chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is still sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Pfizer. A 66-year-old Male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 01Feb2021 as 2nd dose, single for COVID-19 immunization. Medical history included ongoing enlarged prostate (he was diagnosed about 3 years ago), ongoing high blood pressure (he was diagnosed six years ago, maybe even longer), ongoing erectile dysfunction (he started taking Viagra, but then his doctor switched him to white pills, but they aren't worth it, says he doesn't know what they are. States he needs to get back to Viagra, and is on the website right now, doesn't know how to order online. Says he was diagnosed ten years ago). Co-suspect medication included pneumococcal 13-val conj vac (dipht crm197 protein) (Prevnar 13). Concomitant medication included sildenafil citrate (VIAGRA CONNECT). Patient previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on an unspecified date as 1st dose, single for COVID-19 immunization. On 1Feb2021, patient experienced Arm is still sore. Patient stated it is a little bit sore, he can feel it, it's not much, not anything for him to be worried about it feels like it was getting better, it was better than last week, but its still sore, that's been a long time. Patient stated he does not really have one. States he didn't get the shot there. Patient stated he has no one to list. Patient does not have his vaccine card with him and does not know the information. Patient stated he received this in his left arm, and he remembers because he told them you already broke this arm, put the second one in it too. Patient stated his job made him. Says well they did not make him, he worked for his son, and he told me he needed to do it, and he did it. Patient stated he took a high blood pressure pill, it starts with an A, but he cant think of the name, says he has been taking it for six years. Patient stated he took, what do you call it, he takes medicine for benign prostate, says he cant think of the name, he does not have the information, he took it every night for an enlarged prostate. States he had been taking this for three years. Patient stated he started taking Viagra, but then his doctor switched him to white pills, says he does not know what they are. The outcome of the events was recovering.   Information about Lot/Batch number has been requested.
headache for several days; felt that heat is coming out of my shoulder; itchy around injection site; swelling at the injection site/ swollen arm - around injection site; redness at the injection site/ red arm - around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN WARM (felt that heat is coming out of my shoulder), INJECTION SITE PRURITUS (itchy around injection site), INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site), INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site) and HEADACHE (headache for several days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TAMOXIFEN, Venlafaxine HCL ER and COLECALCIFEROL (VITBABY D) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SKIN WARM (felt that heat is coming out of my shoulder), INJECTION SITE PRURITUS (itchy around injection site), INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site) and INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site). On an unknown date, the patient experienced HEADACHE (headache for several days). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Feb-2021, INJECTION SITE PRURITUS (itchy around injection site) and INJECTION SITE ERYTHEMA (redness at the injection site/ red arm - around injection site) had resolved. On 21-Feb-2021, INJECTION SITE SWELLING (swelling at the injection site/ swollen arm - around injection site) had resolved. At the time of the report, SKIN WARM (felt that heat is coming out of my shoulder) and HEADACHE (headache for several days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-Feb-2021, the injection site swelling, redness, and itching resolved.
a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine). At the time of the report, COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-005623 (E2B Linked Report).; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Very limited information regarding this event has been provided at this time.  Further information has been requested US-MODERNATX, INC.-MOD-2021-005623:
headache; muscle pain; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A contactable consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On 22Feb2021, the patient experienced headache and muscle pain. The patient wants to know if the she can take Tylenol. The outcome of all events was unknown.    Follow-up attempts completed. No further information expected.
Patient experienced fever with night sweats first day. Then achy and arm turned red for one week. Patient has since recovered.
Patient complained that her arm was swollen red, hard and painful. she said she had to place ice at the area to relieve the pain. There was no noticeable swelling on arrival (3 days later). Recommended that Patient also see her Physician for further evaluation.
Hepatic encephalopathy. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Shortness of breath; Fatigue; Swelling; Weakness; Sleepiness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Nose bleed within 5 min of COVID Vaccine with 1st and 2nd dose
Seen by dermatologist 06/23/2008. "fulminating blistors clustered on spine/buttocks. area of fanlike redness above. Dx as herpatic lesions? cellulitis in the gluteal cleft. Tx.with Valtrex 1 gm tid,7d. then red blotchy patches appeared all over chest and trunk c/o pain all over. poss rxn. to valtrex, erythema multiformi. Day of interview client still c/o back pain,numbness back of Rt. Leg,L leg,  inside of upper Rt. shoulder.
Bright red oval rash; Tender; Itchy; Constant nagging pain; Uncomfortable; Very irritated; Rash that was painful; Fever; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bright red oval rash/rash erythematous, rash that was painful/rash, tender/tenderness, itchy/pruritus, and uncomfortable/discomfort, fever, a constant nagging pain/pain and was very irritated/skin irritation.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Feb 2021, patient experienced bright red oval rash that was painful, tender, itchy, and uncomfortable, fever, constant nagging pain and was very irritated.  Lab details were not provided by the reporter.  Treatment for the events included alternated warm and cold compress.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, bright red oval rash, rash that was painful, tender, itchy, uncomfortable, constant nagging pain and was very irritated was recovered on 12 Feb 2021. The outcome of the event, fever was unknown.
Patient believes got a partial 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The pharmacist reported that the patient believed that she received partial 1st dose of Shingrix, which led to incomplete dose administered. The dose was administered in October 2021 exact date was unknown. The health care professional did not know the patient's initial, date of birth, vaccination dates and lot number. The reporter consented to follow up.
pt recv vax & became mottled & listless for 5-10min RN encouraged mom to stay on site w/baby;baby was responsive to stimulus (though listless) heart reate 130-140beats/min;
HYPOTENSION 3/11/2022,  8/21/2022,  11/21/2022,  11/29/2022,  3/14/2023,  2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
77 yo M who presents to the ER for AVF bleeding 2/16/2021. He was at dialysis and AVF started bleeding during session. Admitted for hemorrhage of AV fistula; severe stenosis or occlusion of the subclavian vein with increased pressures within his dialysis graft leading to his hemorrhage.  He also has serotherapeutic INR from his Coumadin administration. Found to be COVID positive with no hypoxic symptoms. Supportive care. Patient discharged to home on 2/19/2021.
Patient stated started off as bug bite looking pimple which spread into rash covering waist/back/arm area that lasted a few days that resolved from steroid pills/shots from the doctor and then it came back after the pills wore off. The rash has lasted for approximately eight months. Patient reports that it stings still everyday. The rash has resolved, but still has chicken pox-like marks on waist/back/arm area.
This case was reported by a healthcare professional and described the occurrence of high fever in an adult male subject who was vaccinated with HAVRIX (GlaxoSmithKline).  On 5 February 2008 the subject received unspecified dose of HAVRIX (unknown).  At an unspecified time after vaccination with HAVRIX, the subject experienced high fever (103), lethargy, a liver disorder and a lung disorder (the physician felt that the vaccine attacked the subject's liver and lungs).  At the time of reporting, the subject was still off of work.  The outcome of the events was unspecified.  Limited follow-up information indicated that additional information concerning this report will be provided pending lab results (unspecified).
site allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (site allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (site allergic reaction). At the time of the report, VACCINATION SITE REACTION (site allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of eruption in a 76-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). Concomitant products included levothyroxine and pravastatin. On 5th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced eruption and toothache. On an unknown date, the outcome of the eruption was not recovered/not resolved and the outcome of the toothache was unknown. The reporter considered the eruption and toothache to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced bumps on the right side of face, eyelid, and right side of nose and in the scalp. The bump was not itchy. The patient was having tooth pain on the right side and was seen by dentist and advised by the dentist that the bumps should be evaluated.
Mom called on 10/19/2022 to report that patient had COVID-19 vaccine on 10/14/2022 then on 10/15/2022 developed  low grade fever around 100, and Irritability. On 10/16/2022 patient developed a rash, red dots, Rash worsened and is almost resolved as of 10/19/2022. Mood improved when rash erupted. Also reports that sibling in household started with Viral URI symptoms and has been sick since 10/15/2022
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-JUN-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2 (dose unknown), from lot # 669223/1564Z, with expiry date of 11-NOV-212.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
Fever of 105 started during the night and could not stand or walk without assistance. Extreme dizziness. In the morning started suffering from tinnitus and her hearing became very muffled.
a 72 y.o. female w/ a hx of HTN, Sjogren's (on Plaquenil), GERD, anxiety, tobacco use who presented to the ED w/ c/o near-syncope. Pt developed sinus congestion, facial edema last Sunday (1 week ago). Seen by her PCP and diagnosed w/ sinusitis and started on Doxycyline. Pt reports that her symptoms initially improved. ~ 3 days ago pt developed exertional dyspnea, non-productive cough, night sweats, nausea, emesis x1, diarrhea, decreased appetite and loss of taste and smell. Pt reports that today she was ambulating to her kitchen when she had sudden onset lightheadedness and dizziness and almost passed out. She reports that her husband and son had to lower her to the floor. EMS was called. Pt's son tested positive for COVID on Friday. Pt had initial vaccination, has not yet had booster.  Pt denies fever, chest pain, abdominal pain, dysuria, edema, syncope, confusion.  Pt evaluated in the ED. COVID detected. CXR unremarkable. Noted to be 93% on room air. Pt admitted to the hospital medicine service for further evaluation
Patient did not have adverse effect at the time of vaccination. Patient has decided to receive Pfizer for second dose.
PT WAS GIVEN EXPIRED VACCINE, NO ADVERSE REACTION AT THE TIME OF INJECTION.  PARENT WAS NOTIFIED
24hr p/vax pt noticed redness & tenderness 48hr p/vax w/redness @ greatest extend & swelling in soft tissue;nodule noted @ inj site;swelling & redness dec by 72hr point when pt to MD;dx probable cellulitis vs vax rxn;tx erythromycin;
General body ache, head ache, scratchy throat, sore jaw left side, sore inner ear left side, chills, elevated temperature, cough.
starting April 15, 2021, the day after the first shot and lasting 9 days: sore joints - I put a heating pad on the most painful joints (wrists and ankles)  lightheadedness - I laid down distorted vision - I closed my eyes and rested brain fog - nothing helped the brain fog losing time (I can't remember what happened for 20-75 minutes at least 3 times) - nothing helped with losing time Difficulty staying awake - I wasn't able to stay awake for more than 2-3 hours at a time, so I slept.  Extreme fatigue - I slept a lot, 12-15 hours a day nausea - I ate very light meals and snacks high blood sugar - I avoided sugar as much as  I could. Because of other symptoms, I couldn't exercise to lower my sugar levels quarter-sized lump at injection site bruise at injection site soreness at the injection site - I out an ice pack on the injection site  The symptoms started to slowly get better starting day 10. I still have lightheadedness, brain fog, and some tiredness on May 4, 2021 - 20 days after the first shot.
27 yo female pt received one vaccination with 0.3 mL of Pfizer vaccine and 0.2 mL of Janssen vaccine components instead of intended 0.5 mL of Janssen vaccine. Immunizer drew up 0.5 mL of Janssen vaccine, labeled it, and set it down. Immunizer then went through information with patient and picked up a syringe nearby, realized there were only 0.3 mL in it, then added another 0.2 mLs for a total of 0.5 mL. Administered this immunization to the patient. Later, immunizer realized the Janssen vaccine was still sitting where it was left earlier. Immunizer had picked up a Pfizer vaccine (0.3 mL) and added Janssen (0.2 mL) to this syringe before giving it to patient. Patient has since been contacted and made aware of the situation. Plan to schedule second appointment for Pfizer vaccination dose 2.
Blood pooling into the elbow; Right upper extemity pain radiating into his right hand; Right upper extemity pain radiating into his right hand; This is a spontaneous case] and initially received on 26-Nov-2019, concerning a 51-year-old, male patient.  The patient's medical history included heart stent, hypertension, coronary arteriosclerosis, depression, headaches, high cholesterol and sleep apnea. The patient's concomitant medications included atorvastatin, citalopram, clopidogrel, lisinopril with hydrochlorthiazide, metformin, metoprolol tartrate, Nitroglicerin (glyceryl trinitrate) and Topamax (topiramate).  On 11-Nov-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: P100123051, expiration date: 30-Jun-2020] for influenza prophylaxis.  On 15-Nov-2019, four days after vaccination, the patient experienced blood pooling into the elbow and right upper extremity pain radiating into his right hand. The patient was seen in the Emergency Room (ER) and had computerised tomography (CT) scans, however, the results were not provided. The patient was given pain medication as a corrective treatment. The patient was also advised to continue wearing the fling and to follow-up with orthopaedic doctors for further therapy details.  On 18-Nov-2019, the patient was still experiencing some pain.  At the time of initial reporting, the patient was recovering from the events of radiating pain and pan in upper extremities, while the outcome for the event venous stasis was not reported.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment.  Company Comment: The patient experienced peripheral venous disease, pain and pain in extremity 4 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of hypertension, high cholesterol and depression may have contributed to development of the events. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced peripheral venous disease, pain and pain in extremity 4 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of hypertension, high cholesterol and depression may have contributed to development of the events. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.