chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Supraventricular extrasystoles, Walking aid user
Clinical narrative: shuffling feet and inability to walk independently; Experienced subsequent effects of lethargy; pallor; shuffling feet; dizziness; nausea; ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); ekg (showed sinus rhythm, premature atrial complexes, borderline prolonged QT, possible left ventricular hyperthrophy); This spontaneous information has been received from a nurse prescriber via company representative, concerning a 12-years old non-pregnant female patient. The patient did not have any pertinent medical history, concurrent conditions, concomitant therapies or any known drug allergy.  On 21-AUG-2020, 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) 0.5 ml, intramuscularly (IM), for prophylaxis (reported as indicated age range for first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine) (lot number and expiration date reported as: U6321AA and 26-MAR-2022) (strength and anatomical location were not reported).  On the same date, the patient experienced effects of lethargy, pallor, dizziness, nausea, shuffling feet (gait disturbance) and inability to walk independently (gait inability). The patient went with her parent to the emergency department  and was treated with ondansetron (ZOFRAN), monitored and then released. On an unknown date in August 2020, the patient returned with her parent to the emergency department for a second time and was admitted to the hospital for 2 days where she received intravenous (IV) fluids, but still was unable to walk independently.  On an unknown date in August 2020, while she was hospitalized, the following test were performed: chest X-ray was normal, computerized tomography (CT) of head without contrast was normal, electrocardiogram showed sinus rhythm, premature atrial complexes (supraventricular extrasystoles), borderline prolonged QT and possible left ventricular hypertrophy, drug abuse panel and COVID-19 test were negative, C-reactive protein (CRP), complete blood count (CBC), erythrocyte sedimentation rate (ESR) and comprehensive metabolic panel (CMP) did not showed significant findings. It was reported that the cardiac test and electrocardiogram would be repeated because the patient had no prior history. At the time of this report the outcome of gait inability, nausea, dizziness, gait disturbance, pallor and lethargy was reported as not recovered. The outcome of electrocardiogram QT prolonged, supraventricular extrasystoles and left ventricular hypertrophy was not reported.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned adverse events was not provided.  Upon internal review, electrocardiogram QT prolonged was determined to be a medically significant event. Additionally, gait disturbance and gait inability were considered as disabling events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider at physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider at a hospital for shingles (herpes zoster). On an unknown date, she was admitted to the hospital due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she 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 would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion that was intermittent begining 7/28/2020, involving PROQUAD; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter for prophylaxis (lot #T009929 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 16-SEP-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were from -14° Celsius (C) to -10°  C and 38 hours and 30 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion.   No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 12-SEP-2012, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration were not provided) at pharmacy by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, patient would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from herpes zoster. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored temperature excursion; Information has been received from a nurse assistant regarding to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Strength and route of administration not reported) (Lot # S038698, exp. date 01-DEC-2021).  Temperature: -10.2C Time frame: 1 hour and 53 minutes Previous temperature excursion: No Call because of data logger: Yes  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered to patients after excursion occured; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # T002846, expiration date 23-JAN-2022 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis. the data logger registered, that the vaccine was stored at the temperature of -10.2 degree Celsius (C) for 1 hour and 53 minutes. There was no previous temperature excursion.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000132: US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 06-AUG-2014, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration were not provided) at a pharmacy by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, patient would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from herpes zoster. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling after Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient asked to take ibuprofen for swelling after Shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Pain, Pyrexia
Clinical narrative: Flu like symptoms/pretty bad flu like sysmptoms; feel achy/aches all over my body; severe chills; fever; insomnia; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On 24th August 2020, 6 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, chills, fever and insomnia. On an unknown date, the outcome of the influenza-like symptoms, chills, fever and insomnia were recovering/resolving and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, chills, fever and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and in the evening of the infusion day the patient experienced flu like symptoms and feel achy all day and felt a bit better. After approximately 6 hours after infusion, the patient suffered severe chills, aches all over body and the patient believed a fever. The patient also experienced insomnia. The patient wanted to know would the efficacy of Shingrix go down in 4 years.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Can the second does cause low fever reading; How long until muscle aches subside; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown.   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the 2nd dose the patient experienced low fever muscle aches.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: had fevers; chills; has the pain at site of injection; muscle aches in her lower back; muscle aches in / knees; Lack of appetite; abdominal discomfort; fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue. On 18th August 2020, the patient experienced fever, chills and injection site pain. On an unknown date, the outcome of the fever, injection site pain and muscular back pain were recovered/resolved and the outcome of the chills and muscle pain were unknown and the outcome of the appetite absent, abdominal discomfort and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, injection site pain, muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fevers and chills that lasted into that evening but resolved by the following day.  The reporter also stated that she had the pain at site of injection, muscle aches in her lower back and knees, abdominal discomfort, lack of appetite and fatigue.  The muscle aches and pain at site of injection have completely resolved and the fatigue has gotten better but has not resolved completely.  The reporter also stated that she does sill have abdominal discomfort and lack of appetite. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: had fevers; chills; has the pain at site of injection; muscle aches in her lower back; muscle aches in / knees; Lack of appetite; abdominal discomfort; fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue. On 18th August 2020, the patient experienced fever, chills and injection site pain. On an unknown date, the outcome of the fever, injection site pain and muscular back pain were recovered/resolved and the outcome of the chills and muscle pain were unknown and the outcome of the appetite absent, abdominal discomfort and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, injection site pain, muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fevers and chills that lasted into that evening but resolved by the following day.  The reporter also stated that she had the pain at site of injection, muscle aches in her lower back and knees, abdominal discomfort, lack of appetite and fatigue.  The muscle aches and pain at site of injection have completely resolved and the fatigue has gotten better but has not resolved completely.  The reporter also stated that she does sill have abdominal discomfort and lack of appetite. The reporter did not consent to follow up.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Gestational hypertension, Labour induction
Clinical narrative: gestational high blood pressure; Live birth; Boostrix vaccine on 12/30/2019 at 33 weeks gestational age; This is a retrospective pregnancy case. This 31-year-old female subject was enrolled in an open label study titled.. The subject received Boostrix on 30th December 2019, for prophylaxis. The subject received Boostrix at week 33 of the pregnancy.   On 30th December 2019, unknown after receiving Boostrix, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included gestational hypertension in January 2020 with serious criteria of hospitalization and live birth. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included gestational hypertension (recovered/resolved) and live birth (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. After [weeks gestation], the subject gave birth to a [male] neonate via vaginal delivery. The neonate weighed 3175 grams (7lbs) at birth.   It was unknown if the investigator considered the gestational hypertension to be related to Boostrix. Diagnostic results (unless otherwise stated, normal values were not provided):  In January 2020, Blood pressure measurement result was 130/81 mmHg.                                                                                                     See case US2020AMR173287 for details regarding the baby case.  Additional information was provided as follows: Two weeks after receiving the vaccine, the patient developed gestational high blood pressure. Her first high blood pressure reading was 130/81 but caller did not have the other blood pressure readings. At 37 weeks she was sent to the hospital for an induction due to continued high blood pressure. The patient had a normal delivery of a baby boy with a birth weight of 7lbs 3 oz. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR173287:same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information was received on 12-Aug-2020 regarding an unsolicited valid non-serious case from a nurse via phone. This case involves an 11-year-old female patient who received MENACTRA vaccination to close to a previous one (extra dose administered). The patient's medical history, past medical treatment and vaccination were not provided. The patient concomitantly received a dose of TDAP on 11-Aug-2020 in the left deltoid for prophylactic vaccination. On 01-Jun-2020, the patient was vaccinated with a dose of MENACTRA (batch number and other dosing details were not reported) and again received another dose (0.5 ml) of same vaccine on 11-Aug-2020 (lot U6691AA and expiration date 21-Mar-2021) via an unknown route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to extra dose administered. No adverse event was reported at the time of reporting. Laboratory data, corrective treatment and outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case (for previous dose).
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hallucination, Muscle spasms, Pyrexia
Clinical narrative: The patient experienced a high fever, hallucinations and severe leg cramps
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness, swelling, pain, warmth at vaccine site for multiple days after injection. Pt given antibiotics for cellulitis, unknown outcome as pt did not follow-up as recommended for skin check.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: LARGE RED AREA AT INJECTION SITE THAT HAD A KNOT UNDER THE SKIN AND WAS PAINFUL TO THE PATIENT, ALSO SHE STATED IT WAS WARM TO THE TOUCH
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Influenza like illness, Pain in extremity
Clinical narrative: Flu like symptoms for 36-48 hours after vaccination. Joint pain starting about 48 hours after injection.  Pain seems to come and go and show up in various parts of my body (shoulders-both, right knee, hips-both, lower back  and arms.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Irritability
Clinical narrative: Irritability started approximately 3 hours post flu shot during a phone call with my father-in-law. I am usually very patient and enjoy helping him with his computer issues but during this phone call, I completely lost it and had to apologize to him afterwards. When I woke the next day I wondered if the behavior, that was totally unlike me, might have been caused by the high-dose four strain flu shot. I looked to see if irritability was a side effect but found it listed only for children of regular strength four strain flu vaccine. Could my weight at about 110 pounds taking the high-dose be equivalent to a child taking an adult regular dose?  My Irritability was gone by afternoon of next day, so within 24 hours, but thought this event was worth reporting.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 21-AUG-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S021729, expiration date: 20-AUG-2020), 1 milliliter (route of administration and anatomical location were not reported). No additional information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses; This spontaneous report was received from a registered Nurse referring to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   Since 28-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) had intermittent temperature excursion to temperature of - 14 Celsius degrees (°C) to 10°C (maximus -9.5°C) for 38 hours and 30 minutes. On 24-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843, expiration date 23-JAN-2022 0.5 ml (route of administration not provided) for prophylaxis (it was also reported that the lot # S032357 expiration date 14-OCT-2020 was involved, but not information of administration was provided) (Product storage error).  The call was made due to a digital data logger. No previous temperature excursion was reported.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Daptacel was given to a patient instead of Adacel, no AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 11 years old female patient who was vaccinated with 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number :C5732AA  and expiration date:24-Apr-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiration date were not reported) via intramuscular route in the right deltoid as prophylactic vaccination on 26-Aug-2020.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered .  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: patient says she is having leg pain
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeding disorder, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Left arm had slight red /  small amount of swelling to site.   Pt complains painful to site,  unable to move arm.  Father stated  Pt.  unable to eat, and   is very tiered.     Woke up x2 ,  last night  9-1-20  got up to go see eye M.D. and did school work.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: Left arm had slight red /  small amount of swelling to site.   Pt complains painful to site,  unable to move arm.  Father stated  Pt.  unable to eat, and   is very tiered.     Woke up x2 ,  last night  9-1-20  got up to go see eye M.D. and did school work.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Within a few hours, I developed a debilitating headache in the temples and back of my head.  After eating at 5pm, I got a very sore stomach.  Within an hour of that I developed a fever and chills that lasted about 24 hours.  From evening through the next morning, I urinated almost every hour.  My joints started aching worse than normal that night and last for three days.  My headache has yet to go away.  I am still experiencing fatigue.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Within a few hours, I developed a debilitating headache in the temples and back of my head.  After eating at 5pm, I got a very sore stomach.  Within an hour of that I developed a fever and chills that lasted about 24 hours.  From evening through the next morning, I urinated almost every hour.  My joints started aching worse than normal that night and last for three days.  My headache has yet to go away.  I am still experiencing fatigue.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Fever nausea head ache light headed day after vaccine treated with Advil and Benadryl.  Symptoms continued for about a week.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Wound
Clinical narrative: Patient reports some redness around the injection site after vaccination. About 2 weeks after the vaccine was administered, patient reports itchiness on his upper arm around the injections site. It has been about a week since it started and it is on and off according to the patient but the itchiness has remained about the same. Because of the itchiness, patient has been scratching his arm which in turn has been getting red and now he has a few open wounds. He reports the injection site as having a red dot in the middle and redness around it.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Swollen, erythymatous thigh (entire thigh swelled up and hot to touch), fever (101) and nodule at injection site, all symptoms lasting for 2 weeks. Hypersensitivity reaction
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm
Clinical narrative: Swollen, erythymatous thigh (entire thigh swelled up and hot to touch), fever (101) and nodule at injection site, all symptoms lasting for 2 weeks. Hypersensitivity reaction
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: arms so sore I couldn't move them shortly after injections, by evening I had fever, chills, headache, full body aches to joints and muscles everywhere, even my skin hurt to touch it, swollen lymph nodes all over my neck, dizziness, weakness, back aches super bad that not even my norco and muscle relaxer phased it. I hurt so bad I could not sleep at all through the night.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injected limb mobility decreased, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: arms so sore I couldn't move them shortly after injections, by evening I had fever, chills, headache, full body aches to joints and muscles everywhere, even my skin hurt to touch it, swollen lymph nodes all over my neck, dizziness, weakness, back aches super bad that not even my norco and muscle relaxer phased it. I hurt so bad I could not sleep at all through the night.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain of skin, Pyrexia, Sleep disorder
Clinical narrative: arms so sore I couldn't move them shortly after injections, by evening I had fever, chills, headache, full body aches to joints and muscles everywhere, even my skin hurt to touch it, swollen lymph nodes all over my neck, dizziness, weakness, back aches super bad that not even my norco and muscle relaxer phased it. I hurt so bad I could not sleep at all through the night.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Patient developed a rash in  left armpit a week later. Came in to pharmacy and reported to pharmacist on duty started taking benadyrl. It was un relieved and  no developing a rash under right armpit. He stating the rash is now stating to burn.
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: The patient states that he has tingling down his right arm since this vaccination was given.
Age: 79.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: The patient states that he has tingling down his right arm since this vaccination was given.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever 101.6 and then I took an Advil. Muscle aches, headache. Still sick the next day but fever is down. I took another Advil for muscle aches and headache. I have had approximately 10 or more flu shots over the years and this has happened maybe three times. I anticipate I will be better tomorrow.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Lip swelling, Oropharyngeal pain
Clinical narrative: Sx: Swelling lips, chills, cough, sore throat Tx: recommend benadryl, tea, cough syrup
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Weight decreased
Clinical narrative: Patient has lost 4 pounds, had fatigue for several days, and just has a general feeling of unwell
Age: 18.0
Sex: F
Vaccine: HPV9, MMR, TDAP
Symptoms: Dyskinesia, Dyspnoea, Eye movement disorder, Muscle contractions involuntary, Opisthotonus
Clinical narrative: RN presented in room to administer MMR, HPV9, Tdap, Meningococcal vaccines Patient identification verified by 2 forms. RN Patient denied any known drug and food allergies RN administered MMR, HPV9, Tdap vaccines RN unable to administer Meningococcal vaccine During vaccine administration, patient's spine arched back in chair, arms bend upward, and eyes rolled back Patient unable to communicate verbally with RN Movements lasted for approximately 20 seconds in chair RN remained with patient and called for help MA arrived first in room to help RN RN and MA slowly lowered patient to ground, RN kept hand on back of head Patient had tonic-like movements while lowering to ground Once patient was on the ground, patient continued to have tonic-like movements of body Patient positioned on right side and RN kept hand on back of head Tonic movements lasted approximately 30 seconds, no visible frothing at the mouth noted by RN Patient remained continent of bowel and bladder Patient did not have head strike of LOC PCP, resource nurse, and another RN assisted Patient's vital signs were taken: Vitals:   09/02/20 0827 09/02/20 1010 BP: 110/72 110/74 Pulse: 77 103 Resp: 18   Temp: 98.2 °F (36.8 °C) 97.6 °F (36.4 °C) TempSrc: Oral Axillary SpO2: 100% (!) 74% Weight: 112 lb 12.8 oz (51.2 kg)   Height: 5' 5" (1.651 m)   Following tonic-movements: Patient was able to communicate verbally Patient stated that she was having difficulty breathing Patient denied any history of seizure activity Patient denied eating breakfast before visit Patient's body became progressively cold to touch Emergency blanket utilized Patient desaturated to 74% on RA Patient was put on 2 L of Oxygen via Nasal Cannula Patient's oxygen and heart rate were continuously monitored Patient's oxygen saturation elevated to 95-100% on NC Patient stated that she was unable to feel her body Patient's hands remained clenched and tonic Patient remained to have subtle jerky movements of arms and head Emergency services arrived and report of event was given Emergency services was given face sheet, problem list, updated med list, PCP visit summary Patient was able to assist in walking to stretcher in hallway Emergency services are transferring patient to Emergency Care.
Age: 18.0
Sex: F
Vaccine: HPV9, MMR, TDAP
Symptoms: Oxygen saturation decreased, Peripheral coldness, Sensory disturbance
Clinical narrative: RN presented in room to administer MMR, HPV9, Tdap, Meningococcal vaccines Patient identification verified by 2 forms. RN Patient denied any known drug and food allergies RN administered MMR, HPV9, Tdap vaccines RN unable to administer Meningococcal vaccine During vaccine administration, patient's spine arched back in chair, arms bend upward, and eyes rolled back Patient unable to communicate verbally with RN Movements lasted for approximately 20 seconds in chair RN remained with patient and called for help MA arrived first in room to help RN RN and MA slowly lowered patient to ground, RN kept hand on back of head Patient had tonic-like movements while lowering to ground Once patient was on the ground, patient continued to have tonic-like movements of body Patient positioned on right side and RN kept hand on back of head Tonic movements lasted approximately 30 seconds, no visible frothing at the mouth noted by RN Patient remained continent of bowel and bladder Patient did not have head strike of LOC PCP, resource nurse, and another RN assisted Patient's vital signs were taken: Vitals:   09/02/20 0827 09/02/20 1010 BP: 110/72 110/74 Pulse: 77 103 Resp: 18   Temp: 98.2 °F (36.8 °C) 97.6 °F (36.4 °C) TempSrc: Oral Axillary SpO2: 100% (!) 74% Weight: 112 lb 12.8 oz (51.2 kg)   Height: 5' 5" (1.651 m)   Following tonic-movements: Patient was able to communicate verbally Patient stated that she was having difficulty breathing Patient denied any history of seizure activity Patient denied eating breakfast before visit Patient's body became progressively cold to touch Emergency blanket utilized Patient desaturated to 74% on RA Patient was put on 2 L of Oxygen via Nasal Cannula Patient's oxygen and heart rate were continuously monitored Patient's oxygen saturation elevated to 95-100% on NC Patient stated that she was unable to feel her body Patient's hands remained clenched and tonic Patient remained to have subtle jerky movements of arms and head Emergency services arrived and report of event was given Emergency services was given face sheet, problem list, updated med list, PCP visit summary Patient was able to assist in walking to stretcher in hallway Emergency services are transferring patient to Emergency Care.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Rash, Skin exfoliation
Clinical narrative: Large rash above elbow, at wrist and under forearm on the left side (vaccination arm).  After 10 days  the rash area shed the top layer of skin.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Migraine, Visual impairment, Vitreous floaters
Clinical narrative: Patient described having eye "floaters" within 45 minutes of receiving flu vaccination. Patient promptly went to eye doctor who determined she did not have any eye issues or floaters, but most likely had a visual migraine. Patient had visual disturbances for at least a few hours after vaccination, but no typical migraine pain or discomfort, only sensation of "floaters" in  visual field. Patient told to update us or doctor on her status this evening
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Nodule, Pain, Skin warm, Swelling
Clinical narrative: redness, swelling, warm to touch, pain, knot
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, warm to touch, pain, knot
Age: 65.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Blood pressure increased, Chills, Heart rate increased, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, chills, sweating, increased blood pressure, increase pulse rate, rash on right arm
Age: 65.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Rash
Clinical narrative: Fever, chills, sweating, increased blood pressure, increase pulse rate, rash on right arm
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fixed eruption, Rash
Clinical narrative: Fixed drug eruption with a rash in an area where patient previously had Shingles
Age: 79.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness
Clinical narrative: The day following injection, patient became severely dizzy.  Needed to stay in bed for 36 hours until the reaction subsided.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Ear pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Severe ear ache lasting 5 days starting 2 days after injection. Swollen lymph nodes in neck. Sore throat. All lasting 5 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Sore, swollen, hot red arm,  sleepless, no appetite, Fever (101.5), Body Aches, Nausea, Stomach Pain, No Appetite, Dizzy, Sweats especially at night, Headache, Diarrhea, Fatigue, Nervousness, Shortness of breath
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Sore, swollen, hot red arm,  sleepless, no appetite, Fever (101.5), Body Aches, Nausea, Stomach Pain, No Appetite, Dizzy, Sweats especially at night, Headache, Diarrhea, Fatigue, Nervousness, Shortness of breath
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nervousness, Night sweats, Pain, Pain in extremity
Clinical narrative: Sore, swollen, hot red arm,  sleepless, no appetite, Fever (101.5), Body Aches, Nausea, Stomach Pain, No Appetite, Dizzy, Sweats especially at night, Headache, Diarrhea, Fatigue, Nervousness, Shortness of breath
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Sore, swollen, hot red arm,  sleepless, no appetite, Fever (101.5), Body Aches, Nausea, Stomach Pain, No Appetite, Dizzy, Sweats especially at night, Headache, Diarrhea, Fatigue, Nervousness, Shortness of breath
Age: 88.0
Sex: F
Vaccine: FLUA4, TDAP
Symptoms: Asthenia, Headache, Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: patient can't raise her arm up (arm of injection) . patient complain of pain and can't sleep the night after injection. patient complain of  headache the morning after.  vaccine make her weak and itching.
Age: 88.0
Sex: F
Vaccine: FLUA4, TDAP
Symptoms: Pruritus
Clinical narrative: patient can't raise her arm up (arm of injection) . patient complain of pain and can't sleep the night after injection. patient complain of  headache the morning after.  vaccine make her weak and itching.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: PATIENT CAMEBACK TWO DAYS AFTER VACCINE ADMINISTERED AND HIS BICEP AND PART OF ARM WAS RED
Age: 73.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Limb discomfort, Neck pain, Pain in jaw, Pyrexia
Clinical narrative: patient was feeling well before vaccines, got both in same arm at the same time. next morning patient reports severe arm discomfort, pain shotting through her neck and jaw, sustained fever of 101 degrees F
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse non pruritic maculopapular rash on trunk day after administration. Advised supportive care.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Painful and  swollen Rash  on her left arms. Pt had to go to ER and was prescribed steroid for 1 week.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within an hour of injection, the injection site started swelling, red and warm to the touch.  Within 1 day, I experienced a headache, shivering (especially with cold hands), and muscle aches along the back of my legs.  The swelling, warmth, and redness have increased to an area almost the size of my palm.  Cold packs, ibuprofen, and acetaminophen have not alleviated any symptoms, which are ongoing at this time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Peripheral coldness
Clinical narrative: Within an hour of injection, the injection site started swelling, red and warm to the touch.  Within 1 day, I experienced a headache, shivering (especially with cold hands), and muscle aches along the back of my legs.  The swelling, warmth, and redness have increased to an area almost the size of my palm.  Cold packs, ibuprofen, and acetaminophen have not alleviated any symptoms, which are ongoing at this time.
Age: 0.75
Sex: M
Vaccine: HEP, IPV
Symptoms: Crying, Decreased appetite, Discomfort, Irritability, Lethargy
Clinical narrative: Tuesday (aug 25, 2020):  received two shots at his 9 month check up (really 10 mos old ). He received the polio and 1st Hep B vaccine.  Tuesday Late Night: started with a low-grade fever and got up to 100. Restless sleep Wednesday: Morning temp was 103.2 so I gave him Tylenol. Kept up with Tylenol all day and he reached temp of 103.7. He was lethargic, only wanted to breastfeed (no table food), and constant crying.  Thursday: Still screaming/throwing head back. Temp down to 101. Gave Tylenol. Only stopped screaming long enough to breastfeed. Called doctor. They didn?t want to see him since it had only been two days and said this reaction is normal.  Friday: Still screaming/throwing head back, temp at 100. Started pulling on ears, neck, and hair. Gave Tylenol.  Saturday: Fever is gone, still screaming, small rash started on face and behind ears and side of neck Sunday: Still pulling on ears, neck, and hair. No fever. Rash is all over body now. Still screaming/throwing head back but there are longer breaks between episodes. Monday: Called doctor but she isn?t there today. Rash looks redder and more irritated. Went to urgent care. They did strep test (came back negative) and checked his ears (they looked fine). He prescribed Tylenol.   Tuesday: No temp, still has rash, not as irritable but still signs of being uncomfortable
Age: 0.75
Sex: M
Vaccine: HEP, IPV
Symptoms: Poor quality sleep, Pyrexia, Rash, Rash erythematous, Screaming
Clinical narrative: Tuesday (aug 25, 2020):  received two shots at his 9 month check up (really 10 mos old ). He received the polio and 1st Hep B vaccine.  Tuesday Late Night: started with a low-grade fever and got up to 100. Restless sleep Wednesday: Morning temp was 103.2 so I gave him Tylenol. Kept up with Tylenol all day and he reached temp of 103.7. He was lethargic, only wanted to breastfeed (no table food), and constant crying.  Thursday: Still screaming/throwing head back. Temp down to 101. Gave Tylenol. Only stopped screaming long enough to breastfeed. Called doctor. They didn?t want to see him since it had only been two days and said this reaction is normal.  Friday: Still screaming/throwing head back, temp at 100. Started pulling on ears, neck, and hair. Gave Tylenol.  Saturday: Fever is gone, still screaming, small rash started on face and behind ears and side of neck Sunday: Still pulling on ears, neck, and hair. No fever. Rash is all over body now. Still screaming/throwing head back but there are longer breaks between episodes. Monday: Called doctor but she isn?t there today. Rash looks redder and more irritated. Went to urgent care. They did strep test (came back negative) and checked his ears (they looked fine). He prescribed Tylenol.   Tuesday: No temp, still has rash, not as irritable but still signs of being uncomfortable