chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, Swelling, Pain, Headache, Hot to touch, Fever, Chills, Unable to sleep, Unabletolay on the left side,  Nausea
Whole body is achy; Pain in right neck; Pain in right shoulder; Fever with chills; Sweating in palms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever with chills), HYPERHIDROSIS (Sweating in palms), PAIN (Whole body is achy), NECK PAIN (Pain in right neck) and ARTHRALGIA (Pain in right shoulder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Fever with chills) and HYPERHIDROSIS (Sweating in palms). On 26-Mar-2021, the patient experienced PAIN (Whole body is achy), NECK PAIN (Pain in right neck) and ARTHRALGIA (Pain in right shoulder). At the time of the report, PYREXIA (Fever with chills), HYPERHIDROSIS (Sweating in palms), PAIN (Whole body is achy), NECK PAIN (Pain in right neck) and ARTHRALGIA (Pain in right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
t105 x 3-4 days came down w/meds; red swollen leg (lt) mom thinks; screamed x 48 hrs;
the ActHIB portion mixed with normal saline of the Pentacel; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 months and 27 days old male patient who was given ACT-HIB portion mixed with normal saline of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 16-Aug-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via intramuscular route in the left thigh.  The reported batch numbers were for diluent lot: U6216AB expiration date: 10-Oct-2020, box lot: UJ014AAA expiration date: 10-Oct-2020 and powder lot: UJ014AA expiration date: 10-Oct-2020.  It was an actual medication error inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  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.
An attorney reported that a male child received series of Orimune, DTP and Tripedia, Engerix-B, ActHIB, and MMR vaccines from shortly after birth through 18 months of age. It is alleged that, as a result of the cumalative exposure of thimerosal in the vaccines he received until 18 months of age, the child suffered mercury poisoning and neurological injuries that are permanent in nature. He was reportedly healthy at birth, with normal APGAE scores. At 18 months of age, the child reportedly began to regress and now suffers from "disintegrative autism or autism spectrum disorder." Immunization record included by the reporter also indicated that the child continued to receive DTP, Orimune and MMR vaccines past 18 months of age.
Information has been received from a health professional concerning a 37 month old male, with no medical history and no allergies, who on 5/15/2005 was vaccinated once with a first 0.5ml subcutaneous dose in the left anterior thigh of varicella virus vaccine live (lot 644569/1158M). Subsequently the patient experienced a mild case of varicella breakthrough. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that on 6/24/2005 the patient experienced a rash consistent with varicella. It was reported to be mild and no treatment was necessary. It was reported that the patient recovered. Additional information is not expected.
Within an hour of shots, the baby had low-grade fever to high-grade fever of 101F, anorexia, throwing up and excessive fussiness for 2 days, despite a round the clock Tylenol. Prevnar shot.
Runny nose, dry cough, extreme fatigue, vomiting, diarrhea, rash on my arms and trunk area, slight loss of sweet sensation, constant taste of bile in my mouth although I believe this was from the PAXLOVID I was prescribed.
On the eighth day after the shot my arm swelled up to the size of my palm. It was warm to the touch, raised, red and slightly tender. It lasted for about a week before the redness went away.  It was itchy, and the itchiness lasted for about a month, but it would come and go and wasn?t terrible.
Breakthrough case admission after 3 vaccines Moderna 3/5/21 Lot# 029A21A;  Moderna 3/31/21 Lot# 028A21A;  MOderna 12/3/21 Lot# 0027H21B;
Soreness to arm at site of injection, fever, weakness. Symptoms resolved after a day.
Migraine that lasted 12 hours, and high heart rate with resting and minor activities. Running anywhere from 95-130 resting and 130-150 with light walking to and from. Normal resting heart rate is 70's, and moderate activity is usually in the 90's.
Extreme fatigue; Loss of appetite; Low blood sugar; This is a spontaneous report from a contactable consumer, the patient. A 42-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 arm left on 31Mar2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 with unknown start date and end date. The patient had no known allergies. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (LOSEASONIQUE) on unknown date for an unspecified indication. Prior to the vaccination, the patient was 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 vaccination. On 03Apr2021 at 09:00 the patient experienced extreme fatigue, loss of appetite and low blood sugar. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme fatigue, loss of appetite and low blood sugar was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt was leaving immun room & fainted falling face first;BP 130/82 pulse 80 regular;resp were regular;not labored;bleeding noted @ middle of top lip & cut @ bridge of nose;EMT arrived & provided care;pt went to hosp w/mom in pvt car;
child had a facial swelling; Rash across the bridge of nose and under eyes; This non-serious spontaneous safety report, with Case ID: 02395447 (Interaction Number 02395443), was received by partner, on 23MAY2023 and forwarded to agency on 26MAY2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "child had a facial swelling and Rash across the bridge of nose and under eyes".  Further information is expected.
his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week) 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 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 NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week). At the time of the report, NAUSEA (his wife started feeling nauseous after the first dose of the Moderna COVID-19 vaccine taken earlier on the week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient feeling nauseous after the first dose. No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Questioning delayed response  after receiving second vaccine on 02/24/21. Developed  nephrotic syndrome ,MCD , AKI and admitted to hospital on July 14. No previous history of kidney disease, hypertension or diabetes
Headache, arm pain followed by body pain and joint pain, nausea, diarrhea, fatigue, tightness in chest. Took Tylenol, extra lansoprolol, and rest. Limited food intake. Drinking water
MD's office nurse administered ACTHIB vaccine to adult male thinking the product was Tetanus Toxoid vaccine because it said clearly on the box in parenthesis just like a generic name "Tetanus Toxoid Conjugate". (The MD did not want patient to receive the combination vaccine with Pertussis). Patient had to return to get another vaccine of just tetanus.
Doctor called wanting to know side effects of Rabies vaccine, c/o body aches and abdominal cramping, started on menstrual cycle, unsure if relates or not. Report is this don't resolve will go to emergency rm. No further contact. Recovery unknown, will call if s/s unresolved.
Patient received the injection at 1734 and was told to wait 15 minutes for monitoring per protocol. Immediately after receiving the injection, the patient became nonverbal with his head tilted back in the chair. NP immediately attempted to re-arouse the patient but was unsuccessful. At approximately 1735 the patient received Epinephrine 0.03 mg.  Patient became awake and responsive.  patient began screaming he ?could not breathe?. Patient verbalized he had a history anxiety.  EMS was contacted and VS were taken. @1745 EMS arrived on scene
Adverse event: mennhoragia exceeding 50 days Treatment: none  Outcomes: continuing mennhoragia
Information has been received from a physician concerning an approximately 60 year old patient who in approximately October 2002 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 642722/0165M).  Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm.  Within hours of vaccination, in approximately October 2002, the patient developed a "big time reaction" from the deltoid to the elbow.  The reaction persisted for 3 to 5 days.  The patient received palliative treatment.  The physician reported that the patient had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago.  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sough unspecified medical attention.  Additional information has been requested.  This is one of a total of four patients.  Three other patients had similar reactions after vaccinations with pneumococcal vaccine 23 polyvalent (WAES # 0210USA02060, 0306USA02765, 0306USA02766).
This case was reported by a pharmacist via call center representative and described the occurrence of axillary lymph nodes enlarged in a 57-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 5 days after receiving SHINGRIX, the patient experienced axillary lymph nodes enlarged and axillary lymph nodes enlarged was recovering/resolving and the outcome of the axillary lump was unknown. The reporter considered the axillary lymph nodes enlarges to be related to SHINGRIX. It was unknown if the reporter considered the axillary lump to be related to SHINGRIX. Additional details were provided as follows: At 09:45, the patient received the SHINGRIX vaccine in the left deltoid and developed a swollen lymph node under her left armpit approximately five days after the vaccination. It was a large, soft lump easily visible to the eye. It was 2 to 3 inches long and two inches wide. The swelling was significantly less on the reporting date although it was still visible. The reporter gave permission for her physician to be contacted and provided the contact details for the same. The call was transferred to Medical Information.
feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain); The hospital told her it was related to her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 25Aug2023 at 17:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant) with onset Aug2023, outcome "not recovered", described as "The hospital told her it was related to her heart"; PNEUMONIA (medically significant) with onset 25Aug2023 at 23:00, outcome "not recovered", described as "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)". The events "feels like pneumonia (difficulty breathing/when she takes a deep breath she has chest and back pain)" and "the hospital told her it was related to her heart" required physician office visit and emergency room visit. The reporter's mother received PREVNAR 20 around 5pm on 25Aug2023.  She started having difficulty breathing that night at around 11pm. She went to the doctor 27Aug2023 as well as the hospital. The reporter stated when she takes a deep breath she has chest and back pain. She said it feels like pneumonia or like "her lungs grew". The hospital told her it was related to her heart but the tests came out normal. She still felt the same way 28Aug2023 but was getting a little worse now. Whenever she gets stung by a bee she gets a really bad reaction.  The reporter read on the website that a reaction comparison to a bee sting was given as an example and that was what she was having. He was calling to have his mother transported to the hospital.   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.
Two days after my vaccination my head started to hurt in the area called "Central Sulcus". I would describe the pain as a pressure in head with intesity 1-2-3 out of 10, depends on the day. Paracetamol 500g helped. Nevertheless, the headache kept comming back and is persistant day to day. Now two weeks since it began. I will mark Permanent damage, as it does not seem to stop for now. Since this occurance I am a bit worried of getting second dose. I have to add that prior vaccination, i had no headache for years - cannot even remember when it was the last time.
Client states that he woke up at 7:00 - 7:30 extremely nauseated and dizzy. 0 emesis. This lasted until around 12:00 noon.  The client stated that he didn't feel himself the rest of the day, but felt fine the next day.
Day of vaccine started with local rxn in upper arm which became swollen, tender and bruised. The day after receiving the vaccine developed fever, headache, stiff neck, myalgias, nauseaa, vomiting and diarrhea.  Syndrome required ER visit for lumbar puncture and IV fluids.  Sx resolved over 1 week except neck stiffness which persists.
4/2/01 Got Varivax immun. Case of chicken pox on 3/18/08.
On 8/3/01, the infant started feeling a little warm and had a temperature of 100.3F. The infant was fussy but ate well and slept well. He was seen in ER on 8/4/01 with a temperature of 101.3F. This was after the child was given Tylenol. Child also had 2 loose stools. Bumps were present which the doctor said was mosquito bites. The ER doctor said symptoms were due to immunizations.
Initial and follow-up information has been received from a physician concerning a 4 year old female patient with a protease sensitivity and no pertinent medical history who on 23-JUL-2008 was vaccinated SC with a 0.5 mL first dose of MMR II (Lot# 656616/0871U [rHA] or 613567/0871B [HSA]). There was no concomitant medication. The day after receiving the vaccination, on 24-JUL-2008, the patient developed a rash. The maculopapular rash was confluent in the shape of a triangle, 3 X 4 cm in size, and was limited to the left upper quadrant of the abdomen. The rash was slightly itchy. The patient also developed a few hives on her face. The patient was evaluated in the office on 24-JUL-2008 and was prescribed topical hydrocortisone cream. No diagnostic laboratory tests were performed. The patient was evaluated by an unspecified dermatologist but details were not available. No further information was available. No product quality complaint was involved. In follow-up, the physician reported that 24 hours after vaccination on 24-JUL-2008, the patient developed a rash on left to right side. The patient was itchy. Then the patient developed hives on her face. After approximately 29-JUL-2008, the patient recovered. The physician doubted that the events were related to MMR II. It was reported that the patient's mother questioned if protease was in the vaccine. Patient was seen by a dermatologist. It was noted the patient had no illness at the time of the vaccination and no adverse events following prior vaccinations. Additional information has been requested.
I experienced a breakthrough case of COVID-19 with severe sore throat, muscle aches all over my body, serious congestion and headaches. I was able to get PAXLOVID to relieve my symptoms.
Preface: My daughter rarely gets sick. 10 days after the shot she was feeling unwell and had a fever of 102.8. We gave her ibuprofen as we were about to get on a flight. She threw up that night and continued to have a high fever for several days, with vomiting. She developed a croupy cough that caused her severe distress. At our destination a doctor prescribed Zofran and dexamethasone (since she had taken these once before) in addition to the ibuprofen. She was in more distress from this illness than I have ever seen her in, probably because her throat was so swollen and she had trouble breathing and would panic from not being able to breathe. She was extremely clingy and acutely sick with fever and respiratory distress for at least five days.  She lost her voice as part of the illness.  Milder symptoms lingered for several days after. As she was beginning to get better, she acquired a cold from her brother, who was teething (2 year molar). My son (who is usually much more likely to catch things, and always catches what she has) did not get the severe illness.
Really bad scabs; to what extent he has pain to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCAB (hospitalization) with onset Dec2021, outcome "unknown", described as "Really bad scabs"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "to what extent he has pain to". Caller on the line calling about the Pfizer Covid Vaccine. She was calling about her husband who had a reaction. He was experienced really bad scabs. She was on the way to meet her husband as he was on the way to the hospital. She indicated she would tell her husband to call us as she does not know all the details and to what extent he had pain   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were reported. No concomitant medications were reported.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA004529: US-009507513-2109USA004530: US-009507513-2109USA004531: US-009507513-2109USA004532: US-009507513-2109USA004533: US-009507513-2109USA004534: US-009507513-2109USA004535: US-009507513-2109USA004536: US-009507513-2109USA004537: US-009507513-2109USA004538: US-009507513-2109USA004539: US-009507513-2109USA004540: US-009507513-2109USA004541: US-009507513-2109USA004542: US-009507513-2109USA004543: US-009507513-2109USA004544: US-009507513-2109USA004545: US-009507513-2109USA004546: US-009507513-2109USA004547: US-009507513-2109USA004548:
A company representative reported that a 17 month old received an injection of Prevnar and subsequently, developed hives. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar.
Pt received the monovalent vaccine as a mistake instead of the bivalent vaccine. Pt was notified- no actual adverse reaction noted.
pt recvd vax 8SEP95 &  that day, pt exp golf ball size swelling & pain @ inj site, nausea, felt warm;9SEP95 pt exp sores in mouth & down throat an elevated temp, diffuse aches;no further details were provided;