chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Eating disorder, Flushing, Full blood count normal, Injection site pain, Malaise
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Metabolic function test normal, Migraine, Neurological examination normal, Pharyngeal oedema, Rash
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning various unspecified patients of an unknown ages and genders. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown different dates the patients were vaccinated with unknown dose numbers of improperly stored PEDVAXHIB (concentration, rout and dose not reported) lot # L033690, expiration date 14-JUN-2018. It was reported that the PEDVAXHIB was stored with a temperature of 0 degrees C for 72 hours, it had not been out of range before and the vaccine was back in range on an unspecified date. There was no data logger, neither adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning various unspecified patients of an unknown ages and genders. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown different dates the patients were vaccinated with unknown dose numbers of improperly stored GARDASIL 9 (concentration, route and dose not reported) lot # L020015, expiration date 16-AUG-2017 and lot # L043213, expiration date 28-AUG-2017. It was reported that the GARDASIL 9 was stored with a temperature of 0 degrees C for 72 hours, it had not been out of range before and the vaccine was back in range on an unspecified date. There was no data logger, neither adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: 3 spots on arm of vaccine and spot starting on lower lip.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Balance disorder, Computerised tomogram normal, Fall, Gait disturbance, Generalised tonic-clonic seizure
Clinical narrative: Approx. 24 hours after vaccines, child became "wobbly", lost balance and fell to floor (slight head bump) and had a 2 min. tonic-clonic seizure with no cyanosis. Take to ER via ambulance and sx. resolved within 15-20 min. No fever.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Head injury
Clinical narrative: Approx. 24 hours after vaccines, child became "wobbly", lost balance and fell to floor (slight head bump) and had a 2 min. tonic-clonic seizure with no cyanosis. Take to ER via ambulance and sx. resolved within 15-20 min. No fever.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Full blood count, Syncope, Thyroid function test
Clinical narrative: Syncope 4 days after MENACTRA.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Localised oedema, Urticaria
Clinical narrative: Localized edema, redness, few satellite wheals.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Pyrexia, Vertigo
Clinical narrative: 5/14/16 - Pt developed chills, fever 103 degrees F, H/A and dizziness fever broke that night and symptoms subsided. 5/17: Pt c/o dizziness to school nurse. 5/18: Pt taken to PCP dx with vertigo and given meclizine. 5/23: Pt presented to school nurse with c/o dizziness and H/A -> taken to ER by mom and told not vertigo - may be Tdap shot and referred to neurologist and rec. MRI.
Age: 13.0
Sex: F
Vaccine: DTAPHEPBIP, HPV9, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dysstasia, Syncope
Clinical narrative: After receiving vaccines, patient fainted while seated. Placed in reclined position and cool compress placed on nape of neck. After 10 minutes patient attempted to stand and he fainted a second time. Placed in recliner for 20 minutes.
Age: 1.32
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous around the injection site about 1 cm in size. Site has been firm for 5-6 days.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) upper extremity - mild erythema from deltoid - proximal to the elbow with warmth and tenderness. No treatment. Symptoms resolved.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Rash
Clinical narrative: Flu like symptoms, rash near injection site. Started within 24 hours of injection. OK 5-19-16.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Day after receiving vaccines - rash on face, back, and legs. Seen in office 2 weeks after vaccines given treated with ORAPRED.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Malaise
Clinical narrative: Patient reported 2 weeks of chest tightness and feeling generally unwell right after vaccine. She didn't see any medical professional for these s/s and reported symptoms 1 year after vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Feeling cold, Injection site pain
Clinical narrative: Chills, pain at injection site (R) deltoid radiating to (R) shoulder down to (L) elbow. Afebrile.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash generalised
Clinical narrative: Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Allergy test positive, Allergy to animal, Allergy to plants, Arthralgia, Erythema multiforme
Clinical narrative: Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Eye swelling, Lip swelling, Mycotic allergy, Pain in extremity, Pruritus
Clinical narrative: Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash erythematous, Rash generalised, Rash macular, Urticaria, Vaccination complication
Clinical narrative: Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash, Rash macular
Clinical narrative: Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, red significant swelling was presented Cephalexin for it to resolve by Dr. on 4/25/16.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema
Clinical narrative: Red area in a circular pattern 7 cm diameter no treatment.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Grunting, Screaming
Clinical narrative: Infant received vaccines at 10 AM, did well, went home and slept. Infant woke up at 2:30 pm (4 1/2 hr later) screaming and grunting but not discolored. Had a nl bm. Cryed x 1 1/2 hr then resolved with TYLENOL. XM was WNL. Did well.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient got cellulitis after receiving ZOSTAVAX.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, raised 3 inches. Hot to touch. Ran down to elbow.
Age: 1.32
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Eye swelling
Clinical narrative: Periorbital swelling, bilaterally - noted day after vaccinations received. Spontaneously resolved. No other symptoms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Loss of consciousness, Malaise, Rash
Clinical narrative: Pt received vaccine at school, did not feel well afterwards. Rash on arm, short of breath all afternoon. Mother gave BENADRYL. Ran a race in track and pass out afterwards.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 13-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PROQUAD (lot # K007801, expiration date 29-NOV-2015, route and dosage not specified). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 17-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K008927, expiration date 17-MAR-2016, route and dosage not specified). No adverse effect reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a consumer, a 27 year old female patient reporting on herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2001 ("15 years ago"), the patient was vaccinated with VARIVAX (dose, route, lot # and expiration date unknown). In approximately April 2016 (about three weeks ago), the patient had routine blood work done which showed no titers (antibody test negative) after receiving VARIVAX. The patient had visited her physician however she did not receive any treatment for the event. No product quality complaint was involved. The patient had not recovered at the time of this report. Causality was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were orally vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, lot # and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a 64 years old female patient. The patient's medical history and concurrent conditions were not reported. On 12-MAY-2016 the patient was inadvertently vaccinated with a dose of VARIVAX instead of an intended dose of ZOSTAVAX (wrong drug administered). The reason for the error was unspecified. No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a 4 year old patient of unknown gender. Information on the concurrent conditions, medical history and drug allergies of the patient was not reported. On 15-APR-2016, the patient was vaccinated with improperly stored dose of M-M-R II (dose number, dose, frequency, route and anatomical location, lot number and expiration date were not specified). Concomitant medication were not specified. There were no adverse effects reported. This is one of several reports received from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of VAQTA injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Induration
Clinical narrative: Left arm localized induration within 5 minutes of PNEUMOVAX. No shortness of breath, itching or redness. Improving prior to discharge 12:54 pm 5/24/16.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/9/16 - Pt received PPV 23 #1 due to cochlear implant - had PCV 13 on 2/29/16; 5/10/16 pt reported swelling, erythema, tenderness at injection site on 5/10/16 - f/u 5/11/16 continue down rt upper arm to elbow. On 5/12/16 - upper rt arm clearing with sx improving - rx with BENADRYL and ice only. 5/11/16 - seen by PMD - no treatment dx local reaction.
Age: 1.88
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Rash, Rash erythematous
Clinical narrative: 30-45 min. after injection child developed watery diarrhea followed by fine raised red rash on trunk that spread to buttocks and thighs. Saw PMD - dx as adv. reaction. Treated with prednisone 15 mg/5 ml (4 ml) and BENADRYL q 4 hrs.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Injection site reaction - complained of redness/itching/soreness inflammation on 5/23/16 marked the margins. On 5/24/16 patient returned and redness had increased to 3 in wide by 4 in long was hard, swollen, red, hot. Contacted PCP he prescribed prednisone 20 mg 2 tabs x 4 days to decrease inflammation.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Abasia, Dizziness, Feeling hot, Syncope, Tremor
Clinical narrative: After getting vaccine patient fainted, feel dizzy, shaking, feel like have fever, cannot walk. Called 911. Ambulance came and bring patient to hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US094473 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 502154) website on 24 Jul 2014. This report refers to an 11-year-old female patient. She did not have any medical history. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12131) intramuscularly in the right arm on 10 Sep 2013. On the same day she also received GARDASIL (other manufacturer, batch number: J003727) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: 33AG5) intramuscularly in the right arm. On the same day, she was presented to school nurse with redness, pain and swelling at two third of upper right arm. She also complained of cold chills, nausea and tiredness. Her body temperature was 97.6 degrees. The nurse instructed her to take ibuprofen and would evaluate the site the next day. She was also advised to go to emergency room if any life threatening symptoms occurred. The final outcome of the event was reported as unknown. The events were reported as non-serious. The causality of the event was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea
Clinical narrative: Case number PHHY2014US094473 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 502154) website on 24 Jul 2014. This report refers to an 11-year-old female patient. She did not have any medical history. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12131) intramuscularly in the right arm on 10 Sep 2013. On the same day she also received GARDASIL (other manufacturer, batch number: J003727) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: 33AG5) intramuscularly in the right arm. On the same day, she was presented to school nurse with redness, pain and swelling at two third of upper right arm. She also complained of cold chills, nausea and tiredness. Her body temperature was 97.6 degrees. The nurse instructed her to take ibuprofen and would evaluate the site the next day. She was also advised to go to emergency room if any life threatening symptoms occurred. The final outcome of the event was reported as unknown. The events were reported as non-serious. The causality of the event was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Case number# PHHY2014US093249, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515706) website on 24 Jul 2014. This report refers to an 11-year-old female patient. Past medical history included allergy to pork. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A13014), along with ADACEL (batch number: C4332BA) intramuscularly on 20 Nov 2013. On 25 Nov 2013, she developed rash at injection site. Later the rash spread to elbows, knees, abdomen and hands. Also she experienced itching. She had no difficulty breathing. She had seen dermatologist on 07 Dec 2013 and was reported that the rash was due to MENVEO vaccine. The outcome of the events was recovered. The events were reported as non-serious.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immunoglobulin therapy, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US094827, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516048) website on 24 Jul 2014. This report refers to a 13-year-old female patient. On 02 Dec 2013, she was vaccinated with MENVEO (batch number: A12098) in the left arm and BOOSTRIX (batch number: 46995) in the right arm. On the same date, within 1 hour after vaccination she experienced redness, swelling and pain in the left deltoid and had fever. She received immunoglobulins and the events were still persisting. She received BENADRYL 25 mg as treatment. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Case number PHHY2014US093592 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516142) website on 24 Jul 2014. This case refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. On 04 Dec 2013, she was vaccinated with MENVEO (batch number: A13012) intramuscularly in the left arm and PPD (purified protein derivative). Following the vaccination, 18 hours later on 05 Dec 2013, she experienced dizziness. She denied cold symptoms, fever, vomiting and diarrhea. Her mother felt dizziness was related to the vaccination. A follow-up was scheduled the next day. It was reported that she had completely recovered from the events. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: HEPA, IPV, MEN, MMR, YF
Symptoms: Arthralgia
Clinical narrative: Case number PHHY2014US097371, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 516179) website on 04 Aug 2014. This report refers to a currently 60-year-old male patient. Historical conditions and drug reactions were not reported. No concomitant medication was reported. He was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported), along with MMR II (other manufacturer, batch number: not reported), hepatitis A vaccine (unknown manufacturer, batch number: not reported), poliovirus vaccine, inactivated (unknown manufacturer, batch number: not reported) and yellow fever vaccine (unknown manufacturer, batch number: not reported) on an unknown date. On an unknown date after vaccination, he developed joint pain. He did not seek medical attention. The outcome of the event was reported as condition improved. The event was reported as non-serious. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Case number PHHY2014US097720, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 516685) website on 04 Aug 2014. This report refers to a 16-year-old female pregnant patient. Past medical history included mood disorder. Concomitant medications included a WELLBUTRIN, lithium and LO-OVRAL. She was vaccinated with meningococcal polysaccharide vaccine (unknown manufacturer, batch number: not reported) along with first dose of GARDASIL (batch number: 672653/1860AA) on 10 May 2012 during an annual physical exam. It was reported that pregnancy test drawn during that visit returned a positive result for pregnancy. She was seven weeks pregnant. Her last menstrual period was approximately 29 Mar 2012 and expected delivery date would be on 03 Jan 2013 (days approximated). She had sought for unspecified medical attention. No treatment was given. The reporter stated that the patient was not seen in their office recently and could not find any baby information. The pregnancy outcome was lost to follow up. No adverse event reported.
Age: 11.0
Sex: F
Vaccine: 6VAX-F, HPV4, MEN
Symptoms: Rash
Clinical narrative: Case number PHHY2014US096396, is an initial spontaneous report received from a medical assistant via Vaccine Adverse Event Reporting System (VAERS reference number: 517447) website on 04 Aug 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with meningococcal polysaccharide vaccine (unknown manufacturer, batch number: not reported) along with GARDASIL (other manufacturer, batch number: not reported) and HEXAVAX (other manufacturer, batch number: not reported) on 07 Nov 2013. On the same day a few hours after administration of the vaccines, she developed rash on her chest. The rash resolved after one week approximately 14 Nov 2013. The event was reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US093904 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 517628) website on 24 Jul 2014. This report refers to an 11-year-old female patient. Her concurrent conditions included atopic dermatitis; multiple environmental allergies and eczema. She received MENVEO (batch number: A12127) and BOOSTRIX (other manufacturer and batch number: N2K27) both intramuscularly into right arm on 10 Dec 2013. On 11 Dec 2013, one day after vaccinations, she experienced painful, warm and swelling at vaccine site. These events were reported as non-serious. Outcome of the events was reported as recovered. Causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Rash macular
Clinical narrative: Case number PHHY2014US050341 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 519714) on 24 Apr 2014. This report refers to 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal polysaccharide vaccine (unknown manufacturer, batch number: not reported) in arm on 02 Jan 2014. She was also vaccinated with tetanus, diphtheria and acellular pertussis (other manufacturer, batch number: not reported) in arm on 02 Jan 2014. It was reported that within an hour of vaccination she was presented with blotchy rash. She was treated with BENADRYL, antihistamines and TYLENOL which was given immediately. It was also reported that she recovered in 2 days. The event was reported as non-serious. The causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Case number PHHY2014US048248, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520177) website on 14 Apr 2014. This report refers to 11-year-old male patient. His medical history included environmental allergies. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A13017) into left arm on 16 Jan 2014. On the same date he was also vaccinated with FLUARIX (other manufacturer, influenza vaccine, batch number: 39TF5) into left arm and BOOSTRIX (other manufacturer, batch number: B5X7M) into right arm. On the same day post vaccination he experienced severe redness, swelling and tenderness extending to shoulder and neck region in left arm. He visited the emergency room. The outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Case number PHHY2014US048248, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520177) website on 14 Apr 2014. This report refers to 11-year-old male patient. His medical history included environmental allergies. Concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A13017) into left arm on 16 Jan 2014. On the same date he was also vaccinated with FLUARIX (other manufacturer, influenza vaccine, batch number: 39TF5) into left arm and BOOSTRIX (other manufacturer, batch number: B5X7M) into right arm. On the same day post vaccination he experienced severe redness, swelling and tenderness extending to shoulder and neck region in left arm. He visited the emergency room. The outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2014US048874, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520903) website on 14 Apr 2014. This report refers to a 11-year-old male patient. His current condition included asthma. He was vaccinated with MENVEO (batch number: M13012) intramuscularly in the left arm on 24 Jan 2014. On the same date, he also received GARDASIL (batch number: J013324) in the right arm and BOOSTRIX (batch number: AC52B088AA) in the left arm, intramuscularly. On 25 Jan 2014, he experienced redness, itchiness and swelling of the left arm. It was reported that the patient had an ER visit one day after vaccinations. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2014US0555208 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521287) website on 06 May 2014. This report refers to an 11-year-old male patient. His medical history included allergies to OMNICEF, POLYTRIM and RONDEC. His concomitant medications were not reported. He was vaccinated with MENVEO and ADACEL (other manufacturer, batch number: U4612AA); both vaccines administered intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: J011272) intramuscularly in the right arm on 16 Jan 2014. On same date after vaccination, she had rash on his left arm where he received his shot. It was reported that rash was from his upper arm to his left elbow. As per his mother, the rash was localized to site and she applied ice to the site for the swelling occurred. He was also treated with BENADRYL. Mother stated that rash cleared up by 20 Jan 2014. The final outcome of the event was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Local reaction, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2014US055311 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521700) website on 06 May 2014. This report refers to an 11-year-old male patient. His medical history was not reported and concomitant medications included FOCALIN XR. He was vaccinated with MENVEO (batch number: M12132), ADACEL (other  manufacturer, batch number: U4395AA); both vaccines administered in the left arm and GARDASIL (other manufacturer, batch number: J012212) in the right arm on 31 Jan 2014. On 01 Feb 2014, he had local reaction at the vaccination site which was further described as minor swelling, warmth to touch and pink colour. As per patient, the left deltoid area (site) did not hurt any longer and there was only discomfort when touching. He was treated with ibuprofen. The final outcome of the event was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US048698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522202) website on 14 Apr 2014. This report refers to a 12-year-old male patient. He had no illness, no known drug allergies or birth defects and was not on any medications at time of the vaccination. He was vaccinated with MENVEO (batch number: M1206) intramuscularly into right arm on 07 Feb 2014. On 08 Feb 2014, he had a swollen arm from the top of his right shoulder down to about an inch above his elbow. It was wrapped around the outer aspect of his arm. He experienced redness, swelling, itching and burning at the site. The outcome of the events was unknown. Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Induration
Clinical narrative: Case number PHHY2014US055379 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522210) web site on 06 May 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13013) and GARDASIL (other manufacturer, batch number: J013324) both intramuscularly into left arm on 05 Feb 2014. On 07 Feb 2014, he experienced induration and redness of the deltoid. The outcome and causality of the event was not reported. The events were reported as non-serious.
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US048778, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522211) website on 14 Apr 2014. This report refers to 11 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A12130) into left arm on 05 Feb 2014. On the same day she was vaccinated with FLUZONE (other manufacturer, batch number: UH906AE) into right arm and BOOSTRIX (other manufacturer, batch number: C4170AA) into left arm. On 06 Feb 2014, she experienced redness and pain in left deltoid. The outcome of the events was unknown. Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Incomplete course of vaccination
Clinical narrative: Case number PHHY2014US055248 is an initial spontaneous report received from a consumer (patient mother) via Vaccine Adverse Event Reporting System (VAERS, reference number: 523163) website on 06 May 2014. This report refers to 12 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M12120) intramuscular (IM) into right arm on 12 Aug 2013. On the same day received GARDASIL (batch number: H021608, other manufacturer) IM into left arm and BOOSTRIX (batch number: AC52B099CA, other manufacturer) IM into left arm. On the same day patient's mother reported that he developed severe abdominal pain for two weeks. She also reported that he experienced same event after second dose of GARDASIL (batch number: H021608, other manufacturer) on 15 Oct 2013. He refused the third dose of GARDASIL on 19 Feb 2014. Outcome of the event abdominal pain was recovered. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: DPIPV, MEN
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US051264, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 523178) website on 24 Apr 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown), along with diphtheria toxoid, pertussis and polio vaccine (other manufacturer, batch number: unknown) intramuscularly into the arm on 19 Feb 2014. On same day after vaccination, she experienced fever, vomiting and headache lasting over five hours. Treatment for the events was rendered with ADVIL and fluids. She was scheduled for a physician visit later at the time of reporting. The outcome of the events was not reported. The reporter assessed the events as non-serious and the causality was not provided.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US055160 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523183) website on 06 May 2014. This report refers to a 22 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11041), intramuscularly in the left arm on 14 Feb 2014. On the same day after vaccination, she experienced swelling, redness and fever to injection site. The outcome of the events was not reported. The seriousness of the case was reported as non-serious. The causality of the event was reported.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US055258 is an initial spontaneous report received from a consumer (patient mother) via Vaccine Adverse Event Reporting System (VAERS, reference number: 523221) website on 06 May 2014. This report refers to 17 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M13012) into left arm and GARDASIL (batch number: J008423, other manufacturer) into right arm on 08 Feb 2014. On 09 Feb 2014, she reported left deltoid swollen and itchy at the injection site. Outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site reaction
Clinical narrative: Case number PHHY2014US056631 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524084) website on 06 May 2014. This report refers to an 11 year old female patient. She had no medical history or concomitant medication. She was vaccinated with MENVEO (batch number: M13012) into right arm and GARDASIL (other manufacturer, batch number: J012212) into left arm on 24 Feb 2014. On the same day after vaccination, she experienced injection site reaction. The treatment was rendered with ice application and MOTRIN as required. The outcome and causality of the event were not reported. The events were reported as non-serious.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction
Clinical narrative: Case number PHHY2014US055705, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524102) website on 06 May 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13012)into the right arm on 24 Feb 2014. On 25 Feb 2014, she experienced a reaction at the injection site. Treatment for the event included ice and MOTRIN. The final outcome of the event was complete recovery. The event was reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US055870, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524314) web site on 06 May 2014. This report refers to 11 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M13014) and GARDASIL (batch number: J012212, other manufacturer) both intramuscular into right arm on 26 Feb 2014. On 28 Feb 2014, she developed redness and swelling in right deltoid near injection site. Outcome of the event was recovered. Seriousness and causality assessment was not reported.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Delivery, Exposure during pregnancy, Pregnancy test positive, Vaccination site pain
Clinical narrative: Case number PHHY2014US066253 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS ID: 524558) on 28 May 2014. This report refers to a 17-years-old female patient. Her medical history included drug hypersensitivity to amoxicillin, DIFLUCAN and LORABID. She had no concomitant medications. Her last menstrual period (LMP) was on 17 Apr 2012. She was vaccinated with meningococcal polysaccharide vaccine (manufacturer and batch number: not reported) hepatitis A vaccine (other manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported) on 15 May 2012. On 15 May 2012, she had vaccination site pain which hurt for a day or two. She went to emergency room, saw physician and sought medical attention. It was reported that on an unknown date in May 2012, she took 5 pregnancy tests at home which showed that she was pregnant. Her expected delivery date (EDD) was on 22 Jan 2013. It was reported that her hospital record stated that she gave birth to a baby and that the child was in a good health. The outcome of vaccination site pain was reported as complete recovery. The events were reported as non-serious by the reporter. The causality of the event was not reported.