chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain 2-3 weeks after first dose/Arthralgia experienced; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced arthralgia 2 to 3 weeks after vaccination.  The batch number has been updated from 7A554 to 7AS54 as per sales data sheet. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Red "dots" on the front and back of her torso; Red "dots" on the front and back of her torso/ red, blistered "dots" on back and front of torso; Back pain; Tender rash; This case was reported by a physician via call center representative and described the occurrence of back pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date unknown) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 8th March 2020, 2 days after receiving Shingrix, the patient experienced back pain and painful rash. On 11th March 2020, the patient experienced red rash and blistery rash. On an unknown date, the outcome of the back pain, painful rash, red rash and blistery rash were recovering/resolving.   It was unknown if the reporter considered the back pain, painful rash, red rash and blistery rash to be related to Shingrix.  Additional details were reported as follows: The patient receive 1st dose of vaccine and experienced back pain and a tender rash for which she sought medical care. The patient also developed red, blistered dots on back and front of torso. The reporter consented to follow up. This case has been linked with US2020045154, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after dose 1 of Shingrix; This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after 1st dose of Shingrix. The reporter consented to follow up. This case has been linked with US2020045152, reported by same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 2nd dose of Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 5th March 2020, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left arm (injection site) is still sore; Left arm (injection site) is still red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left deltoid. On 20th March 2020, the patient returned to the pharmacy and stated that her left arm (injection site) was still sore and red.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash; Fever; Body aches; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, fever and general body pain. On an unknown date, the outcome of the rash, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the rash, fever and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a lot of adverse reactions after vaccination with Shingrix. She had rash that lasted for 1 to 1.5 weeks. She also had fever and body aches that lasted over a day.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient received Shingrix near the end of October and reports his arm was sore for around 6 weeks. The reporter did not consented to follow up.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: pt called stating her arm is swollen from  her shouler almost to her elbow and warm to the touch  her had the PPV23
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Daily short lasting  shivers, chills that are persisting to date.  Also daily very short lasting sweating episodes
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient is here today for a possible vaccine reaction. She was seen two days ago for her well visit, at which time she received ProQuad in her RT and Quadracel in her LT. Mom states that she has a half dollar size raised red bump on her left thigh. She c/o pain when it is touched as well as a low grade fever. Her fever peaked at 101.2, but she has been afebrile today. Mom denies known exposure to illness. ,  Above documented HPI reviewed and verified. Additional history obtained by MD: confirmed that area of redness larger today than yesterday. Redness started within 24hours of immunizations. had a little limp the first day but has resolved. had temp 101.2 after vaccines but has been afebrile for over 24hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient is here today for a possible vaccine reaction. She was seen two days ago for her well visit, at which time she received ProQuad in her RT and Quadracel in her LT. Mom states that she has a half dollar size raised red bump on her left thigh. She c/o pain when it is touched as well as a low grade fever. Her fever peaked at 101.2, but she has been afebrile today. Mom denies known exposure to illness. ,  Above documented HPI reviewed and verified. Additional history obtained by MD: confirmed that area of redness larger today than yesterday. Redness started within 24hours of immunizations. had a little limp the first day but has resolved. had temp 101.2 after vaccines but has been afebrile for over 24hours.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Injection site pain, Nausea
Clinical narrative: Patient c/o felling faint, light headed, SOB, nausea, but no vomiting with pain at the injection site  with in 3hours.  Patient was advised to go to er.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin G, C-reactive protein, Erythema, Induration, Injected limb mobility decreased
Clinical narrative: My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration, Ultrasound scan, Vasodilatation
Clinical narrative: My right arm had a hard knot, red, raised, burning and bruise at the injection site along with itching redness, discoloration, burning and pain. My whole right arm from the shoulder down to the fingers were twice as swollen as my left arm. I have trouble raising my arm  and immense pain. My whole right arm was red, itching, swollen, disolored, painful, with  raised veins showing path of injection from injection site traveling  around my arm zigzagging until it arrived around under my  right armpit. I had and still have enlarged hard swollen painful multiple lymph nodes even today that have not changed. They were not there before the injection.  I could not use my right arm and hand which I am right handed dominant.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: Myalgia & Rash
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Patient vaccinated on 4/21/20, developed tenderness,  edema and redness in left leg, and low fever after receiving vaccines.  Seen on 4/24/20 and was already improving, no s/s of cellulites
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Respiratory depression
Clinical narrative: RespDepression. Albuterol 3 puff(s) once
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hip arthroplasty, Muscular weakness, Musculoskeletal disorder, Pain in extremity, Spinal operation
Clinical narrative: Hip replacement; Arm was sore; Arm felt incapacitated; This case was reported by a consumer via call center representative and described the occurrence of hip replacement in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced hip replacement (serious criteria hospitalization), pain in arm and weakness of arms. On an unknown date, the outcome of the hip replacement was unknown and the outcome of the pain in arm and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the hip replacement, pain in arm and weakness of arms to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix approximately in October or November 2018 in left arm.  One day after receiving Shingrix, the patient's arm was sore. Her arm felt incapacitated.  It took her 4 days to be back to normal.  The patient was hospitalized from 1st March 2019 till end of June 2019 for a hip replacement surgery that went wrong requiring her to get a back surgery.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix. No further details were provided. The reporter consented to follow up.
Sex: F
Vaccine: HEP, TTOX
Symptoms: Refusal of vaccination
Clinical narrative: patient had a reaction to after administration of vaccine; Initial information was received on 21-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves female patient who had a reaction to after administration of vaccine, while she received vaccines TETANUS TOXOID and HEPATITIS B VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) and a dose of suspect HEPATITIS B VACCINE (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, patient had a non-serious reaction after administration of vaccine (vaccination complication) (unknown latency) following the administration of TETANUS TOXOID and HEPATITIS B VACCINE.  It was reported that patient is in emergency department that had serious wound and needs Tetanus shot but she is refusing because she had previous reaction to one in 90s also, she had similar reaction to Hepatitis B vaccine which she received in 90s.   Details of laboratory data not reported.  Final diagnosis was patient had a reaction to after administration of vaccine.  It was not reported if the patient received any corrective treatment.  Patient was recovered with intensive care both the time of reaction corresponding to TETANUS TOXOID and HEPATITIS B VACCINE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received two doses of IPV on accident. Patient was given 1 dose from the multi-dose vial of IPV administered to her right thigh and an additional dose of IPV from a combination vaccine of Dtap/HepB/IPV in her left thigh. Patient appeared well after vaccines were administered. Mother was informed of what happened. Doctor assessed patient and agreed that she was doing well.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Administrative nurse by rural health nurse stated patient returned to clinic 6 days s/p Shingrix: patient requested to speak to me about a rash she developed over her left deltoid, felt related to Zoster vaccine, shown to dr. agrees, will take otc Benadryl. chart flagged
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Patient called to inform PCP that after shingrix injection last week, arm became swollen, red and painful. Reports it is back to normal at this time but reports does NOT want second injection.Advised patient to come to PC or UR in the future for any reaction to any medication. Will inform PCP.Patient agrees to come in immediately if any reaction appears
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; A physician states that on 04/20/2020 a patient was administered an improperly stored dose of VARIV AX.; This spontaneous report has been received from a physician, referring to a patient of unknown gender and age, Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions and allergies was not provided.  On 20-APR-2020, the patient received an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot number S010465 (had not been valid upon internal validation) and expiration date 20-MAY-2021 (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at 14 Fahrenheit (F) for a timeframe of 339 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: painful blistering rash and continued thereafter to suffering from nerve pain once rash resolved.; painful blistering rash and continued thereafter to suffering from nerve pain once rash resolved.; 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. On or about 12-SEP-2012, 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) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered from a painful blistering rash and continued thereafter to suffer from nerve pain once rash resolved. As a result of these symptoms, pt was seen and treated by medical providers, who diagnosed her with shingles (herpes zoster) and post-herpetic (post herpetic neuralgia). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. Pt sustained severe and permanent personal injuries. 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 of zoster vaccine live (ZOSTAVAX) vaccine, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and post herpetic neuralgia was not recovered. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and post herpetic neuralgia have been considered disabling events by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; developed shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for asthma.   On an unknown date, the patient received Shingles vaccine at an unknown dose and Nucala 100 mg at an unknown frequency. On an unknown date, unknown after receiving Shingles vaccine and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Nucala was continued with no change. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was vaccinated for shingles prior to starting Nucala. The patient started Nucala few years ago from the date of reporting. The patient recently developed Shingles. Till the time of reporting, the patient has not discontinued Nucala. The reporter was not sure if shingles was related to Nucala. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, time to onset for the event and lab test confirming varicella zoster virus infection was unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure, X-ray normal
Clinical narrative: people in your employee test developed shingles after having the vaccine; people in your employee test developed shingles after having the vaccine; Nerve pain; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 1st dose of Shingrix. On 9th December 2019, the patient received the 2nd dose of Shingrix. In March 2020, less than a year after receiving Shingrix and between 2 and 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingrix and Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received both doses of Shingrix and experienced right-side nerve pain along ribs. After X-rays ruled out lesions, the patient's physician tentatively diagnosed shingles, despite vaccine history. The patient did not have rash or blisters. The pain had now persisted for about 62 days though it seems to be lessening in terms of number of episodes, duration of episodes, and severity. The patient just wanted you to know because the patient read that a very small number of people in our employee test developed shingles after having the vaccine, so it could happen. The reporter consented for follow up. This case was linked with US2020AMR068654, same reporter.
Sex: F
Vaccine: MENB
Symptoms: Death, Epilepsy, Generalised tonic-clonic seizure
Clinical narrative: was diagnosed with epilepsy; grand mal seizure took patient's life; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On 6th November 2018, unknown after receiving Bexsero, the patient experienced grand mal seizure (serious criteria death and GSK medically significant). On an unknown date, the patient experienced epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was fatal and the outcome of the epilepsy was unknown. The patient died on 6th November 2018. The reported cause of death was grand mal seizure.   The reporter considered the grand mal seizure and epilepsy to be possibly related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy her whole life until her physician recommended she get the meningitis shot. Shortly after the vaccination, the patient was diagnosed with epilepsy.  On 6th November, 2018, a grand mal seizure took patient's life. It was reported that young woman was killed by the meningococcal vaccine. The case was linked with the case US2020AMR069851 reported by same reporter; Reported Cause(s) of Death: Grand mal seizure
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Atrial septal defect, Atrial septal defect repair, Cerebrovascular accident, Headache, Insomnia
Clinical narrative: The day after the vaccine I began experiencing migraines for the first time in my life.  I couldn't sleep at night and it was constant throbbing pain that would get unbearable a few times a day.  It lasted for about 3 weeks before it began to subside.  Below is the report from my primary doctor when I reported it on 30 Jan 2020:  38 yo M presented in clinic for headaches x 10 days. Pt describes as 2/10 throbbing pain. Pt states he will have headaches twice/day, waking up at 4 am. Pt states taking ibuprofen w/ relief. Pt denies triggers. Patient believes that this could be anthrax related. H/A wakes him up from sleep and occurs at least BID. Patient is questioning the need for subsequent Anthrax innoculation based on this reaction.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine, Pain, Poor quality sleep, Vaccination complication
Clinical narrative: The day after the vaccine I began experiencing migraines for the first time in my life.  I couldn't sleep at night and it was constant throbbing pain that would get unbearable a few times a day.  It lasted for about 3 weeks before it began to subside.  Below is the report from my primary doctor when I reported it on 30 Jan 2020:  38 yo M presented in clinic for headaches x 10 days. Pt describes as 2/10 throbbing pain. Pt states he will have headaches twice/day, waking up at 4 am. Pt states taking ibuprofen w/ relief. Pt denies triggers. Patient believes that this could be anthrax related. H/A wakes him up from sleep and occurs at least BID. Patient is questioning the need for subsequent Anthrax innoculation based on this reaction.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm redness, swelling, and warmth x 3 days
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Paraesthesia, X-ray dental
Clinical narrative: 1 month after shot started feeling pain in left side of jaw. Within a couple days felt electrical shocks, could not talk or eat most of the time. Was given HYDROCODONE/ACETAMINOPHEN and PREDNISONE. Pain subsided but it has gradually returned. I am experiencing pain almost everyday now but not as severe. I do have to stop eating sometimes until the pain stops. My doctor says it will take months until pain goes away completely.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Body height decreased, Dementia, Injection site pain, Myalgia
Clinical narrative: Soreness in both upper arms; soreness in the left arm where she got the injection; Dementia; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, NDC number: 000051971-02), via an unspecified route of administration on 19Apr2020 in left arm at a single dose for immunization. Medical history included swelling, and memory loss. Concomitant medication included spironolactone (SPIROLACTON) from an unspecified date and ongoing for at least 5 years for swelling, donepezil (strength: 15mg) from an unspecified date and ongoing for two years for memory loss; and also took some supplements. On 20Apr2020, the patient had soreness in the left arm where she got the injection, the patient had muscle soreness in the upper right arm; So she had soreness in both upper arms. The patient had dementia in an unspecified date in Apr2020. The patient underwent lab tests and procedures which included height: shrunk, 124.968 centigrade. The outcome of events was unknown. The report is not related to a study or programmer.  Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the event dementia was related to pneumococcal 13-valent conjugate vaccine use. This is more likely associated with the history of memory loss, advanced age, or an intercurrent condition.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Blepharospasm, Heart rate increased, Hypoaesthesia, Impaired work ability, Injection site hypoaesthesia
Clinical narrative: Initial common pain at the injection site began within 5 minutes around 3:15. After returning home about 30 minutes later I felt lethargic and took a nap until about 10 pm. When I woke up from my nap, I still felt extremely lethargic and started feeling a tingling sensation and numbness in my left arm (vaccine administered in left arm). I did not pay attention to it and thought that would be common. I went back to bed and slept through the night until I woke up around 10 am. The tingling sensation and numbness continued from the injection site to the tips of my fingers. Both arms now felt the sensation, but the left arm was worse (similar to the irritation, discomfort, and pain of when your foot falls asleep). My left eye lid to my eyebrow started to twitch 5-10 times per hour for about 36 hours. The arm reactions settled down after a 50mg dose of Benadryl orally directed by my doctor after about 1 hour. The Benadryl only weakened the tingling sensation and numbness. I was directed to continue taking the Benadryl every 4-6 hours as needed. I had an increased heart rate of about 132 bpm when I woke up at 10 am (potentially due to anxiety about the vaccine reactions). I was directed to rest, and I had to call out of work. The facial twitching and arm reactions slowly settled down on 4/26 around 7 pm.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Injection site paraesthesia, Lethargy, Paraesthesia
Clinical narrative: Initial common pain at the injection site began within 5 minutes around 3:15. After returning home about 30 minutes later I felt lethargic and took a nap until about 10 pm. When I woke up from my nap, I still felt extremely lethargic and started feeling a tingling sensation and numbness in my left arm (vaccine administered in left arm). I did not pay attention to it and thought that would be common. I went back to bed and slept through the night until I woke up around 10 am. The tingling sensation and numbness continued from the injection site to the tips of my fingers. Both arms now felt the sensation, but the left arm was worse (similar to the irritation, discomfort, and pain of when your foot falls asleep). My left eye lid to my eyebrow started to twitch 5-10 times per hour for about 36 hours. The arm reactions settled down after a 50mg dose of Benadryl orally directed by my doctor after about 1 hour. The Benadryl only weakened the tingling sensation and numbness. I was directed to continue taking the Benadryl every 4-6 hours as needed. I had an increased heart rate of about 132 bpm when I woke up at 10 am (potentially due to anxiety about the vaccine reactions). I was directed to rest, and I had to call out of work. The facial twitching and arm reactions slowly settled down on 4/26 around 7 pm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Corneal oedema, Eye pain, Ocular hyperaemia, Vision blurred
Clinical narrative: 3 days after immunization, patient developed blurred vision, redness, and pain in left eye. Visited ophthalmologist to diagnosed as corneal swelling from vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Neurological examination normal, Staring, Tonic clonic movements
Clinical narrative: 2-3 minutues after the administration of vaccine, I entered the room after hearing parent calling out patient's name.  On initial observation after entering the room and trying to talk to the patient, he was noted to be having generalized tonic clonic movement with unfocused glance. But wihtin seconds the movements stopped, and he was able to focus on my face and answer my questions. He was talking in his usual voice (with no slurring), and was oriented to person, time, and place. He had normal neurological exam. Vitals (BP 110/61; HR 70; R-18; SpO2 96%; T-98.1). With in a few minutes he was smiling and continued to answer all questions appropriately. Patient stated that he felt dizzy and laid down before the episode occurred, and does not remember what happened after, until he started to answer my questions. He was monitored in clinic for next 30min with no other complaints and walked out of the clinic talking and smiling.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration error. Varicella expired on 4/23/2020 and given on 4/27/2020. Patient had no adverse reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Glycosylated haemoglobin, Injection site pain
Clinical narrative: Patient called clinic the following day to report that she felt extreme pain while getting the vaccine, pain located in front of her upper arm, but not in the location of the injection. When lifting arm, it is difficult and causes pain to lift. unable to lay on that arm and had difficulty sleeping. No bruising or swelling.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain
Clinical narrative: Patient called clinic the following day to report that she felt extreme pain while getting the vaccine, pain located in front of her upper arm, but not in the location of the injection. When lifting arm, it is difficult and causes pain to lift. unable to lay on that arm and had difficulty sleeping. No bruising or swelling.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: sore, throbbing arm lasting since administration - no treatment seen
Age: 1.17
Sex: M
Vaccine: MMR, MMRV, PNC13
Symptoms: Extra dose administered
Clinical narrative: VACCINE DOSING ERROR: MMR AND MMRV BOTH ADMINISTERED TO PATIENT 04-27-2020
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Pharyngeal swelling, Poor quality sleep, Swelling face
Clinical narrative: Swollen face and throat, difficulty breathing, light headed.  Took one Benadryl 25 mg  and slept poorly that night.  I went to work the next day because symptoms began to lessen.  Symptoms went away after 2 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Shingles diagnosed 04-24-2020 1130am at Dr office.  Vesicular itchy painful rash left back.  Put on antivirals 04/24/2020.  04:25:2020 rash continued to Left top of arm, left underarm, and left breast.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Pain
Clinical narrative: The day the vaccine  was given a small hematoma formed at the injection site.  Patient was instructed to apply ice to site once she got home and to take Tylenol.  On 4-21-2020 patient was still having pain and visited her primary care physician.  Her physician prescribed Gabapentin 100 mg once a day
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: This was second dose. I experienced shivering for 8 hrs,  fever (100.2-101.5), muscle aches, tiredness through day two & a half,  just tired, worn out third day, fourth day all good again.  I only experienced sore arm for first dose (February 3, 2020). My husband had Shingrix vaccination at the same times, same places, and only experienced sore arm.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Magnetic resonance imaging, Surgery, Venipuncture, X-ray
Clinical narrative: Patient reported about 10 days after receiving her flu shot that she was beginning to have complications in the shoulder in which she had received her vaccination in. She had stated that she was going to be following up with her doctor to help determine what may be the cause of the shoulder complications and that she would get back to us.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cough, Ear infection, Erythema, Lymphadenopathy, Rash
Clinical narrative: He had coughing fits just a few hours afterwards along with redness and rash on his belly and under his eye. I notified his pediatrician of this. It did resolve within the next day. We have not given him another shot of this due to fear of what may happen the next time. This was evening time around 5-6 pm when this started.  Just a few short weeks later about 2 weeks after this shot he recieved a raised lymphnode in the right side of his neck that still til this day has not disappeared. I have had multiple look at it including his Pediatrician. All have said it appears normal. Its the size of a pea and recently another lymphnode which is close to the original one beside his jugular vein has appeared. It's below it kind of moving down towards his neck which concerns me. I was already hesitant about vaccines and now what was a once healthy baby has lymphnodes that have popped out of nowhere and keeps an ear infection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Myalgia & Nausea Vomiting
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Experienced a small rash with the first MMR vaccine in March 2019. A much more extensive skin rash occurred after the second MMR in April 2019. Rash is itchy and occurred on both arms and the right shoulder.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest discomfort, Cough, Diarrhoea, Headache, Influenza
Clinical narrative: two - three weeks after shot, full flu symptoms. I had not been sick but 1 day in 2002 and not for years before that. Since shot, chest feels flu-ish, coughing a lot, headaches, diaharea, etc. Have not had a good day in 6 mos.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Infection, Pain in extremity, Peripheral swelling
Clinical narrative: 4/26/20 - Patient came in to pharmacy and stated that after he went home from receiving vaccine on 4/24/20 he developing swelling upper arm, felt tired and arm was hurting. On 4/26/20 he reported swelling had extended to elbow. Advised to go ER. Called Dr. office told pt had ar to vacc on 4/24/20
Sex: M
Vaccine: TYP
Symptoms: Throat tightness
Clinical narrative: THROAT CLOSING; This spontaneous case report was extracted through VAERS database (777203-1) on 01-Feb-2019. The case was reported by a consumer via health authority. The report describes a 26-year-old male consumer who experienced the event throat closing following the intake of oral Vivotif (lot number: 3003207) for an unknown indication.  The consumer had no medical history and he was not taking any concomitant medication.  It was reported that the consumer took the first dose of Vivotif on 10-Oct-2018 and on the same day, he felt that his throat was closing for which he received Benadryl (diphenhydramine) and prednisone. His symptoms got resolved in few hours.  The action taken with Vivotif with respect to the event throat closing was unknown.  The clinical outcome of the event throat closing was resolved.  Company's Comment: In this case, a 26-year-old male consumer experienced the event throat closing following the intake of first dose of oral Vivotif. His symptoms got resolved in few hours after receiving Benadryl (diphenhydramine) and prednisone. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event throat closing is assessed as possible.; Sender's Comments: Company's Comment: In this case, a 26-year-old male consumer experienced the event throat closing following the intake of first dose of oral Vivotif. His symptoms got resolved in few hours after receiving Benadryl (diphenhydramine) and prednisone. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event throat closing is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Impaired work ability, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: CONGESTION; IMPAIRED WORK ABILITY; GENERAL FEELING OF ILLNESS; FEVER; This spontaneous case (790476-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by a consumer via health authority It describes a 26-year-old male consumer who experienced congestion, impaired work ability, general feeling of illness, and fever, while being on oral Vivotif for an unknown indication.   Case report: The consumer took the two doses of Vivotif. The second dose was taken on 02-Dec-2018. Then, on 04-Dec-2019, he experienced fever, congestion, general feeling of illness due to which he missed his work.  The consumer had an allergy-induced asthma.  Concomitant medication at the time of events included daily multivitamin, and Allegra (fexofenadine) for an unknown indication.  Action taken with Vivotif was unknown.   The consumer had recovered from the events congestion, impaired work ability, general feeling of illness, and fever.  Company's Comment: In this case it was reported that a 26-year-old male consumer experienced congestion, impaired work ability, general feeling of illness, and fever, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality is assessed as possible for the events "general feeling of illness, and fever". Although the event "congestion" was reported with reasonable time relationship to intake of vivotif, consumer's history of allergy-induced asthma provides a plausible explanation. Hence, the causality is assessed as unlikely. The event "inability to work" can be attributed to the accompanying events; hence the causality is assessed as unlikely with vivotif.; Sender's Comments: Company's Comment: In this case it was reported that a 26-year-old male consumer experienced congestion, impaired work ability, general feeling of illness, and fever, while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality is assessed as possible for the events "general feeling of illness, and fever". Although the event "congestion" was reported with reasonable time relationship to intake of vivotif, consumer's history of allergy-induced asthma provides a plausible explanation. Hence, the causality is assessed as unlikely. The event "inability to work" can be attributed to the accompanying events; hence the causality is assessed as unlikely with vivotif.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Insomnia
Clinical narrative: UNABLE TO SLEEP; STOMACH CRAMP/ PAIN; This spontaneous case (791503-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by a consumer via health authority. It describes a 38-year-old male consumer who experienced stomach cramp/ pain and he was unable to sleep, while being on oral Vivotif for an unknown indication.   Case report: The consumer took Vivotif dose on 05-Dec-2018. On 13-Dec-2018, he experienced terrible stomach cramp and he was unable to sleep due to intense pain. He stated that pain came in waves and seemed to be linked to what he ate/any dairy.  The laboratory test of the consumer included stomach culture which was taken in 2010 resulted no allergies to lactose and sucrose. His test also found negative for Irritable Bowel Syndrome (IBS).  Concomitant medication at the time of events included bupropion, fluticasone, azelestine and Zyrtec (cetirizine and pseudoephedrine) for an unknown indication.  Action taken with Vivotif was unknown.   The clinical outcome of the events stomach cramp/ pain and unable to sleep was unknown.  Company's Comment: In this case, a 38-year-old male consumer experienced stomach cramp/ pain and he was unable to sleep, while being on oral Vivotif. The events were reported with a time gap to intake of the vaccine and seemed to be related to what he ate. Also the consumer's laboratory data is suggestive of some gastrointestinal illness in past. Therefore, the causality of the events with Vivotif is assessed as unlikely.; Sender's Comments: Company's Comment: In this case, a 38-year-old male consumer experienced stomach cramp/ pain and he was unable to sleep, while being on oral Vivotif. The events were reported with a time gap to intake of the vaccine and seemed to be related to what he ate. Also the consumer's laboratory data is suggestive of some gastrointestinal illness in past. Therefore, the causality of the events with Vivotif is assessed as unlikely.