chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Burning sensation, Chills, Head discomfort, Hyperhidrosis, Muscular weakness
Clinical narrative: I had severe muscle aches, burning,  head feeling like it would explode, vomiting, severe nausea, extreme muscle weakness, fever 101.6;  constant chills; later sweats.  Called pharmacist and they just keep repeating no oily foods, sweets, fried.   Seriously, I could not even stand up and could not even hold down water.  I feel they should warn you in advance and tell you to have gatorade or something else around as I live alone and this was quite severe.   I thought I was going to have to go to the hospital.   Thank God fever broke, second day in I feel a bit better but still lots of muscle weakness.
Age: 64.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: I had severe muscle aches, burning,  head feeling like it would explode, vomiting, severe nausea, extreme muscle weakness, fever 101.6;  constant chills; later sweats.  Called pharmacist and they just keep repeating no oily foods, sweets, fried.   Seriously, I could not even stand up and could not even hold down water.  I feel they should warn you in advance and tell you to have gatorade or something else around as I live alone and this was quite severe.   I thought I was going to have to go to the hospital.   Thank God fever broke, second day in I feel a bit better but still lots of muscle weakness.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Injection site pain
Clinical narrative: Fever, chills, muscle aches, joint aches, fatigue, sleeplessness, very tender injection site, reduced strength in injection arm
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, joint aches, fatigue, sleeplessness, very tender injection site, reduced strength in injection arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: shivering ,fever
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia, Vertigo
Clinical narrative: Fever, chills, vertigo, muscle pain
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site bruising
Clinical narrative: Patient reports limited range of motion to L arm, unable to lift arm above head or extended, patient reports he has to use his R arm to help raise his L arm. Patient reports ice pack/heat pack are not helping with pain. First documentation of "left upper extremity glenohumeral"  by physical therapy on 1/31/2020. Patient has bruise to anterior side of L axillary/deltoid area, documentation of flu vaccine to L deltoid on 1/28/2020.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain
Clinical narrative: Body aches, fatigue, joint pain, injection site pain from three hours following injection through the night and the following day. Took naproxen sodium to reduce pain.  Symptoms finally abated by next morning.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction, Vertigo
Clinical narrative: employee stated that she began to feel dizzy after receiving  immunization   immediately after but continued to work instead of notifying msa. . After approximately 1/2 hour she notified msa that she was dizzy and everything was spinning.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pain
Clinical narrative: Fever, chills, body aches
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, body aches
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood thyroid stimulating hormone normal, Facial pain, Full blood count normal, HIV test negative
Clinical narrative: Approximate ten days after 16 NOV 2019 vaccination, facial pain developed, as if tooth ache extending to right year. On Sat 30 NOV 2019 a significant shingles rash with central blisters developed from the chin through the right cheek and eyelids to the middle of the scalp. Aciclovir 800 mg/5 times a dayfor eight days started on 2 DECEMBER 2019. Valacyclovir 1 g/3 times a day for seven days started on 9  DEC 2019.  Ending on 17 DEC 2019. Ocuflox 1 drop/4 times per day started on 4 DEC 2019 for 15 days until 17 DEC 2019. Within three days of antiviral medication, no new lesions developed.  Lesions left apparently permanent scars. On 24 DEC 2019 unbearable facial itching developed, non-responsive to Lidocaine 4%.  Subsided after three days. New shingles rash appeared on the nose on 26 DEC 2019.  On 27 DEC 2019 numerous nose lesions developed. Valacyclovir 1 g/3 times a day for seven days started on 27  DEC 2019.  Ending on 2 JAN 2020.  Rash responded to medication. Prednisolone Forte, 1 drop/2 per day started on 2 JAN 2020 for 26 days, and continuing  1 drop per day until 11 FEB 2020. New significant shingles rash over right eyebrow developed on 11 JAN 2020. Valacyclovir 1 g/3 times a day for seven days started on 11 JAN 2020.  Ending on 18 JAN 2020.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Metabolic function test normal, Pruritus, Skin lesion
Clinical narrative: Approximate ten days after 16 NOV 2019 vaccination, facial pain developed, as if tooth ache extending to right year. On Sat 30 NOV 2019 a significant shingles rash with central blisters developed from the chin through the right cheek and eyelids to the middle of the scalp. Aciclovir 800 mg/5 times a dayfor eight days started on 2 DECEMBER 2019. Valacyclovir 1 g/3 times a day for seven days started on 9  DEC 2019.  Ending on 17 DEC 2019. Ocuflox 1 drop/4 times per day started on 4 DEC 2019 for 15 days until 17 DEC 2019. Within three days of antiviral medication, no new lesions developed.  Lesions left apparently permanent scars. On 24 DEC 2019 unbearable facial itching developed, non-responsive to Lidocaine 4%.  Subsided after three days. New shingles rash appeared on the nose on 26 DEC 2019.  On 27 DEC 2019 numerous nose lesions developed. Valacyclovir 1 g/3 times a day for seven days started on 27  DEC 2019.  Ending on 2 JAN 2020.  Rash responded to medication. Prednisolone Forte, 1 drop/2 per day started on 2 JAN 2020 for 26 days, and continuing  1 drop per day until 11 FEB 2020. New significant shingles rash over right eyebrow developed on 11 JAN 2020. Valacyclovir 1 g/3 times a day for seven days started on 11 JAN 2020.  Ending on 18 JAN 2020.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site vesicles, Injection site warmth, Pruritus
Clinical narrative: I experienced a red welt about three inches in length and two inches wide at the injection site. There was also a sign of a hive/blister in the same area. The whole area was extremely hot to the tough. This lasted for almost six days. I had experienced welts from immunotherapy shots in the past, and the recommendation was to take extra does of antihistamine and to use hydrocortisone and/or antihistamine cream. I did this for about a week, and the welt finally subsided. As it started to subside after six days, I started experiencing itchiness and still had two small bumps as of day 10. Since I am familiar with adverse reactions due to my immunotherapy treatment, I did not seek medical help as I was not having a reaction elsewhere on my body (i.e. hives/rashes in other places, anaphylactic).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: At the time of injection, I felt a hot sensation down my arm. I mentioned it to NP. From that date on, my left arm has been quite sore. At first was unable to reach up or out with my arm. Continues to be sore, improving, but continued soreness and tenderness.~ this is months later.
Age: 0.17
Sex: F
Vaccine: DTAP, UNK, UNK
Symptoms: Tremor
Clinical narrative: After these shots I took her home and went about our day as normal. When I put her to bed her body started shaking in her sleep. As a momma this was very scary for me! I called her doctor and they did see her a couple different times. I was told this is "normal" (I have two older children that never did this so I know it is not normal!) and she told me that she would report it. I recently found out that it was never reported! That is why I am on here now
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Pain, Quality of life decreased
Clinical narrative: Left shoulder discomfort that initially began at time of injection at the injection site.  The pain persisted at the injection site and then radiated anteriorly and posterior to the  injection.  The pain can reach up to level 8 upon certain arm movement, and has affected my quality of life over the past 3 months.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Soft tissue swelling
Clinical narrative: Patient presented to the pharmacy today with soft tissue swelling below the armpit area next to the chest wall with a slight pink tone to skin.  No fever, drainage, hardness, or tenderness at injection site.  The patient received the injection 4 days ago.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Upon injection, some of the dose (exact amount unknown) squirted out of the needle attachment, and thus the patient likely did not receive the full dose of the vaccine. No adverse events occurred.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Patient presneted with redness in arm from shoulder to elbow, multiple bruises; was referred to a physician to determine if this was an allergic reaction (local) or cellulitis
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: RASH ON INJECTION SITE AND DEVELOPING RASH UNDER THE CHIN
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Pain in extremity, Swelling
Clinical narrative: Pain in left arm, 3 inch circle of swelling and redness, diarrhea, tiredness
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Headache, Influenza like illness
Clinical narrative: Pounding/pressure headache started within a few hours.  It worsened as the day went on.  By evening, I was chilled and shivering with no relief from multiple blankets.  Fever was likely 103 that night, although I didn't take my temperature until the next morning after the chills subsided. Then, it was 102.5 -- the highest I've ever had aside from the flu over a decade ago.  I slept ALL day that day -- the day after the vaccine, with my temperature gradually lowering to only 99 by the 3rd morning.  During that time, my left arm was extremely sore, and my whole body was weak and achy (just like the flu).  I did not, (thank you, Jesus) have an gastro-intestinal distress.  According to the internet, only 1 in 6 patients have this reaction.  This was my 2nd dose and I had no reaction to the 1st one, 12 months prior. A friend of mine who is a doctor said that 9 out of 10 of her patients taking this vaccine DO have this reaction.  I do believe that the public should be made aware so they can plan ahead for this debilitating shot.  I would do it all over again to avoid shingles in the future, but it would be nice to be able to plan ahead.  Thank you!
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pounding/pressure headache started within a few hours.  It worsened as the day went on.  By evening, I was chilled and shivering with no relief from multiple blankets.  Fever was likely 103 that night, although I didn't take my temperature until the next morning after the chills subsided. Then, it was 102.5 -- the highest I've ever had aside from the flu over a decade ago.  I slept ALL day that day -- the day after the vaccine, with my temperature gradually lowering to only 99 by the 3rd morning.  During that time, my left arm was extremely sore, and my whole body was weak and achy (just like the flu).  I did not, (thank you, Jesus) have an gastro-intestinal distress.  According to the internet, only 1 in 6 patients have this reaction.  This was my 2nd dose and I had no reaction to the 1st one, 12 months prior. A friend of mine who is a doctor said that 9 out of 10 of her patients taking this vaccine DO have this reaction.  I do believe that the public should be made aware so they can plan ahead for this debilitating shot.  I would do it all over again to avoid shingles in the future, but it would be nice to be able to plan ahead.  Thank you!
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac arrest, Condition aggravated, Pneumonia, Sepsis
Clinical narrative: Patient was admitted to hospital from home for pneumonia. She was vaccinated on day of discharge to a skilled nursing facility. She proceeded to stay ill & did not recover from her illness. She was admitted to hospital 1/12/20 for sepsis and multifocal pneumonia. She cardiac arrested during hospital stay
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Uncontrolled shivering for approximately one hour.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient reported pain on injection on the date of the shot. Called back to pharmacy within 5-7-days of shot complaining of soreness and pain at the site. After ~ 1 month, pain had become a neuropathy/tingling issues
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Disorientation, Eye movement disorder, Seizure
Clinical narrative: seizure disorder; her eyes went off to the side; Disorientated; Confused; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 745961) on 20-SEP-2018.  This spontaneous report was received from regulatory authority referring to a 11-year-old female patient. The patient's concurrent illness, other medications, pertinent medical history and prior vaccinations were not reported.   On 25-APR-2018, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm (lot # N020139, expiration date: 14-FEB-2020, dose and frequency unknown) for prophylaxis. On the same day, the patient was vaccinated with diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (dose number: 2), intramuscularly in the left arm, lot# U5979AA; dose and expiration date unknown) and with meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (dose number: 2), intramuscularly in the right arm (lot# U5848AA; dose and expiration date unknown) for prophylaxis. On the same day, about one hour after the vaccinations, the patient had returned to school and had an episode where she became disoriented. The patient's friend told her eyes went off to the side (Eye movement disorder), which lasted about 2 minutes. The patient was then a little bit confused afterwards (Confusional state). It was reported that, the patient would be having an electroencephalography (EEG) done as outpatient. The outcome of the events was reported as recovered. Causality assessment was not provided.  Follow up information has been received from health professional via FDA on 29-OCT-2019.   The dose number of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) was 1 in series. The patient received the vaccines at 10:30. The patient began to experience the events at 12:00. The patient visited emergency room due to the events. The patient had never had an event following any previous vaccine.  Follow-up information has been received from a registered nurse on 28-JAN-2020. On 28-JAN-2020, a call was received from office manager. She stated that on the day of the call, she faxed vaccine adverse experience form.  Additional information was not expected  The patient's concurrent conditions included staring spells. Meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) expiration date was reported as 11-MAR-2019. Diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) expiration date was reported as 13-JUN-2020. On an unknown date in May 2018, the patient was diagnosed with seizure disorder. The outcome of the event was not reported.  Upon internal review, seizure was considered to be medically significant.  .
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff was treated for shingles or herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of an unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 01-JAN-2015, as prescribed and/or administered by a healthcare provider, pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of herpes zoster or shingles. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles or herpes zoster (herpes zoster). Additionally, as a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain and suffered significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization (unspecified date), 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. At the reporting time, the pt was not recovered from the event and it was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Headache, Hypersomnia, Neurological examination normal, Pain in extremity
Clinical narrative: mild arm soreness; he slept off and on for the next 16 hours; fatigue; headache; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Freedom of Information Act (VAERS # 810131) on 11-NOV-2019.  This spontaneous report was received from a health care professional, referring to a 11-year-old male patient. The patient had environmental allergies to pollens (mild). His medical history included topical, not infectious urethral irritation.  On 15-APR-2019 at 10:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose were not provided) administered intramuscularly in the left arm for prophylaxis. On the same day, he was vaccinated with a first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot # reported as 33CA7) intramuscularly in the left arm; and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # reported as AMVA087A) intramuscularly in the right arm.  On 15-APR-2019 at 14:00, the patient developed fatigue, headache and mild arm soreness. He slept off and on for the next 16 hours. He was seen in clinic on 16-APR-2019 at 09:00 and still had fatigue and frontal headache, but normal neurologic exam and vital signs. There was no injection site swelling or redness. The outcome of headache and fatigue was reported as not recovered/not resolved. The outcome of mild arm soreness and somnolence was unknown.  The relatedness between the events and suspect vaccines was not provided.  Lot number R0009614 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information has been received from the health care professional on 27-JAN-2020. The patient's current conditions included mild seasonal allergies, and he did not have concomitant medications. It was reported that the vaccines were used according to the leaflet.  On 16-APR-2019, the patient was seen in the clinic after developing excessive sleep, arm soreness bilaterally without redness at sites, headache, and fatigue. In approximately 17-APR-2019, the patient recovered from arm soreness, which was considered an appropriate time for a vaccine reaction, and he also recovered from headache. In approximately 18-APR-2019, the patient recovered from somnolence. It was reported that the patient received symptoms' care and it were resolved spontaneously after 48-72 hours.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Somnolence
Clinical narrative: mild arm soreness; he slept off and on for the next 16 hours; fatigue; headache; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Freedom of Information Act (VAERS # 810131) on 11-NOV-2019.  This spontaneous report was received from a health care professional, referring to a 11-year-old male patient. The patient had environmental allergies to pollens (mild). His medical history included topical, not infectious urethral irritation.  On 15-APR-2019 at 10:00, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose were not provided) administered intramuscularly in the left arm for prophylaxis. On the same day, he was vaccinated with a first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot # reported as 33CA7) intramuscularly in the left arm; and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # reported as AMVA087A) intramuscularly in the right arm.  On 15-APR-2019 at 14:00, the patient developed fatigue, headache and mild arm soreness. He slept off and on for the next 16 hours. He was seen in clinic on 16-APR-2019 at 09:00 and still had fatigue and frontal headache, but normal neurologic exam and vital signs. There was no injection site swelling or redness. The outcome of headache and fatigue was reported as not recovered/not resolved. The outcome of mild arm soreness and somnolence was unknown.  The relatedness between the events and suspect vaccines was not provided.  Lot number R0009614 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow up information has been received from the health care professional on 27-JAN-2020. The patient's current conditions included mild seasonal allergies, and he did not have concomitant medications. It was reported that the vaccines were used according to the leaflet.  On 16-APR-2019, the patient was seen in the clinic after developing excessive sleep, arm soreness bilaterally without redness at sites, headache, and fatigue. In approximately 17-APR-2019, the patient recovered from arm soreness, which was considered an appropriate time for a vaccine reaction, and he also recovered from headache. In approximately 18-APR-2019, the patient recovered from somnolence. It was reported that the patient received symptoms' care and it were resolved spontaneously after 48-72 hours.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Developmental regression, Ultrasound scan normal
Clinical narrative: eye avoidance/ regress in social skill milestones that he had met/wasn't smiling, making eye contact or making cooing noises,/can't vocalize as much as before/complete impairment of speech and behavioral changes/adverse reaction symptoms; This spontaneous report was received from a consumer regarding her son, a male patient of 3 months old. The patient had no medical history, drug reactions or allergies (reported as none).  On 10-JAN-2020, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) administered Intramuscularly as a single dose (lot number and expiration date were reported as unknown; strength, dose, were not provided) as mandated by his pediatrician. The vaccine was concomitantly administrated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, frequency, route of administration, lot #, expiration date and indication were not provided)  On an unspecified date in January 2020 (reported as within 48 hours), the patient began to display eye avoidance, which was when the reporter became concerned. She reported that after getting the Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13), her son started to "regress" in all the "social skill milestones that he had met" (developmental regression) prior to these vaccinations; hence, her son post-vaccination was not smiling, making eye contact or making cooing noises, which were all basic social skills he was developing and exhibiting fine prior to getting these vaccinations. The mother said her son also "could not vocalize" as much as before receiving the vaccinations.   Medical attention was sought, since she initially contacted a neurologist on 15-JAN-2020 because she thought some of his symptoms could be neurologically based and then subsequently, she contacted his pediatrician on 17-JAN-2020. No treatment was given for the events, but a head ultrasound was performed on 18-JAN-2020, and an Electroencephalogram (EEG) scan on 22-JAN-2020, but neither test results showed anything negative. It was reported that the patient has had 3 emergency room (ER) visits and in the last one, her son was admitted at a hospital on 22-JAN-2020, at around 02:00 (reported as 2 o'clock am, also reported as in the morning) and released late night on the same date. She stated that the physicians her son had seen, do not know what could be causing her son's condition  She felt that based on her observation of her son post-vaccination, he had a "complete impairment of speech and behavioral changes" and she was very concerned because it had been "about 2 and half weeks" since her son was vaccinated, he had not recovered and she had seen at best only a "10 percent improvement" in his adverse reaction symptoms, so the patient's mother was very worried that his symptoms could be permanent.  The causality assessment between the event and both vaccines was considered as related.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Ultrasound skull normal
Clinical narrative: eye avoidance/ regress in social skill milestones that he had met/wasn't smiling, making eye contact or making cooing noises,/can't vocalize as much as before/complete impairment of speech and behavioral changes/adverse reaction symptoms; This spontaneous report was received from a consumer regarding her son, a male patient of 3 months old. The patient had no medical history, drug reactions or allergies (reported as none).  On 10-JAN-2020, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) administered Intramuscularly as a single dose (lot number and expiration date were reported as unknown; strength, dose, were not provided) as mandated by his pediatrician. The vaccine was concomitantly administrated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, frequency, route of administration, lot #, expiration date and indication were not provided)  On an unspecified date in January 2020 (reported as within 48 hours), the patient began to display eye avoidance, which was when the reporter became concerned. She reported that after getting the Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13), her son started to "regress" in all the "social skill milestones that he had met" (developmental regression) prior to these vaccinations; hence, her son post-vaccination was not smiling, making eye contact or making cooing noises, which were all basic social skills he was developing and exhibiting fine prior to getting these vaccinations. The mother said her son also "could not vocalize" as much as before receiving the vaccinations.   Medical attention was sought, since she initially contacted a neurologist on 15-JAN-2020 because she thought some of his symptoms could be neurologically based and then subsequently, she contacted his pediatrician on 17-JAN-2020. No treatment was given for the events, but a head ultrasound was performed on 18-JAN-2020, and an Electroencephalogram (EEG) scan on 22-JAN-2020, but neither test results showed anything negative. It was reported that the patient has had 3 emergency room (ER) visits and in the last one, her son was admitted at a hospital on 22-JAN-2020, at around 02:00 (reported as 2 o'clock am, also reported as in the morning) and released late night on the same date. She stated that the physicians her son had seen, do not know what could be causing her son's condition  She felt that based on her observation of her son post-vaccination, he had a "complete impairment of speech and behavioral changes" and she was very concerned because it had been "about 2 and half weeks" since her son was vaccinated, he had not recovered and she had seen at best only a "10 percent improvement" in his adverse reaction symptoms, so the patient's mother was very worried that his symptoms could be permanent.  The causality assessment between the event and both vaccines was considered as related.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Heart rate increased, Migraine, Nausea, Palpitations
Clinical narrative: Day after flu shot, left forearm broke out in rash of red bumps across entire arm, and disappeared by day 3. As of today, 2/2-3/2020, I have also had a severe migraine (possibly unrelated as I'm diagnosed chronic migraines), having heart palpitations and continual rapid heartbeat above my usual rate, nausea, and difficulty breathing/shortness of breath.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Rash erythematous
Clinical narrative: Day after flu shot, left forearm broke out in rash of red bumps across entire arm, and disappeared by day 3. As of today, 2/2-3/2020, I have also had a severe migraine (possibly unrelated as I'm diagnosed chronic migraines), having heart palpitations and continual rapid heartbeat above my usual rate, nausea, and difficulty breathing/shortness of breath.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Benign rolandic epilepsy, Eye movement disorder, Rapid eye movement sleep behaviour disorder, Seizure
Clinical narrative: experienced a seizure at night in her sleep / patient was diagnosed with Benign rolandic epilepsy; This spontaneous report has been received from a consumer who was also the patient's mother, concerning to a currently 13-year-old female patient. Her allergies included peanuts, tree nuts, Amoxicillin and TRILEPTAL. Information about patient's past drug included Amoxicillin and TRILEPTAL; and her medical history, as well as concomitant therapies were not reported.  On an unknown date in 2008 (reported as at the age of 1-year-old), the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, one shot (concentration, dosage, frequency, anatomical location, administration route, lot number, and expiration date were not reported), as prophylaxis (reported as child's immunization schedule).  In 2013, the patient experienced a first noticed seizure at night while she was sleeping (reported as during her sleep) when the patient was 6-year-old. The reporter stated that she did not know if her daughter had a previous seizure. The patient was diagnosed with benign rolandic epilepsy, and she had her seizures in her rapid eye movement (REM) around 3 AM to 8 AM.   In 2014, the patient experienced her last seizure, and took her last unspecified medication for benign Rolandic epilepsy in 2017. No additional information was provided. At the time of the report, the patient was recovered from the benign rolandic epilepsy.  The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the event was not reported.
Sex: F
Vaccine: PPV
Symptoms: Muscle rigidity
Clinical narrative: diffuse rigidity in her stomach area; This spontaneous report was received from a nurse practitioner, via a company representative, concerning an elderly female patient (age reported as at least 65 year old). Information on concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On approximately November 2019 (reported as between November and December 2019), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.   On an unspecified day in November 2019 (also reported as the next day), the patient was seen by a physician in the practice the next day for diffuse rigidity in her stomach area and was referred to an unspecified emergency room, but she did not receive treatment for the adverse event. The outcome of the event was unknown.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from  a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878 and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 08-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878 and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number S014948 and expiration date 12-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 09-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 10-JAN-2020,  the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number  S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210  and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 19-DEC-2019, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878  and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).   The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 09-JAN-2020, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number  S014948 and expiration date 12-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in May 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced neuropathy.  As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events of neuropathy. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of neuropathy was determined to be medically significant. The events of neuropathy was considered to be disabling.