chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Psychomotor hyperactivity, Rash, Social avoidant behaviour, Speech disorder, Speech disorder developmental
Clinical narrative: About 10 days after vaccines, our daughter stopped to smile, to talk, to look at us. She was withdrawn.  She had loose stool. Following week I noted abnormal hand motion when reaching for things, I believe she had subtle ataxia. Her walking was more unsteady too.  She was withdrawn, but at times hyperactive, for example climbing her bed and wall, which she never did before. Week 3-4 she had facial rash. Week 4-5 she arched her back. We were told by Dr that she has rare side effect from vaccines called developmental regression. I myself believe she had aseptic meningitis. I am a physician. What is on paper in her chart is speech, emotional and social delay. Our daughter was perfectly fine in regards of social, emotional and speech (in fact growing up in tri-lingual home) till about 10 days after above vaccinations.  We were told that "time will show" what the outcome will be.  We are now 7 months later, working on speech therapy.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient received Prevnar 13 in 2015.  Patient came to pharmacy expecting to receive Pneumovax 23 but received Prevnar 13 again on 8/5/19.  Patient is aware of error and understands she needs to wait to receive pneumovax 23 when her insurance will cover again.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Coma scale normal, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Pt. with fainting-like episode following vaccine. Approx. 3 mins after receiving vaccine, pt. stood up and then fell to the floor. Pt. hit posterior head on tile floor, +LOC, seizure-like movements for approx. 5-10 secs following fall. Pt. very pale appearing for several minutes approx. 2-3 minutes after LOC. VS@1400 : HR 100, RR 16, BP 102/56 RUA. Pt. able to eat and drink after event. Unable to visualize trauma to posterior head. Pt. with GCS 15. Mother informed to seek follow up care for any change in mental status.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Pt. with fainting-like episode following vaccine. Approx. 3 mins after receiving vaccine, pt. stood up and then fell to the floor. Pt. hit posterior head on tile floor, +LOC, seizure-like movements for approx. 5-10 secs following fall. Pt. very pale appearing for several minutes approx. 2-3 minutes after LOC. VS@1400 : HR 100, RR 16, BP 102/56 RUA. Pt. able to eat and drink after event. Unable to visualize trauma to posterior head. Pt. with GCS 15. Mother informed to seek follow up care for any change in mental status.
Age: 1.83
Sex: F
Vaccine: DT, UNK
Symptoms: Dermatitis, Hypersensitivity, Rash
Clinical narrative: Patient had a rash on his back and chest for two months following the tetanus shots. The doctors believed it to be an allergic reaction, dermatitis. We followed doctor recommendations and tried hydrocortisone and two different oral antihistamines, but these did not seem to make any difference. We tried eliminating things from his diet to no avail. Then, finally, after 2 months, it went away on its own. The doctors were very clear that they did not suspect it was from the vaccines when I asked, but my husband and I felt it was a big "coincidence" that the timing of this unexplained rash was directly following these two shots. Patient is unvaccinated otherwise.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Nausea, Seizure
Clinical narrative: After obtaining consent, and per orders of Dr., injection of Bexsero, HPV given by LPN. Patient instructed to remain in clinic for 20 minutes afterwards, and to report any adverse reaction to me immediately.    Patient did pass out for about 4 seconds with some convulsions. He was eased to the floor when he came too. Then he decided he would like to lay down on the floor, felt that like he could vomit. He was given a cold compress and was then brought to the table to lay down with feet, was give water and monitored. Within 5 min of passing out his BP was checked and it was 108/54 left arm while laying on the floor. Pulse was 54. After sitting you his pulse increase to 88 and BP 110/70.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Exercise tolerance decreased, Herpes zoster, Injection site erythema, Injection site swelling, Injection site ulcer
Clinical narrative: 7/23/19 (1 day post injection): redness and swelling at injection site appeared.  patient applied ice and took Benadryl.  As the day progressed, she developed a fever of 99.4 degrees F.  She felt lethargic so she stayed in bed all day.  She said it took her 3 to 4 days to regain her energy.   On approximately 7/29/19, she noticed a sore on her right cheek.  By Friday that sore had spread to other areas of the same cheek and to behind the right ear, but remained only on the right side.  Her daughter, a wound-care nurse, diagnosed it as shingles.  She started taking Lysine tablets over-the-counter with success.  The sores started to seem to dry up and minimize in appearance once the Lysine was started.  They did not seek medical attention (outside of consulting with her daughter) as she had experienced the condition for over a week.  They felt it was too late to start a prescription antiviral and the Lysine seemed to be working.   She still has a small sore at the injection site on the left arm.  The sores are not painful, but mostly cause itching.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pruritus, Pyrexia, Skin ulcer
Clinical narrative: 7/23/19 (1 day post injection): redness and swelling at injection site appeared.  patient applied ice and took Benadryl.  As the day progressed, she developed a fever of 99.4 degrees F.  She felt lethargic so she stayed in bed all day.  She said it took her 3 to 4 days to regain her energy.   On approximately 7/29/19, she noticed a sore on her right cheek.  By Friday that sore had spread to other areas of the same cheek and to behind the right ear, but remained only on the right side.  Her daughter, a wound-care nurse, diagnosed it as shingles.  She started taking Lysine tablets over-the-counter with success.  The sores started to seem to dry up and minimize in appearance once the Lysine was started.  They did not seek medical attention (outside of consulting with her daughter) as she had experienced the condition for over a week.  They felt it was too late to start a prescription antiviral and the Lysine seemed to be working.   She still has a small sore at the injection site on the left arm.  The sores are not painful, but mostly cause itching.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient complained for flu like symptoms: including fever and body aches
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Malaise, Myalgia
Clinical narrative: Day 1:  Stage 1 - soreness / pain in left arm Day 2:  Stage 2 - soreness in left arm, flu-like symptoms of full body muscle and joint aching  and just not feeling well that peaked at 28 hours and lasted to 48  hours after injection.  Stage 1 - shivering at 30 hours after injection; lasted about an hour. I suffered with very severe Stage 3 side effects with the first dose vaccine; this 2nd dose vaccine was much less severe but nevertheless, it was a definite, clear reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Day 1:  Stage 1 - soreness / pain in left arm Day 2:  Stage 2 - soreness in left arm, flu-like symptoms of full body muscle and joint aching  and just not feeling well that peaked at 28 hours and lasted to 48  hours after injection.  Stage 1 - shivering at 30 hours after injection; lasted about an hour. I suffered with very severe Stage 3 side effects with the first dose vaccine; this 2nd dose vaccine was much less severe but nevertheless, it was a definite, clear reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Dehydration, Diarrhoea, Headache
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersomnia, Mobility decreased
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Physical breakdown, inability to move, slept for 18 of first 24 hrs after injection. headache, upset stomach, mild diahrhea, dehydrated, loss of appetite
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Pyrexia, Vaccination site pain
Clinical narrative: fever and chills the night of vaccination.  itching, pain and spreading redness below vaccine site 2 days after vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported when we contacted her  today 08/05/2019 about getting her second dose. She stated a few days after receiving the first dose she had numbing in her arm. She says it has continued to present however the symptoms have lessoned over time. She reported this to her primary prescriber. She was told by the primary prescriber to report to FDA but she did not. She also said the prescriber said she could get the second dose if the patient wanted to get it.
Age: 103.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Malaise, Pain in jaw
Clinical narrative: PATIENT STATED THAT THE DAY FOLLOWING THE INJECTION, SHE HAD REDNESS/SWELLING THAT EXTENDED ALL THE WAY DOWN TO HER ELBOW, HEADACHE (FELT ON LEFT SIDE OF HEAD ONLY), JAW PAIN (FELT ON LEFT SIDE ONLY - ALMOST UNABLE TO OPEN MOUTH), FATIGUE & MALAISE.
Age: 103.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: PATIENT STATED THAT THE DAY FOLLOWING THE INJECTION, SHE HAD REDNESS/SWELLING THAT EXTENDED ALL THE WAY DOWN TO HER ELBOW, HEADACHE (FELT ON LEFT SIDE OF HEAD ONLY), JAW PAIN (FELT ON LEFT SIDE ONLY - ALMOST UNABLE TO OPEN MOUTH), FATIGUE & MALAISE.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Hallucination, Injection site erythema, Injection site pain, Malaise
Clinical narrative: The patient stated she had severe arm pain and redness at the injection site. She said that the day following the vaccine she had extreme malaise. That evening she reported having hallucinations and "weird" dreams. By 8/4, she said she was feeling better.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1 day after vaccine was given, pt experienced pain where the injection was given. the injection site was swollen, pink, and warm to the touch. pt started having symptoms on 8/3 and came to pharmacy to report he is still having these symptoms on 8/5/19. he is taking motrin to help with pain. pharmacist recommended to also ice area for 10-15 min 3 to 4 times per day and to take benadryl before bed which may also help with this reaciton
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Pruritus, Pustule, Rash
Clinical narrative: Grandmother reports baby had temperature yesterday, gave oral tylenol.  Baby woke up this morning with rash.  Grandmother contacted public health office as baby does not have insurance currently.  RN observed rash to entire body, concentrated mostly on legs, left thigh with pustule to possible injection site.  Scant spots to head, moderate to trunk and arms.  Baby is itching but grandmother reports that is normal at times baby gets rash of unknown origin.  Instructed on keeping baby home and away from immunocompromised people, unvaccinated people or pregnant women.  Gave number to local income based clinic to follow up with if does not improve or worsens or tylenol does not control fever.   Grandmother verbalizes understanding.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: High fever of 102.3, dizziness, weak, headache, and chills.  Went to bed and  didn't realize I had a fever.  Woke up about 1:00 am, and took my temperature and realized it was 102.3.  Took ibuprofen and went back to bed. Woke up in the morning still had a headache but no fever.   Was very tired and slept another 4 hours.  Headache was gone by August 1st.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever of 102.3, dizziness, weak, headache, and chills.  Went to bed and  didn't realize I had a fever.  Woke up about 1:00 am, and took my temperature and realized it was 102.3.  Took ibuprofen and went back to bed. Woke up in the morning still had a headache but no fever.   Was very tired and slept another 4 hours.  Headache was gone by August 1st.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hot flush, Malaise, Upper respiratory tract congestion
Clinical narrative: chills, hot flashes, headache, head congestion, general malaise
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus generalised, Swelling face, Swollen tongue
Clinical narrative: She stated she experienced itching which worsened later in the day after the vaccine. The itching spread all over the following day and her face was swollen. She reported there was some tongue swelling and she decided to go to the ER 4/16. She was given a steroid injection which she reported feeling immediate relief. She was also discharged from the ER with scripts for Medrol dose pack, azithromycin, and was instructed to take benadryl.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reacted with some swelling on injection are with some flared red spots.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Moderate lethargy for 24 hours after vaccination.  Redness and pain at the injection site. (approx. 6 in x 3 in. area). No swelling .  Redness and pain started 24 hrs after injection.  Almost resolved as of 8/5/2019.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Diarrhoea, Rash, Vomiting
Clinical narrative: Diarrhea stomach cramps, vomiting and a rash
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: PT presented to the pharmacy on 8-5-19 with a rash on arms, legs and chest.  Worse on left side of body.  small spots not itchy, larger patches were.  She stated it started approximately on 8-3-19.  She had had poison ivy recently but waited until rash had cleared to get vaccination, does not believe she was re-exposed.  She will be checking in with her doctor on 8-6-19.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Patient stated that about 30 minutes after receiving the vaccine she had severe nausea and vomitting she was also experiencing chills.  She reported to me tht she still felt  like that 1 hour later.  She will follow up with the pharmacy.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: she was "12 weeks pregnant". The Patient had agreed to the vaccination prior to receiving the GARDASIL 9; Information has been received from a physician referring to a currently 24 years old female patient. Concomitant therapies included cetirizine hydrochloride (ZYRTEC) and iron (unspecified), minerals (unspecified), vitamins (unspecified) (reported as prenatal vitamins). The patient had sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA) allergy, and egg white/shrimp allergy which caused stomach upset. The patient also had allergies (not specified), wisdom teeth extraction and appendectomy.   The reporter reported that the patient was seen on 08-JUL-2019 for a corporate physical/vaccination prior to going overseas with spouse for work. The patient was given hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot N013698, expiration 19-DEC-2019, intramuscular, in right arm; strength and dose were not reported) for prophylaxis prior to seeing the physician (Exposure during pregnancy). The patient remarked that she was "12 weeks pregnant". Date of LMP was 15-APR-2019. Due date was 20-JAN-2020. Pregnancy outcome was outcome pending. Gestation period at exposure was 12 weeks. The patient had agreed to the vaccination prior to receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was also scheduled to see her obstetrician after this visit on 08-JUL-2019. Treatment was given. No lab test was performed.
Sex: U
Vaccine: PPV
Symptoms: Depressed level of consciousness, Dizziness, Hyperhidrosis
Clinical narrative: sweating; felt like they were going to pass out / felt lightheaded; was inadvertently re-vaccinated with PNEUMOVAX23; This spontaneous report was received from a physician via a company representative and refers to an elderly (reported as over 65-year-old) patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, vaccine status could not be determined and the patient was inadvertently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was sweating, felt lightheaded and felt like was going to pass out. The patient sought medical attention by calling the doctor and the doctor confirmed the patient had already received one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  The outcome of hyperhidrosis and dizziness and the relatedness between the events and the suspect therapy was not reported.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: administered to 32 week pregnant patient; inadvertently administered dose of GARDASIL 9 instead of DTaP; inadvertently administered dose of GARDASIL 9 instead of DTaP; This spontaneous prospective pregnancy report was received from a physician via company representative and refers to a 32-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-JUL-2019, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, site of administration, lot number and expiration date were not reported) for prophylaxis, instead of an unspecified diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccine. At the time, the patient was 32 weeks pregnant. The date of last menstrual period (LMP) was not reported but it was estimated as 28-NOV-2018 and expected delivery date (EDD) was estimated as 04-SEP-2019. The pregnancy outcome was unknown and the fetal outcome was pending.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient was administered an expired dose ofMMR II; This spontaneous report was received from a pharmacist and refers to a 2-year-old patient of an unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 11-JUL-2019, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, albumin status rHA (lot # N019615 has been verified to be a valid lot number, expiration date 09-JUL-2019) for prophylaxis (exact dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult patient received an unspecified number of doses of PROQUAD; This spontaneous report was received from an unspecified healthcare provider and refers to an unspecified adult patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an unspecified number of doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, therapy type, dose, frequency, route and site of administration, lot # and expiration date were not reported) for prophylaxis.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; PROQUAD which was administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-NOV-2018, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# R015742 and expiration date 02-DEC-2019) (dose, frequency and route not reported) for prophylaxis, which was diluted in Merck's sterile diluent (MERCK STERILE DILUENT) (lot# L028663 and expiration date reported as 29-MAR-2018) (Expired product administered). No adverse effect were reported.; Sender's Comments:  US-009507513-1908USA001173:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported.; a first dose of GARDASIL 9 on 5/29/2018 and a second dose of GARDASIL 9 on 7/20/2018. patient would like to receive the third dose now/ Altered dosing schedule; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.    On 29-MAY-2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1; one dosage form; strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On 20-JUL-2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2; one dosage form; strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On 22-JUL-2019(reported as now), the patient would like to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Chills, Impaired work ability, Injection site pain, Injection site reaction
Clinical narrative: Diagnosed with oral candidiasis of the mouth./ gross mouth; Diagnosed with localized bacterial infection at the injection site on the right arm.; Few hours later developed sore throat.; Few hours later developed pain in the right arm at the injection site. / Arm became painful to light touch.; Few hours later developed an urticarial rash below the injection site.; Few hours later developed fever.; Few hours later developed chills.; Few hours later developed myalgias.; Few hours later developed bodyaches; This spontaneous report was received from a physician referring to a 37 year old female patient with a history of sinus infections. The patient's concurrent conditions, concomitant medications, historical drugs, drug reactions and allergies were not reported.   On 18-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) by intramuscular injection in the right arm (strength, dose, and frequency were unknown) with lot # S004548 and expiration date reported as August 2020, but upon internal validation established as 12-AUG-2020. Fewhours later after the vaccination, the patient developed pain in the right arm at the injection site, an urticarial rash belowthe injection site, fever, chills, myalgias, bodyaches, sore throat and the right arm became painful to light touch.  The physician reported that on 23-JUL-2019, the patient was seen at an unspecified urgent care facility and was diagnosed with oral candidiasis of the mouth, and a localized bacterial infection at the injection site on the right arm. The patient was treated with nystatin reported as via "swish and swallow", azithromycin and ibuprofen (MOTRIN) reported as "around the clock".  At the time of the report, the outcome of oral candidiasis, bodyaches, myalgia, sore throat, chills, fever, urticarial rash, injection site pain and localized bacterial infection was reported as not resolved.   Oral candidiasis and localized bacterial infection were determined to be disabling by the the physician because the patient had not been able to return to work due to these symptoms. Causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Oral candidiasis, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Diagnosed with oral candidiasis of the mouth./ gross mouth; Diagnosed with localized bacterial infection at the injection site on the right arm.; Few hours later developed sore throat.; Few hours later developed pain in the right arm at the injection site. / Arm became painful to light touch.; Few hours later developed an urticarial rash below the injection site.; Few hours later developed fever.; Few hours later developed chills.; Few hours later developed myalgias.; Few hours later developed bodyaches; This spontaneous report was received from a physician referring to a 37 year old female patient with a history of sinus infections. The patient's concurrent conditions, concomitant medications, historical drugs, drug reactions and allergies were not reported.   On 18-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) by intramuscular injection in the right arm (strength, dose, and frequency were unknown) with lot # S004548 and expiration date reported as August 2020, but upon internal validation established as 12-AUG-2020. Fewhours later after the vaccination, the patient developed pain in the right arm at the injection site, an urticarial rash belowthe injection site, fever, chills, myalgias, bodyaches, sore throat and the right arm became painful to light touch.  The physician reported that on 23-JUL-2019, the patient was seen at an unspecified urgent care facility and was diagnosed with oral candidiasis of the mouth, and a localized bacterial infection at the injection site on the right arm. The patient was treated with nystatin reported as via "swish and swallow", azithromycin and ibuprofen (MOTRIN) reported as "around the clock".  At the time of the report, the outcome of oral candidiasis, bodyaches, myalgia, sore throat, chills, fever, urticarial rash, injection site pain and localized bacterial infection was reported as not resolved.   Oral candidiasis and localized bacterial infection were determined to be disabling by the the physician because the patient had not been able to return to work due to these symptoms. Causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Urticaria
Clinical narrative: Diagnosed with oral candidiasis of the mouth./ gross mouth; Diagnosed with localized bacterial infection at the injection site on the right arm.; Few hours later developed sore throat.; Few hours later developed pain in the right arm at the injection site. / Arm became painful to light touch.; Few hours later developed an urticarial rash below the injection site.; Few hours later developed fever.; Few hours later developed chills.; Few hours later developed myalgias.; Few hours later developed bodyaches; This spontaneous report was received from a physician referring to a 37 year old female patient with a history of sinus infections. The patient's concurrent conditions, concomitant medications, historical drugs, drug reactions and allergies were not reported.   On 18-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) by intramuscular injection in the right arm (strength, dose, and frequency were unknown) with lot # S004548 and expiration date reported as August 2020, but upon internal validation established as 12-AUG-2020. Fewhours later after the vaccination, the patient developed pain in the right arm at the injection site, an urticarial rash belowthe injection site, fever, chills, myalgias, bodyaches, sore throat and the right arm became painful to light touch.  The physician reported that on 23-JUL-2019, the patient was seen at an unspecified urgent care facility and was diagnosed with oral candidiasis of the mouth, and a localized bacterial infection at the injection site on the right arm. The patient was treated with nystatin reported as via "swish and swallow", azithromycin and ibuprofen (MOTRIN) reported as "around the clock".  At the time of the report, the outcome of oral candidiasis, bodyaches, myalgia, sore throat, chills, fever, urticarial rash, injection site pain and localized bacterial infection was reported as not resolved.   Oral candidiasis and localized bacterial infection were determined to be disabling by the the physician because the patient had not been able to return to work due to these symptoms. Causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Limb discomfort, Local reaction, Pain in extremity
Clinical narrative: large area of swelling, arm was heavy and painful which went down her arm to her wrist; significant local reaction at the injection site; large area of swelling, arm was heavy and painful which went down her arm to her wrist; large area of swelling, arm was heavy and painful which went down her arm to her wrist; This spontaneous report as received from an office manager, and refers to a 15 year old female patient. Information regarding the patient's pertinent medical history, drug reactions/ allergies and concomitant medications was not provided.  On 18-JUN-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot number and expiration date were not reported for vaccination.         On the same day, as soon after received the vaccine, the patient had a significant local reaction at the injection site, describe as a large area of swelling, arm was heavy and painful which went down her arm to her wrist. It was reported this lasted several days, the patient was seen in the physician office on 16-JUL-2019 with some residual pain, but was improving almost back to normal. It was unknown if a treatment was given or if the laboratory tests were performed.  The relatedness between the adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she has missed her second vaccination of GARDASIL 9; No adverse reactions reported; This spontaneous report was received from a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The patient reported that she had missed her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse reactions were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event reported; A patient was givien a VARIVAX shot deltoid instead of subcutaneous; This spontaneous report, was receivend from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent drug reactions, allergies and concomitant medications were not reported.   On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) in the deltoid instead of subcutaneous, (incorrect route of product administration) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of an unknown gender and age.  No information regarding drug reactions, allergies or medical history was reported.   On 16-JUL-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #R023500, expiration date: 13-FEB-2020, therapy type: rha) (dose and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion of -12.7 degrees Celsius; time frame was 58 minutes. There was no previous temperature excursion. Concomitant therapies included sterile diluent. The sterile diluent was properly stored. There was no adverse effect reported. The call was made because of a digital data logger.  This is 1 of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000927:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Inappropriate administration schedule; This spontaneous report was received from a pharmacist refers to a 13-year-old male patient. No information regarding the patient pertinent medical history, concomitant medications, drug reactions or allergies was provided.   On 21-JUL-2018, when the patient was 12-year-old, he was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported). On 17-NOV-2018, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported). No additional doses administered. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Injection site pain, Injection site swelling
Clinical narrative: Elevated liver function enzymes; Swelling and pain at the injection site; Swelling and pain at the injection site; This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (lot# K009770 and expiration date October 2015) subcutaneously (dose and frequency not reported), diluted in Merck's sterile diluent (lot# and expiration date not reported) for prophylaxis.  On an unspecified date in 2014, the patient experienced elevated liver function enzymes (hepatic enzyme increased), as well as swelling and pain at the injection site (infusion site swelling, injection site pain). It was reported that the patient sought medical attention due to the events, but it was unknown if the patient received any treatment. At the time of the report, the outcome of the events was unknown.  The causal relationship between the suspect therapies and the mentioned events was not reported.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: During her lifetime, she has received 5 doses of M-M-R II; No known adverse effects; This spontaneous report was received from a registered nurse who was also a female patient of unknown age referring to herself.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 13-DEC-1979, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) as prophylaxis.   The patient stated that during her lifetime, she had received 5 doses of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). A second dose was administered on 02-AUG-2002, a third one on 24-MAY-2019 and she could not remember the other 2 dates. No known adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles; Vaccination failure; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.     In 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, the pt experienced shingles (herpes zoster). The pt healthcare provided, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects (vaccination failure). Pt was treated at a physician office an hospitalized on an unspecified date.   As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.         At the time of the report, the outcome of herpes zoster was reported as not recovered. The outcome of vaccination failure was unknown. The lawyer considered herpes zoster and vaccination failure to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was vaccinated with improperly stored doses of GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.  On 30-JUL-2019, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number R029117, with expiration date: 10-JUL-2021 for prophylaxis. No adverse effects were reported.  The doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent temperature excursions of 47.5 degrees Fahrenheit (°F) for a time frame of 2 hours and 45 minutes, which was called by the digital data. There were no previous temperature excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA001263:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions. Subsequently, pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles; Vaccination failure; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.     In 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, the pt experienced shingles (herpes zoster). The pt healthcare provided, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects (vaccination failure). Pt was treated at a physician office an hospitalized on an unspecified date.   As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.         At the time of the report, the outcome of herpes zoster was reported as not recovered. The outcome of vaccination failure was unknown. The lawyer considered herpes zoster and vaccination failure to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of an unknown gender and age.  No information regarding drug reactions, allergies or medical history were reported.   On 26-JUL-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #R023500, expiration date: 13-FEB-2020, therapy type: rha) (dose and route of administration was not provided) for prophylaxis. The vaccine underwent temperature excursion of -12.7 degrees Celsius; time frame was 58 minutes. There was no previous temperature excursion. Concomitant therapies included sterile diluent. The sterile diluent was properly stored. There was no adverse effect reported. The call was made because of a digital data logger.  This is 1 of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA000135: