chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16JUN92 devel diarrhea & vomiting, teething also t103, recommended call MD & get some suppositories for temp; 17JUN T106 all noc; had flu & tonsillitis also rash all over body;
RECEIVED COVID VACCINE 1ST DOSE ON 02/03/21.  REPORTED TO ICC ON 2/12/21 FOR HEADACHE, NO TASTE, FATIGUE, AND CONGESTION. REPORTED COVID EXPOSURE 1 WEEK PRIOR.  HAD POSITIVE COVID PCR 02/12/21. RECIEVED BAM INFUSION ON 02/12/21.
swelling of upper arm and pain at injection site. Started to feel some pain in shoulder. Still painful on 11/19. Moving it to keep it from getting stiff and taking over the counter pain med IBU. No pain in shoulder now. just around area of injection .
Arm pain; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 19Jul2021 (at the age of 26 years old) (Lot Number: FA6780) as single dose for COVID-19 immunization. Medical history included, prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient experienced arm pain on 19Jul2021, fatigue on 19Jul2021, diarrhea on 19Jul2021. AE did not result in Emergency Room Visit/Physician Office Visit. No treatment received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jul2021.
Systemic: Headache-Medium, Systemic: Hypertension-Mild, Additional Details: said her head started hurting her from behind. her bp was 140/77 heart rade 77. told her to take tylenol and her regular meds. if her headache persists or gets worse to go to the er. her son has a bp cuff and will check her bp
Rash, swelling of entire upper arm around injection site, onset 3 days after injection
Fever 101.9, Vomiting, Lethargy, achy, headache, dizzy. Symptoms started about 7 hours after vaccination on 9/24/09
This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received FLULAVAL.  On an unknown date, the patient received FLULAVAL at an unknown dose On an unknown date, an unknown time after receiving FLULAVAL the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage od drug was unknown.   Additional information: A dose of FLUVLAV which was stored at an inappropriate temperature was inadvertently administered to a patient. No patient specified or vaccine info available.
started  from 11:00 pm,  experiencing bad headache, whole body joints painful, muscle ache, and diarrhea. Took one pill of the pain reliever at 12;00AM 4/5/2021, diarrhea getting better during 4/5/2021 and 4/6/2021. No headache no diarrhea from 4/6/2021. The joints pain continued  until 4/11/2021.
Pt c/o throat feeling swollen. VSS. Able to swallow and speak without difficulty. Pt refused to have treatment in the ED.
Had first dose at vaccination site on March 3rd.  Upon arriving home, was unable to raise arm forward and upward.  Pain described as aching.  Not any relief with Tylenol or Ibuprofen.  Thought on the 21st it was getting better, but on the 23rd was getting ready to go to the store felt like "both shoulders being pressed upon" and also could feel in upper back/neckline "pressure and ache."
Started with intermittent tightness and cramping in back of calf x 3 days starting 7/30/2021, noticeable at bedtime. The cramping went away after 3 days. Felt a tightness in back of right calf but did not seem swollen and when measured never increased in size. After the cramping went away seemed like SOB getting worse on activity. Went to ER, on 8/6/2021 and diagnosed with Bilateral pulmonary embolism, acute deep vein thrombosis of proximal vein of right lower extremity, and exertional dyspnea, and was put on Rivaroxaban 15mg 1 po bid x 21 days and then Rivaroxaban 20 mg 1 po daily.
Body aches, cold chills, hives (small patch) on left arm, headache, fatigue
Had a serology and had a level of 3.9 but her other family members tested above 20.; Her husband just told her that her arm hurt a little after getting it; This is a spontaneous report from a contactable consumer (wife reported for her husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she and her other family members does not have a history of Covid. Had a serology and had a level of 3.9 but her other family members tested above 20. She added that she knew that there are also people who are fully vaccinated and tested zero on their antibodies test. She stated that she got the double vaccine as well as the rest of her entire family. While reporting for herself, she stated that her husband just told her that his arm hurt a little after getting it. It was like a tetanus shot but nothing bad. The patient underwent lab tests and procedures which included serology test: tested above 20 (other family members tested above 20) on an unspecified date of 2021. The outcome of events was unknown. Information on Lot/Batch information has been requested.
She did not get her second dose.; Swollen lymph nodes on her left side; Pins and needles in her arms and legs; Intermittent twitching in her toes; She felt tired; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles in her arms and legs), MUSCLE TWITCHING (Intermittent twitching in her toes), PAIN IN EXTREMITY (Arm was sore), PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) and FATIGUE (She felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), ESTRADIOL (ESTRING) for Dryness vaginal, AZELAIC ACID (FINACEA) for Rosacea, ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 22-Feb-2021, the patient experienced FATIGUE (She felt tired). On 25-Feb-2021, the patient experienced PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on her left side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.). On 22-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (She felt tired) had resolved. On 02-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes on her left side) had resolved. At the time of the report, PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes) had not resolved and PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Unspecified blood work came back normal.     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.   No treatment medications provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The primary reporter contacts updated. The patient demographics updated. The patient's relevant history was updated. The concomitant products were added. The event outcome were updated as not recovered/not resolved for the events  "Pins and needles in her arms and legs" and "Intermittent twitching in her toes".
I received my vaccine #1 03/27/21 and then the 2nd does 4/24/21 and my periods become irregular and more frequent in btw both doses and thereafter for a couple months. I got two sets of labs for these and they looked like I was going perimenapause but then they just balanced out over the summer with no problem.   In Nov on the 19th of 2021 I went for my booster shot and the next day my body began to have Hot flashes, into sweats, into chills, aches etc and for the last 4 weeks to date this has not let up. My mood is more irritable and eventually I went to my doctor who thinks I could be perimenopause again. I am on progesterone for the next week until I receive my period and then I'm going to get labs that he has ordered. I am also seeing a specialist.  this is not a coincidence that the vaccine created an irregularity with my hormones and then the booster has basically triggered me into early menopause. I am in the process of seeing doctors
-Fast and pounding heart rate, tachycardia, palpitations. Up to 140. -Developed POTS, dysautonomia, exercise/heat intolerance, nausea, tinnitus, shortness of breath
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 24-APR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, frequency and route were not reported) lot # L017265 with expiration date of 10-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL5265), on 19Feb2021 as dose 2, single (Lot number: EN6201), on 24Sep2021 as dose 3 (booster), single (Lot number: FC3182) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "mild hyperlipidemia" (unspecified if ongoing), notes: mild hyperlipidemia; "mildly enlarged prostate" (unspecified if ongoing), notes: mildly enlarged prostate; "thyroid disease" (unspecified if ongoing), notes: thyroid disease; "Known Allergy: penicillin" (unspecified if ongoing), notes: Known Allergy: penicillin. Concomitant medication(s) included: UNITHROID taken for thyroid disorder, start date: 01Jan2022; FINASTERIDE taken for prostatomegaly, start date: 01Jan2022; ATORVASTATIN taken for hyperlipidaemia, start date: 01Jan2022, stop date: 20Jun2022. Past drug history included: Aspirin, reaction(s): "Known Allergy: aspirin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Negative, notes: Day after treatment ended/ asymptomatic; (Jul2022) Positive, notes: Day 4, after treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:The patient took other medications/products within 2 weeks of starting COVID-19 treatment and Paxlovid from 23Jun2022 to 28Jun2022. The patient previously received a COVID-19 Vaccine. Day after treatment ended his rapid test was negative and he was asymptomatic. On Day 3 after treatment ended, he was symptomatic. On Day 4, tested positive on unspecified date in Jul2022, and received a second course of Paxlovid with outcome of Recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPERTENSION (hospitalization), outcome "unknown", described as "He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: elevated.  Clinical course: pharmacist has a drug question about the Pfizer bivalent vaccine. They have a patient who would like to get a vaccination for the Pfizer bivalent vaccine. They are concerned about the inactive ingredients of the Pfizer bivalent vaccine. They are concerned about raising possible blood pressure with the inactive ingredient, because the patient received the previous vaccine with no concern, but theres a concern about the new bivalent vaccine. He was wondering if theres any information about the inactive ingredients that we can send to him and see if anything would possibly cause any increase in blood pressure for the patient. He also mentioned that the patient was recently diagnosed with hypertension, possibly uncontrolled. The patient has been in and out of the Hospital with uncontrolled elevated Hypertension. Medical information included Customer and/or medical inquiry forwarded or referred.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Flu-like symptoms started approximately 6 hours after injection and lasted for approximately 24 hours afterward.  Localized lymph node swelling began once flu-like symptoms subsided and lasted approximately one week.  On 01/05/2022, base of scalp developed an itchy rash, swelling and bumps and occurred sporadically.  Hot, itchy, inflamed skin then developed on forearms and back of hand, include deep itch in each palm.  Face swelling about the ears, eyes, and lips.  Torso, buttocks, and groin developed widespread inflammation, rash,  raised red and white linear bumps.  All come and go to varying extremes throughout the day, and are especially pronounced after a shower.  Periodic chest pans are felt, top and central sternum.  All symptoms continue to this day.
Had very swollen lymph  node on left side, bottom of neck, along my collar bone.  Tender and sore, like a pulled muscle but resolved itself within 36 hours. Very minor side effect, but wanted to report it for public health data gathering efforts.
2-3 weeks post vax, the pt experienced a mile case of chickenpox with 50 to 100 pustules and a fever. The pt sought unspecified medical attention and recovered.
Anaphylactic reaction: vomiting, weakness, fatigue, throat swelling, tongue swelling and burning. No known food allergies, including no allergy to eggs.
Symptoms:  Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16.21) She fell the first evening (4.16.21) after losing her balance.  She denies significant dizziness, weakness or numbness.  She fell again yesterday (4.27.21).  (called nurse triage line to report on 4.28.21) She also reports worsening of her urinary incontinence and isn't sure if its related.  She reports a headache only because she fell hit her head when she fell.     Balance issues-recent fall twice concern seeking medical advice Noticed no balance control Noticed increased of dreams of falling while sleeping first fall on same day of vaccine 7:30pm second fall yesterday -around 10am Symptom duration: couple days  Recommended ED or Urgent Care - no follow up or visit by patient at this time of reporting (evening 4.28)
Instantly complained of pain and tingling in the left arm that traveled up towards the head. Instructed to sit in a chair for a few minutes. After sitting down, patient complained of not feeling well and passed out. He remained unconscious for approximately 2 minutes (best guess). When he regained consciousness, he was still very out of it and complained of needing to vomit. As he vomited, he lost consciousness again. He regained consciousness approximately 30=45 seconds later. This time he was much more coherent but vomited again. The doctor and nurses laid him down with feet elevated and he remained conscious.  He appeared to have low blood pressure. The doctor called the ambulance and he was transported to Medical Center. He remained in the ER for observation and tests and was released around 10pm that night.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant mediation was reported. No treatment information was reported.
3-1-22 Work up thinking he had a stroke went to ER and Vertigo was diagnosed. Two weeks later still bad vertigo, used wheel chair assist to get back after doing many head maneuvers with specialist.  In town saw primary care doctor, Ear Nose and Throat specialist, two series of therapy. Had falls with balance issues - times he was fine. Continued with Vertigo diagnosis Returned by car - had falls and then 5- 24-22 had seizure?, performed CPR taken by ambulance to hospital in City where he spent 6 days - numerous tests, etc. Released 5-29-22 went to primary care doctor, GI specialist and consult with neurologist week of June 5th 2022
Breastfeeding with her 3 month old baby; This spontaneous case was reported by an other caregiver and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby) in a 3-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Immunocompromised and Cholangitis.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No medical history reported.).    On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby). On 27-Mar-2021, EXPOSURE VIA BREAST MILK (Breastfeeding with her 3 month old baby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-060390 (Patient Link).
Headache and nausea - they got a little worse after the second shot; headaches got a little more intense . I still get headaches now. I still get nausea but not as much as before. January 25th, 2021 and another one on January 26, 2021 at the medical center.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (strength: 0.5ml, lot # K020188, expiration date 22-OCT-2016, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 168 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was Frozen (F). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
2 days after receiving TdaP, MCV4, and HPV9 patient had a new onset seizure.  Found to have swelling of the brain per mother in hospital.  Now taking prednisone and valproic acid.
The patient was at the clinic for her 2nd Hep A immunization on 04/11/22.  On 04/13/22, during a spot check it was identified that she was given the pediatric dose instead of the adult dose.  The patient has not had any adverse effects.  Notified the Health Department on 04/13/22 and telephoned the patient to return to clinic for re-administration of 2nd Adult dose.
VS 170/100, 112;  Anxiety, tachcardia, hypertensive, no meds given, patients resolved.
the arm of the shot has been very achy; mild headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (the arm of the shot has been very achy) and HEADACHE (mild headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (the arm of the shot has been very achy) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE PAIN (the arm of the shot has been very achy) and HEADACHE (mild headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 events, a causal relationship cannot be excluded.
Injection site rash aprox 2x2 inches. It is red and swollen. Feels hot but does not have a fever.
Vaccine given was expired on September 30th, 2023. Vaccine Given on 10/10/2023.  No treatment,  or no adverse outcome observed
PATIENT WOKE UP WITH PAIN IN HIS ARM FROM HIS SHOULDER SOCKET TO THE MID BICEP ON THE INJECTED ARM (LEFT).  THERE WAS NO DISCOLORATION ANYWHERE OR BRUSING.  THERE WAS NO HEAT.  IT WAS DEFINATELY MUSCULAR PAIN. THE PAIN PERSISTED FOR  3 WEEKS TREATING WITH IBUPROFEN  OVER THE COUNTER.  THE ARM HURT SO MUCH HE COULD BARELY LIFT IT TO EVEN SHOWER OR WASH HIS HAIR.