chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Pt developed recurrence of her shingles on her R chin (where she has had before) the afternoon of receiving Shingrix. She then developed lesion on her L abdomen and on her R shoulder.  She contacted my office that afternoon at which time she had very few lesions and I had recommended she hold on using Valtrex as it was still early and my understanding was that Shingrix could not cause shingles. She was agreeable to this but 3 days later, she contacted the office to report continued spread to new locations. I recommended she resume Valtrex at that time.
Age: 41.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Severe edema, erythema, firmness, ecchymosis, warm and severe tenderness to touch. 2 hours past vaccination are ecchymosis, firmness, edema and warmth set, later progressing in severity around vaccination site and around arm, reaching a diameter 6.5in x 3.5in
Age: 41.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site warmth
Clinical narrative: Severe edema, erythema, firmness, ecchymosis, warm and severe tenderness to touch. 2 hours past vaccination are ecchymosis, firmness, edema and warmth set, later progressing in severity around vaccination site and around arm, reaching a diameter 6.5in x 3.5in
Age: 41.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Contusion
Clinical narrative: Severe edema, erythema, firmness, ecchymosis, warm and severe tenderness to touch. 2 hours past vaccination are ecchymosis, firmness, edema and warmth set, later progressing in severity around vaccination site and around arm, reaching a diameter 6.5in x 3.5in
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Awakened at 2 a.m. by extreme sore throat. Accompanied by a fever of 100 degrees at 5 a.m.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Severe pain at injection site, for 7 days, inability to move arm for 2 days, fever 100.6 for 24 hours, flu-like aches and pains for 3 days
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Leg swelling started evening of vaccine, worsened into next day.  feels warm at site and red.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Severe pain and swelling of right arm from shoulder to hand started 1 day after vaccine.  Difficulty moving right arm persisting on 10/5/20 when patient returned to office.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Patient called the pharmacy to complain of a black and blue arm and sore muscle that had been happening since the shot was given. Patient had not been to see the doctor and the swelling and pain was going down in the left arm that the vaccine was given in
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis infection
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Fatigue, Tremor
Clinical narrative: about 1pm he felt extremely weak, and then went into incredible shaking, even his spine shaking and that lasted almost 2 hours, at 2 am he got diahrrea and had that horrible, felt drained
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Unknowingly administered expired quadrivalent flu vaccine. Given IM in the left deltoid
Age: 13.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Expired product administered
Clinical narrative: Unknowingly administered expired quadrivalent flu vaccine. Given IM in the left deltoid
Age: 13.0
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Unknowingly administered expired quadrivalent flu vaccine. Given IM in the left deltoid
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Pts. states she had a fever of 99.8, fatigue, localized redness at the injection site, and swelling of the left arm. Pt. states that all adverse effects resolved by the 30th of September 2020.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye pruritus, Headache, Lacrimation increased, Pruritus, Rash
Clinical narrative: About 10:30 pm patient stareted having itchy watery eyes and sinus congestion along with severe headache. At 4;30 am started getting itchy and rash on shoulder and neck area. After work around 6:00-6:45 am patient went to emergency room.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Sinus congestion
Clinical narrative: About 10:30 pm patient stareted having itchy watery eyes and sinus congestion along with severe headache. At 4;30 am started getting itchy and rash on shoulder and neck area. After work around 6:00-6:45 am patient went to emergency room.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, skin very warm to touch.
Age: 67.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Chills, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Patient received vaccines around 1 pm. His wife called around 6:45 pm to report that patient was having chills, and tingling/ numbness in his hand. He also complained about nausea.  All these symptoms lasted about an hour.  Patient did not report taking any medications for the symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing
Clinical narrative: flushing reaction and difficulty breathing. able to speak and was conscious. reaction started about 5-10 minutes post vaccination as patient returned to pharmacy. patient sat while paramedics arrived no treatment administered. no reaction at site of vaccination. patient continued to shop after about 15 minutes
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Hypotension, Syncope, Tremor
Clinical narrative: Administered vaccine and within 10 minutes patient fainted. BP was 86/43 and HR was 51 after a few minutes when patient came to. Very flushed, shaking. EMS visited her, her BP was still low 10 minutes after I took the measurement.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; Nurse called and reported vaccination to patient with improperly stored vaccine; This spontaneous report was received from a Registered Nurse and refers to a currently 2-months old patient of unknown gender and race. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date in 2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally for prophylaxis (lot #, expiration date, and frequency not reported). No additional adverse events were reported.  The improperly stored suspect vaccine experienced a temperature excursion of 28 Fahrenheit (F), 33.9 F, and 50.2 F; for a time frame of 7 hours and 10 minutes. No previous temperature excursion was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009631: US-009507513-2009USA009674: US-009507513-2009USA009426: US-009507513-2009USA009631: US-009507513-2009USA009446:
Sex: U
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Fatigue, Giant cell arteritis, Neuralgia, Weight decreased
Clinical narrative: atrial fibrillation; giant cell arteritis/fatigue, weight loss; nerve pain; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 06-JAN-2014,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from nerve pain, fatigue, weight loss, atrial fibrillation and was diagnosed with giant cell arteritis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitation not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expanses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of atrial fibrillation, nerve pain and giant cell arteritis were considered to be disabling.  Upon internal review, the event of atrial fibrillation was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Gait disturbance, Guillain-Barre syndrome, Nerve injury, Paralysis
Clinical narrative: cardiovascular problems; diagnosed with Guillain-Barre syndrome/suffered paralysis from her waist to her toes/suffered permanent nerve damage/gait issues; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 15-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered paralysis from her waist to her toes. The pt was diagnosed with Guillain-Barre syndrome and had suffered permanent nerve damage. In addition to gait issues, the pt had also suffered cardiovascular problems. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events of Guillain-Barre syndrome and cardiovascular disorder to be related to zoster vaccine live (ZOSTAVAX) (reported as all of these injuries were caused by zoster vaccine live (ZOSTAVAX)).  The events of Guillain-Barre syndrome and cardiovascular disorder were considered to be disabling. Upon internal review, the event of Guillain-Barre syndrome was determined to be medically significant.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no reaction or other AE in patient; high temperature excursions; This spontaneous report was received from a registered nurse and refers to a 2 -year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-SEP-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot # R006746, expiration date 09-NOV-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). The nurse reported that the vaccine had undergone the following high temperature excursions: 49.1 degrees Fahrenheit (15 minutes in August 2020), 46.6 degrees Fahrenheit (1 minute on 09-SEP-2020), 46.9 (8 minutes on 17-SEP-2020) and 46.8 degrees Fahrenheit (6 minutes on 20-SEP-2020). A data logger was involved. The nurse confirmed no reaction or other adverse event in the patient. No further information provided, and no product quality complaint (PQC) identified.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a VAQTA pediatric dose was administered today post expiration date; This spontaneous report was received from a medical assistant and refers to a 15-year-old male patient. The patient's pertinent medical history, concomitant medications and previous drug reaction or allergies were not reported. On 30-SEP-2020 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 1 pediatric dose, lot # S019435, expiration date 23-AUG-2020 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Unknown; 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
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pruritus
Clinical narrative: received the first dose of Shingrix subcutaneously instead of intramuscular; slight itching; red arm; This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix (subcutaneous). In September 2020, less than a week after receiving Shingrix, the patient experienced pruritus and erythema of extremities. On 23rd September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pruritus and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pruritus and erythema of extremities to be related to Shingrix.  Additional details were as follows: After receiving 1st dose of Shingrix, the patient experienced red arm and a slight itching. The patient received the first dose of Shingrix subcutaneously instead of intramuscular, which led to intramuscular formulation administered by another route. The reporter reported that, the adverse events lasted 2 days and the patient is completely fine now. The reporter mentioned that next dose will be administered intramuscularly.  No further information provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rosacea
Clinical narrative: experienced rosacea; This case was reported by a consumer via call center representative and described the occurrence of rosacea in an unspecified number of 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 rosacea. On an unknown date, the outcome of the rosacea was unknown.   It was unknown if the reporter considered the rosacea to be related to Shingrix.  Additional details were as follows: The age at vaccination was not applicable for this report.  The caller reported that, a couple of her friends experienced rosacea after receiving the Shingrix vaccine. The patient had to be treated with prescription medication to treat the rosacea. The caller reported that, did not have specific patient identifiers. The caller did not feel comfortable providing any specific or additional information about the adverse event reported. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pain and Swelling at the injection site; Swelling at the injection site; Could not move her arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, injection site swelling and injected limb mobility decreased. The patient was treated with paracetamol (Tylenol) and baclofen. On an unknown date, the outcome of the pain in arm, injection site swelling and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: On 23rd or 24th September 2020, the patient received first dose of Shingrix vaccine in right arm. The patient had pain and swelling at the injection site after receiving the vaccine. The pain spread throughout the entire right arm and became so severe that she could not move her arm. The patient went to her physician who recommended Tylenol. The patient also went to the emergency room where the physician recommended Tylenol and prescribed baclofen. The pharmacist stated that the patient was improving. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: hives/ hives spread to the chest at the bra line area and up to the shoulders; itchy/ still very itchy/ scalp is also itchy; rash/ rash and hives spread to the chest at the bra line area and up to the shoulders; This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, 5 weeks after receiving Shingrix, the patient experienced hives, pruritus and rash. The patient was treated with triamcinolone acetonide, steroids nos (Steroids) and antihistamine (Antihistamines). On an unknown date, the outcome of the hives, pruritus and rash were recovering/resolving.   It was unknown if the reporter considered the hives, pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm. The rash and hives that was very itchy presented on the patient's back 5 weeks after receiving the vaccine. Several weeks later (6 weeks before time of reporting) the rash and hives had spread to the chest at the bra line area and up to the shoulders. It was very itchy till the time of reporting. The patient's scalp was also itchy. The patient had been treated by a dermatologist with various steroids and antihistamines. The patient was currently being treated with a cream and ointment called Triamcinolone acetonide 0.1% that seemed to help with the itch. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; headache; fatigue; vomiting; diarrhea; extreme chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 27th September 2020, the patient experienced fever, headache, fatigue, vomiting and diarrhea. On 28th September 2020, the outcome of the chills, fever, headache, fatigue, vomiting and diarrhea were recovered/resolved.   The reporter considered the chills, fever, headache, fatigue, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Later on the same night of vaccination the patient started having extreme chills. The next day on 27th September 2020, the patient developed fatigue, headache, fever, vomiting and diarrhea. The patient stated all of her symptoms lasted through 27th September 2020, but have resolved as on the day of reporting. The reporter declined to provide health care professional information and offered copy of personal information. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever; headache; fatigue; vomiting; diarrhea; extreme chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 27th September 2020, the patient experienced fever, headache, fatigue, vomiting and diarrhea. On 28th September 2020, the outcome of the chills, fever, headache, fatigue, vomiting and diarrhea were recovered/resolved.   The reporter considered the chills, fever, headache, fatigue, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Later on the same night of vaccination the patient started having extreme chills. The next day on 27th September 2020, the patient developed fatigue, headache, fever, vomiting and diarrhea. The patient stated all of her symptoms lasted through 27th September 2020, but have resolved as on the day of reporting. The reporter declined to provide health care professional information and offered copy of personal information. The reporter did not consent to follow up.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 year old patient received FLUBLOK QIV, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 year old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 26-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  At the time of report no adverse event was reported.  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.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Local injection site pain, generalized muscle aches and fatigue.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Benign rolandic epilepsy, Differential white blood cell count normal, Electroencephalogram abnormal, Full blood count, Generalised tonic-clonic seizure
Clinical narrative: Tonic Clonic Seizure lasting 4-5 minutes. Ambulance was called and immediate transport to Emergency room.  This is the first ever Tonic Clonic seizure for the patient.  Once we returned home we found additional stains under the pillow when changing the sheets indicating additional potential incidents in the previous week.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Magnetic resonance imaging brain normal
Clinical narrative: Tonic Clonic Seizure lasting 4-5 minutes. Ambulance was called and immediate transport to Emergency room.  This is the first ever Tonic Clonic seizure for the patient.  Once we returned home we found additional stains under the pillow when changing the sheets indicating additional potential incidents in the previous week.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: PT BEGAN GETTING HIVES ON BODY 10-2-20 AND WAS COMPLETELY COVERED BY MORNING OF 10-3-20. PT CONTACTED HER PCP AND WAS TOLD TO TAKE ZYRTEC AND PEPCID. RASH BEGAN TO LESSEN IN SEVERITY. ON 10-4-20 RASH WAS GONE. PT CONTACTED PHARMACY ON ADVICE OF HER PHYSICIAN TO NOTIFY PHARMACY OF RASH.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache
Clinical narrative: developed a stabbing headache for the second year in a row after getting the vaccine.  In addition this year she developed a pruritic popular rash at site of reaction the next day while in the shower.  The rash continued to spread around the site of vaccination in the deltoid region.  No SOB or spread of rash to other areas of the body.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt was administered the Menactra instead of MMR. When drawing up vaccine it was double checked by another MA in the office. Called and spoke with the patients mother, states that the patient is fine and there is no signs or symptoms.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin swelling, Swelling
Clinical narrative: Localized swelling and redness, extending from site of injection up to neck/scalp. Increased in size until 48 hours after injection, then began fading . Today with slight redness around injection site as well as on neck.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Mass, Pain in extremity
Clinical narrative: Severe pain to the arm, large lump, redness, bruising
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Injection site pain
Clinical narrative: Time course: Symptoms began  appx 12 hours following vaccination.  --Fever resolved day 2, body aches and headache still present on day 2 Treatment:acetaminophen PO, cold pack at injection site Symptoms:  fever, fatigue, headache, pain at injection site, stomach pain, general muscular and joint pain --Symptoms forced cessation of normal activities for 2 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain, Pyrexia
Clinical narrative: Time course: Symptoms began  appx 12 hours following vaccination.  --Fever resolved day 2, body aches and headache still present on day 2 Treatment:acetaminophen PO, cold pack at injection site Symptoms:  fever, fatigue, headache, pain at injection site, stomach pain, general muscular and joint pain --Symptoms forced cessation of normal activities for 2 days
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: 101 -102 fever and rash from neck to extremities, tachycardia (144 pulse) for two days before seeking treatment at an urgent care facility.  Fever and rash more severe than what allergic reaction is described and I never have had any adverse reactions to vaccine in the past.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria
Clinical narrative: Two events: 1 - site injection Reaction w/ hives, Redness, tenderness, myalgia - left deltoid. 2 - Left leg with herpes zoster classic Rash L3 dermatome
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: Two events: 1 - site injection Reaction w/ hives, Redness, tenderness, myalgia - left deltoid. 2 - Left leg with herpes zoster classic Rash L3 dermatome
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site warmth, Pain
Clinical narrative: Two events: 1 - site injection Reaction w/ hives, Redness, tenderness, myalgia - left deltoid. 2 - Left leg with herpes zoster classic Rash L3 dermatome
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Muscle tightness, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The morning following the vaccine I woke with a very sore arm about 5AM.   My arm was tight and hard to lift or move behind my back as the day went on.   I used the internet to see if this was unusual, the site said you could have symptoms for up to 10 days, which was very rare, or two days following the injection.   As the days went on I have had less and less motion and more and more pain.   I cannot sleep through the night, I have a very difficult time driving, turning the wheel as well as backing up.   Yesterday, 10/4/20, I went back to the pharmacy and spoke with the pharmacist.   The pharmacist said I should file a complaint, as well as make an apt with my doctor.   The pharmacist also said this was much to long to be from the shot.   The pharmacist then asked where it hurt, when I showed her my shoulder area, she said "that is much to high for a shot".   When I asked if I could speak with the young man you gave me the shot, she said "he is no longer with the pharmacy.      I have made an apt with my doctor and will know more but this is absolutely without any doubt from the shot.     I am 65 on no medications, very healthy, play golf, tennis, ski, hike.    I currently am unable to lift my arm or pull it behind me.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea
Clinical narrative: Diarreas
Age: 20.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Chills, Headache, Loss of consciousness, Oropharyngeal pain, Pyrexia
Clinical narrative: 5 hours after doc appt, had 103 fever, chills, headache, sore throat, wheezing, fever increased to 104 by morning; once at urgent clinic, started passing out after they gave steroid injection
Age: 20.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Wheezing
Clinical narrative: 5 hours after doc appt, had 103 fever, chills, headache, sore throat, wheezing, fever increased to 104 by morning; once at urgent clinic, started passing out after they gave steroid injection
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: Symptoms: Widespread rash, hives, erythema in and around injection site of the L shoulder, upper back, chest and abdomen Treatment: 10/5/2020 = solumedrol 125mg IM, RX= prednisone 20mg BID x 5 days, OTC Claritin 10mg PO Daily, Zantac 150mg PO BID x5days, Benadryl 25-50mg PO BID PRN itching
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Paraesthesia
Clinical narrative: Adverse event was the tingling and pain of my skin from my neck to my toes.  I did not develop a rash, but the pain of my skin was a surprise.  Felt like I had the shingles.  Depending on activities it would seem to dissipate, but at night it seems to get worse.  I did take an antihistamine (24 hr.) generic which did seem to help a little.   I did not go to a Dr. or ER to be examined.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: High fever=101.4; Chills; Headache; muscle pain
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Pain, Skin reaction, Skin warm, Swelling
Clinical narrative: Red, Swollen/Hard, Hot to touch, Painful Treated with Prednisolone
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Dizziness, Headache, Malaise
Clinical narrative: Vaccination happened at 0900 on a Thursday.  Felt fine all day until all of a sudden at around 7:00 that evening.  It hit me like a ton of bricks.  Felt bad all over.  Took 600mg Ibuprofen, mainly for unrelated hip pain.   Four hours later I felt very much worse with an axillary temperature of 101.  Fever continued despite further doses of Ibuprofen all day Friday.  Was nauseated.  Threw up once.  Was barely able to  get out of bed except to go to the bathroom.  Dizzy.  Extreme body aches and headache with fever all day Friday.  Still sick Saturday morning, but started feeling better.  By mid afternoon I felt great again.  It left as quickly as it came, but it was as sick as I've ever been.  Thought I had Covid but that test was negative.   Should I get the second dose?  Would it help to take Benadryl before the second dose?
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Vaccination happened at 0900 on a Thursday.  Felt fine all day until all of a sudden at around 7:00 that evening.  It hit me like a ton of bricks.  Felt bad all over.  Took 600mg Ibuprofen, mainly for unrelated hip pain.   Four hours later I felt very much worse with an axillary temperature of 101.  Fever continued despite further doses of Ibuprofen all day Friday.  Was nauseated.  Threw up once.  Was barely able to  get out of bed except to go to the bathroom.  Dizzy.  Extreme body aches and headache with fever all day Friday.  Still sick Saturday morning, but started feeling better.  By mid afternoon I felt great again.  It left as quickly as it came, but it was as sick as I've ever been.  Thought I had Covid but that test was negative.   Should I get the second dose?  Would it help to take Benadryl before the second dose?
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vaccination happened at 0900 on a Thursday.  Felt fine all day until all of a sudden at around 7:00 that evening.  It hit me like a ton of bricks.  Felt bad all over.  Took 600mg Ibuprofen, mainly for unrelated hip pain.   Four hours later I felt very much worse with an axillary temperature of 101.  Fever continued despite further doses of Ibuprofen all day Friday.  Was nauseated.  Threw up once.  Was barely able to  get out of bed except to go to the bathroom.  Dizzy.  Extreme body aches and headache with fever all day Friday.  Still sick Saturday morning, but started feeling better.  By mid afternoon I felt great again.  It left as quickly as it came, but it was as sick as I've ever been.  Thought I had Covid but that test was negative.   Should I get the second dose?  Would it help to take Benadryl before the second dose?
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Normal pain and weakness the day of vaccination, and the next 2 days. pain went away for 3-4 days, then came back 9/17/20.  Pain/ weakness in right arm/shoulder. Weakness / limited range of motion in right arm for 3 weeks after shot administered. Could not lift  arm full for over 3 weeks straight due to weakness. Severe pain when crossing arm in front of body.
Age: 55.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Muscle spasms, Pain
Clinical narrative: Received the FLU shot (type unknown) and the Zoster (Shingrix - part 1) shot on 9/28/2020.  The following day I started having headaches and craping. On 9/30/2020 I started experiencing some tingling in my right leg-thigh. The next day 10/1/2020, that night, I noticed blisters starting to form on my right butt, right thigh, back, and a small blister on my face. The following day, 10/2/2020, the blisters got worse and pain started to increase. The pain was like needles sticking into my skin in the blistered areas. On Saturday 10/3, after researching the symptoms it become obvious to me that I had the Shingles. On Sunday 10/4 I decide to go to ER-clinic to get diagnosed. The clinic diagnosed it as shingles.  The prescribed antiviral famciclovir.
Age: 55.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Received the FLU shot (type unknown) and the Zoster (Shingrix - part 1) shot on 9/28/2020.  The following day I started having headaches and craping. On 9/30/2020 I started experiencing some tingling in my right leg-thigh. The next day 10/1/2020, that night, I noticed blisters starting to form on my right butt, right thigh, back, and a small blister on my face. The following day, 10/2/2020, the blisters got worse and pain started to increase. The pain was like needles sticking into my skin in the blistered areas. On Saturday 10/3, after researching the symptoms it become obvious to me that I had the Shingles. On Sunday 10/4 I decide to go to ER-clinic to get diagnosed. The clinic diagnosed it as shingles.  The prescribed antiviral famciclovir.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchospasm, Influenza like illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: 3 Days after shot given the patient experienced flu like symptoms, general overall malaise, bronchospasms, then deep muscle pain down arm
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 3 Days after shot given the patient experienced flu like symptoms, general overall malaise, bronchospasms, then deep muscle pain down arm
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: swollen / sore arm. rash in the form of a large square
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Pt states that she is experiencing swelling and redness that is also spreading for about a week.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Decreased appetite, Hypoaesthesia, Lethargy, Nausea
Clinical narrative: Pt states at about 3 hours after receiving the flu shot, pt started to feel achy, shaking, teeth grindind and nausea and her 2 fingers were numb. next day she states that she didn't have appetite and felt lathergic. after that she states she was fine and no issues.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Tremor
Clinical narrative: Pt states at about 3 hours after receiving the flu shot, pt started to feel achy, shaking, teeth grindind and nausea and her 2 fingers were numb. next day she states that she didn't have appetite and felt lathergic. after that she states she was fine and no issues.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Headache, Myalgia, Neck pain, Vomiting
Clinical narrative: The patient had severe neck and muscle pain.  Due to the pain caused the patient to vomit.  The patient was seen at the emergency room 24 hours later where he was given penicillin and pain medications due to severe head pain.  The back pain has subsided as of 10/5/20.  The patient has received a doctors note never to receive any meningitis shot again.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that upon exiting store post-vaccination experienced pain/swelling in upper left arm with limited mobility.  Patient reported also experiencing chills, headache, and nausea.  Patient called to report these symptoms 10/5/20 at approximately 1530, and was beginning to feel relief from symptoms and some signs of improvement.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Patient reported that upon exiting store post-vaccination experienced pain/swelling in upper left arm with limited mobility.  Patient reported also experiencing chills, headache, and nausea.  Patient called to report these symptoms 10/5/20 at approximately 1530, and was beginning to feel relief from symptoms and some signs of improvement.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: 24 hours after vaccines mom noted redness around site worse next day with warmth, no tenderness Seen 10/5 redness there but improved
Age: 58.0
Sex: U
Vaccine: FLU4
Symptoms: Arthritis, Discomfort, Pain, X-ray limb
Clinical narrative: After typical soreness from flu vaccine resolved in 1-2 days, shoulder discomfort persisted in the joint area and continued to worsen.  Discomfort and pain continues when using shoulder for everyday activities.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Paraesthesia
Clinical narrative: felt hot immediately after vaccines administered, described tingling sensation in hands, lightheadedness, dizziness and sweating.  All resolved by around 1:45pm
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness, Hyperventilation, Vomiting
Clinical narrative: After 15 minutes of vaccine administration client c/o dizziness, light headiness. Client taken to exam room via w/c, placed in supine positions with cold compresses in back of neck. Blood pressure 129/81, HR 102. Client after 5 minutes had x3 episodes of emesis , and started hyperventilating. Blood pressure  135/76, HR 100.  911 called @ 2: 20 agreed  by mother to be transported for medial eval  to nearest E.R, Client left via stretcher accompany by mother x 2 emt's.
Age: 78.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient said within an hour after her pneumovax vaccination, her arm was swollen, red, and painful. It has gotten better each day, but her whole arm was red and swollen.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Dysphonia, Vaccine positive rechallenge
Clinical narrative: mom called to say the last time after 4 month vaccines and again after 6 month vaccines, patient developed a hoarse voice for a few dasy no difficulty in breathing or swallowing, resolved on its own.  patient was not seen, resolved.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was indicated for pneumonia vaccine however since she is under 65 years old she should have received the Pneumovax 23 instead of the Prevnar 13.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Decreased appetite, Diarrhoea, Fall, Fatigue, Febrile convulsion
Clinical narrative: 09/28/201:30 pm vaccines. 5:30 pm 101.3 fever. Tylenol administered. Vomiting. 12am vomiting 102.7 fever. Lethargic. 1am 103 fever. Tylenol. Vomiting. Motrin 5:50 am febrile seizure lasting approximately 4 minutes. Followed by vomit. Taken to ER. Monitored and given Tylenol. Tylenol and Motrin were administered recommended by pediatrician and tepid bath and pushed fluids. Nothing would bring the fever down.  10/05/20: refusing to walk. Regressed to crawling. Fumbling and falling when trying to walk. Muscle weakness. Excessively tired. No appetite. Diarrhea
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Gait inability, Lethargy, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: 09/28/201:30 pm vaccines. 5:30 pm 101.3 fever. Tylenol administered. Vomiting. 12am vomiting 102.7 fever. Lethargic. 1am 103 fever. Tylenol. Vomiting. Motrin 5:50 am febrile seizure lasting approximately 4 minutes. Followed by vomit. Taken to ER. Monitored and given Tylenol. Tylenol and Motrin were administered recommended by pediatrician and tepid bath and pushed fluids. Nothing would bring the fever down.  10/05/20: refusing to walk. Regressed to crawling. Fumbling and falling when trying to walk. Muscle weakness. Excessively tired. No appetite. Diarrhea
Age: 11.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Chest pain, Dizziness, Hypoaesthesia
Clinical narrative: Pain in chest shoulders, weakness, dizziness, numbness in face, itchy throat.
Age: 11.0
Sex: F
Vaccine: FLUA4
Symptoms: Throat irritation
Clinical narrative: Pain in chest shoulders, weakness, dizziness, numbness in face, itchy throat.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Retching
Clinical narrative: Dizziness, dry heaves, loss of balance No treatment yet
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Limb discomfort, Paraesthesia, Rash erythematous
Clinical narrative: Burning down the right arm, heavy feeling sensation within 20 minutes and  redness, tingling, and rash (red prickly), entire arm was warm to touch within 6-8 hrs lasting for 24 hrs
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Burning down the right arm, heavy feeling sensation within 20 minutes and  redness, tingling, and rash (red prickly), entire arm was warm to touch within 6-8 hrs lasting for 24 hrs
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain of skin, Pyrexia
Clinical narrative: I had BOTH the Shingrix vaccine and a flu shot (fluarix quadrivalent 0.5 ML INJ GLAX NDC:58160-0885-52) in the same arm at the same time. I took 2x 220 naproxin sodium about 30 minutes afterward. I had malaise and fatigue in the afternoon and retired early.  I awoke around 1 AM with a high fever (not measured), severe headache, intense fatigue, and skin painful and sensitive to touch and movement. I took 2 more naproxin. Symptom severity receded by about 3:30 AM. By morning my fever was 99F (measured) and headache and skin sensitivity lesser though not gone. I had 2 regular strength acetiminophen around 9 AM. By evening all symptoms other than fatigue and injection site sensitivity were gone.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin sensitisation
Clinical narrative: I had BOTH the Shingrix vaccine and a flu shot (fluarix quadrivalent 0.5 ML INJ GLAX NDC:58160-0885-52) in the same arm at the same time. I took 2x 220 naproxin sodium about 30 minutes afterward. I had malaise and fatigue in the afternoon and retired early.  I awoke around 1 AM with a high fever (not measured), severe headache, intense fatigue, and skin painful and sensitive to touch and movement. I took 2 more naproxin. Symptom severity receded by about 3:30 AM. By morning my fever was 99F (measured) and headache and skin sensitivity lesser though not gone. I had 2 regular strength acetiminophen around 9 AM. By evening all symptoms other than fatigue and injection site sensitivity were gone.
Age: 50.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: swelling, redness, itching and pain in left arm; body aches, headache, dizziness, fever, nausea
Age: 50.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: swelling, redness, itching and pain in left arm; body aches, headache, dizziness, fever, nausea
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received a second prevnar 13 instead of pneumovax 23. First prevnar 13 was given in February, 2019.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: I received the seasonal flu vaccine, I don't know what particular name it has.  My symptoms started that night and went through the next day. They included: fever, great fatigue, headache, and a little diarhhea.