659344) website on 21 Dec 2016. This report refers to 59 years old male patient. Past medical history was not reported. Concomitant medication included as Gabapentin tablets, Lisinopril, JANUVIA, Glimepiride, Levothyroxine, Hydrocortisone ointment, Venlafaxine HCL ER capsules, Hydrocodone/APAP. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) (previously reported as invalid) intramuscularly into the right arm and PNEUMOVAX (batch number: M027552) intramuscularly into the left arm on 13 Oct 2016. On the same day after vaccination, he experienced severely painful reaction in which he felt like his arm was paralyzed. The outcome of the events was reported as condition unchanged. The seriousness assessment of the event monoplegia was upgraded to serious (medically significant) based on the NVS IME list. The seriousness assessment of the event pain was upgraded to serious (medically significant) based on the information available in the source document. Upon follow up initially reported batch number: 168704 was not valid for FLUCELAX QUADRIVALENT and hence investigation would not be performed. The batch number 168704 previously reported was invalid for FLUCELVAX QUADRIVALENT. Previously reported lot number was listed for FLUVIRIN. Follow up report received from Quality assurance department on 03 Jan 2017: Suspect drug batch number (invalid) removed and updated reporter comment and narrative accordingly.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Malaise, Nausea, Pain, Swelling
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient. The patient had no drug reactions or allergies. Concomitant medication was unknown. On 03-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose unknown, route: intramuscular, lot # M020521, expiration date: 17-NOV-2017) for prophylaxis (reported as "vaccine"). On 04-JAN-2017 (reported as the next day), the patient called the pharmacy complaining of redness, swelling, pain, and inflammation. No treatment was given for the events and no lab was performed. The patient was recovering from the events. The causal relationship between the event and PNEUMOVAX 23 was unknown. This is one of three "multiple patient reports". Additional information has been requested. Sender's Comments: US-009507513-1701USA003855: US-009507513-1701USA004988.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain, Swelling
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old male patient. The patient had no drug reactions or allergies. Concomitant medication was unknown. On 03-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose unknown, route: intramuscular, lot # M020521, expiration date: 17-NOV-2017) for prophylaxis (reported as "vaccine"). On 04-JAN-2017 (reported as the next day), the patient called the pharmacy complaining of redness, swelling, pain, and inflammation. No treatment was given for the events and no lab was performed. The patient was recovering from the events. The causal relationship between the event and PNEUMOVAX 23 was unknown. This is one of three "multiple patient reports". Additional information has been requested. Sender's Comments: US-009507513-1701USA003855: US-009507513-1701USA004988.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain
Clinical narrative: Arm where shot was administered feels like I'm being stung by a bee but nothing is there I feel like Im going crazy I have this happen throughout the day when I use my arm it gets worse.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: My left arm is so sore. The place in my arm where I was given the shot feels like fire. I have a bump where the shot was given. It feels like the pain is extending. I had a different physical feeling after the shot like not feeling well. I will contact my doctor today.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Constipation, Dehydration, Listless, Pain in extremity, Pyrexia
Clinical narrative: Symptoms: high pitched, prolonged screaming, fever, leg pain, projectile vomiting, listlessness, dehydration, crossed eyes, and no bowel movement for eight days. Stopped smiling until roughly 3 weeks after the vaccine was administered. TYLENOL was given twice to help with leg pain and fever on 02/17/2016.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Screaming, Strabismus, Vomiting projectile
Clinical narrative: Symptoms: high pitched, prolonged screaming, fever, leg pain, projectile vomiting, listlessness, dehydration, crossed eyes, and no bowel movement for eight days. Stopped smiling until roughly 3 weeks after the vaccine was administered. TYLENOL was given twice to help with leg pain and fever on 02/17/2016.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2016, the patient who was indicated to receive M-M-R II received in error a dose of PROQUAD, recombinant human albumin (rHA) (dose and route of administration were not reported), lot # M010478 with expiration date on 01-SEP-2017. The reporter did not know why the error occurred. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received an improperly stored dose of PROQUAD (lot# M007694, expiration date 15-AUG-2017; lot# M033908, expiration date 16-JAN-2018) (dose, frequency and route were unknown). The lot# M007694 was not valid for PROQUAD. The vaccines (lot# M007694, expiration date 15-AUG-2017) were exposure to -15 to -10 degree Centigrade for 13 hours 48 minutes. The vaccines (lot# M033908, expiration date 16-JAN-2018) were exposure to -15 to -10 degree Centigrade for 14 hours 5 minutes. There was no previous temperature excursion reported. The improper storage of vaccines was not found by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up. Sender's Comments: US-009507513-1701USA005033.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (intramuscularly, dose, injection site, lot# and expiration date were not reported), after the vaccine had experienced a temperature excursion. No adverse effects were noted. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Immunisation, No adverse event, Product quality issue, Underdose
Clinical narrative: This spontaneous report was received from a R.Ph pharmacist concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On an unknown date, the patient did not receive a full dose of PNEUMOVAX 23 due to product quality complaint issue (accidental underdose) 0.5ml, one shot (lot number M040804, expiration date 20-MAY-2018, route was not reported) for prophylaxis, so a new dose of PNEUMOVAX 23 was given with no issues (extra dose administered) (dose, route, lot number and expiration date were not reported). No adverse experiences were reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: This spontaneous report as received from a patient of unknown age and gender, who is also a licensed chiropractor, concerning themselves. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the, patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The other suspect vaccine was given on the same date and included ZOSTAVAX for prophylaxis in an area other than the deltoid region (dosage schedule, route, lot number and expiration date were not reported).  Concomitant therapies were not reported. The patient thought that the PNEUMOVAX 23 was given in the wrong area and she had complaint of pain in the arm (pain in extremity) where PNEUMOVAX 23 was given. No product quality complaint was involved. The outcome of pain in extremity was unknown at the time of reporting. The relatedness between the event and the suspect therapies was not provided by the reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash, Thermal burn
Clinical narrative: This spontaneous report was received from a patient's mother concerning to her 3.5 years old male son. The patient did not have any medical history or drug reaction/allergy. No concomitant medications were reported (also reported as topical silver sulfadiazine cream  on his burn). On 20-DEC-2016, the patient was vaccinated with VARIVAX 0.5ml once, injection into the leg (unspecified leg) (lot number and expiration date were not reported) for prevention (prophylaxis). Subsequently, on the same date (reported  as since the patient got the vaccination) the patient "got a burn on his hand" (thermal burn). On approximately 29-DEC-2016 (reported as 5 or 6 days ago), the patient developed "little bumps that look like flea bites. The first one was at the injection site on his leg (injection site mass), Subsequently, on 31-DEC-2016 (reported as two days later), another one appeared on his belly (skin mass), and on 04-JAN-2017 (reported as this morning) the patient had another two on his neck (neck mass). It was reported that the patient did not have fever and felt fine, however, the reporter spoke with the patient's doctor's office by phone. A topical silver sulfadiazine cream had been used for the local burn, but no treatment was given for the little bumps. No laboratory diagnostic was performed and a product quality complaint was not involved. At the time of the report, the outcome of the events was reported as not recovered.  The causal relationship between the events and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant (also reported as nurse), referring to patient of unknown age (reported as "pediatric aged") and gender. Information regarding medical history, drug reactions and concomitant therapies was not reported. On 15-DEC-2016, the patient was vaccinated with an expired PROQUAD, subcutaneously, (dose, and frequency were not provided), lot# K022285 and expiration date 12-NOV-2016 for prophylaxis. No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Injection site reaction, Wrong technique in product usage process
Clinical narrative: This solicited report was received from a 55 year old female patient as part of a marketing research, referring to herself. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date in 2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The needle hit the bone and it was very painful. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was unknown. Additional information is not expected as there was no consent for follow up.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MMR
Symptoms: Blood test, Fall, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 19 year old female patient. There were no concurrent conditions, medical history or concomitant medications. On 05-JAN-2017, the patient was vaccinated with GARDASIL for prevention of Human Papillomavirus (HPV), M-M-R II for prevention of measles, mumps and rubella and hepatitis a vaccine, inactivated (Manufacturer unknown) (dosing details were not reported) for prevention of Hepatitis A. On the same day, after the vaccines were administered, the patient stiffened up, fell over and was unresponsive. The patient was taken to the emergency room at an unspecified hospital. There were unspecified tests and blood work performed (results not reported). It was unknown if any treatment was provided for the adverse events. On the same day, the patient recovered. Reporting physician had not assessed the causality of the events with respect to the suspect vaccines. Upon internal review, the event, unresponsive to stimuli was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On unspecified dates, multiple unspecified patients received improperly stored VAQTA lot # M003011, expiry date : 15-NOV-2017 (dosing details not reported). No concomitant medications were reported. No adverse effects were reported. Temperature/time frame: 30.2 F for 56.47 hours. There was no previous temperature excursion. The call was due to data logger. There was no product quality complaint reported. This is one of the three reports from the same reporter source (1701USA003860 and 1701USA003747). Additional information has been requested. Sender's Comments: US-009507513-1701USA003747: US-009507513-1701USA003860.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This non-valid spontaneous report was received from a consumer via social media and refers to several female patients of unknown ages. On an unknown dates, the patients were vaccinated with a dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) for prophylaxis. The reporter did not specify the type of human papillomavirus (HPV) vaccine used. On an unknown date (reported as hours after this vaccine), the patients expired (reported as "friends lost their daughters. Upon internal review, the events of death was considered medically significant. This is one of the three cases provided by the same reporter. Additional information is not expected, as there was no contact information for the reporter provided. Sender's Comments: US-009507513-1701USA005923: US-009507513-1701USA005922.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # M020100, expiration date 07-MAR-2019 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of PEDVAXHIB were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M025565, expiration date 08-NOV-2017 (dose was not reported). There were no adverse effects reported. Administered doses of ROTATEQ were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as L049455, expiration date 03-DEC-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of PROQUAD experienced the temperature excursion of -11 degrees Fahrenheit for 44 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009271.
Sex: U
Vaccine: HEPA, MMRV, PNC
Symptoms: Dehydration, Gastroenteritis
Clinical narrative: This is a Literature report. This author reported similar reports for 2 subjects. This is the first of two reports. This author conducted an open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2; n=323) VAQTATM (25 U/0.5 mL) (hepatitis A vaccine; HAV) with PROQUAD (measles/mumps/rubella/varicella; MMRV) and PREVNAR (7-valent pneumococcal; PCV-7) in healthy, 12-23 month-old children. Group 1 received HAV/MMRV/PCV-7 concomitantly on Day 1 and second doses of HAV/MMRV at Week 24. Group 2 received MMRV/PCV-7 on Day 1, HAV at Weeks 6 and 30 and MMRV at Week 34. A subject of an unspecified age, race, and gender received on Day 1 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR) and measles, mumps, rubella, and varicella vaccine (PROQUAD); both via an unspecified route of administration on an unknown date at a single doses for immunization. At week 6 of study, the patient also received hepatitis a vaccine (VAQTATM, 25 U/0.5 mL) via an unspecified route of administration on an unknown date at a single dose for immunization. The subject's medical history and concomitant medications were not provided. On an unknown date, on day 52 of study, the patient experienced dehydration and gastroenteritis, which were serious for being medically significant. The clinical outcome of the serious adverse events, dehydration and gastroenteritis, was unknown. The author reported the serious adverse events dehydration and gastroenteritis (Group 2 post-administration of MMRV/PCV-7) possibly vaccine-related.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety valuation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2017007364 different patient/event, same drug.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Chills, Cyanosis, Headache, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician. A 20-year-old female patient receive the first dose of TRUMENBA, at 0.5 ml single in the right deltoid on 07Aug2016 for immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2016, the patient experienced numbness and tingling in all four extremities, headache, chills, some perioral cyanosis, chest tightness. The outcome of the events was recovered on 08Aug2016.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician. A 20-year-old female patient receive the first dose of TRUMENBA, at 0.5 ml single in the right deltoid on 07Aug2016 for immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2016, the patient experienced numbness and tingling in all four extremities, headache, chills, some perioral cyanosis, chest tightness. The outcome of the events was recovered on 08Aug2016.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Abasia, Injection site swelling, Mobility decreased
Clinical narrative: Upper left leg swelling into knee area. As reported by mother child was unable to walk or bend knee.  Mother stated that she gave him Tylenol, and applied home remedy cream.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL, lot # M018810, expiration date 28-MAY-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of GARDASIL were exposed to temperature excursion of 31.3 degrees Fahrenheit for 87 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005338: US-009507513-1701USA005336: US-009507513-1701USA005337:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse  and refers to a 12 month old male patient. There were no concurrent conditions, concomitant therapies and medical history. On 21-DEC-2016, around 15:00, the patient was vaccinated with a dose of PROQUAD 0.5 ml injection, 0.5 ml once, which had a lot # of L016393, an expiration date of 08-NOV-2016, as need for measles, mumps, rubella and varicella (MMRV) vaccine. The patient did not experienced adverse events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a vaccine administrator via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date. the patient was diagnosed with shingles. The outcome of shingles was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information is not expected as there are no reporter's contact details.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant therapies, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M020103 with expiration date 15-FEB-2018, lot # L038503 with expiration date 18-DEC-2017(dose and route of administration were not reported). There were no adverse effects reported. Product quality complaints (PQC) were not involved. Administered doses of vaccines were exposed to the temperature of 32 degrees Fahrenheit for 9650 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005330.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant therapies, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M014927 with expiration date 18-FEB-2019, lot # M010440 with expiration date 09-DEC-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaints (PQC) were not involved. Administered doses of vaccines were exposed to the temperature of 32 degrees Fahrenheit for 9650 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005289.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse of unknown age referring  to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2013, the patient was vaccinated with an improperly stored vial of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported. There was no product quality complaint (PQC) involved. Additionally, the registered nurse stated that she called previously about this event in 2013; she did a trial with a vial of ZOSTAVAX and put it on the ice packs with a calibrated thermometer the way the medical assistant did in the facility where she received her ZOSTAVAX injection (no adverse effects reported). She recorded all the temperatures and the highest it got was 38F for 20 hours. It was unspecified if a data logger was involved, but it was reported that at the time of original case intake, the administration of improperly stored vaccine was considered as not a reportable event. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA005504.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2013, the patient was vaccinated with an improperly stored vial of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported. There was no product quality complaint (PQC) involved. Additionally, the registered nurse stated that she called previously about this event in 2013;  she did a trial with a vial of ZOSTAVAX and put it on the ice packs with a calibrated thermometer the way the medical assistant did in the facility where she received her ZOSTAVAX injection (no adverse effects reported). She recorded all the temperatures and the highest it got was 38F for 20 hours. It was unspecified if  a data logger was involved, but it was reported that at the time of original case intake, the administration of improperly stored vaccine was considered as not a reportable event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005381:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Inoculation site pain and swelling, feverish, red face.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient had a fever around 101 degrees that night, after waking up around 130am. He also reports moderate pain at the injection site during this time. The following morning, the fever had subsided, and the soreness decreased over time.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy, Pain, Pruritus, Swelling
Clinical narrative: Redness, painful to touch, lymph node under the armpit was swollen, and itchy.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site coldness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Employee received a Flu shot on 01/9/17 in her left upper deltoid IM in the Employee Health (EH) clinic. On 1/10/17 Employee returned to EH complaining of minor pain and swelling at the site. Nurse observed redness, minimum swelling and cool to touch at the site. Employee was provided with two instant ice packs with instruction to apply to site for twenty min. intervals. Employee voiced understanding of the instructions.
Age: 37.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen and soreness at site of injection. Headache.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swollen.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Differential white blood cell count normal, Full blood count normal, Pyrexia, White blood cell count normal
Clinical narrative: Fever 102.9F(forehead) reported by mom, 101.4 F(tympanic) in office on 1/11/17- Acetaminophen 1.25 mL given at home 830a 1.25 mL Acetaminophen given in office 1/11/17 at 1135a = 2.5mL adequate for weight.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bone pain, Chest pain, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: Pt. received vaccine on 12-8-16. Pt. was seen in office on 12-13-16 and reported having adverse effects. Atypical chest pain - S/P immunization, arm that received injection - soreness, weakness, edema, LROM. Delayed fever, chills, eye pain, bone pain, fatigue, foot discoloration of Bilat feet. Pt. c/o slight SOA, but stated unknown if R/T injection. (Occassional SOA).
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Eye pain, Fatigue, Injected limb mobility decreased, Muscular weakness, Oedema peripheral
Clinical narrative: Pt. received vaccine on 12-8-16. Pt. was seen in office on 12-13-16 and reported having adverse effects. Atypical chest pain - S/P immunization, arm that received injection - soreness, weakness, edema, LROM. Delayed fever, chills, eye pain, bone pain, fatigue, foot discoloration of Bilat feet. Pt. c/o slight SOA, but stated unknown if R/T injection. (Occassional SOA).
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: Pt. received vaccine on 12-8-16. Pt. was seen in office on 12-13-16 and reported having adverse effects. Atypical chest pain - S/P immunization, arm that received injection - soreness, weakness, edema, LROM. Delayed fever, chills, eye pain, bone pain, fatigue, foot discoloration of Bilat feet. Pt. c/o slight SOA, but stated unknown if R/T injection. (Occassional SOA).
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bone pain, Chest pain, Chills, Electrocardiogram, Fatigue
Clinical narrative: Pt. received vaccine on 12-8-16. Pt. was seen in office on 12-13-16 and reported having adverse effects. Atypical chest pain - S/P immunization, arm that received injection - soreness, weakness, edema, LROM. Delayed fever, chills, eye pain, bone pain, fatigue, foot discoloration of Bilat feet. Pt. c/o slight SOA, but stated unknown if R/T injection. (Occassional SOA).