chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/3/2022- My symptoms were fatigue, slight cough, some sneezing, low grade fever that eventually got over 100 degrees. I did a COVID-19 home test on 10/5/2022 and the result was positive that morning. And later, on 10/5/2022, I took a COVID-19 PCR test, and it was positive. On 10/5/2022 I contacted my doctor, and he prescribed me Paxlovid. I took my last dose 10/10/2022. I took a home test 10/10/2022 and the result was negative. For the most part, my symptoms have resolved. I feel good. Appetite is good. No chills. I think I am getting the Paxlovid rebound because I am having a fever.
My period is 6 days late. This is not normal for me and nothing else has changed in my life since my last menstrual cycle. My period is incredibly predictable and it is physically impossible that I am pregnant. I took a pregnancy test just as an extra precaution and it was negative. I have been seeing news reports of women indicating that their cycle was disturbed by the vaccine and until it happened to me, I questioned the veracity of these claims. However it has now affected me and I believe that the vaccine is the cause. I do not know if this constitutes an adverse event but since it is a side effect that is not listed on the CDC website, and since it is affecting my physiology, I believe that it should be considered seriously.
Thursday 4/1/21:  Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain especially on left side, ear ache on right side, congested, head ache, fever up to 102.3, fever for approximately  20 hours, nauseous. Friday 4/2/21: awoke with chest (not heart) pain, congested, runny nose, cough (I sometimes have a little congestion and cough in the mornings but not like this)
General malaise; Covid arm; Body ache; Chills; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (General malaise), VACCINATION COMPLICATION (Covid arm), MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis).    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced MALAISE (General malaise), VACCINATION COMPLICATION (Covid arm), MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, MALAISE (General malaise), VACCINATION COMPLICATION (Covid arm), MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Body temperature: 100.9 (High) fever of 100.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Patient had an existing popliteal cyst in the left leg with intermittent leg pain, and swelling. Chronic varicose veins present and a referral was sent to general surgery due to 2 + pitting edema . Patient had numerous MRI's, US, and CT's previously with no evidence of  a blood clot. Patient had a left leg venous insufficiency ultrasound completed on April 8th, 2021, provider was immediately called due to an incidental finding of a new DVT, patient was placed on Eliquis and will follow up in clinic.
Cellulitis, Injection site mass; pruritus; rash - Information has been received from a 27 year old female concumer who on approximatley 06 Apr 2000 was vaccinated with varicella virus vaccine live.  There was no concomitant medication.  Two and half weak post-vaccination, the patient developed an injection site reaction described as up to a 3 inch diameter swollen purple mass.  The patient went to a physician who prescribed penicillin and a corticosteroid to help the swelling, but she was unable to take the medication.  Subsequently, the patient broke out with a blotchy skin rash all over her body that was itchy.  It was a very atypical rash, and now her physicain is not willing to administer a second dose of varicella virus vaccine live.  Follow up information from a registered nurse indicated that the  patient's chart stated the patient's experience was questionable cellulticis, and that prior to administering the second dose of varicella virus vaccine live, the physician wanted to check the patient's varicella titer.  In addition, the physician  indicated that this was not a very severe reaction.  It was not known if the patient recovered.  Additional information has been requested.
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single dose for immunization. Medical history included frequent headaches on an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received PNEUMOVAX in 2014 for immunization and experienced headache at night after vaccination, however was not sure if that was related to the vaccination because she gets frequent headaches. The patient also received TDAP on an unknown date for immunization and she thought that she was going to die. On an unknown date, the patient experienced headache. The outcome was unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patient of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown dates the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (dosing regimen unspecified) lot # L018001, expiry date 19-MAY-2017. No adverse effects were reported. The call was the result of a data logger. No previous temperature excursions were present. The temperature excursion included 14F for 127 hours and 15.1F for 22.5 hours. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two cases from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine  Very sore arm, unable to use. Day 1-3 Soreness moved to armpit. Day 2-4 Chills. Day 1 Headache for 48 hours. Day 1-3 Muscle and joint aches. Day 1-3
pt recv varicella in 9/96 & in 4/98 pt devel over 50 lesions
1238 - patient feels blurred vision, itching, tingling sensation in her tongue and on the left side of tongue. Did not take her BP medications today. EMT on site in attendance 1241 - BP 194/110; HR 62; O2 99% on room air.  1246 - BP 200/160 manual auscultated left arm. Patient states she has an appointment to see physician tomorrow. EMT advised on EMS for further eval and/or transport to hospital. Patient does not want to go to the hospital. She states she will have her husband drive her and will take her BP meds when she gets home.  1253 - patient states that the itching on her tongue is subsiding. States she was anxious today because her sister had a reaction the the COVID vaccine and that she also had a sister recently pass from COVID disease. States she was feeling anxious and scared when coming in for the shot today.  1258 - BP 220/140, HR 72; O2 99% 1301 BP 206/121 1305 - Denies blurred vision or numbness in her tongue. Itching is subsiding. Recommended EMS transport to local hospital. Pt. declined. Nurse stressed to patient that BP is critical and that she should seek immediate care to risk stroke or MI. Patient decided to have her husband drive her to the hospital from vaccination site.
Gave the Pfizer Bivalent booster and found out this was her first COVID vaccine
pt reports getting a rash on her stomach and back 2 days after the vaccine was administered.  States it wasn't very itching did take Benadryl and the rash did last for 2 days
diarrhea; This is a spontaneous report received from a non-contactable consumer (parent)via medical information team. A female patient of unspecified age received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 01Aug2021, at dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced diarrhea on an unspecified date in Aug2021. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Little headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and MYALGIA (Muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A, 032120A and 050E214) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (Little headache) and MYALGIA (Muscle aches). The patient was treated with DILTIAZEM for Blood pressure, at a dose of 120 mg once a day and METOPROLOL for Blood pressure, at a dose of 25 mg twice a day. At the time of the report, HEADACHE (Little headache) and MYALGIA (Muscle aches) had resolved.            Concomitant medications were not reported .   This case was linked to MOD-2021-353234, MOD-2021-353246 (Patient Link).
Fatigue and Body Aches 4 days Arm soreness up to and including today Sore hot red lump at injection site today
The injection on the first dose was totally painless. Thus, it was a shock when the injection stung so much at the time it was administered.   The pain in my arm continued  throughout the 12th and 13th necessitating being on pain relievers. By the evening of the 13th , a 3" red swollen area became apparent .  The pain continued which was annoying but did not limit my activities .   I remain puzzled as to why I responded as I did when I hadn't before; it almost appears I have a cystitis issue now.
Patient experience what it look like a seizure right after getting the COVID-19 vaccine. He started shaking and lost consciousness. The patient was sitting on a chair and the immunizer technician hold the patient so he didn't fell on the floor and requested 911 to be called. The paramedics came an assisted the patient. The patient recovered consciousness and stated that he felt fine. The paramedic help him get into his car. The patient's wife was present at the time the event happened.
Extreme headache, nausea, dizziness Vomiting. Unable to keep down water or food for 14+ hours Dr. consulted after 12 hours. Dr. Prescribed Zofran/ Ondansetron ODT 8 mg tablets Took two doses as directed. Then able to drink and eat a little. Nausea and headache continuing - at times mild, at times moderate. Today is April 10, 3021. Symptoms still  continue.
About 24 hours later I experienced pink colored urine. It cleared up in 24 hrs.
Chills and dizziness in the middle of the night. Tiredness the next day. Chills the next evening. Extreme injection site swelling and pain getting progressively worse throughout the day after the vaccine. Slight redness and hot to the touch at injection site. For reference, pain in arm is bad enough that pulling on a pair of pants is extremely difficult. Pain extends down forearm and into wrist and hand, but is the worst right above the elbow.
Primary series doses from 1/1/21 and 2/1/21 were not recorded in EMR. Booster dose from 12/21/21 was showing up as Dose 1 of primary series. "Dose 2" of Moderna monovalent COVID vaccine was ordered and administered on 10/17/22. Volume of 12/21/21 dose prompted further investigation and documentation of primary series from 1/21 and 2/21 was found on 10/19/22. CDC Interim Clinical Considerations document does not include this particular sequence of events, but does state 1 bivalent booster dose can be given as a repeat dose based on clinical judgement and patient preference, spaced after the dose given in error by at least 2 months. Patient is not reporting any side effects at this time.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: 6:05pm  - BP 92/60 hr 71 patient reports feeling dizzy and flused, alert and oriented X4  6:20pm - BP 95/64 hr 81 - no longer reports feeling dizzy - alert and oriented x4 laughing with father and drinking water, walks out to waiting room and sits with dad  6:30pm BP 99/64  hr 81 - denies dizziness and all symptoms. Alert and oriented x 4
Information has been received from a licensed practical nurse concerning an 11 year old patient of unknown gender. On 21-OCT-2014 the patient was vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016) (dose and route not reported). There was no concomitant medication reported. The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
about 5 minutes after immunizations patient stated she felt like she couldn't breathe and had a lot of low back pain.  I had her sit down and rest and gave her an ice pack for her back and after about 15 minutes she was feeling better and finished her shopping and went home.  I called her at about 6pm the same day to check on her and she said she was feeling fine
5/13/04 [Pt] developed a low grade fever 100 degrees. Tx with Tylenol. 5/14, 5/15, 5/16, He slept a minimum of 20 hrs q day. Late 5/14 he developed a head to toe peppered rash with cold like symptoms which included cough and runny nose. 5/9 [Pt] had developed several puss filled lesions on his back, stomach, arms, legs, and face. [Pt] was born 3 months premature weighing 2 lb 12 oz. He spent 8 weeks in the NICU.
1.  Sore Arm the next day.  Expected because the first shot made the same arm a little sore. 2.  Low Grade Fever  and Chills. (can't take anything else due to PE caused by DVT.)  3. Light cough. Not a sore throat but  not right. 4. Terrible headaches. But Tylenol takes it away in time. 5. All over Achy body.  What is most concerning is the oxygen level Because of my PE I watch my levels at night. Average for me with PE  I'm around 94-97 saturation But from Wednesday Night March 3 my levels are lower. Dropping to 88-85. My finger montor goes off at 88 so I cake a couple of deep breaths to bring it back up.
3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching; 3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching; 3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching; 3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching; 3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching; Initial information regarding an unsolicited valid non-serious case was received from Non-Healthcare Professional  via Agency (Reference number- 00766640) and transmitted to Sanofi on 13-Sep-2021 in the.  This case involves an unknown age and unknown gender patient for whom it was reported 3 out of 4 patients injected with this lot experienced extreme swelling, warmth, pain and itching (vaccination site swelling, vaccination site pain, vaccination site warmth, vaccination site inflammation and vaccination site pruritus) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6969AB and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious 3 out of 4 pts injected with this lot experienced extreme swelling, warmth, pain and itching (vaccination site swelling, vaccination site pain, vaccination site warmth, vaccination site inflammation and vaccination site pruritus) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "they are not comfortable using this lot".  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.
LD area - redness, swelling, induration, tenderness, pain. Treatment - KEFLEX 500 mg 1 PO QID x 10 days for cellulitis.
Patient initially started developing weakness, sleeping more than usual, followed by falls. altered mental status patient was initially met criteria of SIRS and was admitted with suspected diagnosis of meningitis and treated with antibiotics  but despite receiving antibiotics patient was not improving. He started developing upper extremity rigidity, tremors noted in upper extremity. Neurologist called CDC and patient was transferred to hospital for further evaluation and management.
Patient came to me on 04/17/18 to report the adverse effects he is experiencing which he states is from the flu shot given on 01/22/2018. He said within 7 days of getting the vaccine he started to experience neuropathy in his feet, his feet sometimes feel warm/hot and he experiences a "pins and needles" feeling in his feet.
Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cervical dystonia" (unspecified if ongoing); "Cillins Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Paxlovid for COVID 19 Treatment. The treatment start date was 07Jul2022 and stop date was 11Jul2022. The patient did not receive any other medication in 2weeks. Device timestamp was reported as 17Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported drug ineffective cannot be ruled out.
21 months old and should have gotten DTaP and IPV in separate injections but instead received Quadracel,with no reported adverse event; Initial information received on 22-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 21 months old and unknown gender patient who have gotten dtap and ipv in separate injections but instead received quadracel,with no reported adverse event after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2022, the patient received unknown  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE suspension for injection lot C5970AA and expiry 02-Feb-2024  ( with unknown strength, route ) at  unknown administration site for immunization.  On 11-NOV-2022 the patient had a non-serious event of  21 months old and should have gotten dtap and ipv in separate injections but instead received quadracel,with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE ( latency : same day )  No lab data included  Action taken : not applicable.  Outcome : Unknown   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 the 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.
Fever, chills, fatigue, nausea  took Tylenol and slept, felt better the next day
INJECTION SITE HARD, HOT AND RED. (IT BEGAN 05/25/2015 AND GETTING WORSE TILL 05/27/2015. SHE PHONED TO PHARMACY 05/27/2015 EVENING)
approx 2min p/driving in the car pt arched backwards w/head on floor-waist toward ceiling;pt was unaware of all outside activity when recovered;no recollection of event;seemed disoriented;skin color was ashen;had h/a;
She experienced an enhanced ringing in the ear after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "She experienced an enhanced ringing in the ear after the first dose".  Additional information: Patient received the first dose and second dose of Covid-19 vaccine. She experienced an enhanced ringing in the ear after the first dose, but forgot to report about it. Asked if this has anything to do with the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer 3/31 and 4/22. Positive on 12/17
Information has been received from a health professional concerning a female patient who on an unspecified date was vaccinated with a dose of varicella zoster virus vaccine live. Within one week of vaccination, the patient developed shingles in her eye. Unspecified medical attention was sought. The reporter had no other information as it was only mentioned to her and was not one of her patients. A product quality complaint was not involved. Additional information had been requested.