chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash - 2-3" long by 1&1/2" oval.  It is red and inflamed.  Not raised and no pain associated with it.  Will take Tylenol or Advil if it starts to hurt and will seek medical help if it worsens.
Employee was feeling dizziness, lightheaded,nausea, clammy. Vitals were BP-133/86, Pulse-82, Temp-98.7. Employee rested on exam table for about 30 minutes and drank fluids. Employee stated feeling better at that time.
Felt pain as flu vaccine was being injected into my left deltoid (around 10:45).  It was injected 1-1.5 fingers below my acromion process, seems higher than where it should've been administered. During and right after injection felt some tingling/numbness through my arm and hand. Throughout rest of day continued to feel dull pain and some pain/feeling of tightness through my left shoulder into my neck. Today (10/6) am still feeling some weakness in my left arm.
Rash hot to touch itchy and painful. Pain radiates into left shoulder. Rash size of grapefruit. Rash seems to move down arm
Sore arm; The vaccine from expired vial has been administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine from expired vial has been administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Treatment information were not provided.  Patient was administered vaccine from vial that was past the 12 hour puncture time.  Vial had been kept cold in the fridge.   This case was linked to US-MODERNATX, INC.-MOD-2021-153743, US-MODERNATX, INC.-MOD-2021-154363, US-MODERNATX, INC.-MOD-2021-154462, US-MODERNATX, INC.-MOD-2021-155107, US-MODERNATX, INC.-MOD-2021-155542 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Patient demographics and additional event (Sore arm) were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-153743:case: same reporter US-MODERNATX, INC.-MOD-2021-154363:case: same reporter US-MODERNATX, INC.-MOD-2021-154462:case: same reporter US-MODERNATX, INC.-MOD-2021-155107:case: same reporter US-MODERNATX, INC.-MOD-2021-155542:case: same reporter
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No known allergies. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Oct2023 to 05Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Temp. 102.5 Pulse 110 Blood Pressure 148/82, Nausea, headache, pain in right arm, rash and swollen around injection site, lightheaded, chills, I went to urgent care, and they checked for flu, which came back negative. They then gave me an injection of TORADOL for the fever. Told me to take 1000mg. of TYLENOL.
Approx 6 weeks at time of second administration with a due date of sept 28th. Would have been 3 weeks pregnant at time of 1st injection. 3 days after second injection, I began to miscarry. This was confirmed by declining HCG levels. Ultrasound to follow in one week.
CONTINUED REDNESS, SLIGHT PAIN, AND HEAT EVEN 1+ WEEK AFTER VACCINATION
I can't remember how soon after the injections or if it was before or after my 2nd dose (so the time frame mentioned above is a guesstimate)... but since receiving the shots I have experienced tingling and numbness in my left arm.  The tingling goes from my shoulder to my finger tips and will last min or so.  My entire arm will no numb and weak.  In the begging was very frequent throughout the day since going to the chiropractor it has decreased some what but it will flare up from time to time.  I mentioned the issue when I had my physical exam in July with my Dr, but no further testing was done other than my vitals and routine blood work.  I'm currently going to the chiropractor since 7/31/21 thinking this could haven been from a pinched nerve, but the treatments don't seem to be helping. I just heard from a co-worker today that a person she knows is having the same issue with their arm after receiving the Moderna shot and I just wanted to report this to see if the shot is why I'm having these issues. I didn't have the numbness or tingling prior to the shot. I noticed that stress seems to induce the tingling and numbness.  I've also noticed that I have chest pains on the right side, just above my top rib/under the breast done.
Redness, swelling, warmth, itching, tenderness, induration of 25cm lasting greater than 4 days (still persists as of this reporting).
If covid tested post vaccination: Yes; If covid tested post vaccination: Yes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, administered in arm left, administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single, administered in arm left, administration date 21Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single and administered in arm left, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 41 years 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "If covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive, notes: Nasal Swab. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Golf ball size raised red area warm to touch. Pt feels nausea "sick to stomach".
A little stiffness around knees after 2nd dose; Can now run, walk and jump after 2nd dose; Improvement in knees since 2nd dose; Very little pain in knees after 2nd dose; Really bad chills after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (A little stiffness around knees after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Can now run, walk and jump after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in knees since 2nd dose), ARTHRALGIA (Very little pain in knees after 2nd dose) and CHILLS (Really bad chills after 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020b21a and 044a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Congestive heart failure and Knee pain since 2014.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (A little stiffness around knees after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Can now run, walk and jump after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in knees since 2nd dose), ARTHRALGIA (Very little pain in knees after 2nd dose) and CHILLS (Really bad chills after 2nd dose). At the time of the report, JOINT STIFFNESS (A little stiffness around knees after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Can now run, walk and jump after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (Improvement in knees since 2nd dose), ARTHRALGIA (Very little pain in knees after 2nd dose) and CHILLS (Really bad chills after 2nd dose) outcome was unknown.            No concomitant medications were reported.  The patient reported that the doctors advised her a full knee replacement, but after a few days after administration of the second dose of vaccine, her knee pain and stiffness had reduced and mobility improved.  Treatment information included sleep and liquids. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine),was not applicable.
Vaginal bleeding that began with a slight red coloration in the urine, as the days progressed the red coloration was transformed into bleeding; as if it were menstruation, however, in a matter of my period I was already on the 16th day of my menstrual cycle, my last menstruation began on August 19 and ended on August 24. My next period was scheduled to run until September 16th.
shingles; had a sore injection site; getting shingles is awful and mine could have been much worse; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with shingles and had a sore injection site after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious shingles (herpes zoster), a sore injection site (vaccination site pain), getting shingles is awful and mine could have been much worse (condition aggravated) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event shingles and was Recovered / Resolved on an unknown date for the event had a sore injection site.
pulmonary embolism; has issues with breathing; pain in his left upper chest; This is a spontaneous report from a contactable consumer (patient self). An 88-year-old male patient received second dose of bnt162b2 via an unspecified route of administration, administered in left deltoid on 07Mar2021 (Batch/Lot Number: EN6206) at age of 88-year-old as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient previous received first dose of bnt162b2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EN5318) at age of 88-year-old as single dose for covid-19 immunisation. There were no concomitant medications. The patient experienced pain in left upper chest on 10Mar2021. On 20Mar2021, 13 days post vaccine, patient had issues with breathing, patient was admitted to the hospital with pulmonary embolism on the same day. Seriousness criteria of events were reported as caused/ prolonged hospitalization. Patient was on an oxygen generator at night and during day if needed. Stated that he had pain in his left upper chest and thought that he was having a heart attack but was told it was pulmonary embolism and was hospitalized. Stated that the breathing has become a chronic situation. Stated that he was given blood thinners. Was taking Eliquis to prevent future blood clots. The patient was discharged on 22Sep2021. The outcome of event pain in left upper chest was recovered with sequel on unknown date in 2021, of other events was unknown.  Follow-up attempts are completed. No further information is expected.
The arm was sore for 2 days. I have diverticulitis and it flared up a few days letter. my legs feel a little heavy. I don't think that a vaccine should be attacking my weaknesses or current health conditions. I eat very bland and I don't have issues but now I have terrible issues since the vaccine.
Received vaccine at local pharmacy on 10/19/20.  Reportedly felt well for first 24 hrs.  Afterward, patient developed large are of swelling and redness as well as Tmax 100.0F.    From chart review, looks like patient was started on Macrobid around same time as vaccine (though only vaccinated arm affected).
Within 24 hours pt developed lip tingling and within 72 hours developed multiple herpes lesions on lips. No sore throat. Low-grade fever, no other symptoms. Lesions resolved in 7-10 days. 1 year earlier 924 Sept 2009), pt developed nausea, vomiting and diarrhea within 24 hours of vaccination. Low-grade fever, no respiratory symptoms. No sore throat. Did require ED visit. Lasted 3-5 days.
administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 8 weeks patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 29-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1660704, expiration date 20-MAR-2021, dose and route of administration were not reported) for prophylaxis. On 13-AUG-2020, the patient was also administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine (lot # 1660946) was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine (lot # 1660946) was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2009USA002369: US-009507513-2009USA002370:
Information has been received from a nurse practitioner concerning a 23 year old female with no prior medical history and no allergies who on 07OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Concomitant vaccination on 07OCT2003 included a dose of influenza virus vaccine and diphtheria toxoid + tetanus toxoid + typhoid vaccine inactivated. There was no other concomitant medication. On 21OCT2003, two weeks later, the patient developed a rash with small red bumps, no itching, and was afebrile. The patient's rash persisted. Medical attention was sought and no treatment was required. Additional information has been requested.
allergy cough; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 about 12:30 or 1:00 in the afternoon (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from 2010 and ongoing, high blood pressure from 2016 and ongoing. Concomitant medications included ongoing insulin detemir (LEVEMIR) for blood sugar (it was insulin and she had been on it for maybe 4 years); ongoing lisinopril taken for blood pressure (she had been on this for about a year or two); levothyroxine sodium (SYNTHROID) from 2006 and ongoing (she had been on this since she had her thyroid taken out in 06); ongoing empagliflozin (JARDIANCE) taken for diabetes. No prior vaccinations (within 4 weeks), no events following prior vaccinations, no family medical history relevant to events. No additional vaccines administered on same date of the Pfizer Suspect. The patient took the COVID vaccine on 31Mar2021 and she had a side effect from it like a cough she thought it was allergies but it seemed a little more different. she thought the cough was just her allergies. She thought the cough started about Sunday evening (04Apr2021). She said the cough was not like it was, it settled down, it was not like it was in yesterday. She coughed like it was allergy cough but yesterday it was more than like an allergy cough last night she was grieving down with Vicks Salve and just sweated it out. She said the product was called Vicks Salve but it was a generic brand topical analgesic cough suppressant a chest rub NDC 4612215754 she saw an ABC number LOT 10209SC. She said she did not need anything else at this time and asked if she needed to go get tested to wait for the vaccine does she get the vaccine. The event did not require a visit to emergency room or physician office. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 50-years-old) at 14:30 as a single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Concomitant medications included synthroid (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for unknown indication on an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 50-years-old) at 14:30 as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 16:30, patient experienced headache, chills, fever, vomiting and body aches. The patient did not receive any treatment for the events. The outcome of the events headache, chills, fever, vomiting and body aches was not resolved.   No follow-up attempts are needed. No further information is expected.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccines 03/18/21 and 04/08/2021. COVID + at outside facility 1/6/22 and in ED 1/21/22. Presented to ED 1/21/22 with SOB and melena with HGB of 6. Recently admitted to outside facility for osteomyelitis and d/ced on doxycycline and flagyl on 1/18/22. Admitted to ICU for GI bleed and acute hypoxemic respiratory failure due to Covid PNA. Stablized and transferred to floor for 2 days then returned to ICU 2/2 GI bleed post RRT during HD session. Went to IR for embolization and went into cardiac arrest with ROSC after 35 min. Treated with amiodarone. On 1/29/22 developed hypotension and anemia worsened. She had mild improvement  in BP and was transferred to the GI lab for emergent EGD and went into another cardiac arrest during intubation. CPR was initiated and later stopped at request of family at bedside. Patient expired on 1/29/22
Initial case was received from a non-health care professional on 24 January 2014. A 61-year-old male patient whose medical history and concomitant medication was not reported has received an intradermal FLUZONE (batch number UT4723AA, dose) on 20 January 2014 in deltoid. On an unspecified date, the patient developed "welt" at the injection site on his forearm. The patient consulted dermatologist on 24 January 2014. No corrective treatment or laboratory investigations were reported. The event of "west" at the injection site on his forearm was not recovered. The list of documents held by sender: none
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO (batch number 16B501, expiry date February 2019). Concomitant products included FLULAVAL QUADRIVALENT and PROZAC. On 21st December 2017, the patient received the 2nd dose of BEXSERO .5 ml. On 21st December 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain, headache, pain in hip, neck pain and general body pain. On an unknown date, the outcome of the injection site pain, headache, pain in hip, neck pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, headache, pain in hip, neck pain and general body pain to be related to BEXSERO. Additional information was reported as follows: The patient received BEXSERO in the right arm and FLULAVAL QUADRIVALENT in the left arm. After vaccination, the patient experienced side effects on the BEXSERO vaccine. The patient was had severe pain on right side of body, soreness where the patient received the BEXSERO, joint pain and hip pain.
Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient in his 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 4 decade 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: CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: Patient said that he had checked in on a friend of mine who got it and he said he had chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child received Vaccine - on 4/4/23. Vaccine expiration date was 3/22/23. Intact Vial was stored in refrigerator with no temperature excursions. Vial was diluted prior to child being given the vaccine dose of 0.2ml . Parent contacted, child had no adverse effects post vaccination.