chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant mediations were not reported. On 22-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M027552, expiration date 04-FEB-2018 (dose and route of administration were not reported). On 23-JUN-2017, she was seen at an unspecified urgent care facility for redness and soreness at the injection site and fever (onset date on an unknown date in June 2017). The patient was given a "Zpack" at the urgent care as treatment. The patient went to her primary care doctor on the same day as her urgent care visit and was given aspirin (manufacturer unknown) tablet, orally (strength, dose, frequency, indication, lot# and expiration date were not reported). On 24-JUN-2017, the patient's primary care doctor prescribed the patient cephalexin. On 25-JUN-2017, the patient was seen at an unspecified Emergency Room and prescribed a higher dose of cephalexin and also prescribed BACTRIM. The pharmacist stated that on 28-JUN-2017, the patient's primary care physician prescribed a higher dose of BACTRIM. The pharmacist stated that on 02-JUL-2017, the patient was prescribed VALTREX. On an unknown date in 2017, the patient was diagnosed with cellulitis. The outcome of the events was not provided. The relatedness between the events and the suspect medication was not reported. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005526.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a five patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients was vaccinated with ZOSTAVAX 19400 PFU (dose, route and site of administration were not reported) lot # M040145 with an expiration date on 08-JAN-2018 or lot #M040145 with an expiration date on 26-DEC-2017, pharmacist was unsure which patient received which lot number. Concomitant therapies included sterile diluent (manufacturer unknown). On unknown dates, the patients developed shingles, they developed rashes along their backs. Two from unspecified patients had confirmed cases of shingles by unspecified physicians. The pharmacist offered Polymerase Chain Reaction (PCR) Testing kit. The outcome of the events and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified amount of patients (ages and genders not known). On unknown dates the patients were vaccinated with VAQTA lot # M033611 (exp 02-MAR-2018), PROQUAD lot# M038277 exp 16-MAR-2018, PEDVAXHIB lot# M007762 exp 07-DEC-2018, lot# M036057 exp 18-MAY-2019, and VARIVAX lot# M010480 exp 01-MAR-2018. The products were all stored improperly with temperature excursions but were reconstituted with sterile diluent which was stored properly. VAQTA and PEDVAXHIB were stored at 47F to 77F for 40 minutes. PROQUAD and VARIVAX were stored at 6F to 14F for 9 hours 5 minutes and 15F to 46F for 4 hours and 55 minutes. There were no previous excursions. Data logger was yes. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a company representative refers to unknown number of patients. On an unknown date the patient(s) were vaccinated with VAQTA for prophylaxis. Lot# not provided. The field representative reported that an unspecified physician reported to him that their VAQTA had expired and was administered. He had questioned whether this was okay. The field representative stated he did not hear of any adverse effects. No other additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 29-JUN-2017 from a vaccine coordinator regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-JUN-2017 the patient received an improperly stored dose of PEDVAXHIB lot # M032150, expiration 21-APR-2019, intramuscular for prophylaxis. No adverse effects reported. The vaccine was stored between the temperatures of 47 degrees Fahrenheit to 77 degrees Fahrenheit for the time period of 50 hours. There were no previous temperature excursions reported. The call was made because of a data logger. No further information available. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004392.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Patient experienced a local injection site reaction. She said at first she had a white round silver dollar shape whelp where the vaccine was administered. She said that it itched and it hurt. Over the course of a week, the site started to look better then a red rash began to appear around the whelp and the whelp started changing colors to a dark red.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Local reaction, Rash erythematous
Clinical narrative: Patient experienced a local injection site reaction. She said at first she had a white round silver dollar shape whelp where the vaccine was administered. She said that it itched and it hurt. Over the course of a week, the site started to look better then a red rash began to appear around the whelp and the whelp started changing colors to a dark red.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT NOTICED A TENDER, RED, SLIGHTY PUFFY AREA AT THE SITE OF INJECTION MEASURING APPROXIMATELY 1" X 3". PATIENT WAS NOT SURE WHEN IT BEGAN BUT FIRST NOTICED IT AND CAME TO US ON 07.18.17. AT THIS TIME PATIENT HAD NOT DONE ANYTHING TO TREAT THE AREA.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Pain in extremity, Swollen tongue, Urticaria
Clinical narrative: Pt had tongue swelling when patient woke up the next morning, fatigued, developed whelps, arm soreness, no shortness of breath. Whelps have lasted at least 2 weeks. Instructed to report it by GSK.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Cough, Dysphagia, Lumbar puncture, Petechiae, Pyrexia
Clinical narrative: Difficulty swallowing, fever, cough, runny nose and petechial rash.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rhinorrhoea
Clinical narrative: Difficulty swallowing, fever, cough, runny nose and petechial rash.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, init on 2017-07-15.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-07-12.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Rash maculo-papular, Rash pruritic
Clinical narrative: Localized left arm swelling with a maculopapular pruritic rash over the left arm and torso with fever.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cough, Injection site induration, Injection site rash, Pyrexia, Vomiting
Clinical narrative: Mom states patent developed a fever, and "hard bumps" all over legs shortly after receiving the vaccines. Mom also states the patient has been vomiting, and coughing since receiving her vaccines.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: This spontaneous report was received from a nurse and refers to a 16 year old female patient. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. In JUN-2017, (about 2 weeks ago at the time of reporting), the patient was vaccinated with both GARDASIL 9 (dose, frequency, route, site of administration and lot # were not reported) for prophylaxis and TRUMENBA (other suspect therapy). The nurse reported that the patient had received both the GARDASIL 9 and TRUMENBA vaccines simultaneously about 2 weeks ago and experienced injection site pain and nausea immediately after receiving the two vaccinations. Within the last two weeks, the patient also experienced "brain fog"  for one week after receiving both the GARDASIL 9 and TRUMENBA vaccines. The outcomes of injection site pain, nausea and brain fog was unknown. Causality assessment was not provided.  Additional information is not expected, as no contact details were provided.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable health care professional reported that a patient received PREVNAR 13 on an unknown date at single dose for immunization. Medical history and concomitant medication were not reported. The patient had gotten redness around the injection site with outcome unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (65 but was unsure) and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date (several years before reporting) at single dose for pneumococcal immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a rash around the injection area under the arm a few days after receiving on an unspecified date with outcome of recovered. The rash went away quickly so the patient thought it may have been due to deodorant or something.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain, Pruritus, Skin warm
Clinical narrative: 1 day following injection; red bicep (upper arm) - pain to the touch - warm - itching, headache.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 12th June 2017, the patient received the 1st dose of BEXSERO .5 ml. On 13th June 2017, 1 days after receiving BEXSERO, the patient experienced injection site erythema, injection site lump, injection site induration and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site lump and injection site induration were not recovered/not resolved. The reporter considered the injection site erythema, injection site lump, injection site induration and injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by the patient's mother. The mother reported that the patient experienced a red ring around the injection site and it was very sore with a hard knot.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture urine, Differential white blood cell count, Full blood count, Lethargy, Poor feeding infant
Clinical narrative: Patient developed fever 101-102 after immunizations. Is lethargic; slept a lot, with poor feeding. Seen in office next day, sent to ER for observation, observed and sent home.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Somnolence, Urine analysis
Clinical narrative: Patient developed fever 101-102 after immunizations. Is lethargic; slept a lot, with poor feeding. Seen in office next day, sent to ER for observation, observed and sent home.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Feeling abnormal, Headache, Mononucleosis heterophile test negative
Clinical narrative: HPV Vax given 7-5-17, felt "off" the next day. The following day had diarrhea, nausea. 4 days after admin still felt "off" "blah" and had headache. Talked w/Mom on 5th day. Seen by provider on day 6 post vax for headache, abdominal pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Streptococcus test negative, Urine analysis normal
Clinical narrative: HPV Vax given 7-5-17, felt "off" the next day. The following day had diarrhea, nausea. 4 days after admin still felt "off" "blah" and had headache. Talked w/Mom on 5th day. Seen by provider on day 6 post vax for headache, abdominal pain.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Shortly after injection to Left thigh mom reported to ER staff rash began to injection area then spread to other extremities and torso. Mom treated with oatmeal bath and BENADRYL prior to bringing to ER. Dx rash-hives.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Diarrhoea, Lethargy, Malaise, Oropharyngeal pain
Clinical narrative: Given vaccine 7/10/17. Mom called 7-11-17 and stated that by the time they got home from the office, patient started c/o not feeling well. Patient had diarrhea, lethargy, and a temp of 101-102, and sore throat.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Within 10 minutes, pt fainted.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Dizziness. Loss of conscious (few seconds). Feet elevated. Vitals every 10-15 min. Given juice and crackers.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Rash generalised, Rash macular, Rhinitis
Clinical narrative: Pt. developed fever, after administration w/persistence and then a macular rash from head down, no defervescence. Possible viral exanthem. BENADRYL given with no improvement of rash. Pt. also had purulent nasal discharge. No fever or URI at the time of administration of vaccine.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe arm pain. Unable to lift arm. Generalized body aches.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash papular, Vaccination site rash
Clinical narrative: SMALL RAISED RED BUMPS APPEARED AT ALL VACCINATION SITES. RASH ON BILATERAL ARMS RESOLVED AFTER 5 DAYS. RASH REMAINS ON BILATERAL THIGHS. AREA OF RASH APPROX 1 WEEK LATER WAS 2 INCH DIAMETER. DENIES FEVER, DENIES ITCHINESS. SIMILAR REACTION AT EACH OF PREVIOUS REACTIONS. MOTHER OF CLIENT STATES COOL BATH HELPS FOLLOWING REACTION. AT MOST PREVIOUS VACCINE ADMINISTRATIONS, BANDAIDS WERE NOT USED ON CLIENT ARMS OR LEGS.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Neutrophil percentage, White blood cell count normal
Clinical narrative: Localized erythema from deltoid to elbow on left lateral arm with localized tenderness.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Body temperature increased, Electroencephalogram normal, Eye movement disorder, Full blood count normal, Hiccups
Clinical narrative: On 6-22-17 at 5:00 am parent heard a hiccup like noise coming from patient followed by unusual eye movements, eyes rolled upward, twitching of arms and legs. Axillary temp was 100.5 at time of seizure. Parent gave 2 doses of Diastat with no improvement so patient was taken to the Emergency Room where she received Ativan. Patient was admitted to hospital where she was followed by neurology. Patient was discharge on 6-23-17 and sent home on Keppra 80 mg twice daily and will need to follow up in 3 months from date of discharge.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Metabolic function test normal, Muscle twitching, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: On 6-22-17 at 5:00 am parent heard a hiccup like noise coming from patient followed by unusual eye movements, eyes rolled upward, twitching of arms and legs. Axillary temp was 100.5 at time of seizure. Parent gave 2 doses of Diastat with no improvement so patient was taken to the Emergency Room where she received Ativan. Patient was admitted to hospital where she was followed by neurology. Patient was discharge on 6-23-17 and sent home on Keppra 80 mg twice daily and will need to follow up in 3 months from date of discharge.
Age: 67.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, Paraesthesia, Poor quality sleep
Clinical narrative: The patient reported instant pain at the time of injection which caused him to jump.  He said that night he was unable to sleep well due to pain radiating down his arm. His wife is an RN, and she advised him to take some ibuprofen and apply an ice pack, which he did. The pain continued to worsen, and he began noticing tingling in the fingers of the left hand, and a loss of strength in the arm. He then sought care from his primary care physician on approximately 7/14/17. He was prescribed prednisone 20mg tabs, 60mg x 3 days, 40mg x 3 days, 20mg x 3 days. He visited me today, 7/18 to give me this report. He was still experiencing pain.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, UNK
Symptoms: Dyskinesia, Electroencephalogram, Emotional distress, Myoclonic epilepsy, Tic
Clinical narrative: Received shots at around 2:45-3:00 PM July 5th 2017. At around 9:55 PM  he began having what looked like myoclonic  seizures. Did not turn blue or lose consciousness but was visibly upset that his body was repetitively jerking to his left uncontrollably, He continues now to have jerks or TICS 4+ times daily. Pediatrician recommends we cease vaccinations for time being.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever for over 24hours /temp 101// irritability.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Patient complained of sore arm but also had a rash about the size of a hand that was warm to the touch starting 1 day after vaccine was administered. Day 2 the rash has expanded around the arm. Day 3 the rash diminished in size and was resolved by day 4.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash papular, Vaccination site rash
Clinical narrative: Four days after vaccination the patient developed a fine papular rash approx. 4cm in diameter on her left outer arm at the site of one of the vaccines. No pustules.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. Information regarding concomitant therapy was not reported. On 06-JUL-2017, the patient was vaccinated with an expired dose of M-M-R II, batch/lot# reported as: 024266, expiration date: 01-JUL-2017(dose number, anatomical location and frequency were not) for prophylaxis.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site infection
Clinical narrative: Information was received from a physician via a Company Representative regarding a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N003997 (dosage, frequency and indication unknown). It was reported that the patient experienced an infection at the injection site two days after receiving PNEUMOVAX 23. The outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as there was no contact information for the physician.
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Rash generalised
Clinical narrative: Information was received on 30-JUN-2017 from a field representative who overheard a physician explaining to an office staff member that a parent called in and reported that their four year old male child had developed a rash all over their body, which is suspected to be measles (event start date reported as "about 3 years ago"). The patient was en route to another country. It was confirmed that the child had received his first dose of M-M-R II prior to this symptom (date, lot#, expiration and dose not reported). Outcome of event was not reported. No further adverse event information was provided. No consent for follow-up. Upon internal review, measles was determined to be a medically significant event. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: ED HPI Comments (7/12/17): This is a 4-year-old female presenting to the emergency Department today with complaints of redness and swelling at the site of her immunizations. The patient's mother states that she had her well-child check visit with her pediatrician yesterday and had immunizations in her bilateral thighs. The mother notes that the immunization sites were bruised following the visit and then throughout the evening into the morning became erythematous and edematous. The mother notes the patient seems to be walking without any difficulty and does not have any other symptoms to include fever, cough, congestion, headache, nausea and vomiting or irritability. The patient's mother states she is eating and drinking as normal and using the bathroom as normal. At this time nothing seems to make the patient's symptoms any better or worse. ED Assessment/Plan: The patient once again presented with areas of infection following immunizations. On exam the patient had bilateral leg cellulitis post-routine vaccination. There is no abscess or systemic issues present. The patient was afebrile, nontoxic, well-appearing in no acute distress. The patient?s mother was informed that we will prescribe her Keflex twice daily for 10 days and to follow-up in the next 1-2 days with her pediatrician for a wound recheck. GH History of Present Illness (7/17/17): The symptoms began 5 days ago.  Had shots 7 days ago.  Dtap-IPV in right leg and MMRV in left leg. The next day noted some redness.  Looked more bruised and swollen in the right leg 2 days after. Went to ER. Documented 2X3 cm of redness and diagnosed with cellulitis of bilateral legs and given cephalexin. Looking better overall. Still a good bruise on left leg. GH Assessment/Plan: Local reaction to tetanus vaccine, subsequent encounter (T50.A95D). Combination shot including Dtap and IPV in right leg. Unclear if infection present as local reaction can be warm, red and swollen. Local reaction to immunization with measles-mumps-rubella (MMR) vaccine, subsequent encounter (T50.B95D)  Combination shot with MMR and VZV given in left leg, bruising still present and normal expected reaction. Unclear if infection was present last week, but normal at this time. Cellulitis, unspecified cellulitis site (L03.90).  On cephalexin for concern for bilateral cellulitis which is unusual given the local reaction to vaccines can be large.  Plan to use cool compresses and Benadryl if local reactions are a concern in the future.  Complete cephalexin as prescribed by previous provider.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient received a PREVNAR vaccine on Monday. The following day she developed a increasingly red, enlarging, tender rash on the injection site. She reports mild fatigue but no fever or chills. No cough or shortness of breath. She denies any joint symptoms. Given 7 days of cephalexin PO, pt returned 7/3 to report that rash seemed to be increasing and was changed to different abx (Bactrim). Patient presented back to PCP 7/5 and rash was resolving, tolerating abx well.
Age: 16.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dry skin, Malaise, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Had Var and MMR on 7-6-17. Mom states on 7-9-17 client had a low grade fever, malaise, and a rash. Client states rash started on ankles and legs. Mom states she had some on waist and on her back and states it was chicken pox. Mom also states client possibly had some flea bites on lower legs. Came in today to report reaction. Client has a resolving rash to lower legs and a few on arms. All areas are dry. Mom states the low grade fever only last one day. She had applied calamine lotion to rash and gave some Benadryl. Did not go to a doctor. Mom had client stay home, rest,  and avoided babies and older people. Client states she feels well now. No complaints.
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was ordered PROQUAD by provider which is off label for pt due to his age-  pt experienced no side effects from vaccination at this time.
Age: 0.92
Sex: F
Vaccine: DTAP, HEPA, HIBV, MNQ, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient has not had any adverse events, mother of pt has been informed of incidence and advised to monitior patient for any adverse symptoms.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: About 5 minutes after completing the immunizations, the patient became light-headed and fainted.  I helped her back into her seat, gave her an alcohol swab to sniff to wake her back up, gave her a drink of water, and gave her some glucose gel to eat. The patient regained consciousness, gained color back into her face, and was able to stand and walk after a couple of minutes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Called patient per her request after she had come in and spoke with the pharmacist on duty regarding bumps around & on her scalp. She told me that she had bumps to breakout around her hairline and blisters to form on her scalp a few days after she received a shingles vaccine. She thought she was having an outbreak from shingles because of the vaccine. She said the other pharmacist had told her that the bumps were more than likely from the weave and not shingles. Patient had new placed braided extensions done to her hair the day that the vaccine was administered. I also advised her that the bumps around her hairline were most likely from the braids being too tight.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Gait disturbance, Headache, Idiopathic intracranial hypertension
Clinical narrative: From mother of child: She had uncontrollable shaking of her Left arm, then vomiting, ashen skin to include face, lips, extremities, instant pounding headache, dizziness, nearly passed out. I had to pick her up and lift her back onto the table. We stayed for an extra hour to recover. Took immediate vitals. HR was 80 BP 90's/50's. I don't believe it was vasovagal, reaction occurred approx 7 minutes later after injection. Also, Right foot drop, she was swinging her right leg around to walk out after over an hour recovery. Also, pustule rash all over left arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Intracranial pressure increased, Pallor, Papilloedema, Peroneal nerve palsy, Rash pustular
Clinical narrative: From mother of child: She had uncontrollable shaking of her Left arm, then vomiting, ashen skin to include face, lips, extremities, instant pounding headache, dizziness, nearly passed out. I had to pick her up and lift her back onto the table. We stayed for an extra hour to recover. Took immediate vitals. HR was 80 BP 90's/50's. I don't believe it was vasovagal, reaction occurred approx 7 minutes later after injection. Also, Right foot drop, she was swinging her right leg around to walk out after over an hour recovery. Also, pustule rash all over left arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor, Visual impairment, Vomiting
Clinical narrative: From mother of child: She had uncontrollable shaking of her Left arm, then vomiting, ashen skin to include face, lips, extremities, instant pounding headache, dizziness, nearly passed out. I had to pick her up and lift her back onto the table. We stayed for an extra hour to recover. Took immediate vitals. HR was 80 BP 90's/50's. I don't believe it was vasovagal, reaction occurred approx 7 minutes later after injection. Also, Right foot drop, she was swinging her right leg around to walk out after over an hour recovery. Also, pustule rash all over left arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient came into the pharmacy and talked with me. She stated that about 20 minutes after receiving the vaccine, her arm began to hurt. The next morning it was so painful that she couldn't move it and the pain persisted for about 5-6 days. She stated that she takes hydrocodone/APAP for her rheumatoid arthritis and was taking it more that usual to help with this pain, although it didn't help much. She stated she had never had a bad reaction from a vaccine before. She felt as though the person giving her the vaccine gave it too high up in her arm and that she felt it hit her bone and thought that might be why she had such pain. She did not seek medical treatment.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Urinary tract infection
Clinical narrative: The patient came to our pharmacy and received a tetanus shot on 07/13/17. She showed back up at the pharmacy on 07/17/17 stating that she developed a Urinary tract infection as a result of the shot she got on the previous Thursday. She did not describe her symptoms at all, but she did state that she was in a lot of pain and that she needed to hurry home to take a bath.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient experienced light-headedness nausea and vomited once. She rested, drank OJ and felt completely back to normal (about an hour later).
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, and swelling at site. Advised to monitor, use ice, TYLENOL/ibuprofen for pain if needed.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Injection site cellulitis, Pain, Pyrexia
Clinical narrative: Pt returned to clinic for evaluation of RUE. Per Dr. notes pt had cellulitis of RUE. Prescribed BACTRIM D/S 800-160 mg. one table BID times 7 days. Pt had redness swelling, fever, pain with  movement. Pt returned 7-17-17 Abx discontinued-did not help with cellulitis, symptoms improving per Dr. Symptoms were more persistent with allergic reaction per Dr.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Pt returned to clinic for evaluation of RUE. Per Dr. notes pt had cellulitis of RUE. Prescribed BACTRIM D/S 800-160 mg. one table BID times 7 days. Pt had redness swelling, fever, pain with  movement. Pt returned 7-17-17 Abx discontinued-did not help with cellulitis, symptoms improving per Dr. Symptoms were more persistent with allergic reaction per Dr.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash-vesicular. Mupirocin ointment, 2 %, 1 app, applied topically. 3 times a day, 5 days, 22 grams.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: ZOSTAVAX vaccination resulted in swollen, hot, red injection site for four days. Then an itchy rash along the right jaw line. A week later another itchy red rash on one side of the waist. Now 17 days later new itchy spots are still appearing. Only BENADRYL was used to prevent killing the vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy inguinal in a 16-year-old male patient who received BEXSERO (batch number 166801, expiry date May 2018). On 3rd July 2017, the patient received BEXSERO. In July 2017, several days after receiving BEXSERO, the patient experienced lymphadenopathy inguinal. On an unknown date, the outcome of the lymphadenopathy inguinal was recovering/resolving. It was unknown if the reporter considered the lymphadenopathy inguinal to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient complained of lymph nodes in the groin area after receiving the BEXSERO vaccine in Hip Area. It was not painful. The patient came to physician's office on 8th July 2017. No additional information was provided. The safety could follow up with health care professional. The patient visited emergency room.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: After a shot of GARDASIL 9 to the left arm, cannot move arm, have excruciating pain and cannot sleep.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Company representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash at the injection site and swollen arm on an unspecified date with outcome of unknown.
Age: 46.0
Sex: M
Vaccine: PNC13, TDAP, VARCEL, VARCEL
Symptoms: Varicella virus test
Clinical narrative: Information has received from an infectious disease physician concerning a 46 year old male patient with graft versus host disease, hypertension, gastrooesophageal reflux disease (GERD), end stage renal disease requiring hemodialysis, and a history of insomnia, hyperglycemia, and stem cell transplant. Prior vaccinations included M-M-R II) on 10-APR-2017. On 26-MAY-2017, the patient was vaccinated with VARIVAX, subcutaneously (lot # unknown) "in order to become eligible for a kidney transplant." The VARIVAX was reconstituted with sterile diluent (MSD). Concomitant therapies included metoprolol, calcium acetate, amlodipine, hydroxyzine, prednisone, folic acid, melatonin, and lisinopril (manufacturers unknown), and AMBIEN. The physician reported that the patient developed a "disseminated varicella rash" on an unspecified date after receiving a dose of VARIVAX. The patient was admitted to the hospital on 23-JUN-2017 and discharged on 27-JUN-2017. The patient received "a high dose of acyclovir" while hospitalized for the varicella rash. The physician reported that there was no visceral involvement. The physician reported that the varicella rash was "potentially life threatening" and also that the adverse event caused a significant disability or incapacity because the patient was hospitalized for four days. The physician requested a varicella zoster virus (VZV) analysis. VZV serology IgG > 135 (negative), IgM 4.32 (positive), VZV phototoxic reaction (PTR) from blood 69000 and from lesion 280 million. The patient was reported to be recovering. No additional information was provided. Follow-up information was received on 12-JUL-2017 from the physician concerning a 46 year old male patient with no known drug allergies and with history of plasmacytoid dendritic cell neoplasia/plasma amyloid malignancy status post (s/p) double cord hematopoietic stem cell transplantation (HSCT) with current post-transplant graft versus host disease (on chronic low dose prednisone [now alternating doses; previously 10 mg daily] which he was on at the time of vaccination). Other concomitant medications included: lisinopril, metoprolol XL, amlodipine, folic acid, calcium acetate, and pantoprazole (manufacturers unknown). The patient has renal failure on hemodialysis and is in work-up for kidney transplant (still pre-kidney transplant). As part of the protocol, an oncologist provided a prescription for the patient to obtain the VARIVAX, which he received at a pharmacy on 26-MAY-2017. There was no rash at the site of injection. On 23-JUN-2017, the patient developed a vesicular rash on his chest, back, arms bilaterally, and a few on his face and legs with >100 chickenpox lesions. The patient was afebrile and had no recent chickenpox or shingles exposure. The patient recovered from the chickenpox on 12-JUL-2017. A Varicella Zoster Virus Identification Program (VZVIP) vesicle/lesion specimen was collected on 24-JUN-2017. Disseminated varicella rash/Chickenpox was considered to be disabling and potentially life-threatening. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Neuralgia
Clinical narrative: I also received PREVNAR 13 at the same time. My husband got the same vaccines and has the same symptoms. We have had horrible pain in our buttocks and down our right leg into the foot. It is following the sciatic nerve. We both went to a chiropractor first thinking we had sciatica issues. Nothing changed and we proceeded to get worse. We contacted our Doctors and I got a steroid shot and he got prednisone pills. It didn't help ,as I figured out we are treating symptoms and not the cause. It has been 6 weeks, we can't sit , i can hardly walk at times. I have seen some improvement but he is worse. We have been prisoners in our own home. They need to have an antidote for issues like this.  We probably shouldn't have got both shots at once. His lot number was from a different lot so it wasn't the lot.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Dyspnoea, Musculoskeletal pain, Pain in extremity, Spinal X-ray
Clinical narrative: I also received PREVNAR 13 at the same time. My husband got the same vaccines and has the same symptoms. We have had horrible pain in our buttocks and down our right leg into the foot. It is following the sciatic nerve. We both went to a chiropractor first thinking we had sciatica issues. Nothing changed and we proceeded to get worse. We contacted our Doctors and I got a steroid shot and he got prednisone pills. It didn't help ,as I figured out we are treating symptoms and not the cause. It has been 6 weeks, we can't sit , i can hardly walk at times. I have seen some improvement but he is worse. We have been prisoners in our own home. They need to have an antidote for issues like this.  We probably shouldn't have got both shots at once. His lot number was from a different lot so it wasn't the lot.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PPV, VARZOS
Symptoms: Back pain, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity, Sciatica
Clinical narrative: I also received PREVNAR 13 at the same time. My husband got the same vaccines and has the same symptoms. We have had horrible pain in our buttocks and down our right leg into the foot. It is following the sciatic nerve. We both went to a chiropractor first thinking we had sciatica issues. Nothing changed and we proceeded to get worse. We contacted our Doctors and I got a steroid shot and he got prednisone pills. It didn't help ,as I figured out we are treating symptoms and not the cause. It has been 6 weeks, we can't sit , i can hardly walk at times. I have seen some improvement but he is worse. We have been prisoners in our own home. They need to have an antidote for issues like this.  We probably shouldn't have got both shots at once. His lot number was from a different lot so it wasn't the lot.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Pigmentation disorder
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated into the right deltoid with a dose of GARDASIL 9 injection, lot # reported as U5557AA, expiration date 13-MAY-2018 (dose and route of administration were not reported) for prophylaxis. On an unknown date in 2017, the patient demonstrated hyperpigmentation of the left side of neck from chin to shoulder. No other side effects were reported. No further information was provided. The outcome of the event and the causality assessment were not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Skin hyperpigmentation
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated into the right deltoid with a dose of GARDASIL 9 injection, lot # reported as U5557AA, expiration date 13-MAY-2018 (dose and route of administration were not reported) for prophylaxis. On an unknown date in 2017, the patient demonstrated hyperpigmentation of the left side of neck from chin to shoulder. No other side effects were reported. No further information was provided. The outcome of the event and the causality assessment were not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Headache, Myalgia, Productive cough, Pyrexia
Clinical narrative: Mild fever, fatigue,headache, muscle aches (legs), vomiting (sputum/phlegm for 2 days)...symptoms started 3 days after immunization, and have lessened although not completely resolved as of 7/18/17.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Mild fever, fatigue,headache, muscle aches (legs), vomiting (sputum/phlegm for 2 days)...symptoms started 3 days after immunization, and have lessened although not completely resolved as of 7/18/17.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome.
Sex: M
Vaccine: HPV9
Symptoms: Dysuria, Penis disorder
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On 28-JUN-2017 the patient was vaccinated with GARDASIL 9 (dose, lot number and route were not reported) for prophylaxis. On 29-JUN-2017, the patient experienced penis disorder and dysuria. The outcome of penis disorder and dysuria was unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered inadvertently one single dose of VARIVAX subcutaneously, Lot # N002203 with and expiration date on 19-JAN-2019 for prophylaxis (strength was not provided) that had been improperly stored during 1 hour at 10°F. Previously, there was a temperature excursion for 1 hour at 9°F. Concomitantly, the doses of VARIVAX were reconstituted with a properly stored sterile diluent (manufacturer unknown). The call was because of a data logger and no adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1707USA005855.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the patient's wife, referring to her husband a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in 2009, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route, lot number and expiration date not reported) for prophylaxis. The reporter stated that the patient inadvertently received a second ZOSTAVAX injection on 11-JUL-2017. No adverse event reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old female patient. On 14-JUL-2017, the patient was vaccinated with VARIVAX, (lot # was reported as M046926, expiration date 28-NOV-2018, 0.5 ml, intramuscular in the left thigh for prophylaxis. Other suspect therapies included sterile diluent (lot # M015993, expiration date 03-DEC-2018). On 14-JUL-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of two reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On multiple, unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # reported as N012488, expiration date 20-APR-2019; lot # reported as N012132, expiration date 17-APR-2019; lot # N001528, expiration date 13-JAN-2019; lot # reported as N000683, expiration date 06-JAN-2019 (dose, route and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered doses of vaccine were stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions reported. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006208.
Sex: U
Vaccine: HIBV, HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 30-JUN-2017 from a nurse regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients received an improperly stored dose of PEDVAXHIB (lot # M020100, exp date 07-MAR-2019; lot # M045206, exp date 27-JUN-2019), GARDASIL 9 (lot # M036059, exp date 03-JUN-2019; lot # M044717, exp date 19-JUL-2019; lot # N002720, exp date 12-MAY-2019), or MMR II (lot # M011667, exp date 08-MAR-2018; lot # M032487, exp date 05-JUL-2018, lot # M045101, exp date 10-NOV-2018) reconstituted with properly stored sterile water diluent (unknown lot # and expiration date). No adverse effects reported. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit Time Frame: 1 hour Previous temperature excursion?: No. Was call because of a data logger?: Yes. The outcome of the event was unknown. Additional information has been requested.