chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 19May2021 at 10:00 (at the age of 43 years old) as second dose, single for COVID-19 immunization in pharmacy/drug store. Medical history included grave's disease. The patient had sulfa drug allergy. Concomitant medications included levothyroxine and montelukast sodium (SINGULAIR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 26Apr2021 at 11:30 (at the age of 43 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive 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 was never tested for COVID-19. The patient experienced chills and headache on 20May2021. No treatment was received by the patient due to these events. The outcome of these events was recovering at the time of report.   Information on the lot/batch number has been requested.
I had a migraine that lasted about a week, body aches that lasted 2 days, vomitting that I couldn't stop and ended  dehydrated. I had a fever, and chills. I was giving IV's.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2020 and Environmental allergy. Concomitant products included LISINOPRIL for Hypertension.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs were reported. Vaccine expired  27-Oct-2021, It was properly stored.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: 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: (unspecified date) Positive; (29Dec2022) Positive, notes: Tested positive for covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: Patient did not received any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A vaccine administrator during a flu clinic for adults and children. A child under 18 years old received 1 dose of "Fluarix" meant for adults 18 and older in error.  No known adverse events.  No adverse event occured.  3-28-07.
Dizziness, light-headed 2:27 PM - states still has dizziness although reports that it has subsided - Mother called; states wants student to call grandmother for f/u if possible. Grandmother states to put on bus, mother ok with bus. 2:43 states feel better; back to class.
Headache: every morning I wake up with a headache goes away by the after noon  Increased fatigue: once in a while I?ll feel very lethargic   Muscle weakness: I notice that It takes a lot to do a simple task
red; itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), PRURITUS (itchy) and RASH (rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Mar-2021, the patient experienced ERYTHEMA (red), PRURITUS (itchy) and RASH (rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. On 26-Mar-2021, ERYTHEMA (red), PRURITUS (itchy) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving FLUMIST (intranasal). It was reported that consumer was administered expired dose which started on 27-Nov-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Chest pain when breathing. On the left side of chest  . This started 10 days after First vaccine shot. I consulted with my doctor. He told me to continue to take the second vaccine. I Started taking pain killers  to ease pain. After the second shot the pain within my chest got extremely worst. On 6/26/2021 I was rushed to the emergency room with  Excruciating chest pain making it extremely difficult to breath.
This serious initial spontaneous case was received from other non-health professional via Merck (other pharma) on 04-Sep-2017, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with influenza vaccine (dose, frequency, batch number, expiry date, manufacturer: unknown, trade name, route of administration and anatomical location: not reported). On an unspecified date, the patient had a several allergic reactions to the egg component of the vaccine. It was reported that, the patient got medical attention. At the time of this report, the outcome of the event was not reported. The reporter considered the causality between the event and suspect medicinal product (INN Flu Vaccine Seasonal) as related. Case comment: Due to missing information about exact time to onset, clinical presentation, medical history and treatment given, the causal role of suspect vaccine cannot be assessed. The company assessed the report as serious (medically significant).
Patient had an allergic reaction to the Zostavax. She had a rash all over her body.
edema around injection site; Delayed skin reaction; Erythema around injection site; Rash and hives on shoulder; Body aches; Low grade fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and PYREXIA (Low grade fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Low grade fever). On 15-Jan-2021, the patient experienced VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and RASH (Rash and hives on shoulder). At the time of the report, PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site), PYREXIA (Low grade fever) and RASH (Rash and hives on shoulder) outcome was unknown.        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.
Tenderness in armpit in the arm the vaccine was given; Possibly a lymph node reaction; This is spontaneous report from a contactable nurse (patient). This 23-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first single dose on 19Dec2020, second single dose on 08Jan2021, both intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included hc of SVT. The patient had no COVID19 before vaccination. The patient had no allergies. Concomitant medications included vitamin D, vitamin C and nylestradiol, levonorgestrel (ASHLYNA) for birth control. On 10Jan2021 at 08:00 the patient experienced tenderness in armpit in the arm the vaccine was given. The reporter was asking of a possible lymph node reaction. No treatment was given. COVID19 was not tested after vaccination. The events were resolving. Information on the lot/batch number has been requested.
rash on his leg and stomach; tired; This is a spontaneous report from a contactable consumer (patient) who reported events after second and third dose of the vaccine. This case is for event after the third dose.  A 71-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;; Lot number was not reported), via an unspecified route of administration in Arm Right on 19Oct2021 at 12:15 (at 71 years) as single dose for covid-19 immunization. Medical history included ongoing glaucoma (took 2 eye drops, unspecified drug) and had bee allergies and was desensitized years ago. Concomitant medication included atorvastatin taken for an unspecified indication, start and stop date were not reported.  Previously on 06Feb2021 (at 70 years) the  patient took first dose of bnt162b2 (lot EL9264) in the right arm for covid-19 immunisation; on 27Feb2021 (at 70 years) the patient received the second dose of bnt162b2 (lot EN6203) in the right arm for covid-19 immunisation and experienced tired. On 19Oct2021 the patient experienced tired; on 20Oct2021 patient experienced rash on his leg and stomach. The patient called his pharmacist and they said to take Benadryl so he did. No Emergency Room or Physician Office.Outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101410901 Same patient, same drug with different dose, different AE
She has light red circle where they gave her the shot; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced injection site redness.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a light red circle where she received the shot that was about 4-5 inches in size. Treatment information was not provided.  Action taken for the event was not reported.  The outcome of the event, injection site redness, was considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Ten days out from injection I developed a hot, red area at the injection site of about 3" with arm soreness (not quite as bad as after injection).  Two days from first noticing this it is still there, unchanged.    The day after the injection my arm was red, hot, hard and swollen with an area about  5".  This lasted for about 4 days.
@ 2:32  (10/12/35) Patient presented to the front desk with concerns about covid-19 vaccine side effects.  She received her first dose on 2/18 and did fine till 2/20 when she started having a red itchy rash that lasted two weeks.  I explained to her that that was one of many normal reactions to the vaccine.  I emailed her an article about it.  She then said she had nausea for two weeks and still has some but less intense.  She is seeing her PCP.  I found a CDC report stating nausea can be one of the side effects.  She stated understanding.  She will be going out-of-town and will not be able to get her second covid-19 vaccine until 4/13. CDC article I referred to re: nausea: Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Moderna COVID-19 Vaccine. Patient was given V-Safe information at the time of her first vaccine.  She said she did not use it because she is not tech savvy. The two weeks of intense nausea and still have some nausea now, though less intense is why the VEARS report.
Developed a rash, fever, conjunctivitis & cervical adenopathy 2 wks after vac.
"MODERNA COVID-19 VACCINE, BIVALENT EUA". It has been about 10 days and I still feel the effects of extreme fatigue. Starting from the beginning: (I received both the Influenza and the COVID shot; I don't have any paperwork with me identifying which Flu shot I received. So, I could not list it above in Item 17), so, the day I got the shots, I was fine, I didn't feel any symptoms. However, the next day I felt terrible with flu like symptoms (aching all over and back pain, etc.) this has been normal with all the COVID-19 shots but by the second day I would be completely fine. However, in this case, from the third day to maybe the 5th day, I had difficulty breathing, I was out of breath just barely doing anything, some chest pain and no energy and extreme fatigue, I just didn't feel good. Now it is just extreme fatigue and no energy.
Per (vaccine administration record) patient wrote DOB incorrectly, but when vaccine was entered in system it was found that the date of birth is different- Per System, DOB was provided by records. Therefore patient received both Moderna vaccines/doses under the age of 18 years old.  Per system- both vaccines/doses say "Not Valid".
Information has been received from a Certified Medical Assistant concerning a 14 year old female with no pertinent medical history who on 07-APR-2009 was vaccinated with the first dose of GARDASIL (lot#: 661952/1129X) 0.5ml IM left deltoid. On approximately 2.5 weeks after the first injection, it's approximately on 24-APR-2009 the patient experienced a rash on her back that was itchy and painful. There was no concomitant medication. The patient was seen by the primary care physician and was diagnosed with shingles. Patient did not express any concern or idea that the shingles was a result of the GARDASIL vaccination. The patient had no fever. The patient was placed on Valacyclovir hydrochloride, 500 mg, 3 times a day for 7 days (It was also reported that the patient was placed on Valacyclovir Hydrochloride, 500 mg, 2 three times a day for 7 days), experienced scabbing on her back. At the time of reporting the patient was recovering and no further information was available. Additional Information has been requested.
The vaccine that was administered was expired. I, RN, failed to waste/discard of the unused vaccines from Monday 08/23/21.
Achy body & bones, fatigue, fever, chills. Then started having excessive and breakthrough menstrual bleeding. Breakthrough bleeding continues randomly and repeatedly to current date. Contacted provider, stated she had heard of this happening, but it is only bothersome.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with the improperly stored doses of PROQUAD (Merck) injection (lot # L008354 with expiry date: 11-SEP-2016; lot # L010142 with expiry date: 24-SEP-2016; lot # L023112 with expiry date: 24-DEC-2016; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Patient brought to the ED by EMS on 12/15/22 for altered mental status, headache, worsening cough, shortness of breath, and generalized pain over the past few days. Prior to presentation, the patient's daughter found the patient unresponsive to questions, so she called EMS. In the ED, patient was found to be hypoxic in the 80s requiring 2L O2 by NC. COVID PCR test preformed in the ED also resulted positive. Patient was admitted 12/15/22 - 12/17/22 with discharge diagnoses including acute hypoxic respiratory failure due to COVID-19 pneumonia. During admission, she required up to 3L of supplemental oxygen, but was able to be weaned down to room air by discharge.
Patient wants to receive second dose (>35 days from first dose); This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)). On 16-Feb-2021, INTENTIONAL PRODUCT USE ISSUE (Patient wants to receive second dose (>35 days from first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication and cholesterol medication. Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event, Patient wants to receive second dose (>35 days from first dose), was not applicable.
Information has been received from a licensed practical nurse concerning her 25 year old female friend who on 18-MAY-2009 was vaccinated with her first IM dose of GARDASIL (lot # not reported), for an unknown reason.  The patient's relevant medical history includes an allergy to penicillin.  She has no relevant concomitant medications or past drug history.  On 18-MAY-2009, she received the first injection of the GARDASIL series in the right deltoid.  On 19-MAY-2009, she began to feel chest pressure, achiness in her neck and a slightly elevated blood pressure.  It is unknown if any relevant laboratory testing was performed.  On 19-MAY-2009, it is unknown if she will continue, receiving the GARDASIL injections, and her chest pressure and the achiness in her neck are subsiding.  It is unknown if her blood pressure remained elevated.  Additional information is not expected.
On day 8, arm was swollen, red, hot, itching, hurting. Rash on arm, on right torso under my right breast
Developed Sudden Constant Burning and Hypersensitivity to the Bottom Surface Entirely of Both of My Feet that will Not Subside. Pain is from tips of toes to heels and from side to side. Sometimes, There have been Multiple Tiny Lumps on the Ventral Foot Surfaces. Over the Counter Pain Medications Will Only Dull the Pain. It Never Goes Completely Away and Feet are Sometimes Red and Feel Hot. There is No Pattern of Increased or Decreased Severity due to Decreased or increased Activity or Exercise, Diet Changes, Alcohol or Caffeine Increase or Decrease, Heat, Ice, Physical Therapy or Massage. I have Never had Foot Problems Before.
PT STATING SEVERAL ABOUT 4.5 HOURS AFTER INJECTION, IS NOT ABLE TO MOVE LEFT ARM, CANNOT RAISE LEFT ARM. HAS BECOME IMMOBILE AND NOW BECOMING NAUSEOUS.
Information has been received from a licensed practical nurse (LPN) concerning a 4 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 23-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M019708 with an expiration date of 25-OCT-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Pt developed diffuse papular rash 9 days after vaccine. no other smyptoms.
Infant seen at ER-diagnosed Rosaelo onset Rash 7/28/00- Rash resolved by 8/12/000-Had overnight with private doctor. Cleared for immunization - up until infant received immunization on 8/21/00 increase temp 101 Aux on 8/21/00 received Tylenol. 8/22/00 temp 99 parent states he won't eat or drink formula-continues to cry. Infant has no appetite infant will drink water continues to cry- currently teething. Infant had appetite on 8/21/00 after shots, 8/22/00 won't eat.
Moderna 2/9/21, 3/9/21, 11/3/21. Positive on 7/19/22
patient received 1 dose on Kinrix vaccine in the AM and a 2nd dose of Kinrix in the afternoon.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number SAY2J, expiry date 10-JUN-2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS TOXOID, POLIO VACCINE, TETANUS VACCINE TOXOID (KINRIX).   On 07-AUG-2023, the patient received the 2nd dose of Kinrix (intramuscular). On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: patient received 1 dose on Kinrix vaccine in the AM and a 2nd dose of Kinrix in the afternoon.). The outcome of the overdose was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-AUG-2023 The reporter reported that the patient received 1st dose of Kinrix vaccine in AM and 2nd dose of Kinrix in the afternoon of the same day. The reporter did consent to follow up. The reporter reported that the patient received 2 doses of Kinrix on same day, which led to overdose.