chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side). At the time of the report, PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included sugar pill and cholesterol pill (unspecified).  Patient did not take medication to treat symptoms.
CHILLS; FEVER  FOR 3 DAYS BETWEEN 102 F TO100.5; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: deaf, eye disease, and penicillin allergy. The patient experienced drug allergy when treated with vancomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever for 3 days between 102 f to100.5. Laboratory data included: Body temperature (NR: not provided) 102 to 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for 3 days between 102 f to100.5 on AUG-2021, and had not recovered from chills. This report was non-serious.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, and start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188388.; Sender's Comments: V0:20210807962-covid-19 vaccine ad26.cov2.s-SUSPECTED CLINICAL VACCINATION FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever 10 hours after receiving the vaccine.  The fever gave me chills and I needed to put on lots of warm clothes to stop the chills which were preventing me from sleeping.  The fever broke after about 2 hours.  All night, though, sleep was interrupted.  I woke up every hour or 2, looked at the clock, and hoped I could fall back asleep again.  Got up at 8:30 am, feeling tired.  Was tired all day and unable to do my daily activities.  Had to rest all day.  Finally, the following day (2 days after getting the shot), after a good night of sleep, I felt like myself again and had my energy back.
Awakened approximately 5AM, attempted to get up to go to bathroom, upon rising extremely dizzy unstable gate, returned to bed for 10 min attempted to walk to bathroom contiued dizziness existed.  Checked BP 122/72 Pulse 88; 1 hour later vomited; Laid back in bed slept until apprx. 950 am dog awakened me hungry. 10am Continue NOT. Feeling well, like usual self; Decided to report; NEVER in 20 years of flu shots, have I been made ill.
Could Barely walk; Muscle in front of Legs above my knee hurts; Pain in her knees, upper legs, and back; Pain in her knees, upper legs, and back; Pain in her knees, upper legs, and back; Joint pain; This is a spontaneous report from a contactable consumer (patient herself) A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization.  Medical history included Thyroid and Cholesterol  from an unknown date and unknown if ongoing.  Concomitant medications included lovastatin taken for an unspecified indication, start and stop date were not reported.  On 27Feb2021 the patient experienced could barely walk, muscle in front of legs above my knee hurts, pain in her knees, upper legs, and back and joint pain. On an unspecified date the patient underwent lab tests and procedures which included international normalised ratio (2.8 mg/dl) and weight: no, that's alright (Weight: Consumer stated No, that's alright). No treatment reported. Upon follow up (04Mar2021) the patient stated, I read all the side effects and stuff my thing was I could barely walk the next day the muscles in front of legs above my knee hurt like heck and I know it says joint pain and muscle pain. But I was not expecting something that I can hardly walk. It didn't last long, but it was there. When probed for is it okay if Pfizer does a follow up with you Consumer stated, That's fine. Lab. work: Consumer stated, It was 26Feb (year not clarified). Patient reported about current status of pain was, Just a little. On Saturday was something else. It just stopped in her tracks. She will be walking and all of a sudden, she had to stop because the pain was very bad. She had pain before. But she was not expecting this in her legs. When probed if the events are worsened improved or persisting Consumer stated, not bad they are slowly kind of going. Caller stated he already spoke to the safety department but did not have any reference number to provide. Caller wanted to know how long the side effects can last. She received the Pfizer covid vaccine first dose about a week ago and has pain in her knees, upper legs, and back. Caller wanted to know why they ask about being on the blood thinner. Caller asks how long the side effects are supposed to last on the Pfizer. Clarified with caller that the product she was calling in regard to be the Pfizer BioNtech COVID 19 vaccine, that's what it says on her card. She says that she has had one of the COVID shots. The side effects she was experiencing are that her back hurts, her legs hurt, and she was having joint pain, but her arm doesn't hurt. When attempting to complete a safety report caller says that she would rather talk to the medical information department because she has already talked to another 800 number and he took all of her information. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
The patient had recieved the vaccine after the mother had to calm her down for a few mintus leading up to the shot. The patient finally calmed down and I administered the shot in the left deltoid muscle. After just a minute or two had passed at most, the patient felt dizzy and started to fall over. The mother was holding the child as the child began to collapse. She held on to her as she fell to the floor. We immediately called the paramedics and she came to after just a brief 3-5 seconds of unconsciousness. She was a little drowsy and nausous for a minute but that wore off quick and the paramedics arrived very quickly. She was checked out by the paramedics and seemed ok to return to normal condition of day
05/04/2022, I got real achy, had a super bad headache, felt like I wanted to suddenly take a nap, and I had no appetite. I tested negative for COVID. The next morning, I had a low-grade fever, congestion, bad headache and a cough. I spent the next 2 days in bed because I had no energy. I started to feel better pretty quickly. All day on 5/6/2022, everything I ate tasted funny. I tested positive for COVID. My taste resolved. Fever went away on 5/7/2022, but I still had congestion and cough. Then I continued to feel tired, and my cough got worse. I called my doctor on 5/13/2022 and let them know what was going on. They had me go to Urgent Care and I was diagnosed with bronchitis. I was prescribed a 5-day z pack. I am feeling better now, about 95%, but still have a cough and still feel tired, but not as tired as I have felt.
Patient claimed she had swelling throat, tongue and cotton mouth,  MD assessed her and instructed her to stay at the pharmacy for 30 more minutes. Nurses measure Oxygen level and Blood pressure. She was getting better after 30 mins and Dr advised her to go home and report to ER if problem breathing occur.
Every time I take a nap or fall asleep, I either wake up gasping for air or I feel pain in my heart with rapid heartbeat.
Was walking my dog the next morning, started out fine, halfway through I was dizzy and nauseous and had to sit down.  I put my head between my knees and was sweating though it was 30 degrees out.  I threw up 3 times (empty stomach so mostly spit and stomach acid).  Took about 10 minutes to feel a bit better to make my way home.  Tired and nauseous the rest of the day.  Had a wonky stomach up until Sunday (shot was on a Wednesday).
unable to work; body ache and pain today; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (unable to work), PAIN (body ache and pain today), PYREXIA (fever) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced IMPAIRED WORK ABILITY (unable to work), PAIN (body ache and pain today), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 05-Apr-2021 at an unspecified dose and frequency. At the time of the report, IMPAIRED WORK ABILITY (unable to work), PAIN (body ache and pain today), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: (Positive) COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided   This case was linked to MOD21-070876 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Added lab data and added events; Sender's Comments:  MOD21-070876:
After I had started getting heart palpitations about 1 every 5 days after the 1st dose. After the 2nd dose they started every 2-3 days after couple of days after the vaccination. And then went daily by the time I went to my OB on August 11th. The symptoms I experience are heart palpitations, increased heart rate, pulse and dizziness. I get shortness of breath with the heart palpitations and increased heart rate. As time goes on it becomes more symptoms, now its a cluster of the symptoms where in the beginning it started with just heart palpitations. This is my 8th pregnancy and I've had 3 live births and so far this one is going well. I'm currently at 24 weeks. Estimated date of delivery is Dec. 10th 2021. No other complications. I was sent to see the Cardiologist on August 31st.
Site: Swelling at Injection Site-Medium, Systemic: Lymph node and armpit swelling-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Pt had hx of lymph nodes and armpit swelling with Pfizer COVID vaccine, pt stated MD approved her to receive booster. Was aware of the chance of reoccurence and was counseled on which steps to take if a reaction occured. Pt reported reswelling of lymph nodes and armpit and wanted us to report the event again.
Tinnitus, ringing in the ear started shortly after vaccine was administered.  Saw an ENT provider.  No current treatment.  Tinnitus is ongoing; not resolved.
caller reported administered MMR II that was improperly stored in the freezer; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 22-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S020161, expiration date: 30-JUN-2021) as prophylaxis (product storage error).  The vaccine experienced a temperature excursion of 10 degrees Fahrenheit (F). There was a previous temperature excursion below 36F (10F) for 50 minutes, as recorded by a data logger.
"Pfizer-BioNTech COVID-19 Vaccine" - received first dose 2/26/2021 and second dose 3/19/2021, admitted for acute segmental LLL PE. Pt endorsed subacute progressive DOE x6 months.  Admitted to hospital with elevated BP and 2 weeks of progressively worsening SOB (after 3/19/2021, at which time pt received the second dose of vaccine.)  EMS reported SaO2 79%.   CXR - moderate diffuse edema or pneumonitis in both lungs, small pleural effusions, cardiomegaly CTA of chest - acute PE involving segmental pulmonary arteries to L lower lobe, moderate diffuse ground-glass opacities in both lungs (R>L) -- > possible drug-induced pneumonitis (lower suspicion because pt had been on palbociclib x2 years) or volume overload.
Patient report to pharmacy with rash surrounding injection site.  Sought treatment from physician and is being treated for cellulitis with Cephalexin 500 mg qid for 7 days.
Right shoulder stiffness and pain. rRduction in range of motion for 2+ weeks.
Redness in other arm; Feel the bumps of the rash; Feels like I've been bit by a bunch of insects; Itching a lot; This morning I had a rash,started in the arm of the injection,started off in one spotfeel the bumps; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness in other arm), RASH MACULAR (Feel the bumps of the rash), FEELING ABNORMAL (Feels like I've been bit by a bunch of insects), PRURITUS (Itching a lot) and RASH (This morning I had a rash,started in the arm of the injection,started off in one spotfeel the bumps) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concomitant products included MILK THISTLE [SILYBUM MARIANUM], OMEPRAZOLE, ZOLPIDEM TARTRATE (AMBIEN), LEVOTHYROXINE SODIUM, BENAZEPRIL, AMLODIPINE, METOPROLOL, METFORMIN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), MONTELUKAST, HYDROCHLOROTHIAZIDE, FOLIC ACID, MULTIVITAMIN [VITAMINS NOS], VITAMIN B12 NOS and FISH OIL for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced ERYTHEMA (Redness in other arm), RASH MACULAR (Feel the bumps of the rash), FEELING ABNORMAL (Feels like I've been bit by a bunch of insects), PRURITUS (Itching a lot) and RASH (This morning I had a rash,started in the arm of the injection,started off in one spotfeel the bumps). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in other arm), RASH MACULAR (Feel the bumps of the rash), FEELING ABNORMAL (Feels like I've been bit by a bunch of insects), PRURITUS (Itching a lot) and RASH (This morning I had a rash,started in the arm of the injection,started off in one spotfeel the bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. .
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022. This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022 at 6:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 6:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported. No concomitant medication information provided. It was reported that, vaccine was administered on 28-Jan-2022 at 18:59:19 It was reported that, vaccine went into 2 to 8 °C thaw state on or about to 24-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022 No treatment information provided.   This case was linked to MOD-2022-542869 (Patient Link).
Ringing in ears on and off after first shot. About a week after the second shot, ringing is continuous. Diagnosis is tinnitus
UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from unspecified adverse events. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
arm pain; decreased mobility of arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 25th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, after vaccination over the weekend, the patient left the massage that, she continued to have pain in her left arm and still could not lift it past her shoulder. The reporter reported that, reviewed the post marketing data from prescribing information and offered the personal information. The reporter offered to be transferred to MIS, but declined.
Patient developed pleuritic chest pain.  Presented to ER and had CT angiogram to eval for pulmonary embolism.  Unfortunately, study was suboptimal but showed possible subsegmental PE vs mixing defect and consolidation in lingula consistent with pneumonia vs pulmonary infarct from PE.  Scan initially read as more likely pneumonia but patient without consistent symptoms and re-read as concerning for pulmonary embolism.  Patient otherwise healthy without other risk factors for PE.  Repeat CTA 2 weeks later with better quality without e/o PE and improving but not resolved opacity in lingula.  LE dopplers 3 wks after onset w/o DVT.  Hypercoaguable labs pending.
Approximately one week after administration of the vaccine, mild swelling and redness started around the injection site.  This area and arm continue to have what looks like a skin reaction that appeared to be spreading.  They did follow up with their primary care physician.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FL3181) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing), notes: he had at age 14, that was it; "depression" (ongoing), notes: was having a lot of depression and anxiety due to loss of fiancé.; "anxiety" (ongoing). The patient's concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "unknown", described as "when he had his Covid-19 vaccination, his health had worsened".
Two weeks after receiving one dose of varicella virus vaccine live the pt experienced a vesicular rash with approximately 20-30 lesions.
Information has been received from a physician who heard of the experience second hand from a colleague (also a doctor) concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced muscle paralysis after the injection. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Upon internal review, the muscle paralysis was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Had approx 10-15 min convulsive seizure Went to ER, no treatment given Followed up with neurologist who increased Zonegran to 500 mg
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.