chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ICKY; BAD HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced icky. On 2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headaches, and was recovering from icky. This report was non-serious.
RN, administered a hepatitis vaccine to pt, even though her lab results indicated that she is already immune to Hepatitis.  RN states: "Patient was immune to Hep B. When pulling vaccines, I pulled the Hep-B along with the other vaccines she needed, and right after injecting her, I noted she did not need it and she reported it to the Clinic Manager." RN stay with the patient for 20 min observations and the patient was asymptomatic, without any complaints.
Severe Headache, Chills, Shaking, considered going to ER, but took OTC meds and waited/watched. Unable to sleep, and Mild Headache persists today. (11/8/2016, reported at 120PM).
Develope dnumbnessRight and pain V2, and RightC8 post injection, symptoms have persisted As wel as neck stiff ness persisted. Neurologic exam benign, still subjective numbness.
On 5/31, fever, chills, achy, headache, fatigue for 3 days and on 6/4 developed sore throat and congestion on top of continued headache and extreme fatigue.  Still do not feel well 14 days after second dose.
The student fainted while getting the vaccines. He fell from the chair and scraped his left wrist. No bumps, no lumps, no redness noted on head or neck. He was placed on supine position with feet up. Ice applied on forehead and neck for approximately 5 minutes. Alert, oriented.  Student was placed on the chair, pale and complained of dizziness. Placed on the ground and 911 was called.
Information has been received from a physician concerning a 7 year old female twin on 02-JAN-2009 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot #662455/1329X). There was no concomitant medication. On the same day of the vaccination, 02-JAN-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-JAN-2009. Reporter stated that she was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. The patient's twin also experienced an adverse experienced following vaccination (WAES # 0901USA01284). Additional information has been requested.
Escalated nausea; Escalated vomiting; severe diarrhea; Headache.; This is a spontaneous report received from a contactable consumer, the patient. A 26 -year-old non-pregnant female patient received her first dose of BNT162B2(PFIZER BIONTECH COVID-19 MRNA VACCINE; Lot number: GP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 12:15 for COVID-19 immunisation. Medical history included clostridium difficile (C Diff) and gastroparesis. The patient had previously received hyoscyamine, haldol and had experienced allergy. The patient had not taken any other vaccinations within 4 weeks of covid-19 vaccination. She was not diagnosed with COVID-19. Concomitant medications included clonazepam, DIFICID, Gabapentin, PANTOP R, TROKENDI for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. The patient had experienced escalated nausea, vomiting, headache and severe diarrhoea on 17Mar2021 at 05:00. The patient did not receive treatment for the reported events. The clinical outcome of events escalated nausea, vomiting, headache and severe diarrhoea was not resolved. No further Follow ups are needed. No further information is expected.
p/vax pt devel a grapefruit size knot, redness, heat & pain in lt hip;also ran a sl temp;
6 hours after injection body chills started 12 hours after injection developed a mild headache, took 1000mg of acetaminophen and then a second dose 6 hours later Chills ceased around 18 hours after shot  Extremely mild headache still lingered after 24 hours of receiving vaccine, so mild it doesn't require medication
Raised red rash on legs within 2 hrs post vaccination. Diphenhydramine HCI administered and rash cleared up. Rash recurred within 24 hrs post vaccination diphenhydramine HCI administered and rash cleared up. Rash recurred third and fourth time within 48 hrs post vaccination. No treatment given and rash cleared up . Varicella rash started 31/2 days post vaccination and pt had over 50 lesions by 5 days post vaccination.
patient received first dose of moderna covid vaccine in pregnancy at 19 wks gestation. she started to have bleeding 6 days later with subsequent abruption , fetal demise and delivery 2 wks later.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 2/03/21, 3/04/21. Covid + 2/03/22. Presented to ED 1/8/22 after fall at home admitted for acute hypoxic resp failure and acute encephalopathy 2/2 Covid PNA, tx'd  w/IV Abx and steroids, transferred to rehab facility 1/15/22.  At rehab facility had increasing SOB and cough. Readmitted 2/26/22 w/PE and acute renal failure. 1/29/22: CXR showing worsening right sided infiltrates and pulmonary congestion and aspiration PNA. Continued to deteriorate, transitioned to comfort care. Tx'd with cefepine and zosyn during current admission. Expired on 2/07/2022.
Onset approximately 8 hrs after injection: muscle/body aches, chills, fever (102.3), nausea, fatigue, pain/redness below injection site. One small emesis approximately 16 hrs after injection. Headache started approximately 24 hrs after injection. Severity of symptoms decreased to moderate after 36 hrs & continued for approximately  60 hrs (excluding symptoms at the injection site) 72 hrs post injection my upper arm  has induration is red, warm, painful to touch with mild purity?s, approximately 5? W x 7? H .
Guionne Barre reaction; Initial information received on 29-Mar-2021 regarding an unsolicited valid serious case from a other health professional. This case involves female patient of unknown age who experienced Guionne Barre reaction (Guillain-Barre syndrome), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s)and family history were not provided.   In 2008, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 15-Oct-2008, the patient developed a serious Guionne Barre reaction (Guillain-Barre syndrome), approximately in the same year (exact latency unknown) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Also reported that patient informed that she was told by her doctor's office that they purchased the vaccine from your company and now she was trying to find out any ingredient that may have caused the reaction so to make an informed decision regarding the COVID-19 (corona virus disease) Vaccine.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event Guillain-Barre syndrome.  Information on the batch number to e requested for this case.; Sender's Comments: This case involves female patient who had Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
About 4 hours after receiving my shot, I could not raise my arm to my waist.  My arm was useless.  I started taking 800mg ibuprofen twice daily starting the evening of the 8th until the afternoon of the 10th.  My arm appeared to be getting better.  By the 12th, I would say I was about 85%, still having pain upon raising my arm and using it in most circumstances - muscle weakness as well.  By the 15th, the full uselessness of my arm returned just like it was 4 hours after vaccine administration.  I again started 800mg ibuprofen twice daily through the weekend of the 17th. Again, there was gradual improvement.  It's now been 2 weeks since vaccine administration and my arm is still only about 80% functional, and always with some pain or discomfort.  I cannot take off my shirt over my head, for example. I will say the nurse who gave me the vaccination gave it way too high so this is definitely a shoulder injury, but I cannot say as to whether it is from her administration technique or the vaccine itself.  I have never had a reaction like this, ever, and I get vaccines every year.
Narrative:  Patient presented to clinic on 1/19/21. PCP reported patient received moderna covid vaccine on 1/14 at the agency clinic. He reported 2 days later he developed pruritus on chest and then rash. PCP documented there was no evidence of fever/chills, sob, swelling of mouth or tongue. Patient denies change in medications, brands of meds, change in detergent, soaps, etc. PCP advised patient not to receive the second dose of the moderna vaccine because of reaction. PCP instructed the patient to taking Benadryl prn q8 hours for itching, OTC hydrocortisone cream, and calmoseptine prn. Doses of medications not documented.
Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020.  No follow-up attempts are possible. No further information is expected.
Flu vaccine by Pharmacist was administered at my work location on Monday, October 2. On Friday, October 6 , experienced dizziness throughout the day. After 5pm experienced vertigo which resolved after 2 hours. Continue to experience ringing in the left ear. The shot was administered in the left arm.  Monday, October 9 experience minor balance issues buy symptoms appear to be improving.
The left-arm pain every day after the second dose of vaccine. It is not going any vare after almost 6 months after.  I'm doing sports activities 3 times a week. Every time when I do push-ups I feel pain in the left arm.
1. Abdominal pain, Left side towards the back, leading to 2.  vasovagal reaction, near fainting episode. 2-3 hours.  3. Rash covering entire left upper arm at site of injection site and surrounding it
with in 10 minutes,  pt was c/o difficulty breathing and tachycardia.  b/p 140's/90's.  heart rate was 112-120's.  resp 22-28.  sao2 98% on ra.  states that she had this with previous injection.  transported to the local er for  care via ems.
Sore throat and cough. Severe bruise. Lethargy for 7 plus days.
VACCINES ADMINISTERED 4-13-09 ON 4-21-09 PATIENT DEVELOPED A FEVER AND HAD A SEIZURE LASTING 2 MINUTES. TRANSPORTED TO HOSPITAL BY AMBULANCE AND DIAGNOSED WITH SIMPLE FEBRILE SEIZURE.  18 HOURS LATER PATIENT HAD ANOTHER SEIZURE AND WAS TRANSPORTED AGAIN BY AMBULANCE TO HOSPITAL AND DIAGNOSED WITH COMPLEX FEBRILE SEIZURE. NO OTHER SIGNS OR SYPTOMS OF ILLNESS AT THE TIME OF FEVERS OR IN THE SUBSEQUENT WEEK.  NO FAMILY HISTORY OR PREVIOUS HISTORY OF SEIZURES.
NauseaVomiting pain, "brain fog"/decreased concentration Narrative: Experienced right deltoid pain without any associated rash, erythema, increased warmth, or other cutaneous symptoms that started about a day after vaccination and remained for 72 hours. Also noting some increased fatigue and "brain fog" without any associated confusion, dizziness, lightheadedness or other concerns for about 24-36 hours afterwards and 1x episode of nausea w/o vomiting the day following vaccination. She was able to go to work and do normal activities with "brain fog."
Pt recv vax on 3/17/99; 2 hr post vax pt exp headache, diffuse myalgias x6hr
She got her vaccine, and approximately 12 hours later she went to bed, was feeling very tired.  Within minutes of getting into bed, her thumb on the right hand was really numb, and felt that the rest of the fingers and the hand was numb.  Within seconds the left hand went numb, only in the fingers, and then her hands went numb.  It had a pins and needles sensation and a little numb.  Her rate was 110, and her oxygen level was between 93-97.  He wanted to take her to the ER, and he took her BP and it was 129/66, then took it again and it was 129/72, so she felt that she didn't need to go in.  She fell asleep and woke up at 12:00, was shouting and was burning up with fever and perhaps delirious.  Her husband gave her Tylenol/Ibuprofen.  In the morning her temp was 102, and then 101.  She went to bed and felt better last night and woke up and then looked in the mirror she has hives on her chest, hives, neck, shoulders and on her stomach.   Her lips and cheeks are slightly numb.  She did call her doctor who has been checking up on her, and gave her instructions to go to the ER if anything worsened.  She did take Ibuprofen as well.   She did have a metallic taste in her mouth, but only when they were administering the shot itself.    She still has hives, her face is still a bit numb.
Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 34th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650: case
pt recv vax OCT96 & w/in 12hr pt exp fist size swelling, tenderness, & warmth @ inj site;tx w/DPH & Ibuprofen;events resolved w/in 3 days;
Patient is a 55 year old female recently admitted 12/24-12/28/21 s/p fall and suffered a closed maisonneuve fractrure of the RLE and underwent percutaneous reduction of right distal tibial fracture and suprapatellar intramedulary nailing who was d/c to Facility for rehab. As per patietn she developed a sore throat, cough and congestion over the past 3 days and c/o increasing difficultly breathing. AS per ED record, patient has had episodes of hypoxia while at Facility and was checked for Covid and has been negative. Patient was also 90% on RA. Patient denies nausea, vomiting, diarrhea and chest pain.  In the ED, patient was placed on 6L/min of O2 AND WAS SATTING 96-98%. GFR 52, PO2 is 63 on 6L/min of oxygen. CXR shows no acute cardiopulmonary disease. CTA of the chest shows no evidence of pulmonary embolism to the proximal second segmental level, There is limited visualization of distal branches in the upper lobes due to respiratory motion, broad-based area of atelectasis in the right lower lobe, there is an adjacent hypodense peripheral consolidation in the right lower lobe suggestive of pneumonia.
Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of (wistar ra 27-3) M-M-R II lots # L034730, L019989,  M010426 and L041456 with expiration dates 09-SEP-2017,  01-JUN-2017, 01-MAR-2018 and 22-OCT-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of (wistar ra 27-3), M-M-R II were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Six days after vaccination, around 3:15pm, I noticed that my stomach was itchy. I thought maybe it was a bug bite so I pulled up my shirt to discover a cluster of hives on the side of my stomach. Over the course of the next six hours I became progressively more itchy and developed more hive clusters elsewhere on my body, including my neck, legs, lower back and underneath my buttocks.
On 2-16-2010. Patient is 58 yo. Administered H1N1 Flumist. Patient should have had the injectable H1N1 vaccine.
Symptom onset was 8-08-2021. Symptoms included cough, shortness of breath, poor appetite, wheezing, headache, fatigue and myalgia. Tested positive with a Covid antigen test at urgent care on 8/10/21. Admitted to Hospital on 8-16-21 (and tested positive with a PCR test for Covid-19). Released from hospital on 8-19-21.
Date and time adverse event started: 3/22/2021 less than 12 hours after 1st dose Adverse events experienced and are they still occurring now:  started with headache and muscle pain less than 12 hours of receiving first dose. On 3/23/21 experiencing body ache, joint pain, hot/cold feeling, upset stomach (no diarrhea). Feeling much better, symptoms resolved except for fatigue.
flu like sx-severe fever, aching joints, muscle aches, sweats;no local rxn very fatigued;
Information has been received from a medical assistant concerning a 12 month old male with egg and peanut allergies and no other medical history who on 19-MAR-2007 was vaccinated intramuscularly in the thigh with a 0.5 mL dose of with varicella virus vaccine live (Oka/Merck) (lot# 656566/1511F). The patient later developed a rash around the injection site. On the same day, the patient was also vaccinated intramuscularly in the thigh with a dose of measles-mumps-rubella vaccine (MSD). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Swelling in neck area; lump on left side of neck.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 10:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 at 09:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced swelling in neck area and a medium size lump on left side of neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swelling in neck area and a medium size lump on left side of neck was recovering.  No follow-up attempts are needed. No further information is expected.
PATIENT FELT LETHARGIC, FEVERISH AND HAD MUSCLE PAIN. SHE IS FELLING BETTER SINCE THEN.
injection site heat; injection site redness; fatigue; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site heat), VACCINATION SITE ERYTHEMA (injection site redness), FATIGUE (fatigue) and MYALGIA (aching muscles) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (aching muscles). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site heat) and VACCINATION SITE ERYTHEMA (injection site redness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site heat), VACCINATION SITE ERYTHEMA (injection site redness), FATIGUE (fatigue) and MYALGIA (aching muscles) outcome was unknown.            Other concomitant drugs include Cholesterol medication. Action taken with mRNA-1273 in response to the event was not applicable.
Pt received almost quarter of dose before  pulling arm away. Felt warm & light headed  Had also just donated plasma. She fell from  stool & scratched her arm & cheek. She regained  consciousness without intervention & felt fine after  drinking water.
Had just received H1N1 Live Nasal Mist v c/o itching all over, her lip tingling within 5".