chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site felt painful right after the injection and the pain  escalated and continued for 2 days and then started falling off.  Cannot sleep on the shoulder as the pain is felt when laying on the side / shoulder.  About 3 hours after the shot started feeling overly tired and achey all over.   During the night developed a head ache and spells of feeling very cold.  The  next morning felt like  I had an alcohol hangover on top of the flu.  Tried to get on with my day.  About noon just couldn't do any more.  Retired to the recliner where I spent the day and evening. Fever went up to 100.3.  Several bouts of chills, upset stomach and constant headache.   60 hours after the shot feel about 70% recovered.  Still cannot go thru a full exercise routine.  Hope to be better tomorrow.                                           QUESTION - is this vaccine 1 size fits all?  I am wondering if it is sized for the largest possible person say at 300 pounds.  I'm 135 pounds.  I'm thinking a smaller but still yet effective dose might not provide as sever a reaction.      Based on this experience I'm not sue if I'll go through with the second shot.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Injection site felt painful right after the injection and the pain  escalated and continued for 2 days and then started falling off.  Cannot sleep on the shoulder as the pain is felt when laying on the side / shoulder.  About 3 hours after the shot started feeling overly tired and achey all over.   During the night developed a head ache and spells of feeling very cold.  The  next morning felt like  I had an alcohol hangover on top of the flu.  Tried to get on with my day.  About noon just couldn't do any more.  Retired to the recliner where I spent the day and evening. Fever went up to 100.3.  Several bouts of chills, upset stomach and constant headache.   60 hours after the shot feel about 70% recovered.  Still cannot go thru a full exercise routine.  Hope to be better tomorrow.                                           QUESTION - is this vaccine 1 size fits all?  I am wondering if it is sized for the largest possible person say at 300 pounds.  I'm 135 pounds.  I'm thinking a smaller but still yet effective dose might not provide as sever a reaction.      Based on this experience I'm not sue if I'll go through with the second shot.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient's husband reported soreness at injection site that started the evening of the vaccine then starting 12/8/2019 tingling in the hand and pain in the forearm started.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: The evening of the received vaccination the patient developed tongue swelling and a low grade fever of 101F. The patient took Benadryl that night and felt better afterwards.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swollen tongue
Clinical narrative: The evening of the received vaccination the patient developed tongue swelling and a low grade fever of 101F. The patient took Benadryl that night and felt better afterwards.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Electromyogram, Guillain-Barre syndrome
Clinical narrative: Developed Guillain Barre Syndrome
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site reaction, Nausea, Rash erythematous
Clinical narrative: Patient started experiencing the follow symptoms about 6 to 8 hours after administration of the second Shingrix dose on 12/6/2019: headaches, vomiting, nausea, chills, bullseye rash at the site of injection. Three days later (12/9/2019) all of the symptoms have dissipated except for red bullseye rash at the site of injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient started experiencing the follow symptoms about 6 to 8 hours after administration of the second Shingrix dose on 12/6/2019: headaches, vomiting, nausea, chills, bullseye rash at the site of injection. Three days later (12/9/2019) all of the symptoms have dissipated except for red bullseye rash at the site of injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Scab, Vaccination site pain, Vaccination site rash
Clinical narrative: Patient said area of vaccination turned red, swollen, and painful to touch on the evening of vaccination 10/28/19.  After about 10 days, spots began to appear in the area close to vaccination.  Patient brought issue to the attention of their nurse practitioner after spots began to appear.  The nurse practitioner then diagnosed patient with Shingles when upon visit.  As of reporting to pharmacy on 12/9/19, the shingles spots have scabbed over, and are disappearing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Patient said area of vaccination turned red, swollen, and painful to touch on the evening of vaccination 10/28/19.  After about 10 days, spots began to appear in the area close to vaccination.  Patient brought issue to the attention of their nurse practitioner after spots began to appear.  The nurse practitioner then diagnosed patient with Shingles when upon visit.  As of reporting to pharmacy on 12/9/19, the shingles spots have scabbed over, and are disappearing.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Swelling
Clinical narrative: Sever swelling and pain in shoulder. Unable to lifft arm above head. Improved slightly but still having pain after 2 weeks from vaccination.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: NAUSEA, DIARRHEA, FEVER
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Patient reported flu-like symptoms and redness at injection site
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of deltoid muscle
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: LMP  10/18/19.  EDC 7/24/20.  Patient was inadvertently given an expired influenza vaccine.  Manufacturer,  in-house pharmacist and provider notified immediately.  No adverse reactions noted.  Patient received current year influenza.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Patient came after one month and told us that after getting  this vaccine he could not able to lift his arm  and after 1 month he is able to move his arm.. getting better
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HEPA, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient vomited about 2 hours after vaccines were administered.   I made follow up call to mother one hour after she reported patient vomiting.  He has not vomited again and is resting quietly.He is afebrile- axillary temperature of 97.7 and has no other symptoms.  I will call patient's mother tomorrow to follow up again.  The clinic is now closed so I advised Mother to take patient to the ER if she has any further concerns that arise.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Pruritus
Clinical narrative: Within minutes of receiving the flu vaccine patient reported that she was feeling full body itchiness and mild chest discomfort.  Transported by duty vehicle to branch clinic - approximately 60 second drive.   Patient denied any trouble/difficulty with breathing or chest pain.  Epinephrine was not indicated.   Assessed by provider in clinic and was prescribed Benadryl and monitored for two hours.  Patient started feeling relief 20 minutes after taking the Benadryl.  Assessed by the provider multiple times and after two hours was cleared and released to self care.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: pt called to report slight swelling, redness, and itching at injection site that started 3 days after getting immunization.  she didn't have any reaction after the first dose.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: I got my flu shot on October 15, 2019.  Since then, when I move my left arm (where I got the shot), on scale of 1 to 10 (10 being the greatest pain), I experienced #8 pain level.  I would not be able to abduct my arm beyond 45 degrees.  Now (December 9), almost 2 months later, I am experiencing #3 or 4 pain level when moving my arm back. Last year, I also had the high dose fluzone and recalled similar painful experience in my arm.  The pain did go away after several months from the time of the flu injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Pt reported local redness, warmth, swelling in arm, chills, low grade fever starting the following day.  she states that she is feeling better today.  Pt advised to see/call PCP.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Patient reported headache to another rph on duty and also rash
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Within a  few minutes of administration, the patient began to feel ill and looked as if she was going to pass out.  We laid her on her back on a bench.  She was still conscious.  We called 911 and after they evaluated her, they stated that all her vital signs were good. She sat up for a few minutes, then decided she felt well enough to drive herself home.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Myalgia
Clinical narrative: Severe muscle ache all night and unable to sleep.  Both hips were hurting so much.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count, Full blood count, Leukopenia, Petechiae, Rash
Clinical narrative: On 3/1/19, I woke up with petechiae rash on my both arms and some tenderness in my left armpit. I scheduled my appointment with a PCP, Dr. who shares the practice with my PCP, Dr.. The rash worsen and appeared on my thighs and knee areas as well. On 3/20/19, I was seen by  Dr. and had a lab draw.  I had 10 + lab draws since then.  I also visited the urgent care, and I was also seen by doctors in hematology, dermatology, and rheumatology. The rash did not go away for two months.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, White blood cell count decreased
Clinical narrative: On 3/1/19, I woke up with petechiae rash on my both arms and some tenderness in my left armpit. I scheduled my appointment with a PCP, Dr. who shares the practice with my PCP, Dr.. The rash worsen and appeared on my thighs and knee areas as well. On 3/20/19, I was seen by  Dr. and had a lab draw.  I had 10 + lab draws since then.  I also visited the urgent care, and I was also seen by doctors in hematology, dermatology, and rheumatology. The rash did not go away for two months.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: Pt got shot around 12:15p. Around 5pm he began sweating profusely, hands started tingling, felt dizzy. Pt said he was going to call 911
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness beyond injection site - down arm and into armpit
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Eye irritation, Eye pain, Lacrimation increased, Ophthalmic herpes zoster
Clinical narrative: got 2nd dose of Shingrex and got shingles in my right eye. very painful and caused my left eye to try and unsuccessfully focus with watering and scratchimess of right eye.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: got 2nd dose of Shingrex and got shingles in my right eye. very painful and caused my left eye to try and unsuccessfully focus with watering and scratchimess of right eye.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Exposure during pregnancy, Fatigue, Pain
Clinical narrative: T-dap 12/2/19 IM (L) deltoid 12/2/2019 noon. Pt developed temp 100.2 PO with shaking/chills, aches, pains, fatigue Temp 12/3/19 99.3. PO. Pt sent to Hospital for evaluation. 30wk pregnant with twins. Pt afebrile in 48 hr from 12/2/2019 episode.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: T-dap 12/2/19 IM (L) deltoid 12/2/2019 noon. Pt developed temp 100.2 PO with shaking/chills, aches, pains, fatigue Temp 12/3/19 99.3. PO. Pt sent to Hospital for evaluation. 30wk pregnant with twins. Pt afebrile in 48 hr from 12/2/2019 episode.
Sex: U
Vaccine: FLUA3
Symptoms: Syringe issue
Clinical narrative: nurse was attempting to give the flu shot to a patient and the following occurred: First injection, she went to put the needle on the vaccine and the snapped off with the needle and the hub Second injection, she went to administer and it squirted everywhere other than in the muscle it was intended for Third injection she pulled from the refrigerator had a broken bottom of the syringe.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Area Red and heat to touch (70mml 130mm area)
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: With redness and swelling on injection site (L) thigh
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: (1) swelling at site of injection (2) High fever
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Doctor had sent script for Shingles vaccine to pharmacy but then received it in the office. The pharmacist didn't check the data base and gave another shingles vaccine. Where error took place: Retail Pharmacy How prescription filled: Electronic prescription sent directly to the pharmacy (by computer) from my doctor's office Type of pharmacy: Chain Pharmacy
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A mom called with the following report: Her one year old child received the adult version of the Hepatitis B Vaccine. It was dose number 2 of the series. The mother found it on her child's record and notified the office. It is an adult and pediatric office.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Diagnosis: Frozen Shoulder  Taking physical Therapy from Phisycal Therapy (PT, DPT) for several month. Because I got shoulder pain that can be more severe  and longer-lasting than routine soreness that can follow injections.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cyst, Injection site pain, Peripheral swelling
Clinical narrative: Patient came in for another vaccine and asked me to look at her arm. She said when she got her FLU shot her arm swelled and made a "cyst". She said it was painful, but not now. I felt the cyst and it was lower than her deltoid. Also it was positioned further back than her deltoid. Advised her to seek attention from PCP.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Arms swollen @ the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Varicella, Visual impairment
Clinical narrative: I contracted chicken pox. Had one in my right eye, and now I have a visual impairment.
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Incorrect route of product administration
Clinical narrative: PNEUMOVAX was given intradermally; Information has been received from a medical assistant on 25-NOV-2019 via medical records regarding a currently 70 years old female patient.  On an unknown date (referred as 02-FEB-2018, conflicting information),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), .0.5 milliliter, intradermally (incorrect route of product administration) in the left deltoid for prophylaxis.   On 11-MAR-2016, pt was vaccinated with zoster vaccine live (ZOSTAVAX) and experienced shingles caused by zoster vaccine live (ZOSTAVAX) in 2016 (# US-009507513-1811USA011601).  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-1811USA011601:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Severe pain and swelling, induration at site, erythema of approximately 2/3 of upper arm, bruising.  He has required multiple doses of motrin to relieve pain, which has been ineffective.  He has also been complaining of neck pain and a headache and has had multiple night terrors lasting for 45 minutes or greater nightly since the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Neck pain, Sleep terror
Clinical narrative: Severe pain and swelling, induration at site, erythema of approximately 2/3 of upper arm, bruising.  He has required multiple doses of motrin to relieve pain, which has been ineffective.  He has also been complaining of neck pain and a headache and has had multiple night terrors lasting for 45 minutes or greater nightly since the vaccine.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site scar, Pain, Pain in extremity
Clinical narrative: "I got my flu shot last month at drill weekend (November). I am still having pain from it. When I lift my arm above my head it shoots pain down my arm. Also, when I wake up in the morning it is super sore. There is still a mark from where I got the shot, it?s a scar."
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; Information has been received from a pharmacist referring to a male patient of unknown age. Concomitant therapies included sterile diluent. Information about medical history and drug reactions/allergies was unknown by the reporter.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose in series unknown, frequency, anatomical location, route of administration, lot number and expiration date were unknown) for prophylaxis at another pharmacy.      On 05-NOV-2019, the patient experienced soreness in arm. The patient sought medical attention.  The outcome of soreness in arm was unknown. The causality assessment was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; on 11/11/2019 a patient was administered VAQTA 6 weeks after initial dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 30-SEP-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dosage detail, route, strength, lot # and expiration date were not reported) for prophylaxis. On 11-NOV-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S001360, expiration date 06-MAY-2020, but upon internal validation established as 06-MAR-2020, strength: 25/0.5 (unit unknown), dosage detail and route were not reported) for prophylaxis (inappropriate schedule of vaccine administered).  No adverse effects were reported.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received the last dose of ROTATEQ series on an unspecified date when the patient was 8 months and 29 days old and that the dose was administered outside of the Prescribing Information; No adverse effects reported; This spontaneous report was received from a medical assistant referring to an 8 months and 29 days old patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with the last dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) series (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. This dose was administered outside of the prescribing information (inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; one dose of improperly stored PROQUAD was administered to the patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 13-NOV-2019, one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S017251, expiration date: 01-DEC-2020; strength, frequency and route were unknown) for prophylaxis (product storage error). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.1 degrees Fahrenheit) for 1 hours 10 minutes. There was previous temperature excursion in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (14.5 degrees Fahrenheit) for 1 hour 25 minutes. The digital data logger was involved. No adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Skin swelling, Skin warm
Clinical narrative: skin was significantly hot and swollen to the wrist; skin was significantly hot and swollen to the wrist; red line to lower arm; Information has been received from a nurse referring to a 68 years old male patient (a dentist). The patient was administered pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) one year ago. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 12-NOV-2019, the patient was administered his first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number R012360, expiration date 15-JAN-2020; frequency, anatomical location and route of administration were unknown) for prophylaxis.   On the same date, after receiving the injection the patient developed a reaction at the injection site that his skin was significantly hot and swollen to the wrist. A red line had formed on the lower arm. On 14-NOV-2019, the patient saw an infectious disease specialist and was given antiobiotics for treatment.  The outcome of events was reported as not recovered. The causality assessment was not reported.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site vesicles, Pain in extremity
Clinical narrative: severe arm pain a few hours after injection, and then presented this morning (11/14/2019) with blistering around the injection site; severe arm pain a few hours after injection, and then presented this morning (11/14/2019) with blistering around the injection site; Information has been received from a nurse, referring to a 75 years old female patient. The patient's historical conditions included atrial flutter, general anxiety disorder, hypothyroidism and hypocalcemia. Concomitant medications included prednisone, gabapentin, levothyroxine sodium (SYNTHROID), trazodone, fluticasone propionate (FLONASE), calcium, diclofenac sodium (VOLTAREN) and glucosamine. The patient was reported of no previous drug allergies. The patient had received a dose of pneumococcal 13-valent conjugate vaccine (PREVNAR 13) on 31-JAN-2018.  On 13-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (single dose, strength and dose detail were unknown, lot #S027047, expiration date 20-MAY-2021) intramuscularly for prophylaxis (reported as routine schedule).  On the same date after vaccination (reported as "a few hours after injection"), the patient experienced severe arm pain. In the morning of 14-NOV-2019, the patient presented with blistering around the injection site. It was reported that the patient had received treatment for the adverse events, but the type of treatment was unknown. There were no lab diagnostics was performed. The outcome of the events was reported as not recovered. The causality assessment was not provided by reporter.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; The patient was vaccinated with PNEUMOVAX 23 on 11/21/2018 and 11/13/2019.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 21-NOV-2018, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. On 13-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) (inappropriate schedule of product administration) for prophylaxis. No adverse symptoms reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Pyrexia
Clinical narrative: an induration in the patient's skin where the vaccine had been given; the patient felt febrile; This spontaneous report was received from a physician via a company representative referring to a middle 50 years old male patient.  The patient had diabetes. Information about concomitant medication and drug reactions/allergies was unknown.    On an unknown date in 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis. On an unknown date in 2018 (reported as the day after the patient was administered the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)), the patient experienced an induration in the skin where the vaccine had been given and the patient felt febrile. The patient called the physician office and the physician had sent the patient to the hospital (demographics unknown) the same day as the office visit. If the patient had stayed in the hospital or if it was just an emergency room visit was unknown. The outcome of the events was reported as recovered. Causality assessment was not provided.
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Abdominal pain, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: transient abdominal pain; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019, the patient also received a dose ofGARDASIL 9 on 6/29/2019/ Pregnancy test was "positive".; a patient received a dose of MMRll and VARlVAX on 05/06/2019 and another dose of each vaccine on 06/06/2019; This spontaneous prospective pregnancy report was received from a nurse and refers to a 13-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 06-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live( M-M-R II) lot # N023142, expiration date 24-AUG-2019, subcutaneouslyand with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R021098, expiration date 23-JUL-2020, subcutaneously, both for prophylaxis.  On 06-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live( M-M-R II) lot # R008697, expiration date 22-MAR-2020, subcutaneously and with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R021098, expiration date 23-JUL-2020, subcutaneously, both for prophylaxis.  On 29-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot #, exact dose and expiration date were not reported) for prophylaxis.  On 29-OCT-2019, the patient had transient abdominal pain and was instructed by teacher to go to urgent care. On that same day, the patient visited unspecified urgent care, and had a pregnancy test completed. Pregnancy test was positive. Nurse stated that abdominal pain was transient so it resolved quickly. The patient saw her obstetrician on 05-NOV-2019 with no knew difficulties. The patient's father came to clinic on 12-NOV-2019, and reported that both the patient and her baby were doing well. Nurse reported that the patient was 33 weeks and 2 days pregnant at the time of the report. The last menstrual period (LMP) was calculated as 26-MAR-2019, and estimated date of delivery (EDD) was calculated as 31-DEC-2019. It was also reported that baby was due around 02-JAN-2020. The pregnancy outcome was pending. The outcome of abdominal pain was reported as recovered/resolved on an unknown date in 2019. The causality assessment between the event and suspect therapy was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient was vaccinated with improperly stored ROTATEQ; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 15-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(strength, dose, frequency, lot # and expiration date were not reported) orally for prophylaxis. The vaccine was exposed to highest temperature excursions of above 47 degree Fahrenheit(F) / 9 degree Celsius (58F) for 28 hours. There was no previous temperature excursion. No a data logger was involved. No adverse symptoms reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No symptoms reported/ No complication or adverse reaction noted/reported.; patient received GARDASIL 9 outside of prescribing informaton/ second dose on 2/18/2019; patient received GARDASIL 9 outside of prescribing informaton/ first dose on 12/17/2019; Information has been received from a physician referring to a 45 years old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 17-DEC-2018 (conflicting information: reported as 17-DEC-2019), the patient received the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) outside of prescribing (lot number N009173, expiration date 20-NOV-2019; frequency and anatomical location were unknown) intramuscularly for prophylaxis (product prescribing issue). On 18-FEB-2019, the patient received the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number R005341, expiration date 06-DEC-2020; frequency and anatomical location were unknown) intramuscularly for prophylaxis (product prescribing issue). No symptoms, complication or adverse reaction noted/reported.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: shingles/herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported. On or about 29-JUN-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions, in a pharmacy by a pharmacist. The pt suffered severe burning sensation, itching and pain and on 02-JUL-2016, she was diagnosed with shingles/herpes zoster. The outcome of the event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Bacterial test, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with ataxia telangiectasia (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1912USA000167: US-009507513-1912USA000168: US-009507513-1912USA000169: US-009507513-1912USA000169: US-009507513-1912USA000168:
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Bacterial test negative, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with ataxia telangiectasia (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1912USA000167: US-009507513-1912USA000168: US-009507513-1912USA000169: US-009507513-1912USA000169: US-009507513-1912USA000168:
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Bacterial test, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: This literature marketed report has been received from authors of a published article, titled as below referring to an unknown age patient with ataxia telangiectasia (Primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).  Literature report:   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1911USA008596:
Age: 1.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Bacterial test negative, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: This literature marketed report has been received from authors of a published article, titled as below referring to an unknown age patient with ataxia telangiectasia (Primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).  Literature report:   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1911USA008596:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one unidentified pediatric patient was inadvertently administered an adult dose ofVAQTA; No symptoms were reported; Information has been received from a physician referring to a pediatric patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/ allergies was not provided.  On an unknown date, the patient was inadvertently administered an adult dose of hepatitis a vaccine, inactivated (VAQTA)(dose number, frequency, lot number, expiration date, anatomical location and route of administration were unknown) for prophylaxis (product administered to patient of inappropriate age). No symptoms were reported.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient was administered a dose of improperly stored Varivax; This spontaneous report was received from a registered nurse and refers to a 8 year old male patient. The patient's medical history and concurrent conditions were not provided.  The reporter stated that on 25-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error )lot # S021926, expiration date on 15-JUL-2021, for prophylaxis (strength, dosage, frequency and route were not provided), the sterile diluent used for reconstitute the vaccine was properly stored. It was stated that varicella virus vaccine live (oka/merck)(VARIVAX) was under 15 °F, to 46 °F (35.7 F) for 4 hours 40 minutes, 6°F to 14°F (10F) for 45 minutes and 15 °F to 46 °F(44.7 F) for 8 hours. There were not previous temperature excursion, digital data logger was positive.
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: arm swelling down to elbow, soreness for multiple days; arm  swelling down to elbow; arm  swelling down to elbow/It was unspecified as to which arm was swollen.; a fever; Information has been received from a 52 years old female patient via a field representative referring to herself. The patient's concomitant medication included methotrexate. The patient's pertinent medical history included autoimmune disorder. The patient's drug reactions or allergies were unknown.    On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis.      On an unknown date, the patient developed arm swelling down to elbow, soreness for multiple days and a fever after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was unspecified as to which arm was swollen. The outcome of the events were recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: No additional adverse effects; some of the GARDASIL 9, spilled on the patient's skin; plastic syringe and needle came apart; patient did not receive a complete dose; This spontaneous report was received from a nurse and refers to a 13-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-NOV-2019, the patient was receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mg/once, intramuscularly, lot # R026716, expiration date 30-MAY-2021, for HPV prevention, but the plastic syringe and needle came apart and the patient did not receive a complete dose and some of the vaccine spilled on the patient's skin. The patient's skin was cleansed. No additional adverse effects were reported. The outcome of exposure via skin contact was reported as recovered on 13-NOV-2019. The causality assessment between the event and suspect vaccine was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient experienced no symptoms.; administrated MMR II via intramuscular injection; This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R036582, expiration date 17-DEC-2020, for prophylaxis, via intramuscular route, which was considered incorrect route of administration (strength, frequency and anatomical location were not provided). The patient experienced no symptoms.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not experience any symptoms; improperly stored Varivax or Proquad; This non-valid spontaneous report as received from a medial assistant refers to multiple patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (reported as on multiple dates between 14-SEP-2019, and 15-NOV-2019), the patients were vaccinated for prophylaxis with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011952, expiration date 16-APR-2021, or with lot # S012037, expiration date 17-APR-2021, or with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S003865, expiration date 08-AUG-2020, or with lot # S021617, expiration date 09-JAN-2021 (strength, frequency, route of administration and anatomical location were not provided in neither of vaccines). All of vaccines were reconstituted with a properly stored sterile diluent. The vaccines were exposed to temperature of -10 degrees Celcius (frame: from -14 degrees Celcius to -10 degrees Celcius) for 1 hour and 45 minutes, and -7.1 degrees Celcius for 30 minutes (frame: -9 degrees Celcius to 8 degrees Celcius). There was also a previous temperature excursion of -11.6 degrees Celcius for 7 hours and 10 minutes (frame: from -14 degrees Celcius to -10 degrees Celcius). The digital data logger was involved. The patients did not experience any symptoms.
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: was cut by broken glass from the syringe/ her cut finger; there is a half of the end piece of the syringe by the finger flanges missing/ broken syringe; This spontaneous report was received from a medical assistant who was reporting on herself. The medical assistant was a 25-year-old female with no pertinent medical history, concurrent conditions, concomitant medications or known drug reactions and allergies. On 25-NOV-2019, the assistant was administering a dose of hepatitis a vaccine, inactivated (VAQTA) (0,5 ml, lot # S010727 with the expiration date of 26-JUL-2020) to an unspecified patient, and was cut by a broken glass from the syringe. After administration, she noticed there was a half of the end piece of the syringe by the finger flangers missing. The syringe was mostly intact, only two small pieces of glass were missing from the top by the finger flangers.  The medical assistant reported the event resolved on 25-NOV-2019. The causality assessment between the event and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 21-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA), lot # S009943, expiration date 26-JUL-2020 (strength, route of administration and dose were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion above 47 Fahrenheit degrees (F) / 9 Celsius degrees (C) for 1 hour and 25 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.