chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypertension, Hypotension, Incorrect route of drug administration, Joint dislocation
Clinical narrative: This spontaneous report was received from a 75 year old male patient, regarding himself. Patient's concurrent conditions included hypertension, syncope, dislocation, delusion, acute edema of feet, and gastric reflux. He reported that on an unspecified date, he was vaccinated with ZOSTAVAX eight times in a row (overdose). He explained that each of the 8 injections were consecutive and delivered on the top of his foot by an unknown physician at an unknown hospital. Concomitant therapies included PROZAC, XANAX, potassium sodium hydrogen citrate (Manufacturer unknown) and ADDERALL tablets. Patient reported that he also received a ninth dose of ZOSTAVAX on his shoulder on an unspecified date. On 01-JUL-2015 the patient blacked out on the floor for a period of 30 hours and woke up with terrible pain. He was taken to an unknown hospital for an unspecified amount of time. On an unknown date in 2015, during his hospital stay, it was determined that he was severely dehydrated and had unspecified kidney issues. Patient stated that he felt like he was poisoned and the vaccine was intentionally given to him in the manner to harm him. The patient went on to explain that he felt his mental state was messed. The patient further explained that he then went under an unspecified invasive procedure to test for any heart irregularities. On 06-SEP-2015, he dislocated his shoulder due to a second episode where he blacked out and fell. He was taken back to the same hospital facility for an unknown amount of time, where an unknown medical professional implanted a chip in his chest to monitor his heart on an unknown date in 2015. Furthermore, patient developed hypotension which later turned into hypertension (documented as reported by the patient) and was diagnosed with an autoimmune marker. Patient mentioned that he was in the process of starting a legal case with this unknown hospital. Outcome of the events were unknown. Causality assessment was not provided. Upon internal review, the patient blacked out to be medically significant and considered serious due to hospitalization. The event dislocated shoulder was considered serious due to hospitalization. Additional information is not expected, no contact details were provided.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Mental disorder, Pain, Renal disorder, Therapeutic procedure
Clinical narrative: This spontaneous report was received from a 75 year old male patient, regarding himself. Patient's concurrent conditions included hypertension, syncope, dislocation, delusion, acute edema of feet, and gastric reflux. He reported that on an unspecified date, he was vaccinated with ZOSTAVAX eight times in a row (overdose). He explained that each of the 8 injections were consecutive and delivered on the top of his foot by an unknown physician at an unknown hospital. Concomitant therapies included PROZAC, XANAX, potassium sodium hydrogen citrate (Manufacturer unknown) and ADDERALL tablets. Patient reported that he also received a ninth dose of ZOSTAVAX on his shoulder on an unspecified date. On 01-JUL-2015 the patient blacked out on the floor for a period of 30 hours and woke up with terrible pain. He was taken to an unknown hospital for an unspecified amount of time. On an unknown date in 2015, during his hospital stay, it was determined that he was severely dehydrated and had unspecified kidney issues. Patient stated that he felt like he was poisoned and the vaccine was intentionally given to him in the manner to harm him. The patient went on to explain that he felt his mental state was messed. The patient further explained that he then went under an unspecified invasive procedure to test for any heart irregularities. On 06-SEP-2015, he dislocated his shoulder due to a second episode where he blacked out and fell. He was taken back to the same hospital facility for an unknown amount of time, where an unknown medical professional implanted a chip in his chest to monitor his heart on an unknown date in 2015. Furthermore, patient developed hypotension which later turned into hypertension (documented as reported by the patient) and was diagnosed with an autoimmune marker. Patient mentioned that he was in the process of starting a legal case with this unknown hospital. Outcome of the events were unknown. Causality assessment was not provided. Upon internal review, the patient blacked out to be medically significant and considered serious due to hospitalization. The event dislocated shoulder was considered serious due to hospitalization. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever to 103.3 48 hours after Flu vaccine. No site soreness or local reaction.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Insomnia, Mobility decreased, Nausea
Clinical narrative: Pounding headaches and pounding heart could not move leg arm, nausea, dizzy, could not sleep. 2nd week, dr put me on a med pak for 6 days - +3 ADVIL - 4's a day. Symptoms slowed - but today, it is 4 wks and still hurt.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations
Clinical narrative: Pounding headaches and pounding heart could not move leg arm, nausea, dizzy, could not sleep. 2nd week, dr put me on a med pak for 6 days - +3 ADVIL - 4's a day. Symptoms slowed - but today, it is 4 wks and still hurt.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Flushing, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional on 17 November 2014. A 76-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date and route of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient has been experiencing swollen hot to touch red area at injection site and feeling feverish, burning eyes and flushing of face. Stated symptoms "come and go" now but still having burning eyes, swelling of face, face getting hot and red with the heat radiating to her neck and back which lasts about 1 hour. The physician prescribed prednisone to the patient and is having her see an allergist. Illness at the time of vaccination was unknown and the patient had allergies to Sulfa drugs, latex and environment. Laboratory data and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER visit. The case was assessed as serious upon Company's internal review due to the important medical event. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional on 17 November 2014. A 76-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date and route of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient has been experiencing swollen hot to touch red area at injection site and feeling feverish, burning eyes and flushing of face. Stated symptoms "come and go" now but still having burning eyes, swelling of face, face getting hot and red with the heat radiating to her neck and back which lasts about 1 hour. The physician prescribed prednisone to the patient and is having her see an allergist. Illness at the time of vaccination was unknown and the patient had allergies to Sulfa drugs, latex and environment. Laboratory data and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER visit. The case was assessed as serious upon Company's internal review due to the important medical event. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Pruritus
Clinical narrative: Initial unsolicited report received from a healthcare professional on 25 September 2014. A 28-year-old patient, with no reported illness at the time of vaccination, received an intradermal left deltoid dose of FLUZONE ID (lot number UT4982BA) on 24 September 2014. Approximately 16 hours post-vaccination, on 25 September 2014, the patient experienced swelling of her upper lip. She also complained of itching on her body, and redness and a bump at the injection site. The patient had not received intradermal influenza vaccine in the past. She was seen by a physician; treatment and laboratory testing was not reported. Outcome remained ongoing at the time of the report. Follow-up information received on 01 December 2014 from a healthcare professional. Name of the patient's responsible physician was updated. The patient did not receive any concomitant medications. She received a corrective treatment with OTC ZYRTEC and BENADRYL. History of breathing difficulties were denied. The patient had fully recovered on an unspecified date. She did not seek further care from any physician or NP. Documents held by sender: None.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite
Clinical narrative: Initial report received from a healthcare professional on 15 September 2014. A 74-year-old male patient, whose medical history and concomitant medication were not reported, received an intramuscular dose of FLUZONE HD (batch number, site and dose in series not reported) on an unspecified date. On an unspecified date 9 day after vaccination the patient had experienced severe weakness and decreased appetite for 2-3 days. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events was reported as recovered. List of documents held by sender: none. Follow up information received from a physician on 27 April 2015. Patient's age at the time of event was 73-year-old, previously it was reported as 74-year-old. It was reported that, patient pre-existing, physician-diagnosed allergies, birth defects, medical condition were asthma and bronchitis (chronic) and other medication was valsartan. Patient had no vaccine within 4 weeks of vaccination, and corrective treatment and laboratory investigations were reported as none. List of document held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Erythema, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: The day after patient received the PREVNAR 13 her arm became red and swollen. Over the next few days it turned purple and she developed fever and generalized weakness. She presented the hospital on 11/2 with a temp of 100.8 and was admitted. Pt's symptoms improved and was discharged 11/6/15. She presented to our clinic on 11/19/15. Her arm was healed. She still was weak, but improving.
Age: 29.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Pt c/o pain in the arm since receiving a flu shot. Initially, she was seen in the office for this 9/28/2015 and again 11/23/2015 because the arm still hurts.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Sore arm at injection site.
Age: 63.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Asthenia, Mobility decreased, Neck pain
Clinical narrative: Per patient she could hardly move her arm for 2 to 3 wks & lost strength in same arm. Pain radiated up to her neck. Currently still has pain but not as severe as previously. Taking NSAIDS.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Dry mouth, Fatigue, Headache, Muscle spasms
Clinical narrative: PATIENT EXPERIENCED EXTREME FATIGUE, TERRIBLE CRAMPING AND HEADACHE, DRY MOUTH, DEHYDRATION, AND HEART RATE WAS MEASURED TO BE 130 WHEN TAKEN TO URGENT CARE ON 11/21/15.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red area about the size of her hand around the injection site. A little swollen and hot to the touch.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness in upper arm and shoulder. Constant pain and limited range of motion.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Pt c/o arm pain since receiving a flu shot.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis staphylococcal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, swollen, red at site of injection. Later diagnosed as staph cellulitis at f/u appt.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Severe pain at immunization site, fever, nausea.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Right foot numbness followed three days later by left foot numbness. Progressed up her left thigh. Followed by upper extremity weakness with bulbar involvement (left facial nerve).
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LOCAL REDNESS AND SWELLING TO INJECTION SITE OTC MEDS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Cough, Discomfort, Eyelid oedema, Headache
Clinical narrative: Started feeling congested and coughing (strange cough). As evening progressed, by 8pm bones in mouth and teeth hurt. Then eyes were blood shot and swollen upper lids on face. Took aspirin which helped. Congestion pressure started. Sinus hurting really bad. Had headache but took aspirin even sinuses feel better. Called because it was scary when face started to get swollen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Respiratory tract congestion, Sinus headache, Swelling face, Toothache
Clinical narrative: Started feeling congested and coughing (strange cough). As evening progressed, by 8pm bones in mouth and teeth hurt. Then eyes were blood shot and swollen upper lids on face. Took aspirin which helped. Congestion pressure started. Sinus hurting really bad. Had headache but took aspirin even sinuses feel better. Called because it was scary when face started to get swollen.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Tremor
Clinical narrative: 3:00 on day of shot pt had chills fatigue and shaking, headache.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Head injury, Pallor, Syncope
Clinical narrative: Patient fainted and hit her head on the floor.  She was extremely pale and dizzy at this time.  Patient had shown anxiety like symptoms prior to injection.
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I called several times to the patient, but no one answered, so I am not sure if there any problem.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Began getting hives through the night and next day.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Patient received Prevnar 13 but jerked away in the middle of administration. Received partial dose.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Blood test normal, Chest X-ray normal, Dizziness, Fatigue
Clinical narrative: Dizziness, next day extreme exhaustion, aches, next day unable to focus eyes, next day add extreme back/leg aches and to ER; blood, urine chest Xray normal. Discharged.  5 more days still back pain.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Urine analysis normal, Vision blurred
Clinical narrative: Dizziness, next day extreme exhaustion, aches, next day unable to focus eyes, next day add extreme back/leg aches and to ER; blood, urine chest Xray normal. Discharged.  5 more days still back pain.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cold sweat, Dizziness, Dry throat, Eye swelling
Clinical narrative: 3-4hrs. after vaccine received, experienced symptoms of: chest tightness, wheeze, dry scratchy throat, itchy swollen tongue, gums, swollen around eyes, increased heart rate, tired, dizzy. Took Benadryl.  4-6 after experience cold sweat and fever 100-101.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Gingival disorder, Heart rate increased, Pyrexia, Swollen tongue
Clinical narrative: 3-4hrs. after vaccine received, experienced symptoms of: chest tightness, wheeze, dry scratchy throat, itchy swollen tongue, gums, swollen around eyes, increased heart rate, tired, dizzy. Took Benadryl.  4-6 after experience cold sweat and fever 100-101.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation, Tongue pruritus, Wheezing
Clinical narrative: 3-4hrs. after vaccine received, experienced symptoms of: chest tightness, wheeze, dry scratchy throat, itchy swollen tongue, gums, swollen around eyes, increased heart rate, tired, dizzy. Took Benadryl.  4-6 after experience cold sweat and fever 100-101.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Oedema, Pain in extremity, Rash pruritic
Clinical narrative: Pt states her arm was sore from the time of injection, but she developed a pruritic rash that radiated from her shoulder to her elbow over the course of the weekend. She took APAP and Benadryl with mild relief from itching and inflammation. Pt came to pharmacy on Monday with rash with erythemia, edema, and c/o pruritis. Pt was going to MD to have them look at it, but was not given any medication to treat.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Autism, Crying, Decreased appetite, Hypophagia
Clinical narrative: BABY WAS IN PAIN AND FUSSY. THE FOLLOWING MORNING SHE EXHIBITED TOTAL AUTISM. SHE WOULD NOT SMILE. LOOK INTO YOUR FACE, OR MAKE ANY SOUNDS EXCEPT FOR CRYING AND WHIMPERING.  HER APPETITE DROPPED FROM 22 OUNCES OF FORMULA DAILY TO 16 OUNCES. SHE HAS NOT REGAINED HER APPETITE.  SHE WAS SIMPLY NOT REACTING TO HER ENVIRONMENT AT ALL. THIS WENT ON FOR TWO DAYS, ALL DAY FRIDAY AND SATURDAY, AND ON SUNDAY MORNING, SHE STARTED ACTING NORMAL AGAIN, EXCEPT FOR THE LACK OF APPETITE. A FEW DAYS LATER, WE REPORTED TO THE DOCTOR, WHO SAID WE WOULD POSTPONE OR CANCEL FUTURE DTaP VACCINATIONS.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pain
Clinical narrative: BABY WAS IN PAIN AND FUSSY. THE FOLLOWING MORNING SHE EXHIBITED TOTAL AUTISM. SHE WOULD NOT SMILE. LOOK INTO YOUR FACE, OR MAKE ANY SOUNDS EXCEPT FOR CRYING AND WHIMPERING.  HER APPETITE DROPPED FROM 22 OUNCES OF FORMULA DAILY TO 16 OUNCES. SHE HAS NOT REGAINED HER APPETITE.  SHE WAS SIMPLY NOT REACTING TO HER ENVIRONMENT AT ALL. THIS WENT ON FOR TWO DAYS, ALL DAY FRIDAY AND SATURDAY, AND ON SUNDAY MORNING, SHE STARTED ACTING NORMAL AGAIN, EXCEPT FOR THE LACK OF APPETITE. A FEW DAYS LATER, WE REPORTED TO THE DOCTOR, WHO SAID WE WOULD POSTPONE OR CANCEL FUTURE DTaP VACCINATIONS.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt developed rash with redness and swelling, at site of vaccine admin. Treatment provided to patient included Benadryl and Zyrtec.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Malaise
Clinical narrative: Patient reports fatigue, malaise and redness around injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called on 11/22/2015 saying that she was concerned because her arm was swollen and "as big as a grapefruit" and very pink, hot, and concerned that the swelling was growing. Followed up with her on 11/23/2015 and she said that it was beginning to recede and that it was getting better but she had been very, very concerned on 11/22 and had symptoms from 11/21-11/22.
Age: 1.27
Sex: F
Vaccine: HIBV, MMR
Symptoms: Hypophagia, Irritability, Pyrexia, Rash morbilliform
Clinical narrative: Morbilliform rash, fevers, fussiness, decreased oral intake.
Age: 0.47
Sex: F
Vaccine: RVX
Symptoms: Constipation, Dyspnoea, Heart rate increased, Irritability, Malaise
Clinical narrative: PATIENT STARTED OIUT FUSSY AND SORE, OVER NEXT FEW DAYS WAS SICK, IRRITABLE, VOMITING, FAST HEARTBEAT, DIFFICULTY BREATHING, CONSTIPATION.
Age: 0.47
Sex: F
Vaccine: RVX
Symptoms: Pain, Vomiting
Clinical narrative: PATIENT STARTED OIUT FUSSY AND SORE, OVER NEXT FEW DAYS WAS SICK, IRRITABLE, VOMITING, FAST HEARTBEAT, DIFFICULTY BREATHING, CONSTIPATION.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Inflammation, Musculoskeletal pain
Clinical narrative: Pt wife called and said that his shoulder was extremely sore and shot was given too high above deltoid, in the joint fluid.  He had soreness, inflammation and could not even touch.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Loss of consciousness, Mydriasis, Syncope
Clinical narrative: Patient felt dizzy and fainted moments after receiving the Fluvirin.  Patient came to immediately and rested for a few minutes.  Patient was conscious but no aware of surroundings.  Patient stood back up despite recommendation to stay in horizontal position until paramedics came.  Patient's eyes became very dilated and went unconscious for a second time.  Patient layed waiting for paramedics.  After 10 minutes of rest, patient was coherent and responsive.  No further medical care sought.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, X-ray
Clinical narrative: Pain at the injection site radiated down the arm.  It has been ongoing since 10/22/15.  The shooting pain is intermittent. No redness, no pus, and not swollen.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Pain at the injection site radiated down the arm.  It has been ongoing since 10/22/15.  The shooting pain is intermittent. No redness, no pus, and not swollen.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches, headache, fever, chills. Lasted about 12 hours.
Sex: U
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age (the neighbor of the physician's mother). The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an unidentified Merck HPV vaccine (name and lot number not provided) (GARDASIL or GARDASIL 9 could not be ruled out). Concomitant therapy was not reported. It was reported that on an unspecified date the patient was "paralyzed" after being administered the vaccine. The outcome of "paralyzed" was unknown. It was unknown if the patient sought any medical attention. Upon internal review, the event of "paralyzed" was considered to be medically significant and resulted in disability. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Nuclear magnetic resonance imaging spinal abnormal, Transient ischaemic attack
Clinical narrative: Mini stroke symptoms. Loss of strength in limbs. Current treatment with steroids.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old male patient. The patient had no drug reaction/allergies. The patient had no pertinent medical history. On 03-OCT-2015, the patient was vaccinated with ZOSTAVAX lot # L002423, expiry date 23-APR-2016 in the right arm (dose, strength, dose number, route unspecified). Concomitant therapies included LIPITOR and an unspecified flu vaccine received in his left arm on 03-OCT-2015. Since the time of vaccination of ZOSTAVAX, the patient experienced tingling in his right arm from his elbow to his shoulder. The patient did not seek any medical attention. The patient was not treated for the adverse event. The outcome of paresthesia was reported as not recovered/not resolved. No product quality complaint was reported. Causality assessment was not provided. No further adverse event information was provided. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pruritus, Pyrexia, Urticaria, Vomiting
Clinical narrative: Fever, urticaria, pruritus and nausea vomiting. Hydrocortisone BID.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Mental status changes, Pain
Clinical narrative: Temperature 101 degrees F. Chills. Ache over the whole body. Altered mental status.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site rash, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen below elbow up to top of shoulder, hot to the touch, knot and rash at injection site, arm very sore. Relieved with ice, ibuprofen, hydrocortisone cream.
Age: 79.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Rash erythematous, Skin warm
Clinical narrative: PREVNAR 13 injection caused raised red feverish rash the size of a hand on shoulder.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Several hours after vaccine (FLUMIST) patient had itching and rashes all over the body.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Localized redness, hurts to touch, itchy and warm.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Tinnitus
Clinical narrative: 4 days following shot, Oct. 30, severe dizziness. Ringing in ear. ER->Doctor->ENT. Started 60 mg prednisone. Symptoms persist 2 wks later.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site reaction
Clinical narrative: Bursitis in left shoulder - went to physician.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: Patient got what appeared to be a bullseye cruise with a bump. Complained of pain and bruising, bruise was lower on arm than deltoid. I gave vaccine to best ability. Patient had disformity of the arm.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 20 year old female patient. The patient's medical history and concurrent condition were not reported. On 17-JUL-2015, the patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (Lot# L009445; expiration date: 01-JUN-2017) (dose and route of administration were not reported), in error. Concomitant medication was not reported. No adverse experience has been reported. There was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to multiple, unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored M-M-R II (lot # L020189 and expiry date: 03-JUN-2017, lot# L024264 and expiry date: 01-JUL-2017, lot# L009213 and expiry date: 17-MAR-2017, lot# L012479 and expiry date: 10-APR-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Contusion, Rash, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, medical history, drug allergies and concomitant therapy were not reported. On 30-OCT-2015, the patient was vaccinated with second dose of GARDASIL. On 01-NOV-2015 (reported as approximately 2 days after vaccination), the patient experienced a small fine rash on the arm that the injection was given. On an unspecified date in November 2015, the rash became itchy and had the appearance of hives. He also developed a rash on his face that appeared to be blisters. He sought medical assistance and was prescribed BENADRYL and an unspecified ointment for the rash on an unspecified date. At the time of reporting the patient was still suffering from the rash. The outcome of the events was reported as not recovered. The reporter did not provide the relatedness of the events with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse refers to multiple, unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot # L019298 and expiry date: 22-JUN-2017, lot # L029631 and expiry date: 14-AUG-2017, lot # L016427 and expiry date: 13-APR-2017, lot # L018501 and expiry date: 22-JUN-2017) (dose, route, therapy type not reported). No adverse effects were reported. 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 medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about the patients' concurrent conditions and medical history. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L012034, expiration date- 07-APR-2017, (dose, route of administration and anatomical location were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This initial spontaneous report was received from a female consumer of unknown age reporting on herself. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. On an unknown date reported as "at age 15", the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# and expiration date were not provided). She was refused the second dose of GARDASIL from the doctor at the time as the doctor said it was due to the fact that she "had lost her virginity". On an unspecified date, the patient was diagnosed with HPV (papilloma viral infection). The patient stated that she will get tested for cervical cancer in the coming days. The GARDASIL was not reintroduced. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of papilloma viral infection was not recovered. The relatedness between the event to the suspect product was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received on 28-OCT-2015 from a representative (field employee) who was informed by a physician that a 17 year old female developed "hypotension" (confirmed with the representative that the physician reported hypotension and not hypertension) and postural orthostatic tachycardia syndrome "two weeks" (specific date not reported) after receiving her second dose of GARDASIL (dose and date not reported). Outcome of events was reported as recovered (date unspecified). No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 29-OCT-2015, the patient was vaccinated with an expired dose of VAQTA injection 50/1.0 U/ml, 1 ml intramuscular, lot # K008984, expiration date 21-OCT-2015. No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Psoriasis
Clinical narrative: This spontaneous report was received from a currently 73 year old female patient regarding herself. No concurrent conditions, medical history or allergy/drug reactions were reported. In December 2014, the patient was vaccinated with ZOSTAVAX vial (lot # J012660, expiry date: 10-JAN-2015) (strength, dose and route unspecified). Concomitant therapy included levothyroxine sodium. Within two weeks of receiving the ZOSTAVAX, the patient presented with "psoriasis-like" lesions. The patient visited the doctor in the last few weeks and lab work was done on a sample identified these lesions as psoriasis. The patient was treated with an unspecified cream. The patient reported that she never had psoriasis prior to the ZOSTAVAX injection. She wanted a lot check done to see if other recipients of this particular ZOSTAVAX batch experienced psoriasis since having the injection. These lesions were still present as of the date of this report (not recovered). There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (dose and route were not reported) lot # K010215 with expiration date 05-MAY-2017. No concomitant therapy was provided. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient was vaccinated with expired dose of VARIVAX (Merck) lot # J013905, 0.5 ml injection, subcutaneously, expiration date: 30-OCT-2015 (frequency and indication not reported) as her booster dose on 05-NOV-2015. No adverse effects were reported. 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 licensed practical nurse concerning a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose VARIVAX (lot # L013063, expiration date 14-APR-2015 or lot # L026408, expiration date 15-JUL-2015) (dose and route were unspecified). Concomitant therapy was not reported. No adverse effect was informed. This is one of two reports received from the same source. Additional information has ben requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, Injection site pain
Clinical narrative: This initial spontaneous report was received from a 48 year old male consumer reporting on himself. The patient's concurrent conditions included psoriatic arthritis. History or drug allergies/drug reactions and medical history were not provided. On 17-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # K005402 with expiration date 07-NOV-2015; dose and route were not provided) as he would soon be on medication that could compromise his immune system. Concomitant therapies included meloxicam (manufacturer unknown). After the PNEUMOVAX23 injection, an unspecified pharmacist who administered the injection noticed that it was expired on 07-NOV-2015. The patient also reported on 17-NOV-2015 tenderness at the injection site (injection site pain). The patient sought medical attention (called the physician). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site pain was unknown. The relatedness between the vent to PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Back pain, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a physician of unknown age and gender, concerning themselves. On an unknown date, the patient was vaccinated with PNEUMOVAX23. On an unknown date the patient experienced injection site reaction after PNEUMOVAX23 and reported that it gave them a "very sore arm and spread across upper back to other upper arm for 36 hours". The outcome of the events was unknown. The reporter considered sore arms and upper back to be related to PNEUMOVAX23. Relatedness for the injection site reaction was not specified. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old (also reported as 25 year old) female patient who was anemic. The patient had no known drug allergies (NKDA). The patient's medical history included anxiety, bipolar disorder, substance abuse and hepatitis C. The patient was not ill at the time of vaccination. On an unknown date, the patient received a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 08-AUG-2015 at 17:28, the patient was vaccinated with an expired dose of GARDASIL (second dose, intramuscularly (IM) in the left arm, lot # H020002 with expiry date: 08-AUG-2015). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L008054, expiration date 30-NOV-2016; lot # K011947, expiration date 07-JUN-2016 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter stated that the physician could not be contacted.
Age: 5.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 10-NOV-2015, the patient inadvertently received concomitant doses (unspecified in series) of M-M-R II, subcutaneously injection, 0.5ml, lot # L009212 and expiration date 17-MAR-2017 and PROQUAD (Merck), subcutaneously injection, 0.5ml, lot # L008353 and expiration date 11-SEP-2016. There were no concomitant medications reported. The patient did not seek medical attention. 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 medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L013429, expiration date 21-JUL-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter stated that the physician could not be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose and route were unknown) lot # K004483 with expiration date 26-FEB-2016. No concomitant therapy was provided. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with no drug reactions nor allergies. The patient's concurrent conditions included diabetes mellitus. On 10-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L024997, expiration date 06-OCT-2016, 0.65 ml, subcutaneously in left arm. Concomitant therapies included JANUVIA, glipizide and metformin. In November 2015 (reported as on or after 10-NOV-2015), the patient experienced redness and warmth in a radius of "about the size of a half-dollar" around the injection site on her left arm. The patient also developed an area of bruising "about two inches below" the injection site. The patient visited pharmacist. No lab diagnostics studies were performed and no treatment was given for the adverse events. The outcome of events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to multiple unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored ROTATEQ (L022446 and expiry date 14-FEB-2017, L008577, expiry date: 02-DEC-2016) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse refers to multiple, unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored VAQTA (Lot # L028666 and expiry date: 04-NOV-2016, lot # L018499 expiry date: 25-FEB-2017, lot # L002717 and expiry date 02-JUN-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacist, who refers to a patient of unknown age. Concurrent condition and medical history were not provided. On 15-NOV-2015, the patient was vaccinated with M-M-R II that was reconstituted with an unspecified diluent (expiration date, lot #, dose, route of administration were not provided). Co-suspect therapies and concomitant therapies were not provided. No adverse events were reported. The reporter refers that product quality complaints were not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the health care worker refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 10-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23, lot# L013248, expire date 03-FEB-2017, (dose number, frequency, route not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the health care worker refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 10-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23, lot# L013428, expire date 03-FEB-2017, (dose number, frequency, route not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Pharmacist reported than an unspecified patient, who received all 3 doses series of the GARDASIL (route and site of administration, dose, lot# and expiration date were not reported) on unspecified dates in either 2012 or 2013, received 2 more doses of either GARDASIL or GARDASIL 9 (route and site of administration, dose, lot# and expiration date were not reported) on unspecified dates in 2015. Pharmacist could not confirm which vaccine the patient received for doses 4 and 5. There was no adverse effect reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 56 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not specified. The pharmacist reported that, on 10-NOV-2015, the patient was vaccinated with ZOSTAVAX, intramuscularly in the right deltoid instead of subcutaneously (dose, strength, dose number, # lot, expiry date unspecified). But the pharmacist was not sure. Following the administration, the patient experienced an inch and a half in diameter raised, redness, painful, hot area around the injection site on an unspecified date (approximately in 2015). Rash was not reported. The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of LIQUID PEDVAXHIB (lot # L006546 with expiration 27-NOV-2017: dose, frequency and route were not reported) (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been unspecified.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported, lot # K025760 with expiration date: 08-JUN-2016). No adverse event was reported. This is one of the several reports received from the same source. Additional information has been requested.