chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; Difficult breathing; fast heart beat; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-1900, the patient experienced DIZZINESS (light headedness). On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat). The patient was treated with ANTIBIOTICS for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (light headedness), DIZZINESS (dizziness), DYSPNOEA (Difficult breathing) and HEART RATE INCREASED (fast heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) negative for pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Had 1st Lymerix on 6/2/00 and 2nd on 7/6/00. Had 3rd dose on 6/6/01. In December, I couldn't put on my own shoes; fingers deformed. Lost strength and use of my hands. 5/17/02 Review of medical records indicates diagnosis of inflammatory arthritis. 5/30/02 Review of medical records indicates symptoms of stiffness, joint pain and swelling in hands.
COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 years old male of an unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, dose number in series was 1, 01 in total was administered on 27-MAR-2021 for prophylactic vaccination.  No adverse events were reported for covid-19 vaccine ad26.cov2.s (dose number in series was 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, dose number in series was 2, 01 total, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had covid-19 infection (dose number in series was 2). On an unspecified date patient had done rapid test: severe acute respiratory syndrome (SARS-CoV-2) test which was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Rash broke out approximately 1 week after first dose on both ankles. After second dose rash returned to ankles and also appeared on arms, hands and thighs
Did not have an easy second dose/ usual side effects; It was not painless; Really not well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-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 VACCINATION COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Did not have an easy second dose/ usual side effects), PAIN (It was not painless), MALAISE (Really not well) and PYREXIA (Fever) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient has no pertinent medical history. The patient had no drug allergies. On 13-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # J004270, expiration date 12-JUL-2014, reported as 12-JUN-2014) (subcutaneous, 0.65 ml). Concomitant medications were reported as none. On 14-OCT-2013, the patient developed red, swollen lump at the injection site after receiving the dose of ZOSTAVAX. The patient sought for medical attention by seeing the pharmacist. Cold compress and ibuprofen were given as treatment. Lab diagnostics studies performed were reported as none. The outcome of red, swollen lump at the injection site was reported as not recovered. Additional information has been requested.
Patient is a 65 y.o. female with a history of Stage 4 Squamous NSCLC of RLL with Peripheral Neuropathy, Chronic Hypoxic Respiratory Failure (1L oxygen), NIDDM2, Depression who presented to Hospital 11/29/2022 with several days of cough and sore throat, myalgias after recent COVID exposure. She was found to have acute on chronic hypoxemic respiratory failure and positive for SARS-CoV-2 and influenza A. Hospital course was complicated by finding of new brain mass and suspected progression of metastatic disease. No plan for surgical intervention. RadOnc plans for outpatient stereotactic radiation starting 12/9/22. Hospital course prolonged due to need for continued treatment of COVID/influenza and glycemic control. Patient was placed on insulin gtt on 12/5 with Endocrinology consult placed. Insulin gtt was then discontinued on 12/7/22 and transitioned to subcutaneous insulin regimen.   1. Acute on Chronic Hypoxemic Respiratory Failure, resolved Chronically on 1-2L via NC but required 5L NC in ED. Secondary to COVID and influenza A infection. CTPA 11/30/22: consolidation in right perihilar region consistent with post treatment changes and underlying pneumonia, no PE, progression of mediastinal adenopathy. Patient has returned to  2. Steroid-Induced Hyperglycemia, NIDDM2: A1c 12.8% on 10/14/2021, A1c 10.7% on admit. Home oral medications held. DM Educator consulted, met with patient and family on 12/5, will meet with them again prior to discharge. Patient required insulin gtt on 12/5, transitioned off on 12/7. Transitioned to Lantus 55 units nightly, lispro 55 units TID before meals. Resume metformin on discharge and discontinue all other home diabetes medications. Will need close follow up with PCP as outpatient. 3. New Brain Lesion: CT Head 11/30/22: new 1.8cm hypodense right frontal lobe lesion with vasogenic edema. MRI confirmed. Neurosurgery following with no plan for intervention. RadOnc mapping on 12/2 with outpatient follow up for radiation. Dexamethasone 4mg QID then 4mg TID (12/3-12/6) then 4mg BID until RadOnc follow up on 12/9 who will manage the remaining taper. 4. Adrenal Lesion: Incidentally seen on CT. Oncology follow up outpatient. Oncology Navigator consulted.  5. Stage IV Lung Cancer: Follows with Dr (Rad Onc), Dr. and Dr. (Onc). Diagnosed in 07/2020 on Taxol/Carboplatin prior to admission (missed dose due 11/23/22). Oncology followed, f/u per above.  6. Normocytic Anemia: Likely secondary to chemo medications. Hbg 9.5 on admit, baseline ~10. 9.5 on admit. Carboplatin nadir 28 days. Taxol nadir 15-21 days. Last chemo infusion 11/03. 7. Thrombocytopenia: Likely secondary to chemo medications. Continue to monitor clinically. 8. Hypothyroidism: Secondary to Keytruda use in past. Decreased levothyroxine to 150 mcg daily per Endocrinology recommendations, recommend repeat TSH and free T4 in 4 weeks. 9. Chronic Right-sided Vision Changes: Ongoing for months, possibly related to brain lesion. Encouraged outpatient Ophtho follow up.
Localized swelling and itching started about 3 hrs after the vaccine was given. No fevers. No erythema or streaking noted. No pain or drainage noted at the site. Patient reports some generalized discomfort due to swelling. Benadryl, Claritin, and Motrin given.
Six days after injection I woke up itching with hives.  Started on chest and back, but has continued to shift over the past 3 days.  Has moved to throat, face, legs, arms, stomach.
Vaccinee tested negative for Hepatitis B Surface Antibodies p/a series of 3 inject (IM deltoid).
a patient accidently vaccinated with two doses of quadracel within 34-day time frame/no AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional (practice manager).  This case involves a 6 years old male patient who was accidently vaccinated with two doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] within a 34-day time frame (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  It was of actual medication error due to drug dose administration interval too short.  At the time of reporting, 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.
Running 101.9 temperature,  aching all over, left arm in pain and can not lift, joints and teeth hurt, headache and runny nose.
Pt admitted to hospital 20 days later with myopericarditis, + troponins, chest pain, pericardial effusion and myocardial fluid collection/swelling.
Pruritis and feeling of warmth almost immediately after immunization. Developed dyspnea within four hours.
Pt developed Shingles after vaccination.  Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right  ear hurts.  She says that the pain does not feel like it is in the ear but  right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear  has ringing sound.  She does not note that the ear is red .  When she  rubs under the ear she says the area is painful is painful. She does not note a  lump or bump under her ear.. She states that the jaw/bone area  hurts with the vibration of the conversation." Sore throat and headache, only on right side.  Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.
Pt recvd 1st dose of HIB in JAN91; subsequently devel t100-101;
I had a temperature of 99.1, massive headache which I still have and it's June 1, 2021, extremely exhausted like I've not slept at all. I've had to miss work due to this as well.
At office visit 4/12/18, patient stated that since receiving the influenza vaccine, he has been having left arm pain, numbness, and tingling especially when lifting his arm. Symptoms have not improved since the injection.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. The patients might have been vaccinated with improperly stored dose of M-M-R II (Lot#, dose and route not reported), date unspecified. It was not known if the patients sought for medical attention. No symptoms reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Around 11:00 AM I checked on my child. He was lying down. I looked at him closely in the face his eyes were open staring w/no response. The next day he started to jerk his head to the right side and his face started to twitch. He seemed to be very exhausted, tired, and lazy. He was having difficulty swallowing baby foods juices & TYLENOL. The symptoms occurred everyday after his vaccinations.
FC3182, I think was the lot number.  It was hard to read.  Nausea-same day through day 4.  Light headedness- day 2-4. Pain at injection site-day1-still going. Redness and swelling; hot to the touch- day 2- still going, although the sWelling is going down a little.  Itchiness around the red area; day 3 and still going. The red area is about 3 inches across.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with unknown number of doses of VARIVAX lot # M027886 with expiry date: 03-JUN-2018, lot# M041081 with expiry date: 06-OCT-2018 and lot# N009767 with expiry date: 24-MAR-2019 (dosing details, anatomical location and route were unknown) for prophylaxis, following a temperature excursion (incorrect product storage). It was reported that the vaccines were exposed to a temperature range of -14 to -10 degree centigrade for a duration of 22 hours 7 minutes and -9 to 8 degree centigrade for a duration of 23 hours 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported in any patients. There were no product quality complaints (PQC) involved.
Blotching dry spots all over body, scalp, chest, arms, face; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 18:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and past drug history were reported as not applicable and no respectively. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Apr2021, the patient experienced blotching dry spots all over body, scalp, chest, arms, face. It was unknown whether the patient the received treatment for the events. It was unknown whether the event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blotching dry spots all over body, scalp, chest, arms, face was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A physician reported that an 18 month old female received her fourth dose of Prevnar on 29 MAY 2002. The following day, the child's mother notified the physician's office, that her daughter had developed a rash measuring 3-cm by 2-cm in diameter (site not provided), a maculopapular rash on her trunk and extremities, and hives. The child was seen by the physician on 31 MAY 2002. The mother noted that she had applied sunscreen to her daughter; however, she had used the same product previously without an adverse reaction. The reporter indicated that the child had a dry red rash on her face at the time of vaccination. No further information was available at the date of the report.
Death  felt a little sick 1 day after shot 2/28/21,  felt worse next day 3/1/21 was weak, she was found dead  am  3/2/21  on the floor in her bedroom 1/2 way between bathroom and bed.
I immediately experienced a migraine headache, more of a silent migraine than severe throbbing one, bit it started simultaneously with the actual injection.  I had no Tylenol on hand and it went away with it any OTC medication  within about an hour or less.
Off label use; Drug use in unapproved population; Breakthrough period while breastfeeding 4 months postpartum; anxiety; Decreased milk supply 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jun2021 14:00 (Lot number: Ew0187) at the age of 36 years as dose 2, single and administered in arm left, administration date 03Jun2021 12:00 (Lot number: Ew0178) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Breakthrough period while breastfeeding 4 months postpartum"; SUPPRESSED LACTATION (non-serious) with onset 27Jun2021 14:00, outcome "unknown", described as "Decreased milk supply 2 weeks"; ANXIETY (non-serious), outcome "unknown", described as "anxiety". It was unknown if therapeutic measures were taken as a result of off label use, product use issue, menstruation irregular, suppressed lactation, anxiety.  Additional information: Patient never had a period before on 3 other children. Patient Still having anxiety and no more bleeding. 3 days after second vaccine decreased milk supply. Patient did not tested for covid prior and post vaccination and also not had allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084130 mother-child cases
Numbness/tingling in hands and feet on the 8th. By the 10th the couldn't really walk. Progressive weakness. Had viral illness shortly following Flu shot w/ fever, rigors and chills. Some constipation and loss of appetite. Low back pain.
After vaccine was administered, it was discovered that the pt received a High Dose flu shot for 65 and older. Pt is monitoring symptoms at home. Called and checked in with mother today, and she said she is doing fine, nothing to report yet.
On 11/7/13 patient contacted pharmacist and stated her pneumonia vaccine she received on 11/6/13 is causing extreme pain to the point the patient cannot lift arm patient was asked if there were any signs of swelling or redness and stated no. Patient said there is no tingling either. Patient said no pain relieve even her PERCOCET does not help. States worse than tetanus shot.
One swollen tonsil; one swollen gland, no fever.  Blocked nose.  General joint pain.  Sore arm at location of shot.
7/17/15 10:30AM Pt called call center reporting upper left arm pain, with redness, hard to move arm, body aches. Declined appt of ER visit. Declines phone appt with PCP. Dr. (allergist) called pt at 11:14AM. Pt denies fever, but has swelling and discomfort at site. Instructed to take acetaminophen 1000 mg PO. 7/17/15 12:21PM Pt has less pain and plans to resume normal activities per Dr. follow up phone call.
fever; HEADACHE; DIZZINESS; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (DIZZINESS), PYREXIA (fever) and HEADACHE (HEADACHE) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (DIZZINESS), PYREXIA (fever) and HEADACHE (HEADACHE). At the time of the report, DIZZINESS (DIZZINESS), PYREXIA (fever) and HEADACHE (HEADACHE) 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.   Reporter did not allow further contact
Fever, chills, body aches, nausea and sever headache lasting 24 hours in duration. Vaccination administered at 11am, and adverse reactions began to occur at 11pm that same night - 12 hours post vaccine.
On 02/09/2021, the day after the vaccine, I had a significant fever (102.6) that resulted in a seizure. The fever lasted a full day. I ended up in ER/ hospital.   I had the seizure in the parking lot of the hospital  I work at. The ambulance took me to the hospital.
Pt received a Moderna Covid-19 vaccine after receiving the Pfizer 23 days ago.   Pt had no adverse symptoms.
numbness - tingling in both feet, legs, numbness in pelvic area. Occurred about 2 weeks after receiving H1N1 vaccine. Still present as of 1/16/2010.
pt came in to receive the booster  dose for covida19 Pfizer and Flu vaccine. He stated that he had experienced dizziness after getting blood drawn. Stated he didn't have problem after getting the Covid 19 Janssen in March 2021. Covid vaccine was administered first on the left arm and flu shot was on the right arm. Immediately after the flu vaccine, pt passed out in the chair. I kept tapping on his shoulder and called his name but he didn't answer. I told my staff to call emergency immediately and kept tapping on his shoulder. After maybe 4 or 5 seconds or maybe loner, pt slowly regained consciousness. Pt was in the chair at all time. Paramedic arrived, took his BP and checked blood sugar from finger prick. Glucose was 85. Paramedic asked pt to sign waiver that he didn't want to go to the Er in the ambulance, advised pt to not drive and go see his doctor as soon as possible. Pt was contacting family members but no one came and he said he had to go home and he could drive.
Information has been received from a RN concerning a female with allergies to ciprofloxacin hydrochloride (CIPRO), penicillin (unspecified), codeine, and "sulfa" who on 04/16/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Concomitant therapy that day included an "allergy shot".  On 04/16/2003, shortly after receiving the vaccination, the patient experienced pain at the site, swelling radiating up the arm to the shoulder, redness, hives and nausea.  The patient was instructed to take diphendydramine hydrochloride (BENADRYL) and "call if anything worsens".  The reporter indicated that "the condition is improving but not totally resolved."  Unspecified medical attention was sought.  Follow up information received from a nurse manager indicated that the "patient had redness, edema, warmth, pain and in the entire arm for the first 72 hours following the vaccination".  It was noted that the patient applied ice packs and took oral diphenhydramine hydrochloride (BENADRYL) to help relieve the symptoms.  After the first 72 hours, the patient had redness and pain in the arm and shoulder for approximately 5 days.  It was reported that the patient continued to use heat/cold and take oral diphenhydramine hydrochloride (BENADRYL) to relieve the redness and pain.  There were no labs performed.  The reporter indicated that "the patient is fine".  No further information is expected.