chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (Pfizer- BioNTech COVID 19 vaccine: Solution for injection), administered in arm left, administration date 01May2021 10:40 (Lot number: EW0158) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number is EN4205, Time the Vaccination Was Given: 10:00, Anatomical Location of Administration: left arm), administration date: 10Apr2021, when the patient was 73 years old, for COVID-19 immunization; Flu shot (Adverse Event: Achy, Onset Age: 40 years ago, Vaccine/Brand Name: Flu shot, Vaccination Date: Unknown, RA number, expiry date, lot number: Unknown), reaction(s): "Achy". The following information was reported: CHILLS (non-serious) with onset 01May2021, outcome "not recovered", described as "Chills". Therapeutic measures were not taken as a result of chills.  Prior Vaccinations (within 4 weeks) No Medical History (including any illness at time of vaccination) No. Family Medical History Relevant to AE was no. Relevant Tests were no. Caller stated the chills started after the vaccine but subsided a little after the shot and then it started back up today, 03May2021. Since starting back up today the outcome is still persisting. Seriousness criteria not provided. Patient didn't receive any treatment. COVID 19 vaccine: Caller experienced the adverse event only after the second dose of the vaccine therefore the second dose is the suspect product. Caller stated she received the first dose in her left arm as an injection on 10Apr2021 and the lot number is EN4205. Unknown RA number and expiry date. Causality not provided.  No follow-up attempts are needed. No further information is expected.
Tingling in feet and legs; twitching legs and abdomen; brain fog; pretty bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Rocephin).    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
I started my menstrual cycle on 10/29/21 and I haven't had one in 4 years. My OB ordered an ultrasound, I had that done on 11/12/21. It showed a left ovarian cyst and uterine mass (it's small but it's there) but it was not there last year. I am still having extreme fatigue it hasn't gotten any better actually gotten worse since the vaccine. I still do not want to get off the couch and I still have depression. I also had COVID-19 prior to 8/30/2020 and I got my taste and smell back October 2021. I did wait the 90 days until I got my 1st vaccine. I have had a lot of bloodwork too since getting the vaccine.
within one minute of receiving vaccine, patient developed itching generalized and hives on right forearm x1 and right lower leg x3
Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the R lower extremity with extreme pain and inability to bear weight.
Started itching at injection site on Monday, March 22, 2021 approximately 7 PM. Woke up with itching and red bumpy rash at 4:30 AM on March 23, 2021. Took antihistamine and put topical Bendryl on it. Not itching anymore but still red, raised rash at 8:59 AM.  No pain or soreness.
1 of 2 severe react reported w/vax exp a fever; pt recoverd;
Pt had brief episode of urticaria 4 hrs p/receiving vax; pt recovered w/o treatment; no anaphalaxis;
Friday, 4/16/21 woke up nauseous.  Worked all day.  Went to a store after work.  Felt nauseous did not eat dinner.  Around 9:30 PM arm pain from vaccine that I had been having got worse and my sternum hurt,  Got the chills.  I could not get warm.  Lied down in bed took my temperature...usually I am 98.6...I was 97.1.  After 2 hours I warmed up.  I was in alot of pain....feet, knees, legs, lower back, arms. neck hurt, were weak and stiff.  When I tried to get up from the bed..it was like my mind no longer knew how to "get up".  I tried to count, 1,2,3..get up on 3!! after many attempts I finally made it happen.  I was very unsteady and had to hold on to things.  Walking took a long time.  The bed and couch hurt to sit or lie on.  The only place to sit and feel like I could get up was on a tall stool on my kitchen island.  I used ice packs, cold showers, Tylenol, and topical creams.  I called my Primary care Doctor on Monday, 4/19/21 I was scared.  My legs ached at all times.  As of 5/1/21 I now have pins and needle sensations in my fingers and toes.  I have a pain in my neck to my jaw now when I chew at times.
administered an expired daptacel vaccine to a patient/NO AE; Initial information was received on 27-Feb-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient of an unknown age who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used. (expired dose administered)  At the time of report, 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.  Information on the lot number was requested.
Patient. Received Pfizer booster COVID vaccine (LOT#:FL3197) on 12/30/21 at 1647. Patient alerted EMT and stated that she felt heart palpitations and tightness in her chest. Patient stated that this happened to her about 3 weeks ago when she took melatonin. Patient stated that she went to the ED and Doctor told her she was experiencing an allergic reaction to the melatonin. The Doctor stated that her chest wall was swelling and was causing her heart palpitations. EMT took patients vital signs at 1706. BP: 124/77 HR: 63, O2: 98%. Patient stated that her heart palpitations and chest tightness comes and goes. RN's arrived on scene at 1707.  EMT retook vital signs at 1711. BP: 122/76, HR:79, O2: 98%. Patient stated that her chest tightness was a 9/10. RN called EMS at 1713. Other RN gave patient Benadryl 50mg/mL at 1715. RN asked patient to stay an extra 30 minutes for observation. EMT retook patients vital signs at 1717. BP: 128/97, HR: 78, O2: 99%. EMS arrived at 1725. EMS assessed patient. Patient signed AMA. EMS left vaccination site at 1730. RN educated patient on worsening adverse symptoms from COVID Pfizer vaccine and when to seek EMS. RN recommended that patient go see PCP about heart palpitations. Patient verbalized understanding of education. Patient stated that palpitations are "getting better" and that her dizziness is now at a 4/10. Patient completed her observation time at 1747. Patient left vaccination site with her mom unassisted and with a steady gait at 1747.
Felt nauseous immediately after inj. which continued through the night and off/on until present (1/9/12). About 5:30 PM felt pressure in chest (SOB), coughing and burning in chest, felt weak and dizzy, felt hot. I vomited at 10:00 PM and 2 more times since. Allergies now heightened.
Made a-fib worse; Initial information received on 24-Feb-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves adult and unknown gender patient who experienced made a-fib worse while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine (formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious made a-fib worse (atrial fibrillation) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Made a-fib worse).  At time of reporting, the outcome was Unknown for the event made a-fib worse.
The patient received the PNEUMOVAX vaccine on 9/09/14 referred by her doctor. The next day 9/10/14 she presented at the pharmacy with her arm red, it was warm. The doctor was called to explain the situation and she said she had cases to work on and it wasn't till 9/11/14 that the doctor medicated him with DURICEF 500; DESOWEN lotion; Sulindac 200mg.
mom states 23SEP & 24SEp localized reaction @ DTP site 2-3cm diameter hard erythematous knot on lt thigh; temp in office today 97.8 ax; advised warm moist cloth to DTP site APAP given;
Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22 months old patient (gender not reported) who received a 0.5 ml dose of vaccine QUADRACEL (lot C5325BA) via unknown route in unknown administration site instead of ACT-HIB on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMRV); and PREVNAR 13. It was a case of actual medication error due to wrong vaccine administered. No ill effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 05-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009929: US-009507513-1904USA012658: US-009507513-1904USA012653: US-009507513-1904USA012656: US-009507513-1904USA012659: US-009507513-1904USA012657: US-009507513-1904USA012654: US-009507513-1904USA012655: US-009507513-1904USA012660:
Temperature-unbearable pain in arm. Unable to move. Went to ER next day for pain shot. Terrible breakout on half of upper arm. It looked bruised but begin peeling a week later. Pain lasted several days. Arm started peeling a week later and eventually peeled all breakout off.
Information was received on 05-JUL-2017 from a physician who was reporting on a female patient who was 8 weeks of age. No medical history or concomitant medication were reported. The physician reported that on 05-JUL-2017, the 8 week old patient received a dose of VAQTA (lot # M036459, expiration 18-JUN-2018) (dose, site and route not reported). No adverse effects reported. No further information was provided. Additional information has been requested.
Acute appendicitis with perforation, localized peritonitis and abscess. Patient continued on antibiotics post-op given perforation with abscess. Her diet advanced. She was ready for discharge. ED visit to hospital admission at 8 weeks pregnant; 6 weeks within receiving the COVID-19 vaccine. Re-admitted 2/18/2022 for infection. Treated and discharged. EDD unknown.
Pt complained of raised, white, scaley, lesion that showed up about 1 week after his first dose of shingrix.  It was still present at the time of his second dose 60 days later.
This spontaneous report as received from a registered nurse refers to a 69 year old female patient with dialysis started on 15-SEP-2008 for end stage renal disease and no known drug allergies or reactions. On 08-DEC-2008, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route, anatomical location, lot # and expiration date were not provided). On 31-OCT-2014, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PLAVIX, SINEQUAN, EPOGEN, HUMULIN, SYNTHROID, NEPHROCAPS, ZEMPLAR, ZANTAC, CRESTOR, RENAGEL, COUMADIN and FERRLECIT. It was also reported by the nurse that there was no reaction after first dose of PNEUMOVAX 23. However, on an unknown date, the patient experienced left ventricular (LV) thrombus, diabetes and coronary artery disease (CAD). On 11-FEB-2014, a stent was placed for CAD. On 01-NOV-2014, after the patient's second dose of PNEUMOVAX 23, the patient experienced redness and warmth at injection site, severe tenderness of the entire upper arm and edema. Nurse reported that also on 01-NOV-2014, the patient's upper arm measured 11 cm greater than opposite arm at the antecubital and mid bicep regions. Nurse reported that patient's daughter reported patient felt hot all over on 01-NOV-2014 and 02-NOV-2014, but did not have a thermometer to record temperature. Nurse reported that patient was afebrile on 03-NOV-2014 and patient completed dialysis on the same day. No treatment was given to the patient for the events after the second dose of PNEUMOVAX 23. On 05-NOV-2014, the patient was seen in the clinic and patient's arm was less swollen, and patient verbally described her arm as better, better. At the time of the report, the patient's status for left ventricular thrombus, diabetes, coronary artery disease with stent, redness and warmth at injection site and felt hot all over was unknown. The outcome of upper arm measured 11 cm greater than opposite arm and severe tenderness of the entire upper arm and edema was reported as recovering/resolving. Upon internal review coronary artery disease with stent and LV thrombus were considered to be medically significant. Additional information has been requested.
Developed non-tender left axillary swelling. Seen at urgent care. Dx - viral response, no treatment, resolved. Pt. took ibuprofen.
there wasn't the full 0.5ml in the PFS.; Administered vaccine without the full 0.5ml, less than half; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a adolescent female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 579c9, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination as not reported but it could be 15 or 16 years. The reporter stated that, their nurse administered a Flulaval pre-filled syringe (PFS) to the patient and after she gave vaccine she felt there was not enough vaccine, there was not the full 0.5ml in the PFS, which led to accidental underdose.  The suspect product was not available it was in the sharps container. The needle was put on right before the injection. The volume was less than half the volume compare to other syringes.. The aspiration performed to remove bubbles. The reporter did not experienced a low fill problem with this product before. The noon nurse had put the pre-filled syringe into her pocket prior to administration and her pocket was dry).  The reporter did not observed leaks, cracks or breakage in syringe. The plunger was in its original position. No further details available but the reporter agreed to follow up via email.
Severe fatigue, and severe body chills. Fever. Muscle/joint pain. Took a very hot shower for an hour to stop the chills. It was so bad it was hard for me to walk. Slept for most of day after shot. I was extremely fatigued and all I could do is sleep. Some very minor visual disturbances (trying to focus my eyes). Slight altered level of consciousness when body chills hit.
I started to get very tired during the day and I was feeling tired and I was snoring loudly. The next day I started to cough, and I had a low fever. I was uncomfortable and I had Allergy like symptoms. I went to get tested but my fever was down. On the third day my chest was hurting and my fever returned. I got my test results were positive but they did not come until the third day. I started to experience headaches and it felt like my body was burning. I had some more pressure in my chest and I slept a lot. I went to the ER and I was given some medications. My insurance did not cover one of the medications so I could not get it. I am still coughing but my fever is better after a week. I have some trouble breathing like I can't get enough air. I did not lose any sense of taste or smell. My headaches and fever have improved.
Heart complications/have inflammation around my heart; Heart complications/have inflammation around my heart; D-dimer levels were high; I feel weak; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 12:15 (Lot number: 33130BA) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Covid prior vaccination: no. There were no concomitant medications. Other medications in two weeks: no. Other vaccine in four weeks: no. Past drug history included: Ibuprofen, reaction(s): "Allergy". Other medical history: nothing. The following information was reported: MYOCARDITIS (medically significant), CARDIAC DISORDER (non-serious) all with onset 16Dec2021, outcome "not recovered" and all described as "Heart complications/have inflammation around my heart"; FIBRIN D DIMER INCREASED (non-serious) with onset 16Dec2021, outcome "not recovered", described as "D-dimer levels were high"; ASTHENIA (non-serious) with onset 16Dec2021, outcome "not recovered", described as "I feel weak". Ever since the shot she had experienced heart complications. The patient was taken to the hospital, completed blood work, urine specimen, iodine test because D-dimer levels were high, no blood clot but had inflammation around her heart and she felt weak and on a heart monitor now. The events "heart complications/have inflammation around my heart", "heart complications/have inflammation around my heart", "d-dimer levels were high" and "i feel weak" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (16Dec2021) unknown results; cardiac monitoring: (16Dec2021) unknown results; fibrin d dimer: (16Dec2021) high, notes: No blood clot; investigation: (16Dec2021) unknown results; urine analysis: (16Dec2021) unknown results. Covid tested post vaccination: No. Therapeutic measures were not taken as a result of myocarditis, cardiac disorder, fibrin d dimer increased, asthenia.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
My breast milk production went from 700ml a day (pumping) to less than an ounce. I had to stop breastfeeding my month old child.