chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight metallic taste. Numbness in lower lip on right side. Headache. Neck ache/stiffness center back.
No adverse effects were reported; received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 28-OCT-2019, the patient received rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(lot # and expiration date were not reported) orally for prophylaxis, following a temperature excursion. The vaccine was exposed to temperature excursions of below 36 degree Fahrenheit/2 degree Celsius(35F)(lowest temperature) for 430 minutes. There was no previous temperature excursion and no a "data logger" was involved. No adverse effects were reported in the patient.
heartburn; weak, I had no strength; I couldn't stand; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (heartburn), ASTHENIA (weak, I had no strength) and DIZZINESS (I couldn't stand) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heartburn), ASTHENIA (weak, I had no strength) and DIZZINESS (I couldn't stand). At the time of the report, DYSPEPSIA (heartburn) and ASTHENIA (weak, I had no strength) outcome was unknown and DIZZINESS (I couldn't stand) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Information regarding previous COVID-19 vaccination doses were reported as unknown.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that 18 minutes after my Moderna vaccine patient couldn't stand, she was weak, she had no strength and this was frightening because she was healthy before this. The Medical team checked me, her heart was fine and they gave her orange juice and after 3 containers of orange juice, she developed heartburn and told them to stop. After an 1 hour, she tried to stand and with the help of her husband and a medical staff, she did. Patient stated she left and went home. The patient stated that they contacted their doctor, and she told her to hydrate a lot before going.   This case was linked to US-MODERNATX, INC.-MOD-2023-746995, US-MODERNATX, INC.-MOD-2023-747450 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746995:Same patient (different vaccine) US-MODERNATX, INC.-MOD-2023-747450:Different patient (same vaccine)
Cold, lethargic, achy from around 4-7 pm. Took Advil.  About 9pm, MAJOR Chills, aches, fever over 100 .  Took Advil around 11, fell asleep around 2am.  Following morning , temp back to normal, severe headache.
This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age. On 26-JUL-2017, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (Lot number: N012615), subcutaneous for prophylaxis, which was reconstituted with properly stored sterile diluent. On 26-JUL-2017, the patients experienced incorrect product storage. The administered doses were exposed to a temperature between 6°F to 14°F for 1 hour (digital data logger) with one previous temperature excursion at a temperature between 6°F to 14°F  for 2 hours and 45 minutes (digital data logger). No adverse effects were reported.
Information has been received from a nurse practitioner concerning an approximately 46 month old white male (also reported as 2 years old) who on 11/8/02 was vaccinated with a first dose of varicella virus vaccine live (lot # 643080/0451M). There was no illness at the time of vaccination. In approximately September 2004, the patient developed a breakthrough rash. The patient had less than 50 lesions overall with 20 lesions on the right ankle and six lesions on the back and front trunk. The lesions were papular and vesicular, red, and clear fluid filled on all four extremities and trunk and face. The patient had a fever and was congested during the week of 9/8/04. At a doctor visit on 9/15/04, the patient had no fever and a stuffy nose. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow up information was received from the nurse practitioner who indicated that the patient developed a mild case of varicella and was afebrile. No diagnostic laboratory tests were performed. Subsequently, the patient recovered. No further information is expected.
Experienced expected arm pain at the injection site, as well as slight fever/chills. The unexpected outcome was losing sense of smell in the evening, a few nights later. I've had COVID (late December, early January) and it was the exact same sensation as then. By the next morning, this was gone and my smell had completely returned.
Severe, debilitating muscle and joint paints. Hardly able to walk due to pain. Associated with frontal headache. No pain relief with otc Tylenol not Motrin .  Symptoms lasted for 24 hours
Shoulder started to hurt so badly patient could hardly move it.; Shoulder started to hurt so badly she could hardly move it.; Lymph nodes, on the side patient had the vaccine, under left arm and to the side, became like little rocks or little hazel nuts for 4-5 weeks.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Shoulder started to hurt so badly patient could hardly move it.), VACCINATION SITE PAIN (Shoulder started to hurt so badly she could hardly move it.) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes, on the side patient had the vaccine, under left arm and to the side, became like little rocks or little hazel nuts for 4-5 weeks.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A, 027A21A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Shoulder started to hurt so badly patient could hardly move it.), VACCINATION SITE PAIN (Shoulder started to hurt so badly she could hardly move it.) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes, on the side patient had the vaccine, under left arm and to the side, became like little rocks or little hazel nuts for 4-5 weeks.). The patient was treated with CORTISONE for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Shoulder started to hurt so badly patient could hardly move it.) and VACCINATION SITE PAIN (Shoulder started to hurt so badly she could hardly move it.) outcome was unknown and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes, on the side patient had the vaccine, under left arm and to the side, became like little rocks or little hazel nuts for 4-5 weeks.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. With the first dose lymph nodes on the side patient had the vaccine, under left arm and to the side, became like little rocks or little hazel nuts for 4-5 weeks. Patient's shoulder started to hurt so badly could hardly move it. Patient saw a doctor after a while who recommended physical therapy and took x-rays. The pain didnot go away after physical therapy, but then patient had a cortisone shot which helped a lot. Patient wanted to share some side effects that experienced to include that in the researcher's data so they may be able to fix this.   This case was linked to US-MODERNATX, INC.-MOD-2022-628900 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628900:Reporter's case
pt c/o swollen, red arm p/vax;sx persisted for about 2wk;no evidence of deltoid muscle damage, hematoma;no lymphadenopathy;pt c/o severe arm pain & not being able to move arm for several days;motor exam was normal;
9 hrs after injection pt. experienced lightheadedness, nausea, dizziness, and loss of equilibrium.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt had no pre-existing medical conditions. On 28Feb05, the pt received the fifth dose of Infanrix in the right thigh (lot AC14A009BA). On the same day, the pt also received the second dose of measles, mumps and rubella virus vaccine (MMR II) and the second dose of inactivated poliomyelitis virus vaccine (IPOL) at unspecified sites of administration. At an unspecified time following the fifth dose of Infanrix, on 28Feb05, the pt experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm, and painful. The outcome of the injection site reaction was not reported.
[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17  Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 4:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  Age of the patient was reported as 45.60. On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 31-Mar-2021, 14 vials were moved to the clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 32 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.
Pt states she has left arm pain x3 weeks which started when she received the injection. Pt had a rash start x1 week after the first does that was localized around the injection site. The rash then turned into redness that is tender and warm to the touch. Pt states the left arm pain worsened x4 days ago and she is now having sharp shooting pains up to her neck. Pt states she had some fatigue that lasted about two days when the rash appeared but it has since resolved. Pt denies any body aches, headache, lightheadedness, fever, and SOB.
Pt denied Hx allergic reaction to prior immunizations. Given Hep A and Tet-diph and went to have MMR and Polio and broke out in hives both arms. Left > right. Given 50 mg Benadryl and hives disappeared 20 minutes. No breathing problems observed for one hour and discharged with instructions to take Claritin when gets home and go to ER if further problem. Discharged 14:50. BP 110/68 and 72 R 16.
PATIENT C/O TONGUE SWEELING AND A WEIRD FEELING IN HIS THROAT.
Red splotch 4 inches by 2 inches atinjection site 50 hours after injection
A report has been received from a Health Professional concerning a 10 year old male patient, who had been receiving Nasal FLUMIST, which was started on 09-Nov-2012. When the nurse tried to give 2nd half of dose patient got very upset and turned head and dose went into air and on his face which started on 09-Nov-2012. The outcome of the event of partial dose went into the air & on his face was unknown. The report was considered to be non-serious. Corrected report 12-Dec-2012: reporter's page edited, onset date added. Corrected report 13-Dec-2012: Coding of partial dose went into the air & on his face was changed from inappropriate dose of vaccine administered to drug administration error.
Right after the injection, the patient began to bleed and a lump developed at injection site. The provider came in to check on the patient. The patient denies pain, numbness or any other symptoms.
This study case was received from the investigator in a trial on 24 May 2013. A 36-year-old male subject was found to have other and unspecified acute myocarditis, septic myocarditis, unspecified disease of pericardium and non-specific myocarditis 12 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 14 February 2013. Relevant laboratory data included abnormal troponin I of 07.55 on 26 February 2013 and an abnormal ECG on 08 March 2013. ECG was unavailable. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
The patient received her second dose of the Moderna vaccination one week earlier than she was supposed to. She seemed fine and did not report any complications or adverse effects, when I informed her that she received the vaccination early. She was in a good disposition.
Sudden onset severe hypertension documented by on-site medical personnel followed by documentation by responding ambulance personnel.
"COVID Arm"; heat and minor raised skin rash, approximately 1.5" in diameter. Noticed 8 days after first dose.
My son vaccination was at the Pharmacy issued by pharmacist.  Immediately after received the injection he mentioned to me that he was feeling weird.  We walked around the store to fulfill the observation period.  His complaints started increasing.  We walked back to the pharmacy area about 10 minutes later and he continued to the complain and we let the pharmacist know.  She started asking questions.  His throat was tightening, he was complained about his breathing, he seemed as though he was about to vomit,  he was lethargic,  he was certainly declining.  The pharmacists called 911 and she have him an EpiPen.  Shortly thereafter the paramedics arrived.  We were then taken to the ER.   He experienced an anaphylactic reaction.
Rash on arms, inner thighs & hands; itchy; lasted 2 days;
patient very fatigued, felt warm, loss of appetite, flu-like symptoms 9/26: patient's right eyelid black and blue, resolved within three days.
t104 w/maculopapular rash starting about 12 hrs p/vax recvd; skin Bx -> subacute urticarial & superficial perivascular dermatitis w/Eosinophilia; 30MAR inc liver function tests;
Chills; Headache; Body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Lot number: EP6955) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Mar2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "Body pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to a 50 year old female patient. The patient's concurrent condition included diabetes mellitus. Concomitant therapies included atorvastatin, amantadine, propranolol hydrochloride (manufacturer unknown), escitalopram and gabapentin. The patient had no drug reactions/allergies. On 26-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # L046295, expiration date 17-FEB-2017, subcutaneous; dose was unknown). On 28-SEP-2016, the patient experienced 1/2 inch size redness at the injection site with soreness and headache, pain level 5. No treatment was given. No lab test was performed. The outcome of the events was reported as recovering. The causality was not provided. Additional information has been requested.
throat and tongue swelling; throat and tongue swelling; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3246) via an unspecified route of administration, administered in left arm on 08Jan2021 at 11:00 (at the age of 51-years age) as single dose for COVID-19 immunization in a hospital. Medical history included hypothyroidism, osteoporosis, and allergies to penicillin, sulfa, nitrofurantoin, levaquin (from an unknown date and unknown if ongoing). Patient received atorvastatin (ATORVASTATIN), levothyroxine sodium (SYNTHROID) and fluticasone (FLUTICASONE) within 2 weeks of vaccination for unspecified indications. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Jan2021 at 11:00, the patient experienced throat and tongue swelling. Events resulted in Emergency room/department or urgent care. Patient received treatment with prednisone for the events. On an unspecified date in 2021, events recovered.  Follow-up attempts completed. No further information expected.
Pt recvd vax OCT92 & devel a rash around the inject site; pt recovered; No further details were provided;
About 10 mins after administration, pt complained of itchy throat. The physician  asked the pt to stay for observation and her blood pressure was taken 150/100 and about 15 mins later went up to 154/100. Pt took 1 allegra tablet after 15 mins and epinephrine given IM. Still no relief. After 30 mins, she received Solocorte injection IM 1cc. Pt stated that she felt much better and left.
Mild erythema and swelling at the site of injection. No fever/chills. No other adverse effects.
The injection site was swollen, hot, red, painful and itchy. Went to doctor, who prescribed cephalexin.
Presented to the vaccination site on 10/15/2021. The client notified RN that she received a single dose of the AstraZeneca vaccine in  on 07/10/2021. Medical consult team was contacted, and advised to proceed with first dose of Pfizer per CDC guidance. Client received Pfizer lot #30145BA on 10/15/2021. The client did not report any symptoms during the observation period.
pt recv vax 12NOV97 & the following morning pt woke up & vomited, cheeks were flushed & was hot to touch;
2 inch diameter red area where injection was given. Warm to the touch. An occasional itching similar to an insect bite. The redness appeared the day after the injection and is still there on day 10 after the injection.
9 DAYS AFTER RECEIVING THE VACCINE, PATIENT HAD A SMALL LUMP AND SOME REDNESS NEAR THE INJECTION SITE.  I GAVE HER IBUPROFEN AND PUT HYDROCORTISONE CREAM ON THE RED AREA.   AFTER 3 DAYS OR SO, THE LUMP GOT MUCH SMALLER, BUT THE RED AREA GOT LARGER.  IT GREW FROM ABOUT 2 INCHES IN DIAMETER TO 4 INCHES AS OF LAST NIGHT. AT TIMES, THE MIDDLE OF THE SPOT SEEMS ALMOST A NORMAL SKIN COLOR AND OTHER TIMES, IT GETS RED THROUGHOUT THE WHOLE CIRCLE. PATIENT HAS SAID  IT IS SORE AND PAINFUL.
patient received pfizer covid vaccine dose #1 on 9/11/2021 at a vaccine clinic. patient, then, experienced a chest pain after the pfizer vaccine. patient went to the QMC ER and was evaluated for chest pain. 12-lead EKG - normal. Chest XR - normal. no labs were drawn in ER. patient followed up in our clinic today. Patient was still having chest pain and was referred to Cardiology for rule out pericarditis.
Had headache and low fever day after booster. On 1/10/22, had chills and fever during early hours of the morning. Fatigue throughout day. 1/11 bad headache. Tested positive for COVID on a home test. Quarantined for five days. Runny nose and cough developed after a week. Intermittent fatigue followed.  Recovered but developed a bad cold 1/28 which eventually created chest congestion and was treated with antibiotics