chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soon after administering the vaccine, patient felt dizzy and sat on the floor. He may have passed out for a couple seconds and upon calling out his name he responded and mentioned that he has this kind of a reaction during blood draws. The patient failed to mention that to me before I gave him the vaccine. He came around  and then his arm started to shake as well and he turned very pale at which point we called 911. But within a few seconds he started feeling better and said he was fine and to cancel 911 but they were already on their way.
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.  Company Comment: This is a literature report of Myocarditis in an adult male. 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. Further information has been requested to the author.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-245527, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284010 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of Myocarditis in an adult male. 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. Further information has been requested to the author.
Severe breast pain; Fever; Chills; Headache; Insomnia; Nausea; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 07Aug2021 at 10:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fish oil (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and PRENATAL; all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Aug2021 at 21:30, the patient experienced severe breast pain, fever, chills, headache, insomnia, nausea and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of events severe breast pain, fever, chills, headache, insomnia, nausea and dizziness were resolved on an unknown date in Aug2021.
Severe pain in back of head felt like ice pic stabbing my head. Couldn't sleep for a week straight. Went to hospital and they put me on Prednisone, ibuprofen, Valium and gabepentin
14 year-old female received the 1st dose of Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine). On 10-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old female received the 1st dose of Moderna COVID 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment information not reported.
While I was asleep my partner saw me having what looked like a seizure on Tuesday 03/23/2021 @11:30pm. I was sleeping on my stomach, my partner describes it like a fish flopping.
Local pain (L) deltoid area began promptly, pain peaked at the 1-3 wk period gradually improved beginning in May 1 '09.
Pt was vaxed w/measles vax & 2 wks later pt was noted to be pregnant; subsequently pt underwent a therapeutic abortion; No further details were provided;
injection site reaction; new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date; new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group for a Pfizer sponsored program.  A 5 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Feb2022 12:35 (Lot number: FL0007) at the age of 5 years as dose 2, single for covid-19 immunisation; sodium chloride (SODIUM CHLORIDE), from 12Feb2022 12:35 (Batch/Lot number: unknown, Expiration Date: 01Feb2022) to 12Feb2022 12:35 at unk (diluent). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: FL0007, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 22Jan2022, when the patient was 5 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 12Feb2022 12:35, outcome "unknown" and all described as "new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "injection site reaction". The action taken for sodium chloride was unknown.  Additional Information: Caller clearly stated that, the vaccine was dilated with correct amount from a fresh bottle of sodium chloride on Saturday 12Feb2022 which was expired on 01Feb2022. It was a new bottle but it was expired, it was listed as 10 days after the manufacture date. It was a fresh new pop top sealed vial. Caller called to clarify if the patients need to be revaccinated. The second dose the patients have already received. It has been 21 days,  23 days on Wednesday since the first dose. Parents are concerned because this is a child dose. and there is a high rate of myocarditis with large doses, and wanted to know if they were  putting the children at risk. NDC number of BNT162B2 (dose 1 and dose 2) was 59267105501. Additional vaccines administered on same date were none. Prior Vaccinations (within 4 weeks) were and unknown hence, adverse events following prior vaccinations were unknown. Relevant tests were unknown. The patient provide information to you regarding the reported adverse event with the use of product was no and specific relevant test for thromboembolic events with thrombocytopenia were none. Did it affect the patient with clinical consequences: not as far as we have been made aware yet; sever-al check in calls have been made with the patient's guardian and no adverse effects have surfaced at this time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200268460 same reporter/product/event, diff patients
Day 1: Fatigue and mild headache Day 5: Upper right arm began itching Day 6: On upper right arm, red spots and small patches appeared that were raised and itchy. Day 7: On upper right arm, the red spots merged into larger patches, which were still raised, very itchy, and warm.Over the course of the day, the patches continued to merge, and formed one large area of inflammation, measuring 4"H x 3"W. Day 8: The inflamed area was one solid red area (4"H x 3"W), itchy, warm, and clearly outlined.  Day 9: The rash and inflammation began to lessen. Day 10: The rash  and inflammation had mostly disappeared.
Sore arm at injection site; This is a spontaneous report from a contactable consumer (herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was EL3247) dose 1 via an unspecified route of administration, administered on Arm Right on 01Mar2021 10:45, as DOSE 1, SINGLE for COVID-19 immunization (at the age 54 years). Medical history included breast cancer from Sep2018 to an unknown date (2018 diagnosis), drug hypersensitivity with Sulfa drugs from an unknown date and unknown if ongoing, ligament sprain from an unknown date and unknown if ongoing. Concomitant medications included tamoxifen; paracetamol (TYLENOL); atorvastatin (LIPITOR [ATORVASTATIN]); celecoxib (CELEBREX) and Multi-Vit medications received within 2 weeks. The patient previously took Levaquin and experienced drug hypersensitivity, flu vaccine vii for immunisation and experienced Sore arm at injection site, like when i get a flu shot. The patient was not pregnant at time of vaccination. The patient did not received 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. The patient experienced sore arm at injection site on 02Mar2021 12:00 AM. Sore arm at injection site, like when she got a flu shot. Realized it when she rolled over onto the arm during the night. Had the shot in her non-dominant arm. No therapeutic measures taken as a result of event. The clinical outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
No adverse event; Patient received Monovalent instead Bivalent in the month of January; Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-709060.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2023: Follow-up received which contains significant information: Patient information update, suspect product information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709060:Master case -Female
Next day around lunch time arm started swelling at injection site, hurting, red, hard to touch and warm to touch about bigger than the size of fist
patient came in next day to pick up rx for Medrol and cetirizine from doctor stating she had swelled mouth and throat and thinks its from flu shot - patient gets a flu shot every year and this is first time she reacted to it
Pt here today for reaction - 9 days later 2 large swollen spots about 2" in size about 1 inch apart pt complains of arm discomfort.
Rash on head & back, fever occurred 7 to 9 days after vaccines given. Mother talked to doctor, advised Benadryl & walk in clinic if no improvement (mom didn't take temp but states child felt warm).
COVID 19 Treatment; COVID 19 Treatment; 2 days later it came back and we are again positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day and as dose 4 (booster), single (Batch/Lot number: unknown) for 1 day 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "unknown", described as "2 days later it came back and we are again positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Both me and my wife had Paxlovid. After taken course we were negative; Positive, notes: however 2 days later it came back and we are again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 19Aug2022 to 23Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Reported as no other medication within 2 weeks. Reporter and his wife had Paxlovid. After taken course, they were negative however 2 days later it came back and they were again positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201114827 Same reporter/vaccine/event, different patient;
mom said pt had t102;pt given APAP very fussy w/crying 2-3hr-while feeding formula (bottle) pt started shaking arm & head;taken to ER;seen by MD:t99.6, irritable-red all over;
Rec. typhoid c/o cephalgia, arm pain, n/v and loose stools x 4 days.  Seen at facility.  Dx'd with adverse rx and given IV hydration with ZOFRAM.  Now asymptomatic.
Sore Arm; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported.  No patient demographics were provided. The reporter did not had time to look into that.  Nurse reported that a patient received a dose of Shingrix and had sore arm for 6 weeks. The patient was wondering how effective one dose of shingrix was because he was not sure about getting a second. The reporter  did not probe any further and did not ask permission for follow up due to this. The reporter did not consent to follow-up.
Patient had local pain and swelling in the arm from the vaccine. Had a localized site reaction. Patient was instructed to put ice on the injection site,and to take benadryl and Ibuprofen to help with the local reaction to the vaccine. Patient received the vaccine on 4/1/17 and said he woke up on 4/2/17 to pain and swelling from the vaccine. Patient on 4/3/17 went an saw a physician and they gave him Ibuprofen (NSAID) to help with the reaction. Patient had improved from Sunday, 4/2/17 since he was seen in the pharmacy.
Within 1 week, Psoriatic lesions appeared on the right side of my head and eventually moved around to the left side of my head. Further, I developed Urticaria on my torso which have not resolved. I was seen by a Physician Assistant last week who said that there was not much we could do since I can't take Prednisone. I received an Rx for triamsinolone acetonide to deal with the itching from my PCP at my first clinic visit on Sept 20. All seem to fault the Adjuvant in the Vaccine. I have not ever had an adverse reaction to any other Flu Vaccine.
severe headache; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 23Sep2022, outcome "not recovered"; PYREXIA (non-serious) with onset 23Sep2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 23Sep2022, outcome "not recovered", described as "severe headache".  Additional information: No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder injury (In Mar-2021 had surgery to remove it) from January 2021 to March 2021. Concurrent medical conditions included Asthma (Severe asthma), Acid reflux (esophageal), Anxiety and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, PANTOPRAZOLE for Acid reflux (esophageal), APIXABAN (ELIQUIS) for Anticoagulant therapy, BUSPIRONE for Anxiety, LEVOTHYROXINE, ESTRADIOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALBUTEROL [SALBUTAMOL] and BUDESONIDE for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            Concomitant medication included cholesterol medication. The patient was taking heat as a treatment.   This case was linked to MOD-2021-390768, MOD-2021-390776 (Patient Link).
Chills w/t101 @ approx 7AM 8JAN92 which lasted approx 6 hrs; mom checked w/MD but pt was not seen by MD 8JAN92; was told to just watch pt; p/6hrs pt felt weak;
7 1/2 CM BY 5 3/4 CM AREA OF ERYTHEMA RT UPPER ARM. WARM TO TOUCH.
large red area w/hard place greater than a fifty cent piece-area appeared 1 wk p/shot were given;
Immediately following the vaccines and every 3-4 weeks continuously since then, for the past 9 years, I get a red rash and a hard lump in 2 spots on my right arm where the vaccine was administered. It is hot to the touch, itches, it looks like a raised welt. It surfaces and dissipates at random.
Rash at site of immunization. Pt instructed to take Benadryl po good effect last night. rash appeared and spread by 10 am 9/13/02.
CONGESTION, EAR FULLNESS, SINUS PRESSURE, NOSE BLEEDS- NOTED ON 03/05/2021 PATIENT ACCEPTED ADMINISTRATION OF ANTIBODY INFUSION.
"Pt w/ PMH significant for Asthma.  NKDA.  Pt denies any medications. 7mins post vaccination, pt c/o feeling paint and hot.  Pt denied N/V blurry vision, palpitations, itching or respiratory issues.  Skin dry and VSS. Vitals: @11:15 BP 108/61, HR 60, RR 18, O2 Sat 99%. -- > @11:30 108/83,  57, 18 -- > @11:42 116/91, 57, 18. Pt notes that she has had previous needle anxiety.  No known bradycardia hx.  Last PCP visist a long time ago. Pt given apple juice, crackers, and ice pack.   @11:25 pt reports feeling better @11:30 improving - mild dizziness. @11:48 Pt ambulated off unit, accompanied by family.  Dizziness resolved. Pt stable and released from the vaccination site.  Recommended the patient f/u w/ healthcare provider, f/u instructions provided."
Influenza shot (Right arm) resulted in moderately severe muscle pain in right arm. and severe pain in right wrist.  Moderna Covid shot (Spikevax) in left arm had little effect.  Slight tenderness around injection site.