chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt came in on 8/15/17 to report she developed a swollen, itchy arm where injection was given. Vaccine was administered 8/10/17. Pt reports that swelling and itchiness has gone down from initial reaction.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Skin irritation, Swelling
Clinical narrative: Local irritation developed 2 days after ZOSTAVAX. Patient went to Dr due to the redness and swelling and was prescribed LEVAQUIN 500 mg QD x 5 d.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Hep A vaccine instead of Hep B vaccine.
Age: 67.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Patient develop rash and cellulitis in the injection area.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia, Myositis, Vaccination complication
Clinical narrative: Patient received PNEUMOVAX 23 on 8/16/17. He returned 8/17/17 to pharmacy complaining of redness, soreness, and inflammation on deltoid muscle. I referred him to the local urgent care clinic which confirmed he had a reaction to the PNEUMOVAX vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 16-year-old female patient who received BEXSERO. Co-suspect products included BEXSERO. Concomitant products included MENVEO. On 13th July 2017, the patient received the 1st dose of BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. In July 2017, less than a month after receiving BEXSERO and not applicable after receiving BEXSERO, the patient expeirenced pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported, but it could be 15 or 16 years old. The patient received BEXSERO vaccine into an unknown arm. The patient experienced arm pain which resolved after ADVIL therapy. On the same day, the patient was also given MENVEO in the other arm, but did not experience any adverse events. The patient chose not to receive the 2nd dose of BEXSERO in the series, which led to an incomplete course of vaccination. This case was linked with US2017126956, reported by the same reporter. This case was a medication error associated with an adverse event.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Pain in extremity, Vomiting
Clinical narrative: Pain in arm, radiating into back. Vomiting onset 2nd day after shot. No fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, X-ray limb normal
Clinical narrative: Soon after administration of vaccine, pt experienced left shoulder pain, numbness and tingling with the inability to mover her arm at full ROM. Pt sent to ED for follow-up after hours and has been referred to Orthopedics for further evaluation.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site pain
Clinical narrative: After 10 minutes of giving vaccine MMR patient had a wheal were vaccine was given. Symptoms was only pain, looked red. 12:05pm.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pain, Sleep disorder, Swelling
Clinical narrative: Patient received vaccine (DTAP) on 08/11/17. Sates that swelling started 48 hours ago (08/15/17). Also stating that woke up in middle of night w/pain and this morning with pain from injection site. Large area of erythema noted to right deltoid, swelling, pain w/movement. Referred to clinic.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Rash erythematous, Urticaria
Clinical narrative: 8-19-17-Pt noticed red bumps, soreness-good bit of pain for several days after receiving. Also experienced itching on 8/22/17. Also, patient noticed red whelp on 8/22/17. On 8/23/17 then area gone down a good bit.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: Issue MMRV given IM should have been SQ.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen red leg with tenderness 16 hours after vaccine given.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Large (entire upper arm) has huge bruise. Pt. went to doctor and they said it was pooling blood from injection site.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash generalised, Rash pruritic
Clinical narrative: Injection site reaction (localized) as well as generalized rash beginning 3 days after vaccination initially itchy rash on buttocks, spread to trunk, extremities. No treatment.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Sensation of foreign body
Clinical narrative: Approx 5 min after receiving dose #1 of MENACTRA pt began C/O redness and feeling itchy around injection site. Pt was monitored in office by nurse. Bandaid removed. Redness/itching did not spread. Inhaler used when pt felt 'lump in throat'. BENADRYL given in office. Pt 'felt fine' and returned home w/mom after 30 + min of monitoring w/no change or worsening of symp.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Notice high grade fever 102.4 after several hours of rec'd. shot, went to ER also due to nausea, vomiting then whole week redness of arm about 2/3 of arm-left  arm.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Rash pruritic, Swelling
Clinical narrative: Red, raised, itchy bumps, bruising at site other than injection.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Thirst, Vomiting
Clinical narrative: 30 min to 1 hour after vaccine is administered, patient became thirsty, then she throw up. Patient has chill but no fever.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Coagulation test, Full blood count, Intussusception
Clinical narrative: 8/22/17 Pt was admitted to hospital and diagnosed with intussusception which was surgically repaired.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test, Surgery, White blood cell count, X-ray with contrast upper gastrointestinal tract
Clinical narrative: 8/22/17 Pt was admitted to hospital and diagnosed with intussusception which was surgically repaired.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Starting evening of injection, pt c/o dizziness, chills, feverish, bodyaches, beginning to resolve 36 hours later.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt's mom called clinic on 8/21/17 and reported that patient's left shoulder swelled and became red/hot to touch. She took to PCP on 8/16/17 and PCP reported allergic to vaccine.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling and red.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Loss of consciousness, Malaise
Clinical narrative: The patient stood up after vaccine, did not feel well, had a seat and then fell forward onto the floor because she passed out.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Red-swollen-tender left arm, pain down arm.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema
Clinical narrative: Red-swollen-tender left arm, pain down arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: A few days after PREVNAR injection (patient is not sure of exact timeframe), patient showed signs of redness, inflammation, and pain on upper left arm below injection site. Patient made an office visit 8/23/17 with primary and MD diagnosed her with cellulitis as a result of the vaccine. She was prescribed an antibiotic.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Feeling hot, Sensory disturbance
Clinical narrative: Patient noticed sensation spreading across his chest area. Vaccine administered in Left deltoid. Pt also stated that "it was starting to get warm in here". Also noted pain in joints. More specific to the hip area. Pt given several cups of water and monitored for 15-20 minutes, before being released.
Age: 55.0
Sex: F
Vaccine: FLUR3
Symptoms: Chest discomfort, Cough, Dysphonia, Flushing, Mechanical urticaria
Clinical narrative: Hives on chest, itchy rash BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPCID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days. Adverse events after prior vaccinations: Anaphylaxis / Influenza (seasonal) no brand name. As of 25Apr2017, subject is still experiencing rash, flushing, burning feeling to skin and dermographism since FLUBLOK without any response to BENADRYL or prednisone. Illness at time of vaccination: many allergies and fibromyalgia. Follow up received on 25Apr2017: Added subject's date of birth, non-serious events of flushing, burning feeling to skin and dermographism, included illness at time of vaccination. The events are considered unexpected due to the duration. Reporter's Comments: VAERS ID: 661140-1.
Age: 55.0
Sex: F
Vaccine: FLUR3
Symptoms: Rash, Rash pruritic, Skin burning sensation, Throat tightness, Urticaria
Clinical narrative: Hives on chest, itchy rash BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPCID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days. Adverse events after prior vaccinations: Anaphylaxis / Influenza (seasonal) no brand name. As of 25Apr2017, subject is still experiencing rash, flushing, burning feeling to skin and dermographism since FLUBLOK without any response to BENADRYL or prednisone. Illness at time of vaccination: many allergies and fibromyalgia. Follow up received on 25Apr2017: Added subject's date of birth, non-serious events of flushing, burning feeling to skin and dermographism, included illness at time of vaccination. The events are considered unexpected due to the duration. Reporter's Comments: VAERS ID: 661140-1.
Age: 55.0
Sex: F
Vaccine: FLUR3
Symptoms: Wheezing
Clinical narrative: Hives on chest, itchy rash BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPCID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days. Adverse events after prior vaccinations: Anaphylaxis / Influenza (seasonal) no brand name. As of 25Apr2017, subject is still experiencing rash, flushing, burning feeling to skin and dermographism since FLUBLOK without any response to BENADRYL or prednisone. Illness at time of vaccination: many allergies and fibromyalgia. Follow up received on 25Apr2017: Added subject's date of birth, non-serious events of flushing, burning feeling to skin and dermographism, included illness at time of vaccination. The events are considered unexpected due to the duration. Reporter's Comments: VAERS ID: 661140-1.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Chills, Computerised tomogram head normal, Full blood count normal
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of his daughter). A 19-year-old female patient started to receive TRUMENBA; (Lot number: R65026), via an unspecified route of administration on 26Jun2017 at 16:40 as a single dose for vaccination. The patient had no medical conditions. The patient's concomitant medications were not reported. It was reported that the patient was vaccinated with Trumenba and she had a huge adverse reaction that got her to the Emergency Room. The patient experienced severe pain at injection site, sudden onset severe head pain that spread over the head to the eye, throbbing, cramping, light sensitivity, hyperacusis, and shaking uncontrollable, all on 26Jun2017 at 17:25. All the details were provide to the FDA and Pfizer through the Adverse event reporting system at the hospital. Outcome of the events was unknown.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Hyperacusis, International normalised ratio normal, Metabolic function test normal, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of his daughter). A 19-year-old female patient started to receive TRUMENBA; (Lot number: R65026), via an unspecified route of administration on 26Jun2017 at 16:40 as a single dose for vaccination. The patient had no medical conditions. The patient's concomitant medications were not reported. It was reported that the patient was vaccinated with Trumenba and she had a huge adverse reaction that got her to the Emergency Room. The patient experienced severe pain at injection site, sudden onset severe head pain that spread over the head to the eye, throbbing, cramping, light sensitivity, hyperacusis, and shaking uncontrollable, all on 26Jun2017 at 17:25. All the details were provide to the FDA and Pfizer through the Adverse event reporting system at the hospital. Outcome of the events was unknown.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Photophobia, Protein total decreased, Prothrombin time normal, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of his daughter). A 19-year-old female patient started to receive TRUMENBA; (Lot number: R65026), via an unspecified route of administration on 26Jun2017 at 16:40 as a single dose for vaccination. The patient had no medical conditions. The patient's concomitant medications were not reported. It was reported that the patient was vaccinated with Trumenba and she had a huge adverse reaction that got her to the Emergency Room. The patient experienced severe pain at injection site, sudden onset severe head pain that spread over the head to the eye, throbbing, cramping, light sensitivity, hyperacusis, and shaking uncontrollable, all on 26Jun2017 at 17:25. All the details were provide to the FDA and Pfizer through the Adverse event reporting system at the hospital. Outcome of the events was unknown.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Eye pain, Headache, Hyperacusis, Injection site pain, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of his daughter). A 19-year-old female patient started to receive TRUMENBA; (Lot number: R65026), via an unspecified route of administration on 26Jun2017 at 16:40 as a single dose for vaccination. The patient had no medical conditions. The patient's concomitant medications were not reported. It was reported that the patient was vaccinated with Trumenba and she had a huge adverse reaction that got her to the Emergency Room. The patient experienced severe pain at injection site, sudden onset severe head pain that spread over the head to the eye, throbbing, cramping, light sensitivity, hyperacusis, and shaking uncontrollable, all on 26Jun2017 at 17:25. All the details were provide to the FDA and Pfizer through the Adverse event reporting system at the hospital. Outcome of the events was unknown.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Photophobia, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of his daughter). A 19-year-old female patient started to receive TRUMENBA; (Lot number: R65026), via an unspecified route of administration on 26Jun2017 at 16:40 as a single dose for vaccination. The patient had no medical conditions. The patient's concomitant medications were not reported. It was reported that the patient was vaccinated with Trumenba and she had a huge adverse reaction that got her to the Emergency Room. The patient experienced severe pain at injection site, sudden onset severe head pain that spread over the head to the eye, throbbing, cramping, light sensitivity, hyperacusis, and shaking uncontrollable, all on 26Jun2017 at 17:25. All the details were provide to the FDA and Pfizer through the Adverse event reporting system at the hospital. Outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Full blood count, Muscle spasms
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 15-Aug-2017. This case involves a 55-year-old female patient who was vaccinated with first dose of ADACEL (Batch number, expiration date and dose were not reported) intramuscularly in the left arm on 07-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported that the patient had penicillin allergy and had work injury. The patient had denied about illness at the time of vaccination. Concomitant medications were not reported. On 09-Aug-2017, 48 hours following the vaccination, the patient developed joint pain, muscle spasms, weakness, dizzyness and nausea. It was reported that the patient was evaluated by a physician at the emergency department (ED or ER) of a hospital and the patient was scheduled to see another physician on 17-Aug-17. Patient stated no tests were performed regarding her symptoms. As corrective treatment, the patient was prescribed FAMOTIDINE (PEPCID) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events was reported as unknown. The patient stated that ED physician determined all the events was a vaccine reaction. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 15-Aug-2017. This case involves a 55-year-old female patient who was vaccinated with first dose of ADACEL (Batch number, expiration date and dose were not reported) intramuscularly in the left arm on 07-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported that the patient had penicillin allergy and had work injury. The patient had denied about illness at the time of vaccination. Concomitant medications were not reported. On 09-Aug-2017, 48 hours following the vaccination, the patient developed joint pain, muscle spasms, weakness, dizzyness and nausea. It was reported that the patient was evaluated by a physician at the emergency department (ED or ER) of a hospital and the patient was scheduled to see another physician on 17-Aug-17. Patient stated no tests were performed regarding her symptoms. As corrective treatment, the patient was prescribed FAMOTIDINE (PEPCID) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events was reported as unknown. The patient stated that ED physician determined all the events was a vaccine reaction. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Muscle spasms, Nausea
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 15-Aug-2017. This case involves a 55-year-old female patient who was vaccinated with first dose of ADACEL (Batch number, expiration date and dose were not reported) intramuscularly in the left arm on 07-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported that the patient had penicillin allergy and had work injury. The patient had denied about illness at the time of vaccination. Concomitant medications were not reported. On 09-Aug-2017, 48 hours following the vaccination, the patient developed joint pain, muscle spasms, weakness, dizzyness and nausea. It was reported that the patient was evaluated by a physician at the emergency department (ED or ER) of a hospital and the patient was scheduled to see another physician on 17-Aug-17. Patient stated no tests were performed regarding her symptoms. As corrective treatment, the patient was prescribed FAMOTIDINE (PEPCID) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events was reported as unknown. The patient stated that ED physician determined all the events was a vaccine reaction. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Dizziness, Muscle spasms, Muscular weakness, Nausea
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 15-Aug-2017. This case involves a 55-year-old female patient who was vaccinated with first dose of ADACEL (Batch number, expiration date and dose were not reported) intramuscularly in the left arm on 07-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported that the patient had penicillin allergy and had work injury. The patient had denied about illness at the time of vaccination. Concomitant medications were not reported. On 09-Aug-2017, 48 hours following the vaccination, the patient developed joint pain, muscle spasms, weakness, dizzyness and nausea. It was reported that the patient was evaluated by a physician at the emergency department (ED or ER) of a hospital and the patient was scheduled to see another physician on 17-Aug-17. Patient stated no tests were performed regarding her symptoms. As corrective treatment, the patient was prescribed FAMOTIDINE (PEPCID) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events was reported as unknown. The patient stated that ED physician determined all the events was a vaccine reaction. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Cyanosis, Immediate post-injection reaction, Moaning, Muscle rigidity, Muscle twitching
Clinical narrative: This spontaneous report was received from a nurse, who was also the mother of the patient. A 16 year old male patient with asthma. Concomitant medicationswere not provided. The patient had been administered two doses of GARDASIL 9 on unknown dates "last year," and did not experience any adverse effects following administration of those two doses. On 14-AUG-2017, the patient was vaccinated with the third dose GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV. On the same date immediatelly following vaccination, the patient's "head dropped to his chest and he didn't look right" (head lag); Nurse called the patient's name, but he did not respond (unresponsive); The Nurse stated "it seemed like he wasn't there mentally (Mental status changes), and she thought he was going to pass out. While the patient was sitting on the  examination table, he started to fall forward. Then, his entire body "went completely stiff and rigid, his legs were sticking straight out, and his body made a couple of jerking motions." Nurse described this as "it looked like a seizure" (seizure). During the seizure, as reported, the patient's whole face turned white, his lips turned blue, he started making a groaning sound, and he was still unresponsive and it seemed like he was awake but wasn't able to comprehend anything or communicate (cognitive disorder). Furthermore, the patient's blood pressure was taken and it was 110/64 (units not provided); and nurse reported this was lower than patient's blood pressure earlier in the appointment prior to administration of GARDASIL 9, when it was 120/80 (units not provided). Nurse reported patient continued laying down and was given water, and he started to feel better "within 15 minutes." Patient was kept in the office for another 30 minutes, and his physician performed a "neuro check" which was normal, therefre, the patient fully recovered from the events before leaving the physician's office and had not had any symptoms since then. The reporter considered seizures to be a life threatening. The causal relationship between vaccination with GARDASIL 9 and the events was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA010125:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a nurse, who was also the mother of the patient. A 16 year old male patient with asthma. Concomitant medicationswere not provided. The patient had been administered two doses of GARDASIL 9 on unknown dates "last year," and did not experience any adverse effects following administration of those two doses. On 14-AUG-2017, the patient was vaccinated with the third dose GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV. On the same date immediatelly following vaccination, the patient's "head dropped to his chest and he didn't look right" (head lag); Nurse called the patient's name, but he did not respond (unresponsive); The Nurse stated "it seemed like he wasn't there mentally (Mental status changes), and she thought he was going to pass out. While the patient was sitting on the  examination table, he started to fall forward. Then, his entire body "went completely stiff and rigid, his legs were sticking straight out, and his body made a couple of jerking motions." Nurse described this as "it looked like a seizure" (seizure). During the seizure, as reported, the patient's whole face turned white, his lips turned blue, he started making a groaning sound, and he was still unresponsive and it seemed like he was awake but wasn't able to comprehend anything or communicate (cognitive disorder). Furthermore, the patient's blood pressure was taken and it was 110/64 (units not provided); and nurse reported this was lower than patient's blood pressure earlier in the appointment prior to administration of GARDASIL 9, when it was 120/80 (units not provided). Nurse reported patient continued laying down and was given water, and he started to feel better "within 15 minutes." Patient was kept in the office for another 30 minutes, and his physician performed a "neuro check" which was normal, therefre, the patient fully recovered from the events before leaving the physician's office and had not had any symptoms since then. The reporter considered seizures to be a life threatening. The causal relationship between vaccination with GARDASIL 9 and the events was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA010125:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Blood pressure decreased, Cyanosis, Dyskinesia, Fall, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse, who was also the mother of the patient. A 16 year old male patient with asthma. Concomitant medicationswere not provided. The patient had been administered two doses of GARDASIL 9 on unknown dates "last year," and did not experience any adverse effects following administration of those two doses. On 14-AUG-2017, the patient was vaccinated with the third dose GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV. On the same date immediatelly following vaccination, the patient's "head dropped to his chest and he didn't look right" (head lag); Nurse called the patient's name, but he did not respond (unresponsive); The Nurse stated "it seemed like he wasn't there mentally (Mental status changes), and she thought he was going to pass out. While the patient was sitting on the  examination table, he started to fall forward. Then, his entire body "went completely stiff and rigid, his legs were sticking straight out, and his body made a couple of jerking motions." Nurse described this as "it looked like a seizure" (seizure). During the seizure, as reported, the patient's whole face turned white, his lips turned blue, he started making a groaning sound, and he was still unresponsive and it seemed like he was awake but wasn't able to comprehend anything or communicate (cognitive disorder). Furthermore, the patient's blood pressure was taken and it was 110/64 (units not provided); and nurse reported this was lower than patient's blood pressure earlier in the appointment prior to administration of GARDASIL 9, when it was 120/80 (units not provided). Nurse reported patient continued laying down and was given water, and he started to feel better "within 15 minutes." Patient was kept in the office for another 30 minutes, and his physician performed a "neuro check" which was normal, therefre, the patient fully recovered from the events before leaving the physician's office and had not had any symptoms since then. The reporter considered seizures to be a life threatening. The causal relationship between vaccination with GARDASIL 9 and the events was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA010125:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Joint hyperextension, Mental status changes, Muscle rigidity, Musculoskeletal stiffness, Neurological examination normal
Clinical narrative: This spontaneous report was received from a nurse, who was also the mother of the patient. A 16 year old male patient with asthma. Concomitant medicationswere not provided. The patient had been administered two doses of GARDASIL 9 on unknown dates "last year," and did not experience any adverse effects following administration of those two doses. On 14-AUG-2017, the patient was vaccinated with the third dose GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV. On the same date immediatelly following vaccination, the patient's "head dropped to his chest and he didn't look right" (head lag); Nurse called the patient's name, but he did not respond (unresponsive); The Nurse stated "it seemed like he wasn't there mentally (Mental status changes), and she thought he was going to pass out. While the patient was sitting on the  examination table, he started to fall forward. Then, his entire body "went completely stiff and rigid, his legs were sticking straight out, and his body made a couple of jerking motions." Nurse described this as "it looked like a seizure" (seizure). During the seizure, as reported, the patient's whole face turned white, his lips turned blue, he started making a groaning sound, and he was still unresponsive and it seemed like he was awake but wasn't able to comprehend anything or communicate (cognitive disorder). Furthermore, the patient's blood pressure was taken and it was 110/64 (units not provided); and nurse reported this was lower than patient's blood pressure earlier in the appointment prior to administration of GARDASIL 9, when it was 120/80 (units not provided). Nurse reported patient continued laying down and was given water, and he started to feel better "within 15 minutes." Patient was kept in the office for another 30 minutes, and his physician performed a "neuro check" which was normal, therefre, the patient fully recovered from the events before leaving the physician's office and had not had any symptoms since then. The reporter considered seizures to be a life threatening. The causal relationship between vaccination with GARDASIL 9 and the events was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA010125:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pallor, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a nurse, who was also the mother of the patient. A 16 year old male patient with asthma. Concomitant medicationswere not provided. The patient had been administered two doses of GARDASIL 9 on unknown dates "last year," and did not experience any adverse effects following administration of those two doses. On 14-AUG-2017, the patient was vaccinated with the third dose GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV. On the same date immediatelly following vaccination, the patient's "head dropped to his chest and he didn't look right" (head lag); Nurse called the patient's name, but he did not respond (unresponsive); The Nurse stated "it seemed like he wasn't there mentally (Mental status changes), and she thought he was going to pass out. While the patient was sitting on the  examination table, he started to fall forward. Then, his entire body "went completely stiff and rigid, his legs were sticking straight out, and his body made a couple of jerking motions." Nurse described this as "it looked like a seizure" (seizure). During the seizure, as reported, the patient's whole face turned white, his lips turned blue, he started making a groaning sound, and he was still unresponsive and it seemed like he was awake but wasn't able to comprehend anything or communicate (cognitive disorder). Furthermore, the patient's blood pressure was taken and it was 110/64 (units not provided); and nurse reported this was lower than patient's blood pressure earlier in the appointment prior to administration of GARDASIL 9, when it was 120/80 (units not provided). Nurse reported patient continued laying down and was given water, and he started to feel better "within 15 minutes." Patient was kept in the office for another 30 minutes, and his physician performed a "neuro check" which was normal, therefre, the patient fully recovered from the events before leaving the physician's office and had not had any symptoms since then. The reporter considered seizures to be a life threatening. The causal relationship between vaccination with GARDASIL 9 and the events was not provided. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1708USA010125:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Swelling at the injection site area, inability to raise arm and with a 10 out of 10 pain, temperature of 102 for a 24 hour period of time.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. In 2013 (reported as four and a half years ago) the patient was vaccinated with his first dose of GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products, wrong drug administered and product use issue.  No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no concurrent condition, medical history or concomitant therapy. On 14-AUG-2017 the patient was vaccinated with ZOSTAVAX (Lot number N037016 is not valid for ZOSTAVAX) that was reconstituted with an expired sterile diluent(manufacturer unknown) (Lot number K015794) prophylaxis. On an unspecified date in August 2017 the patient experienced dizziness. No treatment or diagnostic lab was performed. The outcome of dizziness is unknown. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006979:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 5 patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N010247 or lot # N010865 for prophylaxis. Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008323:
Age: 61.0
Sex: F
Vaccine: PPV, UNK, VARZOS
Symptoms: Chills, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 61 years old female patient. The patient had no concomitant therapy, medical history or concurrent condition. On 14-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M029681, 0.5 ml, expiration date of 22-JAN-2018) intramuscularly for prophylaxis. The patient was also administered ZOSTAVAX ("single dose", lot # M037654, expiration date of 29-NOV-2017) subcutaneously in the left arm for prophylaxis on the same date (Inappropriate schedule of vaccine administered). The other suspected therapy also included an unspecified influenza vaccine (administered on 14-AUG-2017). The injection sites for PNEUMOVAX 23 and influenza virus vaccine (unspecified) were all in the left arm, at separate sites (Vaccine administered at inappropriate site). In the evening of 14-AUG-2017, the patient experienced redness at the site of injection of PNEUMOVAX23, and redness and swelling at the site of zoster vaccine live (ZOSTAVAX). On 15-AUG-2017, the patient experienced chills. The patient came to the pharmacy on 16-AUG-2017 and the pharmacist suggested her take ibuprofen and applied ice to the injection sites. The patient was not recovered from the events. The relationship between events and therapies was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N000683 or lot # N002204 for prophylaxis.  Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported. This is one of two reports received from the same reporter; Sender's Comments: US-009507513-1708USA007526:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report has been received from a pharmacy student referring to a 27 year old female patient. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patient was vaccinated with 6 VARIVAX (strength, dose, route, lot number and expiration date were unspecified) for prophylaxis (extra dose administered), since the patient's serologic testing keeps showing low immunity to VARICELLA (no therapeutic response). The outcome of the low immunity to VARICELLA was unknown. The causality between the low immunity to VARICELLA and VARIVAX was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age. On an unknown dates, the patients were  vaccinated with improperly stored doses of VARIVAX lot # M037008 for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The vaccine was exposed to a temperature of 75°F (fahrenheit) , during a time frame of 4 days wich was called by a data logger. No previous temperature excursions reported. No adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a health professional refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II dose 4 for prophylaxis. On an unknown date the patient experienced measles antibody negative, extra dose administered, mumps antibody test negative and rubella antibody negative. The outcome of measles antibody negative, extra dose administered, mumps antibody test negative and rubella antibody negative is unknown.; Sender's Comments: US-009507513-1708USA010123: US-009507513-1708USA010124: US-009507513-1708USA009693:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a three unspecified patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2017 (strength, dose and frequency were not reported) intramuscularly for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccines were exposed to a temperature 32 degrees F to 35 degrees F for a time period of 1 hour. There was no previous temperature excursions. Digital data logger was involved. No additional information was provided. Product quality complaint (PQC) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # M016193, expiry date: 24-APR-2018). On an unknown date, the vaccine was exposed to temperatures of 47 degrees F to 77 degrees F for 108 hours. No adverse effects reported. Previous temperature excursion occurred on an unknown date between temperatures of 47 degrees F to 77 degrees F for 28 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010536:
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram abnormal, Gait disturbance, Nausea, Palpitations, Syncope
Clinical narrative: This spontaneous report received from a healthcare worker via company representative referred to a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2007, the patient took 2 doses of GARDASIL (lot and expiry date not reported). The field representative reported that an unspecified time after receiving the 2 doses of GARDASIL, the patient developed nausea, palpitations, abnormal walking, an abnormal electrocardiogram and had fainting episodes. Outcome and causality assessment for the events were not reported. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # M00462, expiry date 03-MAR-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to cased #s 1708USA009475 and 1708USA010055). Additional information has been requested. Lot # M00462 is an invalid lot # for RECOMBIVAX HB. Sender's Comments: US-009507513-1708USA009475: US-009507513-1708USA010055.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-AUG-2017, the patient was vaccinated with ROTATEQ lot # L027719, 1 DF, oral for prophylaxis. On 21-AUG-2017, the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to ROTATEQ.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old patient. On 22-JUL-2016 the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. On 01-SEP-2016 the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis (inappropriate schedule of drug administration). No adverse event was reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a health professional refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date the patient experienced measles antibody negative, mumps antibody test negative and rubella antibody negative. The outcome of measles antibody negative, mumps antibody test negative and rubella antibody negative is unknown. Sender's Comments: US-009507513-1708USA010124: US-009507513-1708USA009503: US-009507513-1708USA009693.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of children patients of unknown age. On an unknown date, the patients were vaccinated with M-M-R II for prophylaxis. On an unknown date the patients experienced measles antibody negative, mumps antibody test negative and rubella antibody negative. The outcome of measles antibody negative, mumps antibody test negative and rubella antibody negative is unknown. The nurse could not confirm whether or not these patients had received any doses of M-M-R II prior to be tested for immunity. Sender's Comments: US-009507513-1708USA009503: US-009507513-1708USA010123: US-009507513-1708USA009693.
Sex: U
Vaccine: HPV9
Symptoms: Blood pressure decreased, Cyanosis, Head lag, Mental status changes, Pallor
Clinical narrative: This spontaneous report was received from a physician, referring to an unspecified number of patients. Concomitant medications were not provided. The patients were vaccinated with unknown doses of GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV on an unspecified dates. On the same date of vaccination, the patients' experienced head lag, were unresponsive and had mental status changes. Also the had seizures. During the seizures, the patients' whole faces turned white, their lips turned blue, and they started to make a groaning sound and seemed like they were awake but were not able to comprehend anything or communicate (cognitive disorder) (communication disorder). Furthermore, the patients' experienced decreased blood pressure.  The outcome of the events was not provided. The reporter considered seizures to be a life threatening.  The causal relationship between vaccination with GARDASIL 9 and the events was not provided.  This is one of two reports received from the same source.