chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown. No concomitant medications were reported.No treatment medications were reported.
I had a possible ranula occur 17 days after the second covid dose. Im not sure this was in fact related to the vaccine but the timing is close and i never had any ussues of this kind in the past in general or to any other vaccine.
Vaccine inadvertently given to 22 mo. old infant, outside of indication of age 9 y and up. Also given with other vaccines at the same time- PEDIARIX, Hib, PCV13 - baby had some mild fussiness overnight, slight tenderness at imm. site as per mom.
No ADR yet. Patient got 1 ml instead of 0.5 ml (Vaccine error)
After 1st dose had 24 hours of headache, fatigue, aches and very sore arm. Lymph node under arm swollen for weeks.   After 2nd dose started with brain fog, woozy, aches and joint pain, then severe chills, fever, exhaustion and significant gas pain in chest for about 48 hours.  Tylenol taken for 24 hours.
Paralysis of right upper extremity for 1-2 days after vaccine given and rash on chest wall. Rash persistent 3 days after vaccine given.
This spontaneous report was received from a medical assistant referring to a 66 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 22-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly, lot # L031459, expiration date on 30-APR-207 (strength, dose number and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved.
My symptoms began that night approximately 5Pm with severe body aches, a fever 101.6, shaking, tachypnea, a pounding heart rate, and swelling at the site. For the rest of night I felt quite terrible and the next day I felt similarly but with a temp of 100, and less vital sign related symptoms. Around 5 PM on 2/7 I started feeling better and my body started responding to Tylenol. The swelling persisted. I marked the erythema  and measured it as 6 inches of swelling at 9PM, 7 1/2 inches by midnight, and this morning it?s 8 inches at 8am.
After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Administration Error - Patient received 1mL dose instead of the intended 0.5mL dose.
Received 1st dose Moderna at 2:10pm on 3/29/2021.  Five mins later stated she had increased saliva, nose running and trouble swallowing.  Throat scratchy and began to cough. gave one dose of epinephrine 0.3mg via pen. Called EMS at 2:45pm.  EMS evaluated and her symptoms were improving after epi. (She did not require a second dose).  By 3:00pm she felt well enough to drive home and was released.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that Number of doses vials were 4 vials (15 dose) given for 44 patients. and date the vial was initially stored in the refrigerator was 24Sept2021. No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a nurse refers to  an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
My arm got really swollen and sore. Bright red around injection site, was very painful. I got 4 painful sores that got real itchy if they got too warm - was sick in bed for two days (just felt too crappy to be up). Injection site still al little discolored and peeling.
Patient c/o of rash on lower arm. Sensitive to touch, warm H2O, etc. Telephones her MD: Recommended BENADRYL Cream; F/U w/pt on 12/2/14 - condition still present but decreasing.
First vaccine and had side effects of headache, nausea, muscle ache, chills and 100 deg F fever for 8 hours within 30 hours after the shot in the arm.  Local soreness in the arm from the shot is still going 48 hours later otherwise all other systems have passed this morning the second day after receiving the shot.  I also tested positive for Covid on November 30, 2020 and had the same effects for 3 weeks with it then.
01/07/22: FEVER, COUGH, HA, ST, MUSCLE PAIN, POSITIVE STREP.
This spontaneous report as received from a physician assistant refers to the around 13 month old son. On an unknown date the patient was vaccinated with (merck) VARIVAX 1350 U (lot#, dose unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, 5 days later after vaccination, the patient experienced a rash developed on unspecified leg. The patient did not sought medical attention. The outcome was unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information is not expected.
Patient noted on vaccine administration record, a previous reaction after vaccine and she stated her mother told her to "to always bring a companion for vaccinations". I asked her to further expand on her reaction and if this was her first shot, she explained she may faint and this was her first flu shot. I requested she sit for the vaccine and stay seated for about 15 mins or more after so I can monitor her. I gave her flu shot and she seemed fine but within 2-3 mins she asked her friend for water because she was feeling odd, in which her friend swiftly went to store for ice water. When i came around the counter to observe her she had fainted in a seated position over the consultation counter, eyes rolled back and unresponsive. I immediately called 911 to explain the situation and while on phone with 911 she regained consciousness and  I asked if she wanted to go to hospital via ambulance. She declined, stating she was coming back and reassuring me she was going to be okay. I hung up with 911, she drank the water and I fanned her with clipboard. She sat for an additional 30 mins until she was okay, I continously asked if she was feeling better and to contact us if she had any concerns.
FEELS HOT/COLD; ARM SORENESS; NOT FEELING 100 PERCENT; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: UNKNOWN) dose was not reported, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced feels hot/cold. On 21-NOV-2021, the patient experienced arm soreness. On 21-NOV-2021, the patient experienced not feeling 100 percent. On 21-NOV-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feels hot/cold, and arm soreness, and the outcome of not feeling 100 percent was not reported. This report was non-serious.
The patient did not have his card.  The dose from May 11, 2022 was not in the computer.  Only 1 dose was entered, so this was thought to be the 2nd.  The patient actually already had 2 doses and this was the 3rd, so given too soon.  He is in the jail and has been monitored.  He did not have any reaction .
The days after I had the shot my left arm was sore, it was hard to raise it. But 10 days after I got the vaccine, I started feeling discomfort near the injection site, the skin there is very tender and warm. I also felt a lump under my armpits, my lymph nodes are swollen.
No adverse Event occurred.  Patient was in study for the Astro Zeneca Vaccine Trial and received both doses of the vaccine to the best of her knowledge.  She is still in the study, She had minimal reaction from the Astro Zeneca.  She chose to be revaccinated, after being informed that she DOES NOT NEED to be revaccinated, but it was not a contraindication and that we have no data on possible adverse reaction.  Her reason for this is to have documentation.
6-10 Red, raised, very itchy bumps. One on neck, all others on torso. General malaise, sore throat, runny nose.
6 year old male patient who was administered 0.3mL of the undiluted Gray cap vaccine; Sore arm; Nasty cough for 7 days; Sore throat for 4 days; Headaches for 3 days; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 6-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 0.3ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE , outcome "unknown", described as "6 year old male patient who was administered 0.3mL of the undiluted Gray cap vaccine"; PRODUCTIVE COUGH , outcome "recovered", described as "Nasty cough for 7 days"; OROPHARYNGEAL PAIN outcome "recovered", described as "Sore throat for 4 days"; HEADACHE outcome "recovered", described as "Headaches for 3 days"; PAIN IN EXTREMITY outcome "unknown", described as "Sore arm".  Additional information: Patient Age: 6 years. Reporter Subtype: Pharmacist. Consumer is asking for the recommendations on the administration of an adult COVID Vaccine to a pediatric patient. They had a 6-year-old male patient who was administered 0.3mL of the undiluted Gray cap vaccine. She mentioned that the patient's grandmother reported him to have been having a nasty cough for 7 days, sore throat for 4 days, headaches for 3 days, and a sore arm. The information on the batch/lot number for (BNT162B2) has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per client 1 week after receiving  Pfizer Covid vaccine (lot# EW0191), had one episode of palpitations. Client denied shortness of breath or chest pain at this time. Client reported palpitations lasting seconds and resolved on its own. Per Mother did not give medication or consult with medical provider. Per Mother no medical history, current medication is daily vitamin and no known allergies.
Abdominal cramp; Had sore arm; This is a spontaneous report from contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, Yesterday evening patient received second dose Pfizer vaccine and patient was just concerned about some of the symptoms patient was experiencing when patient received first vaccine and all had was a sore arm, it was a little sore for two days and that was it like, said patient received second dose last night and patient arm got a little sore few hours later and now experiencing a little bit of abdominal cramp patient did not experience that last time and patient was looking on the list of side effects and patient did not necessarily see that and patient just wanted to make sure was that a normal reaction. Consumer stated, his/her vaccination card did not have it and it did not have any barcode on it. On an unspecified date, patient experienced abdominal cramp and had sore arm. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
I received my booster vaccine on 09/2021. I began to experience back pain in April 2022. I thought that it was due to a fall. I went to my Physician and was found to have a compressed vertebrae. I was Dx with Singular Myeloma and am currently in treatment.
Breakthrough case admission after two vaccines ; Pfizer x2; Pfizer 10/5/21 Lot# FF2589;  Pfizer 5/3/22 Lot# FJ9943
Menstrual bleeding in middle of cycle.  I have never had menstrual bleeding in the middle of a cycle.  My cycle is always 28 days.
Soreness at site of immunization later that day, Following day fever that reached 101.6, tiredness, and vomiting.
1st doctor's appt. 25apr2021/Thrush fungal -redness and irritation and went into my saliva glands. It came back in May. Using mouth washes. Middle sept in got bad. White mouth sores with white coating. got a prescription and got refilled and went back this week with different prescription.
The first vaccine dose triggered severe migraines 5 days after injection. These continued daily and switched over to cluster headaches into and passed the second vaccine dose. Headaches occur daily, at random times (unlike my regular headache cycle) and last for hours. The worst was 12 hours.
Pt rec'd HIB and pneumoncoccal vaccine at clinic on 1/11/21 on 1/12/21 he developed a maculopapular rash and was seen at this clinic for evaluation I do not know the manufacturer or information for the vaccines
Muscle aches & pain, muscle fatigue, severe headaches, nausea, sore arm at sight
Following my second dose of Moderna I have had high blood pressure and have been treated with HCT. On Sunday Feb 6th I experienced a spike in blood pressure, with chest tightness, difficulty breathing and nausea. All symptoms gradually subsided over a few hours.
11/13/21 presents to EC ED for "worsening shortness of breath, fatigue, leg pain" "fever with cough". PMHx "obesity, CAD" "nicotine use, HTN, diverticulitis, NSTEMI"
Sore arm immediately after injection... spiked a 102 degree fever around 4am the following morning, approximately 12 hours after injection. I  had chills all day and continued to have 100-102 fever throughout the day. Nausea started later in the morning. Muscle aches all day with the fever as well as a Headache and slight dizziness.
Pt started to become irritable and inconsolable around 6:30pm.  She would not eat, nor cooperate or listen to direction. Shortly following a "melt down" she fell asleep on the couch.  A few days later, on the morning of 11/26/2009, she exhibited a red rash on her face looking similar to sunburn.  Ever since that morning, she has had the rash and still has it today.  It is exacerbated by touch or activity.  It is present every day.  We've visited the doctor and they cannot explain what it is.  As a result, she has not received any treatment for it.
Received 1st GARDASIL inj 3/4 arm has been sore since, noticed lump 3/9 - tender when trying to exercise pt informed to call Mon and make appt if not better or sooner if nec. 3/12 pt called with numbness in arm instructed to go to ER - seen in ER 3/12 made appt to be seen in office for follow-up 3/12/10 pt called and cancelled appt she made.
Initial report was received from a health care professional on 15 November 2011. An 11-year-old male patient with no reported past medical history had received on 11 November 2011 an intramuscular left arm injection of MENACTRA, lot number U4243AA and an intramuscular left arm injection of ADACEL, lot number U4137AA (sanofi pasteur ltd lot number C3990) and unspecified amount of time later, experienced injection site reaction of red, warm and tender to touch. The patient developed blisters around the site and a streak down the arm. The patient was diagnosed with cellulitis. Treatment included antibiotics. Concomitant medications were vitamins. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Approximately 14 days after receiving Varicella vaccine patient reports chicken pox outbreak on body.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jan2023 as dose 4 (booster), single (Lot number: GJ6796) at the age of 54 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 21Apr2021 as dose 2, single (Lot number: FR8735), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anxiety induced High BP" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "allergies to food and medications" (unspecified if ongoing); "allergies to food and medications. Sulfer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies to codeine"; Erithmycin, reaction(s): "Allergies to erithmycin"; Epinephrine, reaction(s): "Allergies to epinephrine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of Covid-19 from 03Nov2023 to 07Nov2023.  Based on Investigational results for Batch/lot number FH8028 and EP7534: The complaint for lack of effect of the Pfizer biontech Covid-19 Vaccine lot FH8028 and EP7534 were investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, fill lot FH4341 and the bulk formulated drug product lot FH4347. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366134 Same patient, different drug/events;
First 24 hours pt. had severe sore throat, could not swallow, no rash or hives experienced. After 8-10 hours symptoms improved. Pt. also experienced chest pains, chills, nausea, headache & malaise.
Tooth ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Tooth ache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TOOTHACHE (Tooth ache). At the time of the report, TOOTHACHE (Tooth ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included consulting dentist.   Reporter did not allow further contact
Pediatric/Adolescent Hep A (HAVRIX) dose given. Adult dose should have been given. Pt to return to health dept. in 1-2 mths to receive a 2nd dose of Pediatric/Adolescent Hep A (HAVRIX) to complete the series. Pt. will not be charged for this visit. Pt. verbalizes understanding & will make appt.
No adverse effects; a 19 year old patient received a pediatric/adolescent dose of VAQTA; This spontaneous report has been received from a physician via field representative referring to a 19-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.             On 21-AUG-2019, the patient was vaccinated with a pediatric/adolescent dose of hepatitis a vaccine, inactivated (VAQTA) (strength: 25/0.5 (unit not provided); dose, route, lot number and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No adverse effects were reported in the patient. No product quality complaint (PQC). No other information was available.