chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a physician, referring to a 4 month old male patient. The patient did not have relevant medical history, concurrent conditions or concomitant medications. On 05-JAN-2018, the patient received a dose of improperly stored ROTATEQ, orally for prophylaxis, lot # M043836 and expiration date on 17-JUN-2018. On 22-JAN-2018, the patient experienced fever and runny nose and went to the emergency room. The patient was not admitted to the hospital and it was unknown by the reporter if treatment was given for the events. The physician reported that the vaccine experienced temperatures below 32 F for 9 hours 6 minutes and of 32 F up to 35 F for 19 hours 11 muntes. There were no previous temperature excursions reported and the call was because of a data logger. The outcome of fever and runny nose was not reported. The physician considered that the events were not related to the vaccination with ROTATEQ.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Acute kidney injury, Dehydration, Injection site pain, Laboratory test, Loss of consciousness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old male patient who is non-smoker. The patient's pertinent medical history included high blood pressure (reported as well controlled). Concomitant therapies included BENICAR. On 25-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency unknown) (lot # K010522, Expiration date: 25-FEB-2016), FLUVIRIN (lot #, expiration date, dose and frequency unknown) and Tdap (lot #, expiration date, dose and frequency unknown) via intramuscular route concomitantly in the left deltoid arm for prophylaxis. On 26-SEP-2015, the patient developed soreness and swelling in the left arm. It was unknown if this was treated. On 27-SEP-2015, the patient blacked out (medically significant) while driving, crossed 2 line of traffic and hit a fence. The pharmacist stated that the patient went to an unspecified emergency room and then was hospitalized for a couple of days with dehydration and acute kidney failure (medically significant). The patient also had complaints of pain in shoulder, pain in left deltoid arm and left leg. The patient was treated with Intravenous fluids and the unspecified physicians ran unspecified tests and diagnosis was reaction to vaccinations. The outcome of the events was not recovered (reported as patient was not back to normal but doing ok, limited on what he could do at the time of report). The relatedness of the events to the suspect product was unknown. There was no product quality complaint present. The reporter considered the events acute renal failure and dehydration to be serious due to hospitalization. Upon internal review, the events acute renal failure and loss of consciousness were considered to be medically significant.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Road traffic accident
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old male patient who is non-smoker. The patient's pertinent medical history included high blood pressure (reported as well controlled). Concomitant therapies included BENICAR. On 25-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency unknown) (lot # K010522, Expiration date: 25-FEB-2016), FLUVIRIN (lot #, expiration date, dose and frequency unknown) and Tdap (lot #, expiration date, dose and frequency unknown) via intramuscular route concomitantly in the left deltoid arm for prophylaxis. On 26-SEP-2015, the patient developed soreness and swelling in the left arm. It was unknown if this was treated. On 27-SEP-2015, the patient blacked out (medically significant) while driving, crossed 2 line of traffic and hit a fence. The pharmacist stated that the patient went to an unspecified emergency room and then was hospitalized for a couple of days with dehydration and acute kidney failure (medically significant). The patient also had complaints of pain in shoulder, pain in left deltoid arm and left leg. The patient was treated with Intravenous fluids and the unspecified physicians ran unspecified tests and diagnosis was reaction to vaccinations. The outcome of the events was not recovered (reported as patient was not back to normal but doing ok, limited on what he could do at the time of report). The relatedness of the events to the suspect product was unknown. There was no product quality complaint present. The reporter considered the events acute renal failure and dehydration to be serious due to hospitalization. Upon internal review, the events acute renal failure and loss of consciousness were considered to be medically significant.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old male patient who is non-smoker. The patient's pertinent medical history included high blood pressure (reported as well controlled). Concomitant therapies included BENICAR. On 25-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency unknown) (lot # K010522, Expiration date: 25-FEB-2016), FLUVIRIN (lot #, expiration date, dose and frequency unknown) and Tdap (lot #, expiration date, dose and frequency unknown) via intramuscular route concomitantly in the left deltoid arm for prophylaxis. On 26-SEP-2015, the patient developed soreness and swelling in the left arm. It was unknown if this was treated. On 27-SEP-2015, the patient blacked out (medically significant) while driving, crossed 2 line of traffic and hit a fence. The pharmacist stated that the patient went to an unspecified emergency room and then was hospitalized for a couple of days with dehydration and acute kidney failure (medically significant). The patient also had complaints of pain in shoulder, pain in left deltoid arm and left leg. The patient was treated with Intravenous fluids and the unspecified physicians ran unspecified tests and diagnosis was reaction to vaccinations. The outcome of the events was not recovered (reported as patient was not back to normal but doing ok, limited on what he could do at the time of report). The relatedness of the events to the suspect product was unknown. There was no product quality complaint present. The reporter considered the events acute renal failure and dehydration to be serious due to hospitalization. Upon internal review, the events acute renal failure and loss of consciousness were considered to be medically significant.
Sex: M
Vaccine: HEP, HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical student refers to a 17 year old male patient. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 20-JAN-2018 the patient was vaccinated with improperly stored GARDASIL 9 (dose and route unknown) lot # N021475 expiration date 31-JAN-2020 and RECOMBIVAX HB (dose and route unknown) lot # N002202 expiration date 04-NOV-2019 for prophylaxis (Product storage error). The temperature was 53.2 F, time frame was 5 hours and 57 minutes. It was reported that there was no previous temperature excursion. This case is linked to the case 1802USA001471 (same reporter link).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown demographics. On an unknown date in January 2018, the patients were vaccinated with improperly stored VARIVAX for prophylaxis (incorrect product storage). Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse effects reported. The temperature reported was 6F to 14F. The time frame was reported as 30 minutes. There was no previous temperature excursion. No product compliant reported.
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced high fever, chills, headache, and flu-like symptoms for 24 hours after receiving the first dose of meningococcal group b rlp2086. Outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: First night, pain at sight. 2nd day, pain at sight, sore muscles, headache, upset stomach, tiredness, insomnia - took Tylenol and nap, didn't eat much. 3rd day, pain at sight, extremely sore muscles,  could barely move neck and shoulders, upset stomach, took Tylenol & Tramdol. 4th day, pain at sight, muscle pain in neck and shoulder was less extreme - took Tylenol.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Myalgia
Clinical narrative: First night, pain at sight. 2nd day, pain at sight, sore muscles, headache, upset stomach, tiredness, insomnia - took Tylenol and nap, didn't eat much. 3rd day, pain at sight, extremely sore muscles,  could barely move neck and shoulders, upset stomach, took Tylenol & Tramdol. 4th day, pain at sight, muscle pain in neck and shoulder was less extreme - took Tylenol.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Gait inability, Muscular weakness, Pain, Pelvic pain
Clinical narrative: Started feeling pain in all body parts, unable to walk with weakness to legs, inability to walk. Pelvic pain
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore right arm at injection site. Relieved with ibuprofen.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Insomnia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: At the time of the injection the patient reports nothing unusual. The following day 1/20 there was increased pain which is still present 1/22. Pain is limiting ability to lift arm and to sleep. NSAIDs are partially helpful. There was 1 brief episode of numbness: tingling of hand. I advised continued NSAID: F/U by phone in 2d.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm with erythema and swelling extending from shoulder to elbow. No systemic reaction.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenitis, Skin warm, Swelling, Tenderness
Clinical narrative: Axillary lymphadenitis in right arm and axillae; redness, swelling, tenderness, warmth.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Following the injection of both vaccines in the same day but different arms. Patient reported losing ability to move left arm and has been that way since the day after the injection. Patient has been to the doctor to follow-up with this symptom with no improvement so far.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 16 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # L033549, expiration date 05-JUN-2017 ,for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1802USA003852: US-009507513-1802USA003853:
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Eye movement disorder, Loss of consciousness, Muscle twitching
Clinical narrative: This spontaneous report was received from a patient's mother via a company representative and refers to a 11 year old male patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 01-FEB-2018, the patient was vaccinated with unidentified Merck hpv vaccine administered (name and lot number not provided). On the same day after vaccination, the patient's eyes rolled back in his head, he twitched and passed out for more than two minutes. The outcome of the events was reported as resolved on 01-FEB-2018. The reporter considered aforementioned events to be related to the vaccine.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown demographics. The patient concurrent condition and medical history were not reported. On 15-DEC-2017 the patient was vaccinated with improperly stored PROQUAD lot # N016119 (expiry date: 21-NOV-2018) for prophylaxis and VARIVAX Lot # N007930 (expiry date: 03-MAY-2019) (incorrect product storage). Concomitant therapies included sterile diluent (STERILE DILUENT) lot # N006322 (expiry date: 11-JUL-2019). No adverse effect reported. The temperature was reported as 18.9F. Time frame was reported as 3 hours 10 minutes. There was previous temperature excursion with 15F to 46F for 5 hours 20 minutes. No product compliant reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 06-FEB-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiration date 22-JAN-2018) (dose, route and lot number were not reported) for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 16 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # M007307, expiration date 30-NOV-2017 ,for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1802USA003853: US-009507513-1801USA013280:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 14 months old child patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # L033549, expiration date 05-JUN-2017, for prophylaxis (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 0.8 degrees Fahrenheit for 24 hours and 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013280; US-009507513-1802USA003852.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Invalid dose due to spacing error at office. MMR vaccine was given on 1/24/16 in the office then on 2/2/18 a Varicella dose was given in the same office. No known adverse reaction, school nurse called Local Health Department because office was not understanding that the dose would be invalid and said child didn't need further vaccines as that would be over vaccinating the child.  Local Health Department sent a letter to office that child would need another Varicella vaccine with spacing 3 months from 2/2/18. This will protect child and fulfill school requirements. CDC directed me to report this.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Fatigue, Peripheral swelling, Skin warm
Clinical narrative: Swelling from shoulder to mid arm, redness and warm for 48 hours. Eyes were hurting for 2 days, diarrhea and tiredness for 1 day. Symptoms started to improve after 48 hours of administration. Patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, Mild tenderness, redness, 8"4 effected area.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Patient said the area of shot is red/purple and warm to touch. I informed her to take ibuprofen or TYLENOL and ice it down, and if that doesn't help to see the doctor.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chills, Pain, Pyrexia
Clinical narrative: Body ache, Fever 100 degrees, Chills, Weakness, Back pain.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left upper limp. Treated with Keflex 500 mg 1 tablet every 12 hours for 5 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient reported that she had rash at injection site and around that area, she also reported itching even after 7 days.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Aplastic anaemia, Bone marrow transplant, Chemotherapy, Intensive care, Life support
Clinical narrative: Very severe idiopathic aplastic anemia.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Gianotti-Crosti syndrome
Clinical narrative: Gianotti-Crosti Syndrome occurring 3 days post immunization. Evaluated in Allergy. No exemption needed.
Age: 0.25
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: > 1 dozen red papules with some vesicles on the trunk (1 or the trunk is slightly crusted over) and few vesicles on face.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus generalised
Clinical narrative: Redness, itching and swelling started at site of injection about 7 hours after the injection. She said the swelling didn't last long but the redness and itching continued. Patient stated she is now experiencing itching over entire body. She has not taken anything for the symptoms.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complaining of arm soreness, especially at injection site. Problem started in December (vaccine was given in October) and is still continuing. Says occurs up to shoulder. She is unsure if it is caused by vaccine but she believes it might be.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired driving ability, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Pruritus
Clinical narrative: Extreme pain in entire left arm; extreme itching of left arm; limited movement of left arm; inability to raise left arm; inability to perform routine hygiene and duties; pain made driving extremely difficult. This lasted for at least 7 months. Subsequent treatment included physical therapy, an ultrasound, an x-ray over a period of 9 months.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Extreme pain in entire left arm; extreme itching of left arm; limited movement of left arm; inability to raise left arm; inability to perform routine hygiene and duties; pain made driving extremely difficult. This lasted for at least 7 months. Subsequent treatment included physical therapy, an ultrasound, an x-ray over a period of 9 months.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: The initial shot did not hurt at all, but within a few hours pt couldn't lift her left arm without pain. Toward evening, it became so painful, she thought she was going to pass out. It reminded her of when she injured her rotator cuff on the opposite arm. She took a hydrocodone tablet (from the rotator cuff experience) which helped a little. She slept very little Friday night and took hydrocodone every 6 hours which helped as long as she didn't move her arm up or out. The consistent pain let up on Saturday evening as long as she kept her arm close to her side. It was still quite sore but she had minimal movement without some pain on Sunday.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: On 02/08/18, 22 yo M presented to clinic for immunizations. During this visit, pt was ordered dose #1 of HPV vaccine 9-valent IM (GARDASIL 9). CMA prepared dose and injected it into pt's left deltoid. ~2-3 minutes after injection, the pt requested water, then "passed out" for ~2 minutes. RN and MD called into room. Vitals assessed with no abnormalities noted, heart and lungs were normal and pt had good bilateral pulses. Pt was provided with crackers and juice and rested in supine position for 20 minutes. After MD reassessment, pt was cleared for discharge. Non-preventable event listed in product labeling.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown demographics. The patients concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (unknown lot/expiration), RECOMBIVAX HB (unknown lot/expiration) and ROTATEQ (unknown lot/expiration) (incorrect product storage). No adverse effects reported. The temperature and time frame were unknown. There were no previous temperature excursion. No product quality compliant reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like times 10.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Redness and warm, swelling and pain in the left arm, firm induration about a quarter sized and this is tender around the injection site, Warm compresses 15-20 minutes at a time Monitor. If worsening or new symptoms let me know!
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Redness and warm, swelling and pain in the left arm, firm induration about a quarter sized and this is tender around the injection site, Warm compresses 15-20 minutes at a time Monitor. If worsening or new symptoms let me know!
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash (about 75 minutes after immunization) - 50 mg total diphenhydramine liquid 12.5 mg / 5 ml; difficulty breathing (about 90 minutes after immunization) - called 911, who responded and took over treatment (no further info).
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Reports she had pain in arm shortly after injection of PNEUMOVAX (which she has received in past); and developed swelling of the arm in the evening. Noted redness and warmth this AM. Plan: predniSONE (DELTASONE) 10 mg oral tablet. Cellulitis of left upper extremity. Plan: cephalexin (KEFLEX) 500 mg oral capsule.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever after 24 hours; muscle aches; head ache; dizziness; general malaise/fatigue; red and swollen arm at injection site 48 hours after; lingering headache, dizziness and muscle aches after 72 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever after 24 hours; muscle aches; head ache; dizziness; general malaise/fatigue; red and swollen arm at injection site 48 hours after; lingering headache, dizziness and muscle aches after 72 hours.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A female patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. On an unspecified date (about one year before the report), a little while after the vaccination, the patient experienced a horrible rash. The event required visit to handful of specialists and hospitalizations. The event lasted a year and resolved on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of rash cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received Pneumovax 23 and Shingrix vaccines on 2/1/18.  On 2/3 and 2/4, reported to pharmacist that patient experienced redness, swelling and severe pain in the injection area. On 2/5, patient went to Urgent Care and was given antibiotics as a precaution.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis, unknown time course.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia, Loss of consciousness, Pallor, Syncope
Clinical narrative: Approximately one minute following the vaccine the child began to slump forward as if she was reaching down to pick something up. When I saw that her hands were not reaching and she was going head first I reached down prevent the fall. Upon lifting the child she was limp and her eyes were closed and color of her skin was pale. She regained consciousness in approximately 2-3 seconds. I lifted her on to mother's lap and immediately provided a Sprite to sip on. Mom stated child hadn't eaten anything since the morning. Child remained on mom's lap for several minutes while we ensured safety of child.
Age: 33.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Left arm swelling, redness. Fever, myalgias, headache.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Symptoms: Full body rash that started on his abdomen upon getting home from the office visit and spread. Treatment:  Watch and wait.
Age: 1.67
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received a Hepatitis B vaccination instead of a Hepatitis A vaccines. He did not have any adverse reaction after vaccination. Is the 5th hepatitis vaccine he received.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abnormal behaviour, Gastrointestinal disorder, Social avoidant behaviour
Clinical narrative: Parents report after that series of vaccines, child starting showing behavioral changes (not engaging with parents, isolating himself to play). Also reported GI symptoms that have persisted.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain on the injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Mobility decreased
Clinical narrative: Patient unable to lift arm - Patient had difficulty breathing the evening of vaccination - Patient was breathing easier the next day (2/8/18).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash, Injection site reaction
Clinical narrative: On 1/10/18 pt was brought in for an acute visit regarding a rash on the right leg. Although a significant amount of time has lapsed since the vaccine was administered, the rash that examined was most consistent with shingles in the exact location that the varicella vaccine was administered. The rash remained limited to that specific area before slowly resolving by 1/18/18 (the next time the patient was seen).
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthma, Condition aggravated, Dysphonia, Peak expiratory flow rate, Wheezing
Clinical narrative: Pt reported to clinic 2 days after vaccine with hoarseness and wheezing starting 7 pm on 2/7/18.  Pt had not had asthma exacerbation in 10 years, albuterol nebulizer treatment given and wheezing and hoarseness cleared no other Sx of anaphylaxis present. Set home on step up asthma care. Started Fluticasone inhaled steroid, Albuterol MDI prn, ZYRTEC 10 mg daily, Ranitidine 150 mg bid, SINGULAIR 10 mg qd. (Did not start on oral steroids due to vaccines administration).
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, HPV9, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient is a 4 month old female that was supposed to get the IPV 2nd dose. I gave the patient the wrong vaccine. Instead of the IPV I gave the patient the HPV on the left thigh. I called mother and asked how the baby was doing she stated that she is good and sleeping. Mother stated that she is going to take her to get re-evaluated. I'm not sure if mother is taking her to the ER to be seen.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Severe arm pain and discomfort, starting the evening of the vaccination.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal distension, Arthralgia, Dry mouth, Headache, Heart rate irregular
Clinical narrative: Sore Shoulder at injection site for 1-2 days. Arthralgia, irregular heartbeat, bloating, dry mouth, headache for 5-6 days following shot.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Sore Shoulder at injection site for 1-2 days. Arthralgia, irregular heartbeat, bloating, dry mouth, headache for 5-6 days following shot.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Feeling hot, Malaise, Nausea
Clinical narrative: Patient stated she was dizzy and nauseated after receiving the MMR. Patient thought she was going to vomit and had to lay her head down for a few minutes. Patient complained that she was abnormally hot and didn't feel well.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Gout
Clinical narrative: Patient claimed to develop gout; he got treated for gout on 02/02/2018 by PA with indomethacin 25mg.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Influenza vaccine. Previously administered products included Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated her brother's wife (patient) had the flu right now (at the time of reporting). She reported that it was just not working this year. Permission to contact the reporter was provided. No other details were known. This case was considered as suspected vaccination failure because the time to onset and laboratory confirmation for influenza was unknown at the time of reporting. The case was linked with the case US2018GSK021382, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a 7-month-old patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had flu right now (at the time of reporting). Permission to contact the reporter was provided. No other details were known. This case was considered as suspected vaccination failure because the time to onset and laboratory confirmation for influenza was unknown at the time of reporting. The case was linked with the case US2018GSK021381, reported by the same reporter.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body and itching.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Left arm pain, fever 100.8, hives on chest and abdomen.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Back pain, Electroencephalogram normal, Gait inability, Lethargy, Lumbar puncture
Clinical narrative: Less than 48 hrs after admin of vaccine fevers 103.5. Lethargy - unable to walk - developed neck and back pain. Seen in ER - for meningitis; Sx D/C after spinal tap 2/1/18 admitted to ER due to having seizure. EEG normal. As of 2/7/18 doing better.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Meningitis, Neck pain, Pyrexia, Seizure
Clinical narrative: Less than 48 hrs after admin of vaccine fevers 103.5. Lethargy - unable to walk - developed neck and back pain. Seen in ER - for meningitis; Sx D/C after spinal tap 2/1/18 admitted to ER due to having seizure. EEG normal. As of 2/7/18 doing better.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that side effects as injections site reactions. The patient planned to follow-up with his physician on an unknown date. Only partial information was provided. The patient was at work and wanted to get back to work. The vaccine was prescribed by Family Medicine.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Pt called said she has a golf ball sized lump in her arm at injection site with pain in entire arm down to finger.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: 1/2 dollar sized lump at inj site. C/O itchiness, warm to touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 58-year-old female patient who received SHINGRIX. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th January 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, muscle pain and pain burning. SHINGRIX was continued with no charge. On an unknown date, the outcome of the shoulder pain, muscle pain and pain burning were recovering/resolving. The reporter considered the shoulder pain, muscle pain and pain burning to be related to SHINGRIX. Additional details were reported as follows: The patient stated that the muscle pain, shoulder pain and burning have lessoned but had not completely resolved. The healthcare professional was transferred to MI for additional assistance.
Age: 34.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-JAN-2018, the patient received expired RECOMBIVAX HB (lot# L026037 with expiry date of 17-JAN-2018, dosage unknown) for prophylaxis. No adverse effect was reported. Follow-up information was received from a healthcare professional via Medical Center referring to a 34 years old male patient (previously reported that "unspecified patient "). On 18-JAN-2018, the patient received a second dose of expired one day's vaccination of RECOMBIVAX HB (dosage unknown, lot# L026037, expiration date 17-JAN-2018) intramuscularly on left deltoid. On the same date, the patient received a second dose of M-M-R II (dosage and route unknown, lot# N020924, expiration date system auto-generated as 01-AUG-2019) on right deltoid for prophylaxis. There was no any other vaccinations received within four weeks prior to 18-JAN-2018. No reaction or complications occurred due to RECOMBIVAX HB administration. No temperature excursion occurred before.
Age: 34.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-JAN-2018, the patient received expired RECOMBIVAX HB (lot# L026037 with expiry date of 17-JAN-2018, dosage unknown) for prophylaxis. No adverse effect was reported. Follow-up information was received from a healthcare professional via Medical Center referring to a 34 years old male patient (previously reported that "unspecified patient "). On 18-JAN-2018, the patient received a second dose of expired one day's vaccination of RECOMBIVAX HB (dosage unknown, lot# L026037, expiration date 17-JAN-2018) intramuscularly on left deltoid. On the same date, the patient received a second dose of M-M-R II (dosage and route unknown, lot# N020924, expiration date system auto-generated as 01-AUG-2019) on right deltoid for prophylaxis. There was no any other vaccinations received within four weeks prior to 18-JAN-2018. No reaction or complications occurred due to RECOMBIVAX HB administration. No temperature excursion occurred before.
Sex: F
Vaccine: HPVX
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: This spontaneous report was received from a patient's father and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 16-NOV-2017, the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) for cyst, not for prevention of HPV. The patient had scheduled vaccination with second dose of the vaccine on 08-FEB-2018. No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an administrator referring to an adult female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-JAN-2018, the patient was vaccinated with 2 properly stored, expired, pediatric doses of VAQTA (0.5 ml, lot# M036459, expiration date of 18-JAN-2018, frequency and strength were unknown) intramuscularly in left deltoid for prophylaxis. No adverse effects reported. No product complaints involved.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a nurse practitioner referring to an 11 year old female patient. The patient's pertinent medical history included anxiety, elevated thyroid, precocious puberty and heavy periods. The patient had no drug reactions or allergies. Concomitant medication was reported as topical medications. Information about concurrent condition and medication history was not reported. No lab diagnostics or studies was performed. On 04-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # N007931, expiration date 17-NOV-2019, intramuscular) for prophylaxis. On an unknown date in December 2017 (reported as "late December"), the patient developed menstrual spotting "for a week or two" after she had her period. No treatment was given for the event. The patient intended to complete the vaccine series. The outcome of the event was reported as recovered. The causality assessment of the event was reported as unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The nurse informed that on an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). It was also reported that on 29-JAN-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported) as a second dose (inappropriate schedule of drug administration). The nurse also informed that the patient was scheduled for the third dose of (strength, dose, frequency, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On 21-NOV-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, route, anatomical location, lot # and expiration date were not reported). Subsequently, on 30-JAN-2018, she received a second dose of ZOSTAVAX 19400 PFU, subcutaneously, lot # N020852, expiration date 31-JUL-2018 (dose and anatomical location were not reported). Both doses were given for prophylaxis, and the second dose was reconstituted with sterile diluent (MERCK). No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 02-FEB-2018 (also reported as 02-FEB-2020), the patient was vaccinated with properly stored but expired dose ZOSTAVAX, lot # M041085, expiration date 03-JAN-2018 for prophylaxis (dose, route of administration were not reported). The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning 7 patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 for prophylaxis, lot # N021571 and expiration date on 29-APR-2020 (dose, route of administration and anatomical location were not reported). The administered doses of the vaccine experienced an unspecified temperature excursion of below 32 F for an unspecified timeframe, as recorded by a data logger. The vaccines had had multiple unspecified previous temperature excursions below 32 F for an unspecified time frame. There was no adverse effects reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-FEB-2018 the patient was inadvertently vaccinated with one expired dose of M-M-R II (lot # M002418, expiry date: 12-JAN-2018) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: M
Vaccine: RV5
Symptoms: Dyspnoea, Hypotonia, Loss of consciousness, Respiratory tract congestion, Somnolence
Clinical narrative: This spontaneous report as received from a company representative refers to a 3 month old male patient. The patient's concurrent condition included mild diarrhea. The patient's medical history included crying from the previous vaccinations. Historical drug included multiple unspecified injectable vaccinations (unknown brand and manufacturers). The patient's concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was vaccinated with ROTATEQ (dose, units and frequency) (lot # and expiration date not reported) orally as normal vaccination. On an unknown date, after receiving ROTATEQ, patient experienced congestion, and having a hard time breathing. The patient was then orally suctioned and after being suctioned the patient became unconsciousness and limp. Vital signs and oxygens were checked for the patient and revealed normal. The reporter called the paramedics and were able to wake the patient up. The patient then went home, and was very sleepy after the incident. On 01-FEB-2018, reporter contacted patient's mother and informed patient very sleepy (hypersomnia) for a while but patient was completely recovered. The patient did not seek any medical attention. The outcome of the events pulmonary congestion, dyspnea, loss of consciousness, gait disturbance and hypersomnia was reported as recovered/ resolved. The reporter did not provide causal relationship for the events pulmonary congestion, dyspnea, loss of consciousness, gait disturbance and hypersomnia with the suspect therapy. No product quality compliant was involved. Upon internal review, the events pulmonary congestion and loss of consciousness were determined as serious due to medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 11-JAN-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot # N019251, expiry date: 20-DEC-2018) and properly stored dose of sterile diluent (lot # and expiry date unknown) for prophylaxis. Reporter stated that the vaccine was exposed to temperature between -14 C to -10 C for 12 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported.