chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed swollen and tender lymph node in left armpit area; Developed swollen and tender lymph node in left armpit area; Had full body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) 10 mg and bupropion (WELLBUTRIN) 300 mg; both for unspecified indications and ethinyl estradiol; drospirenone (YAZ) for contraception; all from unknown dates. The patient was allergic to propylene glycol. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 23:00, the night of vaccination, the patient experienced full-body aches. On 19Mar2021, the patient developed swollen and tender lymph node in the left armpit area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of body aches and included treatment with ibuprofen. The clinical outcome of the event full-body aches was recovered on an unknown date in Mar2021 and of the events swollen and tender lymph node in the left armpit area was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
3 years old patient was inadvertently administered Menactra instead of Hib vaccine , no AE; 3 years old patient was inadvertently administered Menactra, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 3 years old female patient who was inadvertently administered a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6596AA, expiry date: 24-May-2021) via an unknown route at an unknown administration site instead of the HAEMOPHILUS TYPE B (HIB) VACCINE on 16-Sep-2020 for prophylactic vaccination (wrong product administered) (product administered to patient of inappropriate age).  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 (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS); POLIO VACCINE INACT (POLIOMYELITIS VACCINE INACTIVATED) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency-same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient has never had FLUZONE before. Several days after immunization she began to experience increased pain. The pain is constant and is sore to even move her arm to do simple ADLs. She denies redness swelling; warmth; or fever. Patient said she began to have symptoms or a Upper Respiratory infection several days after the injection, but it has since become a productive cough with annoying coughing spasms. I advised her to contact her primary care physician, and to call us with the outcome.
Breakthrough case admission after 2 vaccines Moderna 3/23/21 Lot# 044A21A;  Moderna 4/20/21 Lot# 043B21A
On the 2nd i felt no symptoms. the 3rd i was aching and headache and dizzy when i stood up, plus was feeling slightly warm no raised temp. 4th started to run a 100 degree F temperature during the night and dizziness and  headache. 5th headaches were gone. aches were gone. dizzy spells didnt start until after 3pm. 6th no dizzy spells. no headache. later in the afternoon i had tunnel vision really hard to concentrate. had no appetite. 7ththrough the 15th throughout the day had slight dizzy spells towards the evening had headaches and fatigue. 16th throughout the day had slight dizzy spells towards the evening had fatigue but didnt have  headaches. 17th No fatigue only one or two dizzy spells no headache.
Pain on abduction of (L) upper arm that began 4 days after receiving the influenza vaccine in the (L) arm at the level of the shoulder joint.
I received my second Moderna booster for COVID-19 on 4/28/2022. On the morning of 7/21/2022, I began having sinus trouble. I had a headache. Also, my throat wasn't sore, but it was dry; the dry sensation lasted until 7/23/2022. I also had a minor ache in the upper left region of my abdomen, which lasted until 7/24/2022; during this time, this region also felt bloated. When I went to bed on the night of 7/21/2022, I felt very fatigued and had a fever of 99 degrees. On 7/22/2022, the fever reached 100.5. On 7/22/2022, I took a home COVID-19 test, and I got a positive result. On 7/23/2022, I contacted a doctor through their website, and she explained to me that my abdominal pain was caused by my body's immune response. When I asked her about being prescribed PAXLOVID, the doctor said that as a policy, they do not prescribe PAXLOVID online. The doctor just recommended that I rest and recuperate, and if my symptoms got worse, I was to go to the emergency room. Later in the evening of 7/23/2022, I virtually contacted another doctor, and he prescribed a 5-day course of PAXLOVID. After I started taking PAXLOVID, my fever finally went away on 7/26/2022 and my headache diminished, though it didn't completely go away. Along with the PAXLOVID, I have also been taking ibuprofen, which has helped with the fever and headache. At the time of this writing, I still often feel tired. My headache, sinus issues, and abdominal pain are now gone, though. I also took another home test for COVID-19 on 7/30/2022, and the result was negative.
HEADACHE; This spontaneous report received from a consumer concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and the patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache. This report was non-serious.
Dizziness, Fever, NauseaVomiting & HYPERtension Narrative:
The vaccine was inadvertently administered before the minimum age of 9 years old. The patient nearly 2 months away from her 9th birthday, when she would be eligible for the vaccine.
worsening/amplification of tinnitus symptoms.  I have had steady symptoms for approx 5 years.  These symptoms are double what they were previously.
pt had a shot on 9/15/2019 said that 3 weeks after she had pain in her neck. md thinks it might be a side effect to vaccine
The patient presents with allergic reaction. This is an otherwise healthy 32 year old male, who presents to the ED for evaluation for allergic reaction following administration of his first dose of COVID vaccine PTA. EMS reports that his vaccine was administered at approximately 1530 and after 10-20 minutes of injection, patient experienced shortness of breath, chest tightness, and throat swelling with associated itchiness. Patient was given 0.3 epi IM and within 10 minutes of administration, patient's symptoms were mostly resolved. Patient states that he had bilateral rashes to his arms. EMS notes that patient did have an abnormal EKG en route to the ER but suspects it could be a possible cardiac artifact. Denies any daily medications. No history of allergic reactions. .  received diphenhyddramine 25mg iv, famotidine 20mg iv; methylprednisolone 125mg iv;  patient discharged home
2/18/2023  I felt like I had a head cold. I tested positive with an at home COVID Test. I had a telehealth with my doctor and he prescribed Paxlovid. I began taking the Paxlovid on 2/19/23 which I took the full five days. On 3/2/23 I tested positive again with an at home COVID test. I felt like I had a head cold for two days. After that I had nothing.
Upon giving patient his two vaccines, patient appeared to have fainted or "zoned out" (patient's words) for about 60 seconds, patient became pale - became fully alert after that time and had him sit in the booth for over 20 minutes until he was completely back to normal (patient drank bottle of water).
felt awful; fatigue; left arm useless; Body aches; left arm useless due to muscle pain at site of vaccine; This is a spontaneous report from a contactable physician. A 51-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on an unspecified date in Jan2021 (Batch/Lot number and Expiry date was not reported) (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have covid prior to vaccination and it was unknown if covid was tested post vaccination. On an unspecified date in Jan2021, the patient experienced felt awful, fatigue, left arm useless, body aches and left arm useless due to muscle pain at site of vaccine. It was reported as body aches and felt awful on the same day as vaccination. Day 2 fatigue and left arm useless due to muscle pain at site of vaccine. Laboratory tests on an unspecified date included SARS-CoV-2 test: unknown results. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Patient experienced redness, swelling, hot to touch area, over entire right bicep.  States "I did not feel like myself."
FEVER RASH  SHINGLES ON RIGHT BACK, HIP AND GROIN AREA FATIGUE SWOLLEN EYES
Head began to shake, spread to body, then became limp and was tired afterward - lasted about 1 min; referred to neurologist.
2200 on 30 MAR 2021 pt had shooting px from injection site to bottom of L foot. Px dissipated around 0200 with oncoming headache pt treated w/ tylenol relieving the headache till 0700. Pt feels fatigue & felt like his blood was on fire ongoing. Eyes started burning @ 2200 and has continued burning. Pt checked Temp. @ home with 101F. In clinic Pt Temp:98.9F BP: 152/95 HR: 120 SPO2: 99%. Pt will be given Ibuprofen and told to rest at home & to return with worsening symptoms.
Pt became pale and diaphoretic, post vax. Pt was nervous before shots were given. Vital signs stable.
Delayed type hypersensitivity; Rash; Bumped area; warm; little itchy; red; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), RASH (Rash), SWELLING (Bumped area), FEELING HOT (warm) and PRURITUS (little itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SPIRONOLACTONE, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), AMBRISENTAN, TADALAFIL and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity), RASH (Rash), SWELLING (Bumped area), FEELING HOT (warm), PRURITUS (little itchy) and ERYTHEMA (red). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed type hypersensitivity) had not resolved and RASH (Rash), SWELLING (Bumped area), FEELING HOT (warm), PRURITUS (little itchy) and ERYTHEMA (red) outcome was unknown.        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.
heart failure during a race; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 59 year old and unknown gender patient who had heart failure during a race and died 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a long-distance runner and on an unknown date, the patient developed a serious heart failure during a race (cardiac failure) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and was leading to death. It was unknown if an autopsy was done. Final diagnosis was (fatal) heart failure during a race.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart failure during a race).  At time of reporting, the outcome was Fatal for the event heart failure during a race.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 59 year old patient of unknown gender who had heart failure during a race and died after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants and autopsy report would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: heart failure during a race
Tinnitus 3/1/2021 Primary Physician  4/12/2021 Hearing test 7/13/2021
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB injection (exact dose, lot#, expiration date and anatomical location were not provided). The patients were vaccinated at "0 month and 4 months". There were no adverse effects reported. Additional information has been requested.
pt recvd vax;to ofc;began to faint & dad laid him on floor;color turned from gray to blue;began to jerk;MD open mouth & pt began to breathe;legs raised,O2 given;to hosp;P 170-180;sxs appeared to bee vasovagal but suspect neurogenic shock;
Started vomiting middle of night since 4AM. Also some diarrhea. Low grade fever 99. Taking fluids. F/U if not better 1-2 days or sooner if worse.
Patient got 2nd Je-Vax dose on 7/3/08 and on 7/7/08 had a prickly, painful rash around neck lasting 24 hours and off and on for about 2 days. Patient also had a headache, malaise, and difficulty breathing lasting about 1 day. Patient took rapid acting diphenhydramine and otc loratadine for 24 hours. She also got prescription for triamcinolone cream for the rash.
This 62 y.o. female is admitted to the hospital on 6/16/2021 with COVD pneumonia and post discharge of her AICD.  Patient initially presented because her defibrillator had discharged when she was asleep.  This was around 9:30 in the morning.  Her pacemaker was interrogated in the ER and demonstrated a run of V. fib.  Patient denies any chest pain, nausea, vomiting or shortness of breath.  Of significance, she was recently diagnosed with COVID-19 on 6/12/2021 and has been on combination of antibiotics.  Patient does report ongoing headaches, fever, chills, loss of taste, cough along with some nausea, vomiting and diarrhea. Patient was vaccinated more than 2 weeks from the time of diagnosis of COVID.  Follow up Chest XRay on 6/19/2021 showing persistent and somewhat worsening multifocal opacities.  During current hospitalization patient was started on dexamethasone, but this was stopped as patient did not require any oxygen.  She completed a course of antibiotics.
Patient states she had a little bit of itchy throat, itchy nose. No swelling or hives noted. Refused EMS.
Shortness of breath, chest pain, rapid and irregular heart rate, headache, dizziness, fatigue, lightheadedness, pins and needles in extremities
One day after I received the flu shot, I have had a fever.  The fever starts in the afternoon and lasts 5 or 6 hours.  The fever ranges from 99 ot 101.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX .5m l. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was administered SHINGRIX on arm approximately about 12 days before the time of reporting. The patient experienced intense pain at the site of injection on the day of vaccination which woke her up. At the time of reporting the patient was experiencing pain at the site of injection. The reporter did not have the patient's health care provider information. All questions were asked.
End of May, pain started slightly under arm down, it started to spread on side of spine and continued moving under arm and under left practice, Pain is all over , and can even feel it when you breathe
covid test result Positive; covid test result Positive; Head cold/ like; congestion; Tired; Chills; This is a spontaneous report from a contactable pharmacist. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Right Arm on 13Jan2021 (Batch/Lot Number: EL3248) at dose 1, single and administered in Arm Right on 03Feb2021 (Batch/Lot Number: EN5318) (at the age of 58-years-old) at dose 2, single for covid-19 immunization. Medical history included cardiovascular disorder. The patient did not receive other medications within 2 weeks of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced tired, head cold/ like, congestion, chills on 18Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab: positive on 21Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event covid test result Positive was unknown and outcome of rest of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination Failure and COVID-19 cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Constant (permanent) ringing in the ear (I looked it up on the internet and it is known as Tinnitus)
Large oval area of swelling on upper thigh where majority of vx were administered/ screamimg/ crying from extreme discomfort/ pain.  Attempted warm compress but infant too sensitive. Elevated legs while infant layed down, but any movement of the limb would set him off again. Swelling/pain reduced approx. 1-2 hrs after first noticed. (No vx reaction to 4 mos vx series aside from drowsiness).
Rash  in neck and arms, benadryl 25mg 1 cap by mouth as MD ordered Observed the patient for about 20 minutes, was helpful Patient stated he feels better. Discharged stable condition, advised to go ER if any adverse effects noted. Patient's mother verbalized the understanding.
Patient had been vomiting all afternoon since returning home after recieving the shingles vaccine and has a fever. Her daughter has been trying to give her gingerale and crackers but she keeps vomiting them up.
J&J COVID vaccine on Friday 4/9/21   Fatigue, headache, shortness of breath, chest tightness and a racing HR Symptom onset of these symptoms was yesterday Winded with any exertion  Patient denies trouble breathing when she is laying down and resting Reports headaches but not bad Muscle aches Reports tightness in her chest- a dull tightness in her chest  Reports some racing heart rate while she is out of bed  Advised patient to be seen in the ER today for evaluation of her symptoms
PNEUMOVAX administered at 10:00a on 2/4/09 at Pharmacy to patient.  Wife called at 3:30p and reported husband is experiencing excruciating pain about 1 hour ago.  Denied SOB and rash.  Unable to move arm because of pain.  Informed pt that soreness at site is a common side effect.  Pt denied warmth or swelling at site.  Advised pt to take Ibu or another TYLENOL pill and to call back in 30 min.  Pt's wife called back and husband still experiencing pain after taking another TYLENOL tablet.  Asked wife to check BP.  BP was 191/64.  Pt systolic blood pressure usually around 160's.  Temperature reported at 98F.  Denies any signs of warmth or swelling at the site or SOB and rash.  Because BP so high, advised pt to go to ER (Dr is not in office).  Instructed wife to notify ER that he had a vaccination this morning and had taken 2-500mg APAP with no relief.  Asked wife that I would follow up on Friday with her and fill out VAERS form.