chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse referring to an adult female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in 2016, the patient was vaccinated with an expired dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot number an expiration date were not provided) for prophylaxis. It was reported that the patient was vaccinated two months after expiration date of the vaccine, additionally it was mentioned that the dose of ZOSTAVAX was properly stored. No adverse event reported. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAR-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M040623 with an expiration date 31-DEC-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis.  Other suspect therapies included sterile diluent (dose, route of administration, frequency, lot# and expiration date were not reported) used to reconstitute ZOSTAVAX. No adverse reactions were reported. Administered doses of ZOSTAVAX experienced temperature excursions from 15 to 46 degrees Fahrenheit for 720 hours. There was no previous temperature excursions. A digital data logger was not involved. According to the reporter sterile diluent did not have any temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA007528.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 20-APR-2017 from a registered nurse which refers to one patient (age and gender unknown) who received an unspecified dose in PROQUAD (Lot number M038862, Expiration date 13-MAR-2018) immunization series that was improperly stored. The patient's pertinent medical history, current conditions and concomitant medications were not reported. The excursion details reported: The vaccine, PROQUAD (Lot number M038862, Expiration date 13-MAR-2018) was exposed to the Temperature (reported in Fahrenheit (F)) between 6F-14F for the time frame of 18.5 hours plus between 15F-46F for the time frame of 49.15 hours plus 47.8F (between 47F to 77F) for the time frame of 26.25 hours. There were no previous temperature excursions. The call was because of a data logger. No adverse effects reported. No additional information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Injection site pain that worsened to limb weakness in limb of injection, gradually improving today at 5 days after injection.
Age: 12.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Pt passed out after vaccine given, woke up for a few seconds then had a brief seizure.
Age: 15.0
Sex: M
Vaccine: FLUC4, HPV4
Symptoms: Loss of personal independence in daily activities, Specialist consultation
Clinical narrative: Patient has been seen by many specialists. Patient had to give up diving. Patient has missed lots of school. Patient is taking lots of medications. Doing alternative methods also. Slowly improving.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Flu symptoms improving; reports this response every time he gets the flu, will enter as adverse response. Flu like symptoms. Loratadine 10 mg every day.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 20-APR-2017 from a public health official (not further specified if a healthcare professional) concerning an unknown number of patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. The public health official reported that an unknown number of doses of GARDASIL 9 (Lot number L043213, Expiration 28-AUG-2017) may have been administered to an unknown number of patients following temperature excursions (No dates reported) of 1.4 degrees Celsius (1.4C) for 11.5 hours, 1.3 degrees Celsius (1.3C) for 24.5 hours, 10.9 degrees Celsius (10.9C) for 2 hours, and 21.8 degrees Celsius (21.8C) for 6 hours. Previous temperature excursion was reported as yes. The call was because of a data logger. No adverse effects were reported in any patients. No other information is available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 21-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. It was reported that the "fluid came out; it leaked through the barrier Band-Aid". At the time of the report, the outcome of the adverse event was unknown. No product quality complaint (PQC) was involved. The causality between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX lot # M037655 with expiration date of 29-NOV-2017, subcutaneously, for prophylaxis (dose was not reported), which had been improperly stored; diluted in properly stored sterile water diluent MRK lot # M016886 with expiration date of 07-DEC-2018, subcutaneously, for prophylaxis (dose was not reported). Administered doses of vaccines experienced previous excursions of 6-14 degrees Fahrenheit for 12 hours 15 minutes and a temperature excursion of 15-46 degrees Fahrenheit (33F) for 4 hours. Data logger was involved. No adverse effects reported. No product quality complaint was involved. No further information provided. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX, lot number M033214 with expiration date 13-JUL-2018 and lot M041513 with expiration date 11-OCT-2018, other suspect therapy included sterile diluent which was properly stored, lot number and expiration was not reported (dose, route and anatomical location were not reported for the above described therapies for prophylaxis. There was no previous temperature excursion. The vaccine was exposed to temperatures between 9 Celsius (C) and 25 Celsius (C) during 7 hours and 56 minutes. Data logger was filled. On unknown dates, the patients reported "injection site redness and swelling". At the time of the report, the outcome of the vaccination site swelling and vaccination site erythema was unknown. The relatedness between the events and therapy with VARIVAX was not reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA004607.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Dysstasia, Gait disturbance, Injection site erythema, Irritability, Pain
Clinical narrative: When my daughter received her vaccinations the nurse let me know that she might have a side effect that will appear in two weeks, most likely redness around the area. Today is 2 weeks to the day that she got her vaccinations and woke up cranky, with redness around the area where her vaccine was injected and was unable to hold herself up with her legs. She has been a perfect walker for at least two months now and I knew something was wrong. She would move around bent over with her hands on the floor unable to stand fully without pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bronchitis, Chills, Ear pain
Clinical narrative: From December 1, 2016 ongoing to today May 9,2017 I have experienced persistent skin rashes on both legs, arms, shoulders and ankle to a full body eruption with hives and rashes that ooze and bleed, fever, chills, joint pain, clothing sensitivity, severe itching, swollen lips, swollen arms with limited mobility and hard lumps on the arms hot to the touch, disrupted sleep and an immune system feeing compromised allowing a case of bronchitis and earache and general lack of energy. The most adverse issues were experienced starting March 1 2017 to March 31, 2017. KENALOG injections were helpful along with antihistamines, Hydroxyzine Pamoate, Prednisone, and Levocetirizine. On February 24, 2017 Terbinafine was prescribed for my ankle and leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage, Hyperaesthesia, Immune system disorder, Induration, Limb mass
Clinical narrative: From December 1, 2016 ongoing to today May 9,2017 I have experienced persistent skin rashes on both legs, arms, shoulders and ankle to a full body eruption with hives and rashes that ooze and bleed, fever, chills, joint pain, clothing sensitivity, severe itching, swollen lips, swollen arms with limited mobility and hard lumps on the arms hot to the touch, disrupted sleep and an immune system feeing compromised allowing a case of bronchitis and earache and general lack of energy. The most adverse issues were experienced starting March 1 2017 to March 31, 2017. KENALOG injections were helpful along with antihistamines, Hydroxyzine Pamoate, Prednisone, and Levocetirizine. On February 24, 2017 Terbinafine was prescribed for my ankle and leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Mobility decreased, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: From December 1, 2016 ongoing to today May 9,2017 I have experienced persistent skin rashes on both legs, arms, shoulders and ankle to a full body eruption with hives and rashes that ooze and bleed, fever, chills, joint pain, clothing sensitivity, severe itching, swollen lips, swollen arms with limited mobility and hard lumps on the arms hot to the touch, disrupted sleep and an immune system feeing compromised allowing a case of bronchitis and earache and general lack of energy. The most adverse issues were experienced starting March 1 2017 to March 31, 2017. KENALOG injections were helpful along with antihistamines, Hydroxyzine Pamoate, Prednisone, and Levocetirizine. On February 24, 2017 Terbinafine was prescribed for my ankle and leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised, Secretion discharge, Skin warm, Sleep disorder
Clinical narrative: From December 1, 2016 ongoing to today May 9,2017 I have experienced persistent skin rashes on both legs, arms, shoulders and ankle to a full body eruption with hives and rashes that ooze and bleed, fever, chills, joint pain, clothing sensitivity, severe itching, swollen lips, swollen arms with limited mobility and hard lumps on the arms hot to the touch, disrupted sleep and an immune system feeing compromised allowing a case of bronchitis and earache and general lack of energy. The most adverse issues were experienced starting March 1 2017 to March 31, 2017. KENALOG injections were helpful along with antihistamines, Hydroxyzine Pamoate, Prednisone, and Levocetirizine. On February 24, 2017 Terbinafine was prescribed for my ankle and leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: From December 1, 2016 ongoing to today May 9,2017 I have experienced persistent skin rashes on both legs, arms, shoulders and ankle to a full body eruption with hives and rashes that ooze and bleed, fever, chills, joint pain, clothing sensitivity, severe itching, swollen lips, swollen arms with limited mobility and hard lumps on the arms hot to the touch, disrupted sleep and an immune system feeing compromised allowing a case of bronchitis and earache and general lack of energy. The most adverse issues were experienced starting March 1 2017 to March 31, 2017. KENALOG injections were helpful along with antihistamines, Hydroxyzine Pamoate, Prednisone, and Levocetirizine. On February 24, 2017 Terbinafine was prescribed for my ankle and leg.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient stated that she had redness and swelling around the injection site that radiated from close to her elbow up through her upper arm. It was painful and went all the way around her arm that was injected. Lasted for approximately 3 days then went away.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Skin warm, Tenderness
Clinical narrative: Warm to the touch, lump and tenderness.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care worker, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-APR-2015, the patient was vaccinated with PREVNAR (lot #, expiration date, strength, dose, route of administration, anatomical location and indication were not reported). It was reported that the health worker reported that the patient was supposed to receive a dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, anatomical location and indication were not reported) on 20-APR-2017; however due to a nursing error, the patient received a second dose of PREVNAR that day. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information was received on 28-APR-2017 from a nurse practitioner via a company representative regarding the nurse practitioner's daughter. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date (reported as when the patient was 11 or 12 years old- she is now 22 years old) the patient received a dose of "GARDASIL 4" (dose not reported) for the indication of HPV prevention. It is unknown if the patient received the full series of "GARDASIL 4". Just recently, on an unspecified date, the patient developed an "abnormal pap." The reporter was unsure if any other lab work with done. The patient sought medical attention- she went to an unspecified healthcare professional. No further information was provided. Action taken with "GARDASIL 4" was not applicable. The outcome of abnormal pap was not reported and the causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The reporter stated that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M032493, expiration date 06-JUL-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (MRK) injection (lot number and expiration date were not reported). The vaccine data logger measure, on unknown dates, a temperature ranges from 6 degrees Fahrenheit (F) to 14 degrees F for a total time frame of 1 hour and 30 minutes, and another one of 15 degrees F to 46 degrees F for 2 hours and 20 minutes. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from an unspecified source, concerning teenagers from unknown genders and ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that on unspecified dates, an unknown number of patients died due to unknown causes, after vaccination with GARDASIL, reported as "parents and women must know that deaths occurred". It was unknown if autopsies were done. No further information was cited. The relatedness between deaths and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830: Reported Cause(s) of Death.
Sex: F
Vaccine: HPV4
Symptoms: Encephalitis, Multiple sclerosis
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unspecified girls from unknown ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that on unspecified dates, an unknown number of girls experienced multiple sclerosis and encephalitis, (also reported as ''brain inflammation''), after vaccination with GARDASIL. The outcome of the events was not mentioned. The relatedness between 'the events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1507ZAF012830.
Sex: U
Vaccine: HPV4
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from an unspecified source, concerning a 12-year-old patients from unknown genders, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was mentioned that ''totally perfect patients were now in their beds, too tired to went to school '' (disability). No further information was cited. The relatedness between disability and vaccination with GARDASIL was not provided. The event of disability was assessed as serious. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number reported as: M041514, expiration date on 11-OCT-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 6°F (Fahrenheit degrees) to 14°F (10 °F) with a time frame of 4 hours. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1705USA004665.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD, lot number M033209 with expiration date 09-JAN-2018, other suspect therapy included sterile diluent which was properly stored, lot number and expiration was not reported (dose, route and anatomical location were not reported for the above described therapies for prophylaxis. There was no previous temperature excursion. The vaccine was exposed to temperatures between 9 Celsius (C) and 25 Celsius (C) during 7 hours and 56 minutes. Data logger was filled. On unknown dates, the patients reported "injection site redness and swelling". At the time of the report, the outcome of the vaccination site swelling and vaccination site erythema was unknown. The relatedness between the events and therapy with PROQUAD was not reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA002218.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number reported as: M034691, expiration date on 04-NOV-2018 (Strength, dose number, route and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 6°F (Fahrenheit degrees) to 14°F (10 °F) with a time frame of 4 hours. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1705USA004121.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Right deltoid erythema/burning/itching-measures 12x10cm not indurated. Also systemic symptoms-mild headache, myalgia, fatigue, chills symptoms started approx 12-18 hrs post-immunization.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Myalgia
Clinical narrative: Right deltoid erythema/burning/itching-measures 12x10cm not indurated. Also systemic symptoms-mild headache, myalgia, fatigue, chills symptoms started approx 12-18 hrs post-immunization.
Age: 14.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Asthenia, Computerised tomogram head normal, Electrocardiogram, Injection site cellulitis, Laboratory test
Clinical narrative: Mother reports local vaccine reaction and 2 episodes of syncope/weakness. Patient was taken to the ER - Head CT-scan was performed with normal results. Pt was diagnosed with cellulitis at site of injection -treated with Clindamycin.
Age: 14.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Syncope
Clinical narrative: Mother reports local vaccine reaction and 2 episodes of syncope/weakness. Patient was taken to the ER - Head CT-scan was performed with normal results. Pt was diagnosed with cellulitis at site of injection -treated with Clindamycin.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Local reaction
Clinical narrative: Local allergic reaction, (L) upper arm.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Inflammation
Clinical narrative: Local inflammatory reaction.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Weakness. Sweating. Dizziness. Diarrhea. Shortness of breath.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries, Denture wearer
Clinical narrative: Teeth rotted away, requires dentures.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Developed rash from head to toe. Went to MD was treated with ZYRTEC and BENADRYL. Attempts to call mother to check on rash or get name of MD go answered.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Syncope, urinary incontinence about 10-15min after injection Had patient lay down for awhile.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Elevated fever, and prolonged hysterical crying for 3-4 days after receipt of 4 month vaccines (DTaP/Hep B/IPV, Hib, PREVNAR, Rotavirus). She slept intermittently, after wearing herself out. Fevers were as high as 103, although responded to TYLENOL. She did fine with 2 month vaccines. No local reaction. No emesis, hypo responsiveness, limpness, collapse, cough, rigors, diarrhea, or hypotonic/clonic movements. She has no history of neurologic illness or event. Fever, unspecified, other Symptoms and Signs involv ner sysm. Subsequently did well with 6 month vaccines. DTaP given as solitary vaccine with premedication.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, tenderness, itching to (L) arm.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Patient received the vaccination and after going out to eat and after a couple more hours started to feel ill. She experienced nausea and vomiting and perceived the vaccination as the cause.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenitis
Clinical narrative: 06 March 2017 AM, patient presented to ER with pain, redness, and swelling around smallpox injection site. Patient was informed that symptoms are consistent with cellulitis lymphadenitis. Patient was prescribed cephalexin antobiotics and Septra DS to treat infection, along with hydrocodone to manage pain. Pt was advised to f/u.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cow's milk intolerance, Diarrhoea, Mucous stools
Clinical narrative: Sever diarrhea. Egg white like slime in stool.
Age: 20.0
Sex: F
Vaccine: FLU4, VARCEL, YF
Symptoms: Blister, Chest X-ray, Dizziness, Full blood count, International normalised ratio normal
Clinical narrative: Patient called and c/o dizziness but also small blisters that appeared on her neck. Has been email the clinic with the clinic returning her emails about the rash. On 5/1/17 pt returned to clinic for evaluation. Appears that she has chicken lesions on her neck. Gave information about this and precautions. She returned to clinic on 5/3/17 with more lesions.  Given hydrocortisone and precautions about varicella. Seen by provider on 5/4/2017. Same diagnosis. She developed more lesions, vomiting and possible fever on 5/6.  Returned to clinic on 5/8.  Vominting resolved but concerning for Yellow fever vaccine received on same day as varicella. Referring patient to ID MD  same day.  Seen by ID on 5/9.  Given antiviral for varicella rash. Will be seen on 5/11 for follow-up.
Age: 20.0
Sex: F
Vaccine: FLU4, VARCEL, YF
Symptoms: Liver function test normal, Metabolic function test, Prothrombin time normal, Rash, Skin lesion
Clinical narrative: Patient called and c/o dizziness but also small blisters that appeared on her neck. Has been email the clinic with the clinic returning her emails about the rash. On 5/1/17 pt returned to clinic for evaluation. Appears that she has chicken lesions on her neck. Gave information about this and precautions. She returned to clinic on 5/3/17 with more lesions.  Given hydrocortisone and precautions about varicella. Seen by provider on 5/4/2017. Same diagnosis. She developed more lesions, vomiting and possible fever on 5/6.  Returned to clinic on 5/8.  Vominting resolved but concerning for Yellow fever vaccine received on same day as varicella. Referring patient to ID MD  same day.  Seen by ID on 5/9.  Given antiviral for varicella rash. Will be seen on 5/11 for follow-up.
Age: 20.0
Sex: F
Vaccine: FLU4, VARCEL, YF
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: Patient called and c/o dizziness but also small blisters that appeared on her neck. Has been email the clinic with the clinic returning her emails about the rash. On 5/1/17 pt returned to clinic for evaluation. Appears that she has chicken lesions on her neck. Gave information about this and precautions. She returned to clinic on 5/3/17 with more lesions.  Given hydrocortisone and precautions about varicella. Seen by provider on 5/4/2017. Same diagnosis. She developed more lesions, vomiting and possible fever on 5/6.  Returned to clinic on 5/8.  Vominting resolved but concerning for Yellow fever vaccine received on same day as varicella. Referring patient to ID MD  same day.  Seen by ID on 5/9.  Given antiviral for varicella rash. Will be seen on 5/11 for follow-up.
Age: 25.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Chills, Dizziness, Injection site pain, Nausea, Retching
Clinical narrative: Shivering, lightheadedness, nausea, dry heaving, and greater soreness at the injection site.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation
Clinical narrative: PNEUMOVAX 23 was administered to the patient's right arm. Pt returned to the pharmacy today, complaining of significant inflammation that extended to the forearm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, MNQ, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: MENACTRA given at 2 mos by error instead of PREVNAR.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: He had a seizure. He had never had a seizure before. Lasted 20 min. We called 911 and took him to the emergency room.
Age: 80.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema
Clinical narrative: Redness in arm vaccinations given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Excessive eye blinking
Clinical narrative: Very excessive and hard blinking.
Age: 46.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: The site of injection was red and tender to the touch. Signs of inflammation at site. When asked if any trouble breathing, patient mentions "slight issues with breathing."
Age: 2.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of left thigh.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Confusional state, Fatigue, Nausea, Rash generalised
Clinical narrative: Patient reported rash all over his entire body, nausea, weakness, confusion, tiredness. Patient was going home and if he felt worse then he would call an ambulance. 09:00 5-9-17 all resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red bump at injection site.
Age: 94.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 3/9/17 Pt. received PREVNAR 13 and TDaP. Pt. is resident at facility, pt. never C/O any S/S then on the 15th (L) arm slightly swollen, painful, warm to touch and redden - measured 16 x 12 inches (Tx ice and TYLENOL). By day 18th S/S completely resolved.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, itchy injection site. No meds.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cellulitis, Injection site erythema, Vaccination complication, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Redness, swelling, warmth at vaccination site (L)FA (BEXSERO) 16 h after given, decreased 2d later - but minimal warmth and nodule persist - 4 D after vaccination.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vaccination site warmth
Clinical narrative: Redness, swelling, warmth at vaccination site (L)FA (BEXSERO) 16 h after given, decreased 2d later - but minimal warmth and nodule persist - 4 D after vaccination.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Nausea, Pallor, Rash generalised, Skin discolouration
Clinical narrative: Complained of not feeling well, minutes later progressed to pallor, nausea, and vomiting, then developed purple fingers. Mom call EMS. EMG gave BENADRYL, systemic corticosteroid. By the time they arrived at ER then had a rash over her body. Admitted overnight for observation. Released the next day.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Complained of not feeling well, minutes later progressed to pallor, nausea, and vomiting, then developed purple fingers. Mom call EMS. EMG gave BENADRYL, systemic corticosteroid. By the time they arrived at ER then had a rash over her body. Admitted overnight for observation. Released the next day.
Sex: F
Vaccine: HEPA, HPV9, MMR, TDAP
Symptoms: Erythema, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 622330) refers to a 26 year old female patient. The patient's medical history included appendectomy in JAN-2016. No details about current illnesses, lab data, prior vaccination and other medications were provided. On 08-FEB-2016, the patient was vaccinated with M-M-R II lot # L027591, subcutaneous in the left arm for prophylaxis. Other suspect therapies included vaccination with GARDASIL 9, (administered on 08-FEB-2016, lot# L02493, intramuscular in the right arm for prophylaxis), BOOSTRIX (administered on 08-FEB-2016, lot# YM7J9, intramuscular in the right arm for prophylaxis) and HAVRIX (administered on 08-FEB-2016, lot# 925C7, intramuscular in the left arm for prophylaxis). On 09-FEB-2016, the patient experienced 25 x 30 mm redness on an unspecified area and complained of pain. The outcome of erythema and pain was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MMR
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling hot, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 622373) refers to a 13 year old male patient. Patients medical history included Sickle Cell Anemia Disease HbSS. No details about current illnesses, lab data, prior vaccination and other medications were provided. On 10-FEB-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown), intramuscular for prophylaxis (strength, dosing details and lot# unknown). Other suspect therapies included vaccination with GARDASIL 9 (administered on 10-FEB-2016, intramuscularly for prophylaxis). On 10-FEB-2016, the patient experienced severe headache, blurred vision, fever, feeling hot, dizziness, weakness and feeling disconnected. He was administered with TYLENOL. The outcome of asthenia, vision blurred, pyrexia, headache, feeling hot, feeling abnormal and dizziness was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MMR
Symptoms: Pyrexia, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 622373) refers to a 13 year old male patient. Patients medical history included Sickle Cell Anemia Disease HbSS. No details about current illnesses, lab data, prior vaccination and other medications were provided. On 10-FEB-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown), intramuscular for prophylaxis (strength, dosing details and lot# unknown). Other suspect therapies included vaccination with GARDASIL 9 (administered on 10-FEB-2016, intramuscularly for prophylaxis). On 10-FEB-2016, the patient experienced severe headache, blurred vision, fever, feeling hot, dizziness, weakness and feeling disconnected. He was administered with TYLENOL. The outcome of asthenia, vision blurred, pyrexia, headache, feeling hot, feeling abnormal and dizziness was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 624215) refers to a 16 year old female patient. Patient's current illnesses, medical history and other medications were reported as none. no details about lab data and prior vaccination was provided. On 26-FEB-2017, the patient was vaccinated with GARDASIL 9, lot # L023230, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 26-FEB-2016, lot # L024266, subcutaneous in the right arm for prophylaxis), VARIVAX (administered on 26-FEB-2016, lot # L030159, subcutaneous in the left arm for prophylaxis), TENIVAC (administered on 26-FEB-2016, lot # U5280AA, intramuscular in the right arm for prophylaxis), ENGERIX-B, (administered on 26-FEB-2016, lot # CB544, intramuscular in the left arm for prophylaxis) and IPOL (administered on 26-FEB-2016, lot # Ll4421, Subcutaneous in the right arm for prophylaxis). On 26-FEB-2016, after vaccination, the patient went to the waiting room to wait for 15 minutes while guardian made follow-up appointment and she fainted. Patient was pale, drank some water, and patient was given some crackers. Patient's blood pressure was checked and it was at 94/60 (unit unknown). Patient stated she was feeling dizzy when she fainted. Patient's color came back and she stated she felt better. The outcome of syncope, pallor and dizziness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: FLU3, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 626876) and refers to a 13 year old female patient. Patient's current illnesses was reported as none. Her medical history, lab data, other medications and prior vaccination details were unknown. On 25-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L019297, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 25-FEB-2016, lot # L012480, subcutaneous in the right arm for prophylaxis), VARIVAX (administered on 25-FEB-2016, lot # L035126, subcutaneous in the right arm for prophylaxis), BOOSTRIX (administered on 25-FEB-2016, lot # 9NA32, intramuscular in the right arm for prophylaxis), HAVRIX (administered on 25-FEB-2016, lot # N2D79, intramuscular in the right arm for prophylaxis), IPOL (administered on 25-FEB-2016, lot # Ll442, subcutaneous in the right arm for prophylaxis), FLUARIX (administered on 25-FEB-2016, lot # B579K, intramuscularly in the right arm for prophylaxis) and MENACTRA (administered on 25-FEB-2016, lot # U5185BA, intramuscularly in the right arm for prophylaxis). On 25-FEB-2016, approx. 1 minute after the vaccination patient began to faint in chair, mother and nurse assisted patient with safety, nurse cooled patient with cool paper towels and fanned patient. Patient became more alert and was given saltines and 7.5 oz cherry cola. The outcome of syncope was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: DTAPIPV, HPV9, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 632481) and refers to a 4 year old female patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 21-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602, dose 1, via unknown route in the left arm for prophylaxis. Other suspect therapies included vaccination with VARIVAX (administered on 21-APR-2016, lot # L046888, subcutaneous in the left arm for prophylaxis), M-M-R II  (administered on 21-APR-2016, lot # L034730, subcutaneous in the right arm for prophylaxis), and KINRIX (administered on 21-APR-2016, lot # 4F49N, subcutaneous in the left arm for prophylaxis). It was reported that wrong vaccine was administered at the time of patient visit during her well child check-up. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEPA, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 634850) and refers to a 17 year old female patient. No details about current illnesses, medical history, prior vaccination and other medications were provided. On 27-JAN-2016, the patient was vaccinated with GARDASIL 9, lot # L017407, dose 2, intramuscular in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 27-JAN-2016, lot # K005574, subcutaneous in the right arm for prophylaxis), TENIVAC (administered on 27-JAN-2016, lot # C4736CA, intramuscular in the left arm for prophylaxis), IPOL (administered on 27-JAN-2016, lot # L1130, intramuscular in the left arm for prophylaxis), HAVRIX (administered on 27-JAN-2016, lot # AD9Y4, intramuscular in the right arm for prophylaxis), and VARILRIX (administered on 27-JAN-2016, lot # L013826, intramuscular in the left arm for prophylaxis). On 27-JAN-2016, the patient experienced exposure during pregnancy. Patient was unaware of pregnancy at time of vaccination. She was 7 weeks gestation according to EDD. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: DTAPHEPBIP, HPV9, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 637540) and refers to a 13 year old female patient. Patient's current Illnesses and medical history was reported as none. No details about other medications, lab data, and prior vaccination was provided. On 17-FEB-2016, the patient was vaccinated with GARDASIL 9, lot#1016429, subcutaneous in the right arm for prophylaxis. Other suspect therapies included vaccination with VARIVAX, (administered on 17-FEB-2016, lot # 1035127, subcutaneous in the right arm for prophylaxis), M-M-R II (administered on 17-FEB-2016, lot # L004656, subcutaneous in the left arm for prophylaxis), and PEDIARIX (administered on 17-FEB-2016, lot # 5X792, intramuscular in the left arm for prophylaxis). The event inappropriate schedule of drug administration was reported. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17 year old male patient with migraines. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) for prevention of Human Papillomavirus (HPV) and with a dose of BEXSERO (lot#, expiration date, formulation, dose and route of administration were not reported). On an unknown date in January 2017 (reported as "within a few days of receiving the vaccines"), the patient experienced headaches. On an unknown date in 2017, the patient was then sent to emergency department and on an unknown date in 2017, he was tested positive for mononucleosis (reported as mono). The patient then followed up with an unspecified neurosurgeon and he had spinal tap which resulted in being positive for aseptic meningitis, on an unknown date in 2017. On an unknown date in 2017, the patient experienced fever and was diagnosed with influenza. Product quality complaint was not involved.  The patient did make fully recovery, on an unknown date in 2017. The causality between the events and suspect therapies was not reported. Upon internal review, the event of meningitis aseptic was considered to be medically significant. Additional information has been requested.