chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Rash papular, Skin warm
Clinical narrative: Large red , hot, raised rash over entire upper arm, shoulder to elbow, front to back.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash, Sciatica
Clinical narrative: On 8/22 I called my doctor with intense hip and leg pain the night before and was concerned about a possible DVT because of a previous history.  I went to Hospital Emergency Dept and had ultrasound of left leg which was negative for clots and was sent home.   I spoke to doctor's office on 8/23 and was put on 50 mg prednisone decreasing dose by 5mg each day for sciatica.  On 8/27 I saw Dr. and was diagnosed with shingles rash on my lower left leg. I understand that this vaccine is not a live virus and therefore I  cannot contract shingles from the vaccine but I find it hard to understand the onset being so close to receiving the vaccine.  As a note, I did receive the Zoster vaccine for shingles on 9/30/2013. If this is all a coincidence, I guess I will have to accept that, but I think you should be notified.  Getting the second part of this vaccine is a very scary thought right now.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan normal
Clinical narrative: On 8/22 I called my doctor with intense hip and leg pain the night before and was concerned about a possible DVT because of a previous history.  I went to Hospital Emergency Dept and had ultrasound of left leg which was negative for clots and was sent home.   I spoke to doctor's office on 8/23 and was put on 50 mg prednisone decreasing dose by 5mg each day for sciatica.  On 8/27 I saw Dr. and was diagnosed with shingles rash on my lower left leg. I understand that this vaccine is not a live virus and therefore I  cannot contract shingles from the vaccine but I find it hard to understand the onset being so close to receiving the vaccine.  As a note, I did receive the Zoster vaccine for shingles on 9/30/2013. If this is all a coincidence, I guess I will have to accept that, but I think you should be notified.  Getting the second part of this vaccine is a very scary thought right now.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: swollen injection site with warmness around the area but no pain
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Mobility decreased, Neck pain, Spinal pain
Clinical narrative: Tuesday on 9/8,  had painful joints, pain in the neck /skull area up and down to the spine and the cranial area.  Could barely move. It gotten worse throughout the night. Next day the pain started to subside. By the afternoon, was able to move around, not great. This morning took Tylenol and is now feeling fine, pretty much back to normal.
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Pustule, Pyrexia, Rash, Urticaria
Clinical narrative: Pt stated that she developed pustules, itching, rash/hives all over her body (especially down the arms and including the face). She stated she also had a fever. These side effects began three days after receiving the vaccines (shingrix and fluzoneHD). She treated the reaction with Benadryl and cool baths and limited the amount of clothing over the affected areas.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: LINGERING HEADACHE, FEVER 100 TEMP, STIFF NECK SINCE DAY AFTER DOSE. PATIENT IS TAKING ADVIL FOR HEADACHE AND NECK STIFFNESS. LOW GRADE FEVER IS STILL PERSISTING
Age: 50.0
Sex: F
Vaccine: FLU4, HEPA, MMR, TD
Symptoms: Altered state of consciousness, Discomfort, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: Monitored client for 15 minutes after vaccination administration.  Client reported she was feeling well.  No adverse reactions noted.  She was released back to her job duties.  Client called front desk receptionist at approximately 11:15 AM.  She stated that she was feeling dizzy, weird, and not ?feeling right?  Front desk receptionist informed me of client?s status.  I went to assess client and she was laying back.  She stated that she felt like she was going to pass out.  I had her put her head in-between her legs with a cool rag behind her neck.  The overhead lights were turned off and the room dimmed.  She stated that she started to feel better but felt pressure in her head, her nose, and tingling in her ears.  She stated that she had breakfast but had not taken her blood pressure pills.  Wheat Thins and water given to her.  She tolerated it well.  At 11:25 her blood pressure was obtained and was 163/98.  She took her prescribed 20 mg Lisinopril and 1000mg of Tylenol.  Continued monitoring client and reassessed blood pressure at 11:40 AM and was 151/88.  Client ambulated with assistance back to clinic.  She was advised to lay down with lights off.  Client rested for approximately 35 minutes, ambulated to restroom and back to room.  Blood pressure reassessed and was 195/91.  Client education given on the risks for heart disease and other complications due to extremely high blood pressure.  Client was immediately referred to her PCP for follow-up. Client verbalized understanding and said she would have another employee follow her to her PCP. It was reiterated again the importance of going immediately, to ask for a cardiac referral because of extensive family history of heart disease. She was also advised to ask her PCP about her current blood pressure medication; however, she explained that her ?PCP had just recently changed her blood pressure medication about 2 weeks ago?. Client was able to ambulate back to her desk to pick up her belongings and left the building with another employee accompanying her. A follow-up phone call was made at 1502 and client stated that ?she went to her doctor, and they made a referral for a cardiologist, they gave me a shot to help lower my blood pressure and it helped?. She was asked about her blood pressure at her PCP, she stated ?the top number was 172, and after the shot was given the top number was 153. Client stated she was feeling better and was resting. A follow-up call will be made 9/11/2020 to check on her status.
Age: 50.0
Sex: F
Vaccine: FLU4, HEPA, MMR, TD
Symptoms: Hypertension, Paraesthesia
Clinical narrative: Monitored client for 15 minutes after vaccination administration.  Client reported she was feeling well.  No adverse reactions noted.  She was released back to her job duties.  Client called front desk receptionist at approximately 11:15 AM.  She stated that she was feeling dizzy, weird, and not ?feeling right?  Front desk receptionist informed me of client?s status.  I went to assess client and she was laying back.  She stated that she felt like she was going to pass out.  I had her put her head in-between her legs with a cool rag behind her neck.  The overhead lights were turned off and the room dimmed.  She stated that she started to feel better but felt pressure in her head, her nose, and tingling in her ears.  She stated that she had breakfast but had not taken her blood pressure pills.  Wheat Thins and water given to her.  She tolerated it well.  At 11:25 her blood pressure was obtained and was 163/98.  She took her prescribed 20 mg Lisinopril and 1000mg of Tylenol.  Continued monitoring client and reassessed blood pressure at 11:40 AM and was 151/88.  Client ambulated with assistance back to clinic.  She was advised to lay down with lights off.  Client rested for approximately 35 minutes, ambulated to restroom and back to room.  Blood pressure reassessed and was 195/91.  Client education given on the risks for heart disease and other complications due to extremely high blood pressure.  Client was immediately referred to her PCP for follow-up. Client verbalized understanding and said she would have another employee follow her to her PCP. It was reiterated again the importance of going immediately, to ask for a cardiac referral because of extensive family history of heart disease. She was also advised to ask her PCP about her current blood pressure medication; however, she explained that her ?PCP had just recently changed her blood pressure medication about 2 weeks ago?. Client was able to ambulate back to her desk to pick up her belongings and left the building with another employee accompanying her. A follow-up phone call was made at 1502 and client stated that ?she went to her doctor, and they made a referral for a cardiologist, they gave me a shot to help lower my blood pressure and it helped?. She was asked about her blood pressure at her PCP, she stated ?the top number was 172, and after the shot was given the top number was 153. Client stated she was feeling better and was resting. A follow-up call will be made 9/11/2020 to check on her status.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: RED, SWOLLEN (ABOVE ELBOW), SORE, HEADACHE FOR TWO DAYS
Age: 75.0
Sex: F
Vaccine: FLUA4, FLUX
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Ms. was received a Flu Vaccine at Pharmacy this morning (9/10/2020) and mistakenly given another Flu Vaccine this afternoon at Store. At the time she left the pharmacy, she did not show any side effect. She is supposed to receive Pneumovax 23
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient reported vomiting that she believes is connected to vaccine as it began several hours after administration and persisted for several hours.  Did not identify any other changes in day that would contribute to the start of emesis. Directed patient to eat bland foods, try small sips of water/ginger ale or other home treatments and to seek medical help in the morning if it has not resolved or worsens.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Intense shivering
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: patient reported cellulitis on injection sites after immunization
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient reported to pharmacy on 9/5/20, 2 days post-vaccination.  Presented with symptoms in left upper arm, but lower than where the vaccination was administered.  He experienced warmth, redness, and a rough edge in one area where affected skin met normal skin.  He reported symptoms started about 8 hours post-vaccination. Follow-up on 9/10/20, patient reported no worsening of symptoms after visiting the pharmacy, and symptoms have now resolved.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Headache, Respiratory tract congestion, Rhinorrhoea, Skin irritation
Clinical narrative: Headache, followed by congestion build up and runny nose, tightness of chest, and irritation in skin of face though not visible.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Haematochezia, Occult blood
Clinical narrative: Blood in stool within 1-2 hours of vaccination, 5 episodes total, last episode was 2 days ago.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site swelling
Clinical narrative: Headache, swelling of shot, low fever, chills, muscle pain in entire arm and neck area, tiredness, nausea, stomach pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, swelling of shot, low fever, chills, muscle pain in entire arm and neck area, tiredness, nausea, stomach pain.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Ear pruritus, Eye swelling
Clinical narrative: ITCHY RIGHT EAR, SWELLING UNDER RIGHT EYE
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: Extremely black and blue and red spread down arm swollen
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Within 25 minutes of administration of vaccine, patient's mother brought the patient back to the pharmacy to alert the pharmacist that he was experiencing an allergic reaction. Patient experienced swelling of his lower lip, denies itching, hives,  and shortness of breath.  Patient was administered diphenhydramine 50 mg under supervision of the pharmacist and counseled the mother to continue to watch for symptoms of anaphylaxis and follow up PCP if any changes occurred.
Age: 51.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt experienced redness, hot, swelling at injection site the day following injection. pt sought treatment the following day and was prescribed an antibiotic and an antihistamine
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Presyncope
Clinical narrative: vasovagal response. Did not faint.
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Cardiac failure, Death, Tremor, Vomiting
Clinical narrative: Shaking, vomiting, heart failure, death
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Local reaction, Peripheral swelling
Clinical narrative: Symptoms started 2 days after injection. Reaction was initially itching at area of injection. After child itched area, arm had a localized reaction involving extreme swelling of injected arm, extending down to the elbow and up around site of administration. Wrapped around front of arm but did not wrap all the way around arm.  Reaction lasted approximately 2 to 2.5 days and then resolved. Patient is now doing well at time of reporting to pharmacist.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Migraine, Pain in jaw
Clinical narrative: immediate jaw pain that turned into a migraine
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: patient reported pain in the shoulder of left arm that began the evening of receiving flu vaccine, raditating shoulder pain prevented her from sitting in her recliner comfortably or applying deodorant. movement is restricted in the arm.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT REPORTS HAVING A FEVER FOR 4 DAYS AFTER INJECTION
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events/outcomes - pt was 61 and received a high-dose flu shot (only recommended in 65 and older) instead of a regular flu shot
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: The patient stated that a few days after she received the immunization her arm became very swollen and was treated for cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: gave patient vaccine, two days later patient calls reporting she has hives and swelling on her face and lips, patient was not having trouble breathing, she stated she takes multiple antihistamines on a regular basis, counseled her to continue taking  those medications and if at any time it became difficult to breathe to go to the ER.  Patient stated this was not unusual for her, she frequently breaks out in hives therefore the reason for the antihistamines.  I followed up with the patient the next day and she was doing much better and did not have to go to the ER.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient arm was swollen and slightly warm to touch.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cough, Dyspnoea, Swelling face
Clinical narrative: Started with cough, progressed to face swelling and trouble breathing.  patient was transported by ambulance to the hospital around 6:00pm  on 9/5/2020.
Age: 70.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Really swollen red and itchy at injection site, swollen and red spread throughout her upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: At injection site there is a red area that is warm to the touch and sore for the patient. The redness is not itchy at all and there are no visible hives.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Patient states his arm was sore and tender at shoulder above injection site for up to 7 months post injection to the point where he couldn't sleep on his left side.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh - following flu vaccine (unknown what specific flu vaccine was used as vaccine was not administered at our site)
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: patient had arm swelling and soreness, she said she could barely move her arm
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Pain
Clinical narrative: Extreme pain and fussiness
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted about 5 minutes after the vaccine was administered.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling cold, Somnolence
Clinical narrative: Pt came back approximately 30 minutes later saying that she was very cold & feeling sleepy, but otherwise ok. Approximately an hour later patient stated no change. Still cold & sleepy.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Axillary pain, C-reactive protein increased, Chest X-ray abnormal, Full blood count, Lung infiltration
Clinical narrative: 8/19 rt axillary pain, went to gymnastics practice for 3 1/2 hrs, no upper body work out, took alieve 200 mg after due to continued soreness, 8/20 progressive rt axilla and chest wall swelling and pain, not better with warm compresses, ibuprofen 200 mg,  worse 8/21, no fever, no redness, no other sx's, injection site nl, seen by me on 8/21, referred to ER for further evaluation by Dr.,  dx  localized swelling chest wall, possible lymphadenitis, rx clindamycin 300 mg tid x 10 days,  pain and swelling  improved after 3 doses when seen by me on 8/24, all sx's resolved by 8th day of antibx per parent report, did not return for recheck visit,
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Metabolic function test, Musculoskeletal chest pain, Swelling, Ultrasound chest
Clinical narrative: 8/19 rt axillary pain, went to gymnastics practice for 3 1/2 hrs, no upper body work out, took alieve 200 mg after due to continued soreness, 8/20 progressive rt axilla and chest wall swelling and pain, not better with warm compresses, ibuprofen 200 mg,  worse 8/21, no fever, no redness, no other sx's, injection site nl, seen by me on 8/21, referred to ER for further evaluation by Dr.,  dx  localized swelling chest wall, possible lymphadenitis, rx clindamycin 300 mg tid x 10 days,  pain and swelling  improved after 3 doses when seen by me on 8/24, all sx's resolved by 8th day of antibx per parent report, did not return for recheck visit,
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood alcohol, Computerised tomogram pancreas abnormal, Lipase increased, Oedematous pancreatitis
Clinical narrative: Admitted to hospital on 11/29/2019 with symptoms of abdominal pain. Diagnosed with acute pancreatitis. No previous episodes. Drinks 2 units a day. Treated with IV fluids, analgesics.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pancreatitis acute
Clinical narrative: Admitted to hospital on 11/29/2019 with symptoms of abdominal pain. Diagnosed with acute pancreatitis. No previous episodes. Drinks 2 units a day. Treated with IV fluids, analgesics.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Vaccination complication
Clinical narrative: Develop varicella reaction almost 2 months after vaccine on torso
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: syncope event; lost consciousness for four to five seconds; hit his head; This spontaneous report was received from a healthcare professional via Food and Drug Administration (FDA) referring to a 12 years old male patient. The patient's medical history and concomitant therapies were not provided. The patient had no allergy and no chronic or long-standing health conditions.  On 08-JUL-2019, at 09:30, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1602281, expiration date not reported, but upon internal validation established as 21-JUL-2021; strength and dose detail were not provided) intramuscularly in the right arm for prophylaxis. On the same day, the patient also received the second dose of hepatitis a virus vaccine inactivated (HAVRIX) (lot# PA99T, intramuscular route), the first dose of meningococcal acyw conj vaccine (crm197) (MENVEO) (lot# AMVA113A, intramuscular route in the right arm) and the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R030605, expiration date not reported, but upon internal validation established as 23-OCT-2020, subcutaneous route in the left arm; strength and dose detail were not provided).      On 08-JUL-2019, at 09:34 (4 minutes after vaccine administration), the patient had a syncope event. The patient was standing during the syncope event. He fell to the floor and hit his head. The patient lost consciousness for four to five seconds. The patient became responsive and able to answer question. 911 call was ordered. The patient visited doctor or other healthcare professional office, and went to emergency room. The patient was released on the same day with instruction to follow up with pediatrician. The patient was seen on 16-JUL-2019 and was ordered an encephalogram. The outcome of syncope, loss of consciousness and hit head was reported as recovered.     The causality between the events and the suspect products was not provided.  As of 08-SEP-2020, additional information is not expected as the nurse cannot identify the patient based upon the adverse experience form  information. No further information is available. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, UNK
Symptoms: Nausea, Vomiting
Clinical narrative: became nauseated and vomited; became nauseated and vomited; Information has been received from the Health Agency (# 826592-1) on 19-AUG-2020.  This spontaneous report as received from a health professional and refers to an 18 year old female patient. The patient's concurrent conditions included headache, normal allergies runny nose and congestion from hay fever. The patient's concomitant therapies included ibuprofen. The patient's medical history, historical drugs, previous drug reactions, and were not reported.   On 26-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot No. R025730 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 18-JUN-2021;  intramuscular route in the right arm for prophylaxis.  On the same day, she was vaccinated with the first dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) lot number ABX766AA intramuscular in the left arm, the first dose of hepatitis a virus vaccine inactivated (HAVRIX) lot number J35P9, intramuscular in the right arm and with the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot number U6219BA, intramuscular in the right arm.  On 31-JUL-2019 (reported as: las evening), the patient became nauseated and vomited after eating chicken soup. The mother stated she had been feeling well other than her normal. Headaches that she had routinely. Had normal allergies, runny nose and congestion from hay fever. At the reporting time, the outcome of nausea and vomiting was reported as recovered. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.  Follow-up information was received from the health professional on 08-SEP-2020.  The reporter was unable to provide any additional information regarding this case due to patient demographics being unavailable. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R025730; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test, Chills, Confusional state, Disorientation, Dizziness
Clinical narrative: Confused; disoriented; was not making sense; Tonic-clonic seizures; vomited; feeling dizzy, lightheaded and thought she might pass out; chills; somnolence/ she would not wake up; had a migraine; she was unresponsive, the doctors could not perform a neuro exam because she would not wake up; Information has been received from FDA (# 829612) on 18-AUG-2020.  This spontaneous report was received from a consumer, the patient's mother referring to a 11-year-old female patient. The patient had no prescriptions, over-the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products or no other illnesses at the time of vaccination and up to one month prior. The patient was a healthy, well and athletic child. The patient was not pregnant.  On 09-AUG-2019 at 15:45, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R009615 with expiration date not reported, but upon internal validation established as 12-JUL-2020; dose and frequency were not reported) intramuscularly (IM) in the right arm, diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid(BOOSTRIX) (lot# K9DX5; dose, frequency and expiration date were not reported) intramuscularly (IM) in the left arm and meningococcal acyw conj vaccine (crm197)(MENVEO) (lot# AMVA121; dose, frequency and expiration date were not reported) intramuscularly (IM) in the right arm, all for prophylaxis.       On 10-AUG-2019 at 14:30 (reported as less than 24 hours after receiving the vaccines), the patient complained of feeling dizzy, lightheaded and thought she might pass out. About 20 minutes later, she had a tonic-clonic seizure for about 30-45 seconds. Afterward, she was very confused, disoriented and was not making sense. She also vomited several times. On the same day, the patient was taken to a hospital by ambulance. During the post-ictal period, she was unresponsive, had a migraine with vomiting, chills (no fever), somnolence and the doctors could not perform a neuro exam because she would not wake up. The patient was admitted overnight. The patient was hospitalized for 1 day. Medical tests and laboratory results included blood work and electroencephalogram (EEG) and the results were not reported. The patient would have a magnetic resonance imaging (MRI) on an unknown date in August 2019 (reported as next week).  The patient visited emergency room/department or urgent care and doctor or other healthcare professional office/clinic for the events. The outcome of all events was reported as unknown.   The causality assessments between suspect vaccines and all events were not provided.  According to the reporter and Agency, all events were determined to be life-threatening.  Follow-up information has been received from an office staff on 09-SEP-2020 via a telephone call. Due to no patient identifiers, the office was unable to fill out the forms. Additional information was not expected.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: Confused; disoriented; was not making sense; Tonic-clonic seizures; vomited; feeling dizzy, lightheaded and thought she might pass out; chills; somnolence/ she would not wake up; had a migraine; she was unresponsive, the doctors could not perform a neuro exam because she would not wake up; Information has been received from FDA (# 829612) on 18-AUG-2020.  This spontaneous report was received from a consumer, the patient's mother referring to a 11-year-old female patient. The patient had no prescriptions, over-the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products or no other illnesses at the time of vaccination and up to one month prior. The patient was a healthy, well and athletic child. The patient was not pregnant.  On 09-AUG-2019 at 15:45, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R009615 with expiration date not reported, but upon internal validation established as 12-JUL-2020; dose and frequency were not reported) intramuscularly (IM) in the right arm, diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid(BOOSTRIX) (lot# K9DX5; dose, frequency and expiration date were not reported) intramuscularly (IM) in the left arm and meningococcal acyw conj vaccine (crm197)(MENVEO) (lot# AMVA121; dose, frequency and expiration date were not reported) intramuscularly (IM) in the right arm, all for prophylaxis.       On 10-AUG-2019 at 14:30 (reported as less than 24 hours after receiving the vaccines), the patient complained of feeling dizzy, lightheaded and thought she might pass out. About 20 minutes later, she had a tonic-clonic seizure for about 30-45 seconds. Afterward, she was very confused, disoriented and was not making sense. She also vomited several times. On the same day, the patient was taken to a hospital by ambulance. During the post-ictal period, she was unresponsive, had a migraine with vomiting, chills (no fever), somnolence and the doctors could not perform a neuro exam because she would not wake up. The patient was admitted overnight. The patient was hospitalized for 1 day. Medical tests and laboratory results included blood work and electroencephalogram (EEG) and the results were not reported. The patient would have a magnetic resonance imaging (MRI) on an unknown date in August 2019 (reported as next week).  The patient visited emergency room/department or urgent care and doctor or other healthcare professional office/clinic for the events. The outcome of all events was reported as unknown.   The causality assessments between suspect vaccines and all events were not provided.  According to the reporter and Agency, all events were determined to be life-threatening.  Follow-up information has been received from an office staff on 09-SEP-2020 via a telephone call. Due to no patient identifiers, the office was unable to fill out the forms. Additional information was not expected.
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood parathyroid hormone normal, Blood thyroid stimulating hormone normal, Dysphonia, Feeling of body temperature change, Full blood count normal
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177680:same patient
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Metabolic function test normal, Nausea, Pruritus
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177680:same patient
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free normal
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177680:same patient
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphagia, Dysphonia, Dyspnoea, Headache
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177680:same patient
Age: 92.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were recovered/resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The reporter consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177680:same patient
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient reported upper arm near site of injection was swollen and painful. Pt also states feeling a bit of nausea
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Swelling
Clinical narrative: -REDNESS AND SWELLING ON INSIDE APPROXIMATELY 2 -3 INCHES ABOVE ELBOW. -EXTREME FATIGUE. -REPORED 24 HOURS AFTER VACCINATION.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Death, Pyrexia, Seizure like phenomena
Clinical narrative: My son passed away the same night he received the shot and the pediatrician claims they have no record of him even being at the drs that day nor did they have the shot they gave him in there records. That day he received his shots he was having seizure like symptoms and he was also running a fever.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram abnormal, Seizure
Clinical narrative: Seizures she on medication now
Age: 32.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Chest pain
Clinical narrative: Pt presents to the clinic approximately 5 hours post vaccination with complaint of chest pain. Pt rated pain at a 5 on a 0-10 scale. Diagnostic studies and treatment in progress now.
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash on shoulders, chest and sides. Rash reminds me of poison oak. This vaccine is purified rabies vaccine (Vero cell) SPEEDA.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: That night after vaccine, nasal congestion. Now, following day 9/10/2020 11pm, mild fever with nasal congestion.
Age: 32.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Limb discomfort, Pain, Pain in extremity
Clinical narrative: After the nurse gave me the shot, my arm was immediately very sore. I told her this and she replied stating something along the lines of "yeah, that can happen with this one." As I drove home, it was difficult to keep my arm propped onto the steering wheel due to the pain, so I decided to just drive with my right hand. When I got home, I expressed my discomfort to my wife. I would rotate my arm in circles to try and circulate the blood and hopefully help the pain go away. It hurt very bad to lift my arm, especially above shoulder height. I was nervous because I was scheduled to work my warehouse job the next day and wasn't sure I would be able to complete my work properly. The next morning, my arm was still very sore but I decided to go to work anyway and thought moving it around more and using it would help. I limited my use of my left arm, but it was still very sore throughout the day. This pain lasted for about 5 days before it started to subside slightly. It would still be very painful to lift my arm over shoulder height. After another week, it got to the point where I could lift my arm over my shoulder without any initial sharp pain, but if I lifted it up or moved it around a certain way there would be a very uncomfortable deep tissue pinching type sensation, almost like my muscles were catching onto each other. This sensation has slowly faded, but I still have hints of it to this day.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: Initial soreness at injection site, shivering, chills, fever, sweats, muscle and joint aches managed with Ibuprofen and Acetaminophen. Residual symptoms resolved after ~3 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Initial soreness at injection site, shivering, chills, fever, sweats, muscle and joint aches managed with Ibuprofen and Acetaminophen. Residual symptoms resolved after ~3 days.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a dose of PROQUAD which expired on 8/8/2020; This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided.  On 12-AUG-2020, a dose of expired measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) (lot S003864 and expiration date: 08-AUG-2020; strength, route, anatomical location were not reported) was administered to the patient for prophylaxis (expired product administered). This was supported as per stability memo. The outcome was not provided. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller stated that on 8/19/2020, the patient was administered improperly stored VARlVAX; This spontaneous report was received from a registered nurse, referring to a 4-year-old female patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 19-AUG-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error). As concomitant therapy, a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number S008566, which has been verified to be valid, expiration date reported and validated as 16-NOV-2021) was used to reconstitute the vaccine (medication dilution). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) to -10C (-12.1C) for a time frame of 3 hours, and from -9C to 8C (-7.5C) for 8 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA004106:
Age: 67.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Extra dose administered
Clinical narrative: PNEUMOV AX 23 was administered to patient while patient received a prior dose a month ago; PNEUMOV AX 23 was administered to patient while patient received a prior dose a month ago. The error occurred during dispensing; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis, an the next dose of the mentioned vaccine, was administered approximately after month ago (date unspecified). No further information was provided.         This is a non valid report as patient's identifiers were not provided.  Follow up information has been received on 08-SEP-2020 from a registered pharmacist referring to a 67 year old female patient.  On 28-JUL-2020 ( reported as "prior dose a month ago"), the patient was vaccinate with a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose information, route of administration, lot # and expiration date were not reported) for prophylaxis. On 27-AUG-2020, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscularly, lot # S029916, expiration date not reported but upon internal validation established as 12-JUN-2021 for prophylaxis.  Concomitant therapies included zoster rge vaccine (mammalian)(SHINGRIX), influenza virus sag 4v vaccine inactivated(FLUAD QUADRIVALENT) and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX) administered on the same date. The medication error ouccurred during dispensing.  This case was previously considered non-valid, but upon receipt of follow-up patient's identifiers were provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability