chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 7/31 - Immunizations given at 1447 8/1 - Fever - Tylenol given 8/2 - Left deltoid swollen, red and hot - 2230, contacted after hours Peds line - instructed to go to ER. Went to ER - given steroid injection, tylenol and benadryl, sent home with ATB- cephalexin 8/3 - Seen at PCP - only slight pink area noted on left deltoid, very slightly warm to touch, denies tenderness with palpation, itching or pain. No swelling or knots noted. Instructed to observe and monitor.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PT PRESENTED TO THE PHARMACY ON 08/04/2020 STATING SHE WAS EXPERIENCING SIDE EFFECTS FROM RECEIVING SHINGRIX VACCINE IN RIGHT ARM ON 07/31/2020. PT REPORTED SIDE EFFECTS SYMPTOMS STARTED SECOND DAY AFTER RECEIVING THE VACCINE AND INCREASING WORSEN.  PT STATED HER ARM HURT AND WAS HOT TO TOUCH.  HER ARM DID APPEAR TO BE RED AND SWOLLEN. PT TOOK IBUPROFEN TO HELP WITH THE PAIN.  I RECOMMENDED THE PT CONTINUES TO TAKE IBUPROFEN AND ADD BENADRYL DUE TO AFFECTED AREA STARTING TO ITCH. PT TOLD THIS CAN OCCUR AND WILL REPORT HER SIDE EFFECTS.  I WILL FOLLOW UP WITH PT ON THURSDAY, 08/06/2020.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: 2nd dose of Shingrix was given on 6/16/20.  Patient noted a rash on her stomach and buttocks that began on Thursday 6/18/20. Patient did not complain of itching.  Patient called to pharmacy to report incident and was suggested to take an antihistamine and to follow up with her primary MD.  Her primary MD also recommended and antihistamine and to follow up later in the week.  The patient took both Zyrtec and Benadryl with little relief. She followed up with a Dermatologist who prescribed and prednisone taper which did give her a successful outcome.  Patient reported that the MD stated that is was not a shingles outbreak but an actual allergic reaction
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Vomiting
Clinical narrative: Patient became lightheaded, weak and clammy following the administration of all three immunizations. I laid her back on the exam table and put her bent her knees up. Water given and cool cloths applied to head and neck. Father brought into exam room. Sat patient up in a reclined position on exam room table. She did have one episode of emesis. Monitored patient for 20 minutes and allowed her to rest. Fan placed near patient to create a breeze. Patient and father informed me she has had a similar event in the past. Patient had not eaten anything yet for the day. Once patient was feeling better she was sent home with father to continue to monitor and to get something to eat. Patient was walking freely and conversing.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Ear discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 10 minutes after vaccine injection the left side of my face started feeling numb and tingly, started near jaw line, left side of my mouth, radiated up toward left cheek.  A few minutes later my left eye felt weird, then I could feel something not normal in my left ear.   This whole episode lasted approximately 1 1/2  to 2  hours, with decreasing symptoms as time went on.     No treatment was given, I was quite scared and tried to rest and relax in my vehicle in the clinic parking lot for about 30 minutes.   Since the symptoms did not worsen I left and kept monitoring and being aware.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt slumped down to the ground about 10-15 minutes after injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles on my face
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: patient developed fever yesterday 8/3 which went up to 103.6. Was told to treat fever with tylenol or motrin
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm pain, swelling, itching. Arm was swollen, red and hot to the touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea, Somnolence
Clinical narrative: Ache injection site 4 days Extreme sleepiness 24 hours Nausea 48hr Chills 12hr
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hot flush, Visual impairment
Clinical narrative: within couple of minutes of getting flu shot: Hot flashes, Dizziness, Vision blacking out for a second while standing up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen and red from bicep to pit of the elbow and extremely itchy.  Very sore to use but with full range of mobility.
Age: 1.08
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Child was accidently given a MCV4 vaccine instead of a Hep A shot
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was administered to this patient. Vaccine expired 07/31/2020 vaccine was given today 8/4/2020 Ma noticed after she had administered vaccine when she was documenting.  No symptom or signs of a adverse event after the vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever of 99.7 degrees, headache, body aches
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema of eyelid, Rash
Clinical narrative: within 5 min after administration of vaccine, around pt eyes became red around eye lid, rash developed over body,
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives all over entire body - Cetirizine administered
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: patient called on phone saying she had a golf ball size swelling at injection site after going on a walk this morning
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Dizziness, Lethargy, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: She got dizzy, then passed out. Non responsive for over 2 minutes. Once she was responsive she was hysterical, still dizzy.  She was given water and candy after she could sit up. The rest of the day she acted like a concussion victim, lethargic and quiet.  It took 10 hours, tylenol,  and a long nap to get any pep out of her.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Skin warm
Clinical narrative: Patient stated she felt warmth at the site of injection extending downwards toward her forearm a few hours after injection with no fever, chills, difficulty breathing, hives. What she described was just localized erythema. 24 hour pharmacy instructed her to take ibuprofen and ice pain/swelling. Next morning around noon, she called our store detailing the same information to me about her arm feeling warm and red and that she had no other symptoms. She went to ER next day (08/04/20) around 2pm and saw NP, who stated she might have cellulitis unrelated to the vaccine and administered IV dose of antibiotics and sent oral keflex to be filled to be taken as treatment. I spoke to NP later that evening to inquire in detail to document. He stated the infection was unrelated to the vaccine administration, and patient had an inflammatory reaction causing localized erythema. Per NP, the cellulitis ensuing was from unknown cause (he stated it could've been from anything since a puncture of any sort in the skin can introduce bacteria at any time) - he mentioned patient should make a full recovery. Doctor and myself called patient to give updates and to have her call us if she develops a fever (she has not developed a high temperature reading or any other symptoms besides the warm/red inflamed arm). NP stated he will have her come by the next day to have a check up. I called patient again around 7pm, which husband stated she was doing okay with just the warm/red swollen right arm. Patient's husband will call for any updates. Furthermore, he wanted me to call mfg to see if there was any incidences of contaminated syringes related to the lot number. Mfg was closed at the time - open 08/05/20 9-5pm, which I will call in the morning.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Nausea, Tinnitus, Vomiting
Clinical narrative: In approximately 10 minutes after the vaccine was administered, Patient indicated that she was feeling warmth (hot flash), ringing in the years, dizzy, and nauseated. She vomited little bit of milky white fluid and wanted to lay down. Initial BP after symptoms began was 90/64 HR was 104, then in 5 minutes the BP went up to 103/91 with HR 109, called 911 immediately when she started having symptoms,  Paramedics came right around the time when I took the second BP reading,  They took over, gave her fluids to bring BP up and gave her Zofran for nausea and took her to ER for further workup.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Within 1 week I had aching and pain going down the same arm and in my left hand that continued for a month.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Fatigue, Swelling, Vomiting
Clinical narrative: Redness, Swelling, Vomiting , fatigue, aggravated chronic lower back pain.  Patient use ice compress for redness and swelling.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site streaking, Pyrexia, Skin warm
Clinical narrative: Right upper arm - deltoid area with erythema and streaking. edema at injection site - fever and warm to touch, tender to palpate clindamycin 150g 1 PO TID/Ibuprofen
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: Right upper arm - deltoid area with erythema and streaking. edema at injection site - fever and warm to touch, tender to palpate clindamycin 150g 1 PO TID/Ibuprofen
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5 days later had swelling, redness + tenderness at the site of injection.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Contusion, Electrocardiogram normal, Face injury, Fall, Loss of consciousness
Clinical narrative: Patient fainted and fell out of chair and struck face on floor. He was unconscious for approximately one minute and sustained a laceration to his nose and mild bruising. He was sent to ER and was examined approximately one hour later. He had an EKG performed which was normal and dermabond was used for laceration on his nose. He was discharged to home.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Skin laceration, Syncope
Clinical narrative: Patient fainted and fell out of chair and struck face on floor. He was unconscious for approximately one minute and sustained a laceration to his nose and mild bruising. He was sent to ER and was examined approximately one hour later. He had an EKG performed which was normal and dermabond was used for laceration on his nose. He was discharged to home.
Age: 23.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: 07/29/2020 205pm client came to me saying she has rash. Rash, small bumps, about half dollar size noted on bil arm pits & elbow bend, and on neck. 1 Zurtec 10mg administered P.O. D.O.N. notified. Monitored client. 300pm clients rash is noted to be diminishing, another zurtec 1-mg PO given. Con't to  monitored client. 07/29/2020 300pm D.O.N. made aware of clients situation. 325pm client now C/O "throat swelling". D.O.N. made aware of situation. Client is in no respiratory distress, no wheezing etc. Sipping ice water without difficulty, swallows without problems. D.O.N. took over care of client. LVN.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right arm were sobcanteous inj was given was swollen, red, itching
Age: 27.0
Sex: M
Vaccine: ANTH, HPV9, MNQ, TYP, YF
Symptoms: Dyspnoea, Headache, Nausea, Neck pain, Pain
Clinical narrative: neck pain; body aches; rash on chest, back, both arms and thighs; lingering headaches; fever; nausea; shortness of breath; Information has been received on request by the Company from FDA (Agency No. 818720) under the act on 12-MAY-2020.   This spontaneous report was received from a healthcare professional concerning a 27-year-old male patient. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and one dose of meningococcal acyw conj vaccine (crm197) (MENVEO). The patient had no known drug allergies (NKDA). Concomitant medications was not reported. This report concerns 1 patient and 1 combination product.  On 21-MAY-2019 at 11:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm, lot # R027577, expiry date was not reported, but upon internal validation established as 23-JUN-2021 (vaccination schedule was not reported). At the same time, the patient was vaccinated with the first dose of anthrax vaccine intramuscularly in the left arm, lot# FAV 623N (expiry date was not reported); the second dose of meningococcal acyw conj vaccine (crm197) (MENVEO) intramuscularly in the right arm, lot# AMVA059A (expiry date was not reported); the first dose of typhoid vaccine intramuscularly in the right arm, lot# P2A881M (expiry date was not reported) and the first dose of yellow fever virus vaccine subcutaneously in the left arm, lot # W1687AB (expiry date was not reported). All the vaccines were administered for prophylaxis.  On 21-MAY-2019 at 20:00, the patient had neck pain, fever, body aches, rash on chest, back, both arms and thighs. On unspecified date in 2019, the symptoms amplified to nausea and shortness of breath. The patient was treated in emergency room (ER) and hospitalized. Meningitis was ruled out. At the reporting time, the patient still had lingering headaches, but other symptoms had subsided as the patient recovered on unspecified date in 2019.  The causal relationship between all events and suspect vaccines was not provided.  As of 31-JUL-2020, all telephone attempts trying to obtain additional information had been unsuccessful. 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.; devicelotnumber: R027577; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; 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: 27.0
Sex: M
Vaccine: ANTH, HPV9, MNQ, TYP, YF
Symptoms: Pyrexia, Rash
Clinical narrative: neck pain; body aches; rash on chest, back, both arms and thighs; lingering headaches; fever; nausea; shortness of breath; Information has been received on request by the Company from FDA (Agency No. 818720) under the act on 12-MAY-2020.   This spontaneous report was received from a healthcare professional concerning a 27-year-old male patient. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and one dose of meningococcal acyw conj vaccine (crm197) (MENVEO). The patient had no known drug allergies (NKDA). Concomitant medications was not reported. This report concerns 1 patient and 1 combination product.  On 21-MAY-2019 at 11:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm, lot # R027577, expiry date was not reported, but upon internal validation established as 23-JUN-2021 (vaccination schedule was not reported). At the same time, the patient was vaccinated with the first dose of anthrax vaccine intramuscularly in the left arm, lot# FAV 623N (expiry date was not reported); the second dose of meningococcal acyw conj vaccine (crm197) (MENVEO) intramuscularly in the right arm, lot# AMVA059A (expiry date was not reported); the first dose of typhoid vaccine intramuscularly in the right arm, lot# P2A881M (expiry date was not reported) and the first dose of yellow fever virus vaccine subcutaneously in the left arm, lot # W1687AB (expiry date was not reported). All the vaccines were administered for prophylaxis.  On 21-MAY-2019 at 20:00, the patient had neck pain, fever, body aches, rash on chest, back, both arms and thighs. On unspecified date in 2019, the symptoms amplified to nausea and shortness of breath. The patient was treated in emergency room (ER) and hospitalized. Meningitis was ruled out. At the reporting time, the patient still had lingering headaches, but other symptoms had subsided as the patient recovered on unspecified date in 2019.  The causal relationship between all events and suspect vaccines was not provided.  As of 31-JUL-2020, all telephone attempts trying to obtain additional information had been unsuccessful. 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.; devicelotnumber: R027577; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; 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: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Nodule, Skin warm, Vaccination site erythema, Vaccination site nodule
Clinical narrative: he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; Information has been received from FDA on 14-JUL-2020.  This spontaneous report was received from a nurse and refers to a 12-year-old male patient. His concurrent condition included asthma and attention deficit hyperactivity disorder (ADHD). Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL) and melatonin. The patient had no allergies to medications, food or other product. There was no information about the patient's medical history provided.  On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not reported). The patient had no issue with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 04-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm for prophylaxis (exact dose, lot number and expiration date were not provided).  On 06-JUN-2019 (reported also as from the day he got the second dose to right now more than 3 weeks later), the patient experienced large reddened knot in his arm that was warm to the touch and was very painful. By the second day, the red knot was as big as a golf ball.  The outcome of the events was not recovered. The reporter considered vaccination site nodule, vaccination site erythema, vaccination site pain and vaccination site warmth to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Follow-up information was received on 03-AUG-2020. On 03-AUG-2020, an inbound call was received and it was reported that the physician's office received a letter and there was some questions about it. The reporter stated the letter "did not give us any information" and that the office could not assist in follow-up without additional patient information. It was also reported that the events listed on the letter were all "normal symptoms after we give the HPV". The reporter stated that she would keep the letter for future reference but would have no information to include on this event. Additional information was not expected. No further information was available.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; he has a large reddened knot In his arm that Is warm to the touch and Is very painful warm to the touch and Is very painful; Information has been received from FDA on 14-JUL-2020.  This spontaneous report was received from a nurse and refers to a 12-year-old male patient. His concurrent condition included asthma and attention deficit hyperactivity disorder (ADHD). Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL) and melatonin. The patient had no allergies to medications, food or other product. There was no information about the patient's medical history provided.  On an unknown date, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not reported). The patient had no issue with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On 04-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm for prophylaxis (exact dose, lot number and expiration date were not provided).  On 06-JUN-2019 (reported also as from the day he got the second dose to right now more than 3 weeks later), the patient experienced large reddened knot in his arm that was warm to the touch and was very painful. By the second day, the red knot was as big as a golf ball.  The outcome of the events was not recovered. The reporter considered vaccination site nodule, vaccination site erythema, vaccination site pain and vaccination site warmth to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Follow-up information was received on 03-AUG-2020. On 03-AUG-2020, an inbound call was received and it was reported that the physician's office received a letter and there was some questions about it. The reporter stated the letter "did not give us any information" and that the office could not assist in follow-up without additional patient information. It was also reported that the events listed on the letter were all "normal symptoms after we give the HPV". The reporter stated that she would keep the letter for future reference but would have no information to include on this event. Additional information was not expected. No further information was available.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: VOMITING; DIZZINESS; fever of 102 F; Information has been received from Food And Drug Administration (Federal agency VARES# 826281) on 14-JUL-2020. This spontaneous report has been received from a registered nurse on 14-JUL-2020 referring to a 12 years old male patient. The patient's concomitant medication, pertinent medical history and known drug allergies were not reported. On 30-JUL-2019 at 15:53, 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 # R021636, expiration not reported, but upon internal validation established as 12-MAY-2021; exact dose was not reported), via intramuscularly in the left arm and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (lot # C562AA, expiration date and exact dose were not reported) via intramuscular in the right arm for prophylaxis.  On 31-JUL-2019 at 5:00, the patient experienced fever of 102.0 (units not provided). On the same date at 8:00 the patient complained of dizziness and vomiting and the patient's grandmother was advised to follow up with child pediatrician or in a emergency room. At the reporting time the outcome of the event was unknown.. The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow up information has been received from a reporter of an unspecified qualification. The patient's demographic details were provided. He did not have any illnesses at the time of the vaccination or any pre-existing physician-diagnosed allergies, illnesses, birth defects and medical conditions.The administration site of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) was reported as left deltoid (previously reported as right arm). The administration site of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was specified as left deltoid (previously reported as left arm). The single use vaccines were administered by health care professional and discarded after use. It was unknown if the patient received any treatment for the events. The events of fever, dizziness and vomiting were considered by the reporter to be related to suspect vaccines and medically significant. 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: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; 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: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient woke the following morning with pain and redness on his left upper arm, as well as severe headache, body aches, chills. Within a few days the symptoms subsided, except his left upper arm had persistent redness, itching and swelling.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pain
Clinical narrative: Patient woke the following morning with pain and redness on his left upper arm, as well as severe headache, body aches, chills. Within a few days the symptoms subsided, except his left upper arm had persistent redness, itching and swelling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Swelling, Tenderness
Clinical narrative: Initially, no reaction until the next day tenderness statrted, the swelling and redness. Very tired.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches and chills.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; a patient was administered improperly stored doses of ROTATEQ and PEDVAX HIB.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 17-JUL-2020, a patient was vaccinated improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (strength, dose and vaccination scheme were not reported, lot number 1660946, which has been verified to be valid, expiration date reported and validated as 10-APR-2020), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, vaccination scheme, route of administration and anatomical location were not reported, lot number S021457, which has been verified to be valid, expiration date reported and validated as 03-MAR-2022), both vaccines were administered as prophylaxis (product storage error). The administered doses of the vaccines experienced a temperature excursion of 48.7 degrees Fahrenheit (F) for 2 hours 30 minutes as recorded by data logger. There was no previous temperature excursion. No additional adverse effects were reported.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event.; patient was inadvertently administered a dose of PNEUMOV AX 23 that was expired.; This spontaneous report has been received from a pharmacist concerning a 71 year old male patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 07-OCT-2019, the patient was inadvertently administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N019838, expiration date 16-FEB-2019) that was expired. The vaccine was administered for prophylaxis (dose, dose number, anatomical location and route of administration were not provided). No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; This spontaneous report was received from a consumer, referring to a 2-year-old male patient. The patient's pertinent medical history and concomitant medication were not reported. His concurrent conditions included penicillin allergy. No laboratory diagnostics or studies were performed.  On 25-OCT-2018, the patient was vaccinated with 1 shot (dose) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection, lot number and expiration date were not reported; route of administration was reported as injection) as prevention of measles, mumps and rubella (prophylaxis).  On 26-OCT-2018, the patient experienced redness and swelling at the injection site (vaccination site erythema and vaccination site swelling). It was reported that ice was given as a treatment for the adverse events and the patient did not seek medical attention. The reporter stated that the patient had not had any additional doses.  Therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was discontinued on 26-OCT-2018. The outcome of the events was reported as recovered. The causal relationship between the aforementioned events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blindness, Cerebrovascular accident, Conjunctival follicles, Dry eye, Eustachian tube dysfunction
Clinical narrative: adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Eyelid margin crusting, Herpes zoster, Lacrimation decreased, Malaise, Nasal congestion
Clinical narrative: adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nasal dryness, Nasal mucosal disorder, Nasal oedema, Nasal septum disorder, Ophthalmic herpes zoster
Clinical narrative: adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pemphigoid, Pemphigus, Pinguecula, Post herpetic neuralgia, Rash vesicular
Clinical narrative: adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Sinusitis, Tension headache, Trigeminal neuralgia, Varicella zoster virus infection, Vitreous detachment
Clinical narrative: adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: on 28-JUL-2020 the patient who is an adult was adminisered a pediatric dose of VAQTA; This spontaneous report has been received from a medical assistant and refers to an adult patient of unknown gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 28-JUL-2020, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) injection 25/0.5 (units not reported), 1 dose (route of administration not reported; lot # S032358, expiration date 11-JAN-2021) as prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 26.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: post HPV vaccine; This spontaneous prospective pregnancy report was received from registered nurse and refers to a 26 year old female patient. The patient had no previous pregnancies and noted medical history. Concomitant therapies were not reported.   The patient's last menstrual period was on 07-DEC-2019 and the patient became pregnant. During the first trimester of pregnancy the patient had anemia.  On 17-JUN-2020, 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 # 1614898 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast, expiration date not reported, but upon internal validation established as 15-NOV-2021  for prophylaxis (dose and route of administration was not reported) (Vaccine exposure during pregnancy). On 06-JUL-2020, due to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  vaccination, an ultrasound conducted by a maternal-fetal medicine (MFM) specialist was performed and  normal fetal growth activity was seen. Estimated date of delivery (EDD) was for 09-SEP-2020. The pregnancy outcome was pending. 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. ; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse call to report that GARDASIL 9 was stored improperly and administered; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature range of 50 degrees Fahrenheit (degrees F) for the time frame of 1 hour and 46 minutes. There was no previous temperature excursion and the call was because of a data logger.  No additional adverse events were reported. 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.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; 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; Sender's Comments:  US-009507513-2008USA000316: US-009507513-2008USA000266: