chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed fell down floor in bathroom; weak and couple not get up; did not eat or drink anything; pain in lower back; feel dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included AMLODIPINE, VITAMIN D3, ZINC, ACETYLSALICYLIC ACID (BABY ASPIRIN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FALL (collapsed fell down floor in bathroom), ASTHENIA (weak and couple not get up), DECREASED APPETITE (did not eat or drink anything), BACK PAIN (pain in lower back) and DIZZINESS (feel dizzy) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information was received on 06-aug-2021and  included no new information
client received the 1st Pfizer Covid vaccine. Client was sitting approximately 25 mins when she alerted EMTs she was feeling flushed in face, palms of hands and itchiness over body. 1005 vitals: blood pressure 140/80, pulse 91, oxygen 97%. PHN joined team. Upon arrival, client with flushing to face and hands. Alert and oriented. Client denied shortness of breath. Per client has history of allergy to shrimp. Medical history of hypothyroid and diabetes. Medications for both medical conditions, unable to recall names and daily vitamins. PHN  offered client Benadryl, 50mg given orally at 1007. Per client husband could pick her up. 1010 vitals: blood pressure 110/86, pulse 82, oxygen 98%. Symptoms same per client. New onset of feeling "scratchy throat". Client denied shortness of breath or feeling throat was closing. 1015 vitals: blood pressure: 110/86, pulse 86, oxygen 99%. 1017 noticed redness of palms improving and flushing of face. Per client warmth feeling improving. 1020 vitals: blood pressure: 110/86, pulse 82, oxygen 97%. Per client itchiness resolved. Skin color with slight redness. Per client throat feeling improving. Vitals at 1030: blood pressure 112/78, pulse 87, oxygen 98%. Per client all symptoms resolved. Skin color back to normal. Client advised to speak with primary provider prior to second dose, use of V-Safe. ER precautions also given if symptoms returned after leaving. Per client ready to leave, had completed additional 30 min observation. Client advised to have someone pick her up, client declined. Per client feeling fine to drive herself. Client left facility with a steady gait at 1040.
Patient got Covid 5 days after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient got Covid 5 days after receiving the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertensive.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (Patient got Covid 5 days after receiving the 1st dose). At the time of the report, COVID-19 (Patient got Covid 5 days after receiving the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.   This case was linked to MOD-2021-294004 (Patient Link).
Mother states that "rashes, described as heat bumps" appeared on the back of the arms, stomach and thighs. Mother applied hydrocortisone that brought temporarily relief and rashes still visible up to this date.
vaccinated with Pfizer in March 2021. Had Covid in 11/2021. Woke up today  with drainage and sore throat.
On Friday, February 18th, 2021, patient received Moderna COVID-19 vaccine in the left deltoid administered by Pharm D at our pharmacy. The patient called the pharmacy on March 4th, 2021 to explain that her arm was red and itchy.  The pharmacist that day told the patient to use ice compresses and to come by the pharmacy to show us her reaction.   Today, March 5th, the patient came to the pharmacy with her son to show us her left deltoid. I observed her arm was red and hot to the touch. She has very defined edges of the rash on her arm. She did not have streaking on her arm, that I observed.  Patient said she had a small, red spot about 3 days after she received the shot, which started February 21st .  She was complaining of itching and has been watching the red spot get bigger every day. I instructed her to call you to have you look at her arm. She said it was just itching and she would like to try OTC products before going to the doctor.  I instructed her to take Benadryl 25mg up to four times per day.  Because Benadryl will make her tired, she can only take it when she is at home and not driving.  I also gave her Hydrocortisone 1% ointment to use at least twice per day on her arm.  I also reiterated that ice packs would help with the redness and discomfort.  She verbalized her understanding. I instructed her to call you to make an appointment if she is not improving. I also told her if she sees any signs of continued spreading or red streaks on her arm, she needs to seek immediate medical attention.
I felt fatigue, then overall muscle weakness.   About 2 hours later I felt very warm and then chills.  Later my abdomen became very warm and a slight reddening started at my abdomen and covered my body.  I did not feel I needed to call my doctor.  The following 3 days the fatigue and overall muscle weakness stayed with me.  I am fine now *;}
Developed swelling in L knee on 10-16-07. Felt tight, no pain. Developed swelling in both knees 11-17-07. On 11-18-07 swelling went to hands, ankles, wrists. Also developed pain on 11-18-07 in all joints. Has appointment with doctor in afternoon of 11-19-07. Has taken Advil sporatically when developed pain.
Severe chills, fever highest 101.4°, Pulse ran 80-100, fell to do that I think I fainted  Blood pressure 93/49,94/41,99/50,77/46,92/44,
C/o hoarseness. Initially no SOB.  As was listening to lungs, became syncopal/limp.  BP 160/90- pulse 76.  Biox 100% on RA.  EpiPen given.  O2 mask @ 4lpm.  Taken to ER.
Unsteady; eye weakness-> ADEM (Acute Demyelinating Encephalomyelitis. Positive MRI - child on steroids. Follow up with neurology. Possibly 2 hour varicella vaccine. Per follow up report- some unsteadiness.
Muscle pain, ache, soreness - progressing.  Labs done on 11-9-09: EBV 1.3   C-react protein 78.1    Mono (-).
Delayed onset of symptoms: chills, fever, aches, headache; Began almost 72 hours after the shot.
Patient called and reported that within 2 1/2 hours of receiving FLUZONE HD, she experienced red eyes, chills, and a "lump" in her throat.
Right jaw pain, similar to what TMJ would be like, although I've never had TMJ and there's low stress in my life. Pain not relieved by Motrin/NSAIDs, constant 4/10, dull, and interferes with ability to chew.
Swelling of lymph nodes in neck and arm pit on left side of body occurs next day after vaccine.
I feel very crummy; I don't feel good, its still the same, its awful; Back ache; Fever; Chills; No energy at all; I am still sick in bed; I haven't eat; I almost feel like I need to vomit; This is a spontaneous report from a contactable consumer (Patient) reporting for oneself. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 06Mar2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Mar2021, the patient felt very crummy and don't feel good, its still the same and awful, back pain, fever, chills, no energy at all. Patient was still sick in bed and haven't eat. Patient almost feel like to vomit. Patient stated that four days following Wednesday they were not able to get out of the bed, chills, fever, fever is not high its 101. Patient also stated that they don't feel good, still the same, awful, and it is a week already. The patient underwent laboratory tests and procedures which included body temperature not high its 101 on unspecified date. Outcome of all the reported events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
started with rash on both arms. rash travelled quickly from neck to toes. went to the ER. DR confirmed reaction from vaccination. No treatment was done after confirming airway was clear. Advised not to administer steroids to  allow the vaccination benefits to take place.  DR advised- do not take 2nd dose. Return if rash worsens or airway becomes affected.
Acid indigestion; Cholesterol is high; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021(at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable (Na). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced acid indigestion since the vaccination and the patient did not have it before. Also, the cholesterol was high which the patient never had it high before. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events acid indigestion and cholesterol is high was unknown at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient fainted 25 minutes after immunization was given. After incident patient complained of feeling "dizzy and sweaty.  No loss of LOC. Patient didn't get hurt and went home after 40 minutes.
9/9/21 pt had a positive COVID test 9/14/21 pt to ED with c/o SOB, cough, fever, generalized weakness; COVID test showed positive result; COVID pneumonia; respiratory status worsened eventually requiring intubation; given Decadron, ABX, remdesivir; respiratory status continued to worsen; pt was changed to DNR; she passed away in the hospital
Itchy rash on stomach, breast, and legs but not at vaccination site: fever low grade 2-3 days after vaccine
This spontaneous report has been received from a licensed practical nurse (LPN) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-JAN-2018, the patient was inadvertently vaccinated with one dose of expired ROTATEQ oral liquid ( dose not reported, lot # M007301, expiration date 19-NOV-2017) for prophylaxis. No adverse effects were reported. Additionally, no product quality complaint (PQC) was involved.
On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER .  They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.
Had vaccines Pediarix, Hib, Prevnar, Rotateq on 2/13/07 hives began on 2/19/07 ? from Rotateq.
Vaccine given at 3:30pm.  Patient states became nauseated at about 3:45 to 6pm; about 6-6:30 pupils dialated, face flushed/reddened and itchy. Between 7-9pm throat started closing at urgent care.  Urgent care administered benadryl and decron for treatment.
SUDDEN HEARING LOSS ABOUT 10 DAYS FOLLOWING RECEIPT OF THE J&J VACCINE. ALLERGY TO MILK IN THE FORM OF HIVES A FEW DAYS LATER.
Information has been received from a registered nurse (R.N.) concerning a 17 year old female patient who had x-rays performed on 05-DEC-2011 and also on 05-DEC-2011, was vaccinated with a dose of VARIVAX (Merck), a Pregnancy Registry Product, (dose, route and lot number not reported). Other suspect therapy included MMR vaccine, hepatitis B virus vaccine (manufacturer unknown), influenza virus vaccine (manufacturer unknown). Concomitant therapy included Tdap. It was reported that the patient who stated that she was not pregnant, on 05-DEC-2011, received VARIVAX (Merck), MMR vaccine, hepatitis B virus vaccine (manufacturer unknown), influenza virus vaccine (manufacturer unknown), Tdap. The patient tested positive for pregnancy on 10-JAN-2012. Her last menstrual period was on 22-NOV-2011. Estimated delivery date was 28-AUG-2012. No adverse events seen. The patient sought medical attention, she came for pregnancy test. Follow up information has been received from the registered nurse who reported that she was not certain if the patient was given her first or second dose of VARIVAX (Merck), but stated that the health department only administrated one dose by their accounts. It was reported that the patient gave birth to a healthy baby (sex not known) on 22-AUG-2012 at 40 weeks gestation. The patient's vaginal delivery was uncomplicated and the baby weighed 8 lbs., 5 oz. and had no congenital anomalies. There was no other delivery record information available to report. Additional information is not expected.
Fever, chills, aches, nausea, intense arm pain. All started 12 hours after the dose
Body turned purple 1 hour after administration. Diarrhea, fever, rib muscle pain and soreness, vomiting, discoloration, swelling and hard knot at injection site.
Dry skin rashes on the opposite side of the palm of my hand (knuckles area) . Tired , mild fever, headache
pt recvd vax; lab tests done & revealed anti HBs neg & pos ANA 1:16 w/ homogenous pattern; rheumatoid factor was 2. when pt recvd 2nd dose , some more lab test done & revealed neg anti-HBs;
Information has been received from a registered nurse concerning a 4 year old female with allergy to influenza vaccine and a history of Fallot's tetralogy with subsequent surgery in 2003 who on 10-APR-2008 was vaccinated with ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) 0.5 ml SQ (Lot # 658033/0986U).  Concomitant therapy included DTaP, poliovirus vaccine and PPD TINE TEST.  Later that night, the patient experienced injection site reaction with redness and hardness at site.  On 11-APR-2008, the patient was coughing with difficulty breathing, turned red all over and went to the emergency room.  The patient was treated with BENADRYL, prednisone, breathing treatment and epinephrine.  Later the patient went home with an EPI-PEN for emergency use.  The patient's mother stated that the child has been to an allergist.  An allergy panel was negative, including eggs, and the doctor is unsure of the cause of symptoms.  This test did not include neomycin and gelatin.  By 14-APR-2008, the child was feeling better but her whole arm was red and swollen up and down with a pimple like spot in the center.  The patient was treated with amoxicillin for cellulitis.  It was reported that the patient also had an injection site reaction after the flu vaccine but not this extensive.  Additional information has been requested.
02-12-04 Mom called me at my house and stated infant has red blistered areas on chest, arms and back of legs. Child irritable. Advised call Pediatrician tonight. Mom called me back, doctor called told her to give 1 dropper of Benadryl liquid to see doctor in AM. Called mom this AM. Stated vomited after Benadryl. To see doctor re: 11:00 am. Advised call after sees doctor.
weakness; chills; muscle pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "weakness"; CHILLS (non-serious) with onset 18Mar2021, outcome "unknown", described as "chills"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "muscle pain"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "headache".  Additional information: Patient wants to know how long she will be feeling the side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & immed p/vax exp swelling & hard @ inject site; ice applied to area;
0910 patient recieved vaccine. 0920 client described feeling woozy & like she had run fast. (hearting racing) Patient alert, talkative, denies swelling of mouth or tongue, no rash, no difficulty breathing. POX 98%, HR 120, BP 194/110. 0926 BP 200/120, Hr137. Called EMS. 0942 EMS brought her to  Hospital. 1240 husband of patient called me to say "we are going home. She is doing better. The doctor said he did not think it was an allergic reaction to the vaccine."
(L) arm has area of induration 9 cm x 11 cm. Site warm to touch but does not appear tender to touch. Some clearing beginning to present. No acute drainage or lesions.
approx 3yrs p/vax pt devel typical chickenpox w/an unspecified number of lesions. no further info avail
Fever, chills, baseball size swelling of arm at injection site with pain and heat, limited motion. Took ibuprofen, iced arm. Event ongoing at this time
Chest pain, cough, fever, extreme fatigue, headache, fast heart rate The chest pain still hasn?t subsided. It gets worse with any kind of movement- walking, washing dishes, bending over. I still get tired very easily. Still have a cough, though not as bad, but daily. Still get fast heart rate.
experienced COVID-19; experienced COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4245431-00.  A 8 year-old male patient received PFIZER BION-TECH COVID-19 VACCINE (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single and intramuscular, administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf pen for arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "experienced COVID-19". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporter stated that there is a possible causal relationship with the events and suspect PFIZER BION-TECH COVID-19 VACCINE (TOZINAMERAN). The reporter stated that there is no reasonable possibility of causal relationship with the events and suspect drug HUMIRA (ADALIMUMAB).   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a possible causal relationship between reported events and suspect product BNT162B2 cannot be exlcuded
Developed blood clots after the second dose/got blood clot after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clot after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant medications were reported.  8 other women all aged 60 and up developed blood clots after the second dose. Also stated as this was a very serious situation that requires investigation. Reporter states that she knows other women in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No treatment medications were reported. COMPANY COMMENT: COMPANY COMMENT: This is an spontaneous case concerning a  7-decade-old female patient with no  medical history who experienced the unexpected  AESI (seriousness criterion IME ) events   of THROMBOSIS  and CEREBROVASCULAR ACCIDENT unknown days after  receiving the  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566828, MOD-2022-566718, MOD-2022-566813, MOD-2022-566839, MOD-2022-566821, MOD-2022-566814 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow-up received with added reporter Information, verbatim for event thrombosis and new event stroke.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  7-decade-old female patient with no  medical history who experienced the unexpected  AESI (seriousness criterion IME ) events   of THROMBOSIS  and CEREBROVASCULAR ACCIDENT unknown days after  receiving the  2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.