chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Confusional state, Decreased appetite, Electrolyte imbalance, Influenza like illness, Malaise
Clinical narrative: Fever of 103, bilateral muscle weakness, overall flu-like muscle aches, overall sense of feeling unwell, decreased mental acuity, confusion, decreased balance, electrolyte imbalance, shaking, and loss of appetite.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Mental impairment, Muscular weakness, Myalgia, Pyrexia, Scan with contrast
Clinical narrative: Fever of 103, bilateral muscle weakness, overall flu-like muscle aches, overall sense of feeling unwell, decreased mental acuity, confusion, decreased balance, electrolyte imbalance, shaking, and loss of appetite.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Swallow study, Tremor, Urine analysis
Clinical narrative: Fever of 103, bilateral muscle weakness, overall flu-like muscle aches, overall sense of feeling unwell, decreased mental acuity, confusion, decreased balance, electrolyte imbalance, shaking, and loss of appetite.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Increased swelling of arm. Diagnosed with cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Redness, itching, raised area. 3.7 x 3.5 cm.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Endoscopy, Gastric emptying study
Clinical narrative: Immediately following all 3 HPV injections, patient fainted. In October 2015 she started experiencing inexplicable digestive issues culminating in acute pancreatitis in January 2016. Been to many physicians, not one can tell us why.......
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Gastrointestinal disorder, Immediate post-injection reaction, Nuclear magnetic resonance imaging, Pancreatitis acute, Syncope
Clinical narrative: Immediately following all 3 HPV injections, patient fainted. In October 2015 she started experiencing inexplicable digestive issues culminating in acute pancreatitis in January 2016. Been to many physicians, not one can tell us why.......
Age: 0.22
Sex: M
Vaccine: PNC13
Symptoms: Apnoea, Blood culture negative, Full blood count normal, Mechanical ventilation
Clinical narrative: Apnea requiring respiratory support infection screen (CBC, Bld cx) with empiric antibiotics x 48 hrs.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Adverse reaction
Clinical narrative: The reaction was a mild systemic reaction, and not severe.  He ought to be able to complete a full vaccination schedule.  However, there does not appear to be a way to document a mild, non-local, reaction without immediately contraindicating all future vaccines.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot and swollen arm around injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness, redness and some heat at injection site. Presented to pharmacy 6/20/16 and was advised to see her doctor in case of infection.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Dyspnoea, Hypotonia, Pyrexia, Vaccination complication
Clinical narrative: At 6 weeks on February 15, 2016 she got her first round of vaccines, she slept all day. Around 8 at night her fever had hit 103 and she would not wake up. Hospital admitted her and she spent three days there while they ran test. Spinal tap was performed along with a pee test. Results were negative. They said she must had, had a virus that the vaccines intensified or a reaction to vaccines. May 1st she had her 4 month shots. Once again her fever hit 103 almost 104. She began to breathe extremely hard. I called the nurses hotline and they told me to give her a warm bath. I undressed her to put her in the bath and she cried then her body went limp for like 5 seconds and I was screaming and she came out of it and started crying. I rushed her to the ER and we stayed till 5AM on May 2nd. That time was diagnosed as reaction to vaccines.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swollen, warmth, mild erythema, pain.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Diffuse urticarial rash without breathing difficulty.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site movement impairment
Clinical narrative: Can't walk on leg(left) that the shot was given.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Culture throat negative, Lymphadenitis, Pharyngeal inflammation, Pyrexia
Clinical narrative: After 2nd dose MMR, patient developed stomach upset, high fevers up to 105 for 6 days requiring fever reducers. He also had Inflammation of lymph nodes in neck, inflammation of throat, and sinuses. On 3rd day of fever, took him to the doctor. Doctor there sent us home. 4th day of fever, took him to for 2nd opinion. That doctor prescribed antibiotics, and took a throat culture which was negative. Eventually on the 6th day his fever disappeared.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Sinusitis
Clinical narrative: After 2nd dose MMR, patient developed stomach upset, high fevers up to 105 for 6 days requiring fever reducers. He also had Inflammation of lymph nodes in neck, inflammation of throat, and sinuses. On 3rd day of fever, took him to the doctor. Doctor there sent us home. 4th day of fever, took him to for 2nd opinion. That doctor prescribed antibiotics, and took a throat culture which was negative. Eventually on the 6th day his fever disappeared.
Age: 49.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Fatigue, Hypersensitivity, Nausea, Pain
Clinical narrative: Received vaccines early afternoon. By late evening, began to  feel nauseous. 6/18-6/20/16 Patient reported nausea, achy, tired. Arm was swollen and red. 6/21/16 DR. looked at it and reported allergic reaction. Patient took Cetirizine then BENADRYL at bedtime. 6/22/16 improving, arm improving.
Age: 49.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Peripheral swelling
Clinical narrative: Received vaccines early afternoon. By late evening, began to  feel nauseous. 6/18-6/20/16 Patient reported nausea, achy, tired. Arm was swollen and red. 6/21/16 DR. looked at it and reported allergic reaction. Patient took Cetirizine then BENADRYL at bedtime. 6/22/16 improving, arm improving.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered the incorrect vaccination. They should have received Pneumovax 23, but were given Prevnar 13. No adverse effects noted.
Age: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Blood glucose decreased, Bradycardia, Conjunctival pallor, Dizziness, Hunger
Clinical narrative: AFTER X2 IM FELT DIZZY AND BECAME PALE SAYING SHE'S HUNGRY, PUT HER LAYING DOWN EXAM TABLE LOOKING PALE LIPS & CONJUNCTIVA. HR 52/MIN REGULAR STRONG. IMPROVED AFTER REST AND FOOD INTAKE. HR UP TO 70/MIN STRONG, @ 12:10 PM PT. CLAIMED FELT BETTER BP 94/60 LESS PALLOR, NEG DIZZY ABLE TO STAND AND WALK OUT THE OFFICE WAITING FOR THE RIDE.
Age: 14.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Pallor
Clinical narrative: AFTER X2 IM FELT DIZZY AND BECAME PALE SAYING SHE'S HUNGRY, PUT HER LAYING DOWN EXAM TABLE LOOKING PALE LIPS & CONJUNCTIVA. HR 52/MIN REGULAR STRONG. IMPROVED AFTER REST AND FOOD INTAKE. HR UP TO 70/MIN STRONG, @ 12:10 PM PT. CLAIMED FELT BETTER BP 94/60 LESS PALLOR, NEG DIZZY ABLE TO STAND AND WALK OUT THE OFFICE WAITING FOR THE RIDE.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Broke out in varicella rash 4 days after receiving VARIVAX.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Anthrax and Typhoid on the 20th of June. On the 22th of June patient returned to the immunizations clinic with a large red area from injection site down to 1 in above the AC. Slight swelling in read area with significant swelling around injection site. Followed up with patients PCM team. Received Doxycycline for possible cellulitis.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Local redness around injection site as large as a size of a large orange along with itchiness only around the injection site where it became red.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA, HIBV, MMR, PNC13, UNK, VARCEL
Symptoms: Corrective lens user, Eating disorder, Eye movement disorder, Facial paralysis, Gait disturbance
Clinical narrative: Left side of eye and cheek were low. Fever of 102.6, wouldn't eat, walk or talk. Two days after the 9th, eyes started to cross. Both at times, then each eye would rotate. Went back to Dr. he told me he never heard of shots causing this. Took her to see an eye Dr. and now she is in glasses. But her eyes still cross with them.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA, HIBV, MMR, PNC13, UNK, VARCEL
Symptoms: Pyrexia, Speech disorder, Strabismus
Clinical narrative: Left side of eye and cheek were low. Fever of 102.6, wouldn't eat, walk or talk. Two days after the 9th, eyes started to cross. Both at times, then each eye would rotate. Went back to Dr. he told me he never heard of shots causing this. Took her to see an eye Dr. and now she is in glasses. But her eyes still cross with them.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Slow response to stimuli
Clinical narrative: Patient received first Gardasil vaccine, Meningococcal and Tdap vaccines and stood up and told mother she felt dizzy; then fell to floor. She was placed in supine position. She was first slow to respond but then was oriented to her name, recognized her mother, and where she was located. VS on assessment was 110/80, HR 64 apical, respiration was even and unlabored. After several minutes, she was assisted to sitting position; was feeling less dizzy and given water to drink. She recovered more and then assisted to chair where she was now alert and oriented. She reported dizziness had subsided.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Antineutrophil cytoplasmic antibody negative
Clinical narrative: Tdap given, pain in left arm for 2 weeks after administration, patient has asymmetric deltoid.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Few days later, developed pain in the deltoid area.  Persists still, now 1 month later.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Patients Left Arm got very red and sore at site and fever of 102.  Parent gave Tylenol to break fever.  Fever returned through out the night and soreness continued from shoulder to elbow and armpit.  Appointment made in clinic after speaking to Triage Dept on 6/21/16, because soreness and lymph node pain still persisted, appointment made for 10:50 on 6/22/16 to see Dr and the Dr did notice 1 swollen Node and still tender to the touch, patient said she noticed the tenderness even just applying deodorant.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: Patients Left Arm got very red and sore at site and fever of 102.  Parent gave Tylenol to break fever.  Fever returned through out the night and soreness continued from shoulder to elbow and armpit.  Appointment made in clinic after speaking to Triage Dept on 6/21/16, because soreness and lymph node pain still persisted, appointment made for 10:50 on 6/22/16 to see Dr and the Dr did notice 1 swollen Node and still tender to the touch, patient said she noticed the tenderness even just applying deodorant.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint injection
Clinical narrative: Went to ER for a injury to foot and toe. Upon inspection from doctor she ordered Lortab and Ibuprofen and Xrays. She also stated that since I had abrasions on toe that I would need a Tetanus shot. The Nurse, came in and gave me the meds first. Later, after finding that it was only bruised and not broken, before discharge I was given a Tetanus shot in my left shoulder. I immediately told her I thought she hit bone and it was very painful and she give it to me in the top of my shoulder nearly where it starts to turn to come down my arm. She said it would be very sore and hurt for several days and to use warm compresses on it and take Ibuprofen. By the early morning hours, it was significantly more painful. I tried to give it a few days, thinking that it was hurting so bad due to receiving the vaccine. After two weeks, my shoulder was much worse and I couldn't hardly move it. I sought treatment at the local Urgent Care where I received a shot in the hip of steroids. When it was still no better, I went to walk-in orthopedic clinic. I was then told I had a frozen shoulder and given a steroid joint injection. I have been receiving treatment since then with this doctor.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Periarthritis, X-ray
Clinical narrative: Went to ER for a injury to foot and toe. Upon inspection from doctor she ordered Lortab and Ibuprofen and Xrays. She also stated that since I had abrasions on toe that I would need a Tetanus shot. The Nurse, came in and gave me the meds first. Later, after finding that it was only bruised and not broken, before discharge I was given a Tetanus shot in my left shoulder. I immediately told her I thought she hit bone and it was very painful and she give it to me in the top of my shoulder nearly where it starts to turn to come down my arm. She said it would be very sore and hurt for several days and to use warm compresses on it and take Ibuprofen. By the early morning hours, it was significantly more painful. I tried to give it a few days, thinking that it was hurting so bad due to receiving the vaccine. After two weeks, my shoulder was much worse and I couldn't hardly move it. I sought treatment at the local Urgent Care where I received a shot in the hip of steroids. When it was still no better, I went to walk-in orthopedic clinic. I was then told I had a frozen shoulder and given a steroid joint injection. I have been receiving treatment since then with this doctor.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Patient stated she experienced extreme redness and tenderness surrounding the vaccination site.  She was using a cream on the site and it has since gone down but since she was filling her prescription she wanted to show it to the Pharmacist on duty.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Erythema, Hypoaesthesia, Immediate post-injection reaction, Insomnia
Clinical narrative: Initially immediately reacted with swelling, redness, soreness, numbness from the tips of my fingers. Reported to clinic two days later on 7/10/2014. Only one nurse was working that day and I later found out she did not record any notes. She did give me ice packs and told me to take Benadryl. For months had trouble with housework, working out, sleeping, chores. Soon thereafter the injury affected my arm movement. I found it hard to lift my arm. Seemed to improve but didn't go away. Greatly affected my life. At about 5 months the onset of extreme pain returned. It is now almost 2 years since vaccination date but I am still suffering from dull achy pain and have trouble sleeping as a result. I am still suffering. I have no medical insurance and this is really hard. Please note I do not know what time exactly I was given the vaccine. I do know that the onset of adverse reaction was pretty much immediate, say within an hour. I have entered 6:00 pm, as I this would have been at 1 hour after the clinic closed that day. Also, I don't want to lose what I have entered. Please correct the Date Vaccine Administered from 7/14/2014 to 7/8/2014.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Initially immediately reacted with swelling, redness, soreness, numbness from the tips of my fingers. Reported to clinic two days later on 7/10/2014. Only one nurse was working that day and I later found out she did not record any notes. She did give me ice packs and told me to take Benadryl. For months had trouble with housework, working out, sleeping, chores. Soon thereafter the injury affected my arm movement. I found it hard to lift my arm. Seemed to improve but didn't go away. Greatly affected my life. At about 5 months the onset of extreme pain returned. It is now almost 2 years since vaccination date but I am still suffering from dull achy pain and have trouble sleeping as a result. I am still suffering. I have no medical insurance and this is really hard. Please note I do not know what time exactly I was given the vaccine. I do know that the onset of adverse reaction was pretty much immediate, say within an hour. I have entered 6:00 pm, as I this would have been at 1 hour after the clinic closed that day. Also, I don't want to lose what I have entered. Please correct the Date Vaccine Administered from 7/14/2014 to 7/8/2014.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site pain, Pain
Clinical narrative: I woke up in the middle of the night with intense shoulder pain at site of injection. When I tried to move my arm it caused so much pain I almost threw up. I tried to get up to get water and ibuprofen but I felt lightheaded and almost passed out so I layed back down. I layed there in pain until I eventually fell back to sleep. It's been a week and the same pain is still at the site, it is not as intense, but it is still very painful and I have taken Tylenol 5 times in the past week to ease the pain.
Age: 30.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Arm amputation, Blood test, Cardiac pacemaker insertion, Catheter placement, Computerised tomogram
Clinical narrative: 10/5/15 Pain swelling redness. 10/8/15 I.V. antibiotics. 10/9/15 Surgery-left arm (1st of many). 10/15/15 Decreased heart rate-catheter pacemaker. 10/16/15 Dx sepsis, surgery. 10/19/15 Dx necrotizing fasciitis, surgery, muscle removed...11/21/15 Amputation, left arm. 11/25/15 Amputation, forequarter.
Age: 30.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Culture, Erythema, Heart rate decreased, Necrotising fasciitis, Nuclear magnetic resonance imaging
Clinical narrative: 10/5/15 Pain swelling redness. 10/8/15 I.V. antibiotics. 10/9/15 Surgery-left arm (1st of many). 10/15/15 Decreased heart rate-catheter pacemaker. 10/16/15 Dx sepsis, surgery. 10/19/15 Dx necrotizing fasciitis, surgery, muscle removed...11/21/15 Amputation, left arm. 11/25/15 Amputation, forequarter.
Age: 30.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pain, Sepsis, Surgery, Swelling
Clinical narrative: 10/5/15 Pain swelling redness. 10/8/15 I.V. antibiotics. 10/9/15 Surgery-left arm (1st of many). 10/15/15 Decreased heart rate-catheter pacemaker. 10/16/15 Dx sepsis, surgery. 10/19/15 Dx necrotizing fasciitis, surgery, muscle removed...11/21/15 Amputation, left arm. 11/25/15 Amputation, forequarter.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Peripheral swelling, Rash generalised, Swelling face
Clinical narrative: Pt. admitted to medical ctr for leg swelling, facial swelling/erythema, and diffuse body rash a few hrs. after 2 mo vaccines - presumed vaccine reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of ZOSTAVAX , lot # L0146899, expiry date 23-FEB-2017 and lot # L046900, expiry date 23-FEB-2017, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Lip pruritus, Oral discomfort, Oral mucosal blistering, Oral pruritus
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 62 year old female patient. Information regarding pertinent medical history and concurrent conditions were not provided. The patient had no known allergies. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX, injection, subcutaneous, lot # L040442, expiration date 15-JAN-2017. Concomitant therapies were not provided. On 07-JUN-2016, the patient went to the pharmacy and reported that after vaccination on an unspecified date in 2016, she was experiencing tingling, burning, itching and blistering around her mouth and lips. The reporter stated that the patient did not seek medical attention. At the time of reporting the outcome of the tingling, burning, itching and blistering around her mouth and lips was not recovered. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. The pharmacist refused to receive the Varicella Zoster Vaccine packet at this time. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 62 year old female patient. Information regarding pertinent medical history and concurrent conditions were not provided. The patient had no known allergies. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX, injection, subcutaneous, lot # L040442, expiration date 15-JAN-2017. Concomitant therapies were not provided. On 07-JUN-2016, the patient went to the pharmacy and reported that after vaccination on an unspecified date in 2016, she was experiencing tingling, burning, itching and blistering around her mouth and lips. The reporter stated that the patient did not seek medical attention. At the time of reporting the outcome of the tingling, burning, itching and blistering around her mouth and lips was not recovered. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. The pharmacist refused to receive the Varicella Zoster Vaccine packet at this time. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 26-MAY-2016, the patient received improperly stored M-M-R II injection (lot # L007577, expiration date 05-MAR-2017, dose and frequency were not reported, data logger involved), intramuscularly. It was reported that the M-M-R II was exposed under maximum temperature 49.3 Fahrenheit (F) for 20 hours 59 minutes (on 06-MAY-2016 and under 48.88 F for 22 minutes on 12-MAY-2016). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a female patient of unknown age. Information regarding pertinent medical history, concurrent conditions and drug reactions or allergies was unknown. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX, injection, (anatomical location, lot#, route, expiration date and dose were not reported). Concomitant therapies were not provided. In 2016, the patient experienced blisters around her mouth. Product quality complaint was not involved. At the time of reporting the outcome of blisters around her mouth was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same 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. There was not information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M004885 with expiration date 23-OCT-2017 or lot # reported as M014544 with expiration date 27-NOV-2017 (dose was not reported), as part of immunization series. There was no adverse effect reported. Administered doses of vaccine were stored in a freezer and experienced the temperature excursion of 34.1 degrees Fahrenheit for 13 hours. 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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659, expiration date 20-SEP-2017 (dose and route of administration were not reported) as a part of immunization series. There was no adverse effect reported. Administered doses of vaccine were stored in a freezer and experienced the temperature excursion of 34.1 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of VARIVAX, lot # L042266 with expiration date 27-OCT-2017 or lot # reported as M002063 with expiration date 12-JAN-2018 (dose and route of administration were not reported), as a part of immunization series. There was no adverse effect reported. Administered doses of vaccine were stored in a freezer and experienced the temperature excursion of 34.1 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was not information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L034730 with expiration date 09-SEP-2017 or lot # reported as L041455 with expiration date 22-OCT-2017 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine were stored in a refrigerator and experienced the temperature excursion of 66.3 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's current conditions, medical history or concomitant medications was not reported. On an unknown date, the patient was vaccinated with VARIVAX and/or M-M-R-II (dose, route, lot# and expiration date were not reported).  On an unspecified date, the patient developed hives after receiving either VARIVAX or M-M-R II.  The outcome of the event was not reported. The nurse did not know which product caused the patient to develop hives.  Additional information is not expected as there was no consent to contact the reporter.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Interchange of vaccine products, Oropharyngeal discomfort
Clinical narrative: This spontaneous report was received from a certified medical assistant via company representative concerning a 12 year old male patient. On unspecified dates the patient was vaccinated with the first and second doses of GARDASIL, dose route and frequency unknown. On 14-JUN-2016, the patient received third dose (GARDASIL 9) lot # M005714, intramuscularly. Immediately after administration of GARDASIL 9, the patient stated that his throat felt funny. The reporter confirmed that it was not an anaphylactic reaction. The patient was monitored for 10 minutes in the reporter's office and the reaction resolved, the patient recovered (14-JUN-2016). The reporter did not assess the causality of the event with GARDASIL 9 and GARDASIL. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 03-JUN-2016, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, therapy type, dose and site of vaccination were not reported), subcutaneous. Concomitant medication were not reported. On the same day, 5 min after vaccination, the patient experienced hives (reported as "a hive"). The outcome of hives was unknown. The relatedness between the hives and M-M-R II was not reported. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Headache, Photophobia, Syncope, Vertigo
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vertigo in a female patient who received RABAVERT (batch number 586011AA, expiry date 20th January 2019). On an unknown date, the patient received RABAVERT. On an unknown date, 1 day 16 hrs after receiving RABAVERT, the patient experienced vertigo (serious criteria other: As per reporter), headache, photophobia and syncope. On an unknown date, the outcome of the vertigo, headache, photophobia and syncope were not recovered/not resolved. The reporter considered the vertigo, headaches, photophobia and syncope to be possibly related to RABAVERT. Additional details were received as follows: The reporter was not sure, whether the reported batch number and expiry date were the actual dose of RABAVERT which was administered to the patient. The reporter did not have the patient information and had very limited information .
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 07-JUN-2016, the patient was inadvertently vaccinated with a third dose of PROQUAD (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Headache post vaccine, swollen posterior chain lymph node, resolved after 2 days.
Sex: U
Vaccine: RAB
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to RABAVERT. Additional details were provided as follows: The patient's age at vaccine administration was not reported. The reporter stated that, the patient experienced some side effects after RABAVERT vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, injection, lot # L042258, expiry date 18-AUG-2018, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer via MSW research refers to her unspecified friends of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dosing details were unknown). Concomitant medication were unknown. On an unknown date, the patients did not do so well (adverse event) after getting their shot. The outcome of event was unknown. The relatedness of the event with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. Additional information is not expected as there was no consent to follow up.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hypoaesthesia, Myalgia, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 19-year-old female patient who received BEXSERO. In June 2016, the patient received BEXSERO .5 ml. In June 2016, less than a month after receiving BEXSERO, the patient experienced muscle pain, rash and numbness. In June 2016, the outcome of the muscle pain, rash and numbness were recovered/resolved. It was unknown if the reporter considered the muscle pain, rash and numbness to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccine administration was not reported. Sales representative called to report that a physician reported to the sales representative that within the last two weeks in the doctor's office, the patient was vaccinated with BEXSERO. Soon after that the patient had muscle pain, rash, and numbness which got better in about 3-4 days and then which was resolved.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Laboratory test, Mass, Tenderness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 19-year-old female patient who received BEXSERO. In June 2016, the patient received BEXSERO .5 ml. In June 2016, less than a month after receiving BEXSERO, the patient experienced muscle pain, rash and numbness. In June 2016, the outcome of the muscle pain, rash and numbness were recovered/resolved. It was unknown if the reporter considered the muscle pain, rash and numbness to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccine administration was not reported. Sales representative called to report that a physician reported to the sales representative that within the last two weeks in the doctor's office, the patient was vaccinated with BEXSERO. Soon after that the patient had muscle pain, rash, and numbness which got better in about 3-4 days and then which was resolved.
Age: 13.0
Sex: F
Vaccine: HPV4, MENB, PPV
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This case was reported by a nurse via sale rep and described the occurrence of injection site erythema in a 13-year-old female patient who received BEXSERO (batch number 149001A, expiry date 30th September 2016). Co-suspect products included GARDASIL and PNEUMOVAX 23. On 5th April 2016, the patient received the 1st dose of BEXSERO (intramuscular), GARDASIL (intramuscular) and PNEUMOVAX 23 (intramuscular). In April 2016, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy. In April 2016, the outcome of the injection site erythema, injection site swelling, injection site warmth, fever and abdominal pain were recovered/resolved. On an unknown date, the outcome of the headache and latex allergy were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy to be related to BEXSERO. Additional details were provided as follows: The patient received the doses of BEXSERO, GARDASIL and PNEUMOVAX 23 (office records showed BEXSERO administered in the left arm with GARDASIL and PNEUMOVAX administered in the right arm). The nurse was surprised by this information because they had thought it was opposite, with BEXSERO in the right arm. As a result she was now unsure in which arm BEXSERO was administered. It was reported that, the reaction (injection site swelling, redness and warmth with some red streaks going down from the injection site) occurred in the patient's right arm. The patient also had systemic symptoms of low grade fever, abdominal pain and headache. On 7th April 2016, the patient was seen by the office and was suspected of having a latex allergy, so the reporter thought the reaction was caused by the latex in the tip cap of BEXSERO.
Age: 13.0
Sex: F
Vaccine: HPV4, MENB, PPV
Symptoms: Injection site warmth, Pyrexia, Rubber sensitivity
Clinical narrative: This case was reported by a nurse via sale rep and described the occurrence of injection site erythema in a 13-year-old female patient who received BEXSERO (batch number 149001A, expiry date 30th September 2016). Co-suspect products included GARDASIL and PNEUMOVAX 23. On 5th April 2016, the patient received the 1st dose of BEXSERO (intramuscular), GARDASIL (intramuscular) and PNEUMOVAX 23 (intramuscular). In April 2016, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy. In April 2016, the outcome of the injection site erythema, injection site swelling, injection site warmth, fever and abdominal pain were recovered/resolved. On an unknown date, the outcome of the headache and latex allergy were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy to be related to BEXSERO. Additional details were provided as follows: The patient received the doses of BEXSERO, GARDASIL and PNEUMOVAX 23 (office records showed BEXSERO administered in the left arm with GARDASIL and PNEUMOVAX administered in the right arm). The nurse was surprised by this information because they had thought it was opposite, with BEXSERO in the right arm. As a result she was now unsure in which arm BEXSERO was administered. It was reported that, the reaction (injection site swelling, redness and warmth with some red streaks going down from the injection site) occurred in the patient's right arm. The patient also had systemic symptoms of low grade fever, abdominal pain and headache. On 7th April 2016, the patient was seen by the office and was suspected of having a latex allergy, so the reporter thought the reaction was caused by the latex in the tip cap of BEXSERO.
Sex: U
Vaccine: HEP
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. Pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. On 17-JUN-2016 the patient was inadvertently vaccinated with RECOMBIVAX HB lot # K008334 expiry date 09-JUN-2016. The patient experienced no adverse event. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# L019996, expiry date 02-DEC-2016 and lot# L040413, expiry date 13-APR-2016 (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 8.2 degree Fahrenheit for a time frame of 2 hours and 15 minutes. There were no previous temperature excursion. This is one o the two reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a 19-year-old male patient who received BEXSERO. On 6th June 2016, the patient received BEXSERO. In June 2016, less than a week after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO and experienced persistent headache. The GlaxoSmithKline representative did not provide the lot number of expiry date of the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions, medical history and drug allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stores doses of VARIVAX lot # K018964, expiry date 15-OCT-2016, lot# L013824, expiry date 21-APR-2017 and lot # L031066, expiry date 18-AUG-2017 (dose number, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complain (PQC) involved. Temperature at which the vaccine was stored was 8.2 degree Fahrenheit for a time frame of 2 hours and 15 minutes. There were no previous temperature excursions. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report was received from a 52 year old female patient concerning herself. The patient was enrolled in a program. Patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot# and expiration date were not provided). On an unknown date, the patient got immediately sick (malaise) after having a vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) so she considered that vaccinations were scary. At the reporting time, the outcome of malaise was unknown. The causality was not stated. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Emergency Medical Technician refers to a multiple patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown dates multiple unspecified patients received doses of improperly stored VARIVAX, unspecified route, dosage, lot number and expiration date. The doses had some unspecified temperature stability issues (not data logger). No adverse effects were reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse, via Pfizer, Inc. (manufacturer control number 2016262812) on 16-JUN-2016, referring to a 13 month old female patient. The patient has none medical history or concurrent conditions or concomitant therapies. On 01-MAR-2016, the patient was vaccinated with doses of improperly stored ROTATEQ lot # L006184, orally, (Dosage, dose number and expiration date were not reported). Other suspect therapies included PREVNAR 13, PENTACEL, and ENGERIX-B, vaccines given on the same date. No other concomitants therapies were reported. No product quality complain was involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 13 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with his second dose of GARDASIL 9 lot # L016429, expiration date: 09-AUG-2016, intramuscular. On that same date, the patient developed hives all over his body. On 14-MAY-2016, the patient went to an urgent care unit, where he was given oxygen and a SOLU-MEDROL injection. The occurrence of hives continued and patient went to the emergency room again on 15-MAY-2016 to be treated with intravenous SOLU-MEDROL and intravenous steroid. The patient was prescribed prednisone for 12 days and BENADRYL for 2 weeks as an outpatient. The outcome of urticarial was unknown at the time of this report. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Syncope
Clinical narrative: Patient fainted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L035882, expiration date: 19-APR-2017) (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccine experienced the temperature excursion of 0 degrees Celsius for 6 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.