chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Poor quality sleep, Taste disorder, Tenderness
Clinical narrative: About 5pm started to feel bad.  By 10pm had headache, chills, weakness, muscle aches, difficulty with moving, keeping balance and heart palpitations.   Patient slept very poorly.   Patient woke up feeling better but arm was quite sore.  After 3 hours, patient overcome with weakness and fatigue; had to sleep for 30 minutes.  Seemed to be getting tired and tired as the day went on.  On Friday, was still feeling poorly, had chills and totally without energy.   On Saturday noticed redness around injection site 2x3 inch; arm was tender.  All day just felt like lying down and sleeping.  Noticed that there was increased flatulence, had trouble making decisions, chills like hot flashes, decrease in appetite and intermittent nausea.  On Saturday, called the pharmacy around noon about the arm redness since it was odd that it appeared days later.   On Sunday woke up with a moderate headache and about 3 hours later food did not taste goodthings that she loves to eat tasted terrible.  Patient had lack of energy and fatigue.  More bowel movements that are frequent started Saturday and continued to Sunday.  Redness in arm was gone when woke up but came back after shower.   Sunday morning had to lie down again because felt so tired and had no appetite.    On Monday morning felt well when woke up and by afternoon felt like mostly okstill does not feel back to normal.   The fatigue is much better; it comes in waves and not as frequent.   Food taste ok now.   Patient did not call the doctor at any time.  Patient has received the Flu High Dose vaccine for several years prior with no problems.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: the vaccine exp 8/2019 and the vaccine was given on 9/2019. parent to be notified and vaccine will be re-administered.
Age: 59.0
Sex: F
Vaccine: HEP, MMR, VARZOS
Symptoms: Dizziness, Nervousness, Pain, Tinnitus
Clinical narrative: 3 days of general achiness, lightheadedness and nervousness. Ringing of the ears - still present of this report.
Age: 57.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dizziness, Headache
Clinical narrative: Not feeling well, stomach upset, chills, numbness in both hands, severe joint pain that alternated between hands and feet. General joint pain around elbows. Fever of 106 F treated with Tylenol, Advil and cool bath, ice packs on neck and forehead. Headache. Dizziness when bending over and standing up continues. Spiked fever Friday of 102F treated with Tylenol and Advil. Fever on Saturday was 99-100 F. Arm is sore where injected.
Age: 57.0
Sex: F
Vaccine: RAB, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Malaise, Pyrexia
Clinical narrative: Not feeling well, stomach upset, chills, numbness in both hands, severe joint pain that alternated between hands and feet. General joint pain around elbows. Fever of 106 F treated with Tylenol, Advil and cool bath, ice packs on neck and forehead. Headache. Dizziness when bending over and standing up continues. Spiked fever Friday of 102F treated with Tylenol and Advil. Fever on Saturday was 99-100 F. Arm is sore where injected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Anaphylactic reaction, Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient mother reports that the evening of the vaccine, patient's leg became red, swollen and hot to the touch. As the evening progressed, his leg continued to swell with red streaks from the injection site down towards the ankle. Eventually the redness and swelling encompassed his entire thigh. At that point, the patient was taken to the ER. He was treated for cellulitis and anaphylaxis. He was given cephalexin and prednisone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient mother reports that the evening of the vaccine, patient's leg became red, swollen and hot to the touch. As the evening progressed, his leg continued to swell with red streaks from the injection site down towards the ankle. Eventually the redness and swelling encompassed his entire thigh. At that point, the patient was taken to the ER. He was treated for cellulitis and anaphylaxis. He was given cephalexin and prednisone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pain, Gingival pain, Headache, Pyrexia
Clinical narrative: headache, chills, fever, aching eyes, teeth and gums.  Motrin brought down symptoms within 12 hours, headache persisted for a week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Toothache
Clinical narrative: headache, chills, fever, aching eyes, teeth and gums.  Motrin brought down symptoms within 12 hours, headache persisted for a week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Syringe issue
Clinical narrative: Vaccine ran out of the syringe when the plunger was pressed.  Little or none of the vaccine actually got injected. A second vaccine was mixed and immediately administered to the patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Every time I eat I suffer from a sever headache, extreme dizziness and sleep for hours.  If I do not eat, there is no reaction
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; a patient received a dose of ROTATEQ following a temperature excursion /Temperature; LOWEST Temperature BELOW 36°F/2°C (25F); This spontaneous report was received from a officer manager referring, to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant medications, and previously drugs reactions or allergies were not provided.  On 16-AUG-2019, date the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as for prophylaxis. (strength, formulation, dose, dose number and route of administration were not reported; lot number was reported as R042223; expiration date: 24-MAY-2020 (invalid); following a temperature excursion. No adverse effects were reported in the patient.  The temperature of excursion was below of 36 degrees Fahrenheit/2 degrees Celsius  (25 degrees Fahrenheit), the time frame was reported as three hours (product storage error), without a previous temperature excursion. A digital data logger was used.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history and concomitant medications.  On 29-APR-2019, the patient was vaccinated with 1 dose of improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021078, expiration date 12-JUN-2021 (strength, frequency and route of administration was not provided) for prophylaxis.        The doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) were exposed to a temperature excursion of 52.5 ° Fahrenheit(°F) during a time frame of 4 hours and 40 minutes which was detected by the data logger. There was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Encephalopathy
Clinical narrative: acute encephalopathy; This case was reported by a physician via sales rep and described the occurrence of encephalopathy acute in a unspecified adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced encephalopathy acute (serious criteria hospitalization and GSK medically significant). The patient was treated with medication unknown (Fluids). On an unknown date, the outcome of the encephalopathy acute was recovered/resolved.   The reporter considered the encephalopathy acute to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient was hospitalized and given fluids and released after one day. The reporter felt that this event might have been caused by Shingrix. The reporter consented to follow up. This case is one of 3 cases, reported by the same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 19th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reported lot number 7H7H4 was updated to 7A7H4 as per sales data sheet. The medical assistant called to report that the patient experienced Shingles after having 1st dose of Shingrix. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Shingles on eye/ shingles affecting the right eye; Shingles; Blistery rash; This case was reported by a other health professional via call center representative and described the occurrence of ophthalmic herpes zoster in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 30th November 2021) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced blistery rash. On 28th August 2019, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and blistery rash were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and blistery rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the medical assistant. The patient received Shingrix on the right deltoid. On 28th August 2019, 9 days after receiving Shingrix the patient experienced ophthalmic herpes zoster, shingles  The reporter had a consumer that came into the office on 28th August 2019 and was diagnosed with Shingles. The shingles appeared as a blistery rash on the right ear, right side of the neck, and affecting the right eye. The reporter was unwilling to provide any additional details.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 18th April 2019, the patient received the 2nd dose of Shingrix. On 19th August 2019, less than 2 years after receiving Shingrix and 123 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was considered as suspected vaccination failure since the details regarding completion of laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up. The reporter did not have lot or expiration date at time of call.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Laboratory test, Lymphadenopathy, Neck mass, Swelling
Clinical narrative: 5/14 complained of increased swelling in lump on neck. 5/15 diagnosed with cervical lymphadenopathy. 5/21 saw oncologist who noted swelling had decreased and attributes a vaccine reaction to the previous increase in swelling.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Ultrasound scan
Clinical narrative: 5/14 complained of increased swelling in lump on neck. 5/15 diagnosed with cervical lymphadenopathy. 5/21 saw oncologist who noted swelling had decreased and attributes a vaccine reaction to the previous increase in swelling.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Blood test normal, Chills, Dehydration, Feeling cold, Nasopharyngitis
Clinical narrative: Client woke up the next morning  feeling soar all over, freezing cold with dry hives.  Denies any hives, swelling or palpitations.  Client states she felt like she had a terrible cold.  Client did go to emergency department 08/31/19  due to the chills and fever of 100 plus (cannot remember her temperature but stated it was over 100 F)where they did blood work, IV fluids and gave her Benadryl, Toradol, Tylenol .    Client said she was treated for dehydration and blood work did not show anything abnormal with liver.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Urticaria, White blood cell count increased
Clinical narrative: Client woke up the next morning  feeling soar all over, freezing cold with dry hives.  Denies any hives, swelling or palpitations.  Client states she felt like she had a terrible cold.  Client did go to emergency department 08/31/19  due to the chills and fever of 100 plus (cannot remember her temperature but stated it was over 100 F)where they did blood work, IV fluids and gave her Benadryl, Toradol, Tylenol .    Client said she was treated for dehydration and blood work did not show anything abnormal with liver.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Lumbar puncture abnormal, Neuralgia
Clinical narrative: Patient developed acute new neuropathic pain and then a few days later weakness.  Hospitalized with dx made of Guillan Barre Syndrome (GBS) after exclusion of other causes and based on abnormal lumbar puncture.  Protracted course in hospital and rehab.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Patient developed acute new neuropathic pain and then a few days later weakness.  Hospitalized with dx made of Guillan Barre Syndrome (GBS) after exclusion of other causes and based on abnormal lumbar puncture.  Protracted course in hospital and rehab.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Dyskinesia, Posture abnormal, Unresponsive to stimuli
Clinical narrative: About 3 seconds after the vaccination was administered, the patient's head went back, (he was sitting on a chair). His eyes were open. His head and  one of his arms had jerking movements. He was unresponsive for about 20 seconds. After that time he awoke and was responsive.  He was then helped to lay down on the floor.  He complained of dizziness and light headedness for about an hour. He was given some water and apple juice.  He was ok after an hour and was able to leave. His mother was present and indicated that the patient once passed out (no jerking movements) when he had blood drawn at 12 years old.  He also lays down each time he has blood work done.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Influenza like illness, Lethargy, Oropharyngeal pain
Clinical narrative: Injected IM at Pharmacy on Saturday AM, in perfect health.  As of Tuesday (9/3/2019), sore throat, sinus and lung congestion, tired, lethargic and significant joint pain (arms, legs, back).  No knowledge of contact with ill individuals.   No known allergies and no occurrence of flu during the past 5 years with annual High-Dose Flu injections.  Believe there is a likely correlation between High-Dose Influenza injection and occurrence of flu-like symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary congestion, Sinus congestion
Clinical narrative: Injected IM at Pharmacy on Saturday AM, in perfect health.  As of Tuesday (9/3/2019), sore throat, sinus and lung congestion, tired, lethargic and significant joint pain (arms, legs, back).  No knowledge of contact with ill individuals.   No known allergies and no occurrence of flu during the past 5 years with annual High-Dose Flu injections.  Believe there is a likely correlation between High-Dose Influenza injection and occurrence of flu-like symptoms.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: 100.4 fever; Malaise; muscle pain; knee pain. Took acetaminophen. Greatly improved by morning
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Anti-aquaporin-4 antibody negative, Areflexia, Asthenia, Blood heavy metal test, CSF white blood cell count increased
Clinical narrative: Patient presented to Medical Center with chief complaint of headache, urinary incontinence, bilateral paresthesias of lower extremities.   He states that he was in his usual state of health until last night when he states that he had numbness of his penis and urethra and could no longer sense when he was urinating; admits to some urinary incontinence.  This morning, he woke up with sudden onset bilateral foot numbness, worse on the left.  He states that the numbness is primarily in the bottoms of his feet and when touched sends shooting electrical shocks up his legs to his back. He was admitted with BLE parasthesias with progressive ascending numbness/weakness and loss of reflexes. Patient had acute worsening of his numbness/paresthesias up to rib cage with new onset arreflexia.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital hypoaesthesia, Headache, Hypoaesthesia, Immunology test, Laboratory test
Clinical narrative: Patient presented to Medical Center with chief complaint of headache, urinary incontinence, bilateral paresthesias of lower extremities.   He states that he was in his usual state of health until last night when he states that he had numbness of his penis and urethra and could no longer sense when he was urinating; admits to some urinary incontinence.  This morning, he woke up with sudden onset bilateral foot numbness, worse on the left.  He states that the numbness is primarily in the bottoms of his feet and when touched sends shooting electrical shocks up his legs to his back. He was admitted with BLE parasthesias with progressive ascending numbness/weakness and loss of reflexes. Patient had acute worsening of his numbness/paresthesias up to rib cage with new onset arreflexia.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture abnormal, Paraesthesia, Spinal myelogram, Urinary incontinence, Vitamin B12
Clinical narrative: Patient presented to Medical Center with chief complaint of headache, urinary incontinence, bilateral paresthesias of lower extremities.   He states that he was in his usual state of health until last night when he states that he had numbness of his penis and urethra and could no longer sense when he was urinating; admits to some urinary incontinence.  This morning, he woke up with sudden onset bilateral foot numbness, worse on the left.  He states that the numbness is primarily in the bottoms of his feet and when touched sends shooting electrical shocks up his legs to his back. He was admitted with BLE parasthesias with progressive ascending numbness/weakness and loss of reflexes. Patient had acute worsening of his numbness/paresthesias up to rib cage with new onset arreflexia.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: West Nile virus test
Clinical narrative: Patient presented to Medical Center with chief complaint of headache, urinary incontinence, bilateral paresthesias of lower extremities.   He states that he was in his usual state of health until last night when he states that he had numbness of his penis and urethra and could no longer sense when he was urinating; admits to some urinary incontinence.  This morning, he woke up with sudden onset bilateral foot numbness, worse on the left.  He states that the numbness is primarily in the bottoms of his feet and when touched sends shooting electrical shocks up his legs to his back. He was admitted with BLE parasthesias with progressive ascending numbness/weakness and loss of reflexes. Patient had acute worsening of his numbness/paresthesias up to rib cage with new onset arreflexia.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: Customer experienced stomach bloating and stomach cramps for one day only after recieving the vaccination.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Vaccination site reaction
Clinical narrative: 102 Degrees Fahrenheit Fever day after injection. As I complete this report it is 8 days since I received the vaccine and i still have a red rash from the vaccine site to below my elbow.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: EXCESS BLEEDING REDNESS AROUND INJECTION SITE
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electrocardiogram, Hot flush, Laboratory test, Nausea, Postural orthostatic tachycardia syndrome
Clinical narrative: Seen in our office 08/30/2019 for nausea and hot flashes. fainted while having orthostatic vital signs taken. reffered to cardiology dx POTS 09/03/2019
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Seen in our office 08/30/2019 for nausea and hot flashes. fainted while having orthostatic vital signs taken. reffered to cardiology dx POTS 09/03/2019
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Joint swelling, Peripheral swelling, Rash, Swelling face, Urticaria
Clinical narrative: Hives/ rash and swelling of face, hands, ankles and feet
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Generalized rash/hives
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), at a pharmacy for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated for shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The causality between shingles and zoster vaccine live (ZOSTAVAX) was considered as related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; A patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from the medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S005084, expiration date 19-FEB-2021, for prophylaxis (strength, dose, route and frequency were not reported).  The temperature excursion range was of -14 Centigrade degrees (°C) to -10°C (-14.4°C), during 18 minutes. A previous temperature excursion was not reported. A digital data logger was involved due to a calibration. No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 25-APR-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)  (LIQUID PEDVAXHIB) one dose, lot # R021078, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # R028189, expiration date 06-JUN-2020 , for prophylaxis (strength, dose and frequency were not reported).  The temperature excursion was of 52.5 Fahrenheit degrees (°F), during 4 hours 40 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 25-APR-2019, the patient was vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)  (LIQUID PEDVAXHIB) one dose, lot # R021078, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # R028189, expiration date 06-JUN-2020 , for prophylaxis (strength, dose and frequency were not reported).  The temperature excursion was of 52.5 Fahrenheit degrees (°F), during 4 hours 40 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Headache, Imaging procedure
Clinical narrative: Patient received Fluzone quadrivalent influenza vaccine 0.5ml IM in left arm at 0911 am on 09/03/2019 as part of her wellness visit.  Patient's mother called at 0915 on 09/04/2019 to report that patient had a possible seizure while at school that morning.  Mom reported to nurse that she was told by school that patient "tensed up and fell out of her chair and hit her head."  Patient c/o dizziness and HA pain following incident.  Mother reports that she was told patient was able to answer questions correctly after incident.  No previous history of seizures reported.  Mother was advised to report to ER immediately.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Tension
Clinical narrative: Patient received Fluzone quadrivalent influenza vaccine 0.5ml IM in left arm at 0911 am on 09/03/2019 as part of her wellness visit.  Patient's mother called at 0915 on 09/04/2019 to report that patient had a possible seizure while at school that morning.  Mom reported to nurse that she was told by school that patient "tensed up and fell out of her chair and hit her head."  Patient c/o dizziness and HA pain following incident.  Mother reports that she was told patient was able to answer questions correctly after incident.  No previous history of seizures reported.  Mother was advised to report to ER immediately.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: Pt given Bexsero in right deltoid on 8/16/19 and Td in left deltoid on 8/16/19.  No issues with left arm.  Right arm sore at injection site after injection for about 1 - 1 1/2 weeks.  Arm stopped hurting during the last week of August.  Right arm began hurting hurting again on Monday 9/2/19.  Says she went bowling on Saturday 8/31/19.  Discomfort is at the injection site.  No redness or knots at injection site; "just sore".  Has not tried any OTC pain relief.    When lifts arm upwards and back notices more pain.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Vomitting, Influenza type Symptoms
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain, Nausea
Clinical narrative: Patient reports about 3 hours post-vaccination, she started having lower back pain. As the days progressed, she also reported shoulder pain and couldn't lift her arm. The back pain moved from lower back to mid-back. She also is now experiencing waves of nausea that come and go.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Patient's husband called in around noon stating patient not feeling well. Her symptoms are as follows: headache, fever, stomach ache/nausea and some diarrhea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient's husband called in around noon stating patient not feeling well. Her symptoms are as follows: headache, fever, stomach ache/nausea and some diarrhea.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Right upper arm cellulitis and low grade fever. Benadryl for a  few nights. Keflex 250 mg/5mL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Muscle fatigue, Pain, Pustule
Clinical narrative: Patient stated that she got two tiny pustules in the left upper scapula area that were on a pain scale of 6/10. She said her primary care doctor did diagnose them as shingles but the pain was way less than when she had the shingles in 2010. She said that the pain has gone away but every once in a while the muscle of injection site feels fatigued.
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Blood test normal, Diplopia, Electrocardiogram normal, Injection site erythema, Injection site warmth
Clinical narrative: AT 6:30am, Sat. 8/23, 2019 woke up with double vision, also had wide red  hot feeling patch on my left arm 3 inches from shot site, Called clinic nurseline and suggestion was made to go to the ER for double vision.  ER  did head MRI,  Blood Tests and EKG Double vision lasted until about 4PM that day and has only slightly returned 2 times since.      Also saw Opthomologist on 8/26/19 for double vision problem.
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal
Clinical narrative: AT 6:30am, Sat. 8/23, 2019 woke up with double vision, also had wide red  hot feeling patch on my left arm 3 inches from shot site, Called clinic nurseline and suggestion was made to go to the ER for double vision.  ER  did head MRI,  Blood Tests and EKG Double vision lasted until about 4PM that day and has only slightly returned 2 times since.      Also saw Opthomologist on 8/26/19 for double vision problem.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Chills/ Fever 101.3/ Nausea/Loss of Appetite/Next day fever 100.2/Bedridden 5 days/totally fatigued the whole 5 days/slept most of the time.  Finally coming around on day 6, for someone who is never sick.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urine analysis
Clinical narrative: Chills/ Fever 101.3/ Nausea/Loss of Appetite/Next day fever 100.2/Bedridden 5 days/totally fatigued the whole 5 days/slept most of the time.  Finally coming around on day 6, for someone who is never sick.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain in extremity, Pruritus, Rash macular, Swelling
Clinical narrative: I got the first Shingrix shot on Wednesday, August 28th. The first couple of days my arm was very sore but I was prepared for that. It was not until late Saturday and Sunday that the blotches appeared and then swelled up with extreme itching. One of the swollen blotches ended being about 5 inches long and 3 inches wide. I was so uncomfortable that I called a friend who is in the medical profession (it was the holiday) and she recommended to take an antihistamine to help with the itching and internal swelling. I started taking Allegra on Monday noontime, by Tuesday it was better and have been taking it ever since.  I did not have any flu-like symptoms such as fever, headache, nausea or other listed side effects.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient stated that she had developed a rash after getting her shots on Monday. She had a rash on multiple parts of her body. She mostly described under the fold of her abdomen and her thighs. She also stated that she had tried a new fragrance of Tide and had washed her sheets and clothes in it. She stated that she took two benadryl and the rash did not go away, so it could not have been the Tide.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Significant redness, swelling, warmth from the injection site down to her elbow
Age: 47.0
Sex: F
Vaccine: RAB, TDAP, UNK
Symptoms: Body temperature increased, Fatigue, Feeling abnormal, Pain
Clinical narrative: On 8/9/19 The patient emailed Dr. to inform that after 24 hrs. of receiving  the vaccines she started to feel very bad. Had a temperature of 101.6,feeling very achy and tired.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye irritation, Fatigue, Injection site pain, Migraine
Clinical narrative: Migraine, all over body ache, exhaustion, eyes burn, shivering, nausea, extreme pain at injection site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Migraine, all over body ache, exhaustion, eyes burn, shivering, nausea, extreme pain at injection site
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site oedema
Clinical narrative: Left  thigh has slight edema and erythema, left knee slight edema. Keflex. Benadryl as needed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left thigh. Clindamycin Palmitate 7 mL, 3 times a day x 10 days.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Facial pain, Herpes zoster, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Within 12 hours of receiving the vaccine I had pain radiating from shot site into my left ear.  I then had a stiff neck and pain on the side of my neck.  It traveled to my forehead where shingles broke out.  I was NEVER warned that it could trigger a immune response that could trigger shingles.  That should be included in the information. I spread to my eye and I have not been able to shed my body of the virus and I am on drops and Valtrex still today a year and a half later.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Ophthalmic herpes zoster, Ophthalmological examination abnormal, Pain
Clinical narrative: Within 12 hours of receiving the vaccine I had pain radiating from shot site into my left ear.  I then had a stiff neck and pain on the side of my neck.  It traveled to my forehead where shingles broke out.  I was NEVER warned that it could trigger a immune response that could trigger shingles.  That should be included in the information. I spread to my eye and I have not been able to shed my body of the virus and I am on drops and Valtrex still today a year and a half later.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Around an hour after I left the facility I became covered in hives and my face and lips swelled.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Limb mass, Skin warm
Clinical narrative: Left Arm was lumpy and hard to feel approx. 2hours after the shot.  Towards the nighttime also turned warm and red Following morning same symptoms 2 days later hardness decreased but still red and hot
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flatulence, Headache, Pain
Clinical narrative: Pain, 4 in Diameter redness, headache, and flatulence
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injection site reaction, Local reaction
Clinical narrative: patient was administered fluad vaccine and pneumovax 23 on tuesday 9/3/2019. patient called pharmacy wednesday 9/4/2019 to report that she had a reaction to "the pneumonia vaccine" that she received the day before. she stated that she had a local reaction at injection site and that over night she became weak and dizzy and experienced sweating. she took aleve and was starting to feel better. I advised her to report these side effects to her primary care doctor as well. i advised her to apply a cool compress to the injection site  as well as take either APAP or IBU for symptoms (said she has taken both of these products successfully in the past). I advised patient to seek medical attention if symptoms do not improve or worsen.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Patient noticed the morning on 9/4/19 that there was itching on her arm. There was a red area about 2 inches from where the injection site was. Later in the day she noticed there were 3 red areas.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: red swollen hot to touch....went to clinic site was infected
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported that she remembers that her arm was sore for 2 weeks with her first Shingrix vaccine. No other adverse reported. No need to seek medical treatment. Did not further question what she did to treat the soreness since this occurred about 1 year ago.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Ear pruritus, Pruritus
Clinical narrative: Patient reported itching of scalp and ears that still occurs about every 3 days. She also had pimple-like spots on her midriff and back of the neck, which lasted about 1 week. Patient does not currently have a PCP to follow up with due to insurance.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Eye pain, Eye pruritus, Headache
Clinical narrative: Cough Itchy, watery sore eyes Sore throat Muscle ache Chills Headache In that order from 5:00pm until 5:00am, fine after 7:00am
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Lacrimation increased, Myalgia, Oropharyngeal pain
Clinical narrative: Cough Itchy, watery sore eyes Sore throat Muscle ache Chills Headache In that order from 5:00pm until 5:00am, fine after 7:00am
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Experienced headache, nausea, fever, chills and body ache and fatigue for approx 24 hours once symptoms started along with the pain and swelling at location of vaccine
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Experienced headache, nausea, fever, chills and body ache and fatigue for approx 24 hours once symptoms started along with the pain and swelling at location of vaccine
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pt said arm was in extreme pain for over a week
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram normal, Eye movement disorder, Pallor
Clinical narrative: Unsure which version of Hib was given. Did receive Pediarix, Hiv PCV and Rotavirus vaccines. Later in the evening had an episode of appearing pale, eyes roled back into head, took about 25 minutes to return to baseline. Was admitted to hospital for EEG, observation overnight.
Age: 20.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Right after receiving the three (3) vaccines, the patient had syncope.  She fainted and fell on the ground but woke up immediately.  We helped her get up and rested seating on a chair.  She drank some water and was  fine.  She left after 30 minutes and she said she does not feels ok.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Neuropathy peripheral, Pyrexia
Clinical narrative: NEUROPATHY; BURNING SENSATION ALL OVER THE ENTIRE BODY FOR 4 DAYS W/ FEVER
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash macular, Skin warm
Clinical narrative: patient complained of swelling, warmth  and red blotches that extended half way down her arm
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paralysis, Pyrexia, Quadriplegia, Sensory loss, Walking aid user
Clinical narrative: Patient experienced fever around 3 A.M. (around 14 to 15 hours) after getting the injection. She started with a fever but after 2 hours later she woke up and could not feel or move anything below her face. She was taken to the hospital to be treated. She was considered quadriplegia at the time of admission. She is now able to walk with a walker/cane. She is going through rehab and per doctor, she should see full recovery within 3 weeks with treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Intensive care, Loss of personal independence in daily activities, Paralysis
Clinical narrative: Patient experienced fever around 3 A.M. (around 14 to 15 hours) after getting the injection. She started with a fever but after 2 hours later she woke up and could not feel or move anything below her face. She was taken to the hospital to be treated. She was considered quadriplegia at the time of admission. She is now able to walk with a walker/cane. She is going through rehab and per doctor, she should see full recovery within 3 weeks with treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 10.5 x 12 cm left arm redness warmth & pain, not immediately, but following Shingrix vaccine
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: REDNESS, SWELLING OF (L) THIGH SIGN OF INFECTION
Sex: U
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 25-APR-2019, the patient was vaccinated with an improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R021078 expiration date 12-JUN-2021), and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) (lot# R028189 expiration date 06-JUN-2020); both for prophylaxis.   On an unspecified date, digital data logger registered a temperature excursion of 52.5 Farenheit degrees, for the first time, along 4 hours and 40 minutes.
Sex: U
Vaccine: HIBV, RV5, HIBV, RV5
Symptoms: Product storage error
Clinical narrative: patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 25-APR-2019, the patient was vaccinated with an improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R021078 expiration date 12-JUN-2021), and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) (lot# R028189 expiration date 06-JUN-2020); both for prophylaxis.   On an unspecified date, digital data logger registered a temperature excursion of 52.5 Farenheit degrees, for the first time, along 4 hours and 40 minutes.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: After 20-30 minutes from the injection i started to get the following systems of an reaction.   Restricted breathing (worse when lying down) Full body muscle soreness/aches Nausea Headache Sight location was red, swollen, hot to touch Fatigue
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: After 20-30 minutes from the injection i started to get the following systems of an reaction.   Restricted breathing (worse when lying down) Full body muscle soreness/aches Nausea Headache Sight location was red, swollen, hot to touch Fatigue
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Local reaction, Nausea
Clinical narrative: After 20-30 minutes from the injection i started to get the following systems of an reaction.   Restricted breathing (worse when lying down) Full body muscle soreness/aches Nausea Headache Sight location was red, swollen, hot to touch Fatigue
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Flu like symptons came on immediately (approximately 8 hours after vaccine).  Headache, muscle aches, fever, shivering, fatigue
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Flu like symptons came on immediately (approximately 8 hours after vaccine).  Headache, muscle aches, fever, shivering, fatigue
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Endometriosis
Clinical narrative: endometriosis; Information has been received from a nurse via a company representative referring to a 17 years old female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date in 2015, at the age of 13 years old, the patient received one dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. On an unspecified date in 2019 when she was 17 years old, she developed endometriosis. Unknown medical attention was sought. The outcome of endometriosis was unknown.  The causality between endometriosis and hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; expired dose of VAQTA (R022122, 8/9/2019) administered to patient; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.            On 14-AUG-2019, the patient was vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R022122, expiration date: 09-AUG-2019; dose and route were not reported) for prophylaxis (expired vaccine used). No adverse effects was reported. No product quality complaint (PQC).