chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in her mouth; swelling face; severe palpitations; shortness of breath; chest pains; severe redness in face and chest; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0170), via an unspecified route of administration on 22Apr2021 at around 15:00 (at the age of 41-year-old) in left arm as dose 2, single for covid-19 immunisation. Medical history and family medical history relevant to adverse events were reported as none. The report was not related to a study or programme. The patient's concomitant medications were not reported. Historical vaccine included patent previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8734; Expiration dates, dosages unknown), via an unspecified route of administration, administered in left arm as dose 1, single on 01Apr2021 (at the age of 41-year-old) for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe redness in the face and chest, numbness of her mouth, swelling of her face, severe palpitations, chest pains on 22Apr2021 and stated that the worst part lasted 3 days, states she was three weeks in and was still experiencing these side effects. Stated the events started within 20 minutes of receiving the vaccine. Has been to the doctor, treating with Benedryl which works. Caller stated they wanted her to go to the hospital but does not have insurance so she could not go. Stated the palpitations were still there but not as severe, they come and go. Caller stated the redness in her face and chest continued but comes and goes. Shortness of breath and chest pains were in association with the palpitations that come and go throughout the day. She went to the doctor to have an EKG done, blood pressure checked, thyroid levels checked, wanted to see if it was something else, all of her other tests came back perfectly normal, exact measurements unknown. Adverse events palpitations, severe redness of face and chest, numb mouth, swelling of face, shortness of breath and chest pains were resulted in physician office. The patient underwent lab tests and procedures which included blood pressure measurement, electrocardiogram and thyroid function test were normal exact values or readings unknown on unspecified date. At the time of this report, the outcome of the event hypoesthesia oral was recovered on 23Apr2021, for palpitations was recovering and for all other event was not resolved.  No follow-up attempts are needed. No further information is expected.
30 y/o female ADSM admitted to hospital Inpatient Unit for chest and axillary pain commencing 7-9 days after receipt of primary SPV, AVA, and TIV vaccines. Axillary pain commenced 9/30 and then became intertwined with achy chest pain over the weekend, leading to hospital admission on 3 Oct.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-SEP-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same source. Additional information has been requested.
7/16, rash on chest, itchy on axilla last night. No history of meds, new foods or contact agents. Tried Benadryl without improvement in itching. No fever at site of injection. No urticaria, lesions, welts or rash noticed. Throat mildly red. Throat culture-(-). 7/19/05, mom states rash cleared. No longer itching.
2 hrs onset to severe resp congestion; MD dx as bronchitis but 2 hrs later @ hosp stopped breathing; various CNS difficulties-developmental delay; raspyyness & congestion; resp failure; quit breathing;
feeling bad, congestion in lungs, coughing, sweating, inc temp achy bone in arms & legs;
Had urticaria with symptoms of throat tightness. Went to ED and was treated with Prednisone x5 days.
The patient received immunizations (on 3/7/06?) and was admitted to the ER for fever that developed (102 degrees F). (No lot#, manufacturer, or exp date noted in chart - patient did not receive immunizations in this facility). The patient was observed and later discharged home.  Medwatch form submitted. TC to reporter's office.  Reporter confirmed that patient was not admitted to hospital. Only had an ER visit for c/o fever of 102'F, and released.  Per project director, no further investigation needed as patient was not admitted. Changes submitted to VAERS./
The first thing I noticed was that it felt like there was a fever around my head. It was like a heat halo. So I took my temperature and it was 99.6. I felt very tired and drowsy. My throat was a little congestion but there was no coughing. I had a ticklish sensation in my throat. I tested myself using a COVID-19 Home test on June 24, 2022. It was positive. I tested again the following day and it was positive so I immediately called the doctor. I was prescribed PAXLOVID. The doctor called me back and went through my symptoms. I started the medication on June 25, 2022. I took it for 5 days. On the final day that I took it, I tested negative. I still have a slight bit of throat clearing that I am doing. I think I am 99% clear.
Pt reported dizziness and itchy throat. Pt's (L) eyelid appeared mildly swollen. (Pt stated she has experienced bilateral eyelid swelling in past - cause unknown). Pt refused BENADRYL d/t past ADR (severe anxiety). Advised pt to contact PCP ASAP. Pt appeared coherent; normal breathing.
Thrown her immune system off; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). A 36-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Thrown her immune system off".  Additional information: patient reports being evaluated for rheumatoid arthritis but has not been diagnosed with it; unknown if joint symptoms or other reason for work up. reports pre-existing history of elevated cholesterol improved with diet, now under control, not on any meds. educated on importance of blood work to monitor. pt. states she had a "reaction" to her covid-19 vaccination in January, that has thrown her immune system off. reports getting "sick" after starting xeljanz (exact date unknown) with nasal congestion, phlegm, post nasal drip, mild symptoms persisting. states md aware. no more information or dates provided.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Pain on site of upper left arm; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6208), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 Immunisation. The patient had a history of allergy to bee sting and methylchloroisothiazolinone and methylisothiazolinone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021 at 19:00, the patient had pain on site of upper arm which started a few hours later and still continued the following morning (on 17Mar2021). It was 4/10 in the scale of 0/10. The patient did not receive any treatment for the adverse event. The clinical outcome of pain on site of upper arm was not recovered. No follow-up attempts are needed. No further information is expected.
within 1 1/2 hours she began having trouble breathing, tightness, bad stomach pain, felt very hot, very tired - wanted to go to sleep right then, became hoarse, very anxious, felt like she could cry  - she used an inhaler to help with her breathing, she has exercise induced asthma
This spontaneous report as received from a pharmacist refers to approximately 68 year old female patient. Current condition was not reported. The patient's medical history included shingles. On 31-AUG-2014, the patient was vaccinated with ZOSTAVAX lot # J014810, expiration date 21-FEB-2015, (dose, strength and route was not reported). Concomitant therapies included levothyroxine sodium, omeprazole, metoprolol, glipizide, lisinopril, SINGULAIR, pravastatin sodium, alendronate sodium (+) cholecalciferol, vitamin d (unspecified), nystatin, LASIX, fexofenadine hydrochloride, ALLEGRA-D, gastrointestinal preparations (unspecified) and aspirin. Approximately in 2014, as reported patient received ZOSTAVAX on 31-AUG-2014, immediately began to experience an itchy rash at the injection site following the administration. The patient then also experienced an itchy rash on her forehead that consisted of only 2 bumps. The outcome of itchy rash on forehead, an itchy rash at injection site and itchy rash on her forehead that consisted of only 2 bumps was reported as not resolved. No treatment was given for adverse event. No PQC was involved. Patient sought medical attention. Causality was unknown. Additional information has been requested.
No adverse reaction until 3 months after the last injection. Then I noticed a buzzing in both ears especially loud at night. The buzzing comes and goes, but occasionally becomes quite loud in my right ear (within the last 2 weeks). I had what felt like blockage in both ears for about two months after the buzzing began, but the blockage has gone away. I'm not sure if the tinnitus is a result of the Covid vaccine, but I want to report these symptoms that I am having.
Pneumovax administered at flu clinic at 11am. Returned at 1:25pm with c/o pain, inability to move arm. Nr redness, swelling noted. Referred to ER for eval. ER Dr gave vistarel and advised injection may have been given too high in deltoid (rotator cuff area). Saw PCP on 11/7. Has Hx of bad rotator cuff. Pt had prior Pneumovax on 4/13/06 this was unknown to vaccine administrator at the clinic. Pt called on 11/13/06 reports he is back to normal for him. He has chronic pain in that arm and takes pain med regularly.
Pt is on chemotherapy & exp a nosebleed p/recvd flu vax;
Arm  is sore at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Arm  is sore at the site of injection) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant details was provided.  No treatment details was provided.   This case was linked to MOD-2021-067172 (Patient Link).
High blood pressure; Redness; Soreness; Swelling at injection site; Felt like something was pulling at armpit hair; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair). At the time of the report, HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient bled at time of vaccine just a small amount not enough to fill inject safe bandage. Bleeding stopped before he left. Patient states that when he got home there was more blood than when he left the pharmacy. Blood was not oozing or gushing out but there was blood on his arm. He was concerned that since he bled perhaps the entire dose did not enter body as it should. He said he did not have any problems and did not bleed alot but I told him more than likely all the medication stayed in since it went in the muscle but it would be a good question to find out about since it is a series of vaccines I wanted to make sure he had complete coverage. I contacted and they referred me to the CDC. CDC referenced doses not properly administered as the category it would be and they stated that the dose should be repeated. The CDC stated that for Twinrix if the full dose was not properly administered the dose should be repeated and there is no wait time to do it whereas if it had been a live vaccine the patient would have to wait 4 weeks. The patient came in on 9/24/20 and a repeated 2nd dose was administered. Patient vaccination was uneventful.
Ever since I got my second dose of covid vaccine, my menstrual cycle has been extremely irregular. I have very long and painful menstrual cycle that lasts for several weeks at a time. I got checked out at clinic, and they didn?t find anything wrong.
Strange metallic taste in my mouth and heartburn; Strange metallic taste in my mouth and heartburn; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was ewo153 and expiration date was not reported), via an unspecified route of administration, in Left Arm on 26Apr2021 (at the age of 63-year-old) at 10:00 at 1ST DOSE, single for covid-19 immunization. Medical history included mitral valve prolapse and osteoarthritis. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) 75mg and colecalciferol (VITAMIN D [COLECALCIFEROL]) 5000 ui received within 2 weeks of vaccination. The patient previously took iodine and erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient experienced strange metallic taste in her mouth and heartburn on 26Apr2021 at 10:15 after the first dose. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Apr2021.
ACTHIB expired and administered to a patient; Initial information received on 11-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 1 years old female patient who was  administered expired vaccine with no AE with HIB (PRP/T) vaccine [ACT-HIB].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination; pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination; hepatitis a vaccine for Prophylactic vaccination; and diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination.  On 11-May-2022, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE unknown formulation and strength lot UJ661AAA expiry date 06-May-2022 via intramuscular route in the right thigh for prophylactic vaccination.  ACTHIB was expired and administered to a patient  (expired product administered). Medical assistant wants to know how soon the dose should be repeated.  Action taken: Not applicable.  Corrective treatment: Not reported  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 guidelines. 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.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". 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.  Additional information: Anti-viral details: product: COVID-19 treatment. Other medication in 2 weeks was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had pain on his left hand/his wife had the same problem when she took the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain on his left hand/his wife had the same problem when she took the vaccines".   Additional information: Consumer called about the Pfizer COVID-19 vaccine who said he took the first and second one and since he took that he has had pain on his left hand. Caller said the left hand pain started after his second dose, about 3-4 days later. Caller said his wife had the same problem when she took the vaccines. Caller declines to complete a report on his wife without her permission.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine was administered at hospital at 13:00. I felt a minor sting immediately at injection site. No other symptoms noted. Waited in auditorium for 15 minutes and was released to return to work.   @1500  noted pruritis to bilateral under arm area (near axila), no other symptoms noted. @1900 noted pruritis was increasing in intensity to bilateral arms, and began sreading to left antecubital area, bilateral anterior wrists,  neck,  and face along jawline. Noted pink rash to identified areas above also began to develop with increasing intensity in pruritis.  @2300 I took 15mL (37.5mg) of  Benadryll to alleviate symptoms, and fell asleep.   12/31/220: Woke up @0615  noted rash and pruritis had resolved. Noted slight swelling to tongue, which has now resolved as well.
The Patient's mother called at about  1 p.m  on 08/04/2021 and stated that the patient started having headache,  fever(101 temp), Chills , legs hurt, nausea/vomiting, and felt extremely tired which started at approximately 8 pm on 08/03/2021 and lasted through afternoon  of 08/04/2021. Spoke with patient @ 7p.m. on 08/04/2021  and patient stated that he was taking tylenol and ibuprofen because he still had the headache, but other than that he felt better.
Initially after the injection I had no other symptoms other than mild arm pain at injection site. 8 days post injection, I developed bilateral underarm lymphadenopathy and severe swelling, erythema, itching and pain to injection site on my left arm.
Pinching headaches near top/rear of skull for just a second or two everyday. Currently waiting on follow-up visit with doctor.
(L) upper arm mostly red and swollen, started 7/31/18. Assoc w/some discomfort. Warm to touch, w/temp of 99.8. Seen by ARNP who prescribed BENADRYL and cetirizine.
Expired Vaccine Adminitered by LPN: Patient was administered first booster dose (0.5ml) Moderna (lot #058A22-2A) on 07/16/2022. This Moderna vaccine had an "expiration date" of 09/10/2022 and "beyond use date" of 07/13/2022. Therefore, this vaccine was expired by 72hrs.  I was the Staff member Team Lead on shift; however, two LPNs on shift drawing up and administering vaccines on this day are:
Two days after I received the vaccine I developed a rash on my upper body mainly on my chest and stomach area. I have had it now for 15 days.
About 18 hours after injection, I had myalgias and chills.  This was minor in severity and probably lasted about 6-8 hours.  I woke up the following day feeling fine.  About 2-3 days after the injection, I started having spotting from my menstrual cycle and mild headaches.  I am on the 3rd week of my pill pack and should not have a period yet.  I am not pregnant.  I don't know if it is a coincidence or related to the COVID vaccine but figured I should report it.  I am still spotting and suspect I will until I have my actual period with this pill pack.
Two days after the shot I was very ill with nausea, bad headache and was very lethargic.  Four day later I went to an urgent care for treatment for nausea and the headache.  Two days later I was in the emergency room in the Medical Center for treatment of the same symptoms.  Eventually the headache got better so I could function but I was very lethargic and had a constant cough for the next 6-7 weeks.
Sweat, low grade fever (99.2), headache, dehydrated, achiness at injection site, symptoms lasted for 2 days.
Received AVA #1 in preparation for deployment on 5 Jun 07. On 19 Jun 07 she had a positive HCG test. Her LMP was 7 May 07. She says her periods are irregular. She was seen for well-woman evaluation on 31 May 07 that was recorded as normal. A PAP test was done which was also normal. She was started on pre-natal vitamins on 2 Jul 07 and advised to call for an OB appointment.
Local reaction to injection site, red & swollen. Treatment: KEFLEX and BACTROBAN.