chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 20-Sep-2018, from a pharmacist, concerns a 91-year-old, elderly male patient. The patient's historical conditions included dysphagia, left-sided weakness, foot pain, depression, tobacco use, hypomagnesaemia, shoulder pain, weight loss, high risk for falls, hyponatremia, major abdominal surgery, asbestos induced pleural plaques, moderate chronic obstructive pulmonary disease (COPD), chronic pancreatitis, peripheral vascular disease, coronary heart disease, multiple renal cysts, pecan lesion, sleep apnoea, cognitive impairment, congestive heart failure, transient ischemic attack (TIA), degeneration of lumbar intervertabral disc, stable aneurism of abdominal aorta, total replacement of bilateral hip joints, sensorineural hearing loss, bilateral cataract extraction, type 2 diabetes and gastric ulcer. The patient's current conditions included vitamin B12 deficiency, vitamin D deficiency, dementia, essential hypertension and benign prostatic hyperplasia (BPH) without outflow obstruction. The patient's concomitant medications included vitamin D, Vitamin B12, losartan, oxybutynin, tropaeolum, FLOMAX, TYLENOL, and calcium, all for unknown indications. It was reported that the vaccine underwent first time temperature excursion reaching 34 F (Fahrenheit) for 15-20 minutes. On 19-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical site: deltoid, batch number: 250796 and expiry date: 31-May-2019] that underwent temperature excursion. The patient had not experienced any adverse effects after administration. The reporter assessed this case as non-serious. This case 201803915 was cross-linked with the case 201803916 reported by the same reporter. Non-significant follow up received on 12-Oct-2018: The date of vaccination previously reported as 19-Sep-2019 was confirmed to be 19-Sep-2018. No new information was received. No changes were made in the narrative.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) in 2009. The patient had not received doses and was in the office on 09-AUG-2012 to receive the second dose of GARDASIL (Lot #, dose and route not reported). It was not known if the patient sought for medical attention. No adverse effect reported. Additional information has been requested.
oral bleed; states that she just had some anxiety related to this incident; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for A 26-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown; Expiration date: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown; Expiration date: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. concomitant medication were not reported. on an unspecified date patient experienced oral bleed" from the roof of her mouth behind her front two teeth. patient reported that this lasted for about 30 seconds. Caller states that the patient reported no trauma, no fever, no cough, and states that she just had some anxiety related to this incident.it was reported that "There were no other notable patterns or numerical imbalances between treatment groups for specific categories (system organ class or preferred term) of non-serious adverse events, including other neurologic, neuro-inflammatory, and thrombotic events, that would suggest a causal relationship to BNT162b2 vaccine." The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I had the vaccine on Thursday morning, no reaction until I woke on Saturday morning.  I woke with a headache, chills, nauseous, muscle aches and extreme fatigue. Sunday, I had milder symptoms.  Monday felt better but after my work day was extremely tired and went to bed and slept 11 hours before going to work Tuesday.  No symptoms on Tuesday.
rapid heart beat; swollen gland under my armpit; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) and LYMPHADENOPATHY (swollen gland under my armpit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced HEART RATE INCREASED (rapid heart beat) and LYMPHADENOPATHY (swollen gland under my armpit). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat) had resolved and LYMPHADENOPATHY (swollen gland under my armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Patient stated she developed hives in both hands beginning the night after vaccine administration resulting in raised rashes and itchiness. The following day, she presented to the vaccine clinic for clinical advice. Rashes appeared to no longer be raised the day following vaccine administration, but itchiness and redness persisted. Patient referred to and outpatient clinic for further evaluation.
Headache; Chills; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 (Lot number: EL9261) at the age of 77 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Lot Number: EN9581; Intramuscular; Left arm), administration date: 10Feb2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "fine after the first COVID-19 Vaccine dose". The following information was reported: CHILLS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "Chills"; NASOPHARYNGITIS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "Cold"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "Headache". Therapeutic measures were taken as a result of headache. Additional information: The vaccine was administered between 09:05 AM-09:10AM on 03Mar2021. The patient had no prior vaccinations within 4 weeks. The patient had chills and cold that night (03Mar2021) and had to put more and more blankets on. She said when she woke up in the morning (04Mar2021), all she had was a little headache, and the headache went away. The patient took 2 aspirin tablets (BAYER ASPIRIN, 325 mg tablets, Lot Number: 86395878 and Expiration Date: Mar2022) as a treatment for headache. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
severe body aches, massive headache ,eyes hurt, left arm and lymph nodes under arm  sore and painful ,nausea, temperature 101.2, loss of apatite, stomach cramps ,diarrhea, muscle pain in legs ,back hurts .pretty much same aggressive symptom's when I had covid in October . I am still sick day 2 not hungry head hurts ,eyes hurt but feeling a little better .arm and arm pit still hurt
Day of shot at 5:00 pm my palms on both hands had itching and I had to keep scratching them. It was driving me nuts. Later that evening my feet were also itching. All night long and into Tuesday but the itching also included my underarms, chest, and upper thighs. Finally on Tuesday I started taking 2 Benedryl tablets every 6 hours, however at 4 hours the itching came back but seemed to be only on the upper body. It is now a little over 72 hours since my shot and I'm still suffering the itching, but not quite as bad with Benedryl. Since I didn't see this on the list of possible side effects, I thought you should know.
diarrhea daily; appetite is erratic; dizzy; nauseous; migraine headache; shaking; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking), MIGRAINE (migraine headache), DIARRHOEA (diarrhea daily), APPETITE DISORDER (appetite is erratic) and DIZZINESS (dizzy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, DILTIAZEM, HYDRALAZINE, LEVOTHYROXINE, LISINOPRIL, METOPROLOL, RIVAROXABAN (XARELTO), GLIPIZIDE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shaking) and CHILLS (chills). On 28-Feb-2021, the patient experienced MIGRAINE (migraine headache), DIZZINESS (dizzy) and NAUSEA (nauseous). On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea daily) and APPETITE DISORDER (appetite is erratic). At the time of the report, TREMOR (shaking), MIGRAINE (migraine headache), DIARRHOEA (diarrhea daily), APPETITE DISORDER (appetite is erratic), DIZZINESS (dizzy), NAUSEA (nauseous) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided
Rash on head, trunk and legs, 9 days after receiving MMR, also, high fever.
Root canal; This spontaneous case was reported by a consumer and describes the occurrence of ENDODONTIC PROCEDURE (Root canal) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENDODONTIC PROCEDURE (Root canal). At the time of the report, ENDODONTIC PROCEDURE (Root canal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Patient was given on extra dose of meningococcal vaccine - No adverse effect reported at this time.
arm started to get hurt; it knotted up real big all the way across whole upper arm; The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow; The top of shoulder was heating; Kind of like blood bruise that moved down the arm; The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating) and CONTUSION (Kind of like blood bruise that moved down the arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg) had resolved. Not Provided          No concomitant information was reported. Patient stated the adverse reactions cleared up after a few days. Action taken with mRNA-1273 in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received on 07-MAY-2021, outcome of events were updated from unknown to recovered.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PENUMOVAX (lot # H021941, expiration date 11Jul2104). On 10-OCT-2013, the patient experienced an adverse reaction (not further specified) to PNEUMOVAX vaccine. Treatment and outcome of the adverse event was unknown. Additional information has been requested.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 031M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided. patient stated that he got a mole treatment for cancer on his nose
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The pharmacist reported about the administration of expired moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
pt recv vax 3SEP97 & devel hair loss, requiring MD visit;pt completed the 3 doses 30JAN98 despite cont hair loss all over the scalp;
first dose administer past 6 hours mark; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark). At the time of the report, EXPIRED PRODUCT ADMINISTERED (first dose administer past 6 hours mark) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No new information was provided.; Reporter's Comments: This report refers to a case of Expired product administered,  for mRNA-1273, lot # 0440A21A, with no associated AEs.
gave typhoid and covid booster first. when giving yellow fever patient said [he didn't like that one] Upon completion, patient passed out and started seizing. Called 911. He came to for a little bit, then passed out again. Layed him down and elevated feet. EMS arrived and performed vitals. He was taken in for further evaluation.
Oral ulcers with pain, currently ongoing for6 days.  Treated with oragel.
Sore arm since evening of injection, headache and slight nausea beginning midday following injection, lasting into night. No fever
pt had a previous hospitalization and positive COVID test on 8/25/21; pt left the hospital earlier than advised to go home; 8/29/21 pt to ED with O2 saturation on NRB in low 90s; admitted to ICU; DNR/DNI; given ABX; placed on Vapotherm; poor prognosis; pt passed away in the hospital
pt recvd DTP on 3SEP92 on 4SEP92 mom calls reporting pt will not bear wt on lt leg where DTP given; t102, soreness @ site;
received vaccine 11:30am 11:35am-felt warm rush on face and throat which was relived in 5sec or so Following that I had intestinal cramping that did not result in me needing to leave the waiting room for diarrhea.  I left the waiting room at 11:55.  One hour later, I had an extremely dry mouth & needed water.  It resolved after drinking a bottle of water.  At 4:30pm I started itching in my hands, feet, & entire body - itchiness was like prickles, not normal itching.  Took Claritin which kept itching under control.  I have taken Claritin 10mg daily for the last 5 days to keep itching under control. Today I am more itchy than yesterday.
Information regarding PREVNAR was received from a consumer regarding a 12-month-old male patient who experienced wheezing, sore throat, loss of appetite and irritability. The patient recovered a dose on 14-Jun-2007. Relevant medical history was not provided. Concomitant medications were not reported. On 15-Jun-2007, the patient experienced wheezing, sore throat, loss of appetite and irritability. The patient was treated with Motrin, Tylenol, and Nebulizer. The outcome of the events is unknown. No additional information was available at the time of this report.
About 5 minutes after administration pt felt lightheaded, dizzy, and nausea. Gave pt water and smelling salts.
arm that inj given became extremely sore 2hr p/vax; there is a warm, red knot the size of a quarter;arm hurt to the extent that it interfered w/sleep;
Extreme disforia, nausea, joint pain,muscle pain, headache,fever, cold sweats,difficulty breathing,chest pain,sensory overload, loss of appetite, anxiety,depression
Patient received Td in left deltoid and Hepatitis B #1 in right deltoid IM on 7/16/07 at 11:20am; no local reaction after 30 minutes went. Patient called 7/17/07 at 1330 - c/o dizziness and fever of 102.2 since 0530 that AM. Denied diarrhea, vomiting or rash. Temp at 1340 = 101.7. NP advised to come to clinic for observation.  Patient refused, advised patient to go to ER immediately if symptoms worsen. Patient - NP tried to call patient at 1900. Patient called back - feeling better, temp 99.0 and not dizzy. Follow-up on 7/18 no local reaction at site and no complaints per patient.
regular reaction; lips swollen; dizzy; allergic reaction; rash everywhere, not at site of injection, but other arm, around knees, legs, all over the place.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (regular reaction), LIP SWELLING (lips swollen), DIZZINESS (dizzy), HYPERSENSITIVITY (allergic reaction) and RASH (rash everywhere, not at site of injection, but other arm, around knees, legs, all over the place.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (had a reaction to an antibiotic). Previously administered products included for Product used for unknown indication: Pfizer (2 doses of the primary series and her 1st booster dose were Pfizer). Past adverse reactions to the above products included Flu like symptoms with Pfizer. Concurrent medical conditions included Allergy to antibiotic (not specified). Concomitant products included METFORMIN, PREGABALIN (LYRICA), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, FENOFIBRATE, DICYCLOMINE [DICYCLOVERINE], METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]), EZETIMIBE (ZETIA), AMLODIPINE, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CIMETIDINE, AZILSARTAN KAMEDOXOMIL (EDARBI) and IVABRADINE HYDROCHLORIDE (CORLANOR) for an unknown indication.    On 10-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash everywhere, not at site of injection, but other arm, around knees, legs, all over the place.). On an unknown date, the patient experienced IMMUNISATION REACTION (regular reaction), LIP SWELLING (lips swollen), DIZZINESS (dizzy) and HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (regular reaction), LIP SWELLING (lips swollen), DIZZINESS (dizzy), HYPERSENSITIVITY (allergic reaction) and RASH (rash everywhere, not at site of injection, but other arm, around knees, legs, all over the place.) outcome was unknown.            Concomitant medications also include supplements. It was reported that, after her 2nd booster dose of the Moderna COVID-19, patient started to experience an allergic reaction and a regular reaction. Patient reported 45 minutes after her shot, she started to get a rash everywhere, not at site of injection, but other arm, around knees, legs, all over the place. Her lips were swollen, and she was dizzy. She reported the only other time she had a reaction like this was to an antibiotic, and that was how she knew she was experiencing an allergic reaction. She also reported that, the pharmacist who administered the vaccine said he did not know anyone else who experienced the reaction she did.