chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very Hard raised red spot; Achiness in arm and shoulder; A spontaneous report was received from a healthcare facility staff member concerning a 51-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a very hard raised red spot and achiness in arm and shoulder.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, approximately 36 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT # 011JZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. After 36 hours of receiving the vaccine, the patient noticed a very hard raised red spot at the injection site. Treatment provided for the events included naproxen for achiness in arm and shoulder.  On 24 Dec 2020, the patient reported the spot on her arm had grown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, very hard raised red spot and achiness in arm and shoulder, were unknown; Reporter's Comments: This case concerns a  51 year old female patient. The patient's medical history is not provided. The patient experienced an expected event of injection site very hard red raised spot and achiness in arm and shoulder of injection. The event occurred on 36 hours after  receiving first dose of mRNA-1273 (LOT # 011JZ0A) on 22 Dec 2020. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Swelling and Pain at the site of injection is listed on the company's fact sheet for the healthcare providers.
Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pain after inoculation in her arm at the site; dizzy; This is a spontaneous report received from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), intramuscular in the left arm, on 21Jan2021 13:00, at 0.3 mL, single, for COVID-19 immunization. Medical history included "kashi disease" which the reporter further explained as a rare disease that affects shape of red blood cells and has to do with spleen; and brittle bones (pending clarification). Concomitant medications included an unspecified infusion which the patient has to go to every other week (also reported as every two weeks) for "kashi disease" and unspecified medications for brittle bones (pending clarification). The patient did not have any other recent vaccinations. On 21Jan2021, the patient had some pain after inoculation in her arm at the site, was a bit dizzy and had stomach issues which started at night. The patient started feeling "stomach hurt"/stomach pain or sick to her stomach on 21Jan2021 at around 23:00 (reported as "11:00PM-12:00PM"), experienced nausea/felt nauseous, stomach pain, and felt like throwing up. The patient still has that in the morning of 22Jan2021. It was reported that they were not treating the stomach pain with anything. The patient's dizziness went away. The reporter wanted to know if the patient would get the same side effects after the second shot. It was also reported that they check the patient's blood once a month doing labs, results were unknown. The outcome of dizziness was resolved on an unspecified date; "stomach hurt/stomach pain" and nausea were not recovered; and vaccination site pain was unknown.
Administered incorrect vaccine (COVID 19 Pfizer for primary series ) instead of COVID 19 Pfizer Updated Booster Dose Bivalent
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concomitant medications were not reported. On 24-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Been having very bad leg pain in both legs entire legs, pain is so bad it hurts to walk at times, heavy numbness, heavy fatigue, left arm numbness. Blurred vision has been horrible, having dizzy spells, hands have had heavy fatigue pains
Developed PNEUMONIA, Admitted to Hospital on 07/04/2021  Discharged on 07/10/2021 in stable condition.  UNKNOWN if the vaccine precipitated the pneumonia or not.  Never with pneumonia before.
Patient came in January 2010 and mentioned she had itchy rash since getting her vaccine. it varied in intensity and moved around. She was not uncomfortable and no pain. She said it comes and goes and she would see her doctor if it didn't go away.
Information has been received from a physician concerning a male patient between 11-15 years old, who was involved in a patient support program. The patient had no medical history. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency were not reported). No concomitant therapy was reported. On an unknown date sometime between 2008 to 2016, the patient fainted when he received GARDASIL. No diagnostics tests were performed. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be related to GARDASIL. The patient continued to receive administration of 2nd and 3rd doses. Additional information is not expected as no consent for follow up.
mom states pt devel nl began to show neuro deterioration p/vax 21JAN97;had fever for 2wk p/shot, slept a lot, appeared listless;mom states pt may have been sick @ time of vax;taken to PMD 31JAN97 dx OM;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 24Aug2023 to 29Aug2023 as treatment of COVID-19. Patient did not had known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293484 same patient, different drug/event;
my hormones level was out of the wack; Felt ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HORMONE LEVEL ABNORMAL (non-serious) with onset 10Apr2021 12:00, outcome "not recovered", described as "my hormones level was out of the wack"; MALAISE (non-serious) with onset 10Apr2021 12:00, outcome "not recovered", described as "Felt ill". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hormone level abnormal, malaise.  Additional information: Start Taking thyroid pills- methimazole for event treatment. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
was lying in bed 50 minutes; stood up, walked toward bathroom feeling well.  Found myself on the floor, no memory of any lightheadedness, dizziness, or other issue during walk.  Awoke (?) alert, no memory of what happened or how I came to be on the floor.  Chin cut and bruised, chest sore.  Was able to stand, tend to cut chin, and clean up small pool of blood on floor without incident.  No issues since.  No prior history of blacking out.
Vaccine dose, lot number or additional vaccine facility information unavailable at time of tonight's appt. Pt s/p vaccine #1 Moderna thru work on 1/29/2021 in am, in the evening fever tmax 101 noted. This am 1/30/2021 temp 101 and took tylenol at 9am. increased fever and chills and came to urgent care for further evaluations. No other sources for fever, no known contacts. COVID PCR stat to lab to r/o active illness. Tmax today 103.5. VS and exam otherwise stable. strict ER care, alternate tylenol/motrin, hydration, pcp followup on Monday. Increase/worsening or persistent symptoms fever despite tylenol/motrin to ER immediately
Injection site: swelling, rash, heat, red sploches, outcomes YTD.
I am filing a VAERS report in regards to my situation. It has been determined that my husband and I are not carriers of Trisomy 18. I was vaccinated with the Janssen COVID19 vaccine on 03/10/21 (LOT# 1802072) and conceived shortly after ( About 03/27/21). I want to report that my daughter was diagnosed with Trisomy 18 and we are not carriers.  I don't want any other woman to go through this and will do anything I can to prevent this. I am filing this and entering a physician in contact for records.
Pt recv vax on 1/15/98; within 1 hr post vax pt exp angiodema & swollen trachea > 24 hr
This case was reported by a pharmacist (also subject) and described the occurrence of arm numbness in a 43-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). Concurrent medications included SYNTHROID. On 8 January 2014 at 16:00 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, right arm). On 8 January 2014, 15 minutes after vaccination with FLUARIX quadrivalent, the subject experienced arm numbness, tingling in cheek, feeling sleepiness, felt cold and shivering. On 8 January 2014, the events were resolved. The subject reported that she "had to lay down and her symptoms resolved approximately 3 hours after administration" of FLUARIX quadrivalent.
Pt presents left arm swelling red tender after flu shot on Monday (2 days ago). Mother has been icing area with sig reduction in swelling. Mother states that yesterday patient was complaining of severe pain, and was not using arm as much. Pain has improved, and she is using arm more now, but area remains indurated and warm to touch. She was also reports that the area did itch.
The patient had hives after receiving the Trumenba vaccine; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had hives after receiving the trumenba vaccine on an unspecified date. the reporter wanted to know if the patient can get the Pfizer Covid-19 vaccine. The reporter was informed that it would be important to find out what ingredient caused the hives and tocompare the ingredient list of Pfizer and Trumenba vaccine. If there are any similarities then the Pfizer vaccine has been listed to be contradicted in individuals who had a severe allergic reaction to an ingredient in the vaccine. The reporter was told to review this information with an M.D. (medical doctor). The list of ingredients used in the Pfizer vaccine will be forwarded to the reporter. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt tired the same day The next day I woke up with lower back pain. 4/8: lower back pain is increasing and a bump developed.
Warmth, induration, pruritic maculopapular rash 3-5 cm diameter around site of injection. No fever or systemic symptoms.
Rash on arms, back and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on arms, back and chest) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, LEVOTHYROXINE, VALACICLOVIR, ZOLPIDEM, ESTRADIOL (VIVELLE-DOT), HYDROCODONE, GABAPENTIN, OMEPRAZOLE, VITAMIN D NOS and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on arms, back and chest). At the time of the report, RASH (Rash on arms, back and chest) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Benadryl pill, Benadryl cream, and triamcinolone acetonide cream.
Patient was being administered 2nd dose when the syringe leaked contents out and the full dose was not administered. A second syringe was administered with  0.3ml since it was unknown how much was actually administered on the first attempt. Patient has been experiencing muscle pain in the injection site and is having trouble lifting arm up completely
Myocarditis: Patient reports developing intermittent non-radiating substernal chest pain (5/30/21 at 7am) one day following his second Pfizer vaccine. He had also been experiencing cough for the last few weeks starting in early May about a week after his first Pfizer vaccine . He states having an intermittent non-productive cough since receiving his first COVID vaccine in early May. Symptoms are worsened by walking or exertion. No leg swelling. Patient presented to the ER where troponin was elevated to 9000 and EKG was consistent with myocarditis . Patient admitted for NSAID treatment, cardiology evaluation and observation. Troponins quickly down-trended and patient clinically stable. Anticipate discharge home in next 24-48 hours.
This spontaneous report was received from a nurse and refers to eight unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 01-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # reported as L048680, expiration date June 2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 51.3 degree Fahrenheit for 4.5 hours and 31.2 degree Fahrenheit for 1 hour 10 minutes (1 cycle) before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. Additional information has not been provided.
Hospital admission. Community acquired pneumonia. Acute COPD exacerbation. Demand ischemia. To skilled nursing after hospital.
Pt seen on 5/15/00 with two day history of fever and vomiting. Treated with clindamycin for strep. 5/16/2000 pt developed petechiea/purpura legs  and buttocks, Diagnosed with Henoch-Schonlein purpura. No arthritis, or abdominal problems.
TINNITUS has at least doubled in pitch and consistency which is now 24/7 (It was manageable prior to vaccine) It is causing me distress! Left arm still sore to the touch two weeks after shot. Both hands went numb within 10 minutes of receiving vaccine and have stayed swollen and painful joints for two weeks.
Per site and proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
Slightly raised light pink rash on arm. Lower than injection site. Itchy. Faded a few days after noticing.
p/vax pt had T102 which persisted 101-104 until seen 5/30/99;parents feel vaccine implied all siblings had prolonged fever p/vax;
A total of 8 pts had local reactions following immunization; 6 of these 8 pts exp inject reacts which included erythema, hot to touch, pain & swelling w/in 15 mis of immunization; dx allergic topical reaction;
fever; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient's friend). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 21Jan2021 in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Dec2020 in the Left arm at single dose for COVID-19 immunization at the age of 32-year-old and had mild symptoms after first dose, but unfortunately she had a miscarriage about 5-6 days before her second dose. After second dose in Jan2021 she experienced worse symptoms such as fever, chills, nausea and fatigue. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, patient had not been tested for COVID-19. Events were resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The outcome of the events was recovering.
Pt developed malaise, back pain, neck stiffness, and headaches. Self treated and acupuncture to come.
Child woke up to go to the bathroom, and mom indicated that he didn't want to put weight on the left leg. Fever of 101.7, upper leg down to the knee is swollen and painful, lips appeared swollen as well. Child was given Benadryl  and Motrin.   Advised to monitor for any worsening reaction at the site, redness, red streaking, unresolved swelling.
Tenderness at vaccine site; Extreme swelling at vaccine site; Redness the size of a quarter at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at vaccine site), VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MONTELUKAST SODIUM (SINGULAIR), GABAPENTIN, CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, VITAMIN D3, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LOSARTAN, ALBUTEROL [SALBUTAMOL], ZOLPIDEM TARTRATE (AMBIEN), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BIOFLAVONOIDS NOS, VITAMINS NOS (LIPOFLAVONOID [BIOFLAVONOIDS NOS;VITAMINS NOS]), MAGNESIUM, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), GUAIFENESIN (MUCINEX) and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at vaccine site), VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site). At the time of the report, VACCINATION SITE PAIN (Tenderness at vaccine site) outcome was unknown and VACCINATION SITE SWELLING (Extreme swelling at vaccine site) and VACCINATION SITE ERYTHEMA (Redness the size of a quarter at vaccine site) had resolved. Not Provided          No treatment information were reported.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-069877 (Linked Report).; Sender's Comments:  MOD-2021-069877:2nd dose
shingles; This initial spontaneous report was received from a lawyer on 24-MAR-2020, regarding a case in litigation and refers to a 66-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In June 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (the dosage regimen information was not reported). As a result of vaccination, in September 2014, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequel. She has been caused to suffer severe personal injuries which are permanent and lasting in nature, physical pain, suffering, emotional distress, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, as well as to incur substantial economic damages.  The reporter considered that shingles was serious (medically significant).
Right after 4 to 5 hours since I get the 2nd shot of Moderna vaccine, I begin to feel pain in my arm when the shot was given. Then, at the same day evening, I began to have a fever, chill, and body pain. It lasts 4days, Then they are gone. The chill starts first, I feel cold and began to shiver, and body pain every where, then fever start. I take adult tylenol ( 2 pills for one time), fever is reduced, but once again cold/schiver/body pain start. Then it is fever again, I do not like body pain and chill, so I don't take tylenol again because I feel the pain is less when I have fever. So I just drink water. I do not measure but I guess I maybe have 99 to 100 degree fever. All of these symptoms repeat like a cycle.  They lasts 4 days , then disappear.
Injection Tuesday at 10am, felt fine until 6-7pm. By 7pm overcome by crushing exhaustion, unable to complete simple meal prep but no appetite. By 8pm, intense shivering, feeling freezing cold. By 9pm, back/neck/leg/arm muscles stiff & cramped, joints achey, terrible headache. By 11pm, unable to sleep due to discomfort of symptoms - temp 100.1, tylenol taken. Poor, intermittent sleep 12-7am. Wed 7am - ibuprofen for sore achey muscles & joints and headache. Ibuprofen helpful, but exhaustion from poor sleep. Had friend come to care for children because I could not do it. Ibuprofen helpful for symptoms, able to nap. Symptoms slowly resolved. All symptoms gone by Thursday morning.