chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 36 hours after injection I developed a painful golf ball size hard cellulitis. We drew a circle around it to track its spread.  I am now 72 hours from time of vaccination and red site is larger and more painful.  I also had a low fever last night  (100) which is high for me, since cancer treatment I struggle to get a fever, just the side effects ( chills aches). I was also very fatigued yesterday morning and the day before.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA001984: US-009507513-1610USA009081:, MERCK 1610USA009078:Mfr number.
chills, fever (100.8 degrees), body aches, headache - lasting about 6 hours
patient arm hurt/very sore; swollen very hard; arm hurt and it was warm; very painful for him to touch where the injection went in; not comfortable; This is a spontaneous report from a contactable consumer (patient wife). An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, patient arm hurt, started to feel pain on 22Jan2021 and in the morning his arm was very swollen and very sore. He got up in the middle of the night and he said that his arm was swollen, and it was warm and swollen very hard, and 5 days later, the arm was still hard and warm and it was still very painful for him to touch where the injection went in. Caller was very concerned that this point that 5 days later could the shot gone in and then not gone anywhere just be sitting in that muscle. Patient can't touch it because it hurt too much. It was reported patient was not comfortable. Outcome of events was unknown.
5/16/03 Friday evening noted R arm swelling and hot with blisters 3-4" diameter. Went to ED. Advised Motrin and heat pad. Sat. morning worse, swelling elbow to shoulder. Returned to ED. Advised ice compresses and Benadryl, probable allergic reaction. To follow up with Dr. Mon AM improving. Advised to consult with family doctor about future vaccine doses. Will test before next Td due.
SUPER FLUSHED/ KIND OF LIKE FEVER; This spontaneous case (PVX2019-857) was received from a consumer on 10-Apr-2019. It describes a 25-year-old female consumer who felt super flushed/ kind of like fever, after the administration of Vivotif (lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 10-Apr-2019, then after within 10 minutes she felt super flushed. She also felt like she had fever.   The consumer had no medical history.  The consumer was not taking any concomitant medication at the time of this report.  Action taken with Vivotif was unknown.   The consumer had not recovered from the event super flushed/ kind of like fever.  Company's Comment: In this case, it was reported that the consumer felt super flushed/ kind of like fever within 10 minutes of Vivotif administration. There seems to be a strong temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer felt super flushed/ kind of like fever within 10 minutes of Vivotif administration. There seems to be a strong temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.
WRONG VACCINE ADMINISTERED; OFF LABEL USE; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. On an unspecified date, the subject experienced wrong vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong vaccine administered, headache, muscle ache and off label use was not reported. This report was non-serious.
Patient experienced weakness, sweating, crankiness, vomiting, fever of 102.2F, and could not walk. The patient wakes up crying and has a changed personality. The patient's heart was racing and her stools were discolored. The patient was treated with Tylenol and Motrin.
8:00 PM 1-26-21 started with exhaustion abs body aches then woke at 5:00 AM  1-27-21 with 102 temperature. Still have 102 temperature and body aches  1-28-21
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Past drug history: unspecified drug, Reaction: Allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment Paxlovid from 04Sep2022 to 08Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient requested and received a flu & zostavax R vaccines on 10/29/2007.  On 11/12/2007 he went to his primary care physician for painless rashes that have started on 11/9/2007.
Approximately 5 days post Moderna vaccine shot #1, I began having severe pain under my nose.  By the next day I had a very large blister that was very painful and oozing.  The next day was the weekend so I called my doctor at the start of the next week to schedule an appointment as the blister had grown in size and was an open sore.  The doctor Physician's Assistant examined me and came to the conclusion that the blister/open sore under my nose was either shingles or impetigo.  She told me she would refer me to a dermatologist for further consultation.  I saw the dermatologist on March 25, 2021 and the dermatologist determined it was most likely shingles due to the pain I felt prior to the blister appearing.   I have never had shingles before in my life until now.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX (batch number 32ZG4, expiry date 31st July 2021) for prophylaxis. On an unknown date, 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 erythema, injection site swelling, injection site inflammation and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site inflammation and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site inflammation and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in left arm. The patient experienced redness, swelling, and inflammation in a circular area at the injection site. She also experienced a low grade fever. The reporter did not consent to follow-up. The reporter was in a hurry and was unable to provide additional information.
This spontaneous report as received from a registered nurse (R.N.) refers to a 19 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 27-JAN-2013 the patient was vaccinated with GARDASIL (lot # not reported) (first dose, intramuscular, 0.5 ml, strength not specified). On 11-APR-2013 the patient was vaccinated with GARDASIL (lot # not reported) (second dose, intramuscular, 0.5 ml, strength not specified). The patient had begun taking unspecified "birth control pills" beginning in February 2013. The patient's mother reported that after the second dose, the patient began experiencing abdominal pain in the left upper and left lower quadrants, for "a couple months". The patient also had a lower back injury on unspecified date where she "pulled her lower back" while exercising. The patient was seen in office on 18-JUN-2013 for abdominal pain. Abdominal and pelvic ultrasounds were performed and were found to be within normal limits. Also a "urine dip" was performed to determine whether a urinary tract infection was present, but the results were negative. No treatment was given, but the abdominal pain had resolved. The outcome of lower back injury was unspecified. The patient had not yet received third dose of GARDASIL. Additional information has been requested.
Tiny lumps where she got the injection. It doesn?t hurt. She tried to peel/scrape it off but unable to do so. She told me about the bumps a couple of weeks after her second shot.
The day after the second shot (Wed. 3/17/21), I developed pains in my intestines and started to run a temperature. It ultimately got so bad that I ended up in the ER with a 104  degree temperature and bad pains on March 19th. After a series of tests it was determined to be Diverticulitis which I never had before.  I am not sure it is related to the Covid shot, but, it is interesting that it started the day after the second shot.
Information has been received from a health professional referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018, dose and route unknown). The vaccine was stored under 55 F for 15 hours. It was back in range. There was no previous temperature excursion. It was called because of a data logger. No adverse effects were reported. Additional information has been requested.
Temp 102.4 and has continued to spike everynight and awakened patient. Arm injection was given in swelled was extremely painful, r breast swelled indurated and painful (had procedure 9/2/2011) but physicians at breast center are blaming vaccine because of swelling in r upper arm and pain in r arm with movement. Nausea, diarrhea, feeling weak and lightheaded, headache, chest/breast pain.
Moderate to severe swelling with erythema and hyperemia involving the arm, forearm and hand with tingling sensation of the fingers. No fever.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 Centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA003984: US-009507513-1704USA012141: US-009507513-1704USA012142.
A little tenderness at the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little tenderness at the arm of the injection) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (A little tenderness at the arm of the injection). At the time of the report, VACCINATION SITE PAIN (A little tenderness at the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided by the reporter included blood pressure medication, heart medication, diabetes medication and some other medications which the reporter was not able to remember. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The event outcome was updated to recovered.
Pins and needle sensation in extremities, swelling in hands and feet, high level of sensitivity to foods that did not cause problems prior to vaccine, digestion issues, eye pain, blurred vision, achy joints, numbness in extremities, enlarged veins. All ongoing.
Parotitis (swelling in the region of the right Parotid gland), fever.
40+ Warts on multiple parts of my body began to itch and then went away.; 40+ Warts on multiple parts of my body began to itch and then went away.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201) via an unspecified route of administration in Arm Right on 21Feb2021 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination, was not COVID tested post vaccination. The patient had no known allergies. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Other medications included Diabetes medications (unspecified, in two weeks). On 28Feb2021, the patient experienced 40 plus Warts on multiple parts of my body began to itch and then went away. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts were possible. No further information was expected.
Immediately hurt when administered in the left arm. Continues to have dull ache in this location. Reported today 2/5/16.
Hives on face and neck within 4 hrs of vaccine admin chest pressure, 6/10 pain, shortness of breath. Rash on hands 0715 Benadryl PO, 1 hr prior to administration. Benadryl 2-3 hrs later, reduced reaction Sx but still directed (self) to ER, Directed to cont. Benadryl & follow up with PCP.
How long can I expect my fever to last after my 2nd shingrix shot yesterday?; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know how long could he/she expect the fever to last after 2nd shingles shot. This was 1 of the 5 cases, reported by same reporter.
Experienced same symptoms as someone diagnosed with covid toes.  Took 6 months for lesions to heal.
Patient complains of pain in arm where vaccine was given and says pain goes down to elbow. She contacted primary physician and was referred back to this facility.
52 Y male with PMHx of chronic lymphoid leukemia (in remission since 2/2021), gout, anxiety, COVID-19 positive on 8/5/2021, who presented to ED on 8/31/2021 with worsening cough, fever, and SOB. Patient has had these progressive symptoms over the last 1-2 months. Patient met sepsis criteria presenting with fever 100.7F, tachycardia HR 138, and tachypnea RR 48, lactate 2.1-- >0.8 (after IV NaCl). He was positive for COVID-19 on 8/5/2021 after ~1 month of persistent productive cough, SOB, fevers (having tested negative on 7/16/21). Patient recently completed 2 courses of levofloxacin in July and August (8/26-8/30) for presumed CAP. On exam however patient is non-toxic and breathing comfortably on RA. Patient is fully vaccinated with Moderna COVID-19 vaccine since 4/2021 and has been in remission from CLL since 2/2021. CXR 8/31 with increasing opacity primarily in the right upper lung. Extensive workup initiated to r/o infectious vs malignant sources. Workup consisted of sputum cultures, sputum gram stain, AFB smear and culture, beta-d-glucan, aspergillus antigen, legionella antigen urine, procalcinotin, coccidiodes AB serum, TB gamma interferon, albumin, CRP, D-Dimer, PT, LDH, ferritin, HIV, CMV, PJP.    CAP coverage started on 8/31 with ceftriaxone and doxycycline. Case was discussed with with ID, Pulm, and Onc. Imaging findings suggested COVID-19 process rather than opportunistic infection, so recommended CT contrast of chest/abd/pelvis. 9/1 CT showed progression with 1. Overall worsening multifocal groundglass infiltrates/pneumonia, particularly in the upper lobes compared with the previous chest CT. 2. New finding of trace bilateral pleural effusions with some relatively of modest suspected adjacent compressive atelectasis in the dependent left lung base. 3. No new developing intrathoracic or abdominal bulky adenopathy. No new localized intra-abdominal inflammatory process demonstrated. Patient has allergy to contrast but consented to CT with benadryl for relief of symptoms (had had multiple CTs done in past).  9/1 COVID-19 test returned positive, cycle threshold 30.7 and 33.1 per ID. Given still COVID-19 positive, it is possible he has not fully cleared the virus. Per Onc, less concerned for recurrent CLL. Patient continued to be non toxic on exam, breathing on room air, but had sweats and fevers overnight 9/1-9/2. Still unclear what is leading to prolonged symptoms. Differential includes viral, fungal, bacterial - less likely HSP or COP. Respiratory viral panel negative. AFB smear negative. Remaining workup pending.    # COVID-19 Pneumonia vs Community-Acquired Pneumonia - Complete abx course for possible bacterial co-infection: Vantin/Doxycycline - Repeat CXR in 3-4 weeks to document resolution, if not clear, refer to Pulm   # h/o Chronic Lymphocytic Leukemia (remission since 2/2021) # Low IgG  Reason for Hospital Admission (Admitting Diagnosis):  PNEUMONIA
Mild pain, moderate itching, erythema (approximately 3cm diameter) symptom first noticed approx. 12 hrs after administration. Some relief with APAP (500mg), diphenhydramine (50mg), topical hydrocortisone (1%) and ice.
EXTREME TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced extreme tiredness. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and headache. This report was non-serious.
Shingles; pain in eye; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included appendectomy in 2011, chickenpox as a child, and also have sulfonamide (sulfa) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included levonorgestrel (MANUFACTURER UNKNOWN) for birth control on unknown date, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021, within 28 days of second dose of vaccine, the patient was diagnosed with Shingles within 28days of second dose of vaccine. This was first experience with shingles. Previously, the patient had chickenpox as a child. The patient was in good general health. Diagnosed with shingles within 2 days of symptoms and took prescription Valtrex. The patient visited to emergency room at eye hospital due to pain in eye. Therapeutic measures were taken as a result of adverse event shingles and included treatment with prescription drug Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The events singles resulted in doctor or other healthcare professional office/clinic visit. The event pain in eye resulted in emergency room/department visit or urgent care. The clinical outcome of the event pain in eye and shingles was recovering at the time of this report.    The batch numbers for BNT162b2 were not provided and will be requested during follow up.
Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms
Patient got up after her shot and was walking to the waiting area when she passed out and fell on the floor. Patient gained consciousness  and checked for head and neck injuries. Patient did not have any injuries, no aches or pains or deformities. Patient was released with mom.