chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and HEADACHE (mild headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE (LAMICTAL) and GLIMEPIRIDE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (mild headache). At the time of the report, PAIN IN EXTREMITY (arm soreness) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: follow-up received with no new information
Mother called advising pt's arm where the Dtap was given had gotten Red hot swollen and he complained of it itching.  The swelling went all the way to his elbow.  Today 2/27/09-  it is the sized of an apple and looks better after she applied heat to it.  I suggested for her to take to PMO for evaluation due to itching!
Information has been received from a physician concerning a 12 month old female child who on 25-OCT-2010 was vaccinated orally with a first dose of ROTATEQ (lot # 668266/0521Z). No adverse effect was known. The patient did not seek medical attention. Follow-up information has been received from the physician who indicated no adverse effect. No information is available.
Initial unsolicited case received from consumer (patient herself) on 12 Dec 2016. This case involves a 39 year old female patient who was vaccinated with a dose of ADACEL (Batch number, expiry date and dose was not reported) administered intramuscularly in left deltoid on 09 Oct 2015. The patient illness at the time of vaccination was reported as scrapped knees and wound care, and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as NKA (no known allergies) and any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications was not reported. On 09 Oct 2015, four minutes after the vaccination the patient developed metallic taste in mouth/taste continues/taste has been constant since vaccine, and on an unknown date reported as states taste continues and throat is so dry, like I'm going to choke (choking sensation and dry throat). On an unknown date the patient was seen by ENT, rheumatologist, other family doctor, dentist, and allergist for tests. The patient lab tests include endoscopy and blood work, stated all normal. The patient corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Pt. received Pneumovax vaccine in left arm at 13:00 on 05/18/04. He complained his arm got sore shortly after. By evening he got chilled & put heat on the area. Later broke out in hives went to hospital where they gave him a shot and some pills to take. Don't know what they were.
chills-achy, neuralgia x 6hr w/confirmed malaise 24hr later;tx bedrest;
puffy face about 6hrs p/vax;treated w/DPH;no local rxn
Slight soreness of injection site, Fever, Chills, Nausea, Headache, Fatigue  Within 6 hours of Injection
Rash that began as itchy bumps all over the body one day after the vaccination. On day 2 they started to look as though they were filled with pus. Patient also had low grade fevers, chills, and redness and warmth around the injection site.
Patient experienced trouble breathing and hives about an hour after getting Moderna  vaccine. She was hospitalized for couple of days and was diagnosed with liver issue, edema and allergic reactions
Pt developed anaphylaxis, was given IM Benadryl, and was sent to the ED.  Pt spent 1 night in the hospital, went home, and has come back and is in the ICU. Pt had hives, itching, chest tightness, swollen lips.
2 circular lesions at the site of the injection. She was placed on BACTRIM and mupirocin. Will follow-up in one week.
Hives at injection site and all over body on arms and back, and left leg.  Injection was right arm upper muscle.  More hives and extreme itching feeling for one week and continous since.  Pharmacist said to take Benadryl.  Lot number for vaccine is 1307601 per Pharmacist.  RX #0155447-13463. Fluvirin Vial #2013-14 5ML NDC #66521-0116-10.
Pain, unable to move arm, fever redness, infection in arm, nausea, chills, sore joints, arm swollen and warm.
No additional information provided. No additional adverse event reported.; measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to a patient after experiencing a temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter lot # T035393, expiration date 14-APR-2022 (route of administration and anatomical location not reported) for prophylaxis. measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to a patient after experiencing a temperature excursion on 27-DEC-2021 (product storage error), temperature was -9.6C and time frame unknown by reporter. No additional information provided. No additional adverse event reported (no adverse event).
Itching all Over Body; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all Over Body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itching all Over Body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all Over Body) had resolved. Not Provided      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 medication was provided.
vaccine has not been fully administered; less than a full recommended dose of a vaccine is administered because of syringe or needle leakage; when vaccine was given to patient a few drops ran down patients arm; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves patient of unknown demography who did not receive vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] fully as few drops ran down patients arm while administration via unknown route and unknown site on an unknown date (not number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   This is a case of exposure via skin contact   It was also a case of actual medication error due to vaccine underdose and syringe or needle leakage.  It was not reported if 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 holders 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.  Follow up information was received from a physician on 04-Apr-2019.  No new information was reported.  List of documents held by sender: none.
HPV given 8-8-14 10:00 am. He went to bed at 9:00pm having chills and headache. Up all night with vomiting and stomach pain. 8-9-14 he took MOTRIN at 9:00 am rested all day, drank 7up. By noon he was feeling better. His symptoms of headaches, nausea, vomiting, diarrhea continue to come and go since August 8th. Went to PCP yesterday. Diagnosed with dehydration and sinus infection. IV fluids given at ER. Given zithromycin 3 day treatment.
So I went to urgent care and they prescribed two different antibiotic. I also had an ear infection. It took me weeks to get over it. I had sinus infection and a middle ear infection for over a month. It has been about two weeks since I have had no issues or problems with my sinuses.
Approximately 16 hours after 2nd dose I experienced a severe headache with chills. I did not run a fever but the headache persisted with medication. The only relief was laying down. Headache and chills subsided approximately 12 hours later.
Sore arm for a couple of weeks; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from consumer (patient) via social media.  This case involves a patient (unknown age and gender) who experienced sore arm for a couple of weeks (pain in extremity), while received INFLUENZA VACCINE.  Patient's vaccination included Influenza vaccine as prophylactic vaccination. Medical history, medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm for a couple of weeks (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There would be no information available on batch number for this case.
Noon the day after the vaccine I was suddenly overcome with nausea, and dizziness that sent me stumbling to bed and vomiting into a bucket next to me. Vomiting lasted for one session, but dizziness and nausea stayed for about 3 hours, and then nausea, fatigue and general sick feeling kept me in bed until the next day. April 9 I woke up still feeling out of sorts, but not as bad. Note: 28 minutes after having the vaccine, once I started driving home, the vision in my left eye suddenly went blurry, and I nearly lost vision in that eye. I tried to find a safe place to pull over but couldn't. After 5-8 minutes the vision came back but stayed a bit blurry for a couple hours. Never had any such thing happen before.
Itching; erythema; chills; Muscle aches; Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), PRURITUS (Itching), ERYTHEMA (erythema), CHILLS (chills) and MYALGIA (Muscle aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Flu symptoms). On 17-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (Muscle aches). On an unknown date, the patient experienced PRURITUS (Itching) and ERYTHEMA (erythema). On 20-Feb-2021, INFLUENZA (Flu symptoms) had resolved. On 20-Mar-2021, CHILLS (chills) and MYALGIA (Muscle aches) had resolved. At the time of the report, PRURITUS (Itching) and ERYTHEMA (erythema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was not reported. No treatment medication was not reported    This case was linked to MOD-2021-025582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Events like itching/ pruritus, redness/ erythema and flu symptoms were added.
Feeling like a cold; nasal congestion; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough). At the time of the report, NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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.
sore arm super cold body aches dry cough fatigue, extreme rapid heart rate shortness of breath
Pt began having chest pain within 15 minutes post injection. Left facility and continued having shortness of breath with chest pain intermittently for two weeks. He kept stating, that he was feeling short of breath upon exertion. Pt began to have a seizure and went into cardiac arrest. CPR initiated on scene, transported to emergency room and was pronounced dead.
Upon insertion of the needle, needle became detached from syringe and vaccine leaked onto left arm before it could be administered.  Chief Safety Officer (myself) was notified of event and RN contacted Covid Hotline confirming that per CDC recommendation, if less than half of dose of undetermined amount administered, then give additional dose in opposite arm. Patient agreed to receive additional dose. Received LOT # 032B21A as re-administered dose to right deltoid. Moderna Hotline case.
On Tuesday, 8/3/21, Patient received her dose of Janssen Covid-19 vaccine (LOT #: 201A21A, exp: 9/21/21) at 2:15 pm on her left deltoid. During assessment questions, client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. At 2:29 pm, while waiting in Observation Area, client stated to RN, she is feeling "faint and anxious" with no prior anxiety attacks in the past. Upon observation by RN and RN client appeared diaphoretic and pale. At 2:29 pm, client was seated in anti-gravity chair and vitals were started and taken every 5 minutes. Client was also given a bottle of water and juice to that the patient drank. Vitals at 2:29pm: BP: 71/52, HR: 47, O2 sat: 98%, RR: 20. Client was alert and oriented to person, place, time and orientation. At 2:34 pm, BP: 91/63, HR: 56, O2 sat: 98%, RR: 20. Client also stated she was "feeling nauseous and dizzy." Client was offered a protein bar to which she declined and stated the last time she ate was dinner the night before. Client AOx4, skin dry and pink.At 2:39pm, BP: 107/68, HR: 57, O2 sat: 97%, HR: 18. Client AOx4, skin dry and pink, no distress. At 2:44pm, BP: 103/69, HR: 55, O2 sat: 97%, RR: 16. Client was AOx4, skin dry and pink. At this time, client stated to RN & RN she felt no distress and denied nausea/vomiting. No further interventions needed. Client was educated by RN & RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait and driven home by her husband at approximately 3:00pm.
Patient says she has pain at the injection site still 11 days after her vaccine. She says it is not red and does not look infected. Says that it is more inside her arm and she feels tightness/tingling and pain from her shoulder to her elbow throughout the day. Today was the first that she has contacted anyone about it.
Pfizer-BioNTech COVID-19 Vaccine EUA nausea  flush/heat chest
About 15 minutes after his 2nd vaccine the patient arm went numb and could not grasp anything in his left ( vaccine) arm.
rash: other than @ inj site;rash devel coincidentally to episode of hand-foot-mouth disease;
redness, warmth, swelling of arm from shoulder to elbow;nausea, fever, dizziness, h/a;
Information has been received from a nurse practitioner concerning a male who in March 2004, was vaccinated with a dose of varicella virus vaccine live.  The nurse practitioner reported that on 07/15/2004, the patient developed full blown chickenpox.  Unspecified medical attention was sought, but no treatment was required.  Subsequently, the patient recovered.  Additional information is not expected.
abscess at injection site; Initial information was received on 26-Oct-2017 regarding an unsolicited valid serious case from a other health professional.  This case involves a 50 year old male patient who had an abscess at injection site (vaccination site abscess), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 27-Sep-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT5911NA, expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On 02-Oct-2017, the patient developed a serious abscess at injection site (vaccination site abscess) 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the event was recovering.; Sender's Comments: This case concerns 50 year old male patient who had vaccination site abscess after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies, safety of the vaccination procedure would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
red, inflamed skin, grows about 30% every day.  as of today, the red area is 5"x 8" and very sore.
Headache, Arthralgia CHILLS, PAIN/SWELLING INJ SITE Narrative:
Hives and rash on both arms, face, and torso. That developed several days after the vaccination.
About an hour after pneumonia 23 Imm. Pt. began having (L) arm pain, redness and swelling that continued to get worse. Went to E.R. 4 1/2 hours after getting immunization. No shortness of breath.
Hearing loss; Ear infection; Got really sick; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer vaccine and got really sick. He lost more of his hearing (hearing loss) and had severe ear infection; doctor confirmed that it was from the shot. Patient was asking if he should get the second shot. Patient was advised to contact the primary care provider for any medical advice. The physician and neurologist agreed. Outcome of the events was unknown.  Information on lot/batch number has been confirmed.
Pt recvd DTP/OPV on 12AUG91 & became unresponsive & limp until name was called a few times; pt responded immed & started crying; pt seen by MD;
Significant increase in loudness of pre-existing tinnitus; noticeable decrease in hearing acuity with pre-existing hearing impairment.
Site of injection of ZOSTAVAX red and swollen, painful to touch. No rash. Area sore for 4 days and then resolved.
Swelling in face.  Swelling is minor and not causing any discomfort.  Symptoms started approximately 48 hours after the injection.  Today is 96 hours post injection and the swelling is almost gone.  It was not severe enough to seek medical treatment. One dose of Childrens Benydryl was given and that seemed to help.  We spent all day in the sun after receiving the injection, and I'm guessing this minor reaction is a result of that.  We just wanted to report that she did have a reaction. Thanks!
12/19/03 pt was with mother shopping, began having seizures. Was taken to first to hospital then transferred to another hospital ICU due inability to stop seizures. Pt had CT scan, MRI brain, EKG, and they did attempt a spinal tap to r/o meningitis. Pt dc'd from hospital 12/22/03. The hospital discharge summary received on 2/3/04 states fever.
a day after receiving first dose of the vaccine, he developed a discoid, red rash in both axillae, 5 x 2 cm on the right, and 6 x 3 cm on the left axilla; non-papular and no pustules
cough; fever; I got a tickle in my throat; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 19Apr2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday, 20Apr2021, she got a tickle in her throat, and on Wednesday, 21Apr2021, cough started along with fever. The fever went away but cough was not going away. She woke up and she voice was a little worse today. She don't feel completely sick, feel like body is fighting it. She don't feel like dying or anything. Outcome of the event was unknown. Overall Safety Summary section and per attached documents and VR noting cough is not listed as a common side in our trials and listed as a possible symptom of Covid 19. Referred to HCP for further discussion/guidance, based on medical history; unfortunately, we are unable to make specific recommendations. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown demography. On an unknown date (also reported as on a Friday) the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported). On an unknown date (also reported as the following Monday) the patient experienced shingles. The outcome of the event shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA007894 (same reporter link). Additional information has been requested.
All over body aches 10/10.  Upper and lower extremity weakness. Inability to perform ADLs without assist.
Developed pruretic rash 06/21/2005, no symptoms illness, fever exposure.  06/23/2005 20 lesions: 4 head, extremities and back; 2mm each, red papules, 13 with roof scratched off.