chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:00 patient received second pfizer vaccine  10:40 reported feeling a flushing sensation x 1 approx 10:30, provided bottled water to drink, denies any difficulty breathing, throat swelling, or tongue swelling 11:00 finished bottle of water feeling fine left vaccine clinic accompanied by her husband 11:30 returned to vaccine clinic c/o thick tongue and difficulty swallowing, denies difficulty breathing. Sent to ED.  ED note states that patient presented after "near syncopal episode" after developing lightheadedness and flushing after vaccination. Similar episode an hour later (prompting return to medical center). Denied chest pain or shortness of breath on presentation to ED. Described difficulty swallowing and "thick tongue" leading to her presenting back to clinic, but asymptomatic when arrived to ED. Oropharynx free of any swelling. EKG done but only showed sinus bradycardia.  Patient observed multiple hours then discharged without any medical intervention taken.
Body aches Chills Sore throat Ear ache Headache Nausea
I had a slight headache immediately after vaccine, I had a tennis ball sized red area where I received the vaccination. My joints started to really bother me about 2-3 weeks after vaccination. It started in my knees and went to my wrists and hips. It was extremely painful, I couldn't walk and couldn't sleep.
Intense itching and then red marks, hive like bumps. Discovered it was dermatographia urticaria. Didn?t make the connection until later.  Also experienced acid reflux since this time. Occasionally an ear or both will get red and hot for no reason.
This spontaneous report as received from a medical assistant refers to a 19 year old female patient who was not pregnant. The medical assistant reported that the patient received two doses of (Oka/Merck) VARIVAX (lot#, dose, route not reported) as a child on unspecified dates. Concomitant therapy was not reported. The patient had titer for varicella drawn on an unspecified date and the titers for varicella was "low". The patient was adminsitered a third dose of (Oka/Merck) VARIVAX on an unspecified date. It's also reported that "No adverse effect reported". Outcome of the event was not reported. Additional information has been requested.
A few hours after patient received the shot on 11/20/18 at the pharmacy by a pharmacy intern, she felt pain and chills and profuse sweating, that occured and subsided every few hours. She felt weak and could barely get out of bed for almost 3 days. When she returned to the pharmacy on 11/23/18 to report her symptoms she had a huge bruise at the injection site about 2-3 inches in diameter. She will go to her PCP to get checked out today (11/23/18). She appeared to be in good spirits today and is able to perform her grocery shopping with no physical difficulties.
No adverse events; Expired VAQTA was administered; This spontaneous report was received from an office manager referring to a 14 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-DEC-2020, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, lot # S032055, for prophylaxis (dose, route and site of vaccination were not provided) which had expired on 01-NOV-2020.  The reporter stated that there was not confusion just human error. The dose was stored at the appropriate storage condition, specified in the product label, through the date of administration.  There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Slight soreness on injection site (left arm) -- lasted 3 days. Lethargic 1/17/21 Pain on left armpit since 1/17/21; pain worsened 1/18/21 (pain level 4 -- took aleve then tylenol); pain diminished today. Joint pain and rashes 1/18/21 (1 day)
I conceived my baby the day I got the second dose of Pfizer. I miscarried  13 days later. I went to my local ER to confirm pregnancy as well as to receive the Rogham shot.
I have been post menapausel for 20 years and 8 days after receiving this I started to have spotting and light bleeding I have never had this in 20 years, I have had to go through many painful procedur; This is a spontaneous report from a contactable other hcp and nurse (patient). A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0187) via an unspecified route of administration, administered in left arm on 03Aug2021 16:45 (at the age of 65-years-old) as single dose for covid-19 immunization. The patient's medical history included HTN Seizures from an unknown date and unknown if ongoing. The patient previously took percocet and experienced vomiting. The patient's concomitant medications were not reported. On 13Aug2021 04:00, the patient has been post menapausel for 20 years and 8 days after receiving this she started to have spotting and light bleeding she never had this in 20 years, she have had to go through many painful procedure. The patient was hospitalized for 1 day and therapeutic measures were taken as a result of the adverse event. Treatment reported that uterine bx and scheduled d&c. The outcome of the event was recovered on unspecified date.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Injection site hot/tender. Thurs chills fever 103 itching in random areas, Site hard, swollen, painful. Friday little sleep, painful.
Awoke with red raised itchy rash around vaccination site on L arm.  Hydrocortisone ointment.    Day 2  no change
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen), PRURITUS (itchy) and INJECTION SITE INJURY (seems worse this morning) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen) and PRURITUS (itchy). On 03-Feb-2021, the patient experienced INJECTION SITE INJURY (seems worse this morning). At the time of the report, INJECTION SITE PAIN (injection site started hurting), ERYTHEMA (got red), SWELLING (swollen), PRURITUS (itchy) and INJECTION SITE INJURY (seems worse this morning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Concomitant medication includes OTC supplements.
after the 2nd dose injection blood started running down on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm). On 14-May-2021, VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was reported as none.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tachycardia approximately 30 minutes post injection lasting 20 to 30 minutes
Chief Complaint  Hx COPD. Increased weakness over the last 2-3 days. Coughing more than normal. Increased mucous production. Febrile in triage.  History of Present Illness  87-year-old male who is now being admitted for COPD exacerbation due to COVID illness.  He completed his Moderna Covid vaccination series x2 in April.  To my knowledge he has not received a booster as the Moderna vaccine was just approved for booster consideration.  He has felt ill for the last 3 days, primarily manifested by weakness, decreased appetite, some diarrhea and some mild worsening of his chronic shortness of breath.  He has oxygen and prednisone dependent COPD.  He normally wears 3 L of oxygen during the day and wears 4 L of oxygen with his CPAP at night.  He follows in the clinic with Dr. at the pulmonology specialty clinic.    He presents to the ER with the aforementioned symptoms this evening.  His chest x-ray shows a left pleural effusion at the costophrenic angle.  He is not hypoxic worse than his usual 3 L of oxygen however at this time.  Nonetheless, due to his age and comorbid factors, I agree with the ER physician that admission to the hospital and aggressive treatment for Covid is warranted due to the high risk for further decompensation.  He has been given dexamethasone already in the ER.
Tachycardia, joint soreness on March 5th. Low grade fever (100.5), severe headache, nausea, whole body ache on March 6th.  Severe shaking on the evening of March 6th, duration over 60 minutes.  Night sweats, nausea, headache that night.
Initial report received from a vaccine provider on 21 November 2012. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. Cluster of 5 children from the same reporter and same lot number UH753AB. Five children (age and gender not provided) had received a dose of FLUZONE (lot number UH753AB, IM) on an unspecified day in October 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on an unspecified day in November 2012. Some children tested positive 3-4 days after vaccination, and some 2 weeks post-vaccination. Pre-existing medical histories and illness at time of vaccination were unknown. Outcomes for all five children were not recovered. Documents held by sender: None.
Pt.  homecare person came up and stated that he was sleepy and was not able to get out of bed.  Was responding and eating and drinking well.  Was told to go to the ER.  To let us know.  Finally reached pt. today.  Said he was in and out of hospital for 3 weeks.  Not feeling well since the shot.  Is trying to get to a long term center
G47.33 OBSTRUCTIVE SLEEP APNEA 3/29/2023 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
Pfizer on 4/1 and 4/22. Positive on 9/23
5:30pm developed weakness, chills, pallor, aluminum taste in mouth, feverish (did not check temp), itchiness on neck(no rash or hives). Went to bed- woke up at 3am diaphoretic, wet feeling. Feeling weak, but better today.
Chills, Fever, Nausea and Vomiting, General feeling of malaise (not feel well)
inflammation; Tested positive for strep; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced inflammation and tested positive for strep. Customer verbatim reported as, I took your two vaccines for covid. I still have some inflammation and now tested positive for strep. I am on amoxicillin and over 70% of my family that went I. For covid tests I. The beginning tested positive for strep with testing positive for strep. You may be able to save lives if you encouraged individuals to take strep tests along with covid. So their bodies can fight both. Laboratory tests on an unknown date included streptococcus test was positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Swelling, warmth, itchiness, and pain in arm at injection site, before leaving the clinic after the shot.  Began about the size of a quarter and today is a bit bigger than a baseball.  Treated with rest and ice and otc pain medicine, with sightly less pain for a time.  Vomiting 4 times the following day.  Treated with Tums and antacids, avoiding food.  Tooth pain and headache.  Treated with otc pain meds, with little effect.  These symptoms persist today.
This spontaneous report was received from a pharmacist concerning to a 62 year old female patient. The patient had no concurrent conditions, medical history or concomitant medications. On 28-NOV-2016, the patient was vaccinated with ZOSTAVAX VIAL 19400 pfu (lot number reported as M032638, expiration date 04-OCT-2017, dose and route were not reported) for prophylaxis. On unspecified date in 2016 after vaccination, the patient developed a "chickenpox type rash". It was reported that the patient sought medical attention and no treatment was given for the event. It was unknown if any lab diagnostics studies were performed to the patient. The reporter stated that the "patient did not affer when the rash developed since vaccination". A product quality complaint was not involved. At the time of the report, the outcome of "chickenpox type rash" was not recovered. The causal relationship between the event and ZOSTAVAX VIAL was unknown. Additional information has been requested.
Initial report was received 25 October 2011 from a health care professional. A 25-year-old female patient had received an intramuscular left deltoid injection of MENACTRA, lot number U4073BA on 21 October 2011 at 3:24 pm and three days later on 24 October 2011 AM, she developed a swollen lymph node under her left arm. The patient had no past medical history or concomitant medications, and she had not received any other vaccines during the four weeks prior. The event did not require a doctor's visit. At the time of the report, outcome was unknown. Documents held by sender: None.
she felt pressure between eyes; dizzy; Her arm hurt more the 2nd day after 1st dose; hangover feeling; This is a spontaneous report received from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1284 and expiry date: on an unspecified date in Apr2021) via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 1st day of the vaccination, the patient felt pressure between eyes and was slightly dizzy and hangover feeling for 5 minutes but then went away and felt fine. Her arm hurt more the 2nd day after 1st dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Minor body aches; fever; headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 11:45 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (lot number: GJ6742) at the age of 54 years, administered in the left arm for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, (unknown manufacturer)), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "Minor body aches"; PYREXIA (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "fever"; HEADACHE (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022). Therapeutic measures were not taken as a result of pain, pyrexia, and headache.  Additional information: Facility type vaccine is a Workplace clinic. Patient did not receive other vaccine in four weeks. Other medication in two weeks: N/A. If covid Prior vaccination: No. If covid tested post vaccination: No. Known allergies: N/A; Other medical history: N/A.
after about 5 hours of getting the COVID vaccine patient experienced elevated blood pressure,  feeling achy and off. Felt her heart racing. Sat down at work and was just staring off into space. Eyes rolled back. Felt like she was going to pass out, but did not lose consciousness.  she was taken to the emergency room  lab work done, everything normal, did get better with rest. recommendations to go home and rest and drink plenty of fluids.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 15th July 2018, refer case US2018GSK183755). On 3rd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 3rd October 2018, 6 hrs after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced nausea, muscle soreness and headache. On an unknown date, the outcome of the nausea, muscle soreness and headache were not recovered/not resolved. It was unknown if the reporter considered the nausea, muscle soreness and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details reported as follows: About 6 hours after vaccination, the patient experienced headache, sore muscles and a little bit of nausea. The patient felt worse after the 2nd dose as compared to 1st dose.
Left upper arm has a red swollen area that is warm to the touch and measures 7.5 cm X 7.5cm. The spot appeared 01/30/21 and grew bigger on 01/31/21. Injection site is lower than then deltoid and the reddened area is toward the inner arm. Explained conservative measures including cool compresses and if allowed by PCP OTC IBU and antihistamines. Explained to watch for sign of cellulitis including red streaking and skin tightness. Employee verbalized understanding and agrees with plan.
TONGUE SWELLING, TONGUE TINGLES, SOB,  TX:  EPINEPHRINE 1:1 0.3MG IM          BENADRYL  50MG IM          PARAMEDIC TRANSFER TO HOSPITAL
Extreme fatigue, nausea, lightheadedness, malaise; couldn't eat. Lasted 24 - 48 hours.
7-10 mins post vax, pt became lightheaded, c/o dizziness, pt administered O2, min nasal canula.  After dizziness passes BP x 2 and ECG performed.  Left with instructions to return if sx's returned.
Information has been received from a physician and a nurse concerning a 4 month old male (also reported as 19 weeks old) who on 23-AUG-2007 was vaccinated with Rotateq (Lot # 657615/008U). Concomitant therapy included ActHIB, Prevnar and Pediarix all given on 23-AUG-2007. The physician reported that the patient experienced vomiting and blood in the stool and on 06-NOV-2007 the patient was diagnosed with intussusception. The nurse reported that the patient had surgery and is "doing fairly well now." Additional information has been requested.  11/28/2007 Vax record received.  Info updated in VAERS database. 02/01/2008 MR received for DOS 11/6-7/2007 with D/C DX: Dehydration. 2' DX: Intussusception s/p reduction by air enema. Pt presented to ER with 2 day hx of crampy abdominal pain, and intermittant lethargy, nausea and vomiting. Decreased UO and PO intake.  IS noted on Air enema and reduced by same. Pt had one bloody bowel movement then a normal one following. D/C home next day with good po intake and UO.
No additional adverse events reported; a dose of PROQUAD was administered to a patient on 18-NOV-2020 that had been involved in a temperature excursion that was not reported; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, and previous drug reactions or allergies was not provided.   On 18-NOV-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 5 milliliter (strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T015261, which have been verified to be valid, expiration date reported and validated as 31-OCT-2021) as prophylaxis (product storage error). It was reported the use of sterile diluent to reconstitute the vaccine (dose, lot number and expiration date were not provided).  The temperature excursion was not reported, as the nurse had not finished the temperature excursion information and was unable to read the data logger at the reporting time. There was no previous temperature excursion reported. No additional adverse events were reported.
Swelling, redness, itchy and very tender at injection site, per patient c/o headaches and diarrhea, fever.
Started having diarrhea right after the rotavirus vaccine. Diarrhea continued for more than two weeks.