chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Reflux/gargling acids moving inside my body.; Intestinal hyperactivity; Weakness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 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 PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish). The patient was treated with ESOMEPRAZOLE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Patient consume only natural sugars (found in fruits etc) and I am on a low sodium diet. Concomitant medication was not provided.   This case was linked to MOD-2021-344284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow-up received on 11-OCT-2021 contains no new information.
Patient reported Rash on abdomen and lower legs, self treated with left over shingles medications. 9/14/15 rash with streaks and swelling of lips. Patient reported she went to Private MD who administered injection (?) for possible allergy and gave Rx for prednisone and Zyrtec. Provided relief.
chills; I am running like a 99 fever; headache; I don't feel good; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0198), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Aug2021, the patient experienced chills, running like a 99 fever, headache and did not feel good. The reporter stated that she did not feel good hence she go on and took something to get rid of her headache that could lower her fever so she would feel better. The outcome of the events was not recovered.
p/vax @ next clinic visit mom states child had chickenpox 1wk p/vax; 15-20 lesions seen by school nurse;
Patient stated to staff that his MD told him that he needed a 4th dose due to being immunocompromised. Patient was given a 4th dose without verifying info with lead.
No adverse event; Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake) and NO ADVERSE EVENT (No adverse event) in a 100-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 055F22B and AS7147B) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Received 2 Bivalent booster doses, in 1 month/2nd Bivalent booster dose was administered 21 days after the first bivalent booster by mistake).    Concomitant medications were not reported. Patient had 4 Monovalent shots previously, 2 Primary and 2 boosters. Patient did not have the Monovalent shot information handy, but the last Monovalent booster was administered more than 3 months ago. No treatment information was provided by the reporter. The patient received a 2nd Bivalent dose by mistake on 26-Oct-2022.
Per Mom day after Flu vaccine pt hot fever of 101.0F for about 2 hours then had a seizure. History underlying seizure disorder and was on Fentanyl patch which seems to  increase seizures.
Patient began reporting numbness and tingling in his left arm several minutes after vaccination. These symptoms persisted for 30 minutes without worsening or lessening. He did not have any SOB, syncope or other symptoms. Physical exam WNL. Pt was instructed to seek ER care for worsening symptoms. His mother was present with him today and will keep an eye on him as well.
My child at age 2 began to have unexplained seizures, head banging, failure to thrive, and behavioral issues. Saw many DRs whom would not pin point the diagnose he had. Recently we have discovered he suffers with the MTFHR gene which vaccines causes a huge reaction to. Being that a confirmed diagnose was never given but all this his symptoms besides eczema have improved since stopping vaccines it is believe that the MTFHR gene causes a toxin build up and caused the reactions. HEP B and 2-4 months vaccine combos are to blame.
small red, firm area @ site of vax;warm to touch parents noticed 2 days p/vax was given;no tx @ this time;advised to observe site for changes;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 4 (booster), single (Lot number: PF1315FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Severe coronary artery disease" (unspecified if ongoing), notes: Severe coronary artery disease; "Smoking" (unspecified if ongoing), notes: Smoking; "lung nodules" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives; "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient took concomitant medications. Other medication in 2weeks reported as Yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Seriousness reported as No. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral treatment with Paxlovid taken from 08Oct2022 and stopped on 15Oct2022.
She's thinking about not getting the second dose; Her blood pressure was "very high"; Her heart started beating very "strong"; Feeling unwell; Felt pain but did not specify where; Felt dizzy; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1st dose, single at 32 years old at the time of vaccination for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date on Apr2021 (reported as not sure if it is the correct date), three minutes after getting it, the patient started feeling unwell, she felt pain but did not specify where, she felt dizzy, her heart started beating very "strong", she was told at the clinic her blood pressure was "very high". The patient asked if she should get the second dose as she's thinking about not getting the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Shortness of breath, developed acute bronchitis, fatigue, numbness in my arms, blurry vision,  body aches, nausea and headaches. Treated by  ibuprofen, Tylenol, topical pain relievers and rest.
It felt like my period was going to start one week early but instead it was 8 days late. Day 2 of my period was heavier than normal but all of the other days were light and ended on day 6. Throughout the time of waiting for my period I felt like my hormones were out of whack. I experienced PMS symptoms that I?ve never experienced in my life.
PATIENT PRESENTED RASH ON BACK, LOWER PART OF THE ABDOMEN, BOTH ARMS AND FACE. ALSO HE PRESENTED FEVER.
terrible itching on neck and chest; I got red spots on arms and legs of the body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (terrible itching on neck and chest) and RASH MACULAR (I got red spots on arms and legs of the body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included UTI from 11-Mar-2021 to 18-Mar-2021. Concurrent medical conditions included Drug allergy (Allergic to medications, food, and other products.), Food allergy (Allergic to medications, food, and other products.) and Allergy NOS (Allergic to medications, food, and other products.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, ATORVASTATIN, METOPROLOL and CALCIUM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (terrible itching on neck and chest) and RASH MACULAR (I got red spots on arms and legs of the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRETIC) on 11-Mar-2021 for Itching, at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 11-Mar-2021 for Itching, at a dose of 1 dosage form and DIPHENHYDRAMINE on 11-Mar-2021 for Itching, at a dose of 1 dosage form. On 10-Apr-2021, RASH MACULAR (I got red spots on arms and legs of the body) was resolving. At the time of the report, PRURITUS (terrible itching on neck and chest) was resolving. Not Provided          The patient reported that at the beginning, there was just mild itching on neck area. It progressed after the 2nd shot to terrible itching on neck and chest. It was stated that Zyrtec or Allegra did not help the patient very much so she took Benadryl in the evenings.   This case was linked to MOD-2021-050242 (Patient Link).
This was NOT an adverse event.  It was a vaccine administration error.  We thought we were administering the Pfizer bivalent vaccine and discovered in the mid afternoon on 9/8/22 that we were actually administering the Pfizer Grey Cap (monovalent/original) formulation of the vaccine.  Upon discovery corrective action was taken.  Patient was notified of vaccine administration error as was the regulatory authority.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1308 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
swollen axillary lymph nodes; Prolonged trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 14:30 (Lot number: EW0202) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic Pain" (unspecified if ongoing); "Moderate Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: YAZ; WELLBUTRIN. Past drug history included: Amoxicillin, reaction(s): "Reaction: Allergy: Amoxicillin". Vaccination history included: Bnt162b2 (dose number=1, dose product=COVID 19, brand=Pfizer , lot number=EN6202, administration time=03:45 PM, vaccine location=Left arm), administration date: 01Mar2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "Prolonged trouble breathing"; Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer , lot number=EN6206, administration time=02:30 PM, vaccine location=Left arm), administration date: 22Mar2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "Prolonged trouble breathing", "Dizziness", "Passed out (fainted)".  The following information was reported: DYSPNOEA (non-serious) with onset Oct2021, outcome "recovering", described as "Prolonged trouble breathing"; LYMPHADENOPATHY (non-serious) with onset 04Oct2021, outcome "recovering", described as "swollen axillary lymph nodes". The events "prolonged trouble breathing" and "swollen axillary lymph nodes" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dyspnoea, lymphadenopathy.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine same date vaccine date was 04Oct2021. It was unknown that the patient had other vaccine in four weeks. The patient had no covid prior vaccination. The patient had not been tested for COVID-19 post vaccination. The device date was reported as 11Jul2021.  Follow-up attempts are completed. No further information is expected.
Mild itchiness was noted to vaccine site the evening of 12/28/2020. The next day, 12/29/2020, a hard, red, warm, raised area about 2x2 inches  developed at the site. The red area was marked with a permanent marker, and the next morning on 12/30/2020, the area had grown in size and continued to feel hot, red, and hard to touch with mild itchiness.
Pain at time of injection, pain afterward at injection site and complete left arm ache for next three days.  Pfizer shots 1 and 2 taken in March of this year did not hurt at all. No pain during or after injection.  Needle comparison is the needle on the booster shots were much larger than needles used for shots 1 and 2.  Would be interested to know if there was a reason for changing the needle size. Larger needles always hurt more than fine needles.  This seems to be a consensus with everybody I have spoken with about the booster shot. The pain was worst.  No other adverse reactions.
w/in 30-60 seconds p/DTP/HIB/OPV lower legs turned red, then pt became limp; had shallow breathing & became ashen; 10 mins later devel purple blotches over head & legs; nonresponsive approx 1 hr & then recovered; hospitalized 6 hrs;
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced fever, skin discoloration and skin peeling. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the skin discoloration and skin peeling were not recovered/not resolved. It was unknown if the reporter considered the fever, skin discoloration and skin peeling to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to the physician. The pharmacist did not wish to provide patient's demographic details. The age at vaccination was not reported. The patient received SHINGRIX vaccine in an unknown deltoid. The pharmacist reported that, the patient's skin has turned brown and started peeling. The reporter did not have any additional details regarding the event and did not know where on the body the skin was brown or peeling.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 53 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "htn" (unspecified if ongoing); "IDDM" (unspecified if ongoing). Known allergies reported as none. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included COVID 19 Treatment from 07Sep2023 to 11Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
soreness on right arm; itchiness; redness at injection site; rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on right arm), PRURITUS (itchiness), ERYTHEMA (redness at injection site) and RASH (rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product CORTISONE for an unknown indication.    Concurrent medical conditions included Drug allergy (Tromethamine).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started CORTISONE (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness on right arm), PRURITUS (itchiness), ERYTHEMA (redness at injection site) and RASH (rash). On 02-Feb-2021, PAIN IN EXTREMITY (soreness on right arm) outcome was unknown. At the time of the report, PRURITUS (itchiness), ERYTHEMA (redness at injection site) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Cortisone.   Reporter did not allow further contact
bursitis around her elbow; elbow is pretty swollen; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 43 year-old female patient who experienced bursitis around elbow (bursitis) and elbow was pretty swollen (joint swelling), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.  On 22-Jan-2021 at 10:00 am, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2060 and expiry date 30-Jun-2021) via unknown route in the right deltoid or shoulder for prophylactic vaccination.  On an unknown date, the patient developed non-serious bursitis around elbow (bursitis) and elbow was pretty swollen (joint swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was also reported that patient said this was not anything she had experienced before.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Patient expressed increased pain over time, reported to office on 11/1/2020 that pain was not getting any better since injection. Patient had tried stretching etc but even difficult to sleep on.
Bloating; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea). At the time of the report, ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 30 year old female who was vaccinated with a dose of MMR II as a child. An unspecified "titer a few years ago was negative" and vaccination with MMR II was repeated, in approximately 2000. In approximately June 2002 the pt had a negative titer for rubella, and vaccination with MMR II was again repeated on 7/9/02. Unspecified medical attention was sought. Additional info has been requested.
Painful cramping a few days after the 2nd shot, followed by miscarriage several days later, confirmed by 2 separate ultrasound doctor's visits.  Baby died around 6 to 7 weeks into pregnancy.
Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.