chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a healthcare professional (patient's mother) on 22 March 2016. This case involves a 4-year-old male patient who was vaccinated with a dose of DAPTACEL (batch number not reported) by intramuscular route in deltoid and also received a dose of IPOL (batch number not reported) by intramuscular route in deltoid on 21 March 2016. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions medical history were reported as none and concomitant medications were not reported. On 21 March 2016, few seconds (reported as immediately after vaccination) following the vaccination, the patient's arm turned red and had rash, became flushed and about 20 minutes following the vaccination, the patient had experienced increased temperature (99.7) and same day following the vaccination, the patient had experienced headache and stomach ache. Laboratory data was reported as none. The patient had received Advil and a nap as corrective treatment. On an unspecified date, the patient was recovered from events. List of documents held by sender: none.
Within 5 hours after 2ND Moderna  vaccine, I developed really severe flu symptoms along with chest & back pain.
Patient is a 76 y.o. male who presented from home on 9/14/2023 with unsteady gait, tremors and urinary symptoms. Tested positive for COVID-19.  Behavioral medicine consulted due to patient's history of bipolar disorder for titration of medications.  Patient was taken out of isolation for COVID.   Gait instability - Etiology unclear. Likely weakness and decompensation from COVID-19. Unlikely cardiac in nature due to normal troponin.  Unlikely stroke though unable to completely rule out as cannot have MRI - Patient uses cane and walker at baseline, since 2011 - Neuro exam unremarkable. Valproic acid level elevated but still within therapeutic range. - CT angio of the head and neck with no acute intracranial abnormality. Atherosclerosis present with moderate stenosis of the L vertebral artery, stenosis of the proximal cervical ICAs b/l. Orthostatics negative. -B12 normal -Unable to undergo MRI due to his cardiac device -Repeat CT negative; will monitor for any evidence of gait instability -He was clinically improving and ambulating better with therapy but then on 9/19 early morning had a fall - got up on own and tripped over bipap tubing - repeat ct stable -Imaging of lumbar spine 9/25 negative for any displacement of previous surgical hardware or acute fractures.   Depression Bipolar disorder - Recently hospitalization for manic episode and meds adjusted. Per wife, patient sleeps often and is fatigued due to depression.  -Also significantly improved on discharge. - Was started on Depakote for bipolar disorder 3 weeks ago. Continue inpatient; however dose reduced due to valproic acid level.  Significantly improved mood. -Dose of Depakote reduced from 2000mg to 1500mg and started on Wellbutrin 150 daily per behavioral medicine recs on discharge.   COVID-19 - Patient vaccinated with Moderna + booster. - Symptom onset day before admission. Patient satting well on room air. - ID consult for possible Paxlovid use; started on Paxlovid 9/15 and course completed  - Given one-time Lasix on 9/16/23; lung exam much improved now and off O2   Thrombocytopenia - Baseline PLT count ~200. 98 upon admission. Likely due to COVID-19 infection. - LDH is normal, haptoglobin is normal - improved to nl range now xysmal atrial fibrillation - On home Xarelto 20 mg.  Rate controlled in NSR - Changed to Eliquis while patient is on Paxlovid, now back on Xarelto.   SA node dysfunction w/ pacemaker - Pacemaker battery last replaced on 9/4. Base pace rate is 45 bpm. - Continue to monitor via telemetry.   Chronic kidney disease - Baseline Cr between ~1.5. Cr 1.60 upon admission.  - Continue to monitor.  - Was given one-time dose of Lasix on 9/16 given his congestion for dry lung strategy, tolerated this well   HTN -On home Norvasc 5 mg, Carvedilol 25 BID at home, Losartan 50 mg. -BP controlled without Coreg, patient was bradycardic to 50-55 HR without Coreg. -continue home meds and monitor. Stop Carvedilol due to bradycardia.
PATIENT RECEIVED THE MODERNDA BIVALENT BOOSTER, BUT HAD NOT COMPLETED THE PRIMARY SERIES. HE RECEIVED THE 1ST DOSE OF THE PRIMARYS SERIES IN MARCH OF 2021, BUT NEVERED RETURNED TO GET THE 2ND DOSE. THE ERROR WAS MADE IN GIVING THE BIVALENT DOSE BEFORE THE 2ND PRIMARY DOSE.
Fever and headache 24 hours after vaccine. Continued fever and chest pain 48 hours after vaccine.
Pt states sxs of feeling very tired & HA x 2 days started about 1 hour after getting shot. Called 3/28/11, pt still just very tired. Arm is fine.
Still feeling weak and tired even upon waking from sleep. I only have a few hours of work time at the most before exhaustion happens.
reconstituted with a non approved diluent; giving Menveo reconstituted with a non approved diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 30th March 2022) for prophylaxis.   On 27th August 2021, the patient received the 1st dose of Menveo. On 27th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received  Menveo reconstituted with a non approved diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Noted elevated area in his axillary ares. He's afebrile. It was warm to touch.  The injection site felt "lumpy". Was sent to Kaiser for evaluation and was advised to monitor the sites for any S&S of infection.
This spontaneous report as received from a registered nurse via a company representative refers to an approximately 19 year old female patient. The concurrent condition and medical history was reported as none. On 28-NOV-1995, the patient was vaccinated with RECOMBIVAX HB dose 1, 0.5 ml, intramuscular. The second and third dose of RECOMBIVAX HB were administered on 26-DEC1995 and 16-OCT-1996 respectively. There were no concomitant therapies. On an unknown date in 2015 (reported as recently), patient was determined to have negative hepatitis B antibody titers. The patient sought medical attention by visiting the office and no treatment was rendered. The outcome of hepatitis b surface antibody negative was unknown (present status was reported as negative antibody titers). Additional information has been requested.
I stayed about 45 mins again. About 12 hours later, my arm started to get sore and. At 24 hours, I had a headache, chills, and I had a long oval red, blotchy, hot arm that extended from the injection site to about 2 inches above my elbow. It was about twice as big as the one from the 1st dose and a lot redder, but it didn't itch as much. I just felt yucky for about 12 hours. About 48 hours after the injection, I was fine, but the redness took about 6 or 7 days to clear up. Didn't seek treatment for this one since I had the same reaction with the first dose.
Developed sudden onset of Bell's Palsy, with paralysis of left side of face, affecting left eye and mouth Received Prednisone - 60 mgm  QD for 10 days  with no improvement Acupuncture 3 sessions a week for 3 weeks with some improvement Physical Therapy - ongoing, with some improvement
TENDERNESS; SORENESS; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced tenderness, soreness, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness, headache, chills and tenderness was not reported. This report was non-serious.
No c/o severe: swelling at injection site with bruising and slight warmth to touch and pain.
Approximately 25 days after administration patient felt pain and stiffness at injection site. I could not locate a nodule or a raised area.
Loss of consciousness, muscle cramps, nausea, numbing of arms and legs, sweating, vaginal bleeding
On 10/7/20 At 2:30 pm pt called & stated this was his first flu shot.  He started to have a headache & feel fatigued.  Discussed possible side effects, informed pt ot call 911 if s/s of anaphylaxis.  Informed to rest, take pain reliever. 10/8 F/U Call - pt stated he had a panic attack & breathing issues last evening.  Fever broke & no headache.
Extreme body aches all over but concentrated on side of injection all the way down to ankle; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle). At the time of the report, MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported.
On 11/9/01, received injection in left arm at 11:30. Approx. 1 hour later, arm was very red and swollen. Later, hives appeared in different areas of the body. Then fever, difficulty in breathing soon followed. Saw my PCP on 11/12/01 as an ER visit. Symptoms are starting to subside but breathing is still impaired. Hopefully making progress.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 27Jun2022 to 02Jul2022 for COVID 19 treatment. Patient got paxlovid immediately so although patient had tested positive, was asymptomatic for the duration of paxlovid treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 16APR97 & devel zoster 19AUG97 immunofluorescent positive;
mild cold symptoms, runny nose, upper respiratory congestion, loss of taste temporarily, no fever.  Setelled into chest and caused asthmatic symptoms, shortness of breath etc.
there was no actual adverse events.  pt got the vaccine less than 18 years of age, they actually lied on the online questionnaire form and then came in for second shot and it was discovered the pt was to young and when confronted about how he made appointment he just changed his dob one year earlier to get the shot early.
He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Herpes simplex. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination). At the time of the report, COVID-19 (He also mentioned that he was COVID Positive in FEB2022 but did not have any symptoms. He is very thankful for the Moderna COVID-19 vaccine / Positive PCR after first booster vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported.  Patient was a clinical trial participant and received the first 3 primary doses on 17AUG2020, 11SEP2020 and 17MAY2021. The first 3 shots were received while participating in the Moderna COVID-19 Vaccine Clinical Trial. Patient reported  that he was COVID Positive in FEB2022 but did not have any symptoms.   No treatment medications were reported.   This case was linked to MOD-2022-657017 (Patient Link).
THE CLIENT DEVELOPED CELLULITIS AFTER RECEIVING A PREVNAR 13 VACCINATION THAT REQUIRED A VISIT TO THE ER AND MEDICAL TREATMENT
Acid reflux/indigestion; Acid reflux/indigestion/having really bad acid indigestion/developed really bad acid indigestion two-three days after getting the second dose; This is a spontaneous report from contactable consumer (patient, self-reported). A 75-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jul2021 (age at vaccination: 75 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0170 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 07Jul2021 (age at vaccination: 75 years), as a single dose for COVID-19 immunization and no events reported. Vaccine was not administered at Facility. The patient reported that on an unspecified date in 2021, she began experiencing acid reflux/indigestion which was still on going. There was no report related to a study or programme. The patient also had acid reflux/indigestion/having really bad acid indigestion/developed really bad acid indigestion two-three days after getting the second dose. The patient asked if this could be from the vaccine. The adverse events required a visit to emergency room and physician office. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
NAUSEA, COLD SWEATS, TREMBLING OF HANDS, PALLOR
Lightning bolt headache, fever, body aches, nausea, dizziness, chills.
On 06/1/1999 and 07/06/1999, the vaccinee received his first and second injections. On 07/20/1999 the pt stated that he began to experience chronic arrhralgia and arthritis. He was treated with Naproxen, Vioxx, and ibuprofen. Physician stated that on two unspecified dates subsequent to 05/04/1999 no knee effusion or swelling was ever detected.  In December, 1999, MRI of the right knee reportedly revealed a posterior tear of the lateral meniscus, calcification of the lateral meniscus, and chondromalacia of the patella, but no finding that he would consider to be consistent with a vaccine-associated arthritis. The vaccinee received his third dose of Lymerix during the summer of 2000. Vaccinee reported that the pain in his knees persists but was not aggravated by the third dose. The most recent info, received on 8/10/00, reports the outcome of the event as ongoing. The adverse event of "chronic arthralgia" does  not meet serious criteria but is being submitted expeditiously for informational purposes. The pt has no history of Lyme disease, gout, psoriasis or Crohn's disease. He has no family history of rheumatoid arthritis or lupus. The following labs were provided by rheumatologist: erythrocyte sed rate was 2mm/hr, rheumatoid factor was negative, and antinuclear antibody was negative. A c-reactive protein was not done. The most recent info, received on 9/1/00, reports the outcome of the event as unknown.
Headache-Tylenol /onset 10 hours after  Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after
4/13- heavy menstrual period (bright red), pt. is was experiencing post. menopausal symp as well, she stated her platelet count was normal  What happened as a result of the adverse event? none does not have medical insurance Recommendation: please visit an urgent care, doctor, or hospital for a check up they could run some labs and determine what is occurring
Information has been received from a healthcare worker who indicated that a patient stated that they knew someone who bled for a couple weeks after they received a dose of GARDASIL (dose, duration and lot number not reported). At the time of the report, the patient's status was unknown. It was noted that the patient who experienced this was not a patient of the physician she was visiting. No further information is available.
Tenderness at the location of injection. Saturday, was soreness under arm (armpit area plus side of body). Sunday started to get soreness in neck on that side of the body.
Slight headache; Ear popping; Pressure in face; Joint pain; Dizziness; itchiness at injection site; Tiredness; Chills; Weird dreams; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 16Apr2021 at 09:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 22:00, the patient experienced slight headache, ear popping, pressure in the face, joint pain, dizziness, itchiness at injection site, tiredness, chills and weird dreams. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events slight headache, ear popping, pressure in the face, joint pain, dizziness, itchiness at injection site, tiredness, chills and weird dreams were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Soreness at injection site and entire arm, inc. muscle pain; tiredness; fatigue; headache; loss of appetite.
First patient noticed her arm at the injection site was red swollen, sore and warm.  Then the pain started going up her arm and into her neck. She woke about 4am the next morning with some difficulty breathing. She waited until about 7am and went to the store and purchased Benadryl. the Benadryl helped a lot.  She took it for a couple of days.
Mom states child is red all over and itches not just at injection site "has a red glow" not blotchy, not chicken pox type rash, no fever, no wheeze. Per physician give Benadryl dose for wt + soaking bath. Rash resolved after 24 hrs.
Patient experienced: leg stiffened; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Patient experienced: leg stiffened) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stiffness. Concurrent medical conditions included Drug allergy, Spice allergy and Multiple sclerosis. Concomitant products included BACLOFEN, DALFAMPRIDINE and LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Patient experienced: leg stiffened). At the time of the report, MUSCULOSKELETAL STIFFNESS (Patient experienced: leg stiffened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was provided.
Fatigue, tired feeling, muscle pain, decreased appetite, injection site pain, redness, swelling, tenderness and a large hard lump, limitation of arm movement, chills, drowsiness, sleeping more than usual, vomiting, low grade fever.
fine papular red rash over all of body..since day after injection. fading by 3/13/20
salivary glands swollen - only happens when eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with ANTIBIOTIC for Salivary gland enlargement, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 18-Jan-2021, the patient woke up with swollen neck, looked like swollen glands. She reported that she talked to her doctor already and figured out it was her salivary glands and called in antibiotic for her. She stated it only happened when she was eating. It was not as she thought it was. Concomitant medications were not provided.
Shortness of breath, throat closing up, sick to stomach, dizzy. Called Primary doctor, was advised to call 911. Paramedics took me to hospital emergency room.