chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site arm was sore; Terrible headache,Covid Headache; High Fever, Fever of 102 degrees Farenheight.; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site arm was sore), HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site arm was sore), HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches). At the time of the report, INJECTION SITE PAIN (Injection site arm was sore) outcome was unknown and HEADACHE (Terrible headache,Covid Headache), PYREXIA (High Fever, Fever of 102 degrees Farenheight.) and MYALGIA (Body Aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102 degrees Fahrenheit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 11 Mar 2021, lot number was 013A21A and did not experience any events after second dose. Patient drank a lot of water before the second dose.  Treatment medication was not provided by the reporter.
herpes-associated erythema multiforme; herpes viral gingivostomatitis; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included SARS-CoV-2 infection (Recovered).    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 ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) (seriousness criterion medically significant) and ORAL HERPES (herpes viral gingivostomatitis). At the time of the report, ERYTHEMA MULTIFORME (herpes-associated erythema multiforme) and ORAL HERPES (herpes viral gingivostomatitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  Company comment: This literature-non-study case report concerns a 40-year-old male patient with medical history of COVID-19 infection, who experienced serious (medically significant) unexpected event of special interest -Erythema multiforme and non serious unexpected event of Oral herpes. Reportedly, the patient developed herpes viral gingivostomatitis and herpes associated erythema multiforme following an unspecified dose of the mRNA-1273 vaccine. Temporal relationship between the reported events and vaccination remained unknown since no dates were provided. At the time of this report, the outcome of the events remained unknown. Recent COVID-19 infection remains a confounder. Case will be re-assessed upon receipt of full text article with more details provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dose number 1: 03Mar2021/ Dose number 2: 15Apr2021; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0162) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot Number: ER8730, Administration Time: 10:00, Anatomical Location: Left arm), administration date: 25Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose number 1: 03Mar2021/ Dose number 2: 15Apr2021"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue". Additional information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. After dose 2 Some fatigue a couple hours after the vaccine .This passed in a few hours No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101826755 similar report from same reporter
Headache, Myalgia, See below. Narrative: Employee emailed: ********************** "I received my booster Tuesday 9/28 . I was fine during the day , but as the day went on I started getting a little rundown. I went to bed early , about 7:30pm , but woke up about 9:30pm shivering. I put more blankets on and tried to go back to sleep. I was up and down all night , experiencing body aches , chills ,headacheand fatigue. I couldn't go in to work Wed or Thurs, the fatigue , body aches and headache lasted through those two days, but the chills went away Wed afternoon. "
Patient received above immunization on 7/14/2021 in error--had already received these immunizations on 1/7/2021.  Physician aware and informed parents as incident occurred during routine office visit.  No adverse outcome noted
Client is a 14 year old female who came in for her 1st dose of the Covid-19 vaccination. Client was scheduled for a Pfizer pediatric (5-11), which she was ineligible for. Client received the Pfizer pediatric (5-11) vaccine. Client's father was notified by vaccinator of the error @ 1610, before they left the clinic.
Dizziness, Headache, Pain in joints,chills, Pain at site, swollen and red
Numbness in both arms and hands....Tingling and pain both hands and arms....Symptoms began approximately 3 weeks after second shot (Feb 19, 2021) Treated  for carpal tunnel syndrome included cortisone shots in both hands and  surgery of left hand.  NO IMPROVEMENT.  Second EMG test , nerve conduction test by Dr.  on 11/02/2021 revealed only mild carpal tunnel and clinical observation revealed possible other causes including reaction to the Moderna vaccine.   X-Ray of neck  normal.   MRI of spinal cord is ordered but not scheduled at this time.
One week later, I have a rash at the injection site and itching this morning that is now a burning sensation. It is now red, spread over 2-3 1/2 diameter and feels warm to the touch.  Other than a very sore arm, I had not experienced any side effects but two days ago I felt like I was coming down with the flu.  I don?t notice that anymore.
Buzzing in my ears started May 9, 2021 that has been diagnosed as a form of tinnitus. My PCP referred me to an Audiologist who ruled out a brain tumor or any out medical condition that would need surgery or would be life threatening. A year later and I still have the buzzing in my ears that sounds like overhead powerlines crackling and buzzing.
1st shot in left arm-I had a red bump that was 3x3 inches and raised. It eventually went away after two weeks leaving behind a bruise. 2nd shot- right arm,by day two I was feeling flu like symptoms. By day three I was short of breath,dehydrated,experiencing rapid heart rate,fever,chills,shortness of breath,sweating,dizziness,migraines which last a week. The bad headaches continued for a month and my blood pressure went from normal to high. I had to go on blood pressure medication after having my vaccine. I still don't feel the same since being vaccinated. I feel fatigued all the time,I have edema, and suffer with chronic headaches.
The only immediate side effect I experienced was a slightly swollen and sore arm for approximately 2 days after dose one.  On February 14 a 2 inch by 1 inch red patchy spot appeared at the injection site.  It is warm to the touch, swollen and sore, but not as sore as the initial first two days.
Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 16Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, celiac and allergy to wheat. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine, estradiol (ESTRACE) and colecalciferol (VIT D3). The patient experienced low grade fever and fatigue for 4-5 days post injection on 16Jan2021 at 16:30. Patient recovered from the events on Jan2021 and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were reported as non-serious.  Information on the lot/batch number has been requested.
the patient got Fluzone HD on  10-27-2022 & swelling occurred on 10-29-2022, informed us on 10-30-2022 ,  only swelling a lot, but no itching no pain
third dose of Moderna COVID19 Vaccine; received the Johnson & Johnson vaccine on 28-May-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (third dose of Moderna COVID19 Vaccine) and INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson vaccine on 28-May-2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson vaccine on 28-May-2021). On 13-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (third dose of Moderna COVID19 Vaccine). On 28-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson vaccine on 28-May-2021) had resolved. On 13-Jul-2021, EXTRA DOSE ADMINISTERED (third dose of Moderna COVID19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also received the Johnson & Johnson vaccine on 28-May-2021  No concomitant medications information was reported. No treatment medications were provided.
red rash on left side of forehead that burns; red rash on left side of forehead that burns; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 15Apr2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer and allergy to sulfa and scallops. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 12:00, the patient experienced red rash on left side of forehead that burns. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with antiviral med Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red rash on left side of forehead that burns was not resolved at the time of this report..   No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a female child who was vaccinated with a dose of MMR II on an unspecified date. Subsequently the patient experienced encephalitis on an unspecified date. The outcome was not reported. Upon internal review, encephalitis was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Pt states, "8 days after I had vaccine, I felt a small bump on my arm and during the next few days it got bigger and hot, then started peeling and now scab.
Moderna COVID-19 Vaccine EUA Extreme Swelling of site area - softball size Site area Hot to the touch Fever of 101.7 Dizziness.
Shortness of breath and tachypneic before and after vaccine. BP 178/71, repeat 154/63. HR 75, then 54. Respiratory rate 30. Given albuterol, resolved.
This spontaneous report as received from a nurse refers to a group of patients of unspecified number and demographics. On unknown dates, those patients received doses of improperly stored vaccines: ROTATEQ (lot#L042216, expiration date 13-JUN-2017; lot#M016238, expiration date 07-DEC-2017, administered orally; dose was not provided). It was reported that the vaccines were improperly stored for one hour, in the temperature of 33 degrees Fahrenheit. It was reported there was no previous temperature excursion and it was not a case of a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006078: US-009507513-1702USA006079: US-009507513-1702USA005322:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No historical conditions, concurrent conditions or concomitant therapies were reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M038859, expiration date 14-SEP-2018, dose and route of administration were not provided) for prophylaxis. The vaccine was exposed to a temperature ranging from 6 to 14 degrees F for 1 hour and 8 minutes. This excursion was captured via a digital data logger. There were no previous temperature excursions. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Patient received her first Pfizer dose with no problems. She came back at her scheduled appointment for the second dose of Pfizer. She initially did well, but after 30-40 minutes the patient came back to the pharmacy complaining of chest pain and felt her throat was tightening up. She felt it was from the vaccine and not from any other reason. I asked her if I could call a paramedic and she declined. I asked about calling a family member/ friend and she also declined. I gave her 5ml of liquid Benadryl and asked her to continue sitting in the pharmacy.  After apx. 10-15 minutes she stated she was starting to feel better. I checked on her every few minutes and kept her in my view the entire time. After apx. 30 more minutes she stated feeling a lot better and wanted to go home. I again offered to call someone or call paramedics and she adamantly refused. I gave her some additional Bendadryl to take home with instructions to take 5 ml every 4 hours for the rest of the day. She left the store. After a apx. 5 minutes a technician went out to see if she had left. She spoke to the patient in her car and patient stated she was fine and heading home. She stated she could drive b/c she only lives a couple minutes from the store. I called the patient at home later that night to check on her and she stated feeling fine, and thanked me for checking on her.
pt recv vax; had urticarial rash & hives & wheel on lt arm where shot was given; tx w/ dph
fainted; broke a tooth; hit her head; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 17-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 17 years for covid-19 immunisation; influenza vaccine (FLUVACCIN), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH FRACTURE (medically significant) with onset 06Oct2023, outcome "recovering", described as "broke a tooth"; SYNCOPE (medically significant) with onset 06Oct2023, outcome "recovering", described as "fainted"; HEAD INJURY (non-serious) with onset 06Oct2023, outcome "recovering", described as "hit her head". The events "fainted", "broke a tooth" and "hit her head" required emergency room visit. Therapeutic measures were taken as a result of tooth fracture, head injury. Clinical course: It was unknown that patient received any other vaccines within 4 weeks prior to the COVID vaccine. 17-year-old adolescent had the Pfizer COVID and flu vaccination. She returned home where she fainted and hit her head and broke a tooth and was taken to the emergency room. Adverse event treatment: Stitches, tooth removal. It was unknown that that prior to vaccination, was the patient diagnosed with COVID-19. It was unknown, since the vaccination, has the patient been tested for COVID-19?: Unknown.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Become pale and faint 5 minutes after receiving his flu vaccination.  Placed supine with feet elevated to prevent injury. Vitals and neuros monitored.  Recovery time was 1 1/2 hours as he would became pale and dizzy when repositioned to sitting and standing.  He did not eat lunch prior to appointment so he was provided juice & crackers 1/2 hour into assessment.  Mother contacted his local physician and she stated Dr felt he was being managed fine and did not need to be seen by physician.  I followed up with father at 4:55 pm that day.  He reported patient was doing fine.  No further episodes of dizziness or apparent injuries.
No adverse effects reported; a 15 year old patient was inadvertenly administered an adult formulation dose of VAQTA; This spontaneous report was received from an office manager referring to an unknown gender 15 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-JUL-2019, the patient was vaccinated with an adult formulation dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml, lot # R027987 and expiration date 09-AUG-2019 (dose, frequency and route were not provided) for prophylaxis (incorrect dose administered). No adverse effects were reported.
Swollen and warm bump at injection side that developed into a large bright red, tender rash all over my deltoid
Approx 11:30 am, pt was administered MMR, IAPD, Hep B, Td. Pt waited 15 mins and then left the building at which time felt flushed, (+) erythema, poss resp difficulty and then RTC for evaluation.
Weakness, dizziness - significant, severe swelling that got larger to about 10" in the next couple of days, significant heat, sweating, headache, disorientation.
Patient was given the Pediarix vaccine (DTap-HepB-IPV) but she needed the Kinrix vaccine (DTap-IPV). So she did recieve an extra Hep-B vaccine. Patient did not have any adverse reactions or problems and mom was informed.
Pt experienced viral-like symptoms, vomiting 3-4 hours after injection, low grade temp, no shortness of breath, missed school one day.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004059: US-009507513-1809USA004061.
acute DVT on right and noted to have chronic DVT on left on 5/25/21
Presents with fever and nausea and vomiting. She was given sotrovimab.
Rash consistent with Henoch-Schonlein Purpura developed the next day.
Patient received a dose of Moderna but is not in the approved age group of 18 years and older.  She has not reported any adverse events from the vaccine.
No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 4 years-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 04-MAR-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005617:same reporter US-009507513-2006USA005620:same reporter US-009507513-1912USA001555:same reporter
Pt complained of pain/soreness as site on evening of 10/10/16. Pt complained of headache, neck pain, fatigue/exhaustion, achiness and photosensitivity since 10/11/16. Pt taking Ibuprofen and Acetaminophen prn.
Patient has had no adverse reactions.  Patient was mistakenly administered a 0.5ml pediatrics dose of Hep B  instead of 1ml adult dose