chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 27 year old female certified medical assistant with allergy to amoxicillin and no relevant medical history, refers to herself. Around 17-MAR-2015 or 18-MAR-2015, the reporter administered RECOMBIVAX HB (pre-filled syringe, 0.5 ml, route, lot#, expiration date and therapy type were not reported) to an unspecified patient. The reporter's concomitant medication included PROZAC. While administering the RECOMBIVAX HB, the reporter noted that "on the bottom of the RECOMBIVAX HB syringe, one side of the glass was broken, where you would hold, when administering the vaccine". The reporter stated that the unspecified patient was administered a full dose of RECOMBIVAX HB however during the actual administration of the RECOMBIVAX HB, the "broken glass" cut the reporter's middle finger on her right hand. The reporter stated that she immediately rinsed the cut out with hydrogen peroxide, put an unspecified triple antibiotic on the cut and then applied a Band-Aid. The reporter stated that the cut healed on an unspecified date, in 2015 and that she currently (at the time of the report) had a scar (onset date unspecified, in 2015). The reporter did not have any laboratory test performed and did not seek any medical attention. No adverse effect was reported for the unspecified patient that received the RECOMBIVAX HB. At the time of the report, the outcome of the scar was not recovered/not resolved. The relatedness between the events of scar and the "broken glass" cut the reporter's middle finger on her right hand and RECOMBIVAX HB was not reported. PQC (product quality complaint) was filed. Additional information has been requested.
55 ur old female was in observation  area  after receiving her first dose of the Covid 19 vaccine (moderna) when she stated feeling her palpitations.  Pt felt warm and  light headed. Pt was moved to medical room via wheel chair and sat in the chair to relax. Pt vs were taken and  bp 152/94 hr 112, resp 18., spo2 was 98% ra. Pt was given a drink of water and relaxed for 15 min. In wheel chair. Vs were taken every 5 min and pt  felt much better.  Final vs were bp 134/87, hr was  82, resp 16, spo2 was 98% ra.  Pt was released back to observation area by providers and pt checked out.
He was at the hospital; He has been in four times for lung problem; He has been in the hospital for two month; He is very very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), on 07Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (hospitalization) with onset Dec2022, outcome "not recovered", described as "He was at the hospital; He has been in four times for lung problem; He has been in the hospital for two month"; MALAISE (non-serious), outcome "unknown", described as "He is very very ill". The patient was hospitalized for lung disorder (start date: Dec2022, discharge date: 2023). Clinical course: Well, reporter had a question about Pfizer medication. Her son had it the injection (Clarified as Pfizer COVID-19 Vaccine) 07Dec2022 and by the end of the month he was at the hospital, he had been in four times for lung problem and reporter did not knew if this was a reaction from the injection or what the problem was, but he had been in the hospital for two month and he never really had any big problem with lungs or anything. Yes, he kept down with the virus and from then on he had lungs problems and he was having lung problems yesterday. Reporter was informed about the Role of Pfizer Drug Safety and also informed about Pfizer Medical Information Department. Okay, Reporter did not see if there was any compensation up for that or not but he was very very ill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: felt lightheaded and dizzy and fell to the floor. We ended up calling paramedics to check on him. Vitals were ok all around, patient was ok and ending up leaving afterwards was able to walk on his own and able to answer our questions and was aware of his surroundings. patient claimed he was anxious prior to getting the vaccine.
My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water helped get it to the 80-90 range. When first receiving the shot I started feeling numbness in left hand. Tingling in mouth. Altogether my left side felt weird the first hour at least.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417529 (Pfizer).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation; multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "recovered" (20Mar2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BP 180/98 on 3/28, 200/100 3/29, took extra hypertensive medication each day.  Put on additional BP med 3/30 and diurectic.  Checked BP due to feeling bad and severe headache.  Never been that high before.
12/18/13 2:15 pm T.C. from (M) stating patient became dizzy and weak within 1/2 hour of receiving the vaccinations. He had not eaten breakfast prior to vaccinations. He took a nap when he went home and required bathroom assistance with ambulation. She has since given him something to eat and MOTRIN - he is now feeling better. 12/18/13 4:25 pm - T.C. to friend/unable to reach (M). Client feeling better.
doses administered after excursion; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medication was provided.  The pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit.   No adverse events were reported.   Treatment medication was not provided by the reporter.
First dose / on 03Aug2019 and the second has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 3rd August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The Healthcare professional stated that they had no time to answer the questions so no patient or vaccine details provided. The reporter consented Follow up.
4 PINPOINT LESIONS THAT "ITCHED" ON CHEST ONSET OF SX 110306. C/O STOMACH ACHE WITH DIARRHEA ONSET 110106.
Erythema involving right forearm, warmth, advised to apply cool compresses and contact office for any worsening symptoms. Area of involvement is approximately 15cm.
I was okay during the 30 minute observation period, and was discharged.  Between 1 and 1:30 am, about 15 hours after receiving the vaccine, I woke up from my sleep suddenly, with an acute episode of chest tightness, cough, severe running nose and lacrimation.  I did not have hives or lip/throat itching or swelling. I felt a little warm in the face. I took Ventolin inhaler two puffs twice 30 minutes apart + Aller-flo nasal sprays. I began to feel a bit better and then took Benadryl 25 mgms (because of my history of Angioedema) around 2:30 am. I feel better now, which is 12 hours after onset of episode, but had to take Ventolin inhaler this morning for a bit of chest tightness. I do not have a history of asthma, but have had seasonal allergies in past years. But if this is seasonal allergy, it is very unusual, since I have never had an acute episode like this without any early milder symptoms. And I haven't needed Ventolin in a couple of years. I am now concerned about taking the second dose.
pt devel petechia on 22DEC95;CBC was obtained stat;pt adm to hosp & adm on 22DEC during the evening;stat CBC was obtained on adm;platelet count was 13;adm to ped hematology oncology;tx w/med;
inconsolable screaming 1/2hr or so p/shot for 5 hrs; fine on exam 14OCT92; nl per mom today 15OCT92;
pt exp elevated temp 100-106;pt very weak;pale & sl flushed cheeks;
Headache; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurts) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurts). On 18-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (arm hurts) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment included Paxlovid from 18Aug2023 to 22Aug2023.
Swelling in the arm where the vaccine was placed and warmth in it, fever up to 101.3 F, general pain (all over the body), diarrhea, sore throat, burning eyes, cold.
I first got aches in my back and legs and started running between 100 - 101 degree fever around noon. Around 4pm, I started feeling what I thought was heartburn. I was lying down, and when I finally sat up, the ?heartburn? got so severe that I could barely take breaths. I broke out in cold sweats and was drenched within minutes. I was very lightheaded and dizzy and in a fog. I had severe aches in my back. My fever got up to 102.6 after that. Those symptoms felt severe for about 30 minutes and then, the heartburn slowly subsided until it was no longer a problem.  Fever and aches remained but improved slightly with Tylenol.
Dizziness since 12:30pm March 2nd, nausea, pain and soreness in left arm. Swelling down to wrist. Diarrhea 6 times since vaccination, vomiting bile, headache, chills. Feeling feverish. Headache. Took Motrin 6pm March 2nd and 9am March 3rd.
sore arm; rash on the arm; little twitching around lip; burning cramping pain that run down from my right thigh to my ankle; burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AC1A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (Patient has multiple sclerosis). Concomitant products included INTERFERON BETA-1A (AVONEX) for Multiple sclerosis, DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm). In March 2021, the patient experienced MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle) and PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode). At the time of the report, MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) outcome was unknown.            No treatment information was reported by the reporter. Concomitant product includes blood pressure medication. Dexilant concomitant was used  for Reflux. Reporter stated that Patient has multiple sclerosis and takes Avonex, which suppresses her immune system. Patient said she takes a shot once a week, and for both doses of the vaccine she took the Avonex shot half way (meaning, took the shot, waited three days, got Moderna Vaccine, three more days, and then again the Avonex shot).
about 15min after injection, pt c/o feeling tightness and lump in throat, hands tingling,  pt states "I felt swimmy headed",  provider notified, assed pt , BP elevated, provider ordered: 0.3 IM Epinephrine 50mg IM Benadryl Monitored additional 30 minutes  Pt VS WNL pt was instructed to follow up with PCP pt  was stable
Time of onset of sx unk; night shot given pt devel elevated temp to 104, vomiting, irritable; Was taken to Hosp on 14SEP91;
Lips begin to swell ( minor) about 2.5 hrs. after second dose of Pfizer (5/12).  Continued to swell the day after but not too bad ( 5/13) . Swelling on  5/14 and 5/15 continued with itching lips, and looking like she had dermal fillers. Day four  swollen a little more with tightness in lips and bleeding from cracks of lips, but no itching.   was diagnosed with Covid in  Nov. 2020 and was admitted to for the same response, but worse, Lips were so swollen, cracked and bleeding , and painful.. Inside of mouth also became swollen and drained with pus. Throat and mouth were sore and she was not able to eat or swallow for about 5 days
Patient developed a rash, low grade fever, pain in private area, and "chipmunk" cheeks
Pt felt tired and short of breath. HGB redrawn on 3/12/21 and was 6.0. Pt sent to ER for transfusion.
large local react w/area of induration the size of a golf ball & surrounding erythema;
running fever; This is a spontaneous report from a contactable consumer reporting for herself.   A 67-years-old female patient  received bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration in the right arm  on 06Feb2021 15:30 at single dose  for covid-19 immunisation .  Medical history included blood pressure abnormal and blood cholesterol increased.  The patient experienced running fever on 08Feb2021 20:00 with outcome of not recovered.  The patient was hospitalized on an unknown date for running fever .  The patient underwent lab tests and procedures which included body temperature: still running temp   on Feb2021, Sars-cov-2 test: negative on 12Feb2021. The patient has received antibiotics as a treatment for pyrexia.  At the time of the vaccination the patient was not pregnant and after being vaccinated she was tested negative to Sars-Cov-2  Information on the lot/batch number has been requested.
Dull headache; I felt really hot even under a ceiling fan and in an air conditioned room.; Intense, migraine like headache; Chills developed about an hour after the headache began.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 20Aug2021 at 10:15 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID vaccine. On 20Aug2021 at 12:45, the patient experienced intense, migraine like headache that improved after 4 hours to a dull headache. The patient felt really hot even under a ceiling fan and in an air-conditioned room and chills developed about hour after the headache began. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense, migraine like headache that improved after 4 hours to a dull headache, felt really hot and chills was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Onset of symptoms occurred 10 minutes after vaccination. Symptoms included elevated heart rate, light headed, heart palpitations, dizziness, dry mouth, mild chest discomfort, chills
nursing supervisor reports an inc in frequency of inj site nodules following vax w/Tetramune w/in the last several months
2/2: sore arm 2/3-2/4: fatigue, chills, headache, low fever, very sore arm, congestion, brain fog (took 2 Advil every 4-6 hours, cool washcloth or ice pack on head, rest). Most symptom began in the morning on 2/3, but the fever and chills didn?t start until late afternoon/evening 2/5: fatigue, headache, congestion, red rash on arm below the injection site that was kind of swollen and firm, also sore to touch 2/6: red rash still on arm but less sore. Seems to get worse when exposed to heat (much more red after a hot shower)
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted  (12/25/20) one day - discharged on 12/26/20 at night
Had a seizure/stroke beginning at 8 pm and was brought to the ER. Was admitted in ICU
? Acute CVA (cerebrovascular accident)  Hospital Course/test results:  Work up with MRI showed 2 small acute infarcts in R temporal lobe region, and findings which could represent subacute infarcts in L frontal lobe.  Neuro deficits now resolved.  Neurology consulting.  Suspicious for embolic phenomenon.  She does also have a IUD to treat her menorrhagia, which may predispose her to clotting.  However when we did further research Mirena IUDs were not found to raise the risk for blood clot-related heart attack and strokes but the company does recommend clinical consideration for removal in such situations. We contacted  OBGYN oncall physician and spoke to doctor today. From his recommendation is not to remove the IUD at present time because the risk is very low comparing to the higher risk of severe menorrhagia that patient had experienced in the past. Since she will have annual visit with her GYN at OBGYN, patient should have that conversation with her GYN for options.    Patient remains stable and symptoms free. Repeated brain MRI and new MRV did not reveal new findings. Her HA resolved on its own. She was initially started statin and full dose of ASA then changed to low dose ASA plus Plavix (21 days) then ASA as monotherapy after. Currently hypercoag panel is still pending. Echo showed no evidence of intracardiac shunting with fair quality and technically adequate study. Neurology recommended outpatient follow up with neurologist and 30 days heart monitor to look for Afib/flutter. Currently her headache is resolved as well R hand weakness/tingling is resolved. She is stable to go home today.    A1C is 7.3 while on Metformin (2000mg daily). She may need additional agent to get A1C < 7 as outpatient.    Neuro also recommended outpatient sleep study.