chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Blood thinner and VITAMINS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
I developed a small knot at the injection site the day after i received it. By the following evening it had grown to the size of a baseball. It was red, warm, indurated and it itched. Though when I attempted to scratch it was very painful.  I took Benadryl on the evening January 2nd and have taken cetirizine for the past two days. It has gotten slightly smaller and the itching has improved though not completely resolved.
Information has been received from a nurse concerning a 14 year old female who on approximately 31-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil. It was reported that after the patient received her first dose of Gardasil she experienced a minor seizures and fainting. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, minor seizures was considered to be other important medical event. No further information is available.
Pt noticed R arm swelling/erythema/pain. Progressively got worse over the next 2 days. Pt walked into our clinic on 4/5/12 and unable to be seen. Given RX for Keflex and scheduled f/u appt for 4/6/12. Erythematous area circuled in black marker. Pt returned for visit at 1:30 PM on 4/6/12. Redness worsening and taken by school nurse's car to the Hospital ED at 2 PM.
Patient began feeling symptoms about two weeks or so since vaccine administration. Symptoms began with right submandibular lymph node swelling and tenderness followed by diffuse myalgias. Other lymph nodes in her neck also became swollen. She also had intermittent chills but no fevers. She has been controlling her muscle aches  with tylenol and advil. Symptoms started to subside for a couple days but now, for the past two days, her myalgias and overall malaise have recurred. In addition, she has mild swelling of the proximal metacarpal of the second digit of her right hand. Lymph nodes are slightly decreased in size since symptom onset and not as tender.
Received SHINGRIX vaccine (first dose) and the next day had sharp stabbing pain in left eye only. Right eye was unaffected. No injury or infection or other issue except the vaccine. Placed Vaseline lubricant made for eyes in the left eye to keep it well moisturized and took pain medications and symptoms resolved in next 24 hours.
Narrative:  88YO MALE PATIENT self presented to local community hospital ER on 9/28/21 with covid infection. Pt died same day at hospital; Death 9/28/2021@1620. Date/Time of Admission: Sep 28,2021@00:01 Admitting Diagnosis: COVID Community Care Provider: HOSPITAL Patient self-presented to community emergency facility Emergency Notification Intake Date Presenting to the Facility: Sep 28,2021 Community Care Hospital Chief complaint: COVID Pt had received covid vaccines at local health dept on 6/?/2021 & 7/13/2021. Covid vaccine failure leading to covid infection on 9/28/21 and then pt's death from covid infection on same day, 9/28/2021.
Had fever to 102 x 4ds fatigue and nausea following vaccination on 30 Sep 03. Also developed 8x8 local induration and erythema at rt arm injection site and severe pain. Also had exquisite tenderness in the rt axilla. No palpable nodes present in axilla.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 08-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K005402, expiration date: 07-NOV-2015, (dose, dose #, route and application site were not reported), because she misread the date on the vial to be 07-NOV-2016. The PNEUMOVAX23 in question did not have any previous temperature excursions and was supported with in-house post-expiry data. No adverse symptoms reported. Additional information has been requested.
patient received a dose of regular FLUZONE QUADRIVALENT the patient would rather have FLUZONE HIGH DOSE instead/ no ae; Initial information regarding an unsolicited valid non-serious case was received from a Healthcare Professional (Reference number- 00357619) on 13-Nov-2020.  This case involves a 67 year old female patient received a dose of regular INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] would rather had INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead (wrong product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, patient received a dose of regular FLUZONE QUADRIVALENT (dosing details and expiry date were not reported) would rather the patient have FLUZONE HIGH DOSE for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered.(latency- same day)  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Local inflammatory lesion 7x8 cm with erythema and edema at site of immunization.
Information has been received from a RN concerning 2 patients who were vaccinated with varicella virus vaccine live. Subsequently, the patients experienced herpes zoster. Their outcomes were unknown. Additional information has been requested. The RN also reported that experience of a 5 year old male who was also vaccinated with varicella virus vaccine live.
This spontaneous report was received from a healthcare business professional and refers to a 17-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 13-AUG-2018, the patient was vaccinated with and unspecified doses of PROQUAD (route of administration, lot # and expiration date were not reported), GARDASIL 9 (route of administration, lot # and expiration date were not reported) and poliovirus vaccine inactivated (manufacturer unknown) for prophylaxis. Concomitant therapies included hydrocortisone cream, clindamycin and DIFFERIN GEL. On 14-AUG-2018, the patient developed a fever of 102.7 degrees Fahrenheit. The patient did not seek medical attention. There were no lab diagnostic or studies performed and there was no treatment given for the event. The outcome of the fever was not reported. The causality assessment between the fever and suspected therapies was not reported.
PATIENT RECEIVED SHOT WITHOUT INCIDENCE . THREE HOURS LATER DEVELOPED 103 FEVER , ACHES, CHILLS, MALAISE. TWO DAYS LATER BETTER BUT STILL WEAK
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/1/2023 SUBACUTE OSTEOMYELITIS OF LEFT FOOT
EXTREME HEADACHE; EXTREME NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme headache, and extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme headache and extreme nausea was not reported. This report was non-serious.
She received her 1st Moderna during a COVID-19 vaccine on 3/4/2021.  About 24 hours later she noticed a splotchy rash on her back.  48 hours after her shot she noticed that the rash had spread to her chest, stomach and arms and that it became itchy.  She states that was very similar to a ?heat rash?.  She reports that the lesions were fixed and did not move around.  She saw her primary care provider who gave her a short course of prednisone and recommended daily Zyrtec and Benadryl at bedtime which she took until Monday and then stopped.  She still has a mild rash though it has greatly improved from the initial.  She denies a history of vaccine reactions, contrast allergy and other medication allergies.  She denies ever having fever, body aches, chills, malaise, nasal congestion, throat swelling, lightheadedness, nausea or vomiting.
Headache, nausea, vomiting, diarrhea, bodyaches, chills. Persistent for 12hrs, extreme nausea with diarrhea continuing past 72hrs.
Wrongful death; Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly patient (pt) of unknown gender. No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medications. On or about 10-JAN-2010 (at 66 years old), the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) at a pharmacy, by a pharmacist, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not provided). Subsequently, the pt was treated by a physician at a medical center for shingles (herpes zoster). On an unknown date, the pt died (reported under specific allegations as Count IV: wrongful death) (conflicting information: pt's death was reported, however the pt was reporting on behalf of herself/himself). It was unknown if an autopsy was performed, and the cause of death was not reported. The outcome of herpes zoster was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Client called stating symptoms of dizziness, bad taste in mouth. Just feel different. Advised client to return. BP taken 92/60, Pulse 72. Client was concerned. Referred to emergency room. Patient history of Diabetes, heart problems, high blood pressure.
Severe headache lasting approx 24 hrs; fever; Chills; Sweats; Nausea; Severe Body ache; Rhinorrhea; This is a spontaneous report from a contactable consumer (patient) via Pfizer Company Representative. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache lasting approximately 24 hours, fever/chills/sweats/nausea lasting approximately 24 hours, severe body ache lasting approximately 48 hours. The patient also experienced significant rhinorrhea on day 2 and 3 after shot. Event took place after use of product. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256 : US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263 : US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257 :
fever to 103.4; few papules on arms; no other sxs or complains;exam neg;
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported) every year, since an unspecified date, at unspecified locations. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Offender was called back to the clinic and vital signs were taken and were within normal limits. Offender showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Offender was released.
Patient stated that she received the flu shot here at the pharmacy and picked up a prescription for smz/tmp ds for a UTI yesterday. She stated that she left the pharmacy and went straight home and took the antibiotic. She stated that later in the evening yesterday she started to break out in hives and itch all over. She then took 25mg of BENADRYL. She also stated that there was NO redness or swelling at the injection site. I explained that her allergic reaction was probably due to the antibiotic, but I instructed her to continue taking the BENADRYL and call her dr.
On October 11, 2022 I began to have symptoms such as fever, chills, sneezing, headaches and bodyaches. I took a home Covid test which was positive (although the PCR test I took that day came back negative). I experienced these symptoms October 11, 12, 13 and 14. On October 14, I tested positive again, and  I saw a doctor via telehealth, who prescribed medicines for these symptoms. I took cough medicines. October 15, the fever was gone, along with the chills and bodyaches. I just had a bit of a headache, sinus congestion, and some exhaustion, which lasted another three days or so. The headache went away, and the sinus congestion continued to break up over the next week. I had to spend the whole next week resting, and continued to test positive until today, October 21, when I got my first negative test. Energy is slowly coming back and congestion slowly continuing to break up.
Nausea, body aches, extreme cold chills then hot flashes, heachache
This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 21-JUN-2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # L048464 with expiration date: 02-DEC-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.8 degrees Fahrenheit for 5 hours 30 minutes. Data logger was involved. Administered vaccine also experienced previous temperature excursion of 9.1 degrees Fahrenheit for 1 hour 15 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
fever (103), ear pain, sore scratchy throat, hot and cold, cough. starting 12/13/21
Post vax, pt noted to be sneezing with red eyes and wheezing. Pt was treated with epi and Ventolin updraft with good results.
Pt recvd vax 14JUN93 & DEC93 had open heart surgery,  & on 12APR94 lab testing revealed HBs antibody less than 2;  Addtl details are being requested;
Nausea, flush, weakness. She did not pass out. Mild course of syncope. She also only had banana to eat. Maybe heat and blood sugar also caused her to have symptoms.
The patient entered pharmacy about 9:30am and displayed a red rash about 2 inches below the site of injection; in diameter about 4 inches in a circle on upper arm. I called office and the patient drove to the clinic and was given triamcinolone ointment and told to ice it. Staff sent by escribe triamcinolone ungt and the patient returned to get the ointment. She says it's itching only. No other reactions.
Pediatric Pfizer (5-11) was given without dilution (1.3 ml NaCl)
C/O itching and pain with movement. Feels tingling sensation in skin of L arm. Erythematous skin of L upper arm from injection site to elbow. Initially there was swelling but currently there is none. Symptoms are resolving.
8/11/08 Received vaccine arm pain from shoulder to elbow with radiation to the fingers. 8/25/08 Arm pain persisted, moderate tenderness, warm to touch and treated with Cephalexin for possible cellulitis. 9/4/08 No change in arm pain, swelling and warmth not present.
Information has been received from a physician concerning a female who was vaccinated with a third dose of GARDASIL.  The physician reported that a lawyer friend of hers mentioned on 17-JUL-2008 that a girl getting paralyzed after her 3rd shot of GARDASIL.  She is currently still in the hospital (duration unspecified).  There was no product quality complaint.  Additional information has been requested.
Started feeling pressure point over heart area.  Comes and goes daily.  Sometimes slight, sometimes sharp pains.
A few days after taking the vaccine she got sick. Brain fog. Went to the ER. Blood pressure dropped low.
Left axillary lymph nodes swollen and painful. Has never happened before despite receiving annual flu vaccines for last 6 years.
30 Seconds post vaccine, the patient appears to grow unresponsive.   Pulse (96) and respiration (20)  rates remained unchanged.   Patient name called and she opened her eyes.   She was able to follow simple commands such as "open your mouth and stick out your tongue".   She c/o SOB.   EMS on site and immediately summonsed.   Upon arrival to the patient's vehicle (vaccine drive through event), they immediately recognized the patient as they are summonsed to her home on a weekly basis for panic attacks.   The patient was assessed and begin to respond to questions by nodding her head.   She was loaded into the EMS ambulance and he family notified.   She was not transferred to the local hospital as her sister arrived and calmed the patient.     No further complications.
Admitted 4 days after moderna #2 with Rhabdo. Could be related to vaccine. Could also be related to a fall at home and patient found down. Suspect the latter, though patient is convinced it is directly related to severe myalgias due to COVID vaccination.
sore throat, stomach pains, runny nose, couldn't really eat cause food would come back up, swallowing was hard, throat was tight
Pt reported Hives, Shortness of Breath, Swelling with first vaccines (unknown time of onset). But states she took benadryl prior to 2nd dose and successfully completed 2nd dose without reaction (2nd dose documented as given on 7/12/2021)
Felt like something else controlling her body; Pink; itching; burning; Got worse as day went on; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning), CONDITION AGGRAVATED (Got worse as day went on), SKIN DISCOLOURATION (Pink) and FEELING ABNORMAL (Felt like something else controlling her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning) and CONDITION AGGRAVATED (Got worse as day went on). On 07-May-2021, the patient experienced SKIN DISCOLOURATION (Pink). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like something else controlling her body). On 07-May-2021, VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (burning) and CONDITION AGGRAVATED (Got worse as day went on) had resolved. At the time of the report, SKIN DISCOLOURATION (Pink) and FEELING ABNORMAL (Felt like something else controlling her body) outcome was unknown.            Patient stated that she does take CBD oil and smokes pot and is very healthy. No treatment information provided.   This case was linked to MOD-2021-114397 (Patient Link).
After 1st vaccination on 02/14/2021 developed fever of 100.0-102.3 degrees with associated muscle aches and fatigue lasting 24hrs. Was somewhat concerned with how severe symptoms were after 1st vaccination. Within 24hrs of 2nd vaccination developed 100.6 - 103.0 degree fever that lasted throughout the day and did not decrease after multiple administrations of Tylenol and Ibuprofen. Associated nausea, vomiting, muscle aches, joint pain and fatigue during this time. After 48hrs from 2nd dose noticed moderately enlarged lymph nodes on the left side of neck and left axillary region and left breast that are still ongoing to date. Besides the enlarged lymph nodes and fatigue all other symptoms have resolved. Concerned about duration and sight of enlarged lymph nodes as there is a family hx of breast cancer.
shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Gave Pediarix instead of DTaP. No adverse Symptoms and do not expect any.
Child kept crying & gasping for breath; Advised to go to ER; Next day child fine; Had elevated temp the night before of 100; ER PMD stated he had a common rxn to immun.