chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a big mass, a huge lump, a gigantic lymph node from about 3 inches/ lymph node became into fat) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 015M20A and 026L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. It was reported that patient has never been diagnosed or tested positive for COVID-19 and no other prior vaccine was given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Blood pressure high (20 years ago, no recent change in status), Cholesterol (20 years ago, no recent change in status) and Drug allergy (Allergic to Demerol). Concomitant products included LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced LYMPHADENOPATHY (a big mass, a huge lump, a gigantic lymph node from about 3 inches/ lymph node became into fat) (seriousness criterion hospitalization) and PRURITUS (felt itching in left armpit). The patient was treated with Surgery (Lymph node removal by surgery on 05-Apr-2022) for Lymphadenopathy and Surgery (Lymph node removal by surgery on 05-Apr-2022) for Pruritus. On 05-Apr-2022, LYMPHADENOPATHY (a big mass, a huge lump, a gigantic lymph node from about 3 inches/ lymph node became into fat) and PRURITUS (felt itching in left armpit) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2022, Scan: lymph node became into fat (abnormal) lymph node became into fat. It was reported that patient received 1st booster dose and did not experienced any side effects at that time. On 03-Mar-2022 patient visited ER and was referred to Surgery. This is a spontaneous case concerning a 70-year-old, male patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of lymphadenopathy and unexpected non-serious event of Pruritus. The events occurred 16 days after the second dose of mRNA-1273 COVID 19 Vaccine. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. This case was linked to MOD-2022-543739 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 70-year-old, male patient with no relevant medical history, who experienced the unexpected serious (hospitalization) events of lymphadenopathy and unexpected non-serious event of Pruritus. The events occurred 16 days after the second dose of mRNA-1273 COVID 19 Vaccine. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
PAIN; NOT FEELING WELL; This spontaneous report received from a patient 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) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced pain. On 2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well and pain was not reported. This report was non-serious.
2 days after the second shot I got a VERY heavy maturation, within the next coming weeks I had it 3 times in under 30 days (the last one beginning on April 10). Each lasted over a week.
Large swollen area in left arm pit (lymph node?), tender to touch.; Large swollen area in left arm pit (lymph node?), tender to touch.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 15:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, at 08:00 the patient experienced large swollen area in left arm pit (lymph node?), tender to touch. Noticed 2nd morning after 2nd dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large swollen area in left arm pit (lymph node?), tender to touch were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
3/18/21 about 6 hours after vaccination- severe muscle cramp Left Leg. Woke about 6am, 3/18/21 with severe headache, muscle aches, temperature 102 degrees Fahrenheit and weakness. I called my physician?s in between help line and left a message.
Injection shoulder extremely sore and aching; swelling in injection shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), IRBESARTAN (AVAPRO), DOXAZOSIN, POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), CALCIUM, MAGNESIUM, ASCORBIC ACID (VITAMIN C ACID), METFORMIN HCL, DIAZEPAM (VALIUM), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder). At the time of the report, VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported.
migraine h/a triggered by vax;pt exp pain in lt neck w/sensation of hearing & speech loud;typical muscle spasm;migraine poss triggered by flu vax but not causal;
When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours.  I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
About 4 minutes after administering the vaccine patient was sitting down in the waiting area and stated that he was not feeling too good. I immediately went over to him, at which point I noticed he was sweating profusely and stated he felt a little light headed. Less than 1 minute afterwards, he stopped talking and his eyes began to roll back, at which point his upper body began to slide over to once side as if he was going to fall. I immediately caught him, motioned for someone to call emergency services  and continued to call him name. He did not respond, was pale and blacked out for about 30 secs. He was still breathing thankfully. When he regain consciousness, he stated that he felt better but he felt some tingling sensation in his forearms bilaterally. Thankfully at this point emergency services were present and upon taking his vitals, realized that his HR and BP were significantly low for someone of his age.
Headache,  body rash on stomach, arms, underarms and on the back of legs. Mild chest pain.
Patient entered pharmacy two days after vaccine. Symptoms described were body soreness and weakness. At injection site, redness presented about the an 2 inches in diameter around the injection site. Advised patient to see provider and watch for worsening symptoms. Two days later, patient returned to the pharmacy and site is still red and area of redness increased to about 3 inches. Advised patient again to go to provider.
Blistery rash; yeast infection; Itchy rash; Feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), FEELING HOT (Feeling hot), RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced RASH PRURITIC (Itchy rash) and FEELING HOT (Feeling hot). On an unknown date, the patient experienced RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection). At the time of the report, RASH PRURITIC (Itchy rash), FEELING HOT (Feeling hot), RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications was  provided by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 70-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th August 2018, 7 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's son. The healthcare professional reported that, the patient developed severe dizziness, 1 week after receiving the SHINGRIX vaccine. The patient was taken to the emergency room to be examined. The adverse event had not resolved.
About two hours after receiving vaccine pt experienced numbness, heaviness in face and progressing to entire head.  Tingling in face, head, neck later.  Feeling like paralysis "like if I went in and looked in mirror I would see facial dropping. Couldn't smile or raise eyebrows.  There was a heaviness in my muscles. My cheeks felt full. "  Symptoms subsided by 8pm (four hours after began). "Felt like being drugged, under the influence.  Felt foggy, cognitvely in a way."
This case was reported by a physician via sales rep and described the occurrence of abnormal dreams in a 52-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abnormal dreams, fever, sleep disturbance, chills and panic attack. On an unknown date, the outcome of the abnormal dreams, fever, sleep disturbance, chills and panic attack were unknown. It was unknown if the reporter considered the abnormal dreams, fever, sleep disturbance, chills and panic attack to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that one of his family member experienced hallucinatory dreams, fever of 100.7, sleep was messed up and though they were having a panic attack. This case was linked with the case US2018GSK124669, reported by the same reporter. Lab Comments: On an unspecified date, body temperature was 100.7.
Probable anaphylaxis. Approximately 1/2 hour after receiving 3/3 RabAvert vaccine (pre-exposure prophylaxis) patient developed a pruritic macular papular rash and shortness of breath. She presented to the emergency room and was given Benadryl, steroids and H2 blocker. Her symptoms resolved over the next couple of hours and she was sent home. She's had no similar symptoms since that time. She did not have similar symptoms with the first 2 doses in a series.
Initial misuse report received from a healthcare professional on 17 May 2013. A medical assistant administered ACTHIB instead of a Hepatitis B vaccine to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Almost immediately after administration of vaccines pt became unresponsive. Her eyes rolled back and her body became limp. She then experienced jerky motions throughout her body but more noticeable in the extremities. Pt was placed in an examination room and vital signs were monitored. The jerky motions and unresponsiveness discontinued about 1 1/2 minutes.
Status asthmaticus with heart rate 130's, SpO2 in high 70's.  Treated with albuterol x2, nearly resolved, transported to hospital via EMS.
7/27/2017: Clinical Notes: Tdap vaccine updated during travel consultation (previous tdap given in 2010 with no adverse events). Patient reported "arm tingling and lightheaded" post vaccine. Syncopal episode with loss of breathing. Patient was given Epi Pen in left Vastus Lateralis muscle approximately 30 seconds after loss of consciousness, seizure-like activity with loss of bladder function, and blue lips and facial complexion. Patient responded to the Epi Pen and awoke 30-40 seconds later with anxiety, shaking, and confusion most likely from the dose of epinephrine. EMS on scene at that time. Vitals stable and continually monitored for about 30 minutes post episode. Blood Sugar checked by EMS 115 mg/dL. Patient mother reports that her daughter has not been sleeping well and didn't eat anything this morning. Patient recovered quickly but monitored for 1 hour post vaccine. She was given juice and a granola bar to eat, tolerated well. She remained in the clinic until she felt that she was able to go home. Her mother will continue to monitor her at home for the remainder of the day. Education about what to watch for given. Mother to call 911 if patient has difficulty breathing, feels lightheaded, dizzy, faints, or seizes again. Mother verbalized understanding. Patient ambulated to car. 8/1/2017: Telephone Encounter: Patient's mother returned phone call to Health Department today and spoke with Office Specialist. She reported that pt was doing "better" and that they have spoken with pt's PCP. Pt is NOT to have Tdap vaccine or vaccine containing similar components or additives again. If she needs immunizations she is to have them given in an Emergency Room setting where she can be closely monitored during administration and after. In order to have vaccines given pt needs a doctors order for emergency room monitoring. Employee relayed this message to me. Actions Taken for Phone Encounter: Completed VAERS reporting 8/2/17, Updated pt's allergy list in EMR. I plan to meet with Dr. to discuss pt's case and determine if Dr. or her PCP should write an order for her to have remaining immunization given under ER monitoring. Pts mother requested list of ingredients for the Tdap vaccine that pt was given and the Meningitis vaccine that she still needs. I plan to review these ingredients, comparing the Tdap to both the MENVEO and MENACTRA brands of meningitis vaccines. Recommend that she get the vaccine with the least amount of similar ingredients.  RN 8/2/2017 8:05:28 AM.
Raised rash all over body, started 8/31/12 no fever but itching over body no blister formation. Child not sick but mom plans to seek care of PMD.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients received second doses of GARDASIL (dose, lot#, route and site of administration were not reported) late. No symptoms were reported. Additional information has been requested.
Swollen node developed on outside of left hip.  Sensitive to touch but not painful.  Approximately the size of a golf ball. Hard to the touch.
First Dose (4/28/2021): Severe Lethargy for about 12 to 24 hours after. Second Dose (5/19/2021): Initially, slight lethargy. Later, as days and weeks progressed, inflamed hands and joints and muscle soreness. Then I was in ER on 7/8/2021, with high blood pressure, arrhythmia, tachycardia, light headedness, and other symptoms consistent with myocarditis and pericarditis.
Patient was administered vaccine at approximately 8:03 am. Shortly after she stated that she did not feel well, that she felt kind of dizzy.  I asked her if she was feeling any better after a couple minutes and she said that she was not, that she felt like she was going to faint.  I proceeded to have the patient lie down on the ground with her feet propped up, this was at about 8:10am. I instructed one of the technicians to call for emergency services/emt; this was at about 8:15am. Ice packs were given to the patient to place around her neck, behind her neck, forehead, by her arm pits and on her stomach. I continued to assess her well-being. She never had any trouble breathing; she did not loose consciousness nor did her lips turn blue. She said she felt less dizzy but that she still did not feel very well. The emt arrived at about 8:30am. They moved the patient onto a stretcher and proceeded to take her to the emergency room.
Received FluMist on Thursday and by Friday afternoon had runny nose, sneezing and body aches. These symptoms lasted for 3 days after which the body aches subsides, but there was lingering stuffiness and runny nose for a couple of weeks.
tired; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6203) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
While completing a 30 mins observation period, the patient began to complain about feeling a little dizzy. This is not a new diagnosis, the patient has medication to treat vertigo. Patient then complained about nausea which was then resolved with a belch.  she started to scratch her harms stating she felt itchy at 12:50. All vital signs were normal. No rash was noted. Patient continued to scratch body causing some red areas to form on skin. Administered children's Benadryl 12.5 mg tab X2. patient was observed for an additional 15 mins. All symptoms resolved and patient expressed relief verbally.
Narrative: PATIENT PRESENTED TO CLINC ON 9/20/2021 WITH C/O SOB, COUGHING, AND SORE THROAT X FEW DAYS. 02 SAT WAS 80% UPON TRIAGE. PMH INCLUDES HEP C WITH CIRRHOSIS, SCHIZOPHRENIA, COPD, AND POLYSUBSTANCE ABUSE. PATIENT TRANSFERRED TO ER AND WAS ADMITTED WITH DIAGNOSIS OF COVID INFECTION, PULMONARY VASUCLAR CONGESTION, HYPOXIC RESPIRATORY FAILURE, AND SEPSIS.
Reporting a side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Reporting a side effects from the vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Reporting a side effects from the vaccine). At the time of the report, ADVERSE EVENT (Reporting a side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
severe L arm pain limiting ability to raise arm followed by slow recovery 2 weeks out but then a day of severe fatigue, feeling unwell and resurgence/worsening of the L arm pain - exam is consistent with a deltoid tendonitis (supraspinatus seems rather intact) and she also has a mass/nodule mid arm inferior to the vaccine site
BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included thyroid issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, and body aches. This report was non-serious.
Sore, red, warm arm. Received a dose too soon. Last dose 10/24/02.
Two to Three days after my 2nd dose of the Pfizer vaccine I woke up around 4 am by a foul odor taste and or smell i stayed in bed the smell and taste got very bad for 2 weeks and went away on it's own,on the 4th day after vaccine i woke up and went to brush my tooth It Felt like I pour acid into my mouth with a severe burning feeling followed by severe gum and tooth pain also some sporadic chest pain.I looked into my mouth and noticed my entire mouth looks  like bumps and or hives looking about 7 days later most of the bumps/hives turned into ulcers.this symptoms is still present,also around day 4 or 5 I shaved my short beard and noticed a tiny balled patch of beard under my chin ever since this is getting worse and it is about the size of a quarter or more.I went to see my Family Physician and was told these symptoms i having could be from nasal polyps and or sinuses she did blood work to check for sickness everything came back negative,i was told to talk to my Immunologist and or an ENT I went 05/25/2021 to see the Immunologist and he said their was no evidenvce of nasal polyps that the vaccine must have did something to my immume.