chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 7th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site pain, injection site swelling and influenza-like symptoms. On an unknown date, the outcome of the injection site rash, injection site pain, injection site swelling and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site pain, injection site swelling and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: SHINGRIX was administered in left arm. The pharmacist stated that the patient experienced pain, rash and swelling at the injection site. The patient also had flu like symptoms. All the events resolved in 5 days. No further details were provided.
Information has been received from a registered nurse (RN) concerning a 15-month-old healthy white male with no medical history or drug allergies who on 24-MAY-2005, at 13:00, was vaccinated IM with the first 0.5ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There were no concomitant therapy.  The RN reported that on 01-JUN-2005, the patient developed a measles rash all over the his body.  The measles rash was noted to be pinpoint in nature, erythematous and "blanches".  There were no vesicles.  The patient was afebrile, had a good appetite and was acting normally.  Unspecified medical attention was sought, but no laboratory/diagnostic test  were performed.  As of 07-JUN-2005, at an office visit, the patients' measles rash was considered to be resolved.  Additional information is not expected.
Pt has had increasing redness, swelling, and skin warmth starting a few hours after the vaccination and continuing/worsening overnight.
94-year-old female with a history of dementia brought in for low oxygen saturations at home in the context of recent COVID-positive test. Patient was diagnosed with COVID-positive on January 4 and received antibiotics on the following day. Patient's daughter has been primarily caring for her and notes that over the past 2 days the patient has become progressively more weak and short of breath. At home, her oxygen saturations were noted to be low at 82%. She is then brought into the ED for evaluation. Patient has a history of dementia and is unable to contribute to further history.
Swelling of entire upper arm, with redness, tenderness and fever. Started evening of vaccine administration. Seen in office 2 days later, difficult to tell whether cellulitis or severe local reaction. Then developed respiratory symptoms triggering his asthma.
Left arm large are redness and swelling started on 8/20/2020 actual time unknown. Mother of child came to clinic on 8/27/20 to report symptoms.
Blood clot and I developed Lymphedema and severe swelling in my right foot, ankle, and leg
I received the influenza vaccine (Fluzone/NDC 49281-013-88, lot UH890AB, in my upper left shoulder on 09/10/2013. Approximately one week later I began to experience severe, sharp pain (9 out of 10) with movement in my left shoulder and arm that radiated to my back. A dull, achy, constant pain was also present in the shoulder, but far less severe (2/10).  I visited an orthopedic doctor on 09-25-2013 who examined my shoulder and took x-rays. The doctor diagnosed me with: "Left Shoulder Pain likely is result of influenza shot sequelae." I was unable to work from 9/25/13 to 10/7/13. My shoulder pain eventually disappeared around the end of October 2013.
This case was reported by a nurse and described an adult male who did not respond to the hepatitis B component of hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  On unspecified dates, the pt received three injections of Twinrix.  Approximately six to eight weeks after the third injection, serology results revealed a "positive" titer for hepatitis A, but an negative titer for hepatitis B.  Comment: The reporter indicated that "three or four" pt's experienced negative hepatitis B titers following receipt of Twinrix.  However, no identifiers were provided for the pt's.
Headache arm soreness; arm redness, swelling, and itching first day and then 1 week later Narrative:
swelling around left wrist and hand-same arm as vaccine injection site; swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm"; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Feb2021 at 12:00 as 1st dose, single for COVID-19 immunisation. The patient's medical history included pneumonia shot taken about 3 years ago. Concomitant medications were not reported. On 01Feb2021 , around 18:00 at the evening, the patient experienced effects like swelling around left wrist and hand-same arm as vaccine injection site (LUE). The patient also experienced pain/throbbing pain at the swelling location and reported as "a little fever", "felt a little warm and "A little unwell, not that bad". Patient did not take his temperature. Treatment medications included Tylenol and iced swelling location, which helped him. there was no more throbbing pain, but swelling and sore existed. Patient experienced similar symptoms to pneumonia shot about 3 years ago. He enquired whether to receive second dose or not. The clinical outcome of the event pain/throbbing pain at the swelling location was recovered on Feb2021, clinical outcome of the event swelling around left wrist and hand-same arm as vaccine injection site was not recovered and outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
injection site tenderness, slight body aches for a couple days afterward. In January 2022 began experiencing facial -sinus pressure and over ensuing months, until mid September 2022, new sxs began to arise and increase in severity: diminished sense of taste and smell (these were lost post Covid infection in  Nov 2020) and never fully recovered; entire body aches and pains, muscular and joint stiffness, with resultant difficulty walking; impaired balance; extreme fatigue; bloating (abdominal and legs); chest heaviness; approx 1-month period of consistently higher than normal BPs; each ankle gave-way in 1-month timespan, resulting in falls off stairs; extreme difficulty focusing, concentrating, remembering.
Tingling in mouth and L arm/fingertips.  BP 113/78, Pox 99%, P 80. Still had slight tingling in mouth.  Instructed to follow up with physician, ER/Urgent Care.  Verbalized understanding
Swelling of lymph node in her arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient has history of breast cancer 6 years ago) in 2015.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of lymph node in her arm).  At the time of the report, LYMPHADENOPATHY (Swelling of lymph node in her arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received the vaccine on 14 Feb 2023, came in for follow up on 16 Feb 2023 stating that she developed large red spot at the sight the vaccine was given on the back of right upper arm. Pt states that she noticed the spot on 15 Feb 2023. Looking at the back of the right arm there is a 7cm x 7cm light red circle with a 3cm x 3cm darker red circle in the center of the lighter red circle. Dark red circle is firm to palpation..
I felt a strong chest pain. I feel it in the heart.; Fever; headache; This was the 3rd dose.; This was the 3rd dose.; This was the 3rd dose; This is a spontaneous report from a contactable other HCP. A 35-year male patient received BNT162B2(COMIRNATY, Solution for injection), in right arm on an 29Sep2021 (Batch/Lot number EL9268), as dose 3 (BOOSTER), SINGLE for covid-19 immunization. Age at vaccination was 35 years. The patient medical history was none reported. The patient did not have any known allergies. The patient did not have any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. List of any other medications the patient received within 2 weeks of vaccination was no. Historical vaccine includes BNT162B2 (COMIRNATY, Solution for injection), in right arm on 14JAN2021 at 16:00 (Batch/Lot number EL3247), dose 1 for covid-19 immunization and BNT162B2(COMIRNATY, Solution for injection), in right arm on an 29Sep2021 at 10:00 (Batch/Lot number FF2588) as dose 2 for covid-19 immunization (at the age of 35 years old). On 29Sep2021 patient experienced off label use, overdose, booster and patient experienced Fever and headache, patient experienced strong chest pain, feel in the heart on 30Sep2021 at 11:00. The patient did not receive any treatment for the events. The outcome for events was Recovering.  Follow-up attempts are completed. No further information is expected.
I received my 1st shot on 03/10/21 and 2nd on 04/07/21 at 9:45am. The following day, 04/08/21 I started getting body aches and pains, and a headache. On 04/09/21 to current, the body aches and pains continue getting worse. Taking ibuprofen and pain medicine doesn?t help it at all.
He developed DRESS syndrome confirmed by labwork (elevated WBCs, elev eos, AKI, ) and biopsy (superficial and perivascular interstitial dermatitis with eosinophils) and clinically (diffuse rash, swollen face, multi morphologies - vasculitic, targetoid, erythema)
pt recv vax & varicella antibody levels indicated that pt failed to seroconvert;
Patient experienced expected aches on 4/29 but ended up in emergency room with neck and shoulder spasms the evening of 4/30/21. That resolved with a muscle relaxant and injection of toradol, but then on Mon May 3 begin experiencing massive new onset of anxiety and overwhelming depression (has never had this before). Unresolved as of today May 5 requiring patient to call off from work and be supervised 24/7 for safety. + loss of appetite. Currently in care of safe, healthcare trained family awaiting outpatient appointment and therapy.
12 hours after vaccine i had chills, headache, diarrhea and 102.1 fever. This lasted 24 hours
Partial numbness in left hand and fingers; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05May2021 at 00:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication and birth control (unspecified) medication; both from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on an unknown date (age at vaccination-unknown) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced partial numbness in left hand and fingers. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event partial numbness in left hand and fingers was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe high blood pressure (BP) and ischemic attack.  The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, bupropion hydrochloride, gabapentin, ibuprofen, estradiol and metformin.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, the patient was taken by ambulance to the hospital with severe high BP. During her hospital stay the patient's BP readings were 190s/109. The patient was diagnosed with ischemic attack.  On 14 Jan 2021, the patient was discharged from the hospital. Her BP readings since then have been 179/85.   On 19 Jan 2021, the patient's BP reading was 145/80.   Treatment for the event included lisinopril.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, severe high BP and ischemic attack, was considered unknown.; Reporter's Comments: This case concerns a 77-year-old female patient with medical history of diabetes who experienced the serious unlisted events of Hypertension and Transient ischaemic attack that required hospitalization. The events occurred approximately four days after receiving their first of two planned doses of mRNA-1273 (Lot number: 027L20A), Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's elderly age and history of diabetes are considered risk factors for the occurrence of the events.
2 hours after FLUMIST complained of lisp (per mom) - not appreciated by Dr upon examination (3d later) - advised BENADRYL - exam (-) to follow up 10-3-11 earlier if needed. ? speech fx if persists.
I woke up 36 hours after the vaccine and chipped my tooth, and went to the hospital.
Chills; Minor joint pain; Cold; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: Unknown), dose 1 in the right arm on 08Apr2021 (13.30) as Dose 1 SINGLE for covid-19 immunization (58-year-old). Medical history and concomitant medications were not reported. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks. On 13Apr2021 the patient had chills and minor joint pain. On an unspecified date of Apr2021 the patient had cold. The reporter stated that only experience he has had is the cold and joints and he has not had a fever, no upset stomach, and no headache, only minor muscle pain and like chills at night.  Reporter clarified he was not experiencing muscle pain it is just chills and minor joint pain. Patient was asked to take Tylenol. The outcome of the event chills was not recovered, event minor joint pain was recovering. The outcome of the event cold was unknown. No follow up attempts are possible. No further information is expected..
numbness in pinky of left arm; soreness at spot of injection; fatigue; This is a spontaneous report from a contactable consumer. An adult female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not available), via an unspecified route of administration on 27Dec2020 at single dose on her left arm for Covid-19 immunization. The patient medical history was not reported. The patient had received unknown other medications within 2 weeks of vaccination. The patient experienced numbness in pinky of left arm and soreness at spot of injection and fatigue on 27Dec2020. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain in her left knee and shoulder; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation via memo. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, nerve damage and pain her left knee and shoulder. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of all the events was considered as not recovered.   The reporters considered all the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered all the event to be disabling.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. The patient's medical history include depression. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, (lot number and expiry date not provided) intramuscular. The physician also noted that the patient had received an unspecified vaccine at the same time. On an unknown date the patient experienced feeling lethargic (hospitalization). The physician reported that the patient/consumer was seen at the unspecified hospital and released. It was not specified whether or not the hospital treatment was an ER visit or an admission to the hospital. The outcome of feeling lethargic is unknown. The reporter did not assess the relationship between the event and GARDASIL. Additional information has been requested.
Blood clot in arm leading to progressive inability to move right arm. Patient had never experienced blood clots before and after vaccine he has started this symptom.
AFTER RECEIVING THE VACCINES THE PATIENT BEGAN SHOWING SIGNS OF CONVULSION, BECAME UNCONSCIOUS AND BEGAN TO SALIVATE WITHOUT VERBAL OR TACTIL RESPONSE. AFTER A SHORT PERIOD OF TIME SHE AWOKE. VITAL SIGNS WERE TAKEN: BP- 109/50, P-62, R-17, T-36.6.
I starting having ringing in both ear. It is still ongoing since my last vaccine. I have been to audiologist about this. They said I have a little loss of hearing in my right ear.
High pitched scream that lasted continuously for 3-4 hours following immunizations. Temperature not taken by mom. Cranky 11/30/04 and stuffy nose. Office appointment offered and declined on 11/30/2004.
(R) arm with lg area erythema from above elbow to shoulder. Smaller area of erythema noted. One small papule at inj site but no apparent pus beneath it. Very warm but not tender on palpation.
Shingles on the same arm that received the injection. Skin rash and water blisters. Burning pain, following nerve pain.
Headache, Myalgia, NauseaVomiting, fatigue Narrative:  Other Relevant History:
Due to faulty syringe vaccine squirted out of syringe during injection.  Pt received at least 0.3 ml.  No additional vaccine given.
(L) thigh w/erythema 3cm to (L) of injection site.
Received YF vaccine 6 hours later describes lower back pain "band across lower waist area" "feels like has a brace on, can't bend over hard to get up and down from a sitting or lying position and in and out of car" 7-8/10 pain scale when attempting above mentioned activities.
Needle puncture; med error; This case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number PK9BY, expiry date 19th March 2021) for prophylaxis.   On 14th October 2018, the patient received the 2nd dose of Shingrix .4 ml. On 14th October 2018, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: The patient received a dose of Shingrix a day before the date of reporting, but 0.1 ml of the vaccine might have been lost (and not administered to a patient) due to the needle being stuck in the patient's skin after administration, which led to accidental underdose. The reporting pharmacist stated that the intern who administered the vaccine reported to her that 0.1 ml might have lost and not administered.   Follow up information received from a pharmacist on 28th November 2018: The reporter's details were updated. The patient received the dose of Shingrix vaccine intramuscularly in an unknown arm. After administering the full dose, the needle seemed to be stuck into the patient's arm. When the intern was removing the needle. When the needle was removed, about 0.1 mg leaked back out at the injection site. The patient did not note any adverse events. He returned to the pharmacy on 17th November 2018 and received a repeat second dose. This was still within the recommended time frame of 2 to 6 months after the first dose. On an unknown date, the outcome of the needle stick/puncture and accidental underdose were unknown.  It was unknown if the reporter considered the needle stick/puncture to be related to Shingrix. The VAERS details were updated. This case was associated with a medication error without harm.