chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin, rHA) injection (lot # M039904 with expiration date at 26-SEP-2018 and lot # M029918 with expiration date at 13-JUN-2018; for prophylaxis; dose, route of administration and anatomical location were not reported), which were reconstituted with properly stored sterile diluent (strength, dose, lot # and expiration date were not reported). The administered doses of vaccine experienced multiple temperature excursions. From 21-MAR-2017 to 14-APR-2017, the doses of M-M-R II with lot numbers: M039904 and M029918 were exposed to a temperature in the range between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) for 3 hours and 27 minutes in total. On 29-MAR-2017, took place the longest (24 min) temperature excursion. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received. Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA000770: US-009507513-1705USA015597: US-009507513-1705USA015598.
dizzy; weak; rapid heartbeat; don't feel well; lot of pain inside both legs. it hurts; Pain in her left site; tired; all her body is hurting; headache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), HEART RATE INCREASED (rapid heartbeat), MALAISE (don't feel well) and PAIN IN EXTREMITY (lot of pain inside both legs. it hurts) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported Medical history).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), HEART RATE INCREASED (rapid heartbeat), MALAISE (don't feel well), PAIN IN EXTREMITY (lot of pain inside both legs. it hurts), PAIN (Pain in her left site), FATIGUE (tired), MYALGIA (all her body is hurting) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), ASTHENIA (weak), HEART RATE INCREASED (rapid heartbeat), MALAISE (don't feel well), PAIN IN EXTREMITY (lot of pain inside both legs. it hurts), PAIN (Pain in her left site), FATIGUE (tired), MYALGIA (all her body is hurting) and HEADACHE (headache) outcome was unknown. Not Provided          Treatment medication was Acetaminophen.   Reporter did not allow further contact
The patient developed a rash 07/05/2001. There were 15 lesions which started as clear vesicles and then became crusty.
Arm swollen completely around from elbow to top of arm. Deep red and hot to the touch. 2nd shot taken Monday morning and today is Wednesday evening.  Continues to be hot to touch, swollen and red
The morning after vaccine receipt, she woke up with a round area of red and raised rash in the center of the forehead. She then noticed her left upper eyelid was swollen and it was hard for her to see. Shortly after that she noticed spasms around left periorbital area. She had a very mild HA. Her family reported facial swelling and mild hoarseness developed on 6/7/08, together with twitching/blinking of the eyes (rt more than lt) and occasional jerking of the arms. She was seen in the ED on 6/7/08 and the ED physician noted twitching of left eyelid and right shoulder. She was given Valium 10mg po and SOLUMEDROL 125mg IV. Twitching decreased and as she was getting d/c paperwork she started having more twitching. Eyes were closing Invot, R >L UE and LE were "twitching". This lasted 45 min and she received SOLUMEDROL 125mg, Valium 2mg IV and BENADRYL 25mg IV. This decreased the movements. She was then admitted for further evaluation and observation. She states the movements are not painful. She is able to stop them briefly but they recur and are more intense. She is still able to voluntarily use the extremities during these episodes.. Other than this episode, movements like this never occurred before. She does not have a h/o ticks or OCD traits. No recent fever, chills, SOB, CP, GI or GU sx, arthralgias. She denied any respiratory symptoms, coughing, nausea, etc. During hospitalization, she continued to have intermittent right or right and left eye twitching with occasional twitching of bilateral mouth. Sx are not painful. Pt felt like she could suppress these but felt uncomfortable during the suppressive episodes. 2 Episodes of jerking to involve right arm and leg, the last one was on the night 6/8/08. Right sided twitching did not last long or as severe as initial presentation. Baseline eye twitching also some what decreased. No further swelling of eye and lips. Pt was discharged on CONGENTIN and BENADRYL to be taken as needed.  08/19/2008 MR received for DOS 6/7-9/2008 with D/C DX: Twitching of eye and limbs. Pt admitted for possible dystonic reaction after new onset of involuntary movements.  Pt noted a red raised patch on forehead, left eyelid swelling with difficulty seeing, and spasms around the L periorbital area. Mild headache and hoarseness. ED physician noted twitching of the L eyelid and R shoulder, somewhat improved with Solumedrol and Valium.  Pt developed upper and lower extremity twitching and involuntary eye closing. Some improvement with Cogentin, Benadryl. 10/20/2008 Additional records recd for f/u visit 6/20/08. Symptoms have resolved. PE WNL.
Client reports vaccine administered approximately 9 AM.  At approximately 1315 PM client began to coughing and could not get the episode under control.  She reports her chest tightening and it became difficult to breath, then a tightening type pain in her jaws. Eyes became very bloodshot. Paramedics were called and client was transported via ambulance to the closest hospital one hour away.  The following test were preformed; CAT Scan, Doppler Study, X-rays, Kidney function test, Chemical Stress test and other unknow blood test were done, all test were negative.  Client recieve "nitro and steriods" while in the ER.  Client sent home the same evening, symptons subsided "late that evening".
Lymph node swelling 24 hour after injection affecting right maxillary node, right suprarcuilar node - seen on 10/26 - sxs resolving also c/o neck stiffness that has resolved
Two weeks after receiving the covid vaccine (4/26/21), the patient presented to the dermatology clinic with a rash on legs, elbows, and hands. The patient has a hx of eczema and stated she was bit by a bug prior to the rash development. Determined by dermatology clinic rash was related to covid vaccine and was given the following treatment option: cerave OTC itch cream, cetirizine 10 mg BID, famotidine 20 mg daily, hydroxyzine 25-50 mg qHS for sleep.
muscle fatigue, headache, stomach upset, sleepy hard time walking. In creased polymyalgia  and had to increase prednisone
Rednes, hot to touch, fever of 102.8 orally site soreness.
6o minutes after shot last patient started feeling bad. Seeing dots, numbness in finger and feet, feeling weak and progressing to inability to move. She was transferred to hospital she was given Epi and Benadryl and was watched for 24 hours by neurology.
Patient complained of incontinence and knee pain the day following vaccine administration.  Patient stated she drank lots of water the night after receiving the vaccine.  Patient also has history of prior knee replacement surgery.  Pain lasted for a day and a half following the administration of the vaccine/.
Swollen between shoulder and neck; Lymph node swollen; A spontaneous report was received from a Consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen between shoulder and neck and lymph node swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient reported to experience swelling between shoulder and neck. She also reported it was like lymph node was swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was not reported.; Reporter'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.
second dose only had me down for one day; Sleep and a bit more sleep; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (second dose only had me down for one day), SOMNOLENCE (Sleep and a bit more sleep), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (second dose only had me down for one day), SOMNOLENCE (Sleep and a bit more sleep), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, ASTHENIA (second dose only had me down for one day), SOMNOLENCE (Sleep and a bit more sleep), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) had resolved.            Patient had a small bowl of cereal and nausea went away. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-322707 (Patient Link).
Bottle of Janssen COVID-19 vaccine was punctured on 7.26 at  17:00 and administered to another patient. Bottle was refrigerated, but not discarded  6 hours after puncture, as is the protocol. Patient  was administered a vaccine from the punctured, refrigerated bottle 46 hours after puncture, but the recommendation is to use all vaccine or discard after 6 hours. Patient was notified of event when it was discovered on 8/3/21. Patient had not noted symptoms or side effects from the medication administration error and declined revaccination. Janssen was contacted for guidance on revaccination, and was not able to provide comprehensive guidance due to lack of data.
shingles outbreak. prodrome developed 2days after vaccination and overt rash 3 days after.
Covid positive 9/6 Symptoms: fever, headache, nausea, sore throat, fatigue
Experiencing sore right arm near injection site.; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the right arm on 03Nov2021 at 18:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 03Feb2021 (at the age of 56-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 24Feb2021 (at the age of 56-years-old), as single doses for COVID-19 immunisation. On 04Nov2021, the patient woke up at 01:37 and noticed experiencing sore right arm near injection site. Soreness was minor and did not interfere with his daily tasks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of event. The clinical outcome of the event experiencing sore right arm near injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fever 99.2F; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 99.2F) and VACCINATION SITE PAIN (Pain at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No adverse event reported in medical history.  Concomitant products included LEVOTHYROXINE, QUINAPRIL and SIMVASTATIN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever 99.2F). 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, PYREXIA (Fever 99.2F) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 99.2 f 99.2 F.         Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-083823 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083823:Case for dose 1
Fever (99.6), chills, muscle aches, fatigue from about 9am day after shot for 12-18 hours; took Aleve  Large red patch at and below vaccine point, hot, hard, painful from day of shot through Monday, Feb 8, and has not yet ended; took Aleve and Advil
8/15/22 transferred from local Memorial hospital following bx of pelvic mass; findings also of small bowel obstruction transfer with s/p NG tube; 8/16/22 found to be positive for COVID; tachycardia, leukocytosis pretension, worsening renal function; ICU; ABX for sepsis; changed status to DNR/DNI and comfort measures; pt passed away in the hospital
Patient presented difficulty breathing and generalized weakness. Patient is still inpatient, being treated with aspirin, tylenol, pantoprazole, and dexamethasone.
3/11 fatigue, just slept the day away. 3/12 tested positive on an at home COVID-19 test. 3/13 telehealth with doctor. Doctor proscribed PAXLOVID and to treat symptomatically. Developed sinus drainage with a little coming up with coughing. Mild coughing. PAXLOVID caused diarrhea while taking it for the 5 days dosage. Symptoms improved over the week of taking PAXLOVID. On day 10, 2 days after PAXLOVID ended, developed a cough that lingers to time of reporting.
Patient received two flu vaccines in one day.  RPh spoke with patient and she reported no issues 15 min after vaccines were given.  Rph plans to follow up with patient in a few days.
severe joint and muscle pain/ it feels like someone is pulling her tendons and bones apart; severe joint and muscle pain/ it feels like someone is pulling her tendons and bones apart; This spontaneous report was received from a consumer referring to her daughter of unknown age. The patient was allergic to penicillin. The patient's concomitant medication and pertinent medical history were not provided.  On an unknown date in July 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiration date were not reported).    On an unknown date in  August 2019, after about a week to 10 days, the patient experienced severe joint and muscle pain. The patient said it felt like someone was pulling her tendons and bones apart. The patient sought for medical attention. Over the counter medication and physical therapy were given for the events. On an unknown date the patient had some blood tests done and a rheumatoid arthritis test but that was negative. The doctors had not been able to give any answers. The outcome of severe joint and muscle pain was not recovered. The causality assessment was not provided.
pt recv vax 20JUN95 & 27FEB97 pt exp rash all over body consisting of approx 150 lesions which was described by MD as classic chickenpox;
Third Shot (Booster): Manufacturer: Moderna; my whole body kind of ached a little bit; arm starting to feel very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 at 15:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Exercise induced asthma" (unspecified if ongoing), notes: Exercise induced asthma; "HLA-B27 associated anterior uveitis" (unspecified if ongoing), notes: which is an autoimmune disease of my eye. Concomitant medication(s) included: FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT#EL3247), administration date: 23Feb2021, when the patient was 37-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, LOT# EL3247), administration date: 16Mar2021, when the patient was 37-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE,), administration date: 01Dec2021, when the patient was 38-year-old, for COVID-19 immunization; Flu shot, administration date: Sep2022, when the patient was 39 years old, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Dec2022, outcome "unknown", described as "arm starting to feel very sore"; PAIN (non-serious) with onset 17Dec2022, outcome "unknown", described as "my whole-body kind of ached a little bit"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 17Dec2022 at 15:00, outcome "unknown", described as "Third Shot (Booster): Manufacturer: Moderna". Therapeutic measures were not taken as a result of pain, pain in extremity.  Additional information: When the needle goes in, it hurts a little bit; 8 hours later, my arm starting to feel very sore. Consumer stated, "So for myself, so actually, we got our shots yesterday, at about 3 pm. I, you know, other than, obviously, you know, when the needle goes in, you know, it hurts a little bit. But other than that, I was fine until about probably 11 or so. So, about 8 hours later, and then, my arm starting to feel very sore and then overnight as I was sleeping, my arm would have gotten worse in terms of soreness and the, my whole-body kind of ached a little bit, you know, up to the point where it woke me up earlier then I had been planning to wake up. And instead of, all day today it was just the same thing, general overall soreness but most specifically in the arm, I received my shot, which was my left arm." Moderna: Reason for no lot number: of Covid Vaccine: Other: LOT#: Consumer stated, "I hope that I could read the handwriting. Looks like 045J21A, I think. This J could also be something else, but I think it's J." Flu Shot: Reason for no lot number: of Unspecified Flu Shot: Other: LOT# could not be probed as the shot was unspecified. Lab Work reported as no. Treatment reported as no. concomitant medication: birth control pill, multivitamin.
Hives started day after getting shot. Then got progressively worse. Went to ER given Benadryl. Went to doctor's office and given Prednisone dose pack. Symptoms resolved.
9/24/04 Loss of equilibrium, nausea and vomiting, weakness. 9/25/04 Went to ER.
patient states he recieced his pnuemonia vaccine on 11/4/02 the next day it was red and warm. He states the redness went down to his elbow. It was painful, but he did not seek medical attention. The report of the reaction was brought to my attention from another person who works in our facillity. Patient did not call our office with any complaints, but I did contact him after hearing that he had a reaction I did speak to him today (11/13/02) and the redness has almost diappeared
tested positive to COVID-19; This is a spontaneous report from a contactable pharmacist via Medical information team. A male patient of an unspecified age (reported as, age: 25; Units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive to COVID-19 on 11Mar2021 and will finish quarantine on 24Mar2021. The patient's second dose is scheduled for Thursday. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt recvd vax;approx 46 hrs  p/ vax;fever,red endurated bump cover from elbow to shoulder;
Muscle spasm and myalgias in calves.  Ascending myalgias.  Intermittent chills.  No fevers.  Mild neck stiffness and headache.