chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Child received 3 vaccinations that day. 2 in her right thigh, and 1 vaccination in her left thigh. Site was cleaned well with alcohol pad prior to the injection. Injection sites approximately 1 1/2  to 2 inches apart. After injections done, bandaids placed. Child tolerated shots well. Mom reports to me that the next morning  she noticed that when her daughter woke up she had  redness and some swelling noted at the injection site. She called me (public health nurse), and I told her is probably having a localized reaction to the vaccines. Mom reports she really hasn't had this before with her other shots. I told her to put a covered ice pack over the site, as she will let you. If the swelling or redness gets any worse, or if she has a fever, she should seek medical treatment. Mom said that she understood and would continue to monitor the site. She took her in to an Urgent Care on Sunday 7/16/17 to seek medical treatment.  The Dr. there diagnosed that the injection site developed localized Cellulitis and opted to treat with Keflex bid X 10 days.   I called the Mom back this morning to get an update on her child and she then reported the above events.  Mom reports that her daughter is doing much better, swelling and redness are down, and she is up and playing.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: No complications, estimated date of delivery 4/06/2016, birth weight 6 lb 15 oz. Baby born with MTHFR heterozygous gene mutation of C677T type; severe tongue-tie and lip-tie and consequent inability to breastfeed. Symptoms included ceaseless crying, starving. Undernourishment was detected by pediatrician at two months old (June 2016) and doctor prescribed formula supplementation to breastfeeding and pumping breast milk. Most symptoms such as crying and gas remained undetected until baby reached six months of age (October 2016), when newly hired lactation consultant diagnosed tongue tie and lip tie and recommended courses of therapy: craniosacral therapy, chiropractic, and also child development assistance and therapy for baby's related sensory processing disorder and consequent discomfort and pain.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Extra dose administered
Clinical narrative: Pt received Hep B vaccination when all 3 doses of Hep B vaccination were already received.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 57 years old female patient. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 06-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 in an unspecified arm (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On 07-JUL-2017, the patient developed a rash on the same arm in which the vaccine was administered, but not near the injection site. The patient's outcome was unknown. The causality assessment between PNEUMOVAX 23 and rash was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 29-JUN-2017 from a registered nurse, concerning an unspecified adult patient (age and gender unknown). No medical history or concomitant medications were reported. The nurse reported that the unspecified adult patient received pediatric doses of VAQTA on unspecified dates (also reported as 29-JUN-2017). No adverse effects reported. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 29-JUN-2017 from a registered nurse concerning a female patient of unknown age. No information regarding the patient's concurrent conditions, concomitant therapies, allergies or medical history was provided. On 26-JUN-2017, the patient was vaccinated with an improperly stored dosage of GARDASIL 9, (route and dosage not reported) lot # M034780, expiration 15-APR-2019 for prophylaxis. No adverse event was reported. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004116.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received on 29-JUN-2017 from a registered nurse concerning a male patient of unknown age. No information regarding the patient's concurrent conditions, concomitant therapies, allergies or medical history was provided. On 26-JUN-2017, the patient was vaccinated with an improperly stored dosage of M-M-R II (route and dosage not reported) lot # L040960, expiration 16-OCT-2017 for prophylaxis. Concomitant therapies included sterile diluent lot number 041248, expiration 27-JAN-2018. No adverse event was reported. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004049.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced redness and swelling not just at injection site but it traveled up the whole area above the elbow. The outcome of erythema, peripheral swelling, injection site swelling and injection site erythema is unknown. The reporter refused to provide any additional information and did not provide permission to contact. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal tenderness, Chills, Headache, Pyrexia, Tenderness
Clinical narrative: She had complaints of severe h/a, fever 101.6, tender abdomen, chills, shaking all over. She was treated was treated with NSAIDs and rest.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: She had complaints of severe h/a, fever 101.6, tender abdomen, chills, shaking all over. She was treated was treated with NSAIDs and rest.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: PT'S LEFT ARM STARTED TO HURT FRIDAY NIGHT AND BY SATURDAY THE PAIN WAS VERY SEVERE. ARM WAS SWOLLEN AND PT WAS UNABLE TO MOVE HER ARM MUCH. PT STARTED WITH A FEVER YESTERDAY. PT WAS SEEN IN OUR OFFICE TODAY. HER LEFT ARM IS SLOWLY GETTING BETTER. SWELLING HAS DECREASED AND PT HAS REGAINED MOBILITY. PT WAS STILL FEBRILE (99.9). PT WAS DIAGNOSED WITH POSTVACCINATION FEVER AND INSTRUCTED TO CONTINUE WITH SYMPTOMATIC CARE (HEAT, ICE, IBUPROFEN FOR AT LEAST 24 HRS). PT INSTRUCTED TO CALL BACK IF CONDITION WORSENS.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: No more space for data above, but pt also received MMRV (Proquad) Lot MO44575) in her Right thigh given subcutaneously at the same time as the other above vaccinations, dose 1 of series. Pt was noted to have hives of face and chest almost immediately after the vaccines were given. No signs of anaphylaxis, wheezing, lip or tongue swelling, emesis, rhinorrhea, diarrhea, no hypotension. SBP 120 after the incident. I evalauted the patient and gave 4 mL (1 mg/kg/dose) benadryl liquid, which the patient took, and hives were resolving after 30 minutes so pt was sent home with strict precautions.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Immediately following the final immunization (GARDASIL given last) the patient fainted. Patient was monitored for 20 minutes by RN's after the incident. A cool compress was applied around his neck, and he was given a glass of water. Mother declined for on site Pediatrician to assess her son. After 20 minutes patient stated he felt fine. Left clinic with his mother, normal gait and stable.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: On Dec 5, 2014 I began experiencing numbness in feet and hands. The numbness quickly spread up legs and arms. I was diagnosed with Guillain-Barre Syndrome in January 2015. I received IVIG treatments every 3 weeks for a year. The numbness in hands improved but I still have numbness in my legs and feet.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Blood glucose normal, Chest X-ray abnormal, Condition aggravated, Febrile convulsion, Pyrexia
Clinical narrative: Seizure and fever started 5th day after vaccine administration. Patient was taken to the emergency room twice within the same day for febrile seizures - once at 2:00 AM and again at 10:30 PM.  Child given acetaminophen and motrin and discharged after both visits.  RX given for Diastat.  Recommended follow up with neurology for evaluation and EEG/MRI. Follow up with PCP.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Seizure
Clinical narrative: Seizure and fever started 5th day after vaccine administration. Patient was taken to the emergency room twice within the same day for febrile seizures - once at 2:00 AM and again at 10:30 PM.  Child given acetaminophen and motrin and discharged after both visits.  RX given for Diastat.  Recommended follow up with neurology for evaluation and EEG/MRI. Follow up with PCP.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Hypoaesthesia, Mobility decreased, Peripheral swelling
Clinical narrative: Left arm red, swollen numbness, cant make a fist, hard to move fingers. Motrin and ice.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: 4 inch diameter expanding induration at injection site, hot, with fevers/chills and significant TTP progressive over next 4 days. Concerning for cellulitis.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: 4 inch diameter expanding induration at injection site, hot, with fevers/chills and significant TTP progressive over next 4 days. Concerning for cellulitis.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dyschezia, Proctalgia, Removal of foreign body from rectum
Clinical narrative: Patient's wife states that patient has had diarrhea since the vaccine. In addition to the diarrhea, states he has had painful bowel movements and feels like knives in the rectal area. He had a stone like object come from his rectum and pain was relieved for a few days then pain has returned. Also, patient is weak. They have tried immodium and is now using vaseline and hemorhoid cream.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother called and spoke with RN. Mother stated that pt. has swelling at site of injection of Left arm (Where KINRIX was given on 07/13/17). Mother states she did ice area off and on after pt. received injection on 07/13/17, but that pt. went to father's home over the weekend and returned last night 07/16/17, and pt.'s arm was according to mother, 'About the size of a good orange,' at injection site. RN reviewed DTaP VIS sheet with mother, and encouraged mother to take pt. to Pediatrician to rule out any other causes other than a normal vaccine reaction, mother agreed to this and verbalized understanding. Mother states that since yesterday area of swelling has decreased, and the area is now, 'smaller, less red, and less warm than yesterday.' Mother denies any other symptoms and states that pt. does not have a fever, and pt. has no difficulty moving his arm, and currently has no pain at injection site. Mother states that she and pt. played catch yesterday with no difficulties. RN encouraged mother to follow-up with pt.'s PCP and to continue to ice arm off and on and to continue to monitor for fever or any new symptoms, mother agreed to this and verbalized understanding. RN informed mother that she should call this RN back if pt. has any new or worsening symptoms, mother agreed to this.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 29-JUN-2017 from a nurse practitioner who was reporting on a 51 year old patient (gender not reported). No medical history or concomitant medications were reported. The nurse practitioner reported that on 28-JUN-2017, the patient was inadvertently administered a dose of PROQUAD (lot, expiration, dose and site not reported) for prophylaxis. No adverse effect reported. No other information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 29-JUN-2017 from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, an unknown number of unspecified patients were administered doses of VARIVAX lot # L045956, expiration 17-NOV-2017, subcutaneous for prophylaxis that were improperly stored. Concomitant medications included sterile diluent (lot number and expiration are unknown) which was properly stored. No adverse effects were reported. The vaccine doses were stored at 30 degrees Fahrenheit for 5 hours. There was no previous temperature excursion reported. The call was made because of a data logger. No additional information is available. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 29-JUN-2017 the patient was vaccinated with VAQTA lot # M040421 exp 26-MAY-2017. The patient received expired product. The patient did not experience an adverse event. The reporter refused follow-up contact. Additional information is not expected.
Sex: F
Vaccine: MENB
Symptoms: Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician regarding her daughter, received via a sales representative. A female patient of an unspecified age and ethnicity received the 1st dose of TRUMENBA, via an unspecified route of administration on an unspecified date in 2016 (about one year before reporting) at single dose for immunisation. The patient medical and concomitant medications were not reported. The patient experienced headache, malaise (she was down for 4 days), and injection site on an unspecified date with outcome of unknown. Also was reported that at the time of the report the patient did not yet received the 2nd dose.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Chills, Contusion, Decreased appetite, Dizziness
Clinical narrative: This is a spontaneous report obtained from a contactable consumer that reported for herself. A 71-year old female patient received, on 29Jun2017, PREVNAR 13 in the left upper arm, single dose, for immunization. Relevant medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID). On 29Jun2017, after the vaccination, the patient experienced burning sensation. On an unspecified date, in 2017, the patient developed also low grade fever, significant bruise, flu like symptoms of chills, hot flashes, loss of appetite, and dizziness and she was red, hot, and firey at the injection site. An enormous swelling of left upper arm was noted on an unspecified date, in 2017. The doctor said it was cellulitis. No treatment was received. The patient was recovering from the events, cellulitis, swelling arm, dizziness, chills, hot flashes, appetite lost, vaccination site erythema and vaccination site warmth; while clinical outcome of the other events was unknown.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Hot flush, Influenza like illness, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer that reported for herself. A 71-year old female patient received, on 29Jun2017, PREVNAR 13 in the left upper arm, single dose, for immunization. Relevant medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID). On 29Jun2017, after the vaccination, the patient experienced burning sensation. On an unspecified date, in 2017, the patient developed also low grade fever, significant bruise, flu like symptoms of chills, hot flashes, loss of appetite, and dizziness and she was red, hot, and firey at the injection site. An enormous swelling of left upper arm was noted on an unspecified date, in 2017. The doctor said it was cellulitis. No treatment was received. The patient was recovering from the events, cellulitis, swelling arm, dizziness, chills, hot flashes, appetite lost, vaccination site erythema and vaccination site warmth; while clinical outcome of the other events was unknown.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer that reported for herself. A 71-year old female patient received, on 29Jun2017, PREVNAR 13 in the left upper arm, single dose, for immunization. Relevant medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID). On 29Jun2017, after the vaccination, the patient experienced burning sensation. On an unspecified date, in 2017, the patient developed also low grade fever, significant bruise, flu like symptoms of chills, hot flashes, loss of appetite, and dizziness and she was red, hot, and firey at the injection site. An enormous swelling of left upper arm was noted on an unspecified date, in 2017. The doctor said it was cellulitis. No treatment was received. The patient was recovering from the events, cellulitis, swelling arm, dizziness, chills, hot flashes, appetite lost, vaccination site erythema and vaccination site warmth; while clinical outcome of the other events was unknown.
Age: 49.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Urinary incontinence
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim letter. A male patient of an unknown age and race received PREVNAR 13 injection on 22Dec2016 for an unknown indication. The dose, frequency and route of administration were unknown. The relevant medical history, concomitant medications and past drug history were unknown. It was reported that since he received his pneumonia injection, he had unspecified urinary incontinence and sweating. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 11Jul2017, the clinical outcome of the events unspecified urinary incontinence and sweating was unknown.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Erythema, Pain of skin, Urticaria, Vaccination complication
Clinical narrative: Patient developed a half dollar sized welt that was red and painful. He was taken to the Emergency Room and was told it was just a reaction to the vaccination.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site urticaria
Clinical narrative: Entire right upper arm red except for injection site, sore, achy and welts, unable to lift up arm. Symptoms started on Saturday (7/15/2017).  Took ibuprofen in the morning and Advil in the evening. On Monday 7/17/17. pain is 4-5/10 on a 1-10 pain scale. 1 (least)- 10 (worst pain ever). Monitor symptoms and if does not continue to get better to call doctor's office.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eyelid function disorder, Hypotonia, Muscle twitching, Pallor
Clinical narrative: Gave the injections and just within seconds of giving them she went pale, eyes closed, limp and twitched slightly. Appeared to be a syncopal episode. Lowered her back onto the exam table and she came around within 30 seconds. She made a full recovery and walked out of the exam room with her mother after we let her sit for 15 minutes after the event.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Asterixis, Blood test, Computerised tomogram head normal, Dyskinesia, Electroencephalogram normal
Clinical narrative: Hand Flapping, Seizure like episodes with Palsy like movements with his hands and head in the car while driving and when relaxed on the couch. They usually last 5-30 seconds but he can have 20 in a matter of 30 minutes. Every time we are in the car he still have these movements with his arms and hands. It seems to always happen in the car, rarely anywhere else except for the couch after waking up from a nap or about to fall asleep. Some days are better than others. When he is having an episode we notice he goes into a staring like fog. We can snap him out of it sometimes but occasionally it takes him a few seconds to snap out of it.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Seizure like phenomena, Slow response to stimuli, Staring, Unresponsive to stimuli
Clinical narrative: Hand Flapping, Seizure like episodes with Palsy like movements with his hands and head in the car while driving and when relaxed on the couch. They usually last 5-30 seconds but he can have 20 in a matter of 30 minutes. Every time we are in the car he still have these movements with his arms and hands. It seems to always happen in the car, rarely anywhere else except for the couch after waking up from a nap or about to fall asleep. Some days are better than others. When he is having an episode we notice he goes into a staring like fog. We can snap him out of it sometimes but occasionally it takes him a few seconds to snap out of it.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Adenotonsillectomy, Blood iron increased, Blood test abnormal, Colonoscopy normal, Cortisol increased
Clinical narrative: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydroepiandrosterone decreased, Gastric emptying study, Gastrointestinal tube insertion, Gene mutation identification test positive, Histamine intolerance
Clinical narrative: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypovitaminosis, Immunoglobulin therapy, Impaired gastric emptying, Laboratory test abnormal, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Plasmapheresis, Postural orthostatic tachycardia syndrome, Serum ferritin decreased, Sinus operation, Thyroid disorder
Clinical narrative: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test abnormal
Clinical narrative: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Angiogram normal, Blood culture negative, C-reactive protein normal, Computerised tomogram, Electrocardiogram abnormal
Clinical narrative: Severe headache and vomiting 1 hour after administering vaccine. Went to Clinic and had full work up including  CT scan and CT-angio done 2nd to his headaches. Symptoms improved in 1-2 days.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Full blood count normal, Headache, Metabolic function test normal, Vomiting
Clinical narrative: Severe headache and vomiting 1 hour after administering vaccine. Went to Clinic and had full work up including  CT scan and CT-angio done 2nd to his headaches. Symptoms improved in 1-2 days.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Nodule, Pain, Skin warm, Swelling
Clinical narrative: Patient had large red "knot" as she called it, it was swollen and warm to touch, she said it caused pain when she moved arm/raised arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury
Clinical narrative: Vaccine was given to the pt, asked if he was ok. He stated he felt good. Mom headed to check out with patient & while at check out patient went down, hit his head off the wall. Patient was brought back with smelling salts, (PA) reevaluated the patient.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004306: US-009507513-1707USA004305: US-009507513-1707USA004307.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 29-JUN-2017 from a pharmacist who reported that on 28-JUN-2017 an unspecified patient (age and gender not reported) was given an expired dose of VARIVAX (lot# L023587, expiration 26-JUN-2017) (dosage not reported). Pharmacist reported that sterile diluent (lot# M013638, expiration 19-NOV-2018) used to reconstitute the VARIVAX was not expired. No adverse effect reported. No additional information was provided. No contact information was provided for the reporter or patient. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004307: US-009507513-1707USA004306.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004252: Source case US-009507513-1707USA004305: US-009507513-1707USA004307.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse stated that the patient received unspecified doses of ROTATEQ (lot # M031802, expiration date 09-NOV-2017) that were improperly stored (dosages and routes of administration not provided). The doses were administered between 06-APR-2017 and 29-JUN-2017. No adverse effects reported. Excursion information: Temperature 35°F for 30 minutes. No prior excursions. Data logger involved. No further information provided. This is one of four cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004305: US-009507513-1707USA004252: Source case US-009507513-1707USA004306.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 19-JUN-2017, the patient was vaccinated with an improperly stored PEDVAXHIB (lot # M032149; expiration 18-APR-2019). Temperature: 47 degrees F to 77 degrees F. Time frame: one hour. Previous temperature excursion: yes, 47-77 degrees F for two hours. Call was because of a data logger. There were no adverse effects. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Throat tightness
Clinical narrative: Patient did not have an immediate reaction. About an hour later she had swelling around the injection site and closing of the throat.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient passed out for a few seconds shortly after getting immunization. I put an ice pack on his neck and had him rest for about 15 minutes before walking.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Body temperature increased, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: 7-13-17  mom called stating that they were on the way to the hospital because patient was not feeling good, headache, sore arm, and temperature of 99.0. I explained to mom that these were common reactions as seen on the VIS. I encouraged her to get her checked out if she wanted and that we could provide any information that they may need. She was very thankful for the call. 7-14-17 I left a message to call me with an update on status. 7-17-17 no return call.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Dizziness, Instillation site reaction, Nausea, Rash erythematous
Clinical narrative: Seizure occurred 48 hours after the TB test and Tetanus booster vaccine - after being seizure free for 2 years. She felt faint, weak and nauseous immediately following the TB test. She has had Tetanus shot before and no adverse reaction therefore seems related to TB as this was the first test she's ever received. The TB test was a PPD skin test- intradermal - Lot # C5039AA exp 11/16/2018, manufacturer Sanofi Pasteur.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Seizure
Clinical narrative: Seizure occurred 48 hours after the TB test and Tetanus booster vaccine - after being seizure free for 2 years. She felt faint, weak and nauseous immediately following the TB test. She has had Tetanus shot before and no adverse reaction therefore seems related to TB as this was the first test she's ever received. The TB test was a PPD skin test- intradermal - Lot # C5039AA exp 11/16/2018, manufacturer Sanofi Pasteur.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Lg area of erythema, warm (R) thigh sug BENADRYL PO every 4 hr. Seen for F/U 7/14/17 (r) thigh redness is fading less indurated not as warm BENADRL helping to ROC Wednesday for F/U.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid redness, sore, hard (at) site, warm, swollen, itching at site. Injection given 2 days ago. Notice area within 24 hrs after injection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Left deltoid redness, sore, hard (at) site, warm, swollen, itching at site. Injection given 2 days ago. Notice area within 24 hrs after injection.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: Hives rash started on 7/12/17 with burning in hands and feet - home treatment with calamine/BENADRYL X 2 days then ER.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Morning after vaccination pt.'s arm was painful and inflamed and she couldn't raise her arm more than 12". A physician advised her to take BENADRYL.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Injection site pain, Peripheral swelling, Swelling
Clinical narrative: Patient called on 7/6/17 with complaints of hard knot at injection site and painful. Told patient to draw line around red area, use ice, can take TYLENOL for pain and apply hydrocortisone ointment to area (patient is allergic to BENADRYL). Patient instructed if gets worse to contact provider or go to emergency department for allergic reaction treatment protocols. Called patient on 7/10/17 as follow-up. Patient returned call on 7/12/17. She  complained of swelling all the way to her feet and she had been asleep for the last 5 days. She had used BENADRYL cream (despite allergy) and was feeling better. She reported never contacted provider as follow-up. She was beginning to feel better at that time. Contacted patient as a final follow-up on 7/17/17. She states is feeling fine now and the injection site is back to normal.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Pain, Urticaria
Clinical narrative: That night about 11 pm, my neck felt like I had scratched it, but I could find nothing. The next day, about noon, I felt stinging pain, as if I had been stung. I had some welts. As the afternoon progressed, I had more and more welts. They are pencil eraser size. I am taking BENADRYL, and using Cortisone-10.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in upper - last a few minutes to a few hours. Has been daily since since first occurred.
Age: 46.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Cough, Pyrexia, Throat irritation
Clinical narrative: Chills, fever, coughing, clearing throat. 50 mg BENADRYL PO. 400 mg Ibuprofen. Sent to ER by wheelchair for further evaluation.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Ear swelling, Pruritus, Swelling face
Clinical narrative: Vaccine administered to right deltoid at 10:35 am. Itchiness from waist up started at 1:30 pm. There was also facial and ear swelling. Pt was taken to ED by mother. ED prescribed Prednisone 20 mg - 2 tabs once daily x 4 days/BENADRYL 25 mg.
Age: 20.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Lymphadenopathy, Malaise, White blood cell count increased
Clinical narrative: Patient mother called in 7/10/17 with the following information (Patient is in college) he received 6/2/17 went back to college the week of 6/12-6/16 not feeling well S/B a Dr and on antibiotics for ? UTI. Returned home and taken to ER by mother 7/1/17, blood work increased WBC and enlarged inguinal glands, treated with antibiotics for ? STD.-Mother thinks symptoms are related to vaccine given 6-2-17.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria under both eyes.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen (3cm) area below the site of injection. No other adverse effects.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Diarrhea two hours after shot explosive GI's occurred for a couple of hours: Black watery stools.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Body temperature increased, Dysstasia, Injection site pain
Clinical narrative: Phone call from mother at 8:15 am today. Reported that patient had difficulty standing last night related to soreness of his legs. About 8:00 pm, he began running a 102 degree temperature and she began alternating MOTRIN and TYLENOL throughout the night. Advised patient to place warm compresses to legs to help with muscle soreness and to contact her pediatrician for further recommendations. Mother immediately contacted the physician and reported that pediatrician stated that symptoms were expected side effects and to continue the MOTRIN and place in tub of warm water to soak legs and to apply warm compresses throughout the day. Asked mother to contact me via my cell number at any time.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt received ZOSTAVAX on 6/30/17 at around 10:10 AM and noticed redness at injection site evening of 6/30/17 upon removal of bandage. The next morning 7/1/17, pt noticed swelling, rash, warmth, and itching. Then on 7/2/17 pt had chills and felt tired. Then on 7/3/17, pt feels fine but swelling is spreading downwards on arm. Pt went to see PCP and was prescribed ALLEGRA and KEFLEX on 7/3/17.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Pt received ZOSTAVAX on 6/30/17 at around 10:10 AM and noticed redness at injection site evening of 6/30/17 upon removal of bandage. The next morning 7/1/17, pt noticed swelling, rash, warmth, and itching. Then on 7/2/17 pt had chills and felt tired. Then on 7/3/17, pt feels fine but swelling is spreading downwards on arm. Pt went to see PCP and was prescribed ALLEGRA and KEFLEX on 7/3/17.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Received vaccine intramuscular to (L) thigh on 7-7-17. Parent noticed redness and puffiness on Saturday 7-8-17. Redness, warmth and swelling increased through Mon. 7-10 prompting appt. No treatment needed.
Sex: U
Vaccine: DTAP
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via other and described the occurrence of injection site discoloration in an unspecified number of patients who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, unknown after receiving INFANRIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was unknown. It was unknown if the reporter considered the injection site discoloration to be related to INFANRIX. Additional details were provided as follows: This case was received from the physician via the vaccine patient assistance program. The age at vaccination was not reported. It was reported that, more than one patient experienced tiny little black dots near the administration area after receiving INFANRIX vaccine.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Client reported on same day of shot,  06-29-2017 at 4:30 pm., stated that about 2 hours after the shot, (on arm and leg of L side), about every hour but only lasts for a few seconds...."feels like when my shoes are too tight". I asked like numbness and tingling and she said yes. Reported no S/S of any allergic reaction. I call CDC and they said to go to ER...I called her back and told her to go to ER, however, she said she was at work and was ok. I tried calling her a few times, but only left messages.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Vision blurred
Clinical narrative: 30 minutes after vaccine patient was experiencing blurred vision and dizziness. 2 hours after vaccine, dizziness and blurred vision had resolved, but the patient was feeling weak and nauseous.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Also had a PPD test placed on LFA at same time as vaccines. Patient presented to my clinic (different from vaccinator's clinic) on Monday 7/17/17 at 3:45pm for the reading. Mother asked me to look at his arm. I noticed the deltoid and surrounding area was red, hot to the touch and felt HARD to the touch. Patient stated 'ouch' when I touched it and tried to pull away but not roughly. I told mother to put ice on it for 30m on and then off for 30m and repeat. Also told parent if it gets worse to see his PMD for an evaluation. Vaccinator was RN at clinic as listed.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported arm red and swollen and pain to touch at area of injection on arm. Patient also reported breathing difficulty previous night. Due to breathing issue told patient to seek immediate care. Also advised patient to use antihistamine and ice packs at site of injection. Also counseled to use ibuprofen for inflammation. I will follow up with patient next day.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: MMRV and varicella given on the same date and at the same time. Mother brought child into clinic on 7/15/17 with low grade fevers not over 99.9, controlled with TYLENOL.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Local reaction
Clinical narrative: LOCAL REACTION:  ITCHING, ERYTHEMA, INDURATION AT SITE AND SURROUNDING TISSUE.  EVALUATED IN ER ON 7/15/17:  WAS GIVEN ORAL BENADRYL, 25MG. AND KENALOG CREAM TOPICAL.  STILL HAS ERYTHEMA/INDURATION AT SITE, SIZE IS DECREASING.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT EXPERIENCING REDNESS AND ITCHING A INJECTION SITE.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Flushing, Hyperhidrosis
Clinical narrative: 100.8  temperature, flushing and sweating in the afternoon.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Blood count normal, C-reactive protein increased, Fatigue, Headache
Clinical narrative: Axial tension. Dull HA. Low grade fevers 99-101. Fatigue/malaise, arthralgias, elevated C-reactive protein, leukopenia, thrombocytopenia.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Leukopenia, Malaise, Platelet count decreased, Pyrexia, Tension
Clinical narrative: Axial tension. Dull HA. Low grade fevers 99-101. Fatigue/malaise, arthralgias, elevated C-reactive protein, leukopenia, thrombocytopenia.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Thrombocytopenia, White blood cell count decreased
Clinical narrative: Axial tension. Dull HA. Low grade fevers 99-101. Fatigue/malaise, arthralgias, elevated C-reactive protein, leukopenia, thrombocytopenia.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Headache, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
Clinical narrative: Immediately after injection, feeling of headache, saw stars, feeling hot and then passed out falling back on exam table, at same time showing seizure like symptoms by kicking legs and body vibrating for 2-3 minutes while mom yelling at her to wake up. Nurse not in room, she was going to look for paperwork concerning another vaccination for that day. Patient woke up from hearing her mom yell and didn't remember passing out. She only remembered headache, stars and feeling hot.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Swelling, redness, hives (for one day) and pain -> pt took Ibuprofen and BENADRYL.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: MENVEO diluent only admin on 7/5/17. No ADR reported. Called Glaxo - revaccination not necessary.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Rash, Skin warm, Urticaria
Clinical narrative: Severe bruising, white spots, and hives within a few hours of shot. Arm is very hot to the touch. Pt had a compress on it. Can't take antihistamines (she is allergic). Dissipating-but still ways to go.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Groin pain, Lymphadenopathy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy inguinal in a 19-year-old female patient who received BEXSERO (batch number 158501C, expiry date March 2018). On 21st June 2017, the patient received BEXSERO. On 3rd July 2017, 12 days after receiving BEXSERO, the patient experienced lymphadenopathy inguinal and groin pain. On an unknown date, the outcome of the lymphadenopathy, inguinal and groin pain were unknown. It was unknown if the reporter considered the lymphadenopathy inguinal and groin pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced lymph nodes in groin area after receiving a dose of BEXSERO vaccine in hip area. It felt tender and painful. No additional information provided.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Insomnia, Lymph node palpable
Clinical narrative: Pain in (R) deltoid immediately following inj. Next day (R) arm red, swollen, couldn't sleep on arm at night. 7/16 called on-call doctor who prescribed KEFLEX. 7/17 office visit, erythema and swelling has gone down, only mild swelling and erythema, slightly warm. 1 palpable lymph node to (R) axilla.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pain in (R) deltoid immediately following inj. Next day (R) arm red, swollen, couldn't sleep on arm at night. 7/16 called on-call doctor who prescribed KEFLEX. 7/17 office visit, erythema and swelling has gone down, only mild swelling and erythema, slightly warm. 1 palpable lymph node to (R) axilla.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient returned to pharmacy w/fluid filled blister, redness, inflamed rash around injection site. Patient stated the site itching terribly. Patient was instructed to apply cold compresses, and to notify MD. 7/14 - Itching, redness, alcohol applied. (7/15) Sm. blister. (7/16) Blister enlarged, more irritation.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Moaning
Clinical narrative: Had severe pain in my right arm where pneumonia vaccine was administered. Taken 1st vaccine 10 yrs ago, nothing happen I was fine. Excruciating pain, moaning, groaning all in night. Finally relief came next day of mid morning.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: As soon as immunization was administered, patient complained of dizziness, which resolved after laying down for a few minutes.