chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doctor using a combination schedule of Pentacel and Vaxelis. 2 doses of each in the 4 dose DTaP series with no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced "doctor using a combination schedule of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [VAXELIS]. 2 doses of each in the 4 dose dtap series" (off label use).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and VAXELIS (not produced by Sanofi Pasteur) (lot number and expiry dates were not reported) via unknown route at an unknown administration site for prophylactic vaccination (off label use).  It was a case of actual medication error due to off label use (latency: same day).  It was reported "however, vaccination should not be deferred if the specific vaccine product previously administered is unavailable or unknown".  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 the 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.  There will be no information on the batch number for this case.
pt recv vax & cried w/inj;w/in min stopped crying & became fussy;2PM mom left office w/child;pt became limp & lethargic;205PM mom & child in exam room;pt arousable but limp & lethargic w/o stimulation;exam by MD;
1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensified and loss of vision out of the right eye. Subsequently, he presented to the ED and was found to have a left occipital lobe intraparenchyma hemorrhage  & 1-acute subdural hemorrhage posterior left tentorial.  He was air transport to another facility for treatment:/monitoring. He is currently still admitted . He remains without right eye vision.
felt lethargic for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic for 24 hours) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced LETHARGY (felt lethargic for 24 hours). On 09-Feb-2021, LETHARGY (felt lethargic for 24 hours) had resolved.            No concomitant medication listed.   No treatment information provided.
Migraine/headache, chills, nauseous/vomiting, body ache,l
Received Pfizer-BioNtech COVId-19 Vaccine EUA. Had vaccine at 12:30 pm. At 11:00 PM, awoke with chills, severe arm pain, and headache. Next morning, had temp of 101.7,  very severe headache, severe arm pain, stomach queasiness, diarrhea. Felt terrible! Next day (today 9/14) have low grade temp, headache, and sore arm. Headache: When I bend down, my headache is worse.
p/vax pt exp flu like feeling;pt felt like was hit by a truck;sx resolved w/in 2r w/o tx;pt recovered;
shortness of breath/Heavy breathing; headache; dizzy; cough; chest pain; chills; This is a spontaneous case from a contactable consumer (patient's wife) or other non HCP via Medical Information Team.  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 18Feb2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that the patient got tested positive for COVID on 06Jan2021, he later received first dose of vaccine on 18Feb2021. On an unknown date, patient experienced Headache, dizzy, cough, shortness of breath/heavy breathing, chest pain, and chills. The reporter would like to know if her husband should get the second dose of vaccine.The patient underwent lab test and procedure which include COVID positive on 06Jan2021.The outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.
middle of the night woke up soaking wet; did not have a lot of energy; had some fever; some chills; fatigue did not go away; muscle pain in her arm; woke up with a headache; did not feel quite right; felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), HYPERHIDROSIS (middle of the night woke up soaking wet), DIZZINESS (did not have a lot of energy) and PYREXIA (had some fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE, BICALUTAMIDE (APOTEX BICALUTAMID), SPIRONOLACTONE, METOPROLOL, LOSARTAN, WARFARIN, WARFARIN, FUROSEMIDE, FUROSEMIDE and METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (middle of the night woke up soaking wet) and DIZZINESS (did not have a lot of energy). On 02-Mar-2021, HYPERHIDROSIS (middle of the night woke up soaking wet) had resolved. At the time of the report, FEELING ABNORMAL (did not feel quite right), SOMNOLENCE (felt sleepy), DIZZINESS (did not have a lot of energy), PYREXIA (had some fever), CHILLS (some chills), FATIGUE (fatigue did not go away), MYALGIA (muscle pain in her arm) and HEADACHE (woke up with a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Non-aspirin and Tylenol.
hives upper torso immed p/hep vax given; VS monitored & remained stable x 30 mins; no resp distress; no further signs of reaction;
A 17 y/o patient was given a Moderna Covid Vaccine on 5/22/21 to complete his series. The patient and his mother were aware of Moderna vaccine not being approved for under 18 year. Patient did not develop any side effects from the vaccine.
1st dose on may 2021 was not informed about a 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date in May 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated he/she received shingles vaccine 1st dose and was not informed about second dose. Additional Supportive Information: The patient did not receive 2nd dose till the time of reporting which led to incomplete course of vaccination.
Patient had unprovored seizure within 12 hours of receiving vaccine. (brief, < 2 min, no sequella, evaluation pending)
fatigue; fever; pain at the injection site; lumbar pain; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:30 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation. Medical history included allergies to Voltaren. Not pregnant at the time of vaccination. Historical Vaccine included first dose of BNT162B2 on 09Mar2021 Administration time: 09:30 AM, Lot number: EL3247, Vaccine location: Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fatigue, fever, pain at the injection site and lumbar pain on 30Mar2021. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received Twinrix 8-30-06 in the afternoon and around 2:00a.m. the next morning he woke up with fever and night sweats, headache, and vomiting. Also has lower back pain.
Unexpected death at 4 1/2 months age (current coroner's case Medical Examiner's Office).  9/26 Autopsy report states COD as undetermined in infant w/cocaine in bloodstream.  Manner of death is undetermined.  Report also states: metabolic screening (-); cardiomegaly; hepato/splenomegaly.  Patient placed on back & found face down in adult size bed.  Born precipitously at home & admitted to hospital 16 days prior to death.  Mother tested (+) for cocaine during pregnancy & hair testing of infant at birth (+) for cocaine.  Dx w/Influeza A 5/08 & right OM  7/08.  Tox screen at autopsy (+) for cocaine.  Was not breast fed.
I've been feeling very tired since April 21st. Tired to the point that I am incapable of performing routine tasks such as preparing breakfast for my children and taking them to school. My brain feels fuzzy. I am not able to perform my routine office work either. I have been on leave since my symptoms started.  I can feel my heart beating very fast at times. At other times I find myself trying to catch my breath while doing routine things like eating food and drinking water. I also feel excessively thirsty.
Shot was given on 12/10/09 (left deltoid). Donor states the next day she noticed it was swollen. States it is slightly tender. 12-12-09 donor came in to donate. States swelling is down. On exam area is 2x2 not warm to touch and no redness. Donor counseled on care.
Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: Practice Manager called in to inquire if they should revaccinate the patient who they inadvertently administered an expired Bexsero dose, which led to expired vaccine used. The reporter declined follow-up.
1-2 hours after shot got uncontrollable severe diarrhea that lasted 3 days. Also got a red circle the side of baseball around injection site that lasted for about a week. This is the flu shot I reacted to.
08:10 vaccine administered 08:14 dizzy, light headed, room spinning.  Sat down 08:25  felt lump in throat, contacted clinic nurse in waiting area.  Uncomfortable but never to the point of difficulty breathing. ~08:30, BP 128/99 (I think) Systolic up only a bit.  Diastolic very high for me sent to urgent care part of clinic.   Monitored BP, oxygen, did EKG (normal), symptoms started easing ~ 09:40.  Sent home. Attending PA though it might just be a Vaso-Vagel response, but, after hundreds upon hundred of needles, I've never had such a response, and, my symptoms did not involve a low BP, fainting or nausea, rather I remained conscious, had throat constriction with increased BP and a narrowed pulse pressure  range.
Chest pain. Started in sternum then moved to left side, eventually caused pain down left arm as well as jaw pain.
got sick every time; Initial information received States on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced got sick every time while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick every time (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick every time).  At time of reporting, the outcome was Unknown for the event got sick every time.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen glands neck Narrative:
transverse myelitis; This literature-non-study case was reported in a literature article and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYELITIS TRANSVERSE (transverse myelitis) to be related.    No Concomitant Medications were reported. No Treatment information was reported. Patient experienced transverse myelitis 11 months previouslyas a result of receiving the Moderna mRNA vaccine.  Company comment.  This is a literature non-study case concerning a 64  year old male patient with no medical history reported, who experienced the unexpected, serious medically significant AESI myelitis transverse, one day after the administration a dose of mRNA-1273 vaccine, considered as second dose of his COVID  19 vaccination schedule; no information about previous dose was provided. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature non-study case concerning a 64  year old male patient with no medical history reported, who experienced the unexpected, serious medically significant AESI myelitis transverse, one day after the administration a dose of mRNA-1273 vaccine, considered as second dose of his COVID  19 vaccination schedule; no information about previous dose was provided. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
one week after first dose, I was having severe chest pains. Ended up in the ER getting all types of test done. EKG, Echo, D Dimer test to rule out blood clots. There were some abnormalities in my  EKG which resulted in an echo.  EKG showed an incomplete heart block and echo was not the best in the world. After my second dose, I had a skin condition pop up. I have tried steroid creams and shots to no avail. The doctor has linked this to the vaccine. It has started from the bottom of my foot and worked its way up the front of my leg.
I started having symptoms around February 2021. I got sick after my second dose for one week with fever, nausea, body aches and had total malaise. I also experienced upper back pain, chest pain and I thought it was due to a neck surgery I had few months before but the pain just worsened. I had exertion and SOB when walking for short periods of time. I was taken out of work in the end of April 2021 due to my symptoms. I went to the ER where lab work was performed in April 2021 along with a D-dimer test and a CT scan of my chest. In the lab work it was found I have a rare genetic mutation, homocysteine marker that causes blood clots in my lungs, and I do not know if the rare genetic mutation caused my symptoms or is it coincidental. On the D-dimer, my levels showed to be elevated. On the CT scan of the chest, my diagnosis was that I had four pulmonary embolisms in the upper left and right side of my chest as well on the lower left and right side of my chest. Today I still have SOB when walking for too long periods of time.
daily fatigue  pain in the right leg from the thigh and knee Knee is swollen went to doctor and told to get sonogram on June 17 after results of sonogram doctor prescribed Xzrelto
Patient's daughter in law called to report the adverse event and will be submitting a VAERS as well. Pt rcvd first dose of vaccine 03/03 and 16 days later on 03/19 he was hospitalized for respiratory unrest, cause unknown. It was not suspected to be caused by the vaccine at that time. Doctors encouraged him to rcv the second dose and pharmacy staff was informed pt had been given the go ahead to do so. Pt marked that he was not currently ill on his informed consent form and that he had not had a previous reaction to the vaccine. 5 days after rcving his second dose (03/30) he arrested again resulting in hospitalization later death on 4/4.
Symptoms include: chest pain, lightheadedness, headaches, blurry vision, difficulty focusing vision.  The only treatment I've received is I was prescribed Hydroxyzine as a sleep aid. Outcome: Still hindered by symptoms 2 months after both vaccine shots
4 hours after vaccination IM (L) thigh -> 4 cm induration with petechiae formation. Treated with ten mg/kg acetaminophen resolved induration and irritability at 24 hours.
My monthly period arrived the day after (as it should have) my first vaccine does of Moderna. My period was heavier for a longer duration than it typically is. It was not necessarily heavier, but the heaviness lasted longer. This level of heaviness typically lasts for one day and after the vaccine it lasted for three days.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX. The patient's past medical history included rotator cuff repair, tendon repair and mobility decreased (had about 80 percent movement of right arm after having the rotator cuff and tendon surgery 4 years before the reporting date). Previously administered products included ZOSTAVAX (received 13 years before the reporting date). Concomitant products included Levothyroxine and spironolactone. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, shoulder pain, injection site pain and pain. On 3rd May 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site pain and pain were recovering/resolving and the outcome of the shoulder pain and injected site mobility decreased were not recovered/not resolved. The reporter considered the injection site warmth, injection site swelling, shoulder pain, injected limb mobility decreased, injection site pain and pain to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included ADDERALL and hormone replacement therapy. Around in noon, the patient received SHINGRIX on the right arm. After the SHINGRIX injection she experienced soreness and warmth at the injection site with pain and it hurt and felt hot for about 24 hours. She received the injection around noon on Tuesday and she claimed that as long as her right arm is bent and her elbow was against her body she was fine but she questions if she was permanently disabled. She wanted to get back to lifting light weights like she did before the SHINGRIX vaccine. She could only lift her right arm about a foot with great pain and she used to be able to lift it higher. Because her shoulder hurt, she was sleeping on her back.
Immediately after receiving vaccine, a cold, tingling, transient sensation was experienced radiating from the site of the injection up into the neck. Roughly 6 hours after injection (1 a.m., 3/9/2021) severe chills were experienced for approximately two and a half hours, preventing sleep. Patient experienced dizziness. spO2 was within normal limits. Temperature was measured w/ oral thermometer to be 101.3 degrees farenheit at 4:55 a.m. in the morning on 3/9/2021.  Treatment was a single dose of ibuprofen at roughly 8 a.m. (3/9/21). Pt. continued to experience fatigue and sporadic chills, with gradual abatement of symptoms over the course of the day. Pt. had no symptoms the following Wednesday (3/10/21). Pt. experienced symptoms the following Thursday (3/11/21), with a sudden onset of intense stomach pain (8/10 on NRS) starting at approximately noon. Stomach pain was more similar to muscle cramps (with aching quality) than nausea. Other symptoms included fatigue and some feverish experiences (such as chills). Treatment was conservative (ginger tea, peppermint candies, rest). Temperature taken that evening via oral thermometer (roughly 7pm, 3/11/21) was 101.4 degrees farenheit.  Symptoms were significantly reduced the following morning, Friday 3/12/21. Temperature taken approximately 10 a.m. was within normal limits.
After patient received the booster dose of the pfizer vaccine, patient passed out and hit her head. She quickly gained consciousness and was unaware of time and place. After speaking with her for a minute, she regained her memory and knew she was getting her vaccine. We called 911, they came and took care of her and took her to the hospital. The father was called he came to the pharmacy
Systemic hypersensitivity reaction lightheaded, urticaria. BENADRYL/hydrocortisone; albuterol/prednisone.
Patient reported L>R sided sore throat 1-2 days after vaccination.  He was seen at ED for this where a CT neck was WNL.  The following Sunday (4/11/21) he developed left sided facial paralysis for which he was seen in our office.  We did not give him the vaccination in our office, he came in primarily for care related to the adverse reaction.