chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe local reaction, from should to elbows. Mother said, it was swollen, red and hot to touch on left arm. Hospitalized overnight per doctor.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 4 (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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cvid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Facial swelling at sites of dermal filler; This is a spontaneous report from a contactable nurse (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 18Feb2021 08:45 (at the age of 38-year-old) as dose 2, single dose for COVID-19 immunisation was in hospital. Medical history included headaches. Patient had no known allergies. Concomitant medication included sumatriptan and cyanocobalamin (B12). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration, administered on an unspecified date as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On 19Feb2021 15:00, patient experienced facial swelling at sites of dermal filler. Patient did not receive treatment in response to the event. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Vaccine given after manufacturer beyond use date exceeded by 2 days (product expired on 9/8/21 but was given on 9/10/21).
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 36  days.  Appropriate steps were taken to notify the state and are coordinating efforts to notify patients to repeat vaccination.
8-17-2021 went to ER; diagnosis was Vasculitis and Accute Kidney Failure.  Treatment received and discharged from hospital on 8-28-21.  Currently on dialysis for unknown time and follow up appointments to treatments
Developed rash on my back, stomach, arms, and legs the day after receiving the vaccine.  Rash disappeared on the fourth day after receiving the shot.
Initial report received from a consumer which was reported from another manufacturer (S2010US32859) on 21 December 2010. A female patient (age not reported) received on an unknown date an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number not reported, an injection (route and site not reported) of TETANUS TOXOID, manufacturer and lot number not reported, and a form (route and site not reported) of NOVOCAINE, manufacturer and lot number not reported. On an unknown date, the patient developed the feeling that she was going to die, inability to move and was bedridden. The patient's medical history was not reported. The patient's concomitant medication was ACTONEL. The patient had an adverse event to ACTONEL which included burning, intestinal problems, skin reactions and high blood pressure. No further information was provided. The outcome was not reported. Documents held by sender: None.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-JUN-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 micrograms/1 ml (Lot # J001183, expiration date 08-SEP-2014) route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the RECOMBIVAX HB had a temperature excursion for 4044 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
3" in diameter itchy, red, raised swollen area at injection site that started on 1/22/2021 and remained until 1/24/2021. It was warm to the touch and tender and painful, but resolved.
Hives, itching and generalized edema 10 min after immunizations given Dexamethasone 4mg IM x 1 given and Atarax 10mg po qid. Pt improved.
Pt developed subepithelial corneal infiltrates in her right eye 1 month after the injection.
Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Department of Health verified with statistical records the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
One week after the injection, I experienced a few days of  soft bowels, and pain and then diarrhea.  Then it turned into mouth sores like I?ve never had before. I had a red rash on the roof of my mouth that would get hot from time to time, was very painful, felt like maybe it went to the back of my mouth ( no sore throat),  and I also had a sore on the tip of my tongue.  I experienced the moth sores for 5 days seems to be getting better, not  all the way gone yet.  I can?t remember the last time I was sick and I felt  very well prior to the injection.  It?s either a coincidence or it?s the vaccine.  I did read after looking things up, that their is a study going on, regarding mouth sores post Covid injection, so it may be of significance.
Pregnant-due date 4/28/22, no complications  Got my 2nd covid shot, had a fever, vomiting fatigue for 2 days following that Had a miscarriage just couple weeks later
blood clots; leg pain due to clots; chills; diarrhea worse than when I had covid; chest pains; nerve sensations up and down back and arms; blood pressure went up; higher fever than when got covid; headaches; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020 and Thrombosis (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020. Concurrent medical conditions included Hypothyroidism, Blood pressure and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, HYDROCHLOROTHIAZIDE and METOPROLOL for Blood pressure, LEVOTHYROXINE for Hypothyroidism, POTASSIUM for Potassium, VITAMIN B NOS, VITAMIN D NOS and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, SAMBUCUS NIGRA (ELDERBERRY EXTRACT) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up), PYREXIA (higher fever than when got covid) and HEADACHE (headaches). On 15-May-2021, the patient experienced DIARRHOEA (diarrhea worse than when I had covid). In May 2021, the patient experienced CHEST PAIN (chest pains) and PARAESTHESIA (nerve sensations up and down back and arms). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain due to clots) and CHILLS (chills). On 16-May-2021, DIARRHOEA (diarrhea worse than when I had covid) had resolved. At the time of the report, THROMBOSIS (blood clots), CHEST PAIN (chest pains), PARAESTHESIA (nerve sensations up and down back and arms), BLOOD PRESSURE INCREASED (blood pressure went up), PAIN IN EXTREMITY (leg pain due to clots), PYREXIA (higher fever than when got covid), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.  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.; Sender'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.
Viral conjunctivitis; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), intramuscularly administered in the left arm on 14Jan2021 14:45 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Medical history included coronary vasospasm, breast cancer, adhesive allergy, and nickel allergy. The patient had no history of COVID-19 prior to vaccination. Concomitant medications included bupropion, duloxetine, metoprolol, nifedipine, spironolactone, and tamoxifen. The patient did not receive any other vaccines within four weeks of the COVID vaccine. On 30Jan2021 08:00, the patient experienced viral conjunctivitis. The event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The event was treated with steroid eye drops and saline rinse. On 03Feb2021 07:30, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL8982) intramuscularly administered in the left arm as dose 2, single for COVID-19 immunization. On 16Oct2021, the patient's nasal swab was negative. The outcome of the event was recovered with sequelae on an unspecified date.; Sender's Comments: As there is limited information in the case provided, the causal association between the event conjunctivitis viral and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
"Moderna COVID-19 Vaccine EUA" Severe headache, body ache through out entire body including my right ear, could not be touched because of the pain, chills, weakness, fever
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Skin warm and red at site of administration. Approx. 3 inch site of redness and warmth noted. Teammate describes "burning" sensation at site. "I feel like the needle is still in there, stabbing me."
Migrane for 3 weeks, 24/7.  Changed to persistent headache, with intermitant migraine.
Patient is a 70 y.o. male patient of, MD with history of remote stroke with residual left-sided deficits, hypertension, and hyperlipidemia, now presented to Hospital with acute hypoxemic restaurant failure secondary to COVID-19.   Acute hypoxemic respiratory failure secondary to COVID-19 pneumonia Place patient on supplemental oxygen in ED Date of onset of symptoms: 9/11/2023. Symptoms present on admission: Chest pain, shortness of breath, fevers, chills, dry cough, upper respiratory congestion. Date of covid positive test: 9/11/2023. Vaccination status: vaccinated Chest x-ray clear Temperature peaked at 103.1-resolved. Tylenol as needed. Patient weaned from 2L NC 9/13. Now on room air. Received remdesivir while inpatient Encourage IS, mucinex, decadron, and albuterol inhaler. Prone positioning as tolerated.   History of remote stroke  Hypertension Hyperlipidemia SBP 130-170's, home meds resumed PT/OT    Obesity Outpatient diet and exercise regimen.   Evaluation for OSA and/or continuation of home CPAP.   BMI: 35.91.
had some effects after the first but they have lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days). At the time of the report, ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. had some effects after the 2nd dose that lasted a day and a half. have since developed the same symptoms as the first but they have lasted 4 days. Treatment information was not provided   This case was linked to MOD-2021-344349 (Patient Link).
Gave FLUZONE QUADRIVALENT 0.5 mL prefilled to 20 month old instead of the prefilled 0.25 mL dose. Was not aware that prefilled even came in 0.5 mL dosing. (This was private purchase stock). Just grabbed the prefilled and proceeded thinking it was the 0.25mL.
Headache, Fever [101.2], Stomach Cramps, Fatigue, Mild Soreness [immediate] at the injection sight. These symptoms began to gradually manifest themselves beginning approximately 16 hours after injection. They got progressively more severe over the 72 hour period commencing the day AFTER injection. None of the symptoms were so severe as to categorize them as debilitating and all were managed with a regular regimen of OTC Ibuprofen. All symptoms were gone by the 4th day AFTER injection.
On 12/8 and 12/9, the pt noticed slight shortness of breath. She went to ER on 12/10 and x-rays showed pulmonary edema bilaterally.
Fever at onset of symptoms 100.5 F, rose to 102.4 F 12 hours later, remained above 100.0 F for more than 48 hours.  Nausea and aches for first 24 hours, dizziness and exhaustion for more than 48 hours.
liquid was dripping down arm; didn't fully screw in syringe; A spontaneous report was received from a consumer, a 45-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) for prophylaxis of COVID-19 infection.   On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A).  The patient reported events of device connection issue and subsequent receipt of vaccine under dose.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome if events consider as recovered.; Reporter's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, batch number: 031L20A with no associated AEs.  Causality for the medication error is not applicable.
Rash all over body - started on face and spread down chest and back and to extremities and low grade fever.  Symptomatic treatment for fever and cough.
Metallic taste on her mouth immediately after the shoot; A spontaneous report was received from a consumer, concerning herself, a 51-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced metallic taste on her mouth immediately after the shot.  The patient's medical history reported included autoimmune disorder. Concomitant medication reported included levothyroxine.  On 29-Dec-2020, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: 026L20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 29-Dec-2020, the patient experienced metallic taste in her mouth immediately after the vaccine shot, which had lasted for 18hrs. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, metallic taste on her mouth immediately after the shoot was resolved on 30-Dec-2020.; Reporter's Comments: This case concerns a 51 year-old, female patient, who experienced events of metallic taste on her mouth immediately after the shot. The event occurred immediately after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 20-MAR-2018, the patient was vaccinated with an improperly stored doses of GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) and VARIVAX, lot number N027002, expiration date: 28-SEP-2018 (exact dose, site and route of administration and frequency were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 28th March 2018, 14 hrs after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced product supply issue. On 29th March 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was beyond the 6 month window for dose 2 of SHINGRIX and she could not find a pharmacy or doctor who carries SHINGRIX. The patient had denied permission to contact their physician.
Swelling/pain in Left arm axillary lymph node within 24 hrs of shot, after 2 weeks still mild swelling and discomfort in left axillary lymph node and some slight swelling/pain to touch in right.  Fatigue/malaise for first 72hrs post vaccine Left arm pain for first 7 days post vaccine
Patient not hungry and unable to keep down food. Throwing up (x 3) 5 - 9 hours after vaccine administered. No other symptoms. Provided with Benedryl.
patient came in to consultation area and asked to speak with rph.  she showed me her arm/shoulder area and asked if a scab was normal after receiving a flu shot.  it was her left arm just below the shoulder  .. about 1/2 a dime sized scab ... she said immediately after her flu shot it was a raised area filled with fluid. it did not puss only leak a small amount of fluid for about a week.  then last week, it scabbed over and it is what it looks like today ... a regular scab.  she said she did experience some more pain than she normally does than when she had received her flu shot in the past and she asked if this was normal.  I asked her about her range of motion in her arm and shouler (because of the placement of the flu shot) .. she said her range of motion and pain right now was good. no pain.  she is an regular exerciser and she is not experiencing any additional pain than what she normally experiences when she exercises. she just came in to ask if she should be concerned with the scab. I felt the area it was not warm to the touch nor was it red.  I told her that if the area did not continue to heal properly or she started to experience pain, then she should come back or then contact her doctor but that we would report this but that it did look like it was now healing.
Fever 100.4, chills, H/A, swollen lips, pains & tingling in arms/legs.  Treated with BENADRYL 25 mg PO and TYLENOL 1000 mg PO.