chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered Pfizer 12 & up MRNA vaccine verses Pfizer 12 & Up Bivalent vaccine.  No reaction. Incorrect Booster administered
Pt fainted and fell to the floor. Recovered consciousness. Moved back to exam room. Pt lost consciousness again and had seizure activity lasting <30 seconds. Supplemental oxygen provided. Pt regained consciousness. Pt was pale during episodes. Taken to ER via ambulance.
Shortly after receiving vaccination Patient experienced ringing in ears, sweating and felt light headed. Patient received Epi in left thigh. EMT arrived and took over care. Patient declined transport to ER.
red raised area; This case was reported by a nurse via call center representative and described the occurrence of red rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   The patient's past medical history included shingles (shingles during pregnancy years ago). Previously administered products included zostavax injection.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a raised red area after injection. The reporter consented to follow up.
given Menactra and not the prescribed Polio vaccine due to the Menactra was placed in the Polio vaccine storage box with no ae; Initial information was received on 08-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00632999).  It was reported that 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6919AA, expiry date: 13-Apr-2022) was administered to a four year old female patient and not the prescribed polio vaccine due to the menactra was placed in the polio vaccine storage box, on 08-Jun-2021 via intramuscular route in right deltoid for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  The consumer did not get the Polio vaccine at the time of this report.  At the time of report, no adverse event 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.
Loss of taste is what concerns me the most. I have had cold chills, chest pain, head congestion, sore throat, coughing and sneezing for 2 days. (10/27/21-10/28/21)  Today is the 3rd day of symptoms, and I have muscle aches, cold chills, and now a loss of taste(10/29/21).
menstruating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3, single, Time: 03:00 pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot FF2587), administration date: 26Sep2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Time: 11:00 am, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot# EL3247), administration date: 15Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, Time: 2pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot# EL3247), administration date: 22Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Apr2022, outcome "unknown", described as "menstruating". The patient was in peri-menopause and she had not had period in almost a year and it came within 2 days of vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306567 same patient/vaccine, different dose and same event;
Patient called into the office and was later evaluated for red, warm, swollen left vastus lateralis. Treated with cold compress and
Fever > 100 deg for 12+ hours, chills, weakness, dizziness, nauseous, severe arm pain, - Symptoms started 18 hours after injection and lasted through next day. Fever broke at 8pm the following day.
received 1st dose of Moderna vaccine on 2/19/2021 Mismatch of the vaccine brands
7.5 cm x 6 cm swelling and erythema at injection site of Menveo. No fever, tenderness, purulent head, pruritis. (right arm)
Patient developed a painful rash that went down her whole arm. She is being treated with acyclovir for 7 days. Patient had received Stelara the same week as the vaccination.
Pt reported feeling warmth in throat and mouth, following vaccination of Pfizer vaccine. Pt denied SOB, Observed patient to have good color, no signs respiratory distress and able to converse in clear strong tone. VS 1012 BP 140/90, SPO2 99, HR 63 Pt had verbalized hesitation and nervousness with receiving the vaccine but ready to proceed after informed consent had been received from RN. Per Pt baseline BP 110s/70s. Pt reported no history of anxiety but had confirmed anxiety associated with vaccine. Pt provided water and apple juice, legs supported on chair and encourage deep breathing. F/U VS at 1017 BP 110/78 HR 67 SPO2 99. Pt maintained good communication with no increase in symptoms. Pt ambulated to couch to sit with legs elevated and administered Benadryl. Pt was monitored for an additional 15 min without any increasing signs distress or respiratory symptoms. VS 1040 SPO2 98 HR 68. Provided education and support to Pt and coworker about S/S anaphylaxis and what to do if any new onset of allergic reaction. PT and coworker confirmed understanding and Pt left in stable condition with coworker.
break a blood vessel in her left eye; felt sick to her stomach; threw up; Half of the white in her left eye turned solid red; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not provided), via an unspecified route of administration on right arm, at 66-year-old (not pregnant at vaccination), on 15Feb2021 at 15:00 as a single dose for COVID-19 immunization. The vaccine was received in hospital. Medical history included ongoing chronic back pain, high blood pressure. No known allergies were reported. The patient did not experience COVID-19 prior vaccination. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO), fluoxetine hydrochloride (PROZAC), triamterene, baclofen. No other vaccine was received in four weeks. On 21Feb2012 at 12:00 (reported as 6 days later) the patient felt sick to her stomach and threw up which caused her to break a blood vessel in her left eye. Half of the white in her left eye turned solid red. Later she felt fine and was able to eat dinner. The patient did not have COVID-19 test post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
Pt  complained of dizziness. Headache pain 7/10. flushing and fatigue. BP was 207/120.  Pt sat down in treatment, She took 650 of APAP.  She eventually had to lay down. Eventually she seemed fine but was recommended to got to the ER. Pt went to ER, got a ketorolac shot, and BP was down to 130/100.
Received first dose of new SHINGRIX vaccine for shingles. As warned by pharmacist who administered, injection site (upper left arm) was sore. It lasted 1 week. When that went away trapezius muscles ached for 2 or 3 days. When that went away, legs ached for 4 weeks most commonly in left leg, with ache becoming episodic but worse lying down in bed for sleeping. At other times ache was intermittent. Those aches gradually became less frequent. Now, almost at end of 7th week, ache in legs rarely occurs except slightly when lying down in bed.
About 35-40 minutes after injection started feeling like had to clear throat.  Went back into Urgent Care and was told to keep an eye on it.  Went home and within another 20 minutes had completely lost voice.  Went back to Urgent Care.  Was told again to keep an eye on it or go to ER.  They didn't even look at me.  My own Doctor was down the street so I went right to her office.  My doctor was not in, so another doctor came right out to look at me.  She checked my breathing and it was okay but I could not speak at all.  She put me on prednisone and Benadryl for several days.  Eventually felt better after meds.  Made appointment with allergist, for follow-up.   He said it was an anaphylaxis reaction.  Was told to not get second dose of Moderna shot. I have since had the J&J vaccine on 3/30/2021 with no immediate adverse reaction, just side effects (chills, severe headache, fatigue, sore arm).
Breathing difficulty-treated with nebulized medication.  Received some relief after breathing treatment.  I am on day 2 of having to take breathing treatments.  Had fever as high as 102  degrees.  I have been sweating profusely for 3 days.  I had one night of hallucinating dreams and hardly slept at all.  I had all of the general side effects, fatigue, headache, muscle pain, joint pain, chills.  I had a rapid heartbeat.
Tightness in chest Feeling of knot/lump in chest and throat Fever 100.3 F Rapid Pulse 110 Low Blood Pressure 80/70
Have had tinnitus in both ears for most of life; the second day after second dose of COVID vaccine and for many days after and now periodically, my tinnitus is noticeably much worse. with flare ups occurring; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 12:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus, allergy to latex, lanolin and nickel. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (reported as generic LEXAPRO) and paracetamol (TYLENOL); both from unknown date for unknown indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 12:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation and took moxifloxacin hydrochloride (AVELOX), erythromycin (MANUFACTURER UNKNOWN), brompheniramine maleate; pseudoephedrine hydrochloride (BROMFED) and cefdinir (OMNICEF); all on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has had tinnitus in both ears for most of life, on 27Mar2021, the second day after second dose of COVID vaccine and for many days after and now periodically, the patient's tinnitus was noticeably much worse. Currently, it seemed to be levelling off at a new, higher volume level than prior to the second dose with flare ups occurring more often. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus worse was resolved with sequelae on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, fatigue Narrative:  The first vaccine, I experienced severe fatigue for 4 days, but was scheduled off those days already. That was my only symptom then. This time, I am experiencing the fevers, headaches, joint and muscle pain along with the diarrhea as well as severe fatigue.
Wheezing, dyspnea, tachycardia, tachypnea, diaphoresis, and anxiety. Taken to urgent care at clinic where oxygen and intramuscular diphenhydramine were given then transferred in stable condition to local hospital.
Broke out in full body hives.  Took her to Dr. And they prescribed steroids and strong antihistamines
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM  pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63  and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
onset 2NOV95 hurt from elbow to axilla on lt arm w/red spot @ inj site; redness @ most painful areas;sxs were totally gone by 14NOV95;saw MD-no treatment;
Multiple doses were administered out of vials that had been punctured for more than 6 hours; A spontaneous report was received from a physician concerning approximately 50 patients who received Moderna's COVID-19 vaccine (mRNA-1273) administered from vials that had been punctured more than 6 hours.   The patients' medical history was not provided. Concomitant product use was not provided by the reporter.   Between 24 Dec 2020 and 08 Feb 2021, patients received their first of two planned doses of mRNA-1273 (Batch number 026L20A and 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, vaccine administered from vials that had been punctured more than 6 hours, was considered resolved on 08 Feb 2021.  Treatment, action taken with RNA-1273 in response to the event  and the outcome of the event were unknown; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, batch number 027L20A. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
High pitched scream for 5 days straight, 105.6 temperature, encephalitis, vomiting, swollen at injection site.
ABOUT 5 MINUTES AFTER THE VACCINE, THE PERSON EXPERIENCED LIGHTHEADEDNESS AND NAUSEA AND VOMITING
arm is swollen; red and itchy at the site of injection; red and itchy at the site of injection; It was sore; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE PRURITUS (red and itchy at the site of injection), INJECTION SITE PAIN (It was sore) and VACCINATION SITE ERYTHEMA (red and itchy at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE PRURITUS (red and itchy at the site of injection) and VACCINATION SITE ERYTHEMA (red and itchy at the site of injection). In April 2021, the patient experienced INJECTION SITE PAIN (It was sore). At the time of the report, PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE PRURITUS (red and itchy at the site of injection) and VACCINATION SITE ERYTHEMA (red and itchy at the site of injection) outcome was unknown and INJECTION SITE PAIN (It was sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
diarrhea x 4 days p/vax;s/sx began 1 day p/vax;no tx required;
Cellulitis on Right Arm. Redness Around site. Reaction occurred on 9/22/19 (Adverse Reaction to Pneumovax 23)
I got sick on July 7, fever up to 102, pounding headache, sore throat, and tired all the time, which I'm never like that. That week, I went to work Wednesday morning and had to immediately leave because of fever. I missed work on from the 7th-10th of July and did a lot of sleeping (anywhere from 14-16 hours at a time). On the 12th, I started feeling better, but I still felt tired and went back to work. Then the week of the 19th, I started having weird facial swelling. My lip would swell and go down, my eye would swell and go down, and then my lip would swell again. I broke out in hives in different parts of my body, first my back and then my stomach. The itching got worse, and the facial swelling continued. I had used no new products or changed my routine. On the 21st, I went to an urgent care for the itching. I was tested for COVID and because of my sore throat, I was also tested for strep throat, had a chemistry panel done and a liver function test. All tests were negative, but the LFT showed elevated AST levels that had doubled from the last test. On the 26th, I went to my new doctor about the hives and itching and was prescribed steroids. I finished the medication yesterday. I've had no new rashes or itching, but I did wake up with a welt this morning that eventually went away.
Jab 1 on 03/30/21 - experienced extreme fatigue shortly after injection, terrible headache, 90 minutes after injection, - slept for over 24 hours straight, then experienced severe heart palpitations and fluctuation blood pressure for 5 days.  I saw my cardiologist who ran a battery of cardio tests on 04/07/21 and also placed me on a 3 week heart monitor as well as prescribed medication for palpitations.  Jab 2 on 04/21/21 @ 1:30 pm - experienced fullness in right ear and eventual hearing loss - three weeks to the date after second jab on 05/05/2021.  I went to urgent care hoping an ear lavage would alleviate the problem but no improvement and was directed to meet with an ENT.  At ENT office, had physical exam and audiogram - was diagnosed with Sudden Sensorineural Hearing Loss.  I could not hear out of my right ear.  After a round of steroids ENT prescribed, hearing improved slightly but I have been diagnosed with a mild/moderate hearing loss, I have tinnitus and hyperacusis.  ENT indicates I qualify for hearing aid but recommends I wait in hopes hearing will recover.  I now have long-lasting adverse effect from this jab, and I am VERY reticent to take any subsequent booster Covid injections after these two adverse effects.
About two hours after injection numbness started in the lips and tongue and slowly throughout the day spread across the right side of the face. Later that night the numbness spread down the right arm to the fingertips. Then Sunday morning burning sensation started on the right side of the face and spread to behind the right eye. Symptoms did not resolve with TYLENOL or BENADRYL. Presented to employee health for evaluation. Methylprednisolone prescribed.
Felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021. Concurrent medical conditions included Vertigo (before the COVID the patient was diagnosed with vertigo).    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt light headed). At the time of the report, DIZZINESS (Felt light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Diabetic medication.   This case was linked to MOD-2021-255400 (Patient Link).
Cant get warm; Chilled all day; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Chills and fatigue are consistent with the established safety profile of mRNA-1273 vaccine.
Bilateral ear pain and ringing in ears. Varies in pain severity from 8/10 to 3/10 depending on activity.
I woke up with vertigo, and my left ear was ringing, my hearing became extremely sensitive (cannot tolerate even the slightest of sound), dizzy, and eyes were moving involuntary. Had to sleep it off for it to go away.
Chest wall pain.  Non-radiating. Not worse with exertion. Not positional: No dyspnea or syncope.  Mild to medium fatigue for 2-3 days.
Itching and tingling about 9:50 am. Dizziness, headache and not able to stand about 10:00 am. Throat started swelling about 10:05 am. Was given 2 maximum doses of Benadryl at approx. 10:10 am. Throat swelling stopped and gradually returned to normal by about 10:45 am. Headache continued through next day.
Pt vaccinated with Pfizer at 16:20, pt reported feeling anxious, numbness and tingling in her hands, like she was going blind, and she couldn?t catch her breath. VS taken immediately, pt oxygenation between 97-99% throughout, tachycardic, respirations 22, BP 110/66. Pt asked for narcan, but explained that it was for opiate overdose, and pt had denied opiate use but said she had smoked marijuana 1 hr ago. No signs of swelling, reddening, or rash observed. Epi or Benadryl injection not indicated. Pt requested an ambulance. Call placed to 911 at 1628, EMTs arrived between 1630 and 1635, they performed assessment including EKG and blood sugar check, pt in sinus tachycardia and BG 110. EMTs counseled pt to perform deep slow breathing, and that they didn?t recommend going to the hospital but that they would take her if she preferred. Pt declined to go to hospital, signed waiver. Pt monitored for 30 minutes and offered water/snacks. Pt symptoms resolved, pt still tearful but VSS. Pt exited ambulating independently in no apparent distress.
Employee called 9 & 10 days post admin of TDAP to c/o severe long lasting pain from vaccination. Advised to see PCP or call vaccine hotline.
RN administered pediatric Engerix B 10mcg/0.5 ml instead if 29 mcg/1 ml IM