chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hands feel hot then cold; fever of 101.1/fevers; chills; aches/her hair hurt; felt like she had been run over by two cement trucks; her kidneys bothered her too; bothered her stomach too and she felt nauseous; bothered her stomach too and she felt nauseous; watering in the mouth/water in the mouth; her toenails hurt; headache; sores in her mouth; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was Unknown), via an unspecified route of administration, in Arm Left, on 24Mar2021, as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 926P and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021, as dose 1, single for COVID-19 immunization. The patient medical history included that she lost a lot of blood at childbirth. Family history included bone cancer of her husband. Concomitant medications were not reported. On an unspecified date, the patient experienced hands feel hot then cold, fever of 101.1/fevers, chills, aches/her hair hurt, felt like she had been run over by two cement trucks, her kidneys bothered her too, bothered her stomach too and she felt nauseous, watering in the mouth/water in the mouth, her toenails hurt, headache, sores in her mouth. The patient stated that she had side effects that lasted form 12 am to 11 pm and stated she had really bad symptoms afterwards. The patient stated that it was like the flu when her hands feel hot then cold, fever of 101.1 and thought she had COVID. She reported chills, fevers, aches, felt like she had been run over by two cement trucks and hurt everywhere and her kidneys bothered her too. The patient reported that it bothered her stomach too and she felt nauseous and had watering in the mouth. She stated that nausea is common for her but not the water in the mouth and her hair hurt her toenails hurt and had a small headache. The patient also reported that she had sores in her mouth days after that lasted a day. She wanted to know what to tell her daughter about the kidney pain. She told her daughter to place blankets and a heating pad due to being cold, but then get hot.  The patient underwent lab test and procedure included Fever 101.1 on an unspecified date. Outcome of the events were unknown.  Follow-up (26Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information included information about first dose.     No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17Feb2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Recovering from prostate cancer" (unspecified if ongoing), notes: Recovering from prostate cancer. Concomitant medication(s) included: AMLODIPINE, start date: 25Mar2019. Past drug history included: Quinine derivatives, reaction(s): "known allergies: Quinine derivatives", notes: Quinine derivatives. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Very faint line; (27Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid for Covid-19 from 14Aug2022 to 19Aug2022. The was patient taking other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & the next day pt exp welts & hives over the upper half of body;MD visit was required;pt treated w/DPH;sx subsided;
SOB started on 4/7 or so, seen in ER 4/9, d dimer elevated, no PE seen on CT chest; persistent hypoxia/SOB over next week; DVT/PE  noted on 4/20 after repeat imaging (LE US and chest CT)
Initial unsolicited report received from consumer on 19 May 2015. A 40-year-old female patient, whose medical history was allergies of latex, egg whites, milk, shrimp and concomitant medication was not reported, had received a dose of TENIVAC (batch number, expiration date, dose, dose number and site of administration were not reported) intramuscularly in morning on 18 May 2015. On 18 May 2015 in evening, after vaccination patient experienced tightness in throat and gained five pounds weight in overnight. Illness at the time of vaccination was reported as none. Laboratory investigation was none and corrective treatment was not reported. At the time of this report, outcome of the event was not resolved. List of documents held by sender: none.
Increase in energy; pain in hands and knees; pain in hands and knees; harder to bend knees; fatigue; hair falling out; feels discouraged or depressed; right middle finger was 'locking up'; stress; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Oct2021 (at the age of 58 year), as dose number unknown, single for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), oral from Aug2021 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatic arthritis. Medical history included pre-existing anxiety from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient stated, medical doctor instructed her to stop XELJANZ XR a couple of days after receiving COVID-19 vaccine. The patient stated, during that time she initially noticed an increase in energy on first day off XELJANZ XR, then increase in pain in hands and knees, right middle finger was locking up and harder to bend knees. The patient stated, she was unsure if increased pain and mobility is related to pause in XELJANZ XR, change in weather, or vaccine. The patient stated, symptoms subsiding since re-start of XELJANZ XR. The patient stated, unknown if medical doctor was aware. The patient stated, she feels fatigue after taking dose of XELJANZ XR, like she needs a nap. The patient experienced, her hair falling out, but unsure if it is related to stress, pre-existing anxiety, or other medications. No date or time frame given in relation to start of XELJANZ XR. The patient stated, she agrees it is hard to cope with rheumatoid arthritis and sometimes she feels discouraged or depressed. The outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Thrombocytopenia Immune thrombocytopenic purpura abnormal lab
Started feeling pains and feverish on Tuesday the 18th around 1:30 pm with an increasing body temperature  around 104. something around 12:00 am on Wednesday even after haven taken Tylenol at the onset. Pains and feverish feelings continued to stay above 100 of body temperature per my wife's readings. Attempt to reach Teledoc was unsuccessful until  Wednesday around 10:00am.
Slight headache upon waking up. Headache progressed around noon. Immediate nausea upon first bite of lunch around 1pm. Between 1-2pm proceeded to feel nausea and vomit 2x. Napped following 2nd vomit and woke up feeling better with only slight headache for the rest of the day, with the headache disappearing as the night continued.
Patient was given 2 doses of COVID immunization instead of 1 COVID immunization and 1 Flu.  No adverse reactions are known as of this time
Approximately 5 minutes after being vaccinated the patient started feeling lightheaded and nauseated, she then had a syncopal episode. When she regained consciousness vitals were taken which were normal, EKG was done showing a PVC but otherwise normal.
The patient has a history of COPD, diabetes, multiple sclerosis, and CHF. On 2/15/23, she developed a fever and took an at-home COVID test which was positive. She had a virtual visit with her primary provider and was started on paxlovid. Later that evening, her daughter went to wake up the patient and noticed it was harder to wake the patient than it normally is. Her daughter also noted the patient was weak and slumping to her side, so she called EMS. In the ED, the patient also endorsed weakness, cough, headache, shortness of breath, and chest pain. A COVID PCR test also done in the ED resulted positive. She was admitted to the hospital 2/15/23 - 2/20/23. Of note, during her admission, she was also diagnosed and treated for a UTI. The patient has received the primary COVID vaccine series and three boosters.
Had a pallor, hypotensive episode after first set of shots. Provider elected to leave out pertussis in future vaccinations.
Received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient vial was punctured on 01-Jun-2021, stored in refrigerator once punctured and was in freezer prior to puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Patient was hallucinating that there were bugs crawling on him and were around him. He was crying and scared. He kept trying to wipe them off and push them away. Had nightmares about bugs that night too.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 12th November 2018, several hours after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness. On an unknown date, the outcome of the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, diarrhea, pain, tremor and weakness to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient developed flu like symptoms (joint pain, diarrhea, aches, shakes, and weakness) several hours after receiving the SHINGRIX. The reporter gave consent to follow up.
pt recv vax 27MAY97 & pt showed arms on 30MAY97;the two days prior pt said they were swollen, red, & hot;pt felt sick but 30MAY97 pt was OK;
Fever of 102.9. Nauseous. Pain, dizzy. Went to ER. Given tordal shot and nausea meds
Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient reports having a rash on both arms below the elbows described as red bumps, but not blisters. Patient reports having soreness and ongoing weakness in left shoulder area since Shingrix vaccine. Patient states the "weird sorness" in his left arm feels similar to the nerve issue he had with a previous bulging disc in back. Patient reports he did previously have a Shingles outbreak in his thirties.  Patient has not discussed issues with his provider yet.  Reported when contacted for 2nd shingrix
Five day development of swollen joints primarily in the feet; oral lesions; lichens Planus; Angular Chelitus including superficial sores; Angular Chelitus including superficial sores and fungal infection; headache; low grade temps; Severe joint pain; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via an unspecified route of administration, administered in arm right on 22Feb2021 at 03:00 (at the age of 67-year-old) as 2nd dose, single dose for Covid-19 immunization. Medical history included Blood pressure high, prostate, anterior cruciate ligament reconstruction repair, tonsillectomy and hay fever. Concomitant medication included metoprolol, lisinopril, amlodipine and finasteride. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL9265) on 02MAR2021 at 04:00 administered in arm left for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 22Feb2021, the patient experienced five-day development of swollen joints primarily in the feet, oral lesions, lichens planus, angular chelitus including superficial sores, fungal infection, headache and low-grade temperature. The patient Sed rate (sedimentation rate) was normal, C-Reactive protein: 10* nl (32.3), uric acid: NL, aspirate of left great toe joint had no crystals, polymorphic cells, and cultures: negative. Severe joint pain relieved by aspiration, but pain continued slightly better over three weeks. Resumed walking more than a couple thousand steps a day yesterday. The patient started treatment of oral lesions today, used Motrin 600 QID for first week after second injection. The patient was receiving treatment for the adverse event. The outcome of events was of not recovered.  No follow-up attempts are needed. No further information is expected.
The day of the vaccine had no side effects. On Sunday morning, I woke up and had shooting pain in my neck. I sat up head felt as if was pounding. My spouse gave me some Tylenol. I immediately started vomiting. I experienced a headache on a scale of 1-10 was 10 lasted a full week. The vomiting lasted full 3 days couldn't keep anything down which made it worse for my headache. I went to the ER at Health System and local Health Department for the headache.
29NOV93 had flu like sx & on 6DEC93 had achy joints no stiffness; Rubella assoc arthropathy;
received three doses of product on the following schedule: when she was 6 weeks old, when she was 18 weeks old, when she was 14 months old with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant female patient who received three doses of product Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] on the following schedule: when she was 6 weeks old, when she was 18 weeks old, when she was 14 months old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received three doses of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] of dose 0.5 ml suspension for injection with unknown strength, route, batch number & expiry date for Immunization, on the following schedule: on 13-Jun-2018 when she was 6 weeks old, on 05-Sep-2018 and when she was 18 weeks old, and on 01-Jul-2019 when she was 14 months old, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Information on the batch number was requested.  It was reported that: Also, the patient is now 5 years old, but at the time she was receiving the DTaP injections, she was under 2 years old.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, not eating/drinking, crying, screaming, inconsolable, cold, clammy.
This spontaneous report was received from a physician via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route, lot # were not reported) dose 1. Concomitant therapy was not reported. On an unknown date, the patient experienced severe rash after administration of the first dose of M-M-R II. Patient sought medical attention by an office visit. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of severe rash was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Immediately after vaccines, right leg and face erythematous, sl. swollen. Resolved about 30 mins. after Benadryl.
No additional AE; HCP calling to report that PROQUAD was accidentally administered to a 13 year old on 29JUN2022. Caller also stated that the patient's birthdate may have been typed into their system incorrectly. No additional details provided. No additional AE/PQC.; This spontaneous report was received from a certified medical assistant and refers to a 13-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 29-JUN-2022, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (strength, lot #, expiration date, dose, route and frequency were not reported); along with a sterile diluent  (strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis; as the patient's birth date was typed into their system incorrectly. No adverse events were reported.
woke up with a ball on the face at the level of the cheekbone, very very hard, that is turning purple; my arm hurts; tired; my head hurts; fever; feeling indisposed; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling indisposed), SKIN MASS (woke up with a ball on the face at the level of the cheekbone, very very hard, that is turning purple), PAIN IN EXTREMITY (my arm hurts), FATIGUE (tired) and HEADACHE (my head hurts) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (aspirin).   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced MALAISE (feeling indisposed), PAIN IN EXTREMITY (my arm hurts), FATIGUE (tired), HEADACHE (my head hurts) and PYREXIA (fever). On 04-Jun-2021, the patient experienced SKIN MASS (woke up with a ball on the face at the level of the cheekbone, very very hard, that is turning purple). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (feeling indisposed), SKIN MASS (woke up with a ball on the face at the level of the cheekbone, very very hard, that is turning purple), PAIN IN EXTREMITY (my arm hurts), FATIGUE (tired), HEADACHE (my head hurts) and PYREXIA (fever) outcome was unknown.            Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
pt recvd vax 3MAR93 & 5MAR93 pt exp flu-like sx consisting of malaise, abdo cramps, aches & pains, nausea, violent vomiting, rash; fatigue & anorexia;
Body aches night of injection. Extreme bloody nose with clots on 3rd day after injection. Swollen and very itchy right wrist 3rd day after injection.  Was able to stop bloody nose after 1 hour, did not need medical help.  Have not experienced a bloody nose in over 50 years so this was quite unusual.
Called Employee health clinic with redness & swelling at site from varicella #2 vaccine on 3/20/12. Declined to be checked. On 3/22 reported to EHC with several red raised areas that were pruritic. Afebrile 8-10 small red raised areas noted on various parts of body. No blisters noted.
No additional Adverse event; Exprired dose of MMR II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drug, concomitant therapies were not provided.  On 02-DEC-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status of rha (recombinant human albumin) (M-M-R II) 1 dose, (lot # S037501, Expiration date; 20-NOV-2021) (route and site of administration not reported) for prophylaxis (expired product administered). No additional adverse events was reported.