chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel not well; I am cold, I am hot; little bit dizzy; sweating; could not sleep; loss of appetite; a little bit of fever; little pain in the shoulder.; felt a lot of burning from the injection site; nauseous; lots of muscle pain; a little headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating) and INSOMNIA (could not sleep) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), ARTHRALGIA (little pain in the shoulder.), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feel not well), BODY TEMPERATURE FLUCTUATION (I am cold, I am hot), DIZZINESS (little bit dizzy), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), DECREASED APPETITE (loss of appetite), PYREXIA (a little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), NAUSEA (nauseous), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired) had resolved and ARTHRALGIA (little pain in the shoulder.) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.
ACUTE PULMONARY EMBOLISM 4/26/2023 CESAREAN DELIVERY
Very sore arm after shot at 4:21 pm on 4/11. Woke up at 4:30 am on 4/12 with terrible migraine, sore all over and experienced nausea but did not throw up.  Drank water and took Tylenol which seemed to help...Stayed in bed until noon. Starting to feel better but still experiencing fatigue and body aches.
Information has been received from a female physician referring to herself. Information about concurrent condition, medical history and concomitant therapy was not reported. In approximately 1996 (reported as about 20 years ago) the patient was vaccinated with 2 doses of VARIVAX (Merck) (lot#, expiration date, dose and route not reported). In July or August of 2015, when she was seen for her annual physical, she had her blood drawn for varicella titers per her doctor's request. The patient stated her doctor felt the titers were inadequate (antibody test negative). At the time of reporting, outcome of antibody test negative was unknown. Additional information has been requested.
I had nausea, vomiting, palpitations, increased heart rate. I tested positive for COVID 19 on 09/21/2022. I sent an email to my provider, and he advised me what to do. I had to rest and let my body go through the symptoms. It has attack cardiac, neurological system, and my thyroid. I never recovered from the first breakthrough case I had in March after being fully vaccinated. I am going thru physical therapy and cardiac therapy.
Urticaria withing few minutes of administration, given Benadryl, but continued rapid progression, given Epinephrine im after about 5 minutes. Next day developed fevers.
Severe back pain starting 12 days post vaccine lasting 3 days, neck pain starting 10 days post vaccine lasting 5 days
developed tightness in the hands, feet and fingertips; arthritic symptoms; throbbing in the hands and feet; Initial information received on 11-Feb-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 54 years old female patient who had developed tightness in the hands, feet and fingertips (joint stiffness), developed arthritic symptoms (arthritis) and throbbing in the hands and feet (pain), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, vaccination(s), concomitant medication(s) and family history were not provided.  On 23-Nov-2020, the patient received dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number: QFAA2038 and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed tightness in the hands, feet and fingertips (joint stiffness), developed arthritic symptoms (arthritis) (One doctor thought it was arthritis and another doctor said that it could be a possible side effect of the vaccine) and throbbing in the hands and feet (pain) (events came on subtly over three weeks) (exact latency unknown) (non-serious events), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  A month later patient went to the doctor when the events got worse.   Relevant laboratory test results included: Blood test and X-ray on an unknown date and the result was normal as reported it was coming up as fine.  The patient was treated with IBUPROFEN (ADAVIL), ice and heat pads.  At the time of reporting, the patient was recovering from all the events as it is reported that patient got lot better but the events were not gone.  The Result of Assessment was as not reported.
Patient called the pharmacy between 7 and 8pm saying that she had felt funny for most of the day, and just started checking her heart rate when she felt light headed.  Her heart rate was high for her, fluctuating between 115 to 130 or so.  I followed up with her today, 10-13-2021 and she was still having those symptoms with some pain in her arm.  Patient spoke with her prescriber (telemed appointment) on10-13-2021 who advised patient to monitor symptoms and seek treatment if symptoms progressed.
Miscarriage, was due April 2022. At time of vaccine I was 6 weeks and 1 day. The baby stopped growing around 6 weeks 4 days.
11SEP95 stomach cramps about 4hrs p/vax;18SEP95 given DPH a/inj stomach cramps about 6hrs p/2nd dose;also joint pains rt arm;OCT95 given DPH 50mgm a/inj;no problems;
I got covid 19 August 31 The only place I had been was to the cvs pharmacy to get my shot.  Also got a bruise with a fever and swelling in my right arm.about 4" from where I received the shot.
On 04/02/2021, 30 minutes after the vaccine I got a severe headache and it lasted for 3 months. I would wake up with a headache, and it was constant. 2 hours later my heart started going crazy, I did not feel well and went to sleep. The next day I just felt like my heart was not feeling right. I took my blood pressure and it was 250/100, pulse150. I have high  blood pressure, but this was not normal for me. 3 days after the vaccination, I lost my taste, but I noticed it more with sugar.  I waited till Monday and called my doctor.  My BP was not that high but my heart did not feel right.  I could actually see my heart beating in my throat, it was irregular. Something was not right.  I could not get an appointment with any doctors.  I  had a phone visit with my kidney doctor, and said my kidneys were good but my BP was very high. He increased the dosage of Norvase from 5mg to 7.5 mg. Around May, I went to urgent care because I broke out in  rash. They diagnosed me with shingles. They wanted me to go to the ER because my BP was very high. I did not want to got to the ER. They prescribed acyclovir 800 mg antiviral. 2 rounds of that, Took it for 7 days, and it did not go away. So the prescribed another round of acyclovir in addition cephalexin 500 mg for 7 days. After that 2nd round of the  medications, it calmed the shingles down,  and my heart down, and it calmed my headache. I was also going to an acupuncture.  Since the end of June,  everyday I  am starting to feel like myself again.   I have an appointment to get an echocardiogram. I don't have all my energy back, my sense of taste is getting better. I am being monitored by doctors for my joints and headache.  My joints are getting better.
Initial unsolicited report received from office person medical assistant on 25 May 2018. This case involves 14-month-old patient (gender not reported) who was vaccinated with a dose of QUADRACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an 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 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. List of documents held by sender: none.
I had Bell's Palsy in July 2020. A few days after receiving the second dose of the Pfizer COVID-19 vaccine, I appear to have had a reoccurrence.
Patient called on 9/12/13 complaining of "sore arm" and inability to raise arm. Vaccine was given on 9/3/13. Patient said issue started morning of 9/4/13. Recommended patient seek medical treatment if she was in severe pain and unable to lift arm.
Left arm was extremely sore; Had a bad headache the first night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 07:45 (Lot number: EW0161) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6207, Anatomical site: Left arm, Administration time: 07:45 AM), administration date: 19Mar2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Apr2021, outcome "recovered" (12Apr2021), described as "Left arm was extremely sore"; HEADACHE (non-serious) with onset 09Apr2021, outcome "recovered" (10Apr2021), described as "Had a bad headache the first night.". Therapeutic measures were not taken as a result of pain in extremity, headache.   Additional information: The patient had not reported any other health issues, had no known allergies to medications, food or other products. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021, after dose 2, the patient experienced the left arm was extremely sore for 2 days (duration) and had a bad headache on the first night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Swelling from shoulder to elbow with erythema on coral aspect of arm with small bruise at injection site. Mild calor, mild pain, full range of motion of arm. (right arm), Ibuprofen Ice Keflex started.
HPV (+) Type 16. (-) pap on 6/17/09. (+) pap on 8/6/10 "carcinoma in situ". 8/17 Colposcopy with biopsies. 9/16 Surgery Scheduled.
Big redness around injection site came on 2/10/16 about 2 PM.
Extreme joint pain 17 hours after the vaccine was administered. started feeling better in about 36 hours  Ongoing joint pain / discomfort  noticed about 2 weeks after the shot and has continued since, even light physical exertion results in joint pain, feels like I aged 20 years
Patient calls the clinic on 9/23 to report symptoms which developed after receiving the Pneumococcal vaccine.   He felt there was no problems with the initial injection. Everything seemed fine." nothing out of the ordinary"  A few hours after returning home he developed Fever of 102, chills, Sweats, diarrhea  and vomiting and pain at the injection site. He later developed swelling of the arm and " Hematoma" Described bruising extending up to shoulder and upper collar bone and down to the forearm. Felt like he could not move his muscle. On 9/22 he was going to seek medical attention if it continued to get worse however the symptoms subsided. Today he is much better and feels the " worst is over" . No further concerns with fever , vomiting /diarrhea . Swelling has gone down with bruising fading.
Information has been received from a registered nurse concerning an 85-year-old female with Alzheimer's disease who on 01-NOV-2005 was vaccinated intramuscularly in the left deltoid with a 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine (lot#651318/1006P).  Concomitant vaccination on 03-NOV-2005 in the right arm included a dose of influenza virus vaccine (unspecified).  It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine five years prior.  On an unspecified day in November 2000, the patient's left arm became swollen, painful, and red after vaccination.  Unspecified medical attention was sought and the problem resolved on its own in November 2005.  No diagnostic laboratory tests were performed.  The nurse requested an investigation into this lot number.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open registered against this lot/fill.  Additional information has been requested.
HOSPITALIZED MEDICAL CENTER DOD 4/3/21 COD GASTROINTESTINAL DISEASE
7 days after injection, at injection site, developed pruritus, by day 8, developed an approx 5 cm area of erythema/induration/pruritus, without pain.
Few minutes p/shot pt became pale & lethargic; pt recovered w/in few minutes; pt had not had breakfast a/coming to office;
chills/severe chills; muscle pain; fever; joints hurt really bad; extreme fatigue; nausea; left tonsil really swollen and red; left tonsil really swollen and red; some tingling and pain in feet; some tingling and pain in feet; This is a spontaneous report from a contactable other healthcare professional (hcp). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included that patient had a Covid19 infection back in Jul2020 to an unknown date, and was later tested for antibodies (date unspecified) and found to have them. The patient's concomitant medications were not reported. Patient received her first Pfizer-Biontech Covid19 vaccine on 08Jan2021 and signed up for the health check-ins and reported "almost all" of the side effects listed, specifically chills and muscle pain that lasted all weekend (dates unspecified in Jan2021).  She signed up with V-safe for text alerts, reminders, etc. She wanted to know if she should expect side effects to be worse with the second dose, and if she even needs to receive her second dose, given her history of Covid19 infection.  Patient had chills muscle pain, most of the weekend, now fine. Patient asked if there's potentially more of the symptoms with second dose and if is it okay to take the second dose and stay according to schedule as patient had COVID-19, Covid virus really bad, back in Jul2020 (also reported about 6 months ago and had blood work recently (date unspecified) and concerned because she still has Covid antibodies and her primary care provider wanted her to still get the first vaccine dose. Along with that,  she has had everything from the muscle pain, severe chills, fever, joints hurt really bad, extreme fatigue, nausea, left tonsil really swollen and red, some tingling and pain in feet, all which has lasted all weekend (unspecified dates in Jan2021). Her concern was on an unknown date in Jan2021, she was set up for the second dose on 21Jan2021 and people say you get more side effects with the second dose, and she wanted the best advice for her next appointment. Patient asked if she was abnormal due to having the antibodies and asked how she should proceed since she was not sure if she should get the second vaccine. The patient recovered in Jan2021 from the events chills/severe chills, muscle pain, fever, joints hurt really bad, extreme fatigue, nausea, left tonsil really swollen and red, some tingling and pain in feet.   Information about lot and batch number has been requested.
Chronic pain in left shoulder. It hurts to lift arm up. Throbbing pain especially late nights and early morning. It does not let you rest. I was told the spot was hot were the shot was administer and to put cold compresses on the arm. Take ibuprofen 800 to help with pain. Prescription was given on Monday 5/24/2021. Regular Tylenol was not helping.
Happy, healthy 2 month old had vaccines at 1:30 pm.  Went home, ate a bottle, and was laid down for a nap.  Began gasping for air, turned blue, eyes rolled back of head, and CPR began.  Taken to hospital and stayed for 2-3 days.  CT head, lumbar puncture, and all work-up was normal.
Second dose delayed; High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old non-pregnant female patient received second dose of BIONTECH (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her right arm on 22Jan2021 04:00 PM (Lot number: EL1283) as single dose for Covid-19 immunization. Age at vaccination: 49-year-old. Facility-type-vaccine: Workplace clinic. Covid was not tested prior vaccination. The patient's medical history included asthma and back injury. Known allergies included sodium benzoate, ASA, NSAIDS, mushrooms and seafood. Concomitant medications included Betacarotene/bioflavonoids NOS/biotin/calcium ascorbate/calcium pantothenate/calcium phosphate/choline bitartrate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/hesperidin/inositol/iron amino acid chelate/lycopene/lysine hydrochloride/magnesium oxide/manganese sulfate, molybdenum trioxide/nicotinamide/phytomenadione/potassium iodide/potassium sulfate/pyridoxine hydrochloride/retinol acetate/riboflavin/selenomethionine/silicon dioxide/colloidal/sodium borate decahydrate/thiamine mononitrate/tocopheryl acid succinate/ubidecarenone/zinc oxide (MULTIVITAMIN), colecalciferol (D3), iron, magnesium citrate and linum usitatissimum seed oil (FLAX SEED OIL) (other medications in two weeks). The patient previously took first dose of BIONTECH administered to her right arm on 22Dec2020 03:15 PM (Lot number: E49899) as single dose for Covid-19 immunization and experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea, and loss of taste and smell (for almost 2 weeks post first dose). The patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, and loss of taste and smell (48 hours for second dose). Second dose delayed, RT-PCR Covid-19 and Influenza, SARS-COV-2 aB test on on 5 Jan, 13 all negative. AE resulted in doctor or other healthcare professional office/clinic visit. Covid-test-post-vaccination: Covid test type: nasal swab, test name: RT-PCR PAN-SARS CORONAVIRUS, SARS-COV-2 (COVID-19), test date: 05Jan2021, result: Negative. The patient did not receive any treatment in response to the events. Outcome of the event second dose delayed was unknown, whereas other events was recovering.  Follow-up attempts are completed. No further information is expected.
Hospitalization: 11/23/2022 - 11/28/2022 (5 days) Presentation to the ED: generalized weakness most prominent in the lower extremities, decreased activity and inability to ambulate.  COVID + date: 11/24/2022 Treatment: ceftriaxone, azithromycin and remdesivir.  Discharge to: SNF. He lives at senior living facility.   Moderna Lot # 027A21A 3/9/2021 Moderna Lot # 026B21A 4/6/2021 Moderna Lot # 032H21A 12/16/2021
Narrative:  Timing error only. No ADR. Patient received 2nd dose 14 days after 1st dose due to scheduling error.
Moderna COVID-19 Vaccine EUA immediately after (around 11:15 am 1/16): headache about 2 hours later: soreness at injection site about 9 hours later: aches, chills, nausea, headache, fatigue next morning (1/17): aches and pains, 100 fever  next evening: symptoms significantly reduced, slight fatigue and pains, some nausea
unable to sit or lie down; unable to breathe at times; Back pain; back pain shooting down her legs; Received the second dose 21 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN (back pain shooting down her legs), HYPOKINESIA (unable to sit or lie down), DYSPNOEA (unable to breathe at times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose 21 days after first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose 21 days after first dose). On 28-Apr-2021, the patient experienced BACK PAIN (Back pain) and PAIN (back pain shooting down her legs). On an unknown date, the patient experienced HYPOKINESIA (unable to sit or lie down) and DYSPNOEA (unable to breathe at times). At the time of the report, BACK PAIN (Back pain), PAIN (back pain shooting down her legs), HYPOKINESIA (unable to sit or lie down) and DYSPNOEA (unable to breathe at times) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose 21 days after first dose) had resolved. Not Provided          No concomitant medications provided. No treatment information provided.
Complaints of dizziness, weak, color pale. Feet elevated, severely diaphoretic. Passed out approximately 25 seconds. open eyes but glazed appearance and states "feel like I'm dreaming." Resps even and slow. BP 126/84 prior to vaccination 114/68 post. Escorted to ER via wheelchair. BP 92/49. O2 sats 97-100. Pulse 62-66. BP further decreased to 86/49. IV fluids given in ER. BP increased 99/63 then to 118/77. Recurred and discharged at 12:00.
patient had numbness on left side of face,  eye brows wouldn't move as much as other one,  ear pain, headache,  and couldn't blink left eye.  Patient was prescribed:  prednisone for 5 days and valacyclovir for 7 days. patient still having some symptoms with left side of face but improving.  not 100% yet.