chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely weak; arm began to hurt; leg ached from her ankle up; really, really cold; heart raced; tired/extremely tired; head was pounding and so painful; pain in different parts of her body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extremely weak), PAIN IN EXTREMITY (arm began to hurt), PAIN IN EXTREMITY (leg ached from her ankle up), FEELING COLD (really, really cold) and PALPITATIONS (heart raced) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (extremely weak), PAIN IN EXTREMITY (arm began to hurt), PAIN IN EXTREMITY (leg ached from her ankle up), FEELING COLD (really, really cold), PALPITATIONS (heart raced), FATIGUE (tired/extremely tired), HEADACHE (head was pounding and so painful) and MYALGIA (pain in different parts of her body). On 05-Mar-2021, ASTHENIA (extremely weak), PAIN IN EXTREMITY (arm began to hurt), PAIN IN EXTREMITY (leg ached from her ankle up), PALPITATIONS (heart raced), FATIGUE (tired/extremely tired) and HEADACHE (head was pounding and so painful) had resolved. At the time of the report, FEELING COLD (really, really cold) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
We started the patient on Moderna 4 weeks ago.  She came in for her second dose and was given Pfizer.
The day after the 0.25cc Influenza vaccine was given, the child started breaking out with a red raised rash at the injection site which gradually progressed to his whole body. Parents did not call the doctors office until 11/11/04. Gave Benadryl and the rash went away.
Patient given her booster as a child's Pfizer instead by RN giving immunizations. Attempted to reach patient x 3 and left message for her to call back to let her know. No response yet. Will continue to try and reach her to inform her of error
Lymph node swelling; Fever; Chills; Muscle pain; joint pain; Loss appetite; Fatigue; Headche; Sensetivity to light and sound; Sensetivity to light and sound; This is a spontaneous report from a Non-contactable consumer or other non-HCP (patient). A 42-year-old Adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration administered in Arm left on an unspecified date (Lot number was not reported) (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other medical history. The patient had no known allergies. The patient had no covid prior vaccination. The patient concomitant medications were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On 08Feb2021, the patient experienced Fever, chills, muscle and joint pain, loss of appetite, fatigue, headache, sensitivity to light and sound and lymph node swelling. No treatment was received to treat the events. The patient outcome of the events was Resolved on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-395985 (Patient Link).
pt recv vax & 1 1/2hrs later high fever,chills,shakes,oral cyanosis developed
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 29-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
new onset sz 7/28/99; inc sleep deprivation since apr98; inc D now noticed; very occasional mild rashes; short term memory loss; severe h/a; kidney pains(started p/meds for sz) do not know if its resolved; new mold allergy. Per follow-up dated 11/01/00, the pt continues to experience headaches, earaches, positive ANA, vertigo, diarrhea, varying body temperature, high blood pressure, sleeping problems, joint problems, and short-term memory loss.
Pt received Pfizer bivalent vaccine as first dose in the series instead of the regular Pfizer.
Gastric distress, higher blood pressure, flu like symptoms, night sweats, weight loss, all with in 24 hours of vaccination. Blood pressure 130's/80's. Weight loss 174 lbs. down to 169 lbs! Sleeplessness first night 12/10/09. Extreme night sweat 12/11/09. Feeling weak next few days.
This case was reported by a healthcare professional and described the occurrence of left sided facial numbness in an elderly female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 24 September 2009 the subject received unspecified dose of FLULAVAL (details unknown). On 25 September 2009, 1 day after vaccination with FLULAVAL, the subject experienced numbness on left side of face and cheek and slurred speech. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
arm pain; red rash on arm; itchiness on arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, red rash and itchy upper limbs. On an unknown date, the outcome of the pain in arm, red rash and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm, red rash and itchy upper limbs to be related to Shingrix.  Linked case(s) involving the same patient:US2023021201   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The case was reported by the patient. The reporter stated that after receiving his Shingrix, he experienced arm pain, a red rash and itchiness on his arm.  The patient did not specify which arm was affected.  The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose of Shingrix, refer case US2023021201.; Sender's Comments:  US-GSK-US2023021201:Same reporter,same patient
A report was received from a healthcare professional on 10Dec02, concerning a 66 year old female vaccinee who experienced soreness, redness, and warmth at injection site within one day of receiving Fluvirin on 12Jun02. On the evening of 12Jun02 the vaccinee c/o soreness at the injection site. The next morning the site was described as being very red and warm to the touch. At the time of reporting, the symptoms were resolving and the vaccinee had not yet recovered from the event. The reporter has assessed the relationship of the vaccine to the event as possible.
Patient is fully vaccinate.  COVID + on 12/29/2021 at ED visit. Chief compaint, dizziness. Had bodyaches, ST yesterday. Associated symptoms: hearing loss (resolved), nausea, shortness of breath, syncope, vision changes and weakness, sore throat. BP 119/70  | Pulse 82  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 17  | Ht 154.9 cm (5' 1")  | Wt 65.8 kg (145 lb)  | SpO2 99%  | BMI 27.40 kg/m²   Labd negative.  CXR neg.  DC home
Patient is a 58 y.o. female patient of, MD with history of cardiomyopathy, CKD stage IV, anemia, HTN, CVA, and hypercholesterolemia presented to Hospital with shortness of breath.   Acute hypoxic respiratory failure Covid-19 Virus Infection P/w SOB, SpO2 83% per EMS requiring 3L NC Date of onset of symptoms: 2 days prior to admission Symptoms present on admission: fever, shortness of breath, nonproductive cough Date of covid positive test: 2/9/23 Vaccination status: vaccinated x3 (last in Dec 2021) Imaging: CXR shows patchy multifocal opacities, cardiomegaly, and small left pleural effusion Oxygen requirements on admission: 3L Current oxygen requirements: RA Medical therapy: steroids. Unable to use Remdesivir due to CKD Consultants following: None Anticipated special isolation end date: tentatively 2/19      Hypoxia completely resolved, currently on room air, did not qualify for home O2.  We will continue 10 days of dexamethasone after discharge.   Chronic HFrEF Echo with EF 40-45%, mild-mod MR.  She has no evidence of decompensation Cardiology was consulted and signed off now Continue home medications Due to AKI, I will liberalize her fluid intake Hold diuretics for next 24 hours    Elevated Troponin  In the setting of chronic kidney disease Troponin is down trending, no history of chest pain Echo stable from previous imaging Cardiology evaluated and signed off  Hyperglycemia without Dx of DM BG 192 on BMP
After 15 minutes, patient  presented of major back spasm and flushing. EMS was notified and vital signs were checked. Patients vitals according to personnel were within normal limits and was assessed properly.
Patient described that approximately 4 hours after receiving second dose, she developed headache, body aches, and chills. She stated that she experienced those symptoms until 2 days after when she developed a fever. She went to Emergency Room where her temperature read 103.9. She was subsequently admitted and diagnosed with decreased kidney function, pyelonephritis, and dehydration. She was discharged 4 days later. This information is all second-hand information received from the patient.
I had lower back and abdominal pain. I went to Urgent Care, where they sent me to the emergency room. They ran a lot of tests on me, EKG, two CAT scans, CBC bloodwork, X-rays. All tests came back as normal, showing nothing that should be causing the pain that I am experiencing. I was given medication to help reduce acid before I eat and something for pain. I am starting to feel better.
dizziness, diaphoresis, chest tightness, hives on torso, itching, throat tightness, swollen lips, bloodshot eyes. Took benadryl and prednisone.
Dizziness, weakness, fever, chills, headache, rapid heartbeat, body aches muscle weakness for 4 days then chest pains for 3 days after other symptoms subsided. I had head pressure for 2 weeks and brain fog for 3 weeks.
accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to the cases 2019SA196355 and 2019SA196387 (same reporter).  This case involves an unknown demographics patient who was vaccinated with an expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (prefilled syringe)(lot not reported and Exp. Date 02-May-2019) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.
crawling sensation in his face and head; pins and needles in his hands and feet really bad; lower back pain; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8737) at right arm on 16Apr2021 14:00 at single dose for COVID-19 immunization (reported as because everybody is saying that we should; because he is 65). Medical history included ongoing Diverticulitis, ongoing Tinnitus, Stroke (About three years ago, he woke up one morning and started seeing two of everything and when he went to hospital they stated he probably had a slight stroke and was started on aspirin), bolt and screw in his neck due to a spinal injury, the disc collapsed, Cholesterol, acid reflux and thyroid. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW) from 2018 and ongoing because had a slight stroke, omeprazole from unspecified date (started taking at let 15 years ago) and ongoing for acid reflux, levothyroxine from unspecified date (started taking about 7 years ago) and ongoing for thyroid and atorvastatin from unspecified date (been taking about 10 years) and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. Family Medical History Relevant to AE was None. Relevant Tests was None. The caller stated she and her husband, got the first dose of the vaccine on Friday 16Apr2021. On Saturday (17Apr2021) her husband started having pins and needles in his hands and feet really bad and lower back pain, and this morning (19Apr2021) is having a crawling sensation in his face and head. She asked if he should get the second dose. No Investigation Assessment. Caller states patient is currently not taking any medication for these events. Events were not required a visit to Emergency Room or Physician Office. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
The patient received the 1st dose of the COIVD-19 vaccination (Pfizer) on 12/28/20 without any adverse events or side effects. After the patient's second dose of the COIVD-19 vaccination (Pfizer) on 1/19/21 she experienced fever, chills, lethargy and joint pain starting 12 hours post injection, lasting 24 hours post onset.  On 1/22/21 the patient began an anticipated menses lasting one week (until 1/28/21) in duration with heavier characteristics than typically experienced. Menstruation resumed  (adverse event) 48 hours later on 1/21/21 and continued until 7/28/2021 when a 10 day course of progesterone was started. During the 10 day progesterone course light spotting continued, with menstruation resuming on 8/8/2021
Left arm hurts when placed in certain positions. The pain affects sleep as  the stress of the arm stresses the neck muscles causing pain. It still hits a month after vaccine
pt recvd vax; pt devel joint pain; pt seen by MD & was dx w/chronic rheumatoid arthritis;
Information has been received from a registered pharmacist, concerning a patient, with no previous medical history reported who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 659406/0298X) subcutaneously on 16-Jun-2008. On 16-JUN-2008, in the evening her arm became red and swollen to the "size of a softball" at the injection site. The pharmacist suggested that the patient see her physician. Sought medical attention: spoke with pharmacist. At the time at the report, the patient had not recovered. There was no product quality complaint. Additional information has been requested.
Multiple raised, red lesions; some with vesicles, very itchy. Some appear like flea bites.
20min-1hour after the injection I was dizzy and nauseous.  Felt seasick and vomited 3 times. 10 hours after the injection I experienced severe body aches in my joints and muscles, had a high fever that that varied between 102.9 and 105.6, and had severe chills, and headache. 17hours after the injection I currently have a fever of 102.7, severe body aches in both muscles and joints, chills, headache, lack of appetite, and severe exhaustion.
Redness, swelling, heat, pain and itching at the injection site nine days after injection. Approximately 2 inches wide and 1 inch tall.
Patient noted tingling of upper lip. This sensation lasted for several minutes but resolved on its own without medical intervention.
Pt had received the vaccination of PCV13 when it was suppose to be the Flu vaccination.
HIVES DEVELOPED ON LEFT LEG AND THEN RIGHT LEG. THEN DEVELOPED ON BOTH ARMS. CHILD HAD ITCHING. SHE WAS SCRATCHING A LOT. MOM CALLED NURSE HOTLINE @ HOSPITAL.
Whole arm went numb for an hour and then was so painful i can't lift it and it's continued into the next day
Headache, joint ache, muscle soreness, nosebleeds, lathargic,  spasms in the chest area
I started having burning sensations in my right ankle that would come and go and went on for 2.5 weeks. On 7/19, the burning was into my mouth and tongue. It was numbing. It went down my throat and it was burning and numb and hard to swallow. It was like it feels when you go to the dentist. I had body aches that day off and on. The feelings would switch between my arms and my legs. By that weekend, I had no taste (July 23-25) in my mouth and was still having burning sensations. One episode lasted for 4 hours at night and couldn't get to sleep. I had foggy feeling brain. This lasted a good week. After about week my tongue started to feel better, and could start to taste. I still had burning sensations throughout different parts of my body. July 26 I went to my doctor, did blood work which was normal. I called her back the next week to tell her that I started getting itchy spots all over my body. My doctor then gave me a prescription to try to help with the itching ( a tablet) that hasn't helped. As of today's date, the burning sensations still come and go and the itchiness all over different parts of are still here. I feel like I constantly need to scratch all over my body. The achy body symptoms are now few and far between.
Woke up at 11 pm on 12/28 with a fever of 102.5 Terrible headache  Body aches  Uncontrollable shaking
Woke at 1am with fever of 104.1, unbearable muscle pain/stiffness, shivering, extreme headache/nausea. At 10am the same day (the day after the vaccine) I was able to get fever down to 102.3 and all the symptoms remained with the addition of shooting sharp nerve pains all over randomly.  It was the worst of these symptoms to the extreme. Then for 2 days I lost all taste. I could barely get water or ginger ale, crackers down. By day 4 the fever went down to 100 with all symptoms remaining and becoming a little less severe, except for the nerve pain shooting everywhere, which lasted for 13 days after the injection. I haven't had any vaccines since a very bad reaction to tetanus in the year 2001. I had a flu shot in 2001 that was by far worse than any flu I ever had so I no longer get any vaccines/shots.
NEAR SYNCOPE/VASOVAGAL- Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
Pfizer COVID-19 Vaccine EUA. Instead of being given a COVID-19 vaccine, patient was stuck with a syringe and needle that did not have any vaccine drawn up in it at the time, only air. This error was caught when it was discovered that there were syringes missing that had not had vaccines drawn up in them yet. The patient was still in the building, had been poked about 2-3 minutes prior to the error being discovered, so the vaccine was then administered to the patient correctly. Pt also tested positive for COVID-19 3/19/21 and received the vaccine within 30 days of testing positive for COVID-19.
Headache, chills, skin hurts to touch, muscle aches especially across shoulders and traveling up neck, joint pain almost everywhere, nausea.
Phone call from client 08/08/2002, became sick next day after MMR - nausea, H/A's, fever, chills, bodyaches, weals, had diarrhea twice a day x 1 week, had vomited x 2. Instructed to see PMD.  P.C. to client 08/12/2002- did not go to PMD- feel better- stomach still "tore up".
Intermittent numbness/tingling in both arms, Intermittent discoloration of his hand and tingling in his feet
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304475. This case involves a 11 years old female patient who had administered MENACTRA that were not stored in appropriate temperature ranges. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BOOSTRIX for Immunisation; and FLULAVAL for Immunisation. On 22-Oct-2018, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, expiry date- 06-Oct-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for administered doses of MENACTRA that were not stored in appropriate temperature ranges. 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.
Forgetfulness 3 days after receiving vaccines, went to ER examined and sent home.  Referred to  Neurology