chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the same patient may have received the second dose of GARDASIL 9 at a later than recommended time interval; This spontaneous report has been received from a pharmacist via a company field representative referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   The patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (route, lot number and expiration date unknown by reporter; strength, dose and frequency were not reported) at 15-years-old (date unknown) for prophylaxis. The patient might have received the second dose of GARDASIL 9 (lot number and expiration date unknown by reporter) at a later than recommended time interval (Inappropriate schedule of product administration).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain in extremity, Rash, Skin warm
Clinical narrative: patient's arm ached, experienced joint pain, and fatigue.   Then she developed a rash that was hot to touch and swollen and sore
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt c/o "so sore that I cannot move arm". Denies paresthesias in hand.
Age: 4.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Injection site erythema
Clinical narrative: Mild redness on arms & legs. Very bright red cheeks. No facial swelling, No fever, No itching. No respiratory symptoms. Child examined by doctor 6/05/19. Parents instructed to give Benadryl if child starts to itch or becomes uncomfortable. Report to ER if child develops wheezing, swelling or respiratory distress.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Call received from patient and spouse reporting an adverse reaction from the shingrix. patient reports after receiving the first dose of shingrix on 3/14/19 a small rash appeared in the middle of his back 2 weeks after administration but did not correlate it to be from the shingrix.  Then, on 5/14/19, pt. received his second dose of shingrix and 6/3/19 started having the rash reappear. patient reports it being itchy but denies pain. Patient reports the last rash went away after 3 weeks with no scaring.
Age: 30.0
Sex: M
Vaccine: JEV1
Symptoms: Adverse reaction, Extra dose administered
Clinical narrative: Patient was given the 2nd vaccine but it was not documented, 3rd given as he was showing overdue at the time. Symptoms started same day as 3rd vaccine
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting 1 daypost immunizations. Started just after dinner and continued over night.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood thyroid stimulating hormone, Chills, Differential white blood cell count, Electrocardiogram, Electroencephalogram
Clinical narrative: Fatigue, headache, mild cramping & shivering. Became nauseous 20 minutes after returning home with episode of syncope. No vomit or incontinence. Pt stated he did not hit his head.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Full blood count, Headache, Metabolic function test, Muscle spasms
Clinical narrative: Fatigue, headache, mild cramping & shivering. Became nauseous 20 minutes after returning home with episode of syncope. No vomit or incontinence. Pt stated he did not hit his head.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Platelet count, Syncope, Thyroxine free
Clinical narrative: Fatigue, headache, mild cramping & shivering. Became nauseous 20 minutes after returning home with episode of syncope. No vomit or incontinence. Pt stated he did not hit his head.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms. Muscle aches, tired, upset stomach, stuffy nose, fever, chills
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Flu like symptoms. Muscle aches, tired, upset stomach, stuffy nose, fever, chills
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to 2 year old at clinic visit for vaccines. Recommended/Licensed age 4-6years of age. No symptoms or signs of any adverse events/reactions at this time.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Vomiting reported 1 day post immunizations. Started just after dinner and continued over night.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored dose administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 24-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R026362, expiration date 15-MAT-2020) (exact dose, frequency, route, site of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -9 degrees Celsius (C) to 8C (5.8C) for 17 days. Digital data logger was involved. There were no previous excursions reported. No adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001445:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an expired dose of VAQTA; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug history, allergies and concomitant medications were not reported.  On 31-MAY-2019, the patient received an expired dose of Hepatitis A Vaccine, inactivated (VAQTA), administered intramuscularly (dose number and anatomical location were not provided) (lot#: R013515, expiration date: 30-MAY-2019) for prophylaxis. It was not known any adverse effects.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; The physician reports that on 5/31/2019, one dose of improperly stored PROQUAD) was administered; This spontaneous report was received from a physician concerning unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant Human albumin (rHA) for prophylaxis (lot number R020677 with expiration date on 15-JAN-2020, route of administration, strength and frequency were not reported). Other suspect therapy included sterile diluent, for prophylaxis (lot number N032755 with expiration date on 04-AUG-2020, route of administration, strength and frequency were not reported).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit up to 46 degrees Fahrenheit (36 Fahrenheit) for 8 hours and temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14 Fahrenheit) for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001160: US-009507513-1906USA001161:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; The physician reports that on 5/31/2019, one dose of improperly stored PROQUAD) was administered to P.V; This spontaneous report was received from a physician concerning unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) for prophylaxis (lot number R021098 with expiration date on 23-JUL-2020, route of administration, strength and frequency were not reported). Other suspect therapy included sterile diluent for prophylaxis (lot number N032755 with expiration date on 04-AUG-2020, route of administration, strength and frequency were not reported).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit up to 46 degrees Fahrenheit (36 Fahrenheit) for 8 hours and temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14 Fahrenheit) for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000968: US-009507513-1906USA001161:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; The physician reports that on 5/31/2019, one dose of improperly stored PROQUAD) was administered; This spontaneous report was received from a physician concerning unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) for prophylaxis (lot number R021098 with expiration date on 23-JUL-2020, route of administration, strength and frequency were not reported). Other suspect therapy included sterile diluent for prophylaxis (lot number N032755 with expiration date on 04-AUG-2020, route of administration, strength and frequency were not reported).  Administered doses of vaccine experienced temperature excursion between 15 degrees Fahrenheit up to 46 degrees Fahrenheit (36 Fahrenheit) for 8 hours and temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14 Fahrenheit) for 15 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000968: US-009507513-1906USA001160:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored dose administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 30-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R026362, expiration date 15-MAT-2020) (exact dose, frequency, route, site of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -9 degrees Celsius (C) to 8C (5.8C) for 17 days. Digital data logger was involved. There were no previous excursions reported. No adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000729:
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site rash, Laboratory test, Malaise
Clinical narrative: Injection site rash; Fatigue; malaise; diarrhea; vomiting; fever; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea (patient experiencing a similar episode one year prior and it resolved), vomiting, fever, injection site rash, malaise and fatigue. Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site rash, fatigue, malaise, diarrhea, vomiting and fever. The patient was treated with paracetamol (Acetaminophen), intravenous fluid (nos) (Intravenous Fluids) and antiemetics and antinauseants (Antiemetics). On an unknown date, the outcome of the injection site rash, fatigue, malaise and fever were unknown and the outcome of the diarrhea and vomiting were recovered/resolved.   The reporter considered the injection site rash, fatigue, malaise, diarrhea, vomiting and fever to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he developed a rash around the injection site, with fatigue and malaise. 3 days following the Shingrix dose, the patient began experiencing diarrhea, vomiting, and a fever of 101degree F. He presented to the clinic.  He received acetaminophen, IV fluids, and antiemetics. The diarrhea and vomiting lasted about 2 days total.      Lab Comments: lab test done on an unknown date
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Injection site rash; Fatigue; malaise; diarrhea; vomiting; fever; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diarrhea (patient experiencing a similar episode one year prior and it resolved), vomiting, fever, injection site rash, malaise and fatigue. Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site rash, fatigue, malaise, diarrhea, vomiting and fever. The patient was treated with paracetamol (Acetaminophen), intravenous fluid (nos) (Intravenous Fluids) and antiemetics and antinauseants (Antiemetics). On an unknown date, the outcome of the injection site rash, fatigue, malaise and fever were unknown and the outcome of the diarrhea and vomiting were recovered/resolved.   The reporter considered the injection site rash, fatigue, malaise, diarrhea, vomiting and fever to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he developed a rash around the injection site, with fatigue and malaise. 3 days following the Shingrix dose, the patient began experiencing diarrhea, vomiting, and a fever of 101degree F. He presented to the clinic.  He received acetaminophen, IV fluids, and antiemetics. The diarrhea and vomiting lasted about 2 days total.      Lab Comments: lab test done on an unknown date
Sex: U
Vaccine: FLUX
Symptoms: Adverse event, Apparent death
Clinical narrative: Near death; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient almost died from flu vaccine and reported that it save some and kills some.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Near death; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provide as follows: The age at vaccination was not reported. The reporter said that, not everyone would be immune to vaccines that's why it so important for everyone to get vaccinated. Maybe you should research a ill more bout immunity. The reporter did not believe in three flu vaccine. For two reasons it almost killed reporter's mother and you could not make a vaccine for the flu because you did not know what strand would hit, but if future grandkids go to daycare or preschool it's a requirement they get the flu shot.
Age: 66.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2018, the patient received the 2nd dose of Shingrix. In May 2019, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient still ended up getting Shingles on the reporting weekend.  At the time of reporting, the patient was being treated with Valacyclovir. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivering; strange sensation; This case was reported by a consumer via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin hydrochloride (Metformin), antihypertensives nos, antihypertensives nos (Anti-Hypertensive) and cholesterol and triglyceride reducers (nos) (Cholesterol Lowering Drugs (Nos)).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering and weird feeling. On an unknown date, the outcome of the shivering and weird feeling were recovered/resolved.   It was unknown if the reporter considered the shivering and weird feeling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced severe shivering as a result of the Shingrix.  Very strange sensation, shivering, but had no sensation of being cold.  It calmed down after about 2 hrs. Not sure it would have any bearing on the situation, but the patient was Type II diabetic and take Metformin.  As well the patient took an anti hypertensive and a cholesterol lowering drug.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Hypotension, Loss of consciousness, Road traffic accident
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blackout in a 66-year-old female patient who received SHINGRIX (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis. On 1st May 2019, the patient received the 1st dose of SHINGRIX. On 2nd May 2019, 1 days after receiving SHINGRIX the patient experienced blackout (serious criteria GSK medically significant) and low blood pressure. On an unknown date, the outcome of the blackout and low blood pressure were unknown. It was unknown if the reporter considered the blackout and low blood pressure to be related to SHINGRIX. Additional information was reported as follows: The patient was blacked out while driving and totaled her car. The patient's physician told her that, the SHINGRIX could have lowered her blood pressure enough to cause her to pass out. At the time of reporting, the patient was facing a DMV charge.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was reported by a other health professional via call center representative and described the occurrence of chills in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication The physician assistant mentioned that he had seen patients reporting chills and fever after getting the Shingrix vaccine. No additional details on the patient. The reporter was in a hurry to get answers about patient having side effects that were reported during this call.
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Axillary mass, Cyst, Erythema, Headache, Pain in extremity
Clinical narrative: Patient started feeling severe pain on left arm on February 26, 19 due to the shots he received on 02/25/19. He woke up with a Fever and headache as well. Patient's left arm was swollen, hot and Red as a tomato. Redness lasted for about a week. On Friday March 01, 2019 we noticed a bump the size - of a cherry under the left arm pit. I MOTHER TOOK PATIENT TO SEE HIS PEDIATRICIAN ON FRIDAY MARCH 08 2019 @ 4:30 p.m.  I EMPHASIZED EVERYTHING THAT HAD HAPPENED WITH PATIENT'S LEFT ARM AFTER HE RECEIVED THE VACCINE (MENINGOCOCCAL) DR. CHECKED PATIENT'S ARM PIT AND CONCLUDED THAT PATIENT HAS A CYST THAT MIGHT HAVE BEEN CAUSED BY AN INFECTION, DUE TO THE VACCINE. HE PRESCRIBED AMOXICILLIN FOR 10 DAYS. UNFORTUNATELY, THE CYST DIDN'T GO AWAY AFTER FINISHING THE MEDICATION THAT DR. PRESCRIBED.  PATIENT FEELS PAIN EVERY TIME HE TOUCHES THE CYST.  I WOULD LIKE TO MENTION THAT THE CYST HAS SHRINK FROM A CHERRY SIZE TO A 1-2 CM BLUEBERRY SIZE.
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient started feeling severe pain on left arm on February 26, 19 due to the shots he received on 02/25/19. He woke up with a Fever and headache as well. Patient's left arm was swollen, hot and Red as a tomato. Redness lasted for about a week. On Friday March 01, 2019 we noticed a bump the size - of a cherry under the left arm pit. I MOTHER TOOK PATIENT TO SEE HIS PEDIATRICIAN ON FRIDAY MARCH 08 2019 @ 4:30 p.m.  I EMPHASIZED EVERYTHING THAT HAD HAPPENED WITH PATIENT'S LEFT ARM AFTER HE RECEIVED THE VACCINE (MENINGOCOCCAL) DR. CHECKED PATIENT'S ARM PIT AND CONCLUDED THAT PATIENT HAS A CYST THAT MIGHT HAVE BEEN CAUSED BY AN INFECTION, DUE TO THE VACCINE. HE PRESCRIBED AMOXICILLIN FOR 10 DAYS. UNFORTUNATELY, THE CYST DIDN'T GO AWAY AFTER FINISHING THE MEDICATION THAT DR. PRESCRIBED.  PATIENT FEELS PAIN EVERY TIME HE TOUCHES THE CYST.  I WOULD LIKE TO MENTION THAT THE CYST HAS SHRINK FROM A CHERRY SIZE TO A 1-2 CM BLUEBERRY SIZE.
Age: 30.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Injection site scar, Oedema, Pyrexia, Robust take following exposure to vaccinia virus, Skin disorder
Clinical narrative: Healthy, 30-year-old  patient who received SPV on 1 May 2019. Patient was assessed for take on 8 May 2019 with "major take"  On 10 May (PVD 9), patient presented with robust response at SPV site plus secondary lesions. surrounding site. Patient had low-grade fever, otherwise no systemic systems. No axillary lymphadenopathy. No other lesions away from smallpox vaccination site.  ---------- 30 May 2019, Follow-up report on patient's reaction:   100% clear with no residuals aside from resolving scar.      In further conversation with patient; he revealed that he failed to follow post-smallpox vaccination care instructions and left the initial bandage in place for greater the 7 days because he went to work and left his bandages at home.        At no time did he voice any other concerns, CP/Dyspnea/fevers.   Symptoms: UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIE
Age: 30.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Vaccination complication
Clinical narrative: Healthy, 30-year-old  patient who received SPV on 1 May 2019. Patient was assessed for take on 8 May 2019 with "major take"  On 10 May (PVD 9), patient presented with robust response at SPV site plus secondary lesions. surrounding site. Patient had low-grade fever, otherwise no systemic systems. No axillary lymphadenopathy. No other lesions away from smallpox vaccination site.  ---------- 30 May 2019, Follow-up report on patient's reaction:   100% clear with no residuals aside from resolving scar.      In further conversation with patient; he revealed that he failed to follow post-smallpox vaccination care instructions and left the initial bandage in place for greater the 7 days because he went to work and left his bandages at home.        At no time did he voice any other concerns, CP/Dyspnea/fevers.   Symptoms: UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIE
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Fall, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: She fainted 5 minutes after the vaccine and fell. She lost her conscience for about 5-10 seconds. She felt weak and weird (in her own words) for about 30 minutes afterwards.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented with redness, swelling and heat in the arm in which vaccine was given.  She reported symptoms starting on 6/3 after vaccine and had not gone away on 6/5.  Dr gave antibiotic.  Patient also reported redness on stomach that the doctor thought may have been due to a tick bite.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Insomnia, Malaise, Muscle spasms, Nausea
Clinical narrative: Patient reported that she felt sick, achy, and nauseous within 24 hours of receiving immunization. She also had muscle spasms in her ribs, back, and shoulder. She had difficulty sleeping and felt as if she couldn't leave her bed for 1-2 days after receiving shot. She also developed a cough and a low fever, but no runny nose. The patient said she began to fell better after a few days, but  was still having the aches and muscle spasms on her right side where she had previously undergone a mastectomy.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Patient reported that she felt sick, achy, and nauseous within 24 hours of receiving immunization. She also had muscle spasms in her ribs, back, and shoulder. She had difficulty sleeping and felt as if she couldn't leave her bed for 1-2 days after receiving shot. She also developed a cough and a low fever, but no runny nose. The patient said she began to fell better after a few days, but  was still having the aches and muscle spasms on her right side where she had previously undergone a mastectomy.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Patient developed redness, swelling and  a "lump" at site of of injection 2 days after vaccination. Her right arm was sore and swollen for the following 5 to 6 days. The lump was approximately the size of a "fifty-cent piece" following the injection but decreased in diameter over the course of 2 weeks. The lump was size of "pea" on 06/05/2019.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient states she has intense pain in left arm after injection. No redness. Appearance is fine but pain is still present days after injection. Pain improved slightly with steroid treatment. Pain returned after steroid was finished. Patient is on second round of steroids now.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Reviewing client's medical record and describing what vaccines were for to client. Did not look further down on medical record to see that client had gotten the Shingrix vaccine 4/2019. Administered varicella vaccine to client as she stated that she is a "believer in getting vaccines," and she wanted all of what the medical record said she needed.  I realized that the error occurred once I went to record the dose given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Patient experienced bruising at the injection site, then a rash about an inch or 2 below the injection site. She described it as inflammed and hot to the touch. She also stated that there was inflammation in the arm in general.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt here with c/o possible vaccine reaction, redness, swelling & heat to area. Patient is a 5 y.o. female. She presents to the office today with complaints of redness, swelling on Lt arm 6cm induration the next day, larger and also on Rt arm 3cm induration the second day that have been ongoing since her vaccinations in office.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: patient reports HSV1 breakout at 3 days and again at 7 days post vaccination. (has had previous hsv1 breakouts)
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Skin discolouration, Vomiting
Clinical narrative: 0935- child got pale and eyes rolled back in head and passed out for 25 seconds. Mom at side. Wakes up and put cold cloth on head. Put child on left side lying position. After 10 minutes I sat child up in chair. Then 5 minutes later I walked child to waiting room. Sat in waiting room for 5 minutes and then vomited.  I got cold cloth and a bottle of water for child. Child sat another 15 minutes and then helped child and mom to car. At the doorway of office building the child felt faint and I carried child to the floor with help from mom. Child then started vomiting again (about 3 times). Child awake but very "out of it" for about 2 minutes. Resp 18 per minutes and Pulse was 62. Child breathing well and starts to awaken. Myself and another nurse moved child with blanket back into the health office room. Cold cloth to head and back of neck. Vitals taken. Blood pressure 88/58. P: 64 and resp 20 per minute. 10:10 am child on floor in supine position with head elevated and mom at side. I called family Dr. at this time to report incident (Dr. at Medical Center). Dr said this was something that could happen after vaccines and to monitor and have mom monitor today and if symptoms worsen she can bring child to clinic if not better in 1-2 hours. 1030 am - child sips at water and rests on floor. Talking and alert. 1045 am - staff sits child up slowly and then sits in a chair for another 5 minutes. Child starts to have pink skin color and denies any dizziness or nausea. 1055 am mom takes child to car and heads home.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Oral mucosal blistering, Oral mucosal eruption
Clinical narrative: Pt had terrible headache that lasted 12 hours the next day, felt fatigue for 7 days, had a rash (blisters) around her mouth
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Joint stiffness, Muscle tightness
Clinical narrative: Patient said shortly after receiving shot she felt tightness across shoulders, back of neck. Stated she did not have any difficulty breathing. Called her about 3:55 she was feeling better and was eating a sandwich.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Contusion
Clinical narrative: bruise in armpit; pain in armpit; This case was reported by a pharmacist via call center representative and described the occurrence of contusion of axillary region in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received Shingrix. On 26th May 2019, 2 days after receiving Shingrix, the patient experienced contusion of axillary region and axillary pain. On an unknown date, the outcome of the contusion of axillary region and axillary pain were unknown.   It was unknown if the reporter considered the contusion of axillary region and axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix, two days later, she reported experiencing a bruise and pain in her armpit. The reporter consented to follow up. The reporter had limited data about the patient at the time of report.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased
Clinical narrative: Woke up morning after vaccination and "knew something was wrong, could not move body for 24 hours"
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Hypokinesia, Malaise
Clinical narrative: Woke up morning after vaccination and "knew something was wrong, could not move body for 24 hours"
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Starting about 5 hours after the injection, I began to feel extremely weak. I laid down for the rest of the evening and began to have a headache, stomach ache, low grade fever, I tried getting up from the couch about 10:30pm the day of the injection and began to shiver violently. I made my way to bed and got warmed up but still felt like my entire body was just beat up. I was unable to get out of bed until 11am the next morning where I am still groggy and have some body aches. I have not ate today; no appetite. It's currently 2:30pm.  I had the same exact symptoms from the first shot of the series on February 20th, 2019.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Starting about 5 hours after the injection, I began to feel extremely weak. I laid down for the rest of the evening and began to have a headache, stomach ache, low grade fever, I tried getting up from the couch about 10:30pm the day of the injection and began to shiver violently. I made my way to bed and got warmed up but still felt like my entire body was just beat up. I was unable to get out of bed until 11am the next morning where I am still groggy and have some body aches. I have not ate today; no appetite. It's currently 2:30pm.  I had the same exact symptoms from the first shot of the series on February 20th, 2019.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Local reaction, Skin warm, Urticaria
Clinical narrative: 80x55mm local reaction wheel, red, warm and raise.  Temp- 100.9
Age: 1.33
Sex: F
Vaccine: MMRV, UNK, UNK, UNK, UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: I gave the Proquad ( MMR- Varicells) and the Varicella to patient on the same day.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient left after first vaccine with no known issues, did not call or complain about any issues. Was called to get second vaccine, as was prepping vaccine and asked which arm he would like, patient stated that in his left arm around where he thinks is the injection site he gets shooting nerve pain that lasts about 5 seconds and goes away. He states these happen one to two times weekly over the past 2 months. Asked when he started noticing the pain and he couldn't recall exact date.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability, Vomiting
Clinical narrative: Infant received oral Rotavirus around 9:30 am and intramuscular Pentacel and PCV 13 around 9:45 am. At around 10:00 am, while Mother was attempting to breastfeed (since infant was fussy), infant threw up breast milk.  Infant was crying and placed in upright position to prevent choking. No cough, difficulty breathing, change in color, redness, swelling, or hives. Infant was cleaned up and calmed down. Parent changed her diaper. Infant was alert, babbling, smiling, and tracking with her eyes. Infant left clinic in stable condition.  Mother previously breastfed infant around 8:30 am.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Muscle atrophy, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness,  swelling, and redness in left arm. Loss of muscle use, forearm muscle hung like a deflated balloon. Lasted four days. No treatment sought.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Hypoaesthesia, Injection site bruising, Injection site rash
Clinical narrative: PATIENT EXPERIENCED AN OUTBREAK OF SHINGLES.  INITIALLY STARTED WITH ARM PAIN, CHILLS, NAUSEA THE SAME EVENING AS SHE RECEIVED THE VACCINATION.  AS WELL AS A RASH/BRUISING AT THE INJECTION SITE.  DEVELOPED MYALGIAS FOLLOWED BY RASH ON NECK AND LEFT BREAST WITH ASSOCIATED NUMBNESS.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Rash
Clinical narrative: PATIENT EXPERIENCED AN OUTBREAK OF SHINGLES.  INITIALLY STARTED WITH ARM PAIN, CHILLS, NAUSEA THE SAME EVENING AS SHE RECEIVED THE VACCINATION.  AS WELL AS A RASH/BRUISING AT THE INJECTION SITE.  DEVELOPED MYALGIAS FOLLOWED BY RASH ON NECK AND LEFT BREAST WITH ASSOCIATED NUMBNESS.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Wife said no problems following vaccination on 5-30-19 until 6-4-19 when right arm started aching and became very sore. Woke up 6-5-19 states barely able to move right arm. Diabetic. Told wife he has not felt good since receiving vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Our Varicella vaccine was accidentally placed in the refrigerator instead of the freezer. Vaccine was administered. Program notified. Manufacturer was questioned by the state and they  had advised not to use this vaccine.  Per the program, no adverse reaction from the incorrect storage of the vaccine. However, the patient will need to have this dose repeated after 28 days d/t the possibility of the vaccine be ineffective because of the incorrect storage.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased activity, Pyrexia
Clinical narrative: Subjective fever and decrease activity level at night time. Patient other continue to have good oral intake and not in acute distress on follow up encounter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Chills, Pyrexia, Tachycardia
Clinical narrative: Presented to dr office 1 hour after immunization administration with fever and chills. Patient reported tachycardic and was quickly found to be in A.fib. Patient did have prior history of A.fib, not disclosed to the pharmacist.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Severe pain/swelling/redness @ injection site within initial 16 hours. Moderate headache and body aches, fever, nausea within initial 24 hours. Fever & nausea ended at four (4) days; redness @ injection site reduced to bruising at five (5) days; remaining symptoms abated by seven (7) days. Initial symptoms were severe enough to cause bed rest for three days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Severe pain/swelling/redness @ injection site within initial 16 hours. Moderate headache and body aches, fever, nausea within initial 24 hours. Fever & nausea ended at four (4) days; redness @ injection site reduced to bruising at five (5) days; remaining symptoms abated by seven (7) days. Initial symptoms were severe enough to cause bed rest for three days.
Age: 92.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pain, Pruritus
Clinical narrative: severe itching injection site swelling  and hardening in area of injection soreness in upper left arm at injection sitte moderate pain in left upper arm; now only slight pain. slight pain in left upper arm when raising arm up
Age: 92.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Administration site pruritus, Administration site swelling, Pain in extremity, Pyrexia
Clinical narrative: severe itching injection site swelling  and hardening in area of injection soreness in upper left arm at injection sitte moderate pain in left upper arm; now only slight pain. slight pain in left upper arm when raising arm up
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Large widespread hives, many over 12"in diameter. Even with Benadryl, lasted days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Feeling abnormal, Muscle twitching
Clinical narrative: Symptoms: Seizures, head twitching, inconsolable crying, high pitched screaming, loss of eye contact, zoning out, stopped talking, babbling, smiling, laughing, complete personality change. Though months of detoxing, child is finally regaining ability to do acts mentioned above.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Personality change, Screaming, Seizure
Clinical narrative: Symptoms: Seizures, head twitching, inconsolable crying, high pitched screaming, loss of eye contact, zoning out, stopped talking, babbling, smiling, laughing, complete personality change. Though months of detoxing, child is finally regaining ability to do acts mentioned above.
Age: 1.83
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure activity for 4 days starting 1 day after the vaccine. His neurologist increased the Keppra dose. Previously had 2 seizures in the past year. Has not had EEG confirmation that these are seizures. He was doing better today, a week after the vaccine, but will have an EEG if the abnormal movements recur.
Age: 30.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain upper, Chills, Pyrexia
Clinical narrative: client began feeling feverish, chills and stomachache 4 days after receiving vaccine (May 25, 2019), contacted health office 4 days later (May 29, 2019) and was told by writer she should seek medical attention through primary care provider or urgent care if symptoms have not improved with treatment, client contacted by writer today (June 5, 2019) to follow up and client is currently admitted to the hospital for symptoms, has been in the hospital for one day,  was previously admitted on June 1st but sent home after a day, was re-admitted per pcp's instructions yesterday, client states she has "been feeling better, but not well enough to go home", will continue to follow up with client
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site rash, Pain in extremity
Clinical narrative: On 6/5/19 at 12:45pm, two days after receiving immunization, the patient reported to the pharmacist and showed the pharmacist her arm that she had a raised patchy localized rash at injection site. She also stated she feels fine and has no pain at this time but her arm was sore yesterday on 6/4/19, but the slight redness and inflammation occurred this morning on 6/5/19 around 8am. The pharmacist provided a low dose of 25mg diphenhydramine liquid. The pharmacist called the patient's primary doctor at 1:09pm. The nurse, stated that the doctor was very familiar with this common reaction and informed the patient to watch her rash closely and call the doctor if fever develops. She did not have to be seen at this time.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Palpitations
Clinical narrative: Patient experienced heart palpitations and an increase in temperature of 103 degrees, which lasted for 3 hours.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: diffuse vesicular rash
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: the patient had a negative urine pregnancy test prior the vaccination/ she was vaccinated with VARICELLA/the patient left a message that she had a positive pregnancy test post administration of VARIVAX; This spontaneous prospective pregnancy report as received from a register nurse refers to currently a 24 years old female patient.  The patient's pertinent medical history included gastrooesophageal reflux disease (GERD) and drug allergy to sulfamethoxazole (+) trimethoprim (BACTRIM). Concomitant therapies included omeprazole (PRILOSEC).  On 14-MAY-2019, the patient had a negative urine pregnancy test prior the vaccination; and on the same day, she was vaccinated with properly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection in the left arm, lot # N034558 expiration date reported as 05-DEC-2019 (dosage was not reported) for vaccination catch up. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (dosage, lot number and expiration date were not reported).    On 28-MAY-2019, two weeks later, the patient called her physician and stated that she had a positive pregnancy test post administration of varicella virus vaccine live (oka/merck) (VARIVAX). The patient became pregnant with last menstrual period (LMP) of 23-APR-2019 and a estimated date of delivery (EDD) of 28-JAN-2020 with a initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 3 week(s) (exposure during pregnancy). At the reporting time, the pregnancy outcome was pending and the fetal outcome was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; The patient inadvertently re ceived first dose VAQTA immunization series that was past its expiration; This spontaneous report was received from a nurse regarding a 16 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 03-JUN-2019, the patient inadvertently received the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, at dose of 0.5 mg once, intramuscular, lot number R010369, and expiration date 25-MAR-2019 for prophylaxis, the immunization series was expired (expired product administered). No adverse effects were reported.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Eyelid function disorder, Facial paralysis
Clinical narrative: Client diagnosed on May 30, 2019 as having Bell-Palsy. Currently being treated by private provider. Left eye does not close and left side of lip drooping with no feeling.  Right side fully functioning. Treatment includes Valacyclovir 1g TID; Prednisone 6 tabs daily, dosage unknown at this time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT REPORTS CONTINUED OUTBREAKS OF SHINGLES SINCE SECOND DOSE. PATIENT HAS NOT SEEN A DIMINISHED SEVERITY SINCE THE DOSE SERIES WAS COMPLETED. OUTBREAKS ARE STILL SEVERE AND THE SHINGRIX DOSE SERIES HAS NOT PROVIDED ANY RELIEF.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Fever and vomiting within 24 hours. By day 5 post-vaccination fever and vomiting have resolved but decreased appetite has persisted.