chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "gout" (unspecified if ongoing); "skin cancer" (unspecified if ongoing). Concomitant medication(s) included: LACOSAMIDE; ZONISAMIDE; ALLOPURINOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Negative, notes: Tested negative on 6Aug2022; (11Aug2022) Positive, notes: on 11Aug2022 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Rebound. Patient took paxlovid on 1Aug2022-5Aug2022. Tested negative on 6Aug2022, no symptoms 6Aug2022-10Aug2022, then started having symptoms again (runny nose & congestion) on 11Aug2022 and tested positive. Had bad diarrhea while on paxlovid from 1Aug2022-5Aug2022.The patient had no known allergies.  No follow-up attempts are possible. No further information is expected
Medical Assistant Administered 1st vaccine, pt took a deep breath while crying; simultaneously, 2nd Vaccine Administered, at that point pt became limp & breathless, had episode of synchopy. Nurse came in & placed him prone, felt mucus plug in chest, & slapped his back a few times. Pt took breath & started crying almost immediately. Please see office visit Note for further clarification. DX: Syncope VS clearing mucus plus vs hyperventilation Patient is a 19 month old male. He presents with acute cough, congestion/drainage, and fainting. The history is obtained from the patient's mother and maternal great grandmother. The history appears to be reliable. 19 m m brought by his mother for vaccination for hepatitis A and influenza vaccination. MA administered his vaccines. Per MA, he began to cry after first vaccine. While crying hard, he inhaled deeply, 2nd vaccine was given and he became breathless. MA sat him up. Mom picked him up. Nurse in doorway stepped over to pick him up from mom, felt mucus move in chest, placed him prone, and slapped his back. He began to cry almost immediately. He was crying, breathing without distress, pink and well-perfused, in nurse's arms as I walked in. Patient's vitals were RR 36 bpm with HR 148. Patient was observed and reassessed every 10 minutes. Repeat vitals 20 minutes later were HR 135 bpm, RR 28 bpm, oxygen saturations 98% on room air also while crying and fighting to climb down from mom's lap. Mom reports that yesterday he developed cough, nasal congestion. Per mom, cough has progressively worsened today becoming gradually more wet and congested as the day has passed. No fever. No loss of appetite. Drinking well. No vomiting. No change in stools. No rash. Wetting diapers normally. On Sunday, 3 days ago, he was moving from mom to dad walking down steps when he fell on step, hitting right cheek and eyelid. No loss of consciousness. He cried immediately. No vomiting. No clumsiness. No unusual irritability. He has abrasions to right upper eyelid, cheek and chin that are healing well. He fell at great-grandmother's house recently and hit chin, on Friday of last week. Fall was witnessed by great-grandmother. He cried immediately, no loss of consciousness. Abrasion on chin is healing well.
Information was received on 19-JAN-2017 from a health care worker regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 18-JAN-2017, the patient was vaccinated with a dose of M-M-R II lot # K021950 expiration 10-NOV-2016, 0.5 ml, subcutaneous for prophylaxis after it had expired. No adverse effects were reported. No further information was provided. Additional information has been requested.
On the night of the first dose I felt my heart racing more than normal. The next day I had pain in my arm, chills, nausea, vomiting, diarrhea and fever. The second dose gave me a fever, pain in my arm, vomiting, chills diarrhea.
Patient received FluMist and was above the approved age for the medication. Have reached out to patient with no response as of 09/09/2013. No adverse events were experienced at the time of vaccination but she was notified of what to watch for and to contact us with any problems.
Covid-19 breakthrough case.  Symptoms started July 25, positive test July 26.  Cold/flu like symptoms, mostly mild with moderate fatigue for about one week.  Fatigue lingered 3-4 weeks.  Neurological side effect started mid-August, including vertigo, dizziness, lightheadedness, and localized headaches.  Made worse with screen time.  Treatment included two doctor visits and physical therapy until early October.  Short-term disability taken from work due to screen time limitation.  Full time leave Aug 30-Sep 12, part time Sept 13- Oct 10, returned full time Oct 11. Mostly resolved, but some lightheadedness, especially with extended screen time (for work) coupled with stress.
I had not had a period for 25 years since I was in my 20s and had reached such low weight I stoppexhaving periods. Even when I reachednormal and slightly above normal weight I didn't have a period .  A day and a half after the second vaccine dose (yesterday) i have had continuous light flow blood...it continues today and I have tummy pain similar to what I had when menstruating in my youth
huge black and blue spot on arm; fever; chills; headache; body ache; vomiting violently; woke up violently ill/sick with each shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A772A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for an unknown indication.    On 28-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (woke up violently ill/sick with each shot). On an unknown date, the patient experienced ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently). At the time of the report, ILLNESS (woke up violently ill/sick with each shot), ERYTHEMA (huge black and blue spot on arm), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VOMITING (vomiting violently) outcome was unknown.            No treatment medication reported.  Consumer reported that after her second booster dose of the Moderna COVID-19 vaccine, she started to experience adverse reactions. She reported 12 hours after receiving the vaccine, she woke up violently ill. She reported she had been sick with each shot of the previous doses, like fever, chills, headache, body aches. She could not go to work. With the second booster dose, she had all those side effects and she was vomiting violently. She reported she had a huge black and blue spot on the arm.
2/22/21 positive for covid and flu b  2/23/21 requested bamlanivimab infusion d/t not eating and weakness 2/24/21 emergency room after infusion: HPI  59 y.o. male who presents with left-sided posterolateral chest pain.  Pain has been present 4-5 days time.  It is worsened by deep inspiration or coughing.  The patient has also had nausea and vomiting.  Fever has been as high as 101.6°.  He was tested and found to be positive for both influenza and COVID-19.  He denies anterior or central chest pain dyspnea or orthopnea palpitations sputum production.  3/1/21 emergency room for worsening condition: 59 y.o. male presented to the emergency room with a several day history of intractable nausea vomiting and severe weakness.  The patient does have a known history of recent coronavirus (COVID-19) infection.  He was diagnosed on February 22nd and did receive Bamlanivimab.  He started feeling a little bit better after this, but a few days ago started having increasing weakness and nausea/vomiting.  He called me this morning and stated he had been unable will keep anything down for several days and was extremely weak and I asked that he go to the emergency room.  In the emergency room is lactic acid was found to be elevated.  His CT scan of his chest with contrast showed severe coronavirus (COVID-19) pneumonia.  This was run after he was found to have an elevated D-dimer.  He was found to be extremely weak and deconditioned.  His oxygen saturations at times or found to be in the low 90s.  Because of all of this he will be admitted and treated for sepsis from coronavirus (COVID-19)..    3/2/21 currently remains hospitalized
Fever 101-102, sore throat, headache, loss of appetite, and rash or hive on 08/31/2017 at night time.
Pt vaccinated with DTP developed "severe" crying and her arm became extremely red from shoulder to elbow immediately following vaccination.
Patient was 15 years old at time of vaccination. At the time, this vaccine was only approved for individuals 16 and older.  The patient's mother filled out his intake forms and the two of them deliberately lied about his age in order to be able to receive the vaccine early.
Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or trouble breathing. Benadryl 25mg PO x 1 given, pt also took 1 puff of albuterol, throat symptoms resolved, then pt developed dizziness/jitteriness. Pt monitored and symptoms resolved. Pt discharged home with family under stable condition.  Respirations unlabored and even.  SpO2 100% RA BP 126/61 HR 85
complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; This is a spontaneous report from contactable Nurse via Pfizer Sales Representative.  A 16-year-old male patient received the second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 07Feb2019 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took the first dose of vaccine on unspecified date.  The patient experienced complaining of chills and tingling sensation to arm and had fever of 100 degrees F. on 08Feb2019. The events were non- serious. The physician advised patient to take Tylenol or Motrin. The outcome of the events was unknown.   The information on the batch/lot number has been requested.
Have always had slight ringing from tinnitus in right ear for at least 10 years. After my first moderna vaccine shot I noticed that the ringing has increased a  lot . Was not sure if it was related to the vaccine, but after reading all the similar complaints, it would make sense to think the vaccine may have something to do with the increased level of ringing. Not sure if I need to continue with my second doasage at this point.
ALS got better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included ALS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (ALS got better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking ALS medications concomitantly.  The patient felt that her ALS got better after getting the vaccine. She stated that 3 weeks after her first dose, it was easy for her to get up off the bed, it normally takes her a lot of effort to get up. She was able to stand up on her own. 3 days later, she had more energy to roll over in her bed. It usually takes a lot of effort. No treatment information was provided.
Tinnitus increase in volume.  I typically have tinnitus with perceived volume just below normal conversation level.  For about 4 weeks after the first shot my perceived tinnitus volume was up several db so that it was slightly above conversation level.
Developed PVCs; Mild elevation of cardiac troponin and HS-CPR; Mild elevation of cardiac troponin and HS-CPR; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious) with onset 22Sep2023, outcome "recovered" (03Oct2023), described as "Developed PVCs"; TROPONIN INCREASED (non-serious), C-REACTIVE PROTEIN INCREASED (non-serious) all with onset 22Sep2023, outcome "recovered" (03Oct2023) and all described as "Mild elevation of cardiac troponin and HS-CPR". The events "developed pvcs" and "mild elevation of cardiac troponin and hs-cpr" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ventricular extrasystoles, troponin increased, c-reactive protein increased. Additional information: Suspect dose is patient's 4th COVID vaccination dose. Developed PVCs (premature ventricular contractions) 3 days after vaccine (as reported). Went from none to rare to 13 or more PVCs/30 second strip. Patient was better after 12 days. Therapeutic measures were taken as a result of ventricular extrasystoles, troponin increased, c-reactive protein increased which included corticosteroids and NSAIDs.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
According to the patient's wife, the patient had flu like symptoms 2/11/2021.    Complaints:  Thirsty, sweaty  and seizure with no prior history.    Died at home.  Not sent to hospital.    Pronounced by coroner
Information has been received from a licensed practical nurse concerning an 8-year-old male who on 02-APR-2007 was vaccinated SC with a second 0.5mL dose of VARIVAX. On 02-APR-2007 the patient experienced an anaphylactic reaction. He had "no blood pressure" and had "difficulty breathing". He as admitted to the hospital for 2 days. He was given large amounts of epinephrine and fluids. The events were considered other important medical events by the reporter. Additional information has been requested.
Patient 1 had swelling at injection site and respiratory swelling and required and Epi-Pen injection.; Patient 1 had swelling at injection site and respiratory swelling and required and Epi-Pen injection.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's current conditions included sulfonamide (also reported as sulfa allergy). The patient's pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot number, expiration date, and route of administration were not provided). After vaccination, the patient subsequently had a reaction and experienced swelling at the injection site (vaccination site swelling) and respiratory swelling (respiratory tract oedema), an epinephrine (reported as Epi-Pen) injection was required to treat the adverse events. At the time of reporting, the outcome of the events vaccination site swelling, and respiratory tract oedema was not known.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event respiratory tract oedema was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003803:
devel maculopapular rash on chest, face & this cont to include mucous membranes; seen by several MD; there was some disagreement as to whether or not it was Stevens Johnson synd, erythem multiform or other rash secondary to virus; fever;
Onset around 9/26 of urticaria hives-started with left ear itch and swelling (entire ear), then moved to neck area.  Subsequent nights moved to thighs, lower extremities, buttock area, eyes, arms, left under arm, left breast area and scalp. Dermatologist prescribed prednisone (10 mg) 30mg to be taken daily along with Claritin in AM and Xyal in the evening.  Prescription given 10/3 - present.
This spontaneous report was received from a Medical Assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 11-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ, lot number M038846 expiration date 26-JUN-2018) and PEDVAXHIB lot number M034189, expiration 23-MAY-2019 for prophylaxis (strength and route were not provided). The vaccine was exposed to a temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit for 2 hours. The call was placed because of a Digital data logger. No previous temperature excursions and no adverse effects were noted. Additional information has been requested.
pain fierce for almost a month in arm - sharp pain up and down; pinky and finer next to pink are numb; looks like a spasm sporadically from elbow to hand; A spontaneous report was received from a consumer concerning male patient of unknown age who was administered Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection experienced pain fierce for almost a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12/Jan/2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 12/Jan/2021 the patient reported adverse events such as pain fierce for almost a month in arm, sharp pain up and down pinky and finger next to pinky are numb, also a spasm felt sporadically from elbow to hand.   The treatment information for the events were calcium and vitamin D intake provided.  Action taken with the first dose of mRNA-1273 vaccine was not reported.  Th e outcome for the events pain fierce for alomst a month in arm, sharp pain up and down, looks like a spasm sporadically from elbow to hand was unknown. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Developed mild pain and redness at the injection site and slight fever that became a moderate fever. Had paleness, stomach cramps, and significant vomiting. Anxiety and headache, weakness, dizziness, and lightheadedness, Dehydration. Went to the ER (night of 6 Aug 16).  Treated with IV solution with meds (Anti-nausea, Toradol, Tylenol).  Admitted: Midnight 7 Aug 16 0r 2300 Hrs 6 Aug 16, Released: 6 hours later.
48 hours later after the I notice I had a res swollen lump on my left arm, and it was painful to even touch. It got bigger the next day and I started taking Benadryl and Ibuprofen and it was gone 2 days later.
The injection site is swollen with redness, very painful to touch and painful to move. There is also lingering pain after any moment of the arm or anything touches the injection site. I also have some itchiness on the injection. The pain has gotten wores today (Monday 3/8) which is more than 72 hours after I received the vaccine Friday (3/5) morning.
101 degree fever overnight with it being around 99 the next day until 4pm , heart racing (my watch said my heartrate was around 90 laying down), couldn't sleep, headache, barely can leave the bed or couch
Arm pain , arm feels heavy and very painful.  Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of ROTATEQ. In August 2007, the patient experienced bloody stools. The patient sought unspecified medical attention and was treated with Lactobacillus. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting nurse practitioner indicated that the infant was "doing fine." Upon internal review, bloody stool (s) was determined to be an other important medical event. This is one of several reports from the same source.
EMS WAS REQUESTED FOR POSSIBLE ALLERGIC REACTION. BP 190/100 HR 110 98% OXYGEN ON ROOM AIR. SHE DECLINED FURTHER MEDICAL EVALUATION/CARE. RELEASE AGAINST MEDICAL ADVISE
Seizure every time she was given a vaccine-Taken to hospital -suffered from seizures for several years, current condition attributed to this.
Swollen and sore gland under the right arm. Fever. Cold chills. Headache. Body aches. Pain in the area of the shot.
PUlmonary embolus noted on her hospital admission 4/21. She was vaccinated 5 days ago. That was her second shot.
SORE ARM AT INJECTION SITE, FEVER, CHILLS, BODY ACHES, FATIGUE RESOLVED IN 36 HOURS  Narrative:
Information has been received from a health care professional concerning a 12 year old male who on 24-NOV-1998 was vaccinated with the first dose of MMR II. On 25-OCT-2009, the patient received the second dose of MMR II. On 20-NOV-2009 the patient experienced mumps, stomach pain and nausea. The patient experienced mumps (date diagnosed was reported as 23-NOV-2009). On 23-NOV-2009, the patient's blood work showed: a IgM <1:10, IgG 7.16 and serum amylase 568. The patient was afebrile and had left parotitis. The outcome for mumps was not reported. No further information is available.
11/20/99 tired,slight headache, 11/21/99 woke up,headache, tylenol, sudafed w/o relief, became worse, had nausea. 11/21/99 to ER. Admitted dx/aseptic meningitis. 11/21/99 to ER Rioaneursym CT scan, lab elev.  WBC Rio bactereal meningitis admited.  Dx aseptic Meningitis.
pt recv vax 25JUN97 & 26JUN97 pt to ER w/redness & tenderness to touch of rt leg @ site of vax;mom felt inj site to rt leg was swollen causing pt pain;t100;inj site red & sore to touch;fussy;cry seemed to be @ a higher pitch than nl;