chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-2 hours following vaccine administration, I experienced moderate injection site pain that limited my mobility with that arm (i.e. pain on shoulder abduction). 18 hours following vaccine administration, I experienced a fever and chills (beginning at 0530 the morning after the vaccine). For the rest of the day, I had mild myalgia, a mild to moderate headache and general malaise that resolved by the following morning (within 48 hours of vaccine administration)
Influenza like illness/Flu-like symptoms; Pharygolaryngeal pain/ Sore throat; Ear pain/Ear ache; Rigors/chills; Pain/Ache NOS; Pyrexia/Fever. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a 35 year old female consumer who experienced flu-like sympttoms, sore throat, earache, chills, body aches and fever between 100-101. At 35 years of age, the patient received a dose on 15-Jan-2004. On 21-Jan-2004, 6 days post-immunization, the patient experienced flu-like symptoms (influenza like illness) characterized by sore throat (pharyngolaryngeal pain); earache/pain, chills/rigors,  body aches/pain and fever between 100-101 degrees/pyrexia. As of 26-Jan-2004, the patient's symptoms were "getting worse".
Fever to 101.4F with redness and swelling and heat on interior 2/3 of thigh. Mild increased inguinal nodes. Redness extends for 4" over injection and 5" below.
Client complained of dizziness upon standing after vaccination.  Sat down and then stated had a "terrible headache"  Vital signs taken and blood pressure found to be increased with systolic over 180 and diastolic at 100.  Client offered a dark, quiet room to rest.  Offered emergency transport due to very high blood pressure; client declined and continued to be monitored in dark room.
Redness and swelling left thigh 25 by 15 centimeter with induration.  Itching, no pain, occasional limp.  Hospitalized 9-11-9/12 with intravenous ANCEF, CBC normal limits. 10/31/06-records received for DOS 9/10-9/12/06 DC DX: resolving cellulitis of the left thigh, which was probably allergic in nature to the DTaP. Originally seen in ER on 9/10/06-RX with Keflex. Redness and swelling got worse seen at MD office and subsequently admitted. RX with IV Ancef. Afebrile throughout, limping and itching prior to admission. At time of DC induration gone swelling is almost normal, still has purplish discoloration.
Flu like symptoms started the same day of the injection stayed for couple of days. today on 04/19/2021 @1400 small spots of blood (circle) underneath the skin 3 inches above the injection site  patient was instructed to call her primary care physician or go to urgent care to get checked.
nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: pending (Inconclusive) pending.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient  is taking medicine for cirrhosis. patient had covid19 test and other lab tests the results will come after 2 days Patients second dose vaccine appointment  on 2Apr2021.
The patient was administered a ProQuad and should have been administered the individual vaccines.  No adverse reaction occurred.
I ended up in the hospital for 3 days.  I got my blood tested and my hemoglobin levels were very low and they wanted to get an iron transfusion. I was feeling shaky and light headed at the time so they sent me to an ER. I got a blood transfusion and an iron transfusion. I was discharged last night and I'm still not feeling the best.
Area around site became swollen, red, warm to touch, patient developed a fever. Redness around site 1.5" X 3". Side effects lasted about 48 hours. Patient did have some swelling after the first time she received this injection but not to this degree.
Redness to injection site LL - informed redness is nl. if getting worse to be seen my MD
Extreme vertigo; Sharp pain behind left ear; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included protein s deficiency. The patient was allergic to latex. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 15:00, the patient experienced extreme vertigo and sharp pain behind left ear. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme vertigo and sharp pain behind left ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; his son was born and has "delayed speech and learning abilities, asthma, and his legs hurt."; Exposure via father; Fetal Exposure During Pregnancy; This spontaneous report was received from the patient's father and refers to his son a male patient of unknown age. Information regarding the patient's medical history, drug reactions and allergies were not provided.  In 2008-2009, the patient's father was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and his son was exposure via transplacental.        The father reported that his son had delayed speech and learning hablities, asthma and his legs hurt The outcome of speech disorder, asthma, learning disorder and pain in extremity was unknown.    The reporter did not provide the causality assessment.; Sender's Comments:  US-009507513-2012USA013606: US-009507513-2101USA001098:
Fever 102, severe lower right quadrant abdominal pain, HR 150, chills, myalgia
Itching all over body sore, red, hot to touch, rash around injection site lasted 1 week.
Local erythema and swelling at site of injection, redness spreads throughout the entire arm. Area warm to the touch. Symptoms persist for over 24 hours.
Symptoms started at 7:00am. I had already been awake for two hours, drank a cup of coffee and had been standing and sitting during this time feeling fine; then I felt my head getting very light and had to go sit down. Even sitting down did not really help the light-headedness go away, I proceeded to laydown, close my eyes and breath deep.  The feeling lessened after 10 or more minutes but I am still feeling wobbly and my mind is not fully clear and alert. I have eaten a full meal and proceed to drink water but my head feels foggy and like I could pass out if I move too quickly or stand for too long.
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EN9581) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot Number/Expiry Date: EN5318, Route: injection, Anatomical Location: Right Arm), administration date: 25Jan2021, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Question: Transferred  NTID: # Reportum Number: # Caller stated she received the second dose of the Pfizer COVID-19 vaccine on February 15th. She's been having diarrhea since three days ago. Could this symptom be related to the vaccine? DSU. E-transmitting possible duplicate OVERALL SAFETY SUMMARY LAB-1457-6.0 Revised: 25Feb2021  Additional Context: Caller states she is calling because she has, as of three days ago, she started having diarrhea. Caller states she had the second shot 15Feb2021 so she's just calling to see if it's possible that there is a connection. Caller states she does have a little bit of time but what she said was the diarrhea just started a few days ago, and she had the second vaccine shot on 15Feb2021. Prescribing Healthcare Professional: Caller states she goes to Mercy Life, caller states she doesn't want to go into that, she is kind of working with a deadline here. Diarrhea: Caller states she started taking Fiber and it has gotten a little better. First Pfizer COVID Vaccine: Caller states she can't read it. Caller verifies information is handwritten. Caller states LOT: #. Caller states unsure of NDC or Expiry date. Caller states received on 25Jan2021. Second Pfizer COVID Vaccine: Caller states received on 15Feb2021, LOT #. Caller unsure of NDC or Expiry date. Caller did verify she received Pfizer COVID Vaccines. Time the Vaccination was Given: Can only remember it was probably the morning. Anatomical Location of Administration of Pfizer Vaccine considered as suspect: Left Arm Vaccination Facility Type: Caller states it was given on the premises of her (facility name)facility, which is (facility name), it's a (facility name)for Seniors, (facility name) History of all previous immunizations with the Pfizer vaccine considered as suspect: Yes, first Pfizer Covid vaccine. Vaccine Name: Pfizer Covid Vaccine Lot Number/Expiry Date:  EN5318 Route: injection Anatomical Location: Right Arm No. of Previous Doses: One Date: 25Jan2021 Time of Onset (24-hour clock): Caller states she does not remember when her diarrhea started. No Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine) to the COVID vaccine.   No follow up attempts are possible. No further information is expected.
Myocarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging heart: Unknown results.  Clinical course: Wederived532post-vaccinecasesofCTorMRfindingsofmyocarditis,including462 (86.8 percent) males and70(13.2 percent)females(agerange:1280years).Intotal,113(21.2 percent)cases had positive disease history or comorbidities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057464 Same article/drug/ event; different patient.;
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that there was a confusion between expiration date printed in the carton and expiration date when the QR code was scanned.  It was reported that patient had not experienced any adverse event and No Temp excursion was happened to the suspect vaccine.  Date the vial was initially stored in the refrigerator: 04-Nov-2021.   This case was linked to MOD-2022-491837 (Patient Link).
New-onset absence of menses while on oral contraceptives,  with confirmed negative serum hcg test.
Breakthrough case of COVID-19. I started having chills and tired, and I had a headache, and then I had a stomachache and I had nausea, and diarrhea. I did not want to eat anything and I had a very bad cough, which made me go to the ER. I took a PCR test and it was positive. I had normal body aches. The coughing lasted for a few days almost a whole week, and it took about an extra week and a half to subside. The fatigue took about two months to go away. I lost weight because I did not want to eat at all because I was sick to my stomach.
Hard chest pain and shortness of breath 4 days after after vaccine and still currently have symptoms.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not provided) lot# M045392 and expiration date: 14-NOV-2018. The M-M-R II was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 47 to 77 degrees Fahrenheit for 80 hour and 30 minutes. There was no previous temperatures excursions. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 17-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023; No adverse event; Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient have received a dose of the Moderna COVID-19 bivalent vaccine from  lot number 045H22A, after a beyond use date of 01-MAR-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 and was administered on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients beyond the use by date of 01-Mar-2023. The vial was initially stored in refrigerator on 30-Jan-2023. The vial never underwent any temperature excursion.  No adverse reaction was reported by patient.  Treatment medications were not provided.
Presented via EMS w/ cough, SOB X 24 hrs, low grade fever, hypoxia. Covid +/pneumonia. Treated w/ O2, Decadron, zinc, vit C
Initially, I just had a sore arm and a hard area at the sight of the vaccine.  Soreness lasted about 3 days but the hardness remained.  On day 8, after the vaccine, I got a red rash at the site and it was itchy.  It was a circular rash like the pictures on the internet of "Covid Arm"  The rash and itching remained and the area started softening, the hardness was going away.  6 days after the injection site rash appeared (13 days after the vaccine}, I got a full body rash.  It was red, itchy, blotchy type of rash, No fluid filled bumps of any kind.  First notice on the left side of my body but then spread.  The itching was awful.  On day 14 after the vaccine, I went to the doctor because of the severe itching and he put me on a Medrol dose pack.  I have taken 4 days of the medicine.   I still have the rash.  I think it's better, I don't have the severe itching like initially.  It's still all over my body except for my face.  At this point, I don't know how long it's going to take to go away and I'm questioning whether I should get the second dose of the vaccine.
This case was reported by a healthcare professional and described the occurrence of increase in thyroid levels in a 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included hypothyroidism. Concurrent vaccination included GARDASIL (non-gsk); Merck; unknown; unknown given on 30 April 2010. Concurrent medications included LOESTRIN. On 30 April 2010 the subject received 1st dose of TWINRIX (unknown route, right arm). On 30 April 2010, immediately after vaccination with TWINRIX, the subject experienced increase in thyroid levels. Relevant test results included thyroid levels over 100. At the time of reporting the outcome of the event was unspecified. The vaccination course with TWINRIX was discontinued. The subject was consulting with thyroid specialist. Follow-up information received on 03 August 2010 reported that following administration of TWINRIX and GARDASIL (given at the same time in the subject's left arm on 30 April 2010) the subject's thyroid levels immediately increased. GARDASIL was also reported to be suspect. It was noted that further vaccinations with TWINRIX were discontinued at the present time.
Had booster shot for COVID (Pfizer) on 10/08/2021 5pm. On 10/09 9am I began to feel chilled, nauseous, and had a very bad headache and extreme lethargy. Symptoms intensified throughout the day
Polyarthritis without swelling/warmth/edema, chest pain worse with swallowing and movement (esophagitis, costochondritis?)  Given NSAIDS, checked labs, EKG, troponin, all negative and reassuring. Echo of heart showed normal wall motion, no effusion. EKG normal. Discharged home with NSAIDS and pepcid.
I was vaccinated at 4pm.  At 2am I work up feeling nauseous.  I walked into the bathroom and was standing at the sink when I suddenly passed out. When I came me to, I was sweating profusely and extremely chilled.  I went back to bed.  The next day I felt wiped out most of the day. I slept from noon till 4pm and then felt much better
Patient called pharmacy to complain that the IMZ caused a knot on her upper arm (10/12/15) she visited pharmacy to show it to RPh there(10/13/15), RPh stated that it appeared to be a normal reaction - small knot in upper arm - shot was given IM with no complaints until Monday 10/12/15.  She said she was not in any pain, but the knot was there so she wanted to report it.
Rash; Pain at the site; A spontaneous report was received from a healthcare facility staff member concerning a patient who developed rash/ Rash, pain at the site/Pain at injection site.     The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). One week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    Patient developed rash and pain at the site. Treatment for the event included Antibiotic.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events, rash, pain at the site were considered recovered/resolved.    The reporting [Other HCP] assessed the event(s), rash and pain at the site as Not provided.
Significant body aches and pains, severe fatigue. Treated with ibuprofen. Significant pain in sight of injection, arm was also hot in sight of injection. Symptoms have lasted 2 days so far, but are improved on the second day. On the first day after the vaccination I could not stay up for more than 4 hours at a time.
Systemic: Fainting / Unresponsive-Severe, Systemic: Very pale upon awakening, sweaty, feeling "hot"-Severe
Patient was supposed to receive lower dose (Pedia) of Pfizer Bivalent but administered the regular dose which is 12+.