chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My Blood Sugar us OUT OF CONTROL; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment information was provided.  The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.  The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.; Sender's Comments: The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.
extreme high blood pressure (exactly 20 minutes after injection) inability to focus dizzy swelling in fingers swollen lymph nodes in neck headache  taken by ambulance to Hospital  treated in the ER and was given Pepcid, saline by IV and some other medications (can't recall the names)  arrived at ER at 4:00 p.m. and left at 7:30 p.m.  BP regulated but swelling, headache and inability to focus remained    All symptoms came back the next few days and finally felt better on Sunday yet was pretty lethargic until the following Wednesday.
A report was received from a healthcare professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-84 years who inadvertently were administered 1.0ml Fluvirin on an unreported date. On an unreported date eleven vaccinees were inadvertently administered 1.0ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002:  A follow up report was received from a health care professional indicated that a 84 year old male vaccinee was  inadvertently administered 1.0ml Fluvirin on 11/21/2002. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.
Patient is a 47 y.o. male with a history of multiple myeloma not having achieved remission on chemotherapy, nonischemic cardiomyopathy EF 40-45% and hypertension who presents with worsening shortness of breath associated with productive yellow/white sputum, and pleuritic chest pain ongoing for last 2 days worse today.  His heart rate in the 140s en route.    Denies fevers and chills, leg swelling, hemoptysis, diarrhea, nausea/vomiting or urinary symptoms.
Acute basilar, medullar, and bilateral cerebellar stroke with associated Wallenberg syndrome. Severe headache, dizziness/loss of balance, right sided numbness and tingling,  rapid involuntary eye movement, and inability to swallow.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Patient began noticing on 11/05/09 redness around site of injection- by morning of 11/06/09 the redness had begun spreading and the area was itching- patient reported to me at 1pm on 11/06/09 and I referred to her primary healthcare provider for evaluation- healthcare provider agreed it was a localized allergic reaction and antihistamine treatment was started
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 46-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history included allergy to mites, allergy to molds, latex allergy, shellfish allergy and tetracycline allergy since approximately 1985.  The healthcare professional reported that the subject receives allergy injections which have caused injection site reactions in the past.  Concurrent medications included Claritin and allergy injections.  The administration site for the allergy injections was not provided.  No other immunizations were administered on 24 October 2007.  The subject received influenza virus vaccine in previous years, however, it was not reported whether adverse events occurred following receipt of prior influenza virus vaccinations.  On the morning of 24 October 2007 the subject received 1st dose of Flulaval (.5 ml, intramuscular, unknown deltoid).  In October 2007, on or after 24 October 2007 and on or before 26 October 2007, less than one week after vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at injection site and injection site discomfort.  The reporter stated that the subject refused treatment for this reaction.  At the time of reporting the events were unresolved.  Follow-up received on 27 November 2007 via the nurse.  She reported that on 26 October 2007, two days following vaccination with Flulaval, the subject experienced injection site redness, warmness to touch at the injection site and injection site discomfort.  The events resolved after approximately one week around 01 or 02 November 2007.  The reporter considered that the events were not serious.  The reporter considered that the events were related to the use of Flulaval.
Stomach ache - daily every since some days are worse than others. After running tests the Dr. have tried Miralax, Pepcid & Prevacid none of them help.
This spontaneous report was received from a registered nurse and refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
On January 27,2023 I experienced a spontaneous coronary artery dissection in the midst of that I erected and was picked up by the paramedics. I underwent a catheter lab and both left ventricles had dissected from my arteries. The doctors decided to connect me to a machine to reoxygenated my blood.  I was transferred to the ICU, and when I was operating room, I bled out and had to be revived. I was centrally canulated unorder to re. I came out of surgery with left foot drop and neuropathy.  I was then put on the heart transplant list. I had a heart transplant on February 20, 2023, and they had to leave my chest open for three days because the heart was too big. I will continue to have cardiac biopsy every two weeks.
Two days after vaccination, patient noticed itchiness which spread into a rash covering the entire trunk and extremities.  Patient had to seek medical attention at an urgent care and received a prescription for steroids and Benadryl.
Pfizer-BioNTech COVID-19 Vaccine EUA: Systemic: Anaphylaxis, Fainting
This spontaneous report was received from a medical assistant and refers to 3 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were each administered a dose of improperly stored (Oka/Merck) VARIVAX injection, lot # M006722, expiration date 08-FEB-2018 (dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Pt recv vax on 10/8/97; on 10/9/97 pt exp itchy vax site
Pt presented with fever, chills, severe abdominal pain, headache, photophobia and nausea a few hours after the second dose of the vaccine was administered. Few days later, pt was hospitalized comatose, and required intubation. Spinal tap showed lymphocytic pleocytosis but all viral and bacterial testing were normal. Elevated LFTs, AKI with GFR at 6 Pt had meningioencephilitis as seen on MRI brain, EEG, and CSF.  Pt improved with
lips and tongue tingling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at the time of vaccination 64-years-old), as a dose 1, single for COVID-19 immunization. The patient's medical history included fibromyalgia, and she has chronic pains that were diagnosed 20 years ago. There were no concomitant medications. On 03Mar2021, the patient experienced lips and tongue tingling. No treatment was received for the adverse event. The outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
For both doses (1 & 2), I had muscle pain, shivering, feeling hot, then cold.  These started in the late evening. The pain was much worse with the second dose.  Also with the second dose, upon waking following morning, I had severe nausea, was so weak I couldn't walk, fell when trying to get off the toilet.  I went back to bed and hours later I was able to get up but I was still very nauseous.  I almost called 911 but was too weak and nauseous to unlock my door.
My body started shaking uncontrollably - lasted for about 30 to 45 minutes. Also developed a mild headache with the shaking.
BLOOD CLOTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots due to the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210921796-Covid-19 vaccine ad26.cov2.s- Blood clots. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Intense itching, mostly on the palms of my hands and soles of my feet. Sometimes on my forearms and my legs and to of my feet. Almost always symmetrical affecting both feet at once or both hands. Comes on super quickly and feels like I am on fire, goes away almost as suddenly. Feels as if it is most active in the morning and in the evening but it comes and goes other times as well. Most intense at night.
Initial report received from a healthcare professional on 12 September 2013. A 45-year-old female patient, had received fourth dose of FLUZONE (lot number UH899AB, route of vaccination was not reported) on 04 September 2013. The patient medical history included hypothyroid, obstructive sleep apnea, vitamin D deficiency and irritable bowel syndrome. The patient had no illness at the time of vaccination. The patient had no known allergies and concomitant medication was not reported. On 04 September 2013, the patient had soreness in the area (first 2 days). Pain down to her arm and into the chest. On 11 September 2013, in the night, the patient was unable to lift her arm and woke up due to pain. The patient had no redness, tingling, numbness or swelling. It was reported that the symptoms were getting worse and was instructed to call back if not improved. No laboratory investigations were done. On an unspecified date, ANAPROX prescribed for pain. The patient outcome was not recovered. Documents held by sender: none.
shoulder pain; unable to move his left arm; twinge of pain; vaccine was administered higher up on his shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th December 2019 04:00, the patient received the 2nd dose of Shingrix. On 18th December 2019 07:00, 3 hrs after receiving Shingrix, the patient experienced shoulder pain, injected limb mobility decreased, injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the injected limb mobility decreased, injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm. The patient received dose of Shingrix at 4 pm  and by 7 pm, the patient was unable to move left arm due to pain in shoulder. Immediately after vaccination with Shingrix, the patient experienced  injection site pain. The patient stated that, the injection site was different from the 1st dose. The reporter reported that, the vaccine was administered higher up on shoulder and felt a twinge of pain as the needle went in, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Severe case of pink eye, in left eye, and a swollen lymph node in front of left ear.  Started mildly on 04/15 and became much worse by 04/16.  Both lids were swollen, itchy, discharge and RED.  Started to get better by 04/23 and was almost gone by 04/25.  Called the doctors office on 04/17 and they subscribed antibiotic eyedrops that I used for 7 days.
pt recv vax & exp a chickenpox-like rash w/about 20 lesions, 36-48 hr p/vax;
Soreness on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness on the left arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
MMR & DTaP shots given in one thigh-leg, according to parents-- ban cellulitis & redness that went all down the leg - warm to touch & fever. Rx Keflex given.  Follow up on 07/16/04 states: "MD nurse did not submit VAERS report and apparetnly MD did not submit it either. I was referred to immunization the nurse there stated vax date was 06/22/04 (not 06/26/04) and gave box 13 info. However she did not submit the VAERS report.
This spontaneous report as received from a physician via agency refers to unspecified number of male patients out of 30 patients, aged between 11 to 22 years old, who were enrolled the program. The patients had no relevant medical history. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. The patients complained of burning at injection site (onset dates unspecified). No tests were carried out for diagnosis. The administration of the second and third dose was not prevented. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. This is one of the two reports from the same reporter. Additional information is not expected because the physician was not willing to be contacted.
sensation in throat/a menthol cough drop stuck in the throat; flushed; diaphoretic; burning into my chest; some random hives; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received first dose of bnt162b2 (lot number: EL0140), via an unspecified route of administration at site of left arm at 11:30 on 19Dec2020 at single dose for COVID-19 immunization. Medical history included Oral Allergy Syndrome, ADHD (attention deficit hyperactivity disorder), multiple food allergies, and allergies: PCN, Ceclor and Lovenox multiple. Concomitant medication included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Within minutes after vaccination, the patient became flushed and diaphoretic followed by a sensation in her throat, it felt that she had a menthol cough drop stuck in the throat and the burning into her chest. Once the medics administered IV Benadryl, the sensation in her throat went away. She was in the emergency room for about 3 hours and had some random hives throughout the rest of the evening. She had anaphylaxis previously to avocado and to an allergy shot. This was definitely nothing close to anaphylaxis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Dec2020.
headache, severe chills, severe body aches, night sweat duration: 6 hours  treatment: Tylenol
ringing in his ears; This spontaneous report was received from a pharmacist referring to a 73 year old male patient with no drug reactions/allergies, "multiple unspecified" medical history conditions, and on multiple unspecified concomitant medications.      On 26-FEB-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S006778, expiring on 28-NOV-2020, via intramuscular route, for routine vaccination.  On the same day, the patient also received a dose of zoster RGE vaccine (mammalian)(SHINGRIX) for an unknown indication (dose, route and site of administration, lot number and expiration date were not reported).   On the same date of vaccination, the patient experienced ringing in his ears (tinnitus).  The patient sought medical attention by contacting the pharmacist.  No treatment was given for the event. Not any laboratory test was performed.  At the reporting time the patient had not recovered of tinnitus.  The reporter did not assess the causal relationship between suspect therapies and the event.
immediate syncope, hypotension, and bradycardia after vaccine. refused hospital transfer resolved with observation
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 19-JUN-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M044724, expiry date 13-JUN-2018, orally (exact dose was not reported) for prophylaxis. No known adverse effects were reported.
?Moderna COVID-19 Vaccine EUA?  patient has the following reactions:                                  -Redness                                 -Warm to the touch                                 -Lump at injection site                                 -Itchy                                 -Swelling in the armpit area but no pain
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has received 1st dose on 21st May and hasn't received 2nd dose yet past 42 days) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has received 1st dose on 21st May and hasn't received 2nd dose yet past 42 days). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (Patient has received 1st dose on 21st May and hasn't received 2nd dose yet past 42 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include 2 Blood Pressure Medicines. No treatment information was reported.
FLU VACCINE ON 9/23/2009 IN LEFT ARM ON 9/24/2009 SEEN IN OFFICE.  LEFT ARM RED, SWOLLEN AND ITCHY.  NO FEVER.  SEEN 9/25/2009 ARM SWELLING MORE AND RASH N/S
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE THAT WAS EXPOSED TO MULTIPLE TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional 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: 1822809 expiry: UNKNOWN) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 21-JAN-2022, the patient experienced administration of vaccine that was exposed to multiple temperature excursions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine that was exposed to multiple temperature excursions and incorrect product storage was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000237054. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650111, 20220650014, 20220649045, 20220649488, 20220649417, 20220649137, 20220649488, 20220649626, 20220649915, 20220649803, 20220650185 and 20220649884.