chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle weakness in legs; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue) in a 55-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Clot blood (blood clot in legs) and Gout.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 milligram/ every 4 hours for 1.5 days. At the time of the report, MUSCULAR WEAKNESS (muscle weakness in legs), PYREXIA (fever) and FATIGUE (fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High.    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Patient received vaccine 9/23/15, face began swelling and throat got scratchy. Took BENADRYL and went to ER.
When I woke up, my entire body felt really bloated and soar. Moderate headache. Dizzy, could not think. Walking very slow. No desire to do anything. Sat in my recliner most of the morning with body aches and sleeping. In the early afternoon, I decided to go lay down in my bed to get more comfortable. Continued drinking water throughout the day. Woke up about 7:00 PM. As I got out of bed, I immediately noticed that I was feeling about 80-90% better. The whole body bloating feeling was gone. Body aches were very reduced. Headache was very minor. I felt like a different person when I woke up (better). Very freaky feeling! I was also able to eat some good at this time.
afib; So sore/I ached all over but felt better; I could hardly get out of bed; sweating; cold; sick to my stomach; had a splitting headache; so tired; chills; fever; joint pain; nauseated; awful diarrhea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 12Aug2021, as dose 1, single for COVID-19 immunisation. The patient medical history included angioedema for 6 or 7 years from BP medications. The patient concomitant medications were not reported. The patient after woke up in the morning experienced sore/ached all over but felt better, could hardly get out of bed, sweating, cold, sick to stomach, splitting headache, so tired, chills, fever, joint pain, nauseated and awful diarrhea on 22Aug2021. This lasted for 2 days then it started to feel better on Sunday/Monday. Then on Monday night, it ached all over but felt better. On Tuesday, went to the ER because of feeling worse while wokeup and they told that afib on 25Aug2021 but they didn't think it was from the shot and was hospitalized for a week. The patient did not had afib before. The outcome of the event afib was unknown and the other events were recovered on an unknown date of Aug2021. The patient second dose was on 02Sep2021.  Information on the lot/ batch number has been requested.
Child came in office 3/6/07 and diagnosed with Varicella. All over back, abdomen and neck. Symptomatic care.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number reported as L026599, expiration date 22-JUN-2017, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician and a healthcare worker referring to a 35 year old female patient with no pertinent medical history and no known allergies. On 06-FEB-2015 the patient was vaccinated dose 1 of M-M-R II (0.5 ml, subcutaneous, right upper arm, lot # reported as K008198 Exp 05-JUN-2016). There was no concomitant medication. The healthcare worker reported that patient took a urine pregnancy test, at home, on 09-FEB-2015, and it was positive for pregnancy. The LMP and EDD was not known. The pregnancy outcome was outcome pending. The outcome of vaccine exposure during pregnancy was unknown. Additional information has been requested.
Fever, chills, muscle aches, headache, brain fog Started 10 hours after vaccine administration, lasted 24 hours
Severe swelling in legs and feet, capillaries breaking, red patches (hot to the touch), extreme pain when standing, lack of circulation, vasculitis and inflammation of the vascular system. Recurring every few months requiring time-off work.
Bladder infection for about a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Bladder infection for about a week) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Handicap and Incontinence (wearing Depends makes it hard not to get an infection).    In February 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 CYSTITIS (Bladder infection for about a week). At the time of the report, CYSTITIS (Bladder infection for about a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  The patient was prescribed antibiotic (unspecified) for bladder infection. She did not take the antibiotics at the time of reporting (she wanted to know if it would be ok to take the antibiotics before getting second dose). The patient had her second dose scheduled on 12-Mar-2021.
Administered Novavax 0.5ml on Lt deltoid IM, lot # 4302MFZ3 Exp 2/28/2023. Once I realized that the vaccine was expired, I contacted Novavax Manufacture, they stated up to provider discretion if patient need to be re-vaccinated. I spoke with Provider Dr., he stated that the patient does not need to be re- vaccinated. I called patient to explain the situation and current recommendations, patient verbalized understanding.
Swollen rt arm-described by mom as a knot in the muscle-some redness & tenderness; taken to MD 2 days p/vax; no tx given; stated a minor react;
headache, temp. of 100.4, chills, body ache, swollen lymph nodes right side, fatigue
Since One month after receiving 1st dose of vaccine, monthly periods are erratic and I've never fluctuated. I have more cramping than have experienced in the past, and reg monthly weeklong migraines have decreased in severity and length. HOWEVER, I am at that age, could it be menopause starting??
Symptoms started 15 min after receiving Moderna vaccine, nausea, chills, on and off leg numbness, fatigue. Syncope on 4/14/2021, work up in ER negative. Hospitalization 4/19-4/20/2021 with chest pain and severe headache. EKG in ER abnormal (T wave inversion, long QT), repeat EKG next day wnl. CT chest for chest and CT head both wnl. Diagnosed with UTI. Started on Pantoprazole and Famotidine for GI symptoms (epigastric pain, bloating).  On Sunday 4/25/2021 left arm numbness and weakness, another  ER visit was told Cervical radiculopathy. Still severe fatigue, muscle, and joint pain, on and off numbness of the left arm, muscle twitching, GI symptoms. All labs and imaging wnl.
Information has been received from a certified medical assistant (CMA) concerning a 19-week-old male with no medical history or allergies who on 03-DEC-2007 was vaccinated PO with the second 2.0 mL dose of ROTATEQ. There was no concomitant therapy. The CMA reported that on 05-DEC-2007, the patient developed diarrhea. No laboratory/diagnostic tests were performed as medical attention was not sought. The patient's diarrhea subsequently resolved without treatment. No other symptoms were reported. Additional information has been requested.
In mid March i developed an itchy rash on the scalp behind the left ear, few days later I was vaccinated  with the first dose of Shingrix. I treated the rash with hydrocortizone which appeased the itching for a while. Few weeks later I developed an itchy rash on the abdomen again i treated the rash with the Hydrocortizone which appease the itching but it the redness never went away .On May 16 I was seen by a dermatologist who prescribed FLUTICASONE PROPIONATE which i used the same day. I went for the second dose of Shingrix while the Fluticasone seemed to have cured the redness on the abdomen. Unfortunately the itchy redness on the abdomen returned on 09/19/2019 and returned also on the scalp beyond the left ear. I am not sure if the redness and the itching are related to the vaccine. I am not on any medication beside a 81mg aspirine.
Pt received series of 3 vaxs of Engerix B, and has not developed any titers
On 8/1 left deltoid at site of vaccine 2" X 4" area of swelling, redness heat. No fever.
woke up with ringing in right ear and discomfort under armpit, discovered had grapefruit size inflammation under armpit area.  Later felt sensation of borderline numbness in arm and side of face.  Went to ER, had an MRI and blood pressure was very high for myself reading at 159/98.  Followed up with primary physician several days later with concerns. Increasing ringing of the right ear increasing daily, made appointment with ENT on 9/07/21 along with a hearing test to be conducted.
62.6kg 52 yo F was in clinic for her first Covid19 vaccination on 8/19/21.  Following IM injection of Moderna vaccine (lot #007C21A) in her left arm at ~1402, within 5 minutes, patient developed tingling of lips, epigastric pain, nausea, visual changes (tunnel vision) and sensation of not being able to get enough air.  Developed tachycardia (120's) and mildly elevated BP with SBP in 150's.  Patient reported palpitations and fluttering in her chest.  No itching.  No hives.  Patient was transferred to ED via EMS.  BP elevations had resolved as of first documented assessment at 1530.  Patient reports similar reaction to Humira.  Treated with promethazine 12.5mg IV, LR 1L and GI cocktail.
Clinic was documenting on paper due to connectivity issues, patient denied having received any COVID vaccines previously, but on annotating to the chart the medical team noted pt received 2 doses of Moderna previously, documented as given on 5/20 and 6/25 (same day as our pop-up clinic giving Pfizer).  Pt was asked twice by clinicians if he had received any other COVID vaccines but denied at time of administration and therefore was give a dose of Pfizer at this clinic. No reaction was noted during his observation period, he was provided with all of the appropriate teaching sheets and informed of the symptoms which would require follow-up with a medical provider. Will follow-up by phone and will ensure pt does not receive another dose of Pfizer.
Patient got second dose past the recommended window; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got second dose past the recommended window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got second dose past the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got second dose past the recommended window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Developed nausea and muscle weakness on the day about 2-3 hrs. after vaccine was given.  Had muscle weakness in lower legs X 4 days and could not climb stairs to her apartment.
INAPPROPRIATE ROUTE OF DRUG ADMINISTRATION; FEELS BEAT; SEVER HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 70 kilograms, and height was 177.8 centimeters. The patient's past medical history included non smoker, and concurrent conditions included 4 drinks per week. The patient had no known drug or non-drug allergy. The patient had no history of drug abuse or illicit drug use. The patient was non-smoker. The patient had no pre-existing acute illness or illness at the time of vaccination or 30 days prior to vaccination. The patient did not have significant past history of similar events and not had any adverse events after any previous vaccinations. The patient did not have significant history of hospitalizations. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feels beat. On MAR-2021, the subject experienced sever headache. On MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced inappropriate route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inappropriate route of drug administration  on 13-MAR-2021, and the outcome of sever headache, feels beat and fatigue was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950781A, A0950782A and A0959783A.
Severe redness was noted, the morning after injection, in the left deltoid region eventually spreading with redness, edema, warmth and tenderness involved entire upper arm extending from top of shoulder to elbow. TX was ZYRTEC and BENADRYL round the clock for three days.
Mother reported to Health Dept. that pt. woke up on the morning of 3-19-09 complaining of being dizzy and unable to get out of bed.  He followed up with a private physician the same day.
pt feldt dizzy and complianed of heigh pulse. we put her dwon to floor and raised her legs. we monior her woth bp which came 179/118 and pulse was 66. we gave pt a cold pak to put it on her neck and let her rest for 15 mintues. she started feeling better. we took bp again =and iut cake 148/89. pulse 63. pt waited another 15 mintues and felt better and left.
administered PREVNAR 20; the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), described as "administered PREVNAR 20"; DEVICE BREAKAGE (non-serious), described as "the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip". Additional information: One of the staff administered PREVNAR 20, and the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip. They still have the syringe and would like to know how to proceed. The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Terribly ill since the second vaccine; Her heart; This is a spontaneous report from a contactable consumer. A 17-year-old female patient received (BNT162B2, formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND Dose, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, formulation: Solution for injection) for COVID-19 Immunization. The patient experienced terribly ill since the second vaccine and her heart on an unspecified date. The outcome of the events were unknown.  Information on lot/batch number has been requested.
3-4 weeks after receiving second Moderna Covid 19 vaccine I began experiencing persistent elevated heart rate.  Continual:resting heart rate in the mid 90 bpm and when exercising or walking fast or up stairs heart rate above 125 bpm.  Experienced heart palpitations and shortness of breath. Diagnosis after all tests done: Sinus Tachycardia Medications: Trial of Metoprolol Er 25 mg- symptoms worsens with fatigue-medication discontinued.  Will reevaluated medication options in January with Cardiologist
nonstop crying for 12hr 11FEB97-12FEB97;fever x 48hr p/vax from 101-104;
Tested positive for COVID-19 after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after first dose of vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received smallpox 31 Mar 09 Lt upper arm, which was followed by swelling, redness, and increasing tenderness, no fever, Pt stated she was vaccinated with Smallpox previously on 28 Nov 2007, but no desired effect and it did not take.
Difficulty breathing; Palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, less than a week after receiving Shingrix, the patient experienced difficulty breathing and palpitation. On an unknown date, the outcome of the difficulty breathing and palpitation were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing and palpitation to be related to Shingrix.  Additional details were provided as follows: About 2 to 3 days after getting the vaccination, one morning, the patient experienced difficulty breathing and palpitations due to which she had to go to the emergency room. The patient was sent back home the same day and was still experiencing the adverse reactions, but not as intense. No other details were provided. This case linked with US2020091749, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091749:same reporter
temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 04-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
woke up with a big headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (woke up with a big headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced HEADACHE (woke up with a big headache). At the time of the report, HEADACHE (woke up with a big 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.   No concomitant medications reported. No treatment information was provided.
Next day --coughing, sneezing and congestion, by the third day symptoms began to resolve with some residual cough
After getting 1st Covid vaccine, patient waiting in lobby and mom comes to check her son. Patinet has vagal response and loss of consciousness for couple of second and blurred vision also. Vital sign: BP 60/38, HR 57, RR 18, O2 SAT 98% RA. Called 911. Patient comes back and drinks some drinks and recheck vital sign. BP 92/52, HR 18, RR 71, O2 SAT 98% RA. Check blood sugar 117. Patient refused to go to the hospital. Patient also refused chest pain, SOB, or any issue. FNP present during this.
FOR SEVERAL DAYS FOLLOWING ADMINISTRATION OF THE VACCINE, PATIENT SUFFERED FOR FEVER OF 101F, SORE THROAT, CHILLS, CONGESTION, RUNNY NOSE AND VOMITING.
per mom-1st sx excessive sleep-26OCT t104.9, 27OCT limp & lifeless, later aroused, seen by MD, not crawling or standing as had previously-partially paralyzed on left-abn CAT Scan;