chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Axillary pain, Chills, Confusional state, Epistaxis
Clinical narrative: 06/25- very bad bloody nose 06/26 armpit pain 06/27 extreme pain in both armpits, in neck and groin 06/28 very swollen glands in armpits, neck and groin  very painful joints - shoulders, elbows, wrists, knees and feet swollen, painful hands and finger joints 06/29 confusion, foggy thoughts 06/29 & 06/30 extreme incontrollable shaking, fever and chills 07/07 red rash spots on Right lower side of neck, upper right upper shoulder and chest 08/06/19- I still have sore shoulder and swollen sore fingers and hands
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Full blood count normal, Groin pain, Injection site pain, Injection site rash
Clinical narrative: 06/25- very bad bloody nose 06/26 armpit pain 06/27 extreme pain in both armpits, in neck and groin 06/28 very swollen glands in armpits, neck and groin  very painful joints - shoulders, elbows, wrists, knees and feet swollen, painful hands and finger joints 06/29 confusion, foggy thoughts 06/29 & 06/30 extreme incontrollable shaking, fever and chills 07/07 red rash spots on Right lower side of neck, upper right upper shoulder and chest 08/06/19- I still have sore shoulder and swollen sore fingers and hands
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Lymphadenopathy, Neck pain, Peripheral swelling, Pyrexia
Clinical narrative: 06/25- very bad bloody nose 06/26 armpit pain 06/27 extreme pain in both armpits, in neck and groin 06/28 very swollen glands in armpits, neck and groin  very painful joints - shoulders, elbows, wrists, knees and feet swollen, painful hands and finger joints 06/29 confusion, foggy thoughts 06/29 & 06/30 extreme incontrollable shaking, fever and chills 07/07 red rash spots on Right lower side of neck, upper right upper shoulder and chest 08/06/19- I still have sore shoulder and swollen sore fingers and hands
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Tremor, Urine analysis normal
Clinical narrative: 06/25- very bad bloody nose 06/26 armpit pain 06/27 extreme pain in both armpits, in neck and groin 06/28 very swollen glands in armpits, neck and groin  very painful joints - shoulders, elbows, wrists, knees and feet swollen, painful hands and finger joints 06/29 confusion, foggy thoughts 06/29 & 06/30 extreme incontrollable shaking, fever and chills 07/07 red rash spots on Right lower side of neck, upper right upper shoulder and chest 08/06/19- I still have sore shoulder and swollen sore fingers and hands
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash
Clinical narrative: Patient received 1st dose of Shingrix on 8/02/19 and noted on 8/04/19 6 small red  dots at injection site which began to merge. Patient phoned clinic on Monday 8/05 and reported rash was now approximately 4 inches by 4 inches. Patient was given same day appointment around 2:30pm. Primary physician diagnosed right arm with cellulitis and prescribed Cephalexin 500mg to be taken two capsules every 12 hours for 14 days. Patient was given follow up appointment on 8/09/19. Patient was also advised to seek ER if she began having any respiratory symptoms as itchy throat , tingling or numbness aroud mouth or throat or any difficulty swallowing or breathing. Patient verbalized understanding.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: High fever of 101 for 48 hours. Chills. Soaked with sweat but after 48 hours fever went back down to normal. Muscle aches especially right arm. My arm still isnt normal  after over a week. Im having second thoughts on the 2nd shot. I didnt take any pain killers but they might help with the second shot.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Emotional distress, Screaming
Clinical narrative: Screaming uncontrollably for several hours; could not be consoled. Did not return to normal behavior until 2-3 days.
Age: 25.0
Sex: F
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: immunization should have been administered subcutaneously. in error, pharmacist administered immunization intramuscularly. spoke with Merck vaccine information, they indicated that the response is unlikely to vary if subQ was given IM and it is not recommended to redose the vaccine. patient was made aware and is not concerned. counseled on possible side effects including soreness and fever.
Age: 25.0
Sex: F
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: immunization should have been administered subcutaneously. in error, pharmacist administered immunization intramuscularly. spoke with Merck vaccine information, they indicated that the response is unlikely to vary if subQ was given IM and it is not recommended to redose the vaccine. patient was made aware and is not concerned. counseled on possible side effects including soreness and fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Urticaria
Clinical narrative: Patient received her 2nd dose of Shingrix on 8/05/19 and went on to work Around noon , patient began scratching behind her knees snd left thigh. Patient thought it was mosquito bites. , but later noted they werewelts in appearance. She did not recall any side effects with first dose given. Patient denied any shortness of air nor difficulty breathing nor swelling of throat , tongue or lips swelling or tingling. States she was also a little nauseated during the night of 8/05/19. Patient denied any heart palpitations nor increased heart rate or weakness. . Patient reported the symptoms on 8/06/19 to primary physician Dr. who prescribed Benadryl for itching and hydrocortisone cream for welts. Patient was advised to call back if symptoms worsened or if respiratory symptoms started to seek ER.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Cough, Dehydration, Dyspnoea, Feeding disorder
Clinical narrative: continuous cough, high fever 105 and over for 5 days, unable to perform daily activities or attend school, muscle weakness, and severe headache. unable to eat, nausea, shortness of breath. dehydration.  treatment consisted of Doctor visits with augmentin and Zithromax prescriptions and inhaler.  Symptoms progressed and required ER visit on 11/28/18. was provided with IV fluids for dehydration. Decadron steroids and breathing treatments for one week.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Laboratory test, Loss of personal independence in daily activities, Muscular weakness, Nausea
Clinical narrative: continuous cough, high fever 105 and over for 5 days, unable to perform daily activities or attend school, muscle weakness, and severe headache. unable to eat, nausea, shortness of breath. dehydration.  treatment consisted of Doctor visits with augmentin and Zithromax prescriptions and inhaler.  Symptoms progressed and required ER visit on 11/28/18. was provided with IV fluids for dehydration. Decadron steroids and breathing treatments for one week.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: continuous cough, high fever 105 and over for 5 days, unable to perform daily activities or attend school, muscle weakness, and severe headache. unable to eat, nausea, shortness of breath. dehydration.  treatment consisted of Doctor visits with augmentin and Zithromax prescriptions and inhaler.  Symptoms progressed and required ER visit on 11/28/18. was provided with IV fluids for dehydration. Decadron steroids and breathing treatments for one week.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood glucose normal, Differential white blood cell count normal, Dizziness, Electrocardiogram normal
Clinical narrative: In the evening started to develop flu like symptoms.  Fever, shakes, weakness.  by the following morning around 8:00 am was slightly nauseous and quite dizzy.  Passed out 2 or 3 times.  went to the ER, blood pressure was quite low when I got there. tests ran and bloodwork came back normal.  Not dehydrated.  Nothing else out of the ordinary was different about that day or night other than the fact that I had the vaccine.  by 11:00 blood pressure was back up to 112/68
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Hypotension, Influenza like illness, Loss of consciousness, Metabolic function test normal
Clinical narrative: In the evening started to develop flu like symptoms.  Fever, shakes, weakness.  by the following morning around 8:00 am was slightly nauseous and quite dizzy.  Passed out 2 or 3 times.  went to the ER, blood pressure was quite low when I got there. tests ran and bloodwork came back normal.  Not dehydrated.  Nothing else out of the ordinary was different about that day or night other than the fact that I had the vaccine.  by 11:00 blood pressure was back up to 112/68
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: In the evening started to develop flu like symptoms.  Fever, shakes, weakness.  by the following morning around 8:00 am was slightly nauseous and quite dizzy.  Passed out 2 or 3 times.  went to the ER, blood pressure was quite low when I got there. tests ran and bloodwork came back normal.  Not dehydrated.  Nothing else out of the ordinary was different about that day or night other than the fact that I had the vaccine.  by 11:00 blood pressure was back up to 112/68
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperaesthesia, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: - Fever starting Saturday, 8/3/19 ending Saturday 8/3/19 bedtime (approximately 11:00 PM) accompanied by muscle  and joint ache (typical with fever) - redness, heat, and skin sensitivity in area of injection extending approximately 2" around injection site starting 8/3/19, as of today, 8/6/19 size of affected area and sensitivity have diminished by about half of that on Sunday,
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Ventricular extrasystoles
Clinical narrative: - Fever starting Saturday, 8/3/19 ending Saturday 8/3/19 bedtime (approximately 11:00 PM) accompanied by muscle  and joint ache (typical with fever) - redness, heat, and skin sensitivity in area of injection extending approximately 2" around injection site starting 8/3/19, as of today, 8/6/19 size of affected area and sensitivity have diminished by about half of that on Sunday,
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: fatigue, chills starting morning after vaccine & lasting throughout that day
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak , vaccine was admistered at pharmacy
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Electroencephalogram normal, Posture abnormal, Protrusion tongue, Tardive dyskinesia
Clinical narrative: She started to drop her head, and smack her lips together 2x while sticking out her tongue
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Patient returned to pharmacy 08/06/2019 displaying redness and swelling of the left arm from his shoulder to mid-forearm. He stated he was also experiencing localized itching and a sunburn-type sensation which began approximately 2 hours after the immunization. He has taken diphenhydramine for the reaction, but has not experienced much improvement.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Skin burning sensation
Clinical narrative: Patient returned to pharmacy 08/06/2019 displaying redness and swelling of the left arm from his shoulder to mid-forearm. He stated he was also experiencing localized itching and a sunburn-type sensation which began approximately 2 hours after the immunization. He has taken diphenhydramine for the reaction, but has not experienced much improvement.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient is still complaining of fairly severe pain from injection 30 days after injection
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site was red and spread about an inch in diameter, area was slightly warm to touch. pt. reports no pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Fall, Loss of consciousness
Clinical narrative: PATIENT WOKE UP THE NEXT MORNING FOLLOWING THE SHOT AND FELT DISORIENTED . SHE STATED SHE WAS ATTEMPTING TO DRESS HERSELF WHEN SUDDENLY SHE PASSED OUT. ACCORDING TO HER HUSBAND (WITNESS), HER EYES JUST WENT BACK INTO HER HEAD AND THEN SHE WENT DOWN. SHORTLY LATER SHE CAME TO, DECIDED TO GO BACK TO BED. LATER THAT DAY SHE WOKE UP FEELING NORMAL.  SHE HAD NOT STARTED ANY NEW MEDICATIONS AND THIS IS NOT SOMETHING COMMON THAT HAPPENS TO HER.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Rash
Clinical narrative: Sore at injection spot and muscles surrounding.  Rash on side of upper arm xs 4 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: PATIENT'S SON CAME IN 3 DAYS AFTER THE VACCINE WAS GIVEN AND STATED THAT ARM WAS RED AND SORE. HE ALSO STATED THAT MOTHER WAS EXPERIENCING FLU-LIKE SYMPTOMS. ARM WAS SWOLLEN AND ITCHY. WE RECOMMENDED IBUPROFEN FOR SWELLING AND LORATIDINE FOR ITCHINESS.  ALSO RECOMMENDED PT FOLLOW UP WITH MD IF STILL CONCERNED. WE DISCUSSED THAT REDNESS, SWELLING AND FLU LIKE SYMPTOMS ARE ALL COMMON SIDE EFFECTS.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperventilation, Pain in extremity, Respiration abnormal, Syncope, Tremor
Clinical narrative: patient began shaking and breathing heavily,fainted and was out for approx 1 minute, came to and did not remember what happened. Three hours later patient feels okay, arm is sore
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Contagious rash (chicken pox), spread to sibling
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Lymph node pain, Pain, Skin warm
Clinical narrative: Large area of redness?sore and hot which is getting more inflamed on day 3+. Also tender lymph nodes in neck on same side as injection arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: red big spot, pain shooting down, red mark spreading
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Injection site pain, Limb discomfort, Muscle spasms
Clinical narrative: Currently pregnant.  29 weeks.  The injection site and arm started to hurt hours after vaccine.  Pain became so extreme with muscle spasms, that arm was immobile for 3 days.  Pain and discomfort have improved somewhat, but continue to date.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Currently pregnant.  29 weeks.  The injection site and arm started to hurt hours after vaccine.  Pain became so extreme with muscle spasms, that arm was immobile for 3 days.  Pain and discomfort have improved somewhat, but continue to date.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: Soreness at the injection site. Mild on the first day, More pronounced on days 2 and 3. Starting to fade on day 4  Extreme shivering starting on day 1 about 13 hours after the injection, followed by strong fever. Unable to sleep much that night. Symptoms subsided by about 20 hours after the injection.  Mild nausea accompanied the shivering.    It should be noted that this was the second shot in the series. I only had injection soreness after the first shot (about 3 months previously)
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Peripheral swelling, Rash erythematous
Clinical narrative: Right arm swelling red & rash noted Mom gave Benadryl & rash gone.
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Blood pressure increased, Chest X-ray, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Nausea Dizzy *Severe pain in right arm swollen right arm elevated BP
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Nausea Dizzy *Severe pain in right arm swollen right arm elevated BP
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: About a week after administration of vaccine pt started to develop an itchy rash on arms & legs -Pt seeing Dr on 8/11/19
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Pyrexia
Clinical narrative: Patient stated she became fevered and had a headache and felt hot later in the evening and overnight after receiving the vaccine.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Asthenia, Dizziness, Electrocardiogram normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Within 2 minutes of receiving vaccines, patient c/o of weakness and dizziness. Had patient sit down. He was profusely sweating. He lost consciousness twice for approximately 1-2 minutes each time. C/O not being able to feel his arms and legs. V/S taken twice. B/P 62/32, P 54. Repeated after 2 minutes, B/P 101/56, P 54. Ambulance transported patient to nearby ER. Spoke with patient's mother approximately 3 hours later. EKG was normal at ER. Patient's V/S had returned to normal. He was feeling better and sent home.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Sensory loss
Clinical narrative: Within 2 minutes of receiving vaccines, patient c/o of weakness and dizziness. Had patient sit down. He was profusely sweating. He lost consciousness twice for approximately 1-2 minutes each time. C/O not being able to feel his arms and legs. V/S taken twice. B/P 62/32, P 54. Repeated after 2 minutes, B/P 101/56, P 54. Ambulance transported patient to nearby ER. Spoke with patient's mother approximately 3 hours later. EKG was normal at ER. Patient's V/S had returned to normal. He was feeling better and sent home.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pallor, Rash, Rash pruritic
Clinical narrative: On Second day 8/3 per mother broke out in Rash both thighs, itchy, no fever no trouble breathing Seen in office 8/6 Rx Benadryl, calamine, hydrocortisone cream Rash was resolving blanches
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: painful when touched, redness & swollen
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Heart rate increased, Hypotension, Pain in extremity
Clinical narrative: Sore arm, headache, low fever, high pulse, low blood pressure, tiredness. Vaccination administered by pharmacy
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm, headache, low fever, high pulse, low blood pressure, tiredness. Vaccination administered by pharmacy
Age: 52.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Patient's husband came into clinic today to report that patient has developed a hot red arm at the site of injection. This developed from the sore arm and general malaise the day after the vaccines were given. This has become larger overnight. Patient is being treated with Rocefin.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; a patient was administered an improperly stored VARIVAX.; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about pertinent medical history, concurrent condition and drug reaction/allergy was not provided. The patient's concomitant medication included sterile diluent.   On 06-JUL-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R003299 with expiration date 01-FEB-2020; strength, dose detail and route were not reported) for prophylaxis(improper storage of product in use). The sterile diluent used to reconstitute the vaccine was stored properly. The vaccine underwent temperature excursion from 15 Fahrenheit degree to 46 Fahrenheit degree for a duration of 3 hours. There was no previous temperature excursion. A digital data logger was not involved. No adverse effects was reported. The outcome of the event was unknown. The causality was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a dose of expired PNEUMOVAX 23 was inadvertently administered to the patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 20-JUL-2019, the patient was vaccinated, inadvertently, with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N030987 (verified to be a valid lot number), expiration date reported and established as 15-MAY-2019, for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Allergic reaction to excipient
Clinical narrative: Allergic reaction to the Ethylenediaminetetraacetic acid (EDTA); This spontaneous report was received from a consumer who was the patient's mom concerning a male patient of unknown age. No information was provided regarding the patient's concurrent conditions, concomitant medications, pertinent medical history and drugs or allergies reactions.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis  (strength, dose, frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported).   On an unknown date (reporter as after receiving the varicella virus vaccine live (Oka/Merck) (VARIVAX)), the patient had an allergic reaction to the Ethylenediaminetetraacetic acid (EDTA) content (allergic reaction to excipient).   The outcome for the event was not reported.   The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was not provided.
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 of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 25-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a pharmacy. On an unspecified date, the patient experienced shingles.Subsequent to pt's inoculation, pt was treated by a healthcare provide for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX) vaccine, pt has 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 reporter considered the event 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, 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.     On or about 07-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, the pt was treated at a hospital for shingles.        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 lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation involving a patient (pt) of unknown age and gender. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On an unknown date in 2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, 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 physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) use the pt suffered and would continue 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, 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: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster keratoconjunctivitis; Information has been received regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On an unknown date in 2010, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, 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 health care provider for herpes zoster keratoconjunctivitis (ophthalmic herpes zoster). As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) use the pt suffered and would continue 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, 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 keratoconjunctivitis was not reported. The reporter considered herpes zoster keratoconjunctivitis to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, herpes zoster keratoconjunctivitis was determined to be a medically significant event.
Sex: F
Vaccine: DTAP, IPV, MEN, MMR, MMRV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: was also late to receive her vaccinations for polio, measles, mumps, rubella, meningitis, diphteria, tetanus and pertusis; received PROQUAD and M-M-R II; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a 14-year-old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-AUG-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). The nurse reported that on an unknown date, the patient was late to receive her vaccination with meningococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (inappropriate schedule of vaccine administered, extra dose administered).
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: The patient bad blood titers drawn three weeks ago, and is showing no titers for the mumps only; Information has been received from the patient's mother referring to a 29 years old male patient who was severe sulfa allergy. The patient had none concomitant medication or medical history.    In 1992 (reported as about 27 years ago), the patient received the full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, schedule, lot# and expiration date were unknown) injection in the arm for prophylaxis.  On 11-JUL-2019 (reported as three weeks ago), the patient bad blood titers drawn and was showing no titers for the mumps only (mumps antibody test negative). Unspecified lab studies performed: lack of mumps titers. The outcome of the event was reported as not recovered. The patient did not seek medical attention and no treatment was given for the event.  Causality assessment was not provided.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; Patient inadvertently received first dose of ROTATEQ in series that had expired.; This spontaneous report has been received from a medical assistant referring to a 3 months old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 31-JUL-2019 the patient inadvertently received first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # R000911, expiration date: 28-FEB-2019, dose unknown) in series that had expired for prophylaxis (expired product administered).         No adverse effects reported.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: severe burning while the medication was being injected; This spontaneous report was received from a medical assistant referring to a 12 year old male patient, with no pertinent medical history and no known drug reactions/allergies.    Concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (right arm, different location).     On 01-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1614897, expiring on 20-SEP-2021, dose 2, intramuscularly,y in the right arm, for vaccination.    The patient experienced severe burning while the medication was being injected into the right arm (injection site pain).   Burning resolved a few minutes after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered.  No treatment was provided.  Not any lab diagnostic test was performed.  The patient did not seek for medical attention.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event.  This is one of two reports from the same source (1908USA002441).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored VARIVAX; This spontaneous report was received from an office manager, concerning a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 05-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S008692 and expiration date on 21-MAR-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complalint was involved.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA002451:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; the patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient's historical conditions, previous drug reactions, allergies, concurrent condition and concomitant medications were not provided.  On 26-APR-2019, the patient was inadvertently vaccinated with an expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) (route of administration and doses were not reported; lot # N012619 and expiration date 21-APR-2019) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). No temperature excursion. No adverse effects were reported. No additional information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored VARIVAX; This spontaneous report was received from an office manager, concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 05-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # S008692 and expiration date on 21-MAR-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complalint was involved.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA002281:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effecet; improperly stored doses of proquad was administered; This spontaneous report was received from a medical assistant regarding a patient of unknown age. Information related to pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 02-AUG-2019 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S003171, expiry date:30-JUL-2020, dose, route and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was stored at a temperature of -11.68 degree Celsius at a time frame of 2 hours and 15 minutes which was noted in digital data logger. There were no previous temperature excursions. No adverse affects reported (no adverse event). No PQC was involved.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; patient received varivax on10/20/2006 after receiving MMR II on 10/10/2006; This spontaneous report was received from a nurse regarding a patient of unknown age. Information on the patient's pertinent medical history, other concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 10-OCT-2006, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) and on 20-OCT-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). Other suspect therapies included sterile diluent. No adverse event reported. No product quality complaint (PQC).
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash on Right Hand; Initial Report Received on 11-Jul-2019 and 25-Jul-2019  A pharmacist from the US reported that a 37-year-old female patient (race unknown) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed a rash on her right hand.  Relevant medical history and concomitant medications were not provided.  On 10-Jul-2019, the patient received the first injection of HEPLISAV-B (unknown site) from a pre-filled syringe (lot # 933094, expiration date 17-Apr-2021, and NDC # unknown). The vaccine was administered by the supervisor of the reporting pharmacist at their pharmacy. The patient developed a rash on her right hand that resolved. The patient had no other adverse reactions and was "okay" at the time of this report.   On 11-Jul-2019, the patient called the pharmacy and reported the above adverse event. The pharmacist was advised to refer the patient to her doctor for any further determination of future injections. The pharmacist stated the patient has an appointment in 2 weeks already.   On 25-Jul-2019, the pharmacist reported that the patient has an appointment scheduled in 1-2 weeks with her physician to obtain a titer result. At the time of this report, a second dose of HEPLISAV-B had not been administered yet.   At the time of this report, the event of rash on right hand was considered resolved.    The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of rash as non-serious. The event of rash is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of rash as non-serious. The event of rash is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: HEP, PPV
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Injection site erythema, Injection site induration
Clinical narrative: Redness at Injection SIte With Firmess and Heat; Redness at Injection SIte With Firmess and Heat; Does not have appetite; Drinking much water; Redness at Injection SIte With Firmess and Heat; Initial Report Received on 11-Jul-2019  A male patient (age not disclosed, race not provided), was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed redness at injection site with firmness and heat; he also "does not have appetite and is drinking much water."  Relevant medical history was not provided (not disclosed). Allergies included horse serum and Lipitor (atorvastatin).  Concomitant medications included pioglitazone, vitamin C (ascorbic acid), Wellbutrin (bupropion), Crestor (rosuvastatin), glipizide, multivitamin, and Aspirin (acetylsalicylic acid).  On 09-Jul-2019, the patient received a dose of HEPLISAV-B in the left shoulder (lot #, expiration date, and NDC # not provided) and Pneumovax (pneumococcal vaccine) in the left shoulder (lot #, expiration date, and NDC # not provided).   On 11-Jul-2019, the patient reported that he developed a three-inch redness at the injection site with firmness and heat. He also stated that he does not have an appetite and was drinking much water. He also reported that these were new symptoms since Tuesday (09-Jul-2019). The patient had telephoned his health care provider (HCP) twice to inform them of his condition but with no return call.  On 11-Jul-2019, the patient was contacted to obtain further information after receiving the initial report from him earlier in the day and he sounded short of breath and weak. The patient stated he had heard back from his HCP but could not travel to their office due to the long distance and his wife had the car. The patient also stated he could not afford to go to the doctor. He was instructed to seek medical help if his condition worsened. The patient stated he had been sleeping, his condition sounded improved, and he verified that he was okay.   At the time of report, the outcome of redness at injection site with firmness and heat, and "does not have appetite and is drinking much water" was unknown.  The reporter did not provide a seriousness assessment for the events.   Company comment:  The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.; Sender's Comments: The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.
Sex: U
Vaccine: HEP, PPV
Symptoms: Injection site warmth
Clinical narrative: Redness at Injection SIte With Firmess and Heat; Redness at Injection SIte With Firmess and Heat; Does not have appetite; Drinking much water; Redness at Injection SIte With Firmess and Heat; Initial Report Received on 11-Jul-2019  A male patient (age not disclosed, race not provided), was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed redness at injection site with firmness and heat; he also "does not have appetite and is drinking much water."  Relevant medical history was not provided (not disclosed). Allergies included horse serum and Lipitor (atorvastatin).  Concomitant medications included pioglitazone, vitamin C (ascorbic acid), Wellbutrin (bupropion), Crestor (rosuvastatin), glipizide, multivitamin, and Aspirin (acetylsalicylic acid).  On 09-Jul-2019, the patient received a dose of HEPLISAV-B in the left shoulder (lot #, expiration date, and NDC # not provided) and Pneumovax (pneumococcal vaccine) in the left shoulder (lot #, expiration date, and NDC # not provided).   On 11-Jul-2019, the patient reported that he developed a three-inch redness at the injection site with firmness and heat. He also stated that he does not have an appetite and was drinking much water. He also reported that these were new symptoms since Tuesday (09-Jul-2019). The patient had telephoned his health care provider (HCP) twice to inform them of his condition but with no return call.  On 11-Jul-2019, the patient was contacted to obtain further information after receiving the initial report from him earlier in the day and he sounded short of breath and weak. The patient stated he had heard back from his HCP but could not travel to their office due to the long distance and his wife had the car. The patient also stated he could not afford to go to the doctor. He was instructed to seek medical help if his condition worsened. The patient stated he had been sleeping, his condition sounded improved, and he verified that he was okay.   At the time of report, the outcome of redness at injection site with firmness and heat, and "does not have appetite and is drinking much water" was unknown.  The reporter did not provide a seriousness assessment for the events.   Company comment:  The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.; Sender's Comments: The company assessed the events of injection site induration, injection site warmth, injection site redness, decreased appetite, and polydipsia as non-serious. The events of injection site induration, injection site warmth, decreased appetite and polydipsia are unlisted and the event of injection site redness is listed per HEPLISAV-B.
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Six Month Old Received Heplisav-B; Initial Report Received on 18-Jul-2019  A vaccine manager reported that a six-month old female patient (race unknown) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Relevant medical history, concomitant medications, and allergies were reported as none.    On the morning of 18-Jul-2019, the patient was administered with a dose of HEPLISAV-B (lot # 933093, expiration date 11-Apr-2021, and NDC # unknown) from a pre-filled syringe. The vaccine was administered by a nurse at a clinic. The patient experienced no adverse events and was doing well. The patient was also administered Pentacel (diphtheria, tetanus, pertussis, polio, and haemophilus influenza type B vaccine), Prevnar 13 (pneumococcal vaccine), and Rotateq (rotavirus vaccine) on this date.   At the time of this report, no adverse events were reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.