chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain in extremity
Clinical narrative: accidentally given a third dose of Shingrix; arm pain; swollen area on arm; Nausea; fatigue; HEADACHE; MUSCLE ACHE; red swollen area on arm, redness from the 3rd dose; This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (also experienced arm pain, headache, muscle ache and redness after receiving 1st dose in left arm on 12th October 2021, refer case US2022AMR060911). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2022, the patient received the 3rd dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain, erythema of extremities and extra dose administered. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities were recovered/resolved and the outcome of the extra dose administered was unknown.   The reporter considered the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR060910, US2022AMR060911   Additional Information: GSK Receipt Date: 02-Apr-2022 and 06-Apr-2022 Reporter's comment: The case was self-reported by the patient. In January 2022 (the patient thought around the 20th of month), the patient received 2nd dose in left arm and experienced nausea, arm pain, headache, muscle ache and redness which lasted about 2.5 days.  Last week from reporting date, the patient accidently given a third dose of Shingrix in left arm. The patient stated side effects from the Shingrix vaccine were rough compared to other vaccines. The patient had pretty significant side effects nausea, fatigue, headache, muscle ache, red swollen area on arm and arm pain. In addition, patient had redness from the third dose of Shingrix that went from the injection site travelling down and wrapping around her arm. The side effects from all three doses were similar, but side effects from third dose were more intense and lasted longer (about a week). The reporter consented to follow up with health care professional (pharmacy) Additional Supportive Information: The patient accidently given a third dose of Shingrix, which led to extra dose administered.  For tolerance of 2nd dose refer case US2022AMR060910. This case was 1 of 3 cases reported by same reporter for same patient for different dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060910:same reporter US-GLAXOSMITHKLINE-US2022AMR060911:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: pain at the injections site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2022060339).   On 4th April 2022, the patient received the 2nd dose of Shingrix. On 5th April 2022, 1 days after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022060339   Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received second dose of Shingrix vaccine yesterday (day before reporting) and was now experiencing pain at the injections. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060339:Same patient/reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea; arm pain; HEADACHE; MUSCLE ACHE; redness; This case was reported by a consumer and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (1st dose received on 21st October 2021, for tolerance refer case US2022AMR060911).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced nausea, pain in arm, headache, muscle pain and erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, pain in arm, headache, muscle pain and erythema were recovered/resolved.   It was unknown if the reporter considered the nausea, pain in arm, headache, muscle pain and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-Apr-2022 Reporter's comments: This case was reported by the patient. She called back to present further details. The patient received the Shingrix in January 2022, she thought around the 20th of the month in left arm. She stated the side effects from the Shingrix vaccine were rough compared to other vaccines. The side effects lasted about 2.5 days.  The reporter gave consent to follow up with the healthcare professional and pharmacy. Additional Supportive Information: For toterance of 3rd dose, refer case US2022AMR060153.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060153:same reporter US-GLAXOSMITHKLINE-US2022AMR060911:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administer post 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administer post 12 hours) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 3rd morning after she had an isolated episode of vertigo.; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (3rd morning after she had an isolated episode of vertigo.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient did not had vertigo for the past 15 years.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (3rd morning after she had an isolated episode of vertigo.). At the time of the report, VERTIGO (3rd morning after she had an isolated episode of vertigo.) had resolved.            Concomitant medications were not reported.  The vertigo passed after a day.  Treatment information was not reported.   This case was linked to MOD-2022-534964 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: TTOX, UNK
Symptoms: Immunisation reaction
Clinical narrative: reaction to tetanus shot; Initial information received on 30-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced reaction to tetanus shot ,while receiving vaccine TETANUS TOXOID and while treated with PALBOCICLIB [IBRANCE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Dec-2021, the patient started taking IBRANCE (PALBOCICLIB) Capsule at a dose of 125 mg daily oral followed by 125mg daily oral (with an unknown batch number) for an unknown indication.  On an unknown date, the patient received a  dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported at an unknown dose via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date ,the patient developed a non-serious event "reaction to tetanus shot" (drug hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID.  It was reported"I had a tetanus shot and i had a reaction to it. It was the TDAP. I just sent my immune system into overdrive. I was miserable, I thought i was coming down with covid or the flu. It only lasted about 18 hours."  Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable and no action taken for another suspect drug   It was not reported if the patient received a corrective treatment for the event (reaction to tetanus shot).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event reaction to tetanus shot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blindness unilateral, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Per recipient, 11/24/21 was out of state when experienced significant heart palpitations, felt like heart racing out of her chest, concerned having heart attack, migraine with loss of vision to right eye, had not had a migraine in a long time but when occurs usually presents as visual disturbance rather than pain, concerned might be having a stroke, took Excedrin Migraine, didn't feel right, heart palpitations increased, couldn't catch breath, called doctor on 11/29/2021 and instructed to go to ED, went to Hospital Emergency Department at 2 PM, short of breath, memory issues, D-Dimer elevated, kept in hospital for 24 hour observation, diagnosis pulmonary embolism, Lovenox 90 mgm, twice a day began 11/29/21 continued through 1/11/22, then reduced to 80 mgm twice a day with plan to continue through 5/22 and then reevaluate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fibrin D dimer increased, Inappropriate schedule of product administration, Memory impairment, Migraine
Clinical narrative: Per recipient, 11/24/21 was out of state when experienced significant heart palpitations, felt like heart racing out of her chest, concerned having heart attack, migraine with loss of vision to right eye, had not had a migraine in a long time but when occurs usually presents as visual disturbance rather than pain, concerned might be having a stroke, took Excedrin Migraine, didn't feel right, heart palpitations increased, couldn't catch breath, called doctor on 11/29/2021 and instructed to go to ED, went to Hospital Emergency Department at 2 PM, short of breath, memory issues, D-Dimer elevated, kept in hospital for 24 hour observation, diagnosis pulmonary embolism, Lovenox 90 mgm, twice a day began 11/29/21 continued through 1/11/22, then reduced to 80 mgm twice a day with plan to continue through 5/22 and then reevaluate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pulmonary embolism, Pulmonary thrombosis, Thrombosis
Clinical narrative: Per recipient, 11/24/21 was out of state when experienced significant heart palpitations, felt like heart racing out of her chest, concerned having heart attack, migraine with loss of vision to right eye, had not had a migraine in a long time but when occurs usually presents as visual disturbance rather than pain, concerned might be having a stroke, took Excedrin Migraine, didn't feel right, heart palpitations increased, couldn't catch breath, called doctor on 11/29/2021 and instructed to go to ED, went to Hospital Emergency Department at 2 PM, short of breath, memory issues, D-Dimer elevated, kept in hospital for 24 hour observation, diagnosis pulmonary embolism, Lovenox 90 mgm, twice a day began 11/29/21 continued through 1/11/22, then reduced to 80 mgm twice a day with plan to continue through 5/22 and then reevaluate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: Per recipient, 11/24/21 was out of state when experienced significant heart palpitations, felt like heart racing out of her chest, concerned having heart attack, migraine with loss of vision to right eye, had not had a migraine in a long time but when occurs usually presents as visual disturbance rather than pain, concerned might be having a stroke, took Excedrin Migraine, didn't feel right, heart palpitations increased, couldn't catch breath, called doctor on 11/29/2021 and instructed to go to ED, went to Hospital Emergency Department at 2 PM, short of breath, memory issues, D-Dimer elevated, kept in hospital for 24 hour observation, diagnosis pulmonary embolism, Lovenox 90 mgm, twice a day began 11/29/21 continued through 1/11/22, then reduced to 80 mgm twice a day with plan to continue through 5/22 and then reevaluate.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Systemic: Lymph node swelling-Medium.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Injection site bruising, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient had syncope with her 1st dose of Pfizer and also experienced similar symptoms this time as well. First BP reading was 98/48 HR 89 and second reading 104/70 HR 87. She recovered after 15 minutes.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Tinnitus, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient had syncope with her 1st dose of Pfizer and also experienced similar symptoms this time as well. First BP reading was 98/48 HR 89 and second reading 104/70 HR 87. She recovered after 15 minutes.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Redness, bump, heat at site, numbness, tingling, pain from site down arm into fingers, weakness, racing heart from first and second vaccine, unable to use arm as she could before vaccine and is left handed, causing sleep issues due to the pain, numbness, tingling.  Mentally causing problems and is ongoing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site rash, Injection site warmth
Clinical narrative: Redness, bump, heat at site, numbness, tingling, pain from site down arm into fingers, weakness, racing heart from first and second vaccine, unable to use arm as she could before vaccine and is left handed, causing sleep issues due to the pain, numbness, tingling.  Mentally causing problems and is ongoing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Pain in extremity, Palpitations, Paraesthesia, Rash
Clinical narrative: Redness, bump, heat at site, numbness, tingling, pain from site down arm into fingers, weakness, racing heart from first and second vaccine, unable to use arm as she could before vaccine and is left handed, causing sleep issues due to the pain, numbness, tingling.  Mentally causing problems and is ongoing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Sleep disorder
Clinical narrative: Redness, bump, heat at site, numbness, tingling, pain from site down arm into fingers, weakness, racing heart from first and second vaccine, unable to use arm as she could before vaccine and is left handed, causing sleep issues due to the pain, numbness, tingling.  Mentally causing problems and is ongoing.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Non - immunocompromised patient received Moderna 0.5mL as B1 on 09/27/21 at health department location as indicated in this report.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization for COVID of a fully vaccinated patient.  Unknown dates of vaccinations and lot number
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Acute Tinnitus. Ringing in the Ears which began shortly after the 2nd injection on June 29 2021
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness on day of vaccination and current day.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 42 year old non-immunocompromised patient received booster 2 by error as indicated in this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram ambulatory abnormal, Palpitations, Sleep disorder
Clinical narrative: I started feeling heart palpations that woke me up in the middle of this night. I was having surges of palpations all through the day. I went to the doctor a week later. I was sent to get blood work which was clear. It took a month to get a Holter monitor that noted surges. I was told if it got worse would get a consult for a cardiologist. I didn't go due to health expenses. I now have a prescription for Propranolol 10mg that I can take 3 times a day prn but I usually take it once to twice a day.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This is a sample VAERS submission for a group of patients who received potentially ineffective vaccine due to a batch being stored under inappropriate storage conditions. Per consultation with CDC a single form will be submitted and a spreadsheet containing pertinent information for all affected patients will be submitted. These were not Adverse Events, but potential administration errors.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Two days after receiving shingles vaccine, patient started having numbness and tingling to  left hand involving his fingers mostly left thumb and index but also 3rd, 4th, and 5th fingers.  Numbness and tingling  lasts an hour and occurs several times a day.  Patient does have  remote history of surgery for fractured left forearm in 2004 but day before shingles vaccine he did not have the current symptoms.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation reaction, Oropharyngeal discomfort, Pharyngeal swelling, Sensation of foreign body
Clinical narrative: presents for evaluation at ED on 4/7/22 after likely allergic reaction from COVID vaccine.  Patient was at his pediatrician's office today getting his prescribed vaccination, and within 20 minutes of the vaccination began feeling as though he was having globus sensation/swelling in his throat.  Per mother, patient was speaking normally and swallowing normally at that time, he was treated with p.o. Benadryl in the office, and evaluated for another 20 to 30 minutes.  After the second observation.  He still felt the swelling in his throat and was noted then to have wheezing, treated with albuterol nebulizer treatment prior to arrival in the emergency department.  Patient still reports "weird feeling" in his throat, but denies difficulty breathing. Patient was treated with weight-based dose of p.o. dexamethasone and observed for over an hour with no worsening of symptoms. Given prescription for EpiPen.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: presents for evaluation at ED on 4/7/22 after likely allergic reaction from COVID vaccine.  Patient was at his pediatrician's office today getting his prescribed vaccination, and within 20 minutes of the vaccination began feeling as though he was having globus sensation/swelling in his throat.  Per mother, patient was speaking normally and swallowing normally at that time, he was treated with p.o. Benadryl in the office, and evaluated for another 20 to 30 minutes.  After the second observation.  He still felt the swelling in his throat and was noted then to have wheezing, treated with albuterol nebulizer treatment prior to arrival in the emergency department.  Patient still reports "weird feeling" in his throat, but denies difficulty breathing. Patient was treated with weight-based dose of p.o. dexamethasone and observed for over an hour with no worsening of symptoms. Given prescription for EpiPen.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The next day following the vaccine, I developed a red itchy rash mostly on the back of both of my upper arms, though it was not very red around the injection site.  The arm rash was very itchy and was from the top of my arms near my shoulders down to the elbow area on both and the back side of the arm was the worst and the most intense itching and felt hot.  The rash also presented on the outer ridge of my left ear.  It was bright red and itched for several days.The right ear was a little itchy, the the left ear the most affected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: The next day following the vaccine, I developed a red itchy rash mostly on the back of both of my upper arms, though it was not very red around the injection site.  The arm rash was very itchy and was from the top of my arms near my shoulders down to the elbow area on both and the back side of the arm was the worst and the most intense itching and felt hot.  The rash also presented on the outer ridge of my left ear.  It was bright red and itched for several days.The right ear was a little itchy, the the left ear the most affected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain
Clinical narrative: slight soreness at the injection site started with severe chills about 12 hours after the injection.  After 3 hours had sweats for about 30 minutes.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: First Covid-19 vaccine was Pfizer given 8/14/2021. Inadvertent administration of other mRNA vaccine. Pt made aware, remained in clinic for approx 20 min post administration. no adverse reactions reported
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Normal labour
Clinical narrative: Normal labor and delivery. Birth weight 8 lb 11.3 oz. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: dizzy, presyncope, nausea, headache, head foggy, tired,  sent home from work, stayed horizontal for the day,
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Presyncope
Clinical narrative: dizzy, presyncope, nausea, headache, head foggy, tired,  sent home from work, stayed horizontal for the day,
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fistula, Haemodialysis, Peritoneal dialysis, Peritoneal dialysis complication
Clinical narrative: ESRD (end stage renal disease) on dialysis - Patient failed PD, had 1 CCPD on admission - Dialyzed through the HD tunneled catheter - MWF - Arrangement for Monday/Wednesday/Friday hemodialysis at DL.  - Has LUE fistula - not ready for use yet - Continue calcitriol and Renvela - Patient was also updated of dialysis after rehab; discharged from Health clinic to Skilled nursing facility.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine. Patient passed away on 3/16/2022
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Severe headache Joint Pains Muscle Pains
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood sodium abnormal, Bronchitis, Cardiac failure acute, Left ventricular failure
Clinical narrative: Acute hypoxic respiratory failure secondary to acute on chronic diastolic - Patient was subsequently admitted and diuresed with IV Lasix.  Her sodium did improve to 129 on day of discharge.  She was back on room air.  She did require oxygen at night.  Patient reports she has oxygen at home. In regards to her bronchitis she was treated with oral prednisone.  Urine retention did resolve. And day of discharge, patient again reported feeling well.  Therapies were recommending home without services. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Polyuria, Urinary retention
Clinical narrative: Acute hypoxic respiratory failure secondary to acute on chronic diastolic - Patient was subsequently admitted and diuresed with IV Lasix.  Her sodium did improve to 129 on day of discharge.  She was back on room air.  She did require oxygen at night.  Patient reports she has oxygen at home. In regards to her bronchitis she was treated with oral prednisone.  Urine retention did resolve. And day of discharge, patient again reported feeling well.  Therapies were recommending home without services. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis
Clinical narrative: Dermatis, right side of body.  Most involvement - hand, arm and lower leg.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: EXTREMELY sore arm. Can't lift it above waist. Can't touch it or lay on it. Can't use it.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Osteotomy, Pain in extremity, Spinal decompression, Spinal laminectomy
Clinical narrative: PAtient was electively admitted secondary to complaints of severe low back pain and leg pain, underwent decompression and laminectomy and osteotomy for reduction of a spondylolisthesis at L4-L5. He has had immediate relief of his low back pain and leg pain. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Spondylolisthesis
Clinical narrative: PAtient was electively admitted secondary to complaints of severe low back pain and leg pain, underwent decompression and laminectomy and osteotomy for reduction of a spondylolisthesis at L4-L5. He has had immediate relief of his low back pain and leg pain. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding
Clinical narrative: Increased menstrual bleeding, severe abdominal cramps with period
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Osteopenia, X-ray limb abnormal
Clinical narrative: Patient received 2nd dose on 3/15/22. On 3/31/2022 patient returned to the office with complaints of R should pain and unable to elevate arm. Patient reports she believed this was due to the injection, x-ray obtained at this time that resulted with no acute process Patient had a subsequent appointment on 4/5/2022 with no relief, cortisone injection given at this time. As of today, 4/8/2022 patient reports her pain continues.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Fatigue, Headache, Nasal discomfort
Clinical narrative: I experienced nose burns, headaches, ear aches, fatigue and breathing trouble.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin irritation, Urticaria
Clinical narrative: Patient vaccinated approx. 5pm.  Patient reported itching following her vaccination period and 15 minutes of observation time.  Patient presented with redden welts from scratching on the upper extremities and abdomen.  Patient placed in triage room and assessed by provider on site.  Benadryl 50mg given at 1730. Patient progresses in irritation to upper torso, thighs, and lower extremities.  911 contacted at 1742, 1mg Epi administered.  EMS  arrives at 1751.  Patient left with EMS to ED at 1803 after assessment.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: This is a sample VAERS submission for a group of patients who received potentially ineffective vaccine due to a batch being stored under inappropriate storage conditions. Per consultation with CDC a single form  will be submitted and a spreadsheet containing pertinent information for all affected patients will be submitted. These were not Adverse Events, but potential administration errors.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Extra dose administered, Lethargy, Myalgia, Night sweats
Clinical narrative: 4/07/2022...Day after injection...Severe muscular soreness and slight lethargy 4/08/2022...2:00 am...Severe night sweats
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I am deaf in my right ear and have had mild tinnitus since 2014 and no tinnitus in my left ear.  After the COVID vaccine the tinnitus was 200% worse, the noise went from a mild roar to a loud jet engine, blow dryer on high noise and the noise level does not change in my right ear.  AND I now have tinnitus in my left ear that does not ever leave, constant noise.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Dyspnoea exertional, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Moderna 2/10/21, 3/15/21, Pfizer 11/24/21 He came to the ER w C/o Worsening fatigue and exertional dyspnea for the last several weeks progressively worsening.  With occasional fever, chills and cough.  He mentioned that he was (+) for COVID a few weeks back.  (+) on 01/25/2022. COVID-19 infection-seems like long COVID in the setting of immunosuppressed state..  Received vaccinations including the booster.  Currently no indication for acute therapy with steroids or antivirals or immunomodulators.  Based on clinical status if patient requiring any supplemental O2-to initiate IV steroids.  Supportive care for now
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/10/21, 3/15/21, Pfizer 11/24/21 He came to the ER w C/o Worsening fatigue and exertional dyspnea for the last several weeks progressively worsening.  With occasional fever, chills and cough.  He mentioned that he was (+) for COVID a few weeks back.  (+) on 01/25/2022. COVID-19 infection-seems like long COVID in the setting of immunosuppressed state..  Received vaccinations including the booster.  Currently no indication for acute therapy with steroids or antivirals or immunomodulators.  Based on clinical status if patient requiring any supplemental O2-to initiate IV steroids.  Supportive care for now
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cardiac disorder, Cardiac monitoring, Cardiac stress test, Cough
Clinical narrative: In January of 2022 she began experiencing breathing problems, constant cough and began having allergies. In March she ended up with pneumonia, was admitted to the hospital for a couple of days. She was diagnosed with asthma. X-rays were performed and it showed left lower lobe damage. An EKG also showed irregularities. Her family has history of AFIB. She then went to a pulmonologist and tests were performed. She was prescribed an inhaler. She saw a cardiologist last week. She continues to have issues with breathing and her heart. Is wearing a heart monitor presently for 3 weeks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram abnormal, Hypersensitivity, Laboratory test
Clinical narrative: In January of 2022 she began experiencing breathing problems, constant cough and began having allergies. In March she ended up with pneumonia, was admitted to the hospital for a couple of days. She was diagnosed with asthma. X-rays were performed and it showed left lower lobe damage. An EKG also showed irregularities. Her family has history of AFIB. She then went to a pulmonologist and tests were performed. She was prescribed an inhaler. She saw a cardiologist last week. She continues to have issues with breathing and her heart. Is wearing a heart monitor presently for 3 weeks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Pneumonia, X-ray abnormal
Clinical narrative: In January of 2022 she began experiencing breathing problems, constant cough and began having allergies. In March she ended up with pneumonia, was admitted to the hospital for a couple of days. She was diagnosed with asthma. X-rays were performed and it showed left lower lobe damage. An EKG also showed irregularities. Her family has history of AFIB. She then went to a pulmonologist and tests were performed. She was prescribed an inhaler. She saw a cardiologist last week. She continues to have issues with breathing and her heart. Is wearing a heart monitor presently for 3 weeks.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: 15 hours after receiving my 2nd booster shot I started getting a low grade fever, chills, body aches, severe headache, nausea, extreme fatigue. The symptoms resolved after after about 16 hours.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 15 hours after receiving my 2nd booster shot I started getting a low grade fever, chills, body aches, severe headache, nausea, extreme fatigue. The symptoms resolved after after about 16 hours.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardio-respiratory arrest, Death, Dyspnoea, Lithotripsy
Clinical narrative: pt presents to ED after being seen earlier in the day by urology for lithotripsy; pt started to have fever, become tachycardic and have SOB; O2 supplementation; found to be positive for COVID; admitted; given remdesivir, ABX, decadron; over time, respiratory status worsened; no signs of PE; pt coded multiple times with CPR administered; wife then chose to not have any more aggressive measures done and pt passed away in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory disorder, Resuscitation, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: pt presents to ED after being seen earlier in the day by urology for lithotripsy; pt started to have fever, become tachycardic and have SOB; O2 supplementation; found to be positive for COVID; admitted; given remdesivir, ABX, decadron; over time, respiratory status worsened; no signs of PE; pt coded multiple times with CPR administered; wife then chose to not have any more aggressive measures done and pt passed away in the hospital
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia the night of the injection
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 30 min after the vaccine I experienced a severe headache on one side. I had a tele-visit w/ my Dr the same day and they advised me to take migraine medicine.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Blister, Condition aggravated, Dermatitis herpetiformis, Dry eye
Clinical narrative: Pt first developed dry mouth and dry eyes with 24 hours of her second series of Moderna in March of 2021.  She reported dry eyes and mouth which was confirmed by her dentist and PCP who did autoimmune testing confirming the dx.  She was seen by rheumatology who again confirmed her dx.  Her symptoms were manageable until she received her first booster in 11/2021 (Moderna) .  She stated that within less than 24 hours her dry eyes and mouth were severely impacted with painful eyes and difficulty with mouth care.  Within a week, she developed several painful and extremely itchy blisters on her arms and body.  She was again seen by rheumatologist who considered lupus and she eventually had a BX of her arms which reveal Dermatitis Herpetiformis (DH) as well.  She now has both Sjogren's disease and DH.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Eye pain, Laboratory test abnormal, Pain, Pain in extremity
Clinical narrative: Pt first developed dry mouth and dry eyes with 24 hours of her second series of Moderna in March of 2021.  She reported dry eyes and mouth which was confirmed by her dentist and PCP who did autoimmune testing confirming the dx.  She was seen by rheumatology who again confirmed her dx.  Her symptoms were manageable until she received her first booster in 11/2021 (Moderna) .  She stated that within less than 24 hours her dry eyes and mouth were severely impacted with painful eyes and difficulty with mouth care.  Within a week, she developed several painful and extremely itchy blisters on her arms and body.  She was again seen by rheumatologist who considered lupus and she eventually had a BX of her arms which reveal Dermatitis Herpetiformis (DH) as well.  She now has both Sjogren's disease and DH.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Sjogren's syndrome
Clinical narrative: Pt first developed dry mouth and dry eyes with 24 hours of her second series of Moderna in March of 2021.  She reported dry eyes and mouth which was confirmed by her dentist and PCP who did autoimmune testing confirming the dx.  She was seen by rheumatology who again confirmed her dx.  Her symptoms were manageable until she received her first booster in 11/2021 (Moderna) .  She stated that within less than 24 hours her dry eyes and mouth were severely impacted with painful eyes and difficulty with mouth care.  Within a week, she developed several painful and extremely itchy blisters on her arms and body.  She was again seen by rheumatologist who considered lupus and she eventually had a BX of her arms which reveal Dermatitis Herpetiformis (DH) as well.  She now has both Sjogren's disease and DH.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is still sick seeking for a solution
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Patient reports symptoms began 2 weeks after administration of the 1st dose of Moderna COVID vaccine. Symptoms include: sharp chest pain, tightness in the chest, shortness of breath, and dizziness - pt expressed that symptoms worsened when he walked, the faster he walked the worse his symptoms, and by getting up after bending over. Patient was subsequently hospitalized and it was identified that the patient had a decreased EF and abnormal MRI of the heart, cardiologist suspected myocarditis. Patient was discharged with aspirin, atorvastatin, carvedilol, and Entresto as new start medications. Patient to have further workup outpatient by cardiologist.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Myocarditis
Clinical narrative: Patient reports symptoms began 2 weeks after administration of the 1st dose of Moderna COVID vaccine. Symptoms include: sharp chest pain, tightness in the chest, shortness of breath, and dizziness - pt expressed that symptoms worsened when he walked, the faster he walked the worse his symptoms, and by getting up after bending over. Patient was subsequently hospitalized and it was identified that the patient had a decreased EF and abnormal MRI of the heart, cardiologist suspected myocarditis. Patient was discharged with aspirin, atorvastatin, carvedilol, and Entresto as new start medications. Patient to have further workup outpatient by cardiologist.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: pt presented to ED with worsening SOB; had been to ED earlier on 12/30/21 with same sx and was diagnoses positive for COVID, but he left AMA; significant weakness; O2 supplementation; admitted to hosp; ICU; given ABX, steroids; respiratory status worsened requiring intubation; renal and respiratory failure; DNR; O2 sats dropped and pt was transitioned to comfort measures; he was extubated and passed away
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Oxygen saturation decreased, Renal failure, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: pt presented to ED with worsening SOB; had been to ED earlier on 12/30/21 with same sx and was diagnoses positive for COVID, but he left AMA; significant weakness; O2 supplementation; admitted to hosp; ICU; given ABX, steroids; respiratory status worsened requiring intubation; renal and respiratory failure; DNR; O2 sats dropped and pt was transitioned to comfort measures; he was extubated and passed away
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory distress syndrome, Anticoagulant therapy, COVID-19, Cerebrovascular accident
Clinical narrative: Patient admitted to an outside hospital on 12/29/2021 due to Covid 19. She had rapid progression of respiratory failure and required intubation and was transferred to hospital for higher level of care. When she arrived, she was already on heparin drip due to a right-sided PE and Levophed due to hypotension. While here she had a drop In hemoglobin with heme positive stool which was from upper GI bleed, EGD was done which showed bleeding from her erosions. Her hospital stay was complicated by possible superimposed bacterial pneumonia treated with antibiotics, ARDS from COVID, acute renal failure requiring hemodialysis. After her paralytics and sedation were removed she had poor mental status so CT head was obtained which showed large right-sided MCA stroke with hemorrhagic transformation. After catastrophic stroke was found family decided to transition to comfort care and patient was terminally extubated on 1/18/2022. Time of death 12.:58
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Death, Endotracheal intubation, Gastrointestinal erosion, Haemodialysis
Clinical narrative: Patient admitted to an outside hospital on 12/29/2021 due to Covid 19. She had rapid progression of respiratory failure and required intubation and was transferred to hospital for higher level of care. When she arrived, she was already on heparin drip due to a right-sided PE and Levophed due to hypotension. While here she had a drop In hemoglobin with heme positive stool which was from upper GI bleed, EGD was done which showed bleeding from her erosions. Her hospital stay was complicated by possible superimposed bacterial pneumonia treated with antibiotics, ARDS from COVID, acute renal failure requiring hemodialysis. After her paralytics and sedation were removed she had poor mental status so CT head was obtained which showed large right-sided MCA stroke with hemorrhagic transformation. After catastrophic stroke was found family decided to transition to comfort care and patient was terminally extubated on 1/18/2022. Time of death 12.:58
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Haemorrhagic transformation stroke, Hypotension, Inappropriate schedule of product administration, Mental status changes
Clinical narrative: Patient admitted to an outside hospital on 12/29/2021 due to Covid 19. She had rapid progression of respiratory failure and required intubation and was transferred to hospital for higher level of care. When she arrived, she was already on heparin drip due to a right-sided PE and Levophed due to hypotension. While here she had a drop In hemoglobin with heme positive stool which was from upper GI bleed, EGD was done which showed bleeding from her erosions. Her hospital stay was complicated by possible superimposed bacterial pneumonia treated with antibiotics, ARDS from COVID, acute renal failure requiring hemodialysis. After her paralytics and sedation were removed she had poor mental status so CT head was obtained which showed large right-sided MCA stroke with hemorrhagic transformation. After catastrophic stroke was found family decided to transition to comfort care and patient was terminally extubated on 1/18/2022. Time of death 12.:58
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Occult blood positive, Oesophagogastroduodenoscopy abnormal, Respiratory failure, Upper gastrointestinal haemorrhage
Clinical narrative: Patient admitted to an outside hospital on 12/29/2021 due to Covid 19. She had rapid progression of respiratory failure and required intubation and was transferred to hospital for higher level of care. When she arrived, she was already on heparin drip due to a right-sided PE and Levophed due to hypotension. While here she had a drop In hemoglobin with heme positive stool which was from upper GI bleed, EGD was done which showed bleeding from her erosions. Her hospital stay was complicated by possible superimposed bacterial pneumonia treated with antibiotics, ARDS from COVID, acute renal failure requiring hemodialysis. After her paralytics and sedation were removed she had poor mental status so CT head was obtained which showed large right-sided MCA stroke with hemorrhagic transformation. After catastrophic stroke was found family decided to transition to comfort care and patient was terminally extubated on 1/18/2022. Time of death 12.:58
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Tinnitus
Clinical narrative: First two shots were AZ. No adverse events. Pfizer booster resulted in severe headaches and pulsatile tinnitus in right ear
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose