chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Flushing, Throat irritation
Clinical narrative: Employee presented to clinic for a hepatitis B booster vaccine (#4).  Approximately 5 minutes after receiving the vaccine, employee returned to clinic reporting a "scratchy throat," dizziness, and feeling flushed. Employee denied respiratory or breathing problems. No hives or itching. Initial BP at 1355 was 143/92. Employee states normal BP is 90s/60s. BENADRYL 50 mg was given to employee at 1355. BP/HR were monitored during visit: 1400 139/82, HR 75, 1405 126/76, HR 69, 1412 122/78, HR 66, 1430 117/78, HR 62. BP and symptoms were monitored until 1433 when employee was feeling well enough to leave the clinic- she denied dizziness, states her throat felt "clear," and was not feeling flushed. Walked employee out to her father's vehicle to get a ride home from her father after taking the BENADRYL. Employee was discharged after assessed by NP, who recommended that employee continue to monitor her symptoms at home, stay well-hydrated, and call 911 or have a family member take her to the ER if symptoms worsen. Employee verbalized understanding and is agreeable.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No reaction occurred. The health care provider wanted to know if the child needed to receive a dose of PEDIARIX since he was given the wrong medication?
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Swelling, soreness, muscle pain at site and radiating up the left side of neck started the next day, and continued for a few weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: 10x9 cm erythematous, warm, firm rash over the left thigh surrounding injection site.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Emotional distress, Haematochezia, Irritability, Occult blood positive, Pyrexia
Clinical narrative: On 7/6/17, Acute onset of fussiness and bright red blood streaked stools (x 5) 1 day following oral rotavirus vaccination, very fussy and inconsolable, fever tmax 101F. Patient seen at Pediatrics by PA-C for above symptoms, + hemoccult stool in office, sent to Hospital Emergency Department, Abdominal US done to r/o intussusception- negative. GI pathogen panel done - + Rotavirus, otherwise negative.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rotavirus test positive, Ultrasound abdomen normal
Clinical narrative: On 7/6/17, Acute onset of fussiness and bright red blood streaked stools (x 5) 1 day following oral rotavirus vaccination, very fussy and inconsolable, fever tmax 101F. Patient seen at Pediatrics by PA-C for above symptoms, + hemoccult stool in office, sent to Hospital Emergency Department, Abdominal US done to r/o intussusception- negative. GI pathogen panel done - + Rotavirus, otherwise negative.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Swelling, burning, tingling, redness, pain at injection site. Patient also complained that her arm was numb. Symptoms occurs approximately 48 hours after immunization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient reported redness and swelling at injection site. Swelling was about 4 inches long and 2 inches wide. She reported itching as well but no pain. Stated no difficulty breathing or hives. Time of onset was about 24 hours after administration.
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Mother of child describes rash starting on left leg 2-3 days after immunizations, child scratching at area. First reported to Clinic on 7-12-17 by mother of child. No other s/sx. Rash improving as of 7-12-17. Provider aware and consultation provided to family according to the child's EHR.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This vaccine, which is recommended for children ages 4-6, was mistakenly given to a 4 month old. This is not the age-appropriate immunization. She was supposed to be given the second dose of her DTap (INFANRIX).
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information was received on 27-JUN-2017 from a medical assistant via a company representative concerning a 4 month old female patient. The patient does not have any relevant medical history. Concomitant medications included PEDIARIX vaccine and the PREVNAR 13 vaccine (dates received not reported). The medical assistant reported that this 4 month old female was given GARDASIL 9 once, on 27-JUN-2017 for no indication. On 27-JUN-2017, the person administering the vaccine accidentally grabbed the wrong vial and administered GARDASIL 9 (lot M028323, expiration 26-SEP-2018) (dose, route and injection site not reported) to the 4 month old patient. The patient's relative laboratory data are unknown. As of 27-JUN-2017, the patient was given one dose of GARDASIL 9 and the outcome of receiving the GARDASIL 9 is unknown. No other information was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a practice manager refers to 10 patients of unknown age and gender. The patients' relevant medical histories, concomitant medications and past drug histories are unknown. The patients were vaccinated with VAQTA (lot #M036057, expiration date 18-MAY-2019) and PEDVAXHIB (lot #M007762, expiration date 07-DEC-2018) on unknown dates between 05-Apr-2017 to 28-Jun-2017 for unknown indication (unknown routes, doses and frequencies) that had experienced temperature excursion on 05-Apr-2017. On unknown dates between 14-Mar-2017 to 28-Jun-2017 these patients received PROQUAD (Lot # M038227 and expiration date 06-Mar-2018) for unknown indication (unknown route, dose and frequency) that had experienced temperature excursion. It is unknown if the patients continue to take VAQTA, PEDVAXHIB, or PROQUAD, and the outcome is unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concomitant medications, current conditions nor medical history were reported. On 12-JUL-2017, the patient was vaccinated with a expired dose of VARIVAX (Lot No. L025210, exp. date 07-JUL-2017) (site and route not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date not reported).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, lot number and expiration date were not provided). Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient experienced pain, redness, swelling and itching at the injection site after administration of ZOSTAVAX. At the time of the report, the outcome of injection site pain, injection site pruritus, injection site swelling and injection site erythema was reported as recovered on an unspecified date. The reporter did not assess the relatedness between the adverse events ZOSTAVAX.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) and refers to a patient of unknown age and gender.  Medical history and concomitant medications were not provided. In June 2017, the patient received PNEUMOVAX 23 0.5 mL one time intramuscularly (lot # N003997; expiration 20-OCT-2018). The RN reported that the patient received the vaccine, which had undergone a temperature excursion on 27-JUN-2017. Total time in the range of 47 degrees F to 77 degrees F: 52F, 1 hour (30 minutes rounded up to one hour). A data logger was involved. When asked if these same vaccine vials/tubes had previous temperature excursion, the RN replied "yes". The details of the previous excursion was 24-JUN-2017, 52 degrees F for one hour (30 minutes rounded up to one hour). The patient had not called the reporter's facility to report any adverse reaction. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Information was received on 28-JUN-2017 from a registered nurse who reported that a 66 year old male patient received one dose of ZOSTAVAX intramuscularly (IM) (dosage not reported) on 28-JUN-2017 for routine vaccination. The patient has no past medical history, concomitant medications or past drug history. There were no labs run for the event. On 28-JUN-2017, the patient received the ZOSTAVAX vaccine that had expired the day before on 27-JUN-2017. The lot# is M024698. The physician's office will monitor the patient. As of 28-JUN-2017, the patient only received one dose of expired ZOSTAVAX and the outcome of administration of an expired vaccine was unknown. Reporter wanted to know if the dose needed to be repeated and was to be contacted if the patient needed to be revaccinated. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information was received on 28-JUN-2017 from a physician via a company representative regarding a 28 year old female student. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient needed to get the VARIVAX, but was mistakenly given Zoster Vaccine Live. The outcome of the event was unknown. No other details were available. No PQC was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) and refers to an unknown amount of patients (ages and gender unknown). Medical history and concomitant medications were not provided. On an unspecified date, the patients received PNEUMOVAX 23. The RN reported that the vaccine underwent temperature excursion on 27-JUN-2017 and an unknown number of patients may have been vaccinated with this product. Total time in the range of 47 degrees F to 77 degrees F: 47.1 degrees F for six minutes. A data logger was involved. Lot numbers and expirations dates were as follows: 7 vials: M026317; expiration 11-JAN-2018; 10 vials: M029681; expiration 22-JAN-2018; 10 vials: M047519; expiration 04-JUL-2018. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse (RN) and refers to an unspecified amount of patients (ages and gender unknown). Medical history and concomitant medications were not provided. On an unspecified date, the patients received RECOMBIVAX HB (lot # M041384; expiration 07-JUL-2019. On 23-JUN-2017, the vaccine underwent a temperature excursion and an unknown number of patients may have been vaccinated with this product. Total time in the range 47 degrees F to 77 degrees F: 47.1 degrees F for six minutes. A data logger was involved. The outcome was unknown. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood chloride increased, Blood culture, Carbon dioxide decreased, Decreased appetite, Electroencephalogram normal
Clinical narrative: Within 3 hours of receiving the vaccines, the patient began to mount a fever (Tmax 103) with decreased appetite. Later that night, the patient experienced a 30-second generalized seizure which involving shaking of all four extremities and the head. This resolved and was followed several minutes later by another 5 second episode of seizure-like activity. When mother attempted to give Tylenol to the patient soon after this, she vomited profusely. She was taken to the ED and subsequently admitted to Hospital. She received Tylenol with resolution of her fever as well as IV fluids. EEG the next morning was found to be normal. There was no recurrence of seizure after this.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Neutrophil percentage, Pyrexia, Seizure, Seizure like phenomena, Tremor
Clinical narrative: Within 3 hours of receiving the vaccines, the patient began to mount a fever (Tmax 103) with decreased appetite. Later that night, the patient experienced a 30-second generalized seizure which involving shaking of all four extremities and the head. This resolved and was followed several minutes later by another 5 second episode of seizure-like activity. When mother attempted to give Tylenol to the patient soon after this, she vomited profusely. She was taken to the ED and subsequently admitted to Hospital. She received Tylenol with resolution of her fever as well as IV fluids. EEG the next morning was found to be normal. There was no recurrence of seizure after this.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: Within 3 hours of receiving the vaccines, the patient began to mount a fever (Tmax 103) with decreased appetite. Later that night, the patient experienced a 30-second generalized seizure which involving shaking of all four extremities and the head. This resolved and was followed several minutes later by another 5 second episode of seizure-like activity. When mother attempted to give Tylenol to the patient soon after this, she vomited profusely. She was taken to the ED and subsequently admitted to Hospital. She received Tylenol with resolution of her fever as well as IV fluids. EEG the next morning was found to be normal. There was no recurrence of seizure after this.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, FLUX, HPV9, MENB, MNQ
Symptoms: Decreased appetite, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Mom states pt has been c/o bodyaches and low grade fever the day of vaccination. Two days later, pt was in bed with severe headaches, fever, and stiff neck. Mom states pt did not have an appetite as well.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, FLUX, HPV9, MENB, MNQ
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Mom states pt has been c/o bodyaches and low grade fever the day of vaccination. Two days later, pt was in bed with severe headaches, fever, and stiff neck. Mom states pt did not have an appetite as well.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: ABOUT A MINUTE AFTER ADMINISTRATION PATIENT COMPLAINED OF SUDDEN HEADACHE (MIGRAINE) ONSET. BP TAKEN AT 10:45AM = 139/89 WHICH WAS THE SAME RANGE/RESULT TAKEN AT THE DR OFFICE. WIFE NOTIFIED (EMPLOYEE AT RX). 10:55 BP=144/88; 11:05 BP=140/84. PATIENT RELEASED AROUND 11:30AM. STILL HAS THE HA BUT SAID IT'S TOLERABLE. ADVISED TO TAKE PAIN PILL.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Bone pain, Chills, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Within one hour of receiving vaccine, patient had sudden onset of chills, profuse sweating, back stiffening, dizziness, sore throat, nausea, shortness of breath, arm tingling and intense muscle and bone pain. Patient was taken to ER. Vital signs upon arrival to ER: Blood pressure of 110/69, Oral temperature of 105, respiration of 16/minute. Treated with I.V. saline infusion, metoclopramide(REGLAN) 5mg/1mL (10mg given), TYLENOL 1000mg, SOLU-MEDROL 125mg /2mL (125mg), BENADRYL 25mg, and famotidine 20mg. Symptoms resolved upon discharge from ER.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Within one hour of receiving vaccine, patient had sudden onset of chills, profuse sweating, back stiffening, dizziness, sore throat, nausea, shortness of breath, arm tingling and intense muscle and bone pain. Patient was taken to ER. Vital signs upon arrival to ER: Blood pressure of 110/69, Oral temperature of 105, respiration of 16/minute. Treated with I.V. saline infusion, metoclopramide(REGLAN) 5mg/1mL (10mg given), TYLENOL 1000mg, SOLU-MEDROL 125mg /2mL (125mg), BENADRYL 25mg, and famotidine 20mg. Symptoms resolved upon discharge from ER.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia, Urine analysis normal
Clinical narrative: Within one hour of receiving vaccine, patient had sudden onset of chills, profuse sweating, back stiffening, dizziness, sore throat, nausea, shortness of breath, arm tingling and intense muscle and bone pain. Patient was taken to ER. Vital signs upon arrival to ER: Blood pressure of 110/69, Oral temperature of 105, respiration of 16/minute. Treated with I.V. saline infusion, metoclopramide(REGLAN) 5mg/1mL (10mg given), TYLENOL 1000mg, SOLU-MEDROL 125mg /2mL (125mg), BENADRYL 25mg, and famotidine 20mg. Symptoms resolved upon discharge from ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT PRESENTED ON 07/13/2017 AND SAID THE SITE WAS RED AND SORE AND FELT A LITTLE  HOT BUT WAS GETTING BETTER. LOOKED AT AREA AND TOLD THE PATIENT TO APPLY ICE PACK FOR 15 MINUTES AND TAKE SOME IBUPROFEN AND TO CALL PHARMACY IF STARTED TO GET WORSE.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Patient came in with right sided facial weakness / Bells palsy.  Pt was given a course of steroids.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash erythematous, Swelling
Clinical narrative: REDNESS, SWELLING, RED PATCHES ON THE SKIN; LASTED FOR 3 DAYS.
Age: 68.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was given the second dose of VAQTA one month from the first dose. The first dose was given 01/20/2017 and second dose 02/21/2017. Per CDC the second dose must be given at least 6 months from the second dose. Patient did not report any adverse affects and cannot be reached at this time.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Fever, body aches, muscle pain, large baseball size red protrusion at injection site, hot to the touch.  Limited mobility in right arm,  couldn't use it for the next four days.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches, muscle pain, large baseball size red protrusion at injection site, hot to the touch.  Limited mobility in right arm,  couldn't use it for the next four days.
Age: 1.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Asthenia
Clinical narrative: Global weakness progressive over 2-3 days, resolved by 1 week.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient received two immunizations (ZOSTAVAX and ADACEL) on 7/11/17. Today, July 13, 2017, the patient called and said she was having an injection site reaction. She stated that there was a clear 1-2 inch mark induration surrounding the injection site (SQ Injection in the back of the arm) that was hot to the touch, swollen, and appeared to have some blisters around the site. I asked that she come in so I may take a look to give her further advice, but she declined stating she was about 40 minutes away. I then gave the options to go to an urgent care to be seen or to give it another day or two and continue taking ibuprofen and to ice the area. The patient states that she will continue her watchful waiting and if the area worsens or stays the same, she will go to an urgent care. Linda said that she has been icing the area and medicating with ibuprofen for the past day. I asked that she call either way to let me know the outcome.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Appetite disorder, Confusional state, Erythema, Lethargy, Pain in extremity
Clinical narrative: Patient is a 84 y.o. female with medical conditions as above, who presents for evaluation of a red hot right arm following a PCV13 immunization on 6/30/2017. She is accompanied by her daughter, who is her primary caregiver. The patient received a PCV-13 vaccine as a part of health maintenance at her first visit here a week ago. That visit was to f/u hospitalization for pneumonia and to establish care. Her daughter check with her the first 2-3 days after she got the vaccine and the patient said that her arm was not hurting. On July 5, and 6, the patient became more lethargic and confused, and her daughter looked at the right upper arm on 7/6 and noted that it was swollen, red and hot to touch. She sent a note through website and we called to f/u. As there was a 6 day delay in developing pain and redness, and a vaccine reaction should have been improving by there, I was concerned about cellulitis. I started the patient on cephalexin yesterday, sending in an order by phone. Today daughter says that her mother's arm is less swollen and tense, and the redness is less (see photo below). In addition, the patient's mental status is improved and almost back to baseline. Her appetite is better. She is able to respond to questions today although she can't recall the sequence of events around her arm pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient is a 84 y.o. female with medical conditions as above, who presents for evaluation of a red hot right arm following a PCV13 immunization on 6/30/2017. She is accompanied by her daughter, who is her primary caregiver. The patient received a PCV-13 vaccine as a part of health maintenance at her first visit here a week ago. That visit was to f/u hospitalization for pneumonia and to establish care. Her daughter check with her the first 2-3 days after she got the vaccine and the patient said that her arm was not hurting. On July 5, and 6, the patient became more lethargic and confused, and her daughter looked at the right upper arm on 7/6 and noted that it was swollen, red and hot to touch. She sent a note through website and we called to f/u. As there was a 6 day delay in developing pain and redness, and a vaccine reaction should have been improving by there, I was concerned about cellulitis. I started the patient on cephalexin yesterday, sending in an order by phone. Today daughter says that her mother's arm is less swollen and tense, and the redness is less (see photo below). In addition, the patient's mental status is improved and almost back to baseline. Her appetite is better. She is able to respond to questions today although she can't recall the sequence of events around her arm pain.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Patient was administered PNEUMOVAX 23 intramuscularly in right arm on 07/12/2017. Patient came by the pharmacy today on 07/13/2017 showing us her right arm that had the reaction. We suggested her to seek medical treatment since her arm was getting worse. Patient stated she was going to go into the E.R.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Fatigue, Nausea, Pallor, Syncope
Clinical narrative: Event Syncope: Paleness, Nausea, Dizziness, Fainting, and Visual Disturbance. Patient Fainted, but regained consciousness with a few seconds. I had patient lie on the ground with blanket and pillow underneath, provided cold compress on head, neck, and injection site. I also provide OJ to increase patients blood sugar. I monitored patient for 30 to 45 minutes, notified family via phone. Once patient was stable patient returned home, I contacted patient at 11:31 AM, to make sure patient was home safe and told her to rest for the day. Patient was informed to call Pharmacy or PCP if any further reactions. Also she can take Tylenol or Motrin for injection site soreness.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Visual impairment
Clinical narrative: Event Syncope: Paleness, Nausea, Dizziness, Fainting, and Visual Disturbance. Patient Fainted, but regained consciousness with a few seconds. I had patient lie on the ground with blanket and pillow underneath, provided cold compress on head, neck, and injection site. I also provide OJ to increase patients blood sugar. I monitored patient for 30 to 45 minutes, notified family via phone. Once patient was stable patient returned home, I contacted patient at 11:31 AM, to make sure patient was home safe and told her to rest for the day. Patient was informed to call Pharmacy or PCP if any further reactions. Also she can take Tylenol or Motrin for injection site soreness.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received both PROQUAD and VARIVAX, totaling 2 doses of varicella vaccine. Patient did not exhibit any noticeable reaction. All other vaccines given as ordered.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose, Exposure during pregnancy, Foetal death
Clinical narrative: 19 days after I got the vaccine my baby passed away in my womb. I delivered her the next evening at 3lbs 11 oz . I have MTHFR gene as well. I am not sure the vaccine caused her death but wanted to provide this information. I also have an 8 year old son with one kidney I received the vaccine as well. (Don't believe vaccine caused kidney).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Fear, Hyperventilation, Loss of consciousness, Pain
Clinical narrative: Patient experienced hyperventilation with syncope within 30 seconds of getting her immunization, complaining of the pain just seconds before leaning forward, head in her mothers lap and then almost violently throwing her self back, unconscious.  Her mother and I got her into supine position on the floor without her hitting her head and she regained consciousness within 20 to 30 seconds.  After a bit of disorientation and fear she settled and progressed from supine, to sitting in recovery position on the floor, to sitting in chair to eventually walking out of pharmacy with her mother 20 minutes later. We monitored her blood pressure and heart rate every 5 minutes throughout the event. She consumed a bottle of water and mom and grandmother speculated that she may have been dehydrated at the time. Mom says she has never reacted adversely to vaccines in the past, but she has had several episodes of fainting, usually at site of blood.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced hyperventilation with syncope within 30 seconds of getting her immunization, complaining of the pain just seconds before leaning forward, head in her mothers lap and then almost violently throwing her self back, unconscious.  Her mother and I got her into supine position on the floor without her hitting her head and she regained consciousness within 20 to 30 seconds.  After a bit of disorientation and fear she settled and progressed from supine, to sitting in recovery position on the floor, to sitting in chair to eventually walking out of pharmacy with her mother 20 minutes later. We monitored her blood pressure and heart rate every 5 minutes throughout the event. She consumed a bottle of water and mom and grandmother speculated that she may have been dehydrated at the time. Mom says she has never reacted adversely to vaccines in the past, but she has had several episodes of fainting, usually at site of blood.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Cough, Dry eye, Eye irritation, Eye pruritus
Clinical narrative: Cough started Sunday 7/9. Itchy, scratchy, dry left eye started 7/8. Visited ophthalmologist on 7/11 and was diagnosed with pink eye. I think it could be case of ophthalmic shingles. I didn't think to tell them I had had the Shingles immunization but I will tomorrow 7/14.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: Woke suddenly, 90 minutes after eating, vomited an excessive amount, fussed for 20 minutes, went back to sleep without eating. Did not offer food for fear stomach was still up. Sleeping 30 minutes now.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Eyelid ptosis, Facial paralysis, Headache, Urticaria
Clinical narrative: Patient states later in the afternoon after her vaccine was given symptoms of her Bells Palsy started to act up (headache, eye drooping, ear pain). On July 5th she woke up with a 3 inch round rash where the vaccine was givens and rashy welts about 6 inches in diameter from where the vaccine was given. She took Benadryl and went to her Dr. (a visit previously scheduled). The Doctor gave her a Vitamin B 12 shot and patient continued to take Benadryl. By July 9 th the rash and welts were cleared up. She states she is still having some ear pain and one eye is slightly droopy.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site rash, Vaccination site reaction
Clinical narrative: Patient states later in the afternoon after her vaccine was given symptoms of her Bells Palsy started to act up (headache, eye drooping, ear pain). On July 5th she woke up with a 3 inch round rash where the vaccine was givens and rashy welts about 6 inches in diameter from where the vaccine was given. She took Benadryl and went to her Dr. (a visit previously scheduled). The Doctor gave her a Vitamin B 12 shot and patient continued to take Benadryl. By July 9 th the rash and welts were cleared up. She states she is still having some ear pain and one eye is slightly droopy.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Headache, Induration, Injection site erythema
Clinical narrative: Patient received the vaccine at 9p.m. 7/10/2017. The next evening, 7/11/2017, patient complained of tenderness and erythema at the injection site. Dr. and ICP nurse notified that evening and BENEDRYL was ordered. Patient was seen by PA on 7/12/17 a.m. and a MEDROL dosepak was ordered. ICP Nurse assessed patient and measured an induration of 25 cm x 15 on left arm. Area was red and warm to touch. Vitals were WNL; Temp: 99.2. Nurse contacted physician who ordered Doxycycline 100 mg PO BID x 7 days. On 7/13/2017, patient was seen by PA and ICP Nurse; minimal induration present, redness subsided. Patient reports lingering headache and tenderness. Vitals WNL.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Skin warm, Tenderness
Clinical narrative: Patient received the vaccine at 9p.m. 7/10/2017. The next evening, 7/11/2017, patient complained of tenderness and erythema at the injection site. Dr. and ICP nurse notified that evening and BENEDRYL was ordered. Patient was seen by PA on 7/12/17 a.m. and a MEDROL dosepak was ordered. ICP Nurse assessed patient and measured an induration of 25 cm x 15 on left arm. Area was red and warm to touch. Vitals were WNL; Temp: 99.2. Nurse contacted physician who ordered Doxycycline 100 mg PO BID x 7 days. On 7/13/2017, patient was seen by PA and ICP Nurse; minimal induration present, redness subsided. Patient reports lingering headache and tenderness. Vitals WNL.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Eyelid oedema, Urticaria, Wheezing
Clinical narrative: PROQUAD administered in office. Within 10 min of administration, patient began wheezing, had swollen/puffy eyelids and broke out in hives. BENADRYL and albuterol nebulizer given with improved symptoms.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Bursitis, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Pt. reports reaction started around 10 PM last night with swelling (65 mm x 60 mm), pain, itchy, very hot to touch and painful to touch. Sx of bursitis. Will treat with ZYRTEC, ZANTAC and prednisone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Computerised tomogram head, Culture urine, Drug screen, Full blood count, Generalised tonic-clonic seizure
Clinical narrative: 8 days post MMR, Varicella, PREVNAR, HepA pt with 2-3 seizures lasting 1 min each, tonic/clonic. No fever with 1st seizure, fever in ER 101.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Metabolic function test, Procalcitonin, Pyrexia, Seizure, Thyroxine free
Clinical narrative: 8 days post MMR, Varicella, PREVNAR, HepA pt with 2-3 seizures lasting 1 min each, tonic/clonic. No fever with 1st seizure, fever in ER 101.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urine analysis
Clinical narrative: 8 days post MMR, Varicella, PREVNAR, HepA pt with 2-3 seizures lasting 1 min each, tonic/clonic. No fever with 1st seizure, fever in ER 101.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Pruritus, Secretion discharge, Sneezing, Throat irritation
Clinical narrative: Mucus (Persists), Throat (Persists), Cough (Persists), Ailments (face) (itchiness) , Sneezing (Persists).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Culture stool, Diarrhoea, Parasitic test, Rotavirus test
Clinical narrative: Diarrhea 6-7 episodes per day beginning the day after 12-month immunizations. No fever. No vomiting. No sick contacts.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Pt. fainted 5 mins after receiving MENACTRA vaccine. Felt dizzy, no Loc. Had pt. laying down for 5 min with feet elevated. Then moved to a room and monitored.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Feeding disorder, Staring
Clinical narrative: W/in 4 hours of shot she stated she was feeling dizzy. She was also not able to eat for the next 12+ hours because of stomach pains. She additionally was noted staring off in a daze and also would stop walking midway and just stare.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Osteoarthritis, Pain in extremity, Vaccination site pain
Clinical narrative: Initial unsolicited report received from consumer on 07-Jul-2017. This case involves 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose and route was not reported) in the right shoulder area (top of right shoulder) on an unspecified date in Dec 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions revealed that she had lupus 20 years, carpel tunnel syndrome 15 yrs, autoimmune hepatitis 1996 and had osteoarthritis. It was also reported that patient had no illness at time of vaccination. Concomitant medications was not reported. On an unspecified date in Dec 2016, following the vaccination, the patient experienced persistent pain in the right shoulder joint area post vaccination that radiates to the left shoulder. It was reported that, it is off and on at this time. On Dec 2016, post vaccination, the patient experience numbness of left arm and hand but states she is left side sleeper and it is relieved with activity. Patient was also under the care of a rheumatologist. Reporter stated a VAERS report was filed February 2017. Patient required emergency or doctor visit. Patient's laboratory data was not reported. It was reported that ultrasound and MRI of left shoulder to be conducted. The patient received corrective treatment with ice to the affected area and OTC painkillers. The patient was not recovered from the events. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site joint pain, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from consumer on 07-Jul-2017. This case involves 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose and route was not reported) in the right shoulder area (top of right shoulder) on an unspecified date in Dec 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions revealed that she had lupus 20 years, carpel tunnel syndrome 15 yrs, autoimmune hepatitis 1996 and had osteoarthritis. It was also reported that patient had no illness at time of vaccination. Concomitant medications was not reported. On an unspecified date in Dec 2016, following the vaccination, the patient experienced persistent pain in the right shoulder joint area post vaccination that radiates to the left shoulder. It was reported that, it is off and on at this time. On Dec 2016, post vaccination, the patient experience numbness of left arm and hand but states she is left side sleeper and it is relieved with activity. Patient was also under the care of a rheumatologist. Reporter stated a VAERS report was filed February 2017. Patient required emergency or doctor visit. Patient's laboratory data was not reported. It was reported that ultrasound and MRI of left shoulder to be conducted. The patient received corrective treatment with ice to the affected area and OTC painkillers. The patient was not recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Information was received on 29-JUN-2017 from a pharmacist regarding a 69 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was administered a dose of ZOSTAVAX (lot # M037013, expiration date 22-NOV-2017; dose, route, site of administration not reported) reconstituted with sterile water diluent (unknown lot # and expiration date). The patient developed a rash around the injection site. The pharmacist stated the patient reported the rash on 27-JUN-2017 and was seen in the pharmacy on 29-JUN-2017 "because the rash was still present, hot to touch and seemed to be 6 inches by 3 inches around the injection site." VZVIP packet offered and the pharmacist declined. The pharmacist declined to be listed as the correspondence contact stating "I will be out for maternity leave", so another pharmacist contact information was provided. The outcome of the events were unknown. Causality was not reported. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Information was received on 29-JUN-2017 from a pharmacist regarding a 69 year old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017, the patient was administered a dose of ZOSTAVAX (lot # M037013, expiration date 22-NOV-2017; dose, route, site of administration not reported) reconstituted with sterile water diluent (unknown lot # and expiration date). The patient developed a rash around the injection site. The pharmacist stated the patient reported the rash on 27-JUN-2017 and was seen in the pharmacy on 29-JUN-2017 "because the rash was still present, hot to touch and seemed to be 6 inches by 3 inches around the injection site." VZVIP packet offered and the pharmacist declined. The pharmacist declined to be listed as the correspondence contact stating "I will be out for maternity leave", so another pharmacist contact information was provided. The outcome of the events were unknown. Causality was not reported. No additional information was provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anxiety, Decreased appetite, Eczema, Lethargy, Panic attack
Clinical narrative: A few hours after the vaccines, she broke out in a facial rash and fever. She was lethargic and had no appetite. She fell asleep sitting up at 7:00 pm. The next morning her legs were both covered in rashes as well, and eczema flared up on her thighs and underarms. She had fever and rashes for a week. I didn't take her back to the Doctor for these concerns because I was always told her rashes and fevers and eczema flare ups are "normal" side effects of vaccines. Within a few weeks she developed anxiety that caused panic attacks. Eventually we took her to a counselor. The counselor decided Felicity was already receiving the best care she could get (through parenting and school), and wasn't concerned for her development or safety.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: A few hours after the vaccines, she broke out in a facial rash and fever. She was lethargic and had no appetite. She fell asleep sitting up at 7:00 pm. The next morning her legs were both covered in rashes as well, and eczema flared up on her thighs and underarms. She had fever and rashes for a week. I didn't take her back to the Doctor for these concerns because I was always told her rashes and fevers and eczema flare ups are "normal" side effects of vaccines. Within a few weeks she developed anxiety that caused panic attacks. Eventually we took her to a counselor. The counselor decided Felicity was already receiving the best care she could get (through parenting and school), and wasn't concerned for her development or safety.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Wheezing
Clinical narrative: He developed wheezing, congestion, runny nose, cough, and fever by the following morning.  Was seen in office on 2/17/13 (9 days after vaccine for the above mentioned symptoms). On 3/6/13 I took him back because he'd remained congested for a month. On 3/14/13 we were seen again for congestion.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Ran high fever for 4 days. Lethargy, loss of appetite. Doctor advised TYLENOL.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Cough, Ear pain, Otitis media, Pyrexia, Rhinorrhoea
Clinical narrative: Developed fever hours after vaccine...within 5 days he also had cough, runny nose and earache.  Was diagnosed 7 days after vaccine with ear infections. Otitis Media. (8-27-13).
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Eye pain, Lymphadenopathy, Pyrexia, Urine analysis
Clinical narrative: Fever, eye pain, loss of appetite, and swollen lymph nodes in his groin. Saw eye doctor on 12/24/14 Talked to Doc about swollen nodes on 12/28/14. Was seen in 1/2/15 about swollen nodes. Urinanalysis done. No infection. Seen again for swollen nodes on 1/7/15 and was DX with Inguinal Lymphadenopathy and it was recorded as an adverse reaction to MMRV.  No treatment. Took weeks to resolve. His loss of appetite has yet to resolve years later.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pyrexia, Rash, Respiratory rate increased
Clinical narrative: 8 days of high fevers, irritability, rapid breathing, and rashes. Was seen in office on 4-15-16 (4 days after vaccine) for these symptoms.
Age: 15.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: On 7/13/17 in the evening, a nurse noticed an approximately 1" firm, non-tender, circular reddened area with an approximately 2" non-tender, circular mildly reddened area surrounding other reddened area at back of left upper arm which client reports is "itchy" where VARIVAX was administered.  It is still present on 7/14/17 at 8:00 AM.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chills, Crying, Erythema, Hypokinesia, Pallor
Clinical narrative: Patient was administered ROTATEQ orally. A couple minutes later patient was given PEDIARIX, PREVNAR, and Hib. Immediately following injections patient began to cry intensely and his face became bright red. Patient then suddenly stopped crying and became very pale and still. Nurse blew in patient's face to motivate a breath from patient. Patient was breathing but very still. Doctor was called in room to evaluate patient. Patient was kept for observation for 45 minutes. "Shivering" and paused breathing observed. Pulse ox and heart rate were within normal limits when check 15-20min after event. After 25-30 minutes, patient's color returned to face and body but child was still very sleepy. Mother informed to observe child throughout the evening and night.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory rate decreased, Somnolence
Clinical narrative: Patient was administered ROTATEQ orally. A couple minutes later patient was given PEDIARIX, PREVNAR, and Hib. Immediately following injections patient began to cry intensely and his face became bright red. Patient then suddenly stopped crying and became very pale and still. Nurse blew in patient's face to motivate a breath from patient. Patient was breathing but very still. Doctor was called in room to evaluate patient. Patient was kept for observation for 45 minutes. "Shivering" and paused breathing observed. Pulse ox and heart rate were within normal limits when check 15-20min after event. After 25-30 minutes, patient's color returned to face and body but child was still very sleepy. Mother informed to observe child throughout the evening and night.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ orally, lot # M043838 with expiration date of 18-JUN-2018, for prophylaxis (dose and frequency were not reported) that experimented a temperature excursion according to a digital data logger. No adverse effects were reported. The temperature excursion frame was between 31°F / -1°C or colder, and lasted 1 hour and 37 minutes. No previous temperature excursion was reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1707USA001986: US-009507513-1707USA001987:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-JUN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection, via intramuscular route, lot # M006922 with expiry date on 21-JUN-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2017, the patient received for ZOSTAVAX and VARIVAX both together in the same syringe at the same time for prophylaxis (dosing details not reported). Both vaccines were reconstituted with one syringe vial of sterile diluent (Merck). No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old female patient. Concomitantly Patient was taking blood pressure and blood glucose medications for blood pressure and blood sugar. On 22-JUN-2017 the patient was vaccinated with PNEUMOVAX 23 once, lot # N010105, expiration date- 15-NOV-2018, dose- 0.65 ml, intramuscular in the left deltoid for prophylaxis. On the beginning of 22-JUN-2017, the patients arm was very swollen and red and warm to the touch, and got worse the morning on 23-JUN-2017 and now the swelling was human head sized and she also had fever. The outcome of swelling, redness and fever was reported as ongoing and was not resolved. Causality between swelling, redness and fever was unknown.       Additional information has been requested.