chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Vomiting; Headache; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the parent.  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 at 14:00 (Lot number: unknown) at the age of 5 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: FLUORIDE and MELATONIN. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot Number: FK5127, Anatomical site: Left Arm, Administration time: 13:45, Route of administration: Intramuscular), administration date: 13Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Fever"; CHILLS (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; VOMITING (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Vomiting"; HEADACHE (non-serious) with onset 05Dec2021 at 18:00, outcome "recovered" (an unknown date in Dec2021), described as "Headache". The events "Fever", "Chills", "Vomiting" and "Headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, vomiting and headache. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified multivitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures which included: SARS-CoV2 test by test type nasal swab on 06Dec2021 and the result was negative. The lot number for BNT162b2 was not provided and will be requested during follow up.
Hives over every inch of her body. Her legs, her arms, her chest, her neck, and her butt. She has never broken out like this before ever. She also seems a bit tired. No other symptoms that we are aware of.
Chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of CHEST PAIN (Chest pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 1:80 (Inconclusive) An autoimmune  workup showed an anti-nuclear antibody titer of 1:80 in a speckled  pattern. On an unknown date, Antinuclear antibody: negative (Negative) negative, negative (Negative) negative and negative (Negative) negative. On an unknown date, Blood immunoglobulin G: negative (Negative) ribonucleic protein IgG negative. On an unknown date, C-reactive protein: 14 mg/l (High) CRP was notably elevated. On an unknown date, DNA antibody: negative (Negative) Negative double stranded DNA. On an unknown date, Echocardiogram: unknown (Inconclusive) Left Ventricular Ejection Fraction (LVEF) 55%, no regional wall motion abnormalities. On an unknown date, Electrocardiogram: abnormal (abnormal) Down-sloping PR depressions, diffuse ST elevations. On an unknown date, Rheumatoid factor: negative (Negative) Negative Rheumatoid factor. On an unknown date, Troponin I: 3785 pg/ml (High) Troponin-I peaked and 6802 pg/ml (High) Troponin-I peaked.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (Chest pain) to be possibly related.    No concomitant medication was provided by the reporter  Patient was presented with chest pain 4 days after receiving his second dose of the Moderna vaccine. His chest pain resolved on the first day of his hospitalization, and he was discharged the following day.  No treatment medication information was provided by the reporter  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.   This case was linked to MOD-2021-293732, MOD-2021-293677 (Patient Link).; Sender's Comments: 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.
About 5 minutes after receiving second COVID19 Pfizer vaccine, patient became unconscious with vasovagal symptoms.  She was able to speak and open her eyes about a minute later.  Mother stated patient experienced this type of vasovagal reaction before after "seeing  blood."  RNs placed patient on a cot from sitting position and ice pack was applied to patient's neck.  Patient also drank water.  About 15 minutes after laying down, patient dangled legs on side of cot without any symptoms for a couple minutes.  Then, RNs released patient under the care of mother.
slightly worse migraine; This is a spontaneous report from a contactable consumer. An adult female patient received the second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included ongoing chronic migraines since the age of 9-years-old. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) on an unknown date for COVID-19 immunization. On 09Nov2021, the patient had slightly worse migraines.  The patient had one episode in afternoon on 09Nov2021 as well as one on 10Nov2021. The patient had been vaccinated for a while (not further specified) and the past month the migraines have been slightly worse. The patient reported feeling much better on 11Nov2021.  The clinical outcome of the slightly worse migraines was recovering.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/13/2023.
heart flutter; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 at 08:11 as dose 1, single (Lot number: FK9894) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 17Mar2019 (ongoing); "Hypercholesterolemia", start date: 19Mar2011 (ongoing); "Hypertension", start date: 17Sep2019 (ongoing); "Prediabetes", start date: 16Nov2016 (ongoing). The patient's family history included: "Diabetes" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure; "stroke" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure; "heart failure" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure. Concomitant medication(s) included: METFORMIN oral taken for glucose tolerance impaired, start date: 16Nov2016 (ongoing); LOSARTAN oral taken for hypertension, start date: 17Sep2019 (ongoing); ATORVASTATIN oral taken for hypercholesterolaemia, start date: 19Mar2011 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 07Jan2015 (ongoing). The following information was reported: CARDIAC FLUTTER (medically significant) with onset 12Apr2022, outcome "recovered" (May2022), described as "heart flutter". The patient underwent the following laboratory tests and procedures: Blood glucose: (06Apr2022) mildly elevated; Full blood count: (06Apr2022) normal; Lipase: (06Apr2022) 51 uL; (09Apr2022) 57 uL; Metabolic function test: (06Apr2022) Normal. Therapeutic measures were not taken as a result of cardiac flutter.  Patient Reported to the office on 27May2022 that she had been having intermittent heart fluttering since COVID vaccine on 11Apr2022 but that it had already resolved after a few weeks. She received on 27May2022 her 2nd COVID Vaccine reports immediately having a "medicinal" taste in her mouth that went away after <1 minute. No treatments were needed or provided for either of these.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of CARDIAC FLUTTER. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Pt at clinic with mother for illness on 12/6/05.  Mother asked about child's upcoming need for further immunizations.  Mother stated child developed generalized body rash 2 days after receiving immunizations on 9/30/02.  Rash lasted 2 months.  Complete recovery after 2 months.  No prior problems with previous immunizations.
Pt experienced loss of consciousness immediately following vaccination. Pt stabilized to floor. Pt regained consciousness within 20 sec. Vitals were taken at 1:15pm; B/P 100/60 pulse-60, RR-22. Pt recuperated laying down on floor. Pt sat up and complained of lightheadedness. Pt was laid down on floor. Vitals were taken; BP-98/60, pulse-72, RR-20 at 1:20pm. Pt. administered 50mg of fast melt BENADRYL. Pt. received H2O. Pt recuperated till 2:15pm with no complaints. Pt. advised to follow up with private MD.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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.    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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported  No treatment information was provided.
Call from clt. on 11/24/14, stated received TDAP on 10/23/14 and left arm has been "tender with movement" since. States no fever noted, redness or drainage from injection site following immunization. States left arm at injection site feels sore when attempting to lie on left side. No medical attention has been sought, advised clt. to speak to her primary medical doctor about left arm discomfort.
No other AE reported; report a temperature excursion; This spontaneous report was received from an other type of reporter and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history. On 12-JAN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date on 03-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not reported). However, no adverse events were reported. This temperature excursion occurred on an unknown date, at a 31.2 F temperature for 30 minutes. There was no previous temperature excursion reported and it was confirmed that a digital data logger was involved. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. In May 2015 (reported as "five months ago"), the patient was vaccinated with a dose of PNEUMOVAX 23. Then on 29-OCT-2015, the patient was inadvertently given an extra dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided). The patient's outcome regarding the extra dose administered was unknown. Additional information has been requested.
Morbilliform rash.  Started on trunk, spread to include extremities. No itching or discomfort. No fever or other symptoms.
I have never missed a menstrual cycle. After getting the vaccine, I've either skipped or have had a delayed cycle. My cycle is on the 25th of each month, it's currently 4/3/22 and I didn't menstruate the month I got my vaccine.
EXTREME CHILLS AND BODY SHAKING FOR ABOUT 6 HOURS. HAD FEVER, HEADACHE AND BODY ACHE FOR 24 HOURS.  VERY TIRED.
Patient was showing signs of weakness, lethargy, change in LOC, and complaints of pain.  She experienced a fall.  Sent to the ER for evaluation.
patient's parent began to notice redness on patient's face and neck about 30 minutes after receiving vaccine. Patient was brought to registered nurse. Blood pressure and pulse were normal. patient was able to breathe normal.  After about 10 minutes, patient began to get redness on upper chest and chest felt hot. Benadryl was offered but patient has a hard time swallowing pills because of swollen tonsils (swollen tonsils before vaccine).  Paramedics were called. when they arrived they decided to take patient to Hospital to due further tests, including a blood test. Patient was able to walk out on her own. Parent noticed that redness had spread to legs.
almost 12 hours after receiving the vaccine I experienced headache, fever, chills, nauseau.  I took Tylenol and laid in bed.  36 hours after the shot I was feeling much better.
Approx 30 min after shot was received, while driving home, my lips and tongue became tingling and my lips felt slightly swollen. Also,, the palms of my hands and my throat were itchy. I previously had an allergic reaction to codeine twice and recognized these symptoms as the onset of an allergic reaction.  I drove to nearby ER but felt the symptoms were not getting worse so I parked in the parking lot to be close to help if needed. The symptoms began to wane and after about 30 min I felt it was safe to continue home. Since then, all is fine. The only other vaccine related affect was next day fatigue and soreness of the arm.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 45 year-old female patient. On 08-Oct-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for not more than 23 hours. The outcome was not reported.
Nausea/mild/loose stool/fever 99 - 100 degrees/malaise.
Local redness and swelling at injection site 1 inch, mildly tender 36 hrs after shot.
Patient reported arms tingling, itchiness, and started to experience rash on bilateral arm. Patient reported tongue feeling like it has" metallic taste". Patient denies SOB, dizziness, chest pain. Vital sign 142/92, HR 84 O2 98. Temp 37.8. Patient given Benadryl. Patient called provider office. Providers office, PA recommended going to the hospital for evaluation.  Patient reported more tongues issues, and generalized feeling of tingling. Called 911 for transport to hospital. EMS arrived and transported.
Redness around site 2 days after admin. Also fever, swollen lymph node above site.
This spontaneous report as received from a physician refers to a 5 year old patient of unknown gender. On an unknown date the patient was vaccinated with GARDASIL. Other suspect therapies included MENACTRA. On an unknown date the patient received GARDASIL in error, rather than MENACTRA as prescribed. The physician indicated that the nurse who administered the dose made an error, and the physician was not certain why GARDASIL was confused with MENACTRA. It was reported that the child was not demonstrating any adverse effects. Additional information has been requested.
That afternoon had itchy red rash and arm hurt left felt throat closing up Tuesday took Benadryl 25mg, used ice pack on arm on Monday. Tried to call hotline # on vis but could not get through. Arm felt hard and hot. Now has some redness and tenderness only.
Marked swelling of arm at site and upper arm, and under armpit and on inside of chest. No redness or warmth. Marked discomfort of outer arm and armpit. Still swollen 5/14/2010.
This spontaneous case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 25-Aug-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 25-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced Chest tightness / Chest discomfort, Did not feel she was in her usual health / Feeling abnormal, Itching / Pruritus. Oral diphenhydramine initiated on 25-Aug-2015, continued following day. Visited walk in clinic on 26-Aug-2015. Unknown drugs administered. Reporter's assessment: The Health Professional considered the event Did not feel she was in her usual health / Feeling abnormal, Itching / Pruritus as non-serious and related.
A nurse inadvertently gave a dose of VAQTA to a 2-month-old; no other AE reported; This spontaneous report was received from a physician referring to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.}  On 05-JAN-2021, a nurse inadvertently gave a dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter (additional dosage regimen information was not reported) for prophylaxis. It was mentioned that the physician ordered an hepatitis B vaccine, however, it was not reported that the patient also received this vaccine.
Pt. states that after receiving the 1st dose of Phizer 09/15/2021, started experiencing symptoms 20mins 09/15/2021 of whole left side feeling of "pens & needles" continuously, right side of the body will have the feeling of "pens & needles"  randomly. Neurologist appt. 09/20/2021 (estimated) no recommendations/ more testing (Cat-Scan). Still continuing to experience symptoms. Neurologist appt. 10/20/2021
approximately 5 minutes post vaccine pt reported feeling tachycardia and bilateral hands tingling. HR noted to be 117 -122, BP 125/79 RR 16 NAD, Lungs CTA bilaterally no wheeze, neck: no stridor, no oral changes. Pt HR 92 after 10 minutes, and reported resolve of symptoms. Pt monitoring extended for a total of 1 hour, no recurrence or progression of symptoms. discussed use of Epi, pt has own epi pen on hand. Pt to discuss with allergist tomorrow, will use Epi if needed as discussed, and instructed go to the ED if any progression of symptoms
Fever, 101.2 (by oral thermometer). Lasted about 12 hours. Fever broke and I felt fine. I also have some soreness in the shoulder, around the site of the injection.
TC from mom had 1 bump or 2 on face a/got shots, now has more bumps; start out as red bump then look like blister then pt scratches them open & now are raw; itchy;
Patient reported redness all down her arm and up around her shoulder and collar bone. She reported arm pain that slowly got better over time, but is still present. Redness has resolved.
Day 1--2: Fatigue, shivers, fever. Day 3: Localized macular hive like rash below the injection site, extending to lower upper arm (above the elbow). Mild itchiness.
uncontrollable shivering/convulsions to the point that my muscles started cramping and were sore the next day  difficulty breathing and hyperventilating  night sweats, vomiting (1 time), confusion, body aches
Ant rash slightly raised face; mild pink rash arms, legs, upper back; abd not raised; no edema or redness at site of immunization. Slight temp. 99.6. Referred to see physician for rash, no other symptoms. Went to follow-up physician on 4/24/06.
Diagnosed with Diffuse large B cell lymphoma January 2022.  Presented with constipation in December 2021; subsequently mass was found in abdomen.  Physicians estimated it had probably been there for 3-6 months at that time.   Note first covid vaccine 4/2/21, second 4/23/21, and third (booster) 11/10/21.   Treated with 6 rounds of R-CHOP chemotherapy with complete response.  Patient doing well currently, being monitored but unsure whether to receive further covid vaccinations. (Note: In May 2021 (just prior to final round of chemo), contracted covid illness.  Treated with Paxlovid, responded, but then had rebound sx.  Reported rebound to Pfizer and they responded by wanting to investigate possible relationship between vaccine and lymphoma.  Now reporting to VAERS as well. I am also a retired physician as well as being the patient.)
little bit of pain, 2 inch diameter, at the injection site; And just a little sort of fatigue. Like I got a kind of tired that afternoon.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Nov2020 (unspecified if ongoing), notes: they tested positive for Covid in Nov. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "little bit of pain, 2 inch diameter, at the injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "And just a little sort of fatigue. Like I got a kind of tired that afternoon.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A (Age: 69, Unit: Unknown) male nurse reported for two patients (Himself and his wife). This is 1st of two reports. The caller stated he got the first dose of the vaccine on 22Feb2021 and was due for the second on 15Mar2021. He stated he didn't seem to have a side effect other than a little bit of pain, 2 inch diameter, at the injection site. He didn't feel anything at all. And just a little sort of fatigue. Like he got a kind of tired that afternoon. He stated many people over 70 told him that they had many more symptoms after the second than the first.  No follow-up attempts are possible. No further information is expected.