chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden pin in my shoulder and neck on the same side if my body as the arm I got the shot in. It has nit gone away with the use if motrin.
Narrative: Pt is a 74y.o. male who died on 04/29/2021 with h/o Polycystic Kidney Disease, ESRD on HD MWF, HFpEF (49% on 11/05/20), DM2 w/ neuropathy and retinopathy (legally blind), OSA (non-compliant with bipap), HTN, HLD, GERD, anemia of chronic disease, depression w/ h/o SI, cervical spondylosis, prostate ca (in remission), and lt distal supracondylar femoral fracture s/p fixation (11/2020), with very frequent hospitalizations over the past year related to complications of ESRD and non-compliance with dialysis. Pt received Moderna Covid-19 vaccination on 4/12/2021. Pt presented to the ED 4/24/21 from dtr's home c/o soa and chest pain x 3 hours. He was admitted for NSTEMI and PNA (w/ pleurisy). NSTEMI, hyperkalemia, and PNA. He developed hypoxia, hypercarbia, and obtunded mental status on 4/26/21, and was placed on bipap. Patient's hypercarbia and alertness improved, however he is now refusing to continue wearing bipap. Per renal team, patient's respiratory acidosis is not likely to improve with dialysis, as it is primarily 2/2 CO2 retention. Palliative medicine is consulted for goals of care discussion. Pt died on 04/29/2021 at 0436 with physician reporting in Death Note "Death was caused by: Acute hypercapnic respiratory failure". Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Superficial Ulcerative genital blistersand lesions; Superficial Ulcerative genital blistersand lesions; broken skin, painful; Superficial Ulcerative genital blistersand lesions; This is a spontaneous report from a contactable other healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, and COVID-19 (prior to vaccination). The patient had no known drug allergies (NKDA). The patient did not receive concomitant medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks. On 27Mar2021 at 12:00, the patient experienced superficial ulcerative genital blisters and lesions, and broken skin, which was painful and symptoms were started within 24 hours after the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of superficial ulcerative genital blisters and lesions, and broken skin, painful and included lab work drawn, assessment performed, and treatment given with unspecified prescriptions. The clinical outcomes of the events superficial ulcerative genital blisters and lesions, and broken skin, painful were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Exasperated my ADHD symptoms. The first dose, I could not process written words. My brain was foggy. I was forgetful. Anxiety significantly increased. Profusely sweating. All of these symptoms last for roughly three to four days. This has occurred each time I?ve received the vaccine and the booster.
mild lip and throat swelling 10 minutes after vaccination.  given IM epinephrine 0.3 mg in right thigh with improvement of symptoms transported to ER
chills; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer.   On 09-Mar-2021, 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 09-Mar-2021, the patient experienced CHILLS (chills). On 09-Mar-2021, CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are listed as thyroid medication, high blood pressure medication, and asthma medication.
injection site Soreness; Swelling at injection site; itchy; hot to touch- injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date 13th April 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling, injection site itching and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: Twenty four (24) hours after receiving a dose of Shingrix the patient reported to have swelling in arm, itchy, and hot to touch. At the time of this report, 3 weeks later the arm was still sore.
```This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Ten patients received BOOSTRIX that was exposed to temperature of 30.4F. Two lot numbers 3P9CL exp 15apr2016 or HM4FY exp 06dec2016.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old patient who was vaccinated with a dose of TENIVAC lot U5541AA in the left deltoid instead of ADACEL on 27-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. No adverse event reported. 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. List of documents held by sender: none.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Rash on stomach.-Mild
Daily headaches started which got progressively worse by August/September along with hip pain, slurring speech, mixing up words, short term memory loss, stumbling, falling, brain fog, confusion,
Initial reprot received from a healthcare professional on 28 June 2013. A 24-year old female patient had received an intramuscular dose 1 of MENACTRA vaccine (batch number: U4258AA and site of administration was not reported) on 28 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was 11 October 2013. At the time of the report, the patient had not experienced any adverse events. It was reported that patient was 'high risk' but did not have the reason why considered high risk. Concomitant medications and past medical history was not reported. Treatment for infertility was not reported. Documents held by sender: none.
I EXPERENCED MY THROAT STARTING TO SWELL SOON AFTER INJECTION AND A RASH STARTED TO DEVELOP FROM THROAT TO COLLAR BONES. I TAKEN BENADRYL TO RELEVE THE SYMPTOMS.
Information has been received from a registered nurse referring to a 48 years old female patient with hypertension. The patient had drug reaction/allergy to DEMEROL. Concomitant therapies included multivitamin, hydrochlorothiazide, fluticasone, and TRAZADONE (manufacturer unknown). On an unknown date, the patient's testing showed that she had no immunity to varicella. On 04-OCT-2016, for employment purposes, the patient received a dose of VARIVAX (lot #M005971, expiration date 02-FEB-2018; dose and route were unknown). On an unknown date in October 2016 following the vaccination, the patient experienced chickenpox. The patient did seek medical attention at an unspecified urgent care facility on 27-OCT-2016. No lab diagnosis was performed. The outcome of the event was unknown. The causality assessment was not reported. Additional information has been requested.
site became swollen & pimple like-arm swelled x2 nl size & painful;does not feel well;
On 9/19/02 patient spiked fever of 103F. Parents gave Tylenol and continues to do so. He does have 2 red spots on face and a few on his chest. Advised to call PMD.
13 1/2 cm x 7 1/2cm area of erythema & induration lt arm;
On 3/19 pt complained nausea, dizziness and sensation of string around top of head, symptoms continued on 3/21 pt became anxious and mentally slow. He went to primary MD was dx with poss inner ear problem and given medication. Symptoms continued and pt was referred to neurologist, pt continues to have same symptoms, is afebrile and to see neurologist on 4/8. Pt has history of TIA in 12/02.
Edema and induration from Deltoid to the proximal forearm. No evidence of cellulitis, vesicles or pustules.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 11:00 as dose 6 (booster), single (Lot number: GJ6665) at the age of 83 years, in left arm 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing), notes: Other medical history: glaucoma; "UTI" (unspecified if ongoing), notes: Other medical history: UTI; "low thyroid" (unspecified if ongoing), notes: Other medical history: low thyroid; "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Known allergies: contrast dye iodine" (unspecified if ongoing), notes: Known allergies: contrast dye iodine. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
5/30/21 - Patient woke up feeling chest pain that was localized to the left side of his chest, pleuritic in nature. The problems persistent despite trying medications like tums for heartburn. Pain improved at night but never fully resolved.   5/31/21: Patient continued to have chest pain and mother became worried and brought the patient to the urgent care
Day p/vax recvd pt c/o achy joint; later in day local react @ inject site noted; 5 cm area redness, hot to touch, tender, somewhat swollen; approx 2-3 days later arm became itchy, was gone approx 5 days p/first noticed;
Headache, muscle aches, trouble breathing, could not eat for 3+ days, had trouble walking. Because of the anthrax shot I have/had leukemia.  I ended up having a bone marrow transplant in Aug 2006 with the hope of going into remission.
I now have low potassium and magnesium since my vaccination. I saw online that there is a correlation between this and vaccinations. The second thing is that my cardiac issues have increased. I require surgery now. It is dilating the left chamber of the heart from severe regurgitation. I have been put on potassium. He can't put me on magnesium because it would be life threatening. I had a 4,000-dollar heart scan and have a follow up with another. I may have to have a camera put down my throat to see what is going on because the scan may not be showing. I will have to have surgery in the future because it is not curable. It causes fatigue, palpitations, cough, and unable to do what I was able to do before.
This is a 34 yo woman with history of multiple anaphylactic reactions in the past, last to honey 1/2021 and Pfizer vaccine 12/2020. Discussed risks, benefits, side effects possible with J&J vaccine and option of no vaccine. Patient selected vaccine. Had epi pens/albuterol with her. Vaccine given 6:10 pm; approximately 6:20 Patient feeling shaky. No skin, resp. symptoms. Moved to chair. Developed more shakiness, increased resp rate; no wheezing.
second dose was improperly stored and administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A Í¾ 20Sep2021) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (second dose was improperly stored and administered) 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Fever, severe muscle pain and body aches, severe headache, shortness of breath,  lightheadedness
I had a cough, sore throat, head sinus, fatigue, mild aches, and pain. I tested positive for COVID-19 at home. My doctor prescribed me Paxlovid, and it help.
Estimated date of delivery: 9/9/2021. Symptoms: Left side of neck feels stiff. Left side of face feels slightly numb. Left eye a little watery. Upper left arm sore. Mild-moderate fatigue. Mild headache. Nausea
swelling and discomfort of lymph nodes in armpit area under right arm; no treatment other than pain reliever minor fatigue
High dose of pediatric Pfizer Covid-19 vaccine  (20 mcg) was administered due to a failure to dilute the vial with 1.3 ml of Sodium Chloride prior to drawing up the dose. Mother was contacted and no adverse reactions are reported at this time. Per CDC guidelines, patient should be monitored for adverse events over next few days and 2nd dose is still recommended after 21 days as long as local and systemic side effects are not clinically concerning following the high dose. From a quality control standpoint, only the pharmacist may dilute pediatric Pfizer vaccine (and not an intern or certified tech immunizer).
lump on the top of her head the size of a 50 cent piece; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported on Sunday (as of 23Mar2021) she noticed a lump on top of her head the size of a "50 cent piece," which she reported to her doctor, who referred her to Pfizer. The clinical outcome of lump on the top of her head the size of a 50-cent piece was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Mom called our office 8/10/11 in the morning to notify us of patient's site reaction to his PREVNAR #13 reaction. He is presently better. Stated the redness on his arm was baseball-sized for approx 4-5 days. Denied signs, symptoms of infection or streaks. (R) deltoid.            us of patient's site reaction to his PREVNAR #13 reaction. He is presently better. Stated the redness on his arm was baseball-sized for approx 4-5 days. Denies signs, symptoms of infection or streaks (R) deltoid.
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center, stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 51 year old female states that she experienced "redness and swelling" which developed into painful itching and burning at the site of the injection (approx. 2 1/2" in diameter). At time of report, pt was experiencing nausea and vomiting, headache and was unable to "lift with arm". Pt has received influenza vaccine before without incident. She has not been ill. She has a positive history of allergies to "ivory dish soap", Codeine and Morphine. follow up #1 06/24/02: during internal auditing of all files, it was deemed necessaryto amend the report by updating the Adverse Event coding (Added Medication Error and Myasthenia; also re-ranked Adverse Events).
Patient has not complained of any adverse events; however, it was realized, after the fact, that the dose administered was expired.
The night after my first shot, I felt pressure on my lungs, It felt as if I had the onset of Pleurisy as I have had that issue in the past.  I figure I would wait to get it treated as it is not always picked up in the x-ray in its infant stages (based on past experience).  On March 2, the pain became unbearable and I went into a urgent care center to get an x-ray and something to help with my issue.  The urgent care did not take my x-ray they immediately sent me to the hospital strongly intimating that the problem was probably more serious than I thought.  I was in the emergency room, they ran tests and made me comfortable enough as they also gave me a ct-scan which is when they found the bi-lateral pulmonary embolisms.  I have since gone to my primary care physician and he directed me to a hematologist/oncologist.  The event was found to be unprovoked.  I am on blood thinners for 6 months.
p/vax pt devel hives over entire body & severe itching;tx w/epi & taken to ER & given DPH;
On 16Nov2021 I tested PCR Positive and had symptoms of covid; On 16Nov2021 I tested PCR Positive and had symptoms of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Mar2021 09:00 (Lot number: EL3247) at the age of 48 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 09:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "post exposure to my unvaccinated 11year old daughter" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Nov2021, outcome "recovered" (Nov2021) and all described as "On 16Nov2021 I tested PCR Positive and had symptoms of covid". The event "on 16Nov2021 I tested PCR positive and had symptoms of covid" and "on 16Nov2021 I tested PCR positive and had symptoms of covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive, notes: Nasal Swab.
Received flu shot at 10:20AM.  At 1:20 PM, I felt dizzy and nauseous, my lips were numb and swelling, as was the rest of my face. I drove to Urgent Care, where I was given prednisone and epinephrine.  I went home to rest around 5:00 PM. I felt better around 8:00 PM that evening.
stomach pain; Chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Severe dental pain (9/10) beginning several days after vaccination, affecting upper left and lower right molars.  Molar on lower right turned out to have an abcess, and required a root canal and crown.  Mild tooth ache on upper left continues at low level.  Immediate post vaccine course after 1st injection complicated by swollen and painful (injection) arm; after second vaccination - course complicated by pain in injection arm, fever to 104, myalgia and fatigue.
Localized erythema, bruising + induration 6-7 cm diameter on L lateral upper thigh
The patient had already had a flu vaccine this season on 9/8/2020 and the nurse who gave it did not see that he had already had one and gave him a second vaccine.
p/vax pt devel a vesicular rash w/more than one hundred lesions;reporter felt it was d/t wild type virus;
Hives of upper chest and upper back 24 hours after immunization. Started w/pruritus 12 hours after vaccine. No dysphagia or SOB.
Patient was administered Moderna booster shot (0.25 mL dose). Had previously received Pfizer series COVID vaccine. Patient is not 18 years old and is not authorized to receive any Moderna vaccines. Patient had fever 102.0 F., chills and body aches the day after vaccine and symptoms ended the same day.
Information was received on 14-OCT-2016 from a medical assistant who reported that multiple unspecified patients received either VARIVAX (confirmed lot no. M028553, expiration 07-JUN-2018) M004330, 26-JAN-2018; M009766, 23-FEB-2018; M017290, 07-APR-2018; M024683, 18-MAY-2018), or PROQUAD (confirmed M006107, expiration 01-AUG-2017; M007962, 15-AUG-2017; M017337, 05-OCT-2017; M029599, 10-DEC-2017) that were improperly stored. No adverse effects reported. All fields pertain to all unspecified patients and all products. No further information was provided. This is one of two reports. All telephone attempts to obtain to follow-up information on 05-JAN-2017 have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments:  US-009507513-1610USA008725:, MERCK 1610USA008744:Mfr number.