chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large bumps around injection site; Large bumps around injection site with itching; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously received morphine (MANUFACTURER UNKNOWN) and pethidine (DEMEROL) on an unknown date for unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 11:15, the patient experienced large bumps around the injection site and itching. The patient did not receive any treatment for the events large bumps around the injection site and itching. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events large bumps around the injection site and itching was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Symptoms started ~0800 the day following vaccination. Significantly sore arm. General malaise / fatigue / muscle aches. All side effects started upon waking up and progressively worsened throughout the day, but did not interfere in work or day-to-day activities until ~1600. By ~2100, general malaise and muscle aches were very noticeable, rated 7/10 with difficulty getting comfortable enough to fall asleep. APAP prn throughout the day and was also taken to pre-medicate prior to vaccination. Fell asleep @~2300. Woke at ~0745 with all symptoms fully resolved other than arm soreness which was then and still currently rated 2/10.
10:00 AM Grandmother called, redness at site, welling of upper left leg noted this AM when child awoke. Walking ok. Advised Motrin, cool washcloth 10 minutes for 3-4 days. Called PRN at 4:00 PM with patient complaining of swelling down, redness increased, quarter size, temperature 99 degrees F. 2 small red streaks from side. Repeat Motrin and use heat 10 minutes 3-4 times a day.  Call PCP for follow up or ER.
Vomiting for 30 hours, Headache, Cold sweats, Feverrish, Body aches, not enough energy.   Pt has taken ibuprofen  otc and rehydrated. She is going to call her doctor.
Serious allergic reaction, anaphylaxis,, facial swelling, bleeding severe head pain, dizziness blurry vision
Pain and swelling at injection site on day 1 and 2. Redness, hot to the touch, inching, and pain on day 2-5. Treated with antibiotics.
Has DLBCL; lymphoma had metastasized; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), SPLENOMEGALY (spleen was double in size) and METASTATIC LYMPHOMA (lymphoma had metastasized) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, SIMVASTATIN and TAMSULOSIN for an unknown indication.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL) (seriousness criteria hospitalization and medically significant), METASTATIC LYMPHOMA (lymphoma had metastasized) (seriousness criteria hospitalization and medically significant),  and MYALGIA (Sore arm). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to DIFFUSE LARGE B-CELL  LYMPHOMA and METASTATIC LYMPHOMA. At the time of the report, DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), METASTATIC LYMPHOMA (lymphoma had metastasized), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood calcium: 10.6 (Inconclusive) Inconclusive. In January 2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 08-Apr-2021, Positron emission tomogram: abnormal (abnormal) Test show damage or stunning of kidneys. In 2021, Biopsy: abnormal (abnormal) Bone marrow and lymph nodes biopsy shows large B-cell lymphoma.. In 2021, Blood calcium: 14.4 (High) Calcium level high. In 2021, Platelet count: 81-82 (Low) low platelet level.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Treatment information was not provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. An alternative explanation is that the events were more consistent with the increased risk due to advanced age related factors. Further information has been requested.
2nd dose PFizer EL 3246, dizzy, high temp, severe chills  uncontrollable for 2 hours, body aches, heart palpitations.  called dr tierney, she told me to get covid test.  I feel better 24 hours later but still have body aches and very lethargic.
Initially had a bump that formed but has gone down. It spread then down front of arm about a 2 by 5 inch on bicep area a few inches from top of shoulder. It was itchy, warm and red for a few days but seems that it is going away now. After shot patient stated that her had felt like getting stiff but does not feel that way no longer.
RIGHT CHEST DISCOMFORT, HEART BURN, SHORTNESS OF BREATH, LEFT ARM SORENESS Narrative: A 61-year-old male with a history of sleep apnea, obesity, hypertension, CVA (7/2020) received his second dose of Moderna vaccine on 3/24/21, at approximately 11:26am. The patient received 1st dose of Moderna vaccine on 2/24/21 without complications other than sore arm. Per primary care provider, the patient developed shortness of breath and slight right chest discomfort on 3/25/21 while on short walk. Wife also reported patient's face hurt (like a pressure as well as soreness of left arm. On 3/28/21, patient was admitted to the Hospital with negative Covid-19 (as per pt) and was found to have a "heart attack" as one of the cardiac enzymes (troponin) was elevated. Per provider, He was admitted to hospital on the 28th March with heartburn and pain right chest (BP sunday am was 143/74 mm hg).he was tested for Covid both rapid and confirmatory. Troponin was negative and was admitted to hospital. Next day am Troponin was very high. Had Angiogram with no blockage( angiographically normal coronaries) Echo was wnl. EF was 55% with no LVWM abnormlaities. No stent was placed. CTb scan chest was not done. . The patient was discharged home on 3/30/21 on carvedilol 3.125mg po q12h.
Headaches, fever, fatigue, muscle aches. Fever lasted from ~7hrs after receiving vaccine to ~13 hrs. Fatigue lasted from 7-40hrs after administration. Took ibuprofen for fever 13hrs after administration.
patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information provided.  There was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped.  The original was kept -15 to -25 and then shipped and kept refrigerate.  This lot was shipped 6 Dec 2021  and the new expiration date should have been 5 Jan 2022 due to the refrigeration of the vaccine.  The error was caught on 11 Jan 2022 when a new shipment was received, immediately stopped giving the vaccine and looked back and 69 patients had received expired vaccine since 6 Jan 2022.   This case was linked to MOD-2022-448109 (Patient Link).
patient passed out within 5 minutes of receiving the vaccine. he was sitting in a chair during the 15 minute observation period and the mother yelled out to my technician and myself to "help, call 911" when we went to check on him he just woke up from syncope. He was given gatorade, water, an ice pack for his neck , and his feet were elevated. the police and local EMT showed up and examined him and determined him to be okay. after about 40 minutes the patient was able to stand comfortably and walk out.
Had covid after taking vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had covid after taking vaccine) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 (Had covid after taking vaccine). At the time of the report, COVID-19 (Had covid after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No treatment Drug was reported
Upon internal review, significant correction done on date (20 May 20155) to correct the product as reported term and modify the narrative introductory sentence. Initial unsolicited report received from Consumer on 14 January 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in deltoid left on an unspecified date in September 2014. On an unspecified date in September 2014 i.e., one week after vaccination the patient had experienced stiffness to the arm; pain is now present in the whole left arm, muscular pain in the left arm, similar to a pulled muscle, the neck, and across the chest, pain on ROM and symptoms became worsened. It was also reported that patient has an upcoming appointment with the cardiologist and will discuss the symptoms. The patient required emergency room or doctor visit. The patient had no laboratory investigations and corrective treatment was not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed seasonal allergies, hypertension, and triple bypass. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow-up information received from a physician on 16 March 2015. Additional information received from the pharmacy on 17 March 2015. The date of vaccine administration was updated on 18 September 2014. Lot number of FLUZONE HD was reported as U5016AA. The reporter had no additional information to provide. List of documents held by sender: none. Addendum: 20 May 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. To correct product screen as reported term and modify the narrative introductory sentence.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). The physician reported that the patient who received ZOSTAVAX was later diagnosed with shingles on an unspecified date. It was not known if the patient currently had active shingles. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Client received flu vaccine 11/4/04 at approximately 12-12:30 pm. At approximately 8pm felt itching under bra line, around waist, panty line and under arms. Noticed large area of hives and red blotches. She took Benedryl (4 tsp (50mg)) and then at 10:30 pm took 25 mg. Client with slight itching today. No red blotches today. Also complained of some congestion but states no difficulty breathing.
Breakthrough case 2 months after. At a conference I was around 2 people who tested Positive for COVID-19. Two days later I started having a cough and had a drop in my peak flow (asthma) Took a home COVID-19  test - positive. Also took PCR test at work - positive. Called Dr. and was prescribed PAXLOVID. Took full course. Started feeling better 2 days later. Tested again at home and the test was negative.
Sx started on 10/31. They had traveled. She had chills, fever, myalgias. She just didn't feel well. She improved somewhat, fever resolved, but then starting on 11/4, she had fever chills, some green sinus drainage and cough production, body aches. She has a "block headache" and points across her forehead. These sx have continued with ongoing fever since that time. Fever was up to 102.2. She has been treating with ibuprofen and Tylenol_ _last dose about 4 hours before being seen today. She had loose stool x 1 last night. She denies SOB, loss of taste/smell, and known exposures. She has completed her Covid series.
Mom reports swelling over right thigh injection site began on Tuesday 6/21 and continued to grow in size, redness, painful to touch, and itching by Thursday 6/25/22.
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.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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, notes: Treatment of COVID-19; negative, notes: tested negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: The patient started paxlovid on 1st day of onset of symptoms and completed 5 days course. Asymptomatic after 5 days and tested negative. 2 days later, recurrence of symptoms and tested positive again. Symptoms more severe during recurrence (Runny nose, sore throat, headache, mild fever), on path to recovery 5 days later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Painful and swollen/tender lymph node in left arm pit. Pain in armpit began approximately 20 hours after injection.  Pain and tenderness continued and worsened for at least 24 hours after pain began (ongoing).  Pain in left arm pit woke patient up from sleep at night.  Treatment was alternating acetaminophen and ibuprofen at onset of pain and applying cool compress on tender area.
This spontaneous report as received from medical assistant refers to an adult patient of unknown gender. On 26-AUG-2013, the patient was administered two pediatric doses of VAQTA injection, (lot number, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Patient was given a flu vaccine on 12/3/18 by this nurse, when this nurse was charting the vaccine in our EMR, it was noted that the patient had previously been given a flu vaccine on 10/25/2018 in a different providers office.
received vaccine 4 weeks too early. Last vaccine given on 7/21/2022.
8/14/2020 developed droop of eyelid and then developed one sided facial droop.  Seen in ER 8/16/2020 and diagnosed with Bell's palsy.  Patient has had this previously, but feels it was brought on by vaccine
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 31-OCT-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after") receiving the ZOSTAVAX, the patient suffered an ischemic stroke, occlusion of the middle cerebral artery, aspiration pneumonia with sepsis, and myocardial infarction, requiring multiple hospitalizations. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to receiving the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, ischemic stroke/occlusion of the middle cerebral artery; aspiration pneumonia with sepsis; and myocardial infarction were determined to be medically significant. Ischemic stroke/occlusion of the middle cerebral artery; aspiration pneumonia with sepsis; and myocardial infarction were considered to be disabling. Additional information has been requested.
Hyperglycemia.  Had to significantly increase my insulin intake to manage my recurrent high blood sugars.  Blood sugars are still regularly running high.  I had very good control of them before the vaccine.  Also, have increased pain and inflammation in my joints, exasperating my rheumatoid arthritis.
This spontaneous report as received from a vaccine specialist from health department (Healthcare worker) who was informed by the mother of a first unspecified child(age unknown). It was reported that a second unspecified child (age unknown) developed "a rash with a few bumps" (onset date unknown), after the second child had received VARIVAX (Merck) (date, dose, route and lot# not provided). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. The mother of the first child was concerned about transmission of the varicella virus to her unvaccinated child. Action taken was not provided. The outcome was unknown. Additional information has been requested.
Was officially diagnosed with PMDD in August 18, 2021. Began having problems with hormones and mood between ovulation and menses starting at the end of February 2021 that have never experienced previously. Has been consistently during luteal phase every month. My women's health NP treated for low estrogen since s/s coincided with that clinical workup by increasing the estrogen in my birth control which made it worse. S/S: depression, anxiety, uncontrollable anger/rage, severe nausea, fatigue, apathy, hot flashes, insomnia, severe headaches, joint pain  Consulted with psychiatric provider in June 2021 who diagnosed with regular depression and anxiety despite feeling fine except during luteal phase. Treated with 25 mg of zoloft which was not helpful and worsened s/s during luteal phase.  Got second opinion from endocrinologist who confirmed PMDD symptoms. Placed me on a low dose of Celexa which only helps with insomnia symptoms and sleeping   Also been having increased output of red blood cells which was discovered in June 2021 (the first time I've had accessible bloodwork results since January 2021). At last doctor's visit in December 2020, red blood levels were fine
Soreness of arm at injection site. Few days after shot. Going to neurologist - got cortisone shot & using heat.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. On 18-Oct-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient had no any adverse event post administration of expired vaccine.
Patient's first 2 Covid vaccines were Pfizer.  His first Pfizer shot was 12/24/2020.  His second Pfizer shot was 01/14/2021.  I did not have his vaccine card in front of me when I administered the 3rd Covid vaccine. His 3rd vaccine was administered on 09/09/2021.  He was administered Moderna.  All literature states what you start with is what you should stick with.  He has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.
Itch occurred almost immediately, red rash appeared on shoulder & down the arm, gradually disappeared over a couple of weeks.
Flu shot arm very tender and a little swollen--painful enough that patient went to the emergency room for assessment.