chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL9262, expiration date unknown), via an unspecified route of administration on 27Jan2021 at 08:30, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that, the patient stated that after taking first dose of vaccine on 27Jan2021, he/she sat there 15 minutes and felt fine but then got on the road to go to job like 10 minutes after or so and the right side of his/her face started burning and tingling, almost like if you get a novocaine shot if you have your tooth pulled, it was sort of like that numbing, numb, tingling feeling it was still there this morning and asked if it will that subside and also stated that there was burning and itching. The patient was just wondering what to do about the burning and itching and mentioned that it was not bad but knew that it was there. The outcome was unknown for the event itching (pruritus) and was not recovered from other events. Follow-up attempts are completed. No further information is expected.
Pt called me in the office at 10:45 am 11/8/16 to report her arm being sore. She received her flu injection on 10/11/16. She stated her arm was sore 2-3 days post injection, felt better then, a week or so ago started to hurt. Today she states it feels just like it did post injection. Tried ice, Ibuprofen, Tylenol and not much relief. Injection per pt was 2-3 fingers breath below shoulder. Pt to follow-up with MD.
Within three months of vaccination patient started exhibiting unusual symptoms of extreme fatigue, unusual bruising, broken capillaries on surface of skin, organ pain.  Patient went to GP, blood tests revealed extremely low platelet counts (roughly 30,000).  Patient has no history of any blood disorders or cancers and no family history of blood disorders or cancers.  Patient underwent extensive blood tests, referral to oncologist and hematologist. Patient received a bone marrow biopsy.   Patient was eventually diagnosed with thrombotic thrombocytopenia.  GP, oncologist, and hematologist could find no cause of the onset of thrombotic thrombocytopenia; all 3 care providers acknowledged that the condition was likely vaccine induced.
ringing in the ears flushed face cough dizziness waken at night in a cold sweat
Her arm was still swollen; Leg on her left side has a rash; Rash look like a big tick tack toe; Arm is red; Under her arm pit is swollen; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Under her arm pit is swollen), PERIPHERAL SWELLING (Her arm was still swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for COVID-19 vaccination.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced AXILLARY MASS (Under her arm pit is swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red). On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (Her arm was still swollen). At the time of the report, AXILLARY MASS (Under her arm pit is swollen), PERIPHERAL SWELLING (Her arm was still swollen), RASH (Leg on her left side has a rash), RASH (Rash look like a big tick tack toe) and ERYTHEMA (Arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included Blood pressure medication were noted. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received on 13-MAY-2021 Included No new Significant Information
noticed a rash/rash on her back; bumpy/bumpy on her back; itchy/itchy on her back; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9202 and Expiration date was unknown), via an unspecified route of administration in left arm on 16Feb2021 at 10:00AM (at the age of 87-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included cholesterol. There was no family medical history. History including any illness at time of vaccination was none. Concomitant medications included Cyanocobalamin (B12), ongoing Rosuvastatin (5mg; take once daily by mouth) taken for Cholesterol, One a Day Vitamin. There was no other vaccines received prior vaccinations (within 4 weeks). History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. There was no additional vaccines administered on same date of the Pfizer suspect. On 23Feb2021, the patient experienced rash on her back, itchy on her back and bumpy on her back. It was reported that patient received the first dose of the Pfizer COVID vaccine on 16Feb2021. Stated that she noticed a rash a week later that was itchy and bumpy on half of her back and it is still there today. She is scheduled for the second dose of the vaccine this Friday at 10 AM. Consumer stated that she thought before she goes for the second shot, she should consult with someone about the rash on her back mostly. She didn't connect it with the shot at first but now she is concerned about whether she should get the second dose. She would like to know if she should receive the second the dose of the vaccine since she had the rash after the first dose. AEs does not require a visit to physician or ER. There was no relevant test done. There was no investigation assessment. Outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Patient called Heath Department 3/1/2021 to report she is experiencing light pain in her left arm where she received the COVID-19 vaccine. The pain started around 2/19/21 and has improved but still present. On 2/28/21 patient noticed a red rash about the size of a half dollar at the injection site. She had not looked at site prior and is unsure if rash was present earlier. Patient asked me to report to VAERS as she does not have internet access and would prefer not to make the phone call herself.
Patient vaccinated 3/21/2021, patient admitted 8/4/2021, tested positive for covid 8/7/2021. discharged 8/12 to Group Home  Pt tested positive for COVID-19 at urgent care admitted for poor PO intake and lethargy for the past week with a diagnosis of Acute hypoxic respiratory failure from covid 19 pneumonitis. This is to report that pt got COVID-19 vaccine. started on Dexamethasone and Remdesivir ( treated 8/5-8/9)  Chief Concern, Brief History of Present Illness, and Hospital Course 59 years old male from group home with history of developmental delay with care giver and legal guardian admitted for covid pneumonia. He was given full course remedesivir and decadron (will complete the course on 8/13). Patient clinically improved. Patient has diabetes type 2 with severe hyperglycemia for which he got 40 units of lantus and 7 units of humalog in hospital but insulin injection can not be arranged in his group home. Alternatively we decided to start on oral metformin 500 mg x BID with prandin pre-meals (three times a day). We recommend monitoring LFTs and renal function very closely. Please follow up with your PCP within 1 week and case manager also set up an appointment with endocrinologist for diabetes control.  Past Medical History He has a past medical history of Hypercholesteremia, Hypertension, Insomnia, and Mental developmental delay.  Principal Problem:   COVID-19    Acute hypoxemic respiratory failure Secondary to COVID-19 PNA Requiring 2L NC to maintain saturation at 92% Continue incentive spirometry Attempt to wean off of oxygen   COVID - 19  Day 7 of symptoms Tested positive on 07/29. Contacted urgent care to fax test records as patient appears to be anxious with the idea of having to be swabbed again.   Inflammatory markers mildly elevated, LDH 307 D-dimer 0.8 Xray showing bilateral airspace opacities suggestive of atypical COVID-19 infection Given hypoxia, will initiate 10 day course of dexamethasone 6mg. Day 1/10 today. Will hold remdisavir given elevated liver enzymes, risks of worsening hepatotoxicity outweighs benefits   Elevated transaminases Unclear etiology at this time Suspect likely related to NASH / fatty liver, but COVID-19 infection could be contributing Check hepatitis panel, Hep C normal Consider  as outpatient   HTN Continue amlodipine 10mg qD   Diabetes vs prediabetes vs stress hyperglycemia BG 281 on admission. No HbA1c on file.  Unclear if patient has stress hyperglycemia or diabetic, but either way expect elevations in BG from dexamethasone use. Nightly Basaglar 10u, Lispro 2u TID WC + SSI. Hypoglycemia protocol   Developmental Delay  Patient independent of activities of daily living, requires assistance with minor activites such as washing himself after using bathroom Attends special needs training for work, has caregiver at home   Insomnia Resume trazodone 100mg at bedtime.
-1 day post Dose #2 of Moderna Covid-19 Vaccine:  Patient awoke on Tuesday, May 11 with symptoms of dizziness, off-balance gait where he is leaning on something, stuttering speech, difficulty swallowing resulting in coughing, but trumped that to possible side effects of the vaccine.  Patient woke up on Wednesday continuing to have further weakness to the point where he is holding onto rails just to stay upright and walking and he was stumbled down the stairs but catching himself before he impacted the floor. -MRI is positive for acute left stroke.
Facial rash, extended to back of neck within 10 minutes of vaccine injection No rash at injection site  Increased blood pressure and pulse  Normal Oxygen saturation Transport to Hospital Emergency  Room at 1615 No medicines given in Emergency Room Discharged from emergency room without complications at 1842
Vomited, lightheaded, fainted - also had MENACTRA & tetanus vaccine along with HPV vaccine.
patient spent months in the hospital fighting for his life after taking flu shot and had an extreme reaction to it; Initial information regarding an unsolicited valid serious case received from a consumer via Social media on 07-Dec-2020.   This case involves an unknown age male patient who spent months in the hospital fighting for his life after taking the Influenza Vaccine and had an extreme reaction to it (Adverse reaction).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date patient received Influenza vaccine produced by unknown manufacturer (lot number and expiry date unknown) via an unknown route at an unknown site for prophylactic vaccination.  On an unknown date, (unknown latency) following vaccination, patient who spent months in the hospital fighting for his life and had an extreme reaction to it (Adverse reaction) (Seriousness criteria- Hospitalization)  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown for the event.  There will be no information regarding batch number for the case.; Sender's Comments: Sanofi company comment dated 09-Dec-2020: This poorly document case concerns patient who was presented adverse reaction with INFLUENZA VACCINE. The time to onset is unknown. However, patient's medical condition, concomitant medications and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
It was reported that a 66 year old female received Fluzone SV 2002-2003 USP (Lot # U0953AA), administered on 11/08/02.  Within 24 hours of dose received, on 11/09/02, the pt experienced a transient ischemic attack and weakness in left leg while driving.  No accident was involved.  The episode resolved quickly. The pt was seen in the ER and the event was diagnosed as a possible transient ischemic attack.  She was released from the ER the same day.  From additional information received on 04/10/03 from a health care facility it was reported that the pt received Fluzone SV 2002-2003 USP (Lot # U0953AA) IM in the right deltoid on 11/08/02 sometime between 8:00 and 9:00 AM.  On 11/09/02 at 12:12PM, the pt experienced a transient ischemic attack and weakness in left leg while driving.  An echocardiogram showed trace MR and Holter monitoring revealed rare SVT.  An ultrasound of the carotids and CT of the head were normal.  The pt did not have any illness at the time of vaccination.  Pre-existing medical conditions included increased lipids, hypertension, psoriasis , TMJ and spinal stenosis. Concomitant medications included calcium, carisoprodol, diclofenac, dovonex, lipitor, nexium and psorcon.  No other medically significant information was provided.  No further information is anticipated, this case is considered closed.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, swollen tongue and throat swelling. On an unknown date, the outcome of the allergic reaction, swollen tongue and throat swelling were unknown. It was unknown if the reporter considered the allergic reaction, swollen tongue and throat swelling to be related to SHINGRIX. Additional information was reported as follows: The reporter reported that, she had a patient who developed an allergic reaction to SHINGRIX, so instead of getting vaccinated with her 2nd dose of SHINGRIX, the doctor recommended her to receive a ZOSTAVAX shot instead. The patient experienced throat and tongue swollenness. No additional information was reported. The dose of SHINGRIX was not administered at the reporter's pharmacy.
Moderna COVID-19 Vaccine: Pt received 2nd dose 22 days after 1st Moderna dose (1/29/21). Pt not registered at time of 2nd dose and computer system was not working.  Pt spouse also received 2nd dose but his was 26 days from 1st Moderna dose (1/25/21)
pt presents to ED with SOB worsening over past 2 days; O2 saturation 80% on RA; pt states she saw PCP and was dx with COVID; COVID test positive in ED; placed on O2; AHRF secondary to COVID; given dexamethasone, remdesivir, ABX; pt needed BiPAP but declined and chose comfort measures; she expired in the hospital
Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and/ or zoster-related conditions by a pharmacist at a pharmacy. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider at urgent care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and 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 included 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 the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Numbness over the lips and then moved to tip of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness over the lips and then moved to tip of the tongue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Numbness over the lips and then moved to tip of the tongue). On 29-Mar-2021, HYPOAESTHESIA ORAL (Numbness over the lips and then moved to tip of the tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
blister lesions -scattered  all over body along with chills, body aches and nasal congestion one hour after exposure
March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling  so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache
Worsening left should pain with subsequent decrease in range of motion, thought to be due to incorrect placement of the injection near or into the shoulder joint.
For 2 1/2-3 weeks it felt like my arm was really weak, hurt to move my arm, the joint was very tender. Felt like someone had punched me a whole bunch of times in the arm. It made it very difficult to work, I couldn't sleep on my right side, it was very painful.  I just took Tylenol.
Tightness in chest, shortness of breath with exertion and decreased exercise tolerance - significant acute change from baseline ability to exercise.  treatment - supportive,  limit exercise and still having symptoms. similar episode occurred after first dose of Moderna vaccination and lasted approx 2 months (first dose 1/9/21 symptoms started heart palpitations on 1/17/21. (received 2nd dose 2/5/21.
The next evening I took a shower and there was a giant golf ball size lump under my left armpit. Its still present but it has decreased in size a little.
Pt complained of feeling light headed and flushed.  Pt was given an IM Benadryl 50 mg injection and stated that she felt better after receiving vaccine.
Fever, diarrhea, lethargic, vomiting all lasting for 5 days.
Heart rate increased while in resting position and escalated from around 65 all the way up to 121 without any activity. Started feeling the rapid beating in my chest and could see the heartbeats increase on my fitbit. Lasted about 10-15 minutes about two weeks after the first shot, Did not report because I thought it was a one-time thing. After the second shot, this occurred again yesterday, and this time I felt the same feeling in my chest and looked at my heart rate and it kept elevating to 116 from 63 and I was sitting the whole time. This event lasted a shorter time, about 8-10 minutes, then it was back to normal. The second thing I notice is that since I took the shot I am spotting and it seems to continue into the second shot. I have not yet visited the doctor as I did not make the connection    to the vaccine until I thought back to when it all started. I was also nervous to visit the doctor because I just got my second shot and did not want to enter a clinic where there could potentially be exposure to COVID.  I plan to contact my primary care physician on Monday to see if I can get in for an appointment next week.
I had typical symptoms the day after (fever, restlessness, nausea, etc) but 14 days later got vertigo that has now lasted 3+ days (still experiencing it). I know of 3 other people who also got vertigo between 2-14 days after their vaccine.
tested positive for covid on Friday, 03Jun; tested positive for covid on Friday, 03Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing); "rheumatoid arthritis." (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. No other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jun2022, outcome "recovering" and all described as "tested positive for covid on Friday, 03Jun". The patient tested positive for covid on Friday, 03Jun2022. Patient started Paxlovid that day. Patient took 5 days (30 pills) and took last dose on Tuesday, 07Jun2022. On Wednesday, 08Jun2022, patient home tested negative. Patient was fine for a week, then started having cold symptoms again on Thursday, 16Jun2022. Patient home tested positive again on Friday, 17Jun2022. Treatment start date was reported as 02Jun2022 and stop date was reported as 07Jun2022 for Covid-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (03Jun2022) Positive; (08Jun2022) Negative; (17Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very high fever, swelling of knees, headaches, chills, redness on legs, difficulty walking
Patient was given Flu Mist at 9;10 am and tolerated well. Patients mom called us at 11:30 am stating he had a rash all over and it was itching. Mom advised to give Benadryl and call with updae in am or sooner if worse.  I called parent the next day and mom said the rash was better but will still give Benadryl. Mom informed to call office if any other concerns or sx. At no time were ther any breathing problems. Rash is now gone.
4 days after vaccines, patient developed bilious emesis and rectal bleeding. Abdominal ultrasound at hospital showed intussusception - non reducible by air enema. Patient underwent exploratory laparotomy  for reduction of intussusception and resection of ileocecal enteric duplication cyst found at that time. 2/5/08-records received for DOS 12/17-12/19/07-DC DX: Intussusception. presented to ED with C/O vomiting greenish yellow 6 episodes. BRBRPR, no stool. Abdominal pain, increased sleepiness, decreased wet diapers.  Exploratory laparotomy, resection of ileocecal enteric duplication cyst. appendectomy.
Information has been received from a physician concerning a 12-year-old female with Crohn's disease, auto immune suppressed, with no known drug allergies, who at 3 years of age was vaccinated with a dose of Varivax. Subsequently, on an unspecified date, the patient underwent a serum varicella zoster virus antibody test that was negative. Unspecified medical attention was sought. No product quality complaint was involved. At the time of this report, the patient was on methotrexate. Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-16.