chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine Name -  Pfizer Vaccine Date - ?  08/27/2021 Is this your first or second dose- 1st Date of symptom onset - ? 08/27/2021 Symptoms - ? Swelling of lymph nodes behind ears, and on neckline on right side at first. Swelling has now progressed to left side. Throbbing in head. Last day of work and shift - ? Worked 8/27/2021, called in 8/28/2021, and is now back at work. Home remedies- Employee stated she has not done anything but rest. Stated that she did not want to interfere with any immune response so she was just waiting it out. Any improvement-Employee stated that the right side swelling is starting to get better but is not gone yet, and the left side is still the same. Recommendation- Advised employee to take tylenol or ibuprofen if not allergic per package instructions to ease any pain and swelling, if symptoms persist to contact her PCP, and to inform us of any new or worsening symptoms. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
body aches; chills; fever at night; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020BZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache). The patient was treated with KETOCONAZOLE (ALVIN I) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
bad dreams/ vivid and frightening; bad dreams/ vivid and frightening; afraid to go to sleep over fear that he would never wake up; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's daughter said she spoke to some who have had bad dreams on an unspecified date from a COVID shot but the patient's were so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Tinnitus in left ear that has persisted through today (4/21/22), Tingling in left arm and fingers (that started on 4/18/22).
Chills, body aches, fever, nausea, and headache starting roughly five hours after injection on 3/11/2021.  Majority of symptoms including the fever lasted three days, ending on Sunday, 3/14/2021.  Headache and body ache still occurring a week later on 3/18/2021.
Patient states that she developed trigger thumb shortly after injection. She feels it is related to this. Had injection - improved; now needs another 1 year later.
My symptoms started on 03/02/2023 with extreme fatigue, cold, low grade fever. On 03/10/2023 I tested positive for COVID-19. On 03/11/2023 short of breath with minimal activity. On 03/12/2023 I was prescribed Paxlovid from provided on telehealth visit. I started to fill better after 3 days and breathing got better.
The day after my shot I felt really sick but went to work and called in to work the next day. It felt like a bad cold headache and congestion with extreme fatigue which lasted for three days. Two weeks after the vaccine I had a rash on the arm which was round and in the area of vaccination. The rash was warm, raised and it was itchy. It got worse for two days and I took Zyrtec and Benadryl which helped resolve the rash. After the second shot I felt like I had the flu fever 103 with body aches and stiffness for three days. I had a few episodes of dizziness. I still have occasional dizziness since the second vaccine dose.
Pt recvd vax 18DEC91 & w/in 24 hrs devel a diffuse rash; @ 48hrs seen by MD & dx as erythema multiforme; scheduled to be rechecked in 1wk; rash resolved by 27DEC91; recovered;
8 or 9 days after receiving vaccine I developed a rash surrounding the injection site about the size of an egg.  Slight swelling and itchiness and warm to touch.  On the 15th area of rash has spread 2 to 3 times the size it was originally.  It is red rimmed and mildly itchy.  No swelling now.
This case was reported by a nurse and described the occurrence of swelling injection site in a 22 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject had no known drug allergies. On 12Sept05 the subject received 4th dose of Infanrix in the left leg (lot AC14A006BA). On 12Sept05, the subject was also vaccinated with measles, mumps and rubella virus vaccine (MMRII) in the right leg, Haemophilus influenzae type b conjugate vaccine (manf unspecified) in the right leg and Varicella virus vaccine (Varivax) in the left arm. On 15Sep05, 3 days after vaccination with Infanrix, the nurse reported that the subject experienced, swelling the size of a medium grapefruit at the injection site (in the left leg) that was red and warm to touch. The subject was seen at a physician's office. The events resolved on an unspecified date on or after 15Sep05 and on or before 12Oct05.
Expired ACT-HIB was administered to patient, no AE; Initial information received on 20-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15 months old male patient who received an expired fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI959AA, expiry date: 19-Jun-2020) once via an unknown route in the left thigh for prophylactic vaccination on 20-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no 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 and Module VI of the 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.
Possibly had the vaccine run down her arm during administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possibly had the vaccine run down her arm during administration) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possibly had the vaccine run down her arm during administration). On 03-Feb-2021, PRODUCT ADMINISTRATION ERROR (Possibly had the vaccine run down her arm during administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This report refers to a case of  Product administration error and Vaccine Underdose for mRNA-1273, (lot #  038K20A) with no associated AEs.
1 day post vax, pt c/o redness and swelling at inject site. Site the size of golf ball, and warm to touch.  Temp of 99.1, c/o feeling tired. In two days, site was larger and harder and had yellow fluid at site. Dx as cellulitis.
She tested positive for COVID-19 on 7/21/22. She had a headache on 7/19/22 and again on 7/20/22. Then, on 7/21/22, she developed a fever, and still had a headache, and body aches, and just felt unwell in general. Then, on 7/23/22, she was back to normal. I called the doctor and they recommended TYLENOL, PEDIALYTE, and fish.
L upper leg swollen, red, warm to touch, no fluctuance noted Suspect iatrogenic cause of cellulitis (flu vax)
After 2nd shot within 24 hours my arm swelled up and became itchy , achy and red . As the night progressed it became worse and now 3 days later my arm is swollen, itchy, achy, and red from my elbow up to my shoulder at the place of injection.  Went and seen my Dr. today.
02/04/2021 Patient c/o feeling hot and throat itched.  h/o angioedema to unknown substance, carries epi pen.  h/o allergies to sulfa 1.0ml Diphenhydramine given IM in right deltoid (50mg per 1ml). administered at 1650.  BP 140/80, pulse 80 and regular.  Pt. reports that she feels like her airway is "opening up" after the Diphenhydramine.  A&O x3, c/o headache.    1715: Spoke to physician via phone.  Explained course of patient.  Physician asked that patient remain for an additional 10 minutes.  Patient agrees.  Responding appropriately.  Has slight cough, reports h/o well controlled Asthma.   1722 - BP 140/86  Pt. reports this reaction as somewhat normal for her.  Airway open and Breath Sounds normal.  Has dry cough, patient requested and received two 16 oz. bottles of water.  RR currently 18 (was 22).  Pt. reports being anxious and nervous.  1750 - BP 180/90 (patient reports BP always runs high), P - 72, RR 18 and regular.  Pt. reports slight h/a and feels stable and requests permission to leave.  Ambulated greater than 100 feet and was not SOB.    Patient managed by RN's
I started getting a rash and it looked like bug bites on the first day it started, I started getting concerned about it on July 16th, 2021, because I am pregnant and did not want it to affect the baby. I went to a urgent care and they had no idea what it was. They did prescribe a very week steroid, topical. I was using that for 7 days, 2 times a day and then had to stop. I then went to a dermatologist on I think July 20th, 2021, and that it when she told me it was a reaction to the vaccine. She told me to continue with the topical steroid and to do a topical Benadryl as well. I was also using a lot of ice packs for relief and cold showers. It actually kept getting worse and I think it was like last week that it started looking better, around August 3rd, 2021. Right now, you can see the little dots and where the rashes were and it's a little itchy still but nowhere near where it had been. I had a previous pregnancy and had my first baby on Feb 12, 2020, and this pregnancy I am due December 20th of 2021. I had no complications in my first pregnancy.
This spontaneous report was received on 27-APR-2017 from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of LIQUID PEDVAXHIB lot number M036056, expiration date 18-MAY-2019 (strength, dose, route of administration were not reported) for prophylaxis.  The patients' concomitant therapies were not reported. The vaccines were exposed to the following temperature of 32° Fahrenheit (F) to 35°F (lowest temperature was 35°F) for a time frame of 72 hours.  The call was not due to a data logger.  There were no previous temperature excursions. Adverse effects were not reported. This is one of three reports received from the same source. Additional information is not expected as the reporter did not consent for follow-up attempts.; Sender's Comments: US-009507513-1704USA014987: US-009507513-1706USA000259:
Within 5to 10 minutes started feeling nauseated  and minutes after that felt weak dizzy. Blood pressure at 155. The staff kept me there for about 1/2 hour to about 40 minutes. They tried to give me ice and apple juice to see if better.  Hours later went to Emergency Room.
Chills, body and headaches, vomiting, shortness of breath, for 24 hrs after vaccine.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Inflamed area on injection site 1 inch in size. Patient went to dermatology for surgery. Oozes yellow discharge since surgery. Not infected or cancerous.
Information has been received from a health professional concerning a patient in the sixth grade who was vaccinated with a dose of Varivax. On 05-APR-2006 the patient experienced chickenpox. Additional information has been requested.
Pt has schizoaffective disorder. HTN, and HLD.  She has had a sore throat, dry cough, and congestion.  Pt was admitted for breakthrough COVID infection with URI symptoms and ground-level fall at home.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
A 52 year old female patient with medical history of myocardial infarction, congestive heart failure, insulin dependant diabetes mellitus, chronic obstructive pulmonary disease and respiratory failure admitted in a hospital on Oct 03 2005 for the treatment of mental changes and also for all the above mentioned diseases. According to the hospital standing orders patient was given influenza vaccine (Fluzone SV 2005 2006) on Oct 5 2005 and the next day, patient developed decreased muscle reflexes in both lower extremities and increased respiration on ventilator. Neurological consultation was pending to rule out Reyes syndrome at the time of the report. CAT scan and LST performed at an unspecified time was normal but LST ap showed no bacteria but positive glucose. As concomitant treatment she was receiving aspirin and she refused to take insulin for diabetes. Outcome was not reported.
Syncope. Pt was pale, anxious, and nervous. Pt fainted 5 mins after flu shot. Pt regain conscious within 5-10 sec and was fully aware of her surroundings. Pt reported that she was not injured and tends to faint when she get nervous. Pt stay in a resting position for approximately 20-25 mins before leaving on her own power.
Information has been received from a community pediatrician concerning a 32 weeks patient who was vaccinated with ROTATEQ (lot # not reported).  Subsequently the patient experienced rotavirus.  There is no knowledge of the number of doses that the infant received.  Additional information has been requested.
tired/ tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (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: FATIGUE (non-serious), outcome "unknown", described as "tired/ tiredness"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.
Pt developed Chest pain went to ER  Dx with Pericarditis  confirmed by. echocardiogram
2PM received vaccine, developed 2:30pm hives face, 4:00 pm pt took Benadryl 25 mg PO Of her own. Pt also has multiple hives on torso and legs.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Batch/Lot number: unknown), on 10May2021 as dose 2, single (Batch/Lot number: unknown) and on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROGESTERONE taken for contraception, start date: 04Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive for covid again and also had new symptoms; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Other medication in 2weeks product included Progesterone only birth control with start date 04Jan2021. Adverse event reported was tested positive for covid again and also had new symptoms with start date May2022 , Treatment start date for COVID-19 was from 02May2022 till 06May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received the flu shot in my right arm, covid booster in my left.  I have been having shoulder pain and numbness from my shoulderblade, down my arm and even in my pinky and ring finger.
Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and sore arm made sleeping difficult. By 2 am on Friday, June 11th, vomiting and diarrhea began. Patient was given 200 mg of Tylenol and 25 mg of Benadryl. Arnaca gel was applied to the rash that formed on the vaccine site. The rash was approximately 3 cm wide and 5 cm tall oval shape. It was bright red and painful to touch (like a sunburn). Arm was also swollen from shoulder to elbow. Patient slept from 4 am - 8am on 6/11. All day on 6/11 patient had trouble keeping down fluids (tried water, juice, gatorade, and broth) and patient refused food (tried popsicles, rice, bananas, scrambled eggs, and plain noodles). Patient complained of throbbing pain in left arm. Patient refused to massage the area and would screen in pain and cry with tears if mom touched it at all. Cold packs and warm packs brought no relief. Patient continued to receive Tylenol every four hours. Fever would reach 102-102.5, break with sweats. Patient reported feeling very cold and then very hot. Fever break would last 30 min - 1 hour before climbing again.   Sunday 6/12 continued the same as 6/11. Patient began alternating Advil 200 mg with Tylenol every four hours. Advil didn't seem to help any more than the Tylenol did.  Parent called consulting nurse and was advised to take patient to urgent care where she received anti-nausea medication.  Monday 6/13 patient continues to have difficulty with food and drink. The phenergan meds help with nausea but make patient so tired, there's little chance to get patient to eat or drink. Vomiting has stopped but diarrhea continues.
9 cm erythema, induration at left deltoid, 6 cm erythema, induration at right arm.
Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 15 year old daughter with a history of ear problems who on 10-SEP-2007 was vaccinated with her first dose of GARDASIL and is pregnant. Her last menstrual period was reported as 22-AUG-2007 and her estimated delivery date was 28-MAY-2008. The patient sought unspecified medical attention. Follow-up information has been obtained from a registered nurse who reported that the patient delivered a full term 9 pound 21 inch long, normal, healthy, female via primary cesarean section on 22-MAY-2008. There were no reported complications or congenital anomalies. Upon internal review it was determined that the labour complication that required a cesarean section was an other important medical event. Additional information has been requested.
Feeling lightheaded; Weak all over, especially on legs; Weak all over, especially on legs; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included "pre-diabet", high blood pressure and high cholesterol. The patient was allergic to shellfish. Concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Apr2021 at 15:15, the patient was feeling lightheaded, felt weak all over, especially on legs. No therapeutic measures were taken as the result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling lightheaded and weak all over, especially on legs were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Developed facial swelling and wheezing with itching after receiving MMR booster. Pt improved with albuterol, combivent, and antihistamine. Mild flares over subsequent days.
I was super fatigued for the first few days, and then I was good. Then at about 3 weeks, I began experiencing the worst fatigue I had ever felt in my life. I have brain fog, extreme exhaustion, so much so, so that I wake-up still so exhausted that I could lay back down. I am also falling asleep at my desk at work, and I am even having to take  a break, and sleep for 10 to 15 minutes, because my body is just shutting down.
Patient had seizure about 19 hours after injections lasting 15-20 minutes. Was taken to hospital via ambulance. Seizure needed meds to resolve. Client in ICU for 2 days. No seizures. Meds provided when discharged. Discharge Summary received which stated that patient experienced febrile seizures.
The pt experienced extreme fussiness, redness, swelling, tenderness of right arm at Prevnar injection site occurring within a few hours of vax. Symptoms resolved within 72 hours.
Fever above 102.6 Extreme Swelling in a 4' diameter, heat radiating at the source whole body aches dizzy irritability, inability to sleep for 48 hours
RECEIVED ADDITIONAL BOOSTER DOSE OF MONOVALENT VACCINE ON 8/10/22.  VACCINE RECORD FOR MONOVALENT DOSE ON 7/7/22 WAS NOT IN RECORD WHEN DOSE FOR 8/10 CLINIC WAS APPROVED.
?MAY92 pt recvd Engerix-B & immediately p/inject exp & irritation & inject site; poss allergic rxn;
Pt was given 0.1 mL intradermal however it didn't produce wheal. #2 0.1 mL intradermal was given again which produce wheal. Pt left in no distress. Husband is a for monkey pox. Explain to pt if symptoms get worse to call active duty Prevention doctor immediately and get seen.