chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness; tingly; fever; headache; good quantity of the vaccine ran down the patients arm on to the floor; syringe came loss from the needle; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle) and HEADACHE (headache). On 14-Apr-2021, the patient experienced PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness), PARAESTHESIA (tingly) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medication included Women multivitamins, frequency 1 tab daily via oral route. Birth control pill frequency 1 tab daily via oral route.  No treatment drugs were provided.  Patient was treated for bilateral hand and feet cramping fever and stiffness with antipyretic fluid.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR form received included Patient demographic information. Information on suspect drug received. Additional events are added. Concomitant medication information added
On 5/14/21 patient began having high subjective fever and skin felt hot like a sunburn. Then, had rigors the same evening. On 5/15/21 patient began vomiting and continued to have subjective fevers off and on and associated sweats On 5/16/21 patient noticed that skin on legs were peeling while taking a shower. No other skin peeling, no swelling, no SOB, wheezing.  On 5/18/21 patient called office reporting this reaction and now clinically better. Fevers gone, no more skin peeling, energy level better.
One hour after second injection on 2/17, felt a little 'out of it', then redness at injection site. 3" by 4" area of redness, warmth, stiffness and soreness at shoulder.
approx 3 min after injection she felt hot, nausea, dizzy, flushed. We laid her flat on the bed and within 10 min she was ok. VS-137/95, HR-77, Sats-98% RA. She fully recovered in 10 min.
Patient received first Covid vaccine of Pfizer on 1/28/21, patient refused her second dose that was due in Feb. Patient received first dose of Moderna today 3/12/21, will she need a second dose? Any reactions?
Warm red painful tender (red at injection site 1" diam.) site is tender. Pt. adm. TYLENOL gave relief.
the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine; he tested positive for covid after being exposed to someone who was positive for covid; diagnosed with COVID-19 7 days after First dose of vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine), PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (the colonoscopy is a 5-year routine exam and had it 3 times in the past per the patient prior to Moderna vaccine). Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN, ATORVASTATIN, METOPROLOL and CLOPIDOGREL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine). At the time of the report, COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported that he went on to take regeneron monoclonal antibodies due to his age. He has beentold by his physician that he can not take the COVID-19 vaccine within 90 days of his regeneron medication.  No laboratory details was given. No treatment information was given.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up was received on 10-MAY-2021 which contained the contact information and second dose details of the suspect product were added.
Headache within 5 mins pain in L ear. On day 3 that radiated around head. Day 4 no control of movement of eyes L stuck open. Jerking on R side of body shaky hand R. Day 5 went to walk in Bell's Palsy DX. Droopy face pain in jaw L
COVID symptoms started on 03/24/22, tested positive with a home test on 03/25/22. I experienced a cough and my throat bothered me. I had exhaustion as the 2nd day kicked in and I felt lightheaded and strong body aches the 2nd night. That Thursday I had a mild fever as well as a headache, and on the 4th day I had more phlegm and a mild cough and started on MUCINEX and continued ibuprofen. Then, slowly all of the symptoms went away except the coughing episodes that would last for a few seconds and then go away. The last 3 or 4 days it was mainly pressure in my head and a mild headache. One of the symptoms I experienced while I had COVID beyond the more expected symptoms were fever, phlegm, cough, exhaustion, body aches, and I also developed sores in my vaginal inner labia. I did consult with planned parenthood and they could only theorize and thought it was an STD but I tested negative. I seen an OBGYN afterwards and concluded that it was a reaction from my immune system because the sores developed were too brief to be an STD. They thought it was one of the ways my body reacted to the virus. In addition to that, I've also experienced hearing loss that has been tied to COVID. The first time I had COVID in 2020 it was disproven at the time, but 6 months later I lost nearly all of my hearing in one of my ears. I had went to an audiologist and they confirmed my hearing loss was due to nerve damage and they left it at that. I recovered most of my hearing but I do have permanent mild hearing loss in my right ear that I monitor since I got COVID the 2nd time.
sore left arm; 12 year old child recived a Moderna Covid-19 booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose). On 07-May-2022, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Pt felt lighheaded, sweating. Slid self to floor. EMS in house responded. Vita signs WNL. Alert, oriented. EMS advised transport to hospital for further evaluation.
This is a spontaneous report from a contactable pharmacist.  A 63-year-old male patient started to receive PREVNAR 13 , subcutaneous from an unspecified date to an unspecified date at single dose for immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was inadvertently given the PREVNAR 13 subcutaneously instead of intramuscularly and it burned on an unspecified date with outcome of unknown.  The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.
Dose given from expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Information has been received from a woman in a medical office concerning a 6 year old female patient with no allergies and no past medical history who on 22SEP1998 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient was exposed to chickenpox at school. On 11NOV2003, the patient "came down with the disease". Medical attention was not sought and laboratory tests were not performed.  Subsequently, the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Hives; Blotchiness; Itchy; Rash; Lost weight; A spontaneous report was received from a consumer who was also a 31-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced rash, hives/urticaria, blotchiness/rash macular, lost weight/weight decreased and itchy/pruritus.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Zyrtec, Allegra, Singular and pantoprazole unspecified.  On 31 Dec 2021, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Jan 2021, 9 days after vaccination patient had hives and a rash appear so patient visited patient's doctor who gave prescribed few medications. After 7 days symptoms got worse. The hives and blotchiness spread to patient's face and the rash was from neck down to thighs. The rash looked like red dots like chicken pox or poison ivy, but nothing came out of them but was itchy. It was also concentrated on the right side of patient's body. patient went back to the doctor. Patient also mentioned that in the first fourteen days after the Moderna COVID-19 vaccine patient lost 10 pounds.   Treatment for the event included prednisone 10 milligram 4 times a day and cream for rash and hives and steroid for hives and blotchiness and rash.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.
One day after the vaccine, I awoke with a headache & body aches.  Later that afternoon, I had a fever of 101.4 and chills.  The next day, I had an elevated heart rate and dizziness.  I had several more episodes of a rapid heart rate that day.  I called my cardiologist's office and they advised me to start on propranolol 20mg twice daily.  They had prescribed that earlier as I have had episodes of that in the past but did not take the medication.  After the 3 doses, approximately 12 hours apart, the lightheadedness and dizziness got worse.  I called the cardiologist on call and they d/cd the med.  Today, the lightheadedness & dizziness is worse.
chills, uncontrollable shaking, fever, fever dreams, headache, dizziness, nausea, loss of vision (momentarily), loss of hearing (upon waking up)
3" long 2" wide red mark where injected, it has turned the area under the red mark rock hard, it burns and is very sore. I've had a slight fever and sore throat. I felt sick and vomited, also have a head ache.
Arm hurt; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Baby born at 36.5 weeks. (Live pre term birth)) on Nov-2018. Concurrent medical conditions included Hypothyroidism since March 2021. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] for Pregnancy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Nov-2020 and the estimated date of delivery was 16-Aug-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prenatal screening test: (normal) prenatal screening for Down syndrome and chromosome abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up received updated medical history, lab data and patient details.
Patient had flu-like symptoms the day after receiving 2nd dose; At night, Patient had severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient had flu-like symptoms the day after receiving 2nd dose) and DIARRHOEA (At night, Patient had severe diarrhea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ATORVASTATIN CALCIUM (LIPITOR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SPIRONOLACTONE, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D [VITAMIN D NOS], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient had flu-like symptoms the day after receiving 2nd dose) and DIARRHOEA (At night, Patient had severe diarrhea). At the time of the report, INFLUENZA LIKE ILLNESS (Patient had flu-like symptoms the day after receiving 2nd dose) and DIARRHOEA (At night, Patient had severe diarrhea) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.
Patient presented with redness around and for 2 to 3 inches below injection site with a possible welt noticed.  It was warm to the touch and she was experiencing injection site pain and irritation.  Upon follow up with patient the area got redder for another day but then started to dissipate and only a small amount of redness remains.
I was not feeling well about 24 hours after then laid down and feverish chills and sweats happened. then when I woke up in the morning I was throwing up and diarrea for the next 48 hours. In that time I started getting terrible back pain and short of breath. I was told this was all issues that would resolve on their own. long story short I am now taking flexeral for the back pain. I am still short of breath and am having trouble keeping up with my two year old who needs his mommy.
After receiving immunizations, stand at check out counter she fell to floor, face up, eyes open and rolled back, unresponsive x 3 seconds to verbal stimulus. Arms shaking. W/in 12 minute, pt able to walk to exam room with assistance. BP 112/68, HR 80. Pt monitored for 1--15 minutes. Rest unremarkable.
Headache, Myalgia, Right arm soreness, fatigue and some nausea Narrative:
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (lot# H020255, Exp date 08-NOV-2014). At the time of report, the status of patient was unknown. Additional information is not expected.
On the morning after, I woke up to pain, swelling and redness at the site of the injection. This am, 3 full days later it is still red and hot to the touch. I also woke up at 3:30 am with my lymph gland under my left arm swollen and sore. I am trying to get an appointment with my family physical but he is booked for several days.
pt recv vax & lab eval revealed a lack of seroconversion for the five patients;no further details were provided;
experiencing coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (experiencing coughing) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (experiencing coughing). At the time of the report, COUGH (experiencing coughing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) swab test was done and came out negative instead the doctor said positive..         No concomitant medications were reported. No treatment medications were reported.  Patient was kind of scared so immediately went ER.
Pt received his first dose of the Moderna COVID19 vaccine today. While sitting down the pt reported feeling tingling and numbness in his arm. Pt denied chest pain. No other symptoms other than reporting feeling anxious. BP 130/84, HR 70, O2Sat 98%. Pt reported it was getting better after sitting for another 20 minutes. Pt declined EMS evaluation. Triaged by MD.
She complained that after receiving the vaccine her arm felt heavy and sore to movement.  She was evaluated EMT and released home feeling better at 1:39 pm.
Pt. came to pharmacy on 4/24/18 to report that she fell sick for 2 days: very weak, tired, slept a lot; painful at injection site = approximately 9/10; Red around vaccine site, swollen, but coming down.
He said he is concerned he "flushed the vaccine out".; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he received the first dose and he donated platelets and plasma through the organization, a few hours later that same day. He asked if his blood donation would interfere with the vaccine. He was concerned that he "flushed the vaccine out". The patient experienced he said he is concerned he flushed the vaccine out on Mar2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
His neck lymph nodes are very stiff and swollen and it hurts badly. He says he has a hard time turning his neck
a expired dose of Tenivac was inadvertently administered to a 87 years old feamle patient,No AE; Initial information received on 25-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 87 years old female patient who was administered with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] inadvertently.  Medical history, medical treatment, vaccination and family history were not provided.   On 15-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U5854AA and expiration date 25-Jan-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
What is being called "COVID Arm".  Developed a red, itchy, warm raised lump approximately 3 inches in diameter at the injections site. It lasted 3 days. 2 days later developed a red, itchy, warm raised ring approximately 2 inches wide around the previous reaction site at the injection site.  This is still ongoing as of today.
Pt called office on 6/9/15 at 6:41pm. Says has cough and malaise and feels side effect from TDAP vaccine received on 6/4/15.