chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient did not have an adverse reaction but received a vaccine outside recommended temperature storage conditions.  The vaccine was supposed to to be moved out of the freezer into the fridge on 09-30-21 and was not moved until 10-09-21.  The patient was given the vaccine in error due to overlooking the dates.
Full body rash with burning sensation; Full body rash with burning sensation; This is a spontaneous report from a Contactable consumer (patient) or other non HCP.   A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration DOSE 2 SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration at DOSE 1 SINGLE for covid-19 immunization. After 3 days post second dose, patient experienced full body rash with burning sensation. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Lump on the arm; Itchy arm; "8-day COVID arm; Red arm; HYPERSENSITIVITY REACTION; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm), VACCINATION SITE ERYTHEMA (Red arm) and HYPERSENSITIVITY (HYPERSENSITIVITY REACTION) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 004M20A) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concurrent medical conditions included Diabetes (DIABETES TYPE 2) since 1998 and Blood pressure high since 1998. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), SERTRALINE HYDROCHLORIDE (ZOLOFT), BUPROPION, SIMVASTATIN, RALOXIFENE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), COLECALCIFEROL (VIT D [COLECALCIFEROL]), AMLODIPINE, EMPAGLIFLOZIN (JARDIANCE), ASCORBIC ACID (VIT C), VITAMIN B COMPLEX (VIT B COMPLEX), CALCIUM and ZINC for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm), VACCINATION SITE ERYTHEMA (Red arm) and HYPERSENSITIVITY (HYPERSENSITIVITY REACTION). On 06-Feb-2021, HYPERSENSITIVITY (HYPERSENSITIVITY REACTION) had resolved. At the time of the report, INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm) and VACCINATION SITE ERYTHEMA (Red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Lantus insulin .  NO TREATMENT DRUGS WERE USED.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADR form addedPATIENT DETAILS WERE ADDED.EVENT WAS ADDED OUTCOME OF EVENT
Information has been received from a registered nurse referring to five patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 19 year old patient. On 31-AUG-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
Began with scratchy throat and chills. Took temp and it was normal. Returned to work and was working on case notes and noticed joint pain. Left for the day and tested positive for COVID-19. A couple hours after testing positive had 103 temperature and the body aches where extreme. Called PCP and was prescribed PAXLOVID. After beginning PAXLOVID noticed improvement in symptoms. Had mild cough and asthma bothered me some during this time. At onset of fever I began noticing heart palpitations and felt them for about 10 days. Took about 2 weeks for symptoms to completely resolve.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: STATING THAT SHE WAS BLANKING ON HER WORDS AND HER FRIEND NOTICED IT WHEN SHE WAS ON THE PHONE WITH HER -Mild, Systemic: Weakness-Mild, Additional Details: CALLED TODAY 05/21/2021 @6PM EST AND SHE STATED SHE FEELS FINE TODAY BUT HAVE ITCHINESS WHICH HOSPITAL PRESCRIBED BENADRYL TO HER, DISCHARGED TODAY IN AM
The parent gave the wrong birthdate for this patient, erring on the side of making him appear older than 16. The patient's mother verbally confirmed the (wrong) birthdate. The patient came in with a letter signed from his pediatrician stating he should get a COVID-19 vaccine as soon as possible. Insurance caught the error in the birthdate. Despite this being fixed, the vaccine was given in error. Consistent with CDC guidelines, the patient was not scheduled for his second dose until he is over the age of 16.
PATIENT HAD COVID VACCINE ON  Dose 1 date:01/21/2021, Dose 2 date: 02/11/2021, AND TESTED POSITIVE TOCOVID.
This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) (seriousness criterion medically significant), NODULE (NODULE ON BIG TOE), HERPES ZOSTER (Shingles) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER). In August 2021, MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER) was resolving, NODULE (NODULE ON BIG TOE) had not resolved and HERPES ZOSTER (Shingles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The reporters causality for the event of nodule on big toe, did not feel well, shingles, shoulder pain/hurt shoulder, rheumatoid arthritis flare ups and worst pain with Humira was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sitting in waiting room- starting feeling "like I'm going to pass out." Pale and sweaty. Patient laid down for app. 15 min. Felt better. Did state she had not eaten this AM.
Patient received vaccinations in morning at clinic. Went home and napped longer than usual. Upon awakening, patient soon appeared ill, started staring off into space, had frothy saliva, lips turned white, appeared as through he was choking/suffocating. Mom had difficulty arousing him, but after several minutes, patient cried. Brought to hospital via EMS. Seemed more lethargic than normal. Recovered without sequelae.  Nurse follow up on 07/30/04 states: "cyanosis; increased salvia; irritability; decreased appetite."
She got her vaccine, it hurt more and thought it was due to the vaccine.  The pain was more painful than the first shot.  She did the exercises that she did with the 1st one.  It hurt way more, and the pain has gotten worse and when reaching behind her is excruciating painful or raising her arms above her head to get dressed .  It radiates from vaccine location up through the shoulder and sometimes down her middle finger.  It always hurts and it radiates from the injection site itself and makes her shoulder and movement hurt.  The arm is significantly weaker now, and sometimes when picking up things she cannot lift them.  It also feels a little bit numb, and prior to the vaccine she did not have any problems.  This happened immediately after receiving the vaccine, and it still radiates from the same spot.  She believes that it was the administration of the shot but not the vaccine itself.  She believes that it was too high on the shoulder itself since the pain radiates from that location.  Her should still has the ongoing pain and has nights were she cannot sleep as she cannot lie on that shoulder.  She props her arm up on a pillow and is able to get some relief.   She has to bunch up pillows on her head to be able to lie on her shoulder to sleep.    She did receive her 3rd booster yesterday and a flu shot and showed the lady where she got her vaccine, and she informed her that it was too high for where she got the 2nd vaccine.  She did not have any problems with the 1st vaccine location other than soreness and tiredness.   The pain from the 1st one was gone within a week.   She just wants the pain to go away and does not want to go into debt due to this.  She does take Advil on a regular basis and throbs very badly and at times this does not help.    She did not go as she was afraid to get COVID as her county has 32% for several weeks.  Her insurance will not cover her PCP at this time, but will after the 1st of the year.   She got her 3rd booster yesterday 10/18/21, Pfizer left arm, Lot#30155BA.
Site: Pain at Injection Site-Severe, Additional Details: Report initiated by District Leader. Patient reports bursitis following first in series of Moderna COVID 19 vaccine with ongoing pain in bursa. District Leader will follow up with patient.
january  13 around the evening, i felt my left side of my face droopy, eye twitching, nerve pulling,  numb and not moving at all.  i went to urgent care and then i was sent to the hospital. i was diagnosed with bells palsy and was given treatment.
heart racing; hyperventilation; shaking of arms and legs; panic attack; Faint after covid vaccine on awakeing,Vasovagal, Passed out; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Allergy to peanuts and tree nuts).   On 27-Jan-2021 at 10:29 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) (seriousness criterion medically significant) and PANIC ATTACK (panic attack). On 27-Jan-2021 at 10:29 AM, the patient experienced HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs). On 27-Jan-2021 at 10:40 AM, the patient experienced PALPITATIONS (heart racing). On 27-Jan-2021, SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) and PANIC ATTACK (panic attack) had resolved. At the time of the report, PALPITATIONS (heart racing), HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 148/88 mmHg (High) 148/88. On 27-Jan-2021, Heart rate: 100 (normal) 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitantly the patient was taking medications for birth control (unspecified).  The patient received treatment with oxygen via NRB @15L.  It was reported that patient approximately had 3 episodes. She reported no loss of consciousness and no loss of bladder or bowel control.  Patient used pulse oximeter  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up serious event updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298672 (same reporter). This case involves a 32 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via intramuscular route in hip on 25-Oct-2018. The date of last menstrual period was 08-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose and Inappropriate age at vaccine administration. It was reported that inadvertently administered FLUZONE HIGH DOSE who was less than 65 years of age. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Pt. had itching, redness and 2mm welps body wide. Symptoms were ongoing. Took pt. to Emergency Room.
I was at home with my family I passed out twice, they called the ambulance, they took me to the hospital. I was not really coherent they did different tests and they found I had blood clots in both lungs and the left calf of my leg. This was Saturday and they started me with blood thinner and oxygen, I stayed for 48 hrs. on bed, I stayed until Thursday. Next week I will get scan to see if the blood clot is gone. They sent me to a hematologist for my blood check. They found that my Factor 8 was elevated.
Initially had itching about 10 minutes following injection, at the injection site. About five minutes following that, developed mild itchiness in the ears, roof of  mouth.  Never experienced difficulty breathing or swelling of face or throat. Checked in with table monitoring the clinic, described symptoms and was advised to take Benadryl and report to an ER if symptoms worsened.  Took 50 mg of liquid Benadryl  as soon as I got home around 6pm and again the following morning and evening.  Injection site remained itchy until 1/31/21 and began to subside.  Mouth then erupted with ulcers and tingling beginning evening of 1/31/21 into 2/1/21 and some minor tongue swelling.   When I arrived at work I asked one of the physicians to take a look and tell me what their thoughts were. They were not sure. I was  then advised by my Supervisor to notify employee health, which I did with my supervisor present. They recommended to fill out an RL 6 form and seek medical treatment if necessary.   I began taking Claritin, Allegra and Pepcid in case this was continued reaction.  I messaged PCP to get their thoughts, but they were unfamiliar with what different side effects of vaccine are or how to proceed.  I did rinses and mouth care to treat ulcers which have begun to subside as of 2/9/21.  Advised to report as no one seems to know if this is something brought about by immune system.  Employee health recommends seeing immunology in case of needing to receive vaccine in future, which I do intend to get again if it is required annually.  Have not seen anyone yet.
pt presented with SOB, HA, non-productive cough, anorexia, weakness x 5dys; positive for COVID; dx with COVID pneumonia; started on decadron and remdisivir; given monoclonal antibodies; hx of HTN; went into septic shock, hypotensive despite vasopressor treatments; pt expired in the hospital
admitted for acute hypoxic resp failure 2/2 covid 19 pna (jan 7-13, 2022)
(5/26) received 2nd covid vaccine at facility.  Woke up on 5/27 feeling bad, left arm sore with the feeling of a tennis ball in my left arm pit (axilla) and sore or tender to touch.  On (5/27) evening slept all night with left arm elevated on pillows.  (5/28) Went to Urgent care /known side affect symptom (lymphadenopathy in left arm axilla d/t covid vaccine #2). When asked what I could take as pain tablet; Ibuprofen was recommended d/t trx of inflammation.  As you can see from my date of vaccination, I have been reluctant to get this vaccine d/t side affects and my own known medical history. To my knowledge, i have not had Covid  and have always worn a mask.  So here I am.....
6/28/10 received vaccines and on 7/2/10 tiny red dots started on right thigh, then became reddened and swollen warm to touch 7/8/10. No fevers noticed. Per mom 7/9/10.
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Fever-Mild
Lethargic, Nausea, Difficulty with hearing, decreased LOC and Blurry vision
Weakness; Severe diarrhea lasting for two and a half days; Severe fatigue; Heaviness of limbs; Severe itching; Redness; Swelling on upper back; This is a spontaneous report from a contactable consumer (patient). A 56-years-old nonpregnant female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 16Apr2021 03:00 (at the age of 56 years old) as single dose for covid-19 immunisation. Medical history included, sleep apnoea syndrome, depression from an unknown date and unknown if ongoing. The patient had seasonal allergies, Pine tree allergy, seafood sensitivity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included Wellbutrin, celexa, levothyroxine, Diuretic taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6208) in left arm on 25Mar2021 03:00PM (at the age of 56 years old) for covid-19 immunisation. On 16Apr2021 12:30 , the patient experienced severe itching , redness , swelling on upper back. severe fatigue, heaviness of limbs on 16Apr2021 18:30. Weakness, severe diarrhoea lasting for two and a half days, on 17Apr2021 10:30. Benadryl were taken as a result of severe itching. The outcome of severe itching, redness , swelling on upper back, Weakness, severe fatigue, heaviness of limbs was recovering and diarrhoea lasting for two and a half days was recovered.   No follow-up attempts are possible. No further information is expected.
- Injection site reaction (erythema & itching). - Recommended topical hydrocortisone 1 % ungi avoid contact with children (immuno compromised ppl) - follow-up with MD if no improvement. Pt has appt in 2 wks.
arm pain; received the Pfizer vaccine as a 2nd dose today. It was later f0ound out that they received the Moderna vaccine as a 1st dose; This is a spontaneous report from a contactable+ Pharmacist. This Pharmacist reported for a patient. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982; Expiration Date: May2021) via an unspecified route of administration on 11Mar2021, left deltoid at 15:30 (age at vaccination 56-year-old) as dose 2, 0.3 ml single for covid-19 immunization and co-suspect covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 12Feb2021 15:30 (Batch/Lot number was not reported) to 12Feb2021 15:30, at DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced received the Pfizer vaccine as a 2nd dose today. it was later found out that they received the Moderna vaccine as a 1st dose (wrong product administered) on 11Mar2021, arm pain. The patient taking Covid 19 Vaccine for protection from Covid 19. The issue was due to a language barrier. Reporter was asked 3 times and they mentioned Pfizer was the vaccine they received. Reporter is asking for any recommendations regarding the situation. Reporter states the doctor is not the one who gave the shot, she was. Provides this as patients regular doctor. Reporter states the patient has been there 20-30 minutes and seems to be doing fine. Reporter states they contacted Moderna, and they said do not repeat the shot but to confirm with Pfizer also. Causality captured as confirmed and provided.  No follow-up attempts are possible. No further information is expected.