chrisvoncsefalvay/vaers-outcomes huggingface dataset:
few months after my lungs got really bad; this flare up has been a bad one in terrible pain and my bronchial tube wont heal; this flare up has been a bad one in terrible pain and my bronchial tube wont heal; Spine and legs hurt bad and left side of neck; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LupusMi-AE2021.11.08.02 (GSK).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "few months after my lungs got really bad"; PAIN (non-serious), BRONCHIAL DISORDER (non-serious), outcome "unknown" and all described as "this flare up has been a bad one in terrible pain and my bronchial tube wont heal"; ARTHRALGIA (non-serious), outcome "unknown", described as "Spine and legs hurt bad and left side of neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lung disorder, pain, bronchial disorder.  Additional information: Patient got Pfizer was okay for a few months few side effects but few months after their lungs got really bad had to be on Prednisone again. They kept saying no more Prednisone but couldn't seem to get better without it. They kept hoping that they will get better cause this flare-up has been a bad one in terrible pain and their bronchial tube won't heal. Had 3 rounds of antibiotics. Tested negative for Covid 3 times my spine and legs hurt bad and left side of neck. Not sure if just a flare-up or what.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One week after the vaccine, my dad noticed that his urine was darker than usual. Then over the weekend, he started having jaundice. He was seen by his PCP who ordered labs and then referred us to a GI specialist. He has had multiple labs and a liver biopsy.
Sore Arm after second dose; Swelling; Little bump at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection). At the time of the report, VACCINATION SITE PAIN (Sore Arm after second dose), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE MASS (Little bump at the site of injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-023217 (Patient Link).
Patient received vaccine and went in the waiting area for the 15 minute observation. He passed out and fell on the floor. He was sweating but was conscious. We put a bag of frozen blueberries on his neck and wiped  his face with a damp towel while waiting for EMS to arrive. He did not require CPR.
Chills, fever, headaches, muscle aches throughout entire body, muscle spasms, nausea, vomiting, diarrhea, fatigue, loss of appetite
Pulse 52.   Fever 99.9 injection site pain body aches and nausea
Patient getting squeezing in chest.  Not able to bet in a deep breath.  No couth.  Getting DOE.  No temp elevation.  O2 sat 98%.  CXR neg.  Albuterol inhaler provided relief and prescription given for albuterol MDI. 11/20/06 Received medical records from provider which reveal patient in good health but with AM stomach aches even on non school days.  Peppermint candy relieves.  Poor appetite.  Received FluMist on 10/27 & became ill on 10/28 with squeezing in chest & SOB.  Treated w/albuterol MDI.  CXR was WNL.
Vaccine give IM and SQ to (R) deltoid on 8/16/17. Today presents with red, swollen, warm to touch area on arm 2" x 3.5" area (circular).
Breakthrough Case admission after 4 vaccines Moderna 2/6/21 Lot# 031K20A; MOderna 3/6/21 Lot# 032M20A;  Moderna 10/30/21 Lot# 939903;  Moderna 4/22/22 Lot# 056A22A
I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30.  I had some very vivid dream & woke up at 11:00, the sheet on the bed was wet with sweat, drool on pillow & every muscle in my body was cramped up. I think it was a convulsion/seizure, but was alone in the hotel room. Today, I feel perfectly normal -
This spontaneous report was received from a pharmacist concerning of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with ZOSTAVAX lot # M041085, expiration date: 03-JAN-2018 and lot#: M041510, expiration date: 27-JUL-2017 (dose, frequency, route and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. There was no adverse effect reported in any patients. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 15.3 degrees Fahrenheit for 1 hour 15 minutes  and 13 degrees Fahrenheit for 8 hour/ 45minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000696.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAR-2014 the patient was vaccinated subcutaneously with an unknown date of ZOSTAVAX. In March 2014, reported as after receiving ZOSTAVAX, the patient experienced red injection site reaction the size of a quarter. The outcome of red injection site reaction the size of a quarter was unknown. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information has been requested.
Swollen arm,redness,painful,severe itching.7×5 spread.tightness in neck and shoulders. Chest tightness, high blood pressure. Coughing.Diagnosed with myocarditis given steriod pack,itch pill,nausea meds,and two inhalers. It's been 7 days and symptoms of chest tightening is still there and coughing.
A non-serious spontaneous report of administration to pregnant female was received from a health professional concerning a female patient. Neither past medical history nor concomitant medications were reported for this patient. As per the reporter, they gave FLUMIST vaccine to the four-week pregnant female. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy. The outcome of event administration to pregnant female was considered resolved.
Spoke to client 1/5/10, stated 2 days after injection (R) arm became more sore, red, swollen, and warm to touch. She had only taken 2 Tylenol a day for 2 days. She did not have any problems moving arm or any decline in function. She states arem is feeling better now & soreness, redness & swelling going away- Encouraged to call back if not better.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with an unknown number of doses of GARDASIL (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information (improperly stored). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Tightness in my chest Weighted pressure on my chest High blood pressure ED visit on 11/8/21
Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pain and muscle soreness and lethargy
SHORTLY AFTER VACCINATION CLIENT BEGAN TO FEEL NAUSEOUS AND SWEATY/CLAMMY.  PO2 97, BG 83, B/P 88/78
Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same day recipient was seen in the ED with itchiness and dry heaves. Was treated with steroids, Benadryl, and Pepcid. On 1/17/2021 recipient returned to the ED with complaints of shortness of breath and itchy throat; she was unable to take oral steroids
Sore arm, redness at site of injection, hot at site of injection, swelling at site of injection, itching at site of injection, headache
pt called clinic 25OCT96 w/ c/o numbness/heavy feeling of same arm that inj given;20NOV96 c/o fever all day & more aware & tingling of lt extremity, more w/fingers;arms feels heavy-fingers numb;plans to see MD today; 26Nov96 tingl lt arm;
Arm was warm to the touch; Arm was red; Red rash on thigh/red rash on neck; It was itching; This spontaneous case was received on 11-Sep-2020, from other non-health professional (consumer) to agency (reference number: SEQW20-01540) and concerned a 67-year-old, female patient.  The patient's medical history was not reported. The patient was healthy. The patient did not have high blood pressure and did not take any medications for cholesterol. The patient's concomitant medications included Premarin (estrogens conjugated) and unspecified vitamins, both used for unreported indications.  On 08-Sep-2020, patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm] for influenza prophylaxis. The batch number was 279787 and expiry date: 18-May-2021.  On 09-Sep-2020, one day after receiving Fluad Quadrivalent, the patient noticed that her arm was red, and when the patient felt it, it was also warm. At the evening, the patient noticed that there was red rash on her thigh. Firstly, the patient thought that it was a mosquito bite, but the patient was wearing long pants and was not sure.   On 11-Sep-2020, the rash got larger and was itching and the patient noticed red rash on her neck when was putting her beauty cream. No corrective treatment was applied for the events.  At the time of initial reporting on 11-Sep-2020, the patient's arm was less red and less warm to the touch, and outcome of these events was considered as resolving, while the outcome for the events of red rash' and itching' was not reported.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
I developed septic arthritis of the hip within a week of getting the second Moderna vaccine. No symptoms or signs.
weak; redness in the cheek and face; skin burning; muscle became sore; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A2 and 029L20A) for COVID-19 prophylaxis.     The patient had never tested positive or diagnosed with COVID-19. The patient had no allergies. The patient was not given any other vaccine within 1 month prior to receiving the Moderna COVID-19 vaccine.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (weak), ERYTHEMA (redness in the cheek and face), SKIN BURNING SENSATION (skin burning) and MYALGIA (muscle became sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  After receiving the second dose of the vaccine, the patient thought that it was normal to feel weak.  The batch number of the second dose of the vaccine was mentioned as 026A2 and the rest is unknown, or ripped off.  The patient was currently not continuing any treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2022-598091 (E2B Linked Report). This case was linked to MOD-2022-598087, MOD-2022-598068 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-598091:same reporter
Pt. right thigh was red, hot to the touch, and swollen.  Leg also had a hard lump at injection site.
breakthrough COVID-19 infections; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID-19 infections) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID-19 infections). At the time of the report, COVID-19 (breakthrough COVID-19 infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Everyone who works at the hospital is getting breakthrough COVID-19 infections even after the have completed the Moderna COVID-19 vaccination series. No concomitant and treatment information were reported.
Severe swelling, redness, pain at injection site accompanied by shaking rigors. (I did not see the patient, he described these symptoms to me on 12/8/06).
A spontaneous report was received from a pharmacist concerning a patient, who received COVID-19 vaccine and experienced more than half the liquid came out onto the patient's skin (accidental under dose, exposure via skin contact).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Feb 2021, the patient received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, during administration of the vaccine, more than half of the liquid came out onto the patient's skin. No treatment information was provided.  Action taken in response to the event was not reported.   The event, more than half the liquid came out onto the patient's skin, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Accidental under dose, lot # unknown with no associated AEs.
Patient reports N, V, high fever, swollen lymph nodes that started approximately 1 day after IM injection. Patient reports s/s fever, N, V decreased within 24 hours with anti nausea medication and OTC TYLENOL. She denies local reax s/s skin infection of injection site. She reports on this date (03/11/19) that her lymph nodes remain swollen and she has a mild ST.
Apparent SIDS in ED 10/26/16 AM co-sleeper may have been in use.
lt deltoid area sl reddened & swollen, warm to touch;parent states child denies any pain or discomfort;
Swollen lymph node; couldn't move/hurts to extend left arm; Arm sore; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (Medical History not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move/hurts to extend left arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Arm sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included ibuprofen.  Company Comment: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship can not be excluded
Pt received dose of vaccine. After a few minutes, he tried to stand up to approach counter. He stumbled repeatedly toward the counter and pharmacy staff rushed to help him. Pt had a pre-syncopal episode resulting in collapse to floor and near syncope. Pt was supported in fall to floor so no significant injuries were caused by fainting. Needed assistance to sit up into chair and was given bottled water and assistance by pharmacy staff.
sore arm; Initial information was received on 04-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who experienced sore arm (pain in extremity) after receiving INFLUENZA VACCINE and Coronavirus disease (COVID-19) VACCINE  The patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a booster dose of suspect COVID-19 VACCINE not produced by pharmaceutical company lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "I got my COVID booster and flu shot together last week and other than a sore arm for one day had no side effects"  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event (sore arm).  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. Employee in Quality was also notified. Communication with patient: The Moderna Vaccine you received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
Began with flu like symptoms, but progressed to "shakes" and nervous "twitches", elevated heart rate (84 bpm) and blood pressure (157/87), flushed face, and skipped heartbeats. Lasted for several hours into sleep. Was only able to sleep with aid of sedative.  I was OK by morning.
started experiencing diarrhea/gets diarrhea every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (patient had a kidney transplant 7 months ago.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (started experiencing diarrhea/gets diarrhea every time she eats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs were not provided    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: follow up received on 14-07-2021 contain non significant follow up
weak; heavy breathing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm). At the time of the report, ASTHENIA (weak), DYSPNOEA (heavy breathing) and MYALGIA (sore arm) outcome was unknown. Not Provided          Reporter did not allow further contact