chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Disturbance in attention, Dyskinesia, Irritability
Clinical narrative: Child became incredibly cranky followed by a significant loss of engagement and attention. He also became orally fixated and began licking and mouthing everything completely out of nowhere. Child was already delayed and received therapies, all therapists agree that he has lost a year of hard work.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Pruritus, Urticaria
Clinical narrative: Initially just hives on left cheek after waking from nap.  Hot skin in area of flu shot injection. Motrin administered. Over next hour hives slowly started spreading to other parts of body as itching sensation increased. Administer Zyrtec while waiting on Dr call back at 07:02 pm.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Flushing, Heart rate increased, Hyperhidrosis, Pallor
Clinical narrative: Fifteen minutes after injection, the patient reported tingling in her hands and feet, pale color of hands, flushed and sweaty face, blurry vision, dizziness, increased pulse rate. She requested orange juice but refused any medical treatment or contact to her PCP. She rested in the IMZ private area while being monitored by RPh and Mgr. At 8:12PM, she stated she felt alot better, had no more symptoms of reaction, her pulse reduced back to normal level after taking blood pressure, and thanked the pharmacist and assistant manager for their care and concern.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Fifteen minutes after injection, the patient reported tingling in her hands and feet, pale color of hands, flushed and sweaty face, blurry vision, dizziness, increased pulse rate. She requested orange juice but refused any medical treatment or contact to her PCP. She rested in the IMZ private area while being monitored by RPh and Mgr. At 8:12PM, she stated she felt alot better, had no more symptoms of reaction, her pulse reduced back to normal level after taking blood pressure, and thanked the pharmacist and assistant manager for their care and concern.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: Chills all evening through the night.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Immediate post-injection reaction, Mental impairment, Nasal congestion
Clinical narrative: Patient felt a little dizzy right after the vaccine admisnistered. He sat down for 20 minutes and got better. He went home. At around 9:30pm that same day, he started to feel more dizzy and his "voice is hoarse", throat swelling, and severe "nasal stuffiness", and "difficulty of making decision." His friend took him to emergency room. He was given prednisone and Benadryl. He stayed in the ER for 3 hours for observation, then went home.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Patient felt a little dizzy right after the vaccine admisnistered. He sat down for 20 minutes and got better. He went home. At around 9:30pm that same day, he started to feel more dizzy and his "voice is hoarse", throat swelling, and severe "nasal stuffiness", and "difficulty of making decision." His friend took him to emergency room. He was given prednisone and Benadryl. He stayed in the ER for 3 hours for observation, then went home.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 days of tenderness, erythema, swelling (mild) at injection site. Erythema/swelling measured 5x6 cm.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Nausea, Urticaria
Clinical narrative: Hives, nausea, severe headache, chest pain. Took ATARAX to stop hives.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Rash around injection site with a few blisters.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema of eyelid, Eyelid oedema, Rash
Clinical narrative: Within 3 hours, mid facial and neck rash spreading to extreme neck, head/face and eyelid redness and edema within 24 hrs.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Mass, Pain
Clinical narrative: Painful lump in the left cervical soft tissue.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives-on 9/30 late morning after vaccination. Patient applied BENADRYL cream at home, counseled to take oral but patient did not.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Rt lower face swelling-no pain. No redness occurred 8 hrs after vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dizziness, Dysstasia, Electrocardiogram, Hypoaesthesia
Clinical narrative: 12:25 shot. 12:30 took TYLENOL (500mg, given). 1:15 a little before arm pain. By at 1:00 severe pain in arm. 1:00=took TYLENOL (800mg, given). By at 2 unbearable pain in arm and got shooting pains down arm right hand became tingling and numb. 2:30-took TYLENOL extra strength. At 2:50pm-pain in arm still severe, shooting pains going down my arm, hand still tingly/numb. 2:51-took 1 TYLENOL Extra Strength unable to use keyboard, pen. 4:40pm dizziness began. 8:00pm called parents to come pick up (I had drove). By 8:15pm so dizzy could hardly stand, thought processes affected went to ER. Note dizziness/vertigo started at 4:40pm 9/28, 24 hours later not dizzy.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 12:25 shot. 12:30 took TYLENOL (500mg, given). 1:15 a little before arm pain. By at 1:00 severe pain in arm. 1:00=took TYLENOL (800mg, given). By at 2 unbearable pain in arm and got shooting pains down arm right hand became tingling and numb. 2:30-took TYLENOL extra strength. At 2:50pm-pain in arm still severe, shooting pains going down my arm, hand still tingly/numb. 2:51-took 1 TYLENOL Extra Strength unable to use keyboard, pen. 4:40pm dizziness began. 8:00pm called parents to come pick up (I had drove). By 8:15pm so dizzy could hardly stand, thought processes affected went to ER. Note dizziness/vertigo started at 4:40pm 9/28, 24 hours later not dizzy.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Body temperature increased, Injection site erythema, Local reaction
Clinical narrative: Local reaction, redness at site low grade temp x 1 day to use ice, BENADRYL, TYLENOL.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Pt mentioned that she experienced a metallic taste within a few minutes after vaccine administration. Symptom didn't resolve until late at night, about 7 hours later.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm warm, mild swelling and redness along left inner upper arm and going down left inner lower arm. No signs of infection/fever. Able to use arm.
Age: 17.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, MNQ
Symptoms: Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Mom reported that <24 hrs after receiving vaccines, pt devrveloped fever, body aches, shakiness, vomiting.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and red spots at injection site. Redness is getting bigger. This was reported 6 days after injection.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Lethargy
Clinical narrative: Patient experienced COPD exacerbation beginning two hours post vaccine dose. Symptoms were fever, shortness of breath, wheezing, chills, lethargy. Eval. at PCP office revealed decreased O2 sat of 89%; wheezing and crackles bilat. lungs. Treated with steroids, antibiotic, inhaled resp. meds. Expected to recover fully.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rales, Wheezing
Clinical narrative: Patient experienced COPD exacerbation beginning two hours post vaccine dose. Symptoms were fever, shortness of breath, wheezing, chills, lethargy. Eval. at PCP office revealed decreased O2 sat of 89%; wheezing and crackles bilat. lungs. Treated with steroids, antibiotic, inhaled resp. meds. Expected to recover fully.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: Chills, fever, difficulty breathing, hospital tests in ER concludes beginning pneumonia.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Rash
Clinical narrative: Pt developed rash/blister on her 24 hours after receiving FLUARIX.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction on face.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Eye movement disorder, Feeling abnormal, Loss of consciousness, Muscle rigidity, Pallor
Clinical narrative: Patient ws given GARDASIL injectio and almost immediately turned pale and mentioned she "felt funny". Patient was assisted into a supine position. Approximately 5 minutes after injection, the patient's eyes rolled back, her hands and arms became rigid, her head turned to the side and she lost consciousness. The pt was unresponsive and appeared to be experiencing a tonic seizure for a period of 5-15 seconds.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Posture abnormal, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: Patient ws given GARDASIL injectio and almost immediately turned pale and mentioned she "felt funny". Patient was assisted into a supine position. Approximately 5 minutes after injection, the patient's eyes rolled back, her hands and arms became rigid, her head turned to the side and she lost consciousness. The pt was unresponsive and appeared to be experiencing a tonic seizure for a period of 5-15 seconds.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Rash, Skin discolouration
Clinical narrative: Bruising at injection site. Red from rash/discoloration approximately 2 inches from injection site. Resembles rash or subdermal infiltration.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Within a few hours after receiving PREVNAR 13 #1 in my (L) deltoid, a red area of 1 inch appeared near the site. Over the next few days a 5 inch vertical and 3 1/2 inch horizontal area, very hot and painful developed. I reported this to facility. By Tues. I began to have a temp. Went to Dr., dx: cellulitis. Given antibiotics.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient stopped by the pharmacy on 9/22/15 to question and report that she is still having muscle aches and throbbing in the arm that she received her BOOSTRIX vaccine. She states that it is more pronounced when she drives a car or lifts her arm above her shoulder. Although it seems to be improving slightly it is still bothersome after 2 months. After her visit to the pharmacist she started taking OTC ibuprofen occasionally which has been somewhat helpful. Patient has not been seen by a medical doctor.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Patient stopped by the pharmacy on 9/22/15 to question and report that she is still having muscle aches and throbbing in the arm that she received her BOOSTRIX vaccine. She states that it is more pronounced when she drives a car or lifts her arm above her shoulder. Although it seems to be improving slightly it is still bothersome after 2 months. After her visit to the pharmacist she started taking OTC ibuprofen occasionally which has been somewhat helpful. Patient has not been seen by a medical doctor.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Chest discomfort, Chills, Culture, Electrocardiogram
Clinical narrative: Shortly after receiving vaccine, heaviness in chest. As day went on fever, chills, palpitations, stabbing pains mostly in legs. Injection site extremely painful - almost can't move arm. Note: Patient received vaccine after a fall off bicycle and had a large dirty wound.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Injected limb mobility decreased, Injection site pain, Laboratory test, Pain in extremity
Clinical narrative: Shortly after receiving vaccine, heaviness in chest. As day went on fever, chills, palpitations, stabbing pains mostly in legs. Injection site extremely painful - almost can't move arm. Note: Patient received vaccine after a fall off bicycle and had a large dirty wound.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Pyrexia, Urine analysis, X-ray limb
Clinical narrative: Shortly after receiving vaccine, heaviness in chest. As day went on fever, chills, palpitations, stabbing pains mostly in legs. Injection site extremely painful - almost can't move arm. Note: Patient received vaccine after a fall off bicycle and had a large dirty wound.
Age: 16.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left arm site of varicella injection swelling 1.5 inch diameter.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash papular
Clinical narrative: Pt complains of rash. Rash has not occurred previously. It is located on the face, chest, and back. Describes rash as pink and papular. Possible contributing factors include IZs on Monday, including MMR.
Age: 0.45
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Clonus
Clinical narrative: Alleged episode of clonic contractions of arms and head. Lasted approx. 30 seconds. No alt LOC.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of GARDASIL (Lot # K016966 Expiration date: 10-MAY-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Pt presented in office on 9/30/15 with left arm red and swollen. Dx cellulitis. Pt put on oral ABx.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Eye swelling, Eyelid rash
Clinical narrative: Eyes swollen, rash around eyes 3-4 hrs. after administration.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Eyelid oedema, Rash
Clinical narrative: Eyes swollen, rash around eyes 3-4 hrs. after administration.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Adverse event
Clinical narrative: Initial report received from a healthcare professional, who was also the patient, via Merck, on 31 October 2014. A 27-year-old male patient received a smallpox vaccine (manufacturer, lot number, and date of administration not reported) "many years ago" and subsequently experienced an unspecified adverse event. No information was reported regarding onset date, type of reaction, treatment, or outcome, and the patient (a physician) did not wish to be contacted for any additional information. The patient outcome is unknown. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Large localized swelling of deltoid extending to mid humerus. Started 1 hour post-vaccination. No systemic symptoms. Resolved gradually over 3 days without intervention.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Facial neuralgia
Clinical narrative: About 3 days after vaccine, pt got intermittent facial neuralgia pain at distribution of trigeminal nerve, ophthalmic branch (left). No other symptoms.
Sex: U
Vaccine: SMALL
Symptoms: Pyrexia, Swelling
Clinical narrative: Initial report was received on 04 September 2014 from another manufacturer nation service center (service request number 1-12238167852), who received the report from a health care professional. An unidentified patient had received  a smallpox vaccine (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a severe reaction including severe swelling and fever. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying
Clinical narrative: Parent described "hours of crying" after 2 mt, 4 mt and 6 mt vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous, Rash generalised, Rash papular, Rash pruritic
Clinical narrative: 19 mo old female who developed a erythematous papular pruritic generalized exanthem starting 24 hours after receipt of DTaP/HepB/IPV, pneumococcal 13, rotavirus and HIB vaccine. It was attributed to DTaP. She received subsequent doses of HIB, Hep A, influenza, HIB and PREVNAR without repeat event.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme, Pain, Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Initial literature case retrieved via a search of the scientific literature on 15 April 2015. A 19-year-old male, with no history of previous skin disorders, received ACAM2000 on an unspecified date. Two weeks post-vaccination, he presented with pruritic, slightly painful targetoid vesicular lesions involving bilateral hands, left knee, left buttock, genitalia, left elbow, and lower lip. The inoculation site was within normal limits, with no satellite lesions or evidence of secondary bacterial infection. Past medical history was negative for exposure to livestock, exotic animals, known insect bites, herpes virus infections, oral medications, or bacterial respiratory infections. The patient was diagnosed with erythema multiforme, and after consultation with infectious disease specialists was treated with histaminic blockade. He experienced complete resolution of lesions without scarring 18 days after initial presentation. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: One day after receiving PREVNAR noted lower abdomen and between thigh c/o itching. Rash spread trunk, arms and leg. BENADRYL given w/ improved rash and decreased itch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Day after injection I woke up with stiff and achy all over and had redness and swelling from injection site to right above elbow. Then ext day the swelling in redness went below the elbow. I went to my doctor and he prescribed Hydroxy HCL 50 mg. The swelling lasted 4 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Day after injection I woke up with stiff and achy all over and had redness and swelling from injection site to right above elbow. Then ext day the swelling in redness went below the elbow. I went to my doctor and he prescribed Hydroxy HCL 50 mg. The swelling lasted 4 days.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site mass
Clinical narrative: Pt. came in to the office with a firm mass in the left thigh after immunizations.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Within days developed shingles. Has had five episodes of shingles since getting vaccinated. No prior history of shingles.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown ages and genders, who had human immunodeficiency virus (HIV). It was reported that the patients were being vaccinated with PNEUMOVAX 23 "every five years" (dose, route, lot # and expiration date were not reported). The reporter stated it was not possible to know how many total doses of the PNEUMOVAX 23 each patient received. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Guillain-Barre syndrome, Headache, Myalgia
Clinical narrative: 8-6-15 - Cut top of rt foot on rusty pipe. Went to Dr. 8-11-15. She gave me 7 days script for KEFLEX and booster for my 4-1-09 tetanus shot of a Tdap on 8-11-15 which caused muscle aches, tiredness, headaches and fatigue - still exhausted.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported. There was no concomitant medication reported. Later, the patient was inadvertently administered a second dose of ZOSTAVAX on an unspecified date, since the patient did not remember receiving the initial dose. No adverse effect was reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The patient is 29 yo healthy female who received anthrax #6 on 25 Sep 2015 (BIOPORT #FAV402A) to her (R) arm, typhoid #4 (GSK lot # K11831) and polio IPV 25 (sanofi Pasteur lot # E02041) to her left arm. She reports she developed pain, pruritus, edema and erythema to her right upper arm, and wants to know if this is normal. The symptoms started approximately 24 hours after vaccine receipt and have continued to worsen. She treated it with ice and topical hydrocortisone. Per p/e (R) upper arm with mild edema compared to left and 8x10 cm patch erythema, with increased warmth to medical aspect, nontender. Distal fingers with normal strength, ROM and brisk capillary refill. P: continue ice, cetirizine po q12 prn and topical triamcinolone.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # K009181 exp. date on 24-APR-2016 and Lot # K017573 exp. date on 11-JUN-2015), oral (strength and dose were not provided). There was no concomitant medication reported. No adverse experiences reported. Product quality complaint was not involved. A phone call was made on 28-SEP-2015 to the reporting Medical Assistant who was no longer with the company. A detailed message was left for the supervisor to return the call. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on trunk and face started "days after vaccines. No fever.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # K008986 exp. date on 01-APR-2016 and Lot # K021444 exp. date on 17-SEP-2016), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse experiences reported. Product quality complaint was not involved. A phone call was made on 28-SEP-2015 to the reporting Medical Assistant who was no longer with the company. A detailed message was left for supervisor to return the call. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. There were no medical history nor concurrent conditions reported for the patients. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of a VARIVAX (Merck) lot # J014152 and expiration date 07-NOV-2015 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. Thiss is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 23-MAY-2015, the patient was vaccinated with the first dose of a RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient received as the second dose a ENGERIX-B (lot # BT248 and expiration date 24-SEP-2015, dose and route were not reported) and PEDIARIX (dose, lot # expiration date and route were not reported) as the third dose on 21-SEP-2015. No concomitant medications were reported. No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complain was involved. At the time of the report, the outcome of interchange of vaccine products and the relatedness with RECOMBIVAX HB, ENGERIX-B and PEDIARIX were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of VAQTA (Lot #K010577 Expiration date: 22-SEP-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of oral, ROTATEQ (Lot # L000433 Expiration date: 09-JUL-2016 and K013861 Expiration date: 18-MAR-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC)) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of PEDVAXHIB (Lot # K009955 Expiration date: 26-MAR-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experiences has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of GARDASIL 9 (Lot # K026247 Expiration date: 19-JAN-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Drug withdrawal syndrome, Eye pain, Herpes zoster, Oral mucosal blistering
Clinical narrative: This spontaneous report was received from a currently 55 year old male consumer, with pre-existing  condition of soft bones, cervical fusion of back and net vertebrae, he was paralyzed and has had many surgeries, which was found out due to pituitary tumor. The patient also had a pertinent medical history of depression, anxiety and was on CYMBALTA medication that caused him to lose cognitive, memory, function and allergic to morphine, penicillin (manufacturer unknown), PAXIL and AUGMENTIN. On an unknown date, about 4 or 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route of administration were not reported). Concomitant therapy included possibly steroids. On an unspecified date approximately in March 2014 (reported as about 1.5 years) the patient developed shingles(herpes zoster) in the left trigeminal nerve; he also experienced pain in left eye, rash, blisters in his mouth and pot herpetic neuralgia. The patient stated he had 7 or 8 recurring episodes of shingles since his vaccination with ZOSTAVAX. The last two episodes were no rash but post herpetic neuralgia. The lasts shingles flare up occurred approximately in August 2015, about one month ago, and lasted for a couple of weeks. The patient stated before he was vaccinated with ZOSTAVAX he had natural occurring shingles which usually presented in the mid thoracic area of his body. The patient's physician told him it was good he got the ZOSTAVAX vaccine, because who knew how bad the shingles could have been. The patient treated the events with Acyclovir and trifluridine eye drops. The patient stopped taking CYMBALTA, "about 4 to 8 weeks" and stated he had terrible withdrawal symptoms from CYMBALTA. He stated he was somewhat improving, his cognitive function, memory, has gone from very bad level of 1 to about a 4; his memory was improving. The outcome and causality of herpes zoster, rash, post herpetic neuralgia, oral mucosal blistering and eye pain were unknown. The patient sought medical attention as he was seen by the physician assistant. he was not hospitalized for the events and there was not a product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a currently 55 year old male consumer, with pre-existing  condition of soft bones, cervical fusion of back and net vertebrae, he was paralyzed and has had many surgeries, which was found out due to pituitary tumor. The patient also had a pertinent medical history of depression, anxiety and was on CYMBALTA medication that caused him to lose cognitive, memory, function and allergic to morphine, penicillin (manufacturer unknown), PAXIL and AUGMENTIN. On an unknown date, about 4 or 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route of administration were not reported). Concomitant therapy included possibly steroids. On an unspecified date approximately in March 2014 (reported as about 1.5 years) the patient developed shingles(herpes zoster) in the left trigeminal nerve; he also experienced pain in left eye, rash, blisters in his mouth and pot herpetic neuralgia. The patient stated he had 7 or 8 recurring episodes of shingles since his vaccination with ZOSTAVAX. The last two episodes were no rash but post herpetic neuralgia. The lasts shingles flare up occurred approximately in August 2015, about one month ago, and lasted for a couple of weeks. The patient stated before he was vaccinated with ZOSTAVAX he had natural occurring shingles which usually presented in the mid thoracic area of his body. The patient's physician told him it was good he got the ZOSTAVAX vaccine, because who knew how bad the shingles could have been. The patient treated the events with Acyclovir and trifluridine eye drops. The patient stopped taking CYMBALTA, "about 4 to 8 weeks" and stated he had terrible withdrawal symptoms from CYMBALTA. He stated he was somewhat improving, his cognitive function, memory, has gone from very bad level of 1 to about a 4; his memory was improving. The outcome and causality of herpes zoster, rash, post herpetic neuralgia, oral mucosal blistering and eye pain were unknown. The patient sought medical attention as he was seen by the physician assistant. he was not hospitalized for the events and there was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of PNEUMOVAX 23 (Lot # K020795 Expiration date: 19-MAR-2016, K020215 Expiration date: 15-MAY-2016 and K019386 Expiration date: 09-JUN-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Cough, Injection site swelling
Clinical narrative: Pt states she noticed swelling over injection site around 1600. Pt iced site throughout the evening and morning, but swelling/erythema increased. No fever/chills or body aches, denies muscle soreness, not tender to the touch. Swelling 125 mm x 120 mm. Pt began antibiotics last night for cough.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown age and gender. On an unknown date, approximately in 2015 (reported as "on unspecified dates since 08-JUN-2015"), an unspecified number of unspecified patients were vaccinated with GARDASIL (lot # K005881, expiration date 14-JAN-2017). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown age and gender. On an unknown date approximately in 2015 (reported as "on unspecified dates since 08-JUN-2015"), an unspecified number of unspecified patients were vaccinated with ROTATEQ (lot # K013868, expiration date 27-MAY-2016). No adverse effect reported. This is one of several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. There were no medical history nor concurrent conditions reported for the patients. The reporting nurse stated that the unspecified number of patients were vaccinated with improperly stored doses of a GARDASIL lot # K006960 and expiration date 19-FEB-2017 (dose and route were not reported) on 18-JUN-2015, 20-JUN-2015, 25-JUN-2015, 26-JUN-2015, 30-JUN-2015, 04-JUL-2015, 06-JUL-2015, 09-JUL-2015, 12-JUL-2015, 18-JUL-2015, 23-JUL-2015, 24-JUL-2015, 25-JUL-2015, 26-JUL-2015, 30-JUL-2015, 02-AUG-2015, 05-AUG-2015, 06-AUG-2015, 08-AUG-2015, 09-AUG-2015, 11-AUG-2015, 12-AUG-2015, 13-AUG-2015, 15-AUG-2015, 16-AUG-2015, 19-AUG_2015, 20-AUG-2015, 21-AUG-2015, 22-AUG-2015, 24-AUG-2015, 25-AUG-2015, 26-AUG-2015 and 20-AUG-2015. No concomitant medications were reported. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event, Underdose
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to a adult male patient of unknown age. There was no medical history or drug reaction/allergies reported. On 20-FEB-2015, the patient received his first dose in the hepatitis B vaccination series with a dose of TWINRIX (dose, route, lot# and expired date were unknown). Then he received a pediatric dose of RECOMBIVAX HB (strength: 5 microgram/0.5 ml, dose, lot#, expired date and route were unknown) on 20-MAR-2015 as his second dose and then another dose of TWINRIX on 20-AUG-2015, as his third dose. No concomitant medication was provided. No adverse effect was reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist via a employee referring to a 28 year old male patient. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dosage, frequency and route unspecified). On an unknown date the patient developed a "huge" rash on his chest and arms, a high fever (no temperature specified) and overall soreness. The patient sought medical attention via asking pharmacist for recommendations. The pharmacist stated that the adverse events had resolved. Additional information is not expected as the reporter did not want to be contacted.
Age: 34.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Ocular hyperaemia
Clinical narrative: Iinformation has been received from a 34 year old male pharmacy technician with seasonal allergy referring to himself. There was no pertinent medical history. On 16-SEP-2015, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included ALLEGRA. After reconstituting ZOSTAVAX on 16-SEP-2015, when withdrawing needle from vial, some of the ZOSTAVAX reconstituted solution might have splashed in his left eye (accidental exposure while preparing drug for administration). Caller stated that he did not rinse his left eye after that occurred. The reporter stated he was really not having any problems with his left eye, except a little bit of redness. The reporter stated the redness can possibly be attributed to  his seasonal allergies. There was no treatment given for events. No other symptoms reported. The outcome of eye redness was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Laceration, Syringe issue
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female clinical assistant of unknown age. The clinical assistant's pertinent medical history and concurrent conditions were not provided. On an unknown date, the clinical assistant was preparing a RECOMBIVAX HB syringe (lot # K008986, expiration date 01-APR-2016) for insertion and there was a syringe issue and a product quality issue because the syringe broke. The clinical assistant experienced laceration as well as an accidental exposure to product when she cut her finger from the glass of the broken syringe. It was unknown if the clinical assistant sought medical attention. At the time of the report, the clinical assistant's status was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with one dose of improperly stored PNEUMOVAX23, lot # L012042, expiration date 18-NOV-2016 (dose and route of administration were not provided). No adverse effects were reported. Addditional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous report was received from a male consumer referring to his wife of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiry date not reported). One month later the patient became pregnant. The last menstrual period (LMP) and estimate due date (EDD) was not known. The pregnancy outcome was pending. The reporter asked if it got any effect for the baby. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of ROTATEQ oral solution (lot # K020181 with expiration date 24-JUN-2016, lot # K019370 with expiration date 16-JUL-2016, lot # L000433 with expiration date 09-JUL-2016 and lot # K022995 with expiration date 22-JUL-2016; dose was not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a male patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 30-SEP-2015, the patient was inadvertently vaccinated with improperly stored VARIVAX (Merck) injection (lot# K010440, expiration date 22-JUL-2016, dose, site and route of administration were not reported) instead of an intended dose of ZOSTAVAX. The nurse saw "varicella virus" on the VARIVAX (Merck) label and assumed that it was indicated for shingles vaccination. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of PEDVAXHIB injection (lot # L009649 with expiration date 29-NOV-2017, lot # K026532 with expiration date 07-AUG-2017 and lot # L030864 with expiration date 07-JUN-2018; doses and route were not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of GARDASIL 9 injection (lot # L011846 with expiration date 16-JUN-2017 and lot # L014415 with expiration date 25-JUL-2017; dose and route were not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Cough, Local reaction, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Patient developed severe localized reaction 24 hours after vaccine. C/o fever school called to tell mom child had low grade temp (had HPV and MENACTRA B yesterday), feels somewhat myalgic, says legs hurt and arms hurt too.  Denies: nasal congestion, cough, sore throat.
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient developed severe localized reaction 24 hours after vaccine. C/o fever school called to tell mom child had low grade temp (had HPV and MENACTRA B yesterday), feels somewhat myalgic, says legs hurt and arms hurt too.  Denies: nasal congestion, cough, sore throat.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician refers to a not pregnant 25 year old female patient with allergy to food colouring Allura Red, which was breaking out in a rash. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated intramuscularly with 0.5 ml dose of GARDASIL 9 (lot # L013429, expiry date 21-JUL-2017). Concomitant therapies included PORTIA for birth control. On 28-SEP-2015, the patient experienced swelling of the lymph node. The patient sought medical attention and, on 29-SEP-2015, she presented to the physician's office with a painful supraclavicular lymph node on the left side, which was the same side as the injection was given on. The physician recommended treatment with unspecified nonsteroidal anti-inflammatory drugs (NSAIDs) and BENADRYL. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.