chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of leg knot in a male subject of unspecified age who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  The reporter is the parent of the subject.  A physician or other health care professional has not verified this report.  On an unspecified date before 17 May 2007, the subject received 1st dose of Pediarix at an unspecified date of injection.  At an unspecified time after vaccination with Pediarix, the subject experienced "a knot in his leg."  At the time of reporting the event was resolved.  The consumer reported that the leg knot "lasted over a month."  The consumer also reported that the subject, "only got Pediarix so far."
06/20/2003: Early AM: patient woke up, father noticed patient to be unresponsive with eyes turned to pink not jerking neck stiff, 2-15 minutes.  No temperature taken.  Parents didn't think baby was hot and gave tylenol.  Brought to ER 12:30 AM 06/21/2003. Temperature 100.3 with normal exam.  CBC, normal
Administered GARDASIL .5 cc IM (L) D and pneumococcal 23 .5 cc IM (L) D. As I moved to patients right side he had an immediate syncopal episode and fell from chair to floor. He was unconscious for approximately 20 seconds.
Nine days after I received my first dose of the Moderna vaccine, a red, warm knot appeared near the injection site. It's about an inch-and-a-half in diameter and is still there 15 hours later.
I have had chronic shoulder, upper back fatigue/soreness, constant. 11/2020 started having PVC/PAC with symptoms.
2" diameter swelling, erythema and pain at site of injection evening after day of injection.
Cold; Chest congestion; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunization.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion). On 19-Jan-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Cold) and CHEST DISCOMFORT (Chest congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The patient had taken Zinc, Aspirin, Vitamin C, OTC decongestant.   Reporter did not allow further contact
no additional Adverse event; The medical assistant could not rule out that the imrpoperly stored vaccines, PEDAVX HIB, VAQTA and ROTATEQ were administered to patients.; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant therapies were not reported.   Between the week of 11-JUL-2022 and 15-JUL-2022, there was a temperature excursion with the lowest temperature at 0.92°C, of 11 hours and 30 minutes of the following vaccines: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #U024091, expiration date: 29-OCT-2023, and lot#batch# W000458, expiration date: 17-JUN-2024 administered to prevent haemophilis influenza B infection (formulation, strength, and route of administration were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1742419, expiration date: 23-JAN-2023, and lo#/batch# W004503, expiration date: 15-MAY-2023,  administered to prevent rotavirus infection (formulation, strength, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) lot #U033212, expiration date: 07-NOV-2022, administered to prevent hepatitis A infection (formulation, strength, and route of administration were not provided); and  hepatitis a vaccine, inactivated (VAQTA) lot #W002889, expiration date: 06-MAR-2023, administered to prevent hepatitis A infection (formulation, strength, and route of administration were not provided).   The reporter could not rule out that the improperly stored vaccines were administered to patients on an unknown date in July 2022. (Improper storage of product in use). There were no additional adverse events reported (no adverse event).  This is a non-valid case due to lack of patient's identifiers.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 19-SEP-2012 the patient inadvertently received a dose of ZOSTAVAX (lot#, dose, route and indication not reported) in a doctor's office. And then on 29-JUN-2013, the patient received a dose of ZOSTAVAX a second time, (lot# and dose not reported), subcutaneous in a pharmacy. The pharmacist stated the patient was not a "regular" patient in pharmacy. Pharmacist stated patient was advised by physician's office to visit pharmacy about ZOSTAVAX he received. Pharmacist stated patient seemed a little confused when he came to pharmacy on 11-DEC-2013, no other effects reported. The outcome of the events was unknown. The patient had not sought medical attention. Additional information has been requested.
Pt recvd flu vax  & was 1 of 15 pts who devel influenza & was hospitalized;
Patient received vaccine and was driving toward the observation area when she abruptly became dizzy, lightheaded and "blacked out" according to the patient.  Patient's vehicle veered off the road and made contact with a parked Police Vehicle.  Patient resumed consciousness and her foot on the gas and recalls the policeman stating, "Hit your brakes."  Patient was evaluated by Fire Rescue and initially presented with hypertension, diaphoresis and was pale.  Fire Rescue was called to transport patient to ER for further evaluation, but patient refused transport.  Vitals stabilized, car accident was documented and patient  drove home at 11:35am.
pt recv vax & became pale white in color;no obvious resp distress;oriented x3;pt reported face was flushed;pt comfortable on knees;exp full feeling in throat;pt later went to MD who states poss d/t recent illness;
Significant redness and swelling at injection site on right arm, known site of pneumonia vaccine. Fever up to 102, arm painful with activity.
Pfizer 12/23/20, 1/13/21. Positive on 2/1/22
The usual mild headache, muscle soreness, fatigue. Most concerning, and first experience after 2 Pfizer vaccines and 2 Pfizer boosters, after this vaccine I experienced pain and sensitivity to slight pressure in hip.
Around 2 hours after the vaccine I had diarrhea for 2 hours (so from about 12:30pm-2:30pm). After that I felt flushed, and around 5:30pm I had a fever and my heart rate began to rise and blood pressure drop.. My heart rate continued to rise until about 9:30pm, and then it began to fall. I also experienced a terrible headache, moderate body aches, and chills and hot flashes. But the diarrhea and rapid heart rate were very concerning to me--I felt very sure something was wrong. This morning I have a low heart rate and low blood pressure and I feel very weak, but other symptoms are gone. I don't have a primary care doctor and read that the diarrhea and heart symptoms could be signs of a severe reaction and I wanted to report it.
Severe pain in spine started 4 hours after vaccine; body aches and severed headache started 8 hours later with inability to sleep;  severe diarrhea, throwing up; extreme exhaustion. Headache, severe diarrhea and throwing up continued for three days.  Diarrhea, nausea  and loss of appetite has continued for two weeks which has led to dehydration and overall body muscle cramps
1wk prior to vax shaking episodes noted (sl tremors);3JAN noted to have first shakes then became stiff w/blank look x 2-4seconds;hospitalized overnoc on 5JAN for observation;all monitors neg;EEG,EKG,blood work on 22JAN96;
pt presented to clinic 1hr later w/SOB & gen urticaria;pt given epi;BP 160/90, R14, P108;
4 days after vaccine, rash on chest and vague itching on back with rash. Consistent with shingles.
Pt is a 60 yr old female who presents for possible vaccine reaction. Pt complains of lower extremity and back muscle pains, rated 10 on 1-10 scale. Vaccines given in left arm on 2/14/11. Medications and allergies reviewed. Pt blood sugar checked as she is diaphoretic, results 197, one hour post prandial. Pt states woke up at 3 am on 2/15 with severe myalgia and fever, HA and left arm soreness. States fever was 101.0; since then, fevers continue (this am 100.3) and arthralgia and myalgia worse to full body but not similar to usual arthritis/myalgia pain. Took Methotrexate on 2/14/11 in evening. Received ADACEL and PNEUMOVAX on 2/14/11 to left arm.
Redness, swelling (L) arm 1-2 days after vaccines were adm. - soreness. Sx improved 7-30-08. Dx: cellulitis.
Information has been received from a nurse concerning a 12 month old female who on 24-APR-2007 was vaccinated SC with a 0.5 mL of Proquad (Lot # 657264/0294U). On 03-MAY-2007 the patient experienced rash, diarrhea and fever of 102F. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Extremely heavy period; Fever; Headache; Body ache; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included light periods for years. Concomitant medications included alprazolam (XANAX) and zolpidem tartrate (AMBIEN); all from unknown date for unspecified indication and unknown if ongoing. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 28Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 24May2021, five days after the vaccine, the patient experienced extremely heavy period after 73 days of no period and having light periods for years, fever, headache, body ache, chills and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely heavy period, fever, headache, body ache, chills and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Additional Details: patient has a complicated medical conditions (i.e., work injuries 3 years ago, diabetes, hypertension, hyperlipidemia, hypothyroidism, and sometimes loss her extremities controls.) she got her second dose of Moderna COvid vaccine at 4:24pm on 3/29/2021 and started having dizziness around 4:40pm and fell down. She had no breathing problem, no pain/ rash. The pharmacist gave her one 25 mg benadryl. Her blood pressure was 173/85 and her heart rate was 96 when 911 came to admit her into hospital.
TIREDNESS; FEELING LETHARGIC; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 63 year old male. 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 admin not reported, batch number: 212A21A expiry: Unknown) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced feeling lethargic. On 03-DEC-2021, the patient experienced fever. On 03-DEC-2021, the patient experienced headaches. On 03-DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.9 F. On 06-DEC-2021, the patient experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling lethargic, headaches, and nausea on 06-DEC-2021, and had not recovered from fever, and tiredness. This report was non-serious.
Information has been received from a consumer concerning her mother, an 85 year old female patient with lymphoma since 2005 and last radiation on 22-JAN-2009, who on 02-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included morphine. On the following morning, on 03-JUL-2009 the consumer's mother health had been deteriorated. Her mother was hospitalized at the time of the report. The consumer reported "her mother is not expected to live through the week due to this adverse event". At the time of the report the patient was not recovered. Additional information has been requested.
Within 45 minutes lightheaded, within an hour extreme fatigue and chills, ear ache. Several hour after skin hyper sensitivity, nausea. The next day fatigue , nausea and mild cold symptons, migrane.
Dizziness Narrative:  PT W/HX TYPE 1 DIABETES STATED "HAD NOT EATEN YET" 1226: C/O DIZZINESS 131/66 55 CBG 97 97% RA 1241: 110/55 53 CBG 92 1251: 127/66 HR 57 STANDING BP 100/66 HR 56 PT STANDING FOR 1 MIN REPEAT BP 109/61 D/C STABE 1255 INTERVENTIONS: JUICE(GATORADE)  Other Relevant History:
Information has been received from a consumer concerning a 40 year old male relative who on 03/15/99, 05/26/99, and 09/27/99 was vaccinated with a three dose series of Hepatitis B vaccine recombinant. On 10/15/99, the patient experienced a loss of strength and arthritis pain in his arms and fingers, atrophy of the arms and legs, loss of balance, and soreness in the upper back. At the time of the report he had lost twelve pounds. The patient sought unspecified medical attention. No further information is available.
92y.o. male with a PMHx significant for bladder cancer, CKD (Stage 4), HTN, CAD, dementia. Pt presents to facility  from SAR after patient was found to have multiple days of fever and generalized weakness. He had received tylenol with some relief, but fever persisted, according to family. Family had noticed that patient had cloudy urine in his urostomy bad and they had concern for infection. In the ED, patient was worked up for sepsis and covid-19 test was positive. He received IVF bolus, started on Vancomycin and Merrem, labs drawn and blood/urine cultures sent. Troponins were negative, Lactic acid 2.0, UA positive for bacteria, chest xray shows small pleural effusion. Upon arrival to the unit, patient had some difficulty with communication due to language barrier. He is not in acute distress, denies chest pain, shortness of breath, headache, dizziness, nausea, abdominal pain, diarrhea. Spoke with patient's son and daughter over the phone to discuss patient's home medications and history. Disposition - Pt stable for dc today home. Daughter refused home care . Pt to continue home meds except lasix. F/u with specialists
Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). On 10-JUL-2007 5 days later, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It is unknown if medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007.  Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# reported as "09607").  Subsequently, the patient experienced shortness of breath, muscle ache, dizziness and nausea.  It was reported on 10-JUL-2007, the patient still had dizziness and some muscle ache.  It was recommended that the patient not continue the series.  At the line of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
MOTHER NOTED THIS AM REDNESS AND SLIGHT SWELLING OF CHILD'S RIGHT DELTOID AREA.  NO FEVER OR ANY OTHER COMPLAINTS REPORTED FROM PARENT.
Localized swelling  since injection first administered. About 7-8 days later redness, itching, and fever began at sight of injection swelling.
Patient passed out approx 15 min after his Gardasil vaccine. Happened with 1st and 2nd dose. Patient has not had 3rd dose yet. 1st dose - 7/5/13; 2nd dose - 10/14/13.
Chest pains, shortness of breath, started 24 hours after 2nd injection, has continued for past 5 days
patient is pharmacy tech on the same pharmacy . after she had Moderna shot on 05/04 , she felt mild nausea feeling that afternoon, took 30  minutes rest  but worked through her shift anyway. After she got home and took shower, same night felt like muscle spam on her left side of the body & unable to walk . that continued till 5/07 and got better. on 05/07 as the muscle spam got better ,she got fever, felt better thorough the weekend and felt normal NOW. Took APAP 500 mg and IBUPROFEN 200 mg , every 6 hours as needed alternatively . On Monday 05/10  she showed up to work.  She wasn't answering calls so VARES completed on 05/10
Administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, OVERDOSE (Administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        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.   Pharmacist didn't mentioned any side effect.  No concomitant product information was provided.  Treatment information was not provided.
Case number PHEH2015US021092, is an initial spontaneous report received from a healthcare professional on 19 Oct 2015. This report refers to a 13 years old female patient. Medical history and concomitant medication were reported as unknown. The patient was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. It was reported that the patient was under the age of 18 years and received the vaccine inadvertently. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Soreness, redness, swelling at injection site X 3 days. Treated with Advil and cold compress. Assessed by RN on day 3-appears resolving.
Had Varivax on 1/31/06 got chicken pox on 8/11/06.
12/13/21 - Moderna booster 12/22/21  Hives, dermatographia, tightening in esophagus  I have had chronic urticaria and dermatographia for almost 5 weeks now. Also some mild acid reflux. The urticaria changes location all over my body and relents after about an hour. Dermatographia - red welts on skin wherever I touch or rub skin. I have been taking antihistamines to treat the urticaria.
Lack of eating; Pounding headache; Stomach upset; Not feeling well; Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well), DECREASED APPETITE (Lack of eating), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Injection arm soreness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, SERTRALINE and LINAGLIPTIN (TRAJENTA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). On 23-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well) and HEADACHE (Pounding headache). On an unknown date, the patient experienced DECREASED APPETITE (Lack of eating). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well), DECREASED APPETITE (Lack of eating), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Injection arm soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications included Pre-plus for weak bone. Patient did not receive any treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow up received on 3-AUG-2021,contains new information. Outcome of events were updated to Recovering from unknown. Narrative updated.
This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after receiving the first dose of the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. Patient received monoclonal antibody treatment for the COVID-19 infection. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU attached NNI.
Site is painful, hot to touch, red, raised and swollen about 5 inches in diameter. Joint pain, breast pain, headache.
No hx of seizures. Woke up with severe abdominal pain and need to have bowel movement. Diarrhea 1x wtih nausea. Severe ear ringing, headache, confusion, and out of body feeling. Loss of control over large muscles, shuffling gait, unable to open eyes or speak, impaired LOC, anxiety and emotions, diaphoresis and hyperventilation.