chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue swelled in her throat, deep in her throat; throat swelled/swelling throat on the right side; swelling of her throat and tongue/ dealt with this reaction in the past; her tongue is paralyzed; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 02Sep2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Lot Number: EM9809) as single dose (at the age of 71-years-old) for COVID-19 immunization. Medical history included angioedema, she does have allergies to some medications. She says they are just simple things like Aspirin, NSAIDs don't ever take them want more, allergic IVP dye, allergy to corn, and 'swelling of throat and tongue'. There were no concomitant medications. The patient previously took aspirin (e.c.) and experienced allergy, and Epipen. The patient experienced her tongue is paralyzed on 2021, tongue swelled in her throat, deep in her throat on 07Feb2021, and throat swelled/swelling throat on the right side on 07Feb2021. Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 07Feb2021, experienced 'swelling of her throat and tongue' within 30 minutes of getting vaccinated. She stated 'I dealt with this reaction in the past and haven't had it in like maybe... 15 years.. I used to carry an EpiPen. I think it was because it was snowing. My Allergist said if I could swallow something to gargle with antihistamines, but I had fear to do that and I didn't.' She further reported that her throat swelled and her tongue swelling in her throat, like deep in her throat. She continued to have that problem during the night. That is something she deals with she has suffered from angioedema, her doctor said, she is not sure whether or not should take the second dose. She is sorry she did do this before. She confirms she got the first dose 07Feb2021 and the throat swelling began the same day about 15 minutes after the dose was given (as reported, also reported as 30 minutes). She says it has resolved, she had it through the night but she was able to sleep so she probably felt it until about midnight that night and then it was resolved. She confirms it has resolved completely (as reported). Patient was advised not to receive the 2nd dose yet. She has been calling because of her side effects since then. She said that she had reported this condition to VSAFE and asked if there is a way to follow up. She is still experiencing a swelling throat on the right side and her tongue is paralyzed. Patient is asking if she can undergo a treatment and proceed with the 2nd dose of our COVID-19 vaccine. The final outcome of the event, tongue swelled in her throat, deep in her throat was recovered on an unspecified date, while for the rest of the events was not recovered. The event "her tongue is paralyzed" is serious (medically significant).
Patient presented 2 days post-vaccines with right facial paralysis. Advised urgent care after looking for signs and symptoms of stroke.
Myocarditis; This is a spontaneous report from a contactable pharmacist. A 15-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW1077), at the age of 15 years old, intramuscularly on 17May2021 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced myocarditis on 21May2021. The event resulted in hospitalization for 2 days. The patient was currently still in hospital. The patient had been tested for covid-19 since the vaccination. The patient underwent lab tests and procedures, which included covid-19 test: negative on 22May2021 by nasal swab. Therapeutic measures were taken as a result of myocarditis and included treatment with analgesic. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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.
Vaccines given, patient in waiting room shortly afterward, I was called to see her as she was not responding appropriately. When I first saw her she was slumped to her left, sitting in a chair, not responding to me, eyes closed mostly, right arm twitching a bit, bradycardic. I asked her dad to lay her down on the floor. I bent her knees. She continued to be unresponsive. Secretary called 911. Heart rate was 44, BP 68/30s, repeat was about the same. I placed a dissolvable sugar candy in her cheek. Breathing was slow and regular, she was swallowing normally. Capillary refill was brisk. Slight response to painful stimuli. Initial pulse ox 89% but resolved to 99% quickly. Within a minute or two her heart rate and BP slowly started to increase, and at the time of EMS arrival were 60s-70s and 101/60s respectively. She remained unresponsive as she was taken away by EMS.
Complained of Right lower leg pain, sent to radiology at local hospital for Ultrasound. Ultraspund was positive for DVT. Went from Radiology to Emergency room. Started on blood thinner medication and returned
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 29-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 29 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "had symptoms 09May and tested positive home AG on 12May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information of the events: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient receives any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Reported Event: COVID + husband 05May2022 and then she had symptoms 09May and tested positive home AG on 12May2022. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid-19 cannot be completely excluded.
This 4 month old has increased sleepiness and decreased appetite followed by onset of bright red blood per rectum. He than had 2 bowel movements, which were described as melanotic or very dark stool that was heme-positive. At an outside hospital, he had 2 episodes of emesis, which had bilious tinge. He was transfered to ICU at the hospital. KUB and ultrasound were obtained. KUB was suggestive of bowel obstruction. Ultrasound was notable for intussusception. The patient did undergo a hydrostatic reduction and was found to have an ilecolonic intussuseption to the level of the splenic flexure. Parents report no fever or diarrhea. Patient did receive the Rotarix vaccine on June 30, 2014. The patient is shedding virus in the stool. The child is otherwise well grown and healthy without any signficant clinical symptoms prior to the hours, according to the parents.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXAMETHASONE ACETATE (PLAVEX), RANOLAZINE (RANEXA) and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection). At the time of the report, INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection) outcome was unknown.            Additional concomitant medication reported was blood thinner for an unknown indication.  Treatment of events was not reported.   Reporter did not allow further contact
Dizziness, nausea, vomiting, angina & patient reported nausea/vomiting, dizziness, and chest pain about 15 minutes after receiving the influenza vaccination.
Elevated and pounding heartrate. Normal resting heart rate of patient is 40-45. Approximately 12 hours after administration of booster, heart rate began increasing (rate tracked via fitness tracker). Resting heart rate averaged 60-70 for the next 8 hours and patient was unable to sleep. Heart rate remained higher than normal for next 36 hours and patient was fatigued.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "I  was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: I still got Covid, notes: then I still got Covid and thought I might not make it. Additional information: I was reminded of my booster which made me sick for two days just like the first two shots of the vaccine, and then I still got Covid and thought I might not make it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called our office 7/8/21 stating she had an adverse reaction to the Pfizer vaccine (second dose) administered on 6/29/21. Pt states she went to urgent care on 7/3/21 due to hives on body and ended up going to ER on 7/4/21  for hives and swollen feet. Tried to submit adverse reaction online herself, was not able to. Called the office 7/8/21 at 10:50am for help with submitted the reaction. Pt states that she is feeling better.
low grade fever, emesis x 3, pale & listless next day;not irritable, appetite 1/2;started 10-12hr p/vax & lasted 24-36hr
Pt received Tdap 0.5ml Im in left deltoid on 6/30/09. She called that evening to complain of pain at injection site. Used ice and took ibuprofen with some relief. Examined 7/1/09, no redness or swelling at site, some tenderness on moving shoulder. Went to ER 7/3/09. Saw Dr. who consulted with orthopedist on call. She received steroids and pain meds. His note states "Lab OK, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa, synovial joint inflamed 2nd to high placement of DT" . On 7/8/09 pt reported she has been taking pain meds and using a sling which helps some, but hard to work. Has appoinment to see Dr on 7/13/09. Spoke with her 7-8-09 she reports still considerable pain but better than before ER visit.
This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 02Jun2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, high cholesterol from 1980, irregular heartbeats started this year ago but had not been told by a doctor. The patient stated she was in her 40s and going through menopause when they diagnosed her. The patient's family history was reported as none. The patient's concomitant medications included metoprolol ER 25 mg every day taken for Blood Pressure abnormal, Duloxetine 30 mg a day and 60 mg a day, olanzapine 10 mg a day at bedtime, amlodipine besylate 5 mg day taken for Blood Pressure abnormal, Potassium 20 mg, acetylsalicylic acid (ASPIRIN) 81 mg and atorvastatin 80 mg taken for cholesterol abnormal. No AEs was reported prior vaccinations. The patient was not administered with vaccine at Military facility. The patient was not administered with any other vaccine on same date of the Pfizer suspect. The patient was not administered with any other vaccine 4 weeks prior to suspect vaccine. The patient stated that after receiving the Pfizer COVID-19 vaccine on 02Jun2021 (Wednesday) she was experiencing an elevated heart rate /noticed her heart rate was elevated this morning. She would like to know if this was a normal side effect. The patient stated her heart races when she gets up and when she sits it goes back down. She stated it has not worsened but it's scary. On 04Jun2021, the patient's heart rate a little faster than normal. After the COVID-19 vaccine her pulse was too low to take her blood pressure medication. The reporter stated this was yesterday (03Jun2021). She stated she does not know when she started taking any of her medications. She stated that, she didn't take her blood pressure medication yesterday as she can't take it if her pulse was below 60. This morning it was in the 90s. The patient had not visited emergency room/physician office. The patient's relevant medical tests were reported as none. The reporter stated that her next vaccine was scheduled for 26Jun2021. She stated that, she cannot find her card for the vaccine and it was in her purse and now she can't find it. She later clarifies that she found the card. The outcome of the events was unknown. Information on Lot/Batch number is available; Further information has been requested.
Initial report received on 04 March 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had four doses of PENTACEL: dose one, lot number C3465AA received on 02 December 2009; dose two, lot number C3287AA received on 25 January 2010; dose three, lot number C3335AA received on 25 March 2010; and dose four, lot number C3603AA (invalid lot number) on 27 December 2010, (routes and sites of administration not reported). The subject developed cold-like symptoms on 24 January 2013 (reported as 24 January 2012), approximately two years after the last dose. On 24 January 2013, the subject developed both cough and paroxysmal cough, without a whoop. The subject also experienced apnea, posttussive vomiting and sleep disturbance (dates not specified). Laboratory testing included a positive PCR on 07 February 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 February 2013 for five days. The subject was not hospitalized. At the time of final contact on 15 February 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 19 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a nurse practitioner via a company representative regarding an 11 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (lot #, dose and route were not provided). On an unknown date, two days after administration of the vaccine the patient experienced full body rash. The outcome of full body rash was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information is not expected as the reporter did not wish to be contacted.
Narrative:  Per 7/27/21 MD note, it was decided to take patient straight to the ER after experiencing reaction. Patient was accompanied by covering MD and POD RN and was placed in room in stable condition with no respiratory distress. Patient was in the ED for 1 day.
Pt with long history of CLL, not on active treatment developed immune mediated thrombocytopenia Platelet count fell from 112 to 5k, did not respond to prednisone but improved with IVIG, event started on the day patient was due for her 2nd dose of the Moderna vaccine. It has been held.
Severe and incapacitating arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and almost immediately experienced severe and incapacitating arm pain. The severe and incapacitating arm pain had gone on for months. The reporter need to speak to someone about serious issues being experienced following Shingrix shots. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR266520, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266520:Same reporter, same patient diff dose
Moderna COVID-19 Vaccine EUA  A 4.5 cm itchy, red, warm rash noticed at about 5:30 pm on 1/19/21. The rash is located 2cm below the vaccine injection site on the left deltoid. The rash has not spread but continues to be bothersome.
Saturday woke up had 2 bouts of vomiting 5-6 times each and 4 bouts of diarrhea
Immediately felt "funny" faint, layed client down, blood pressure 106/60, put cool compress on back of neck - also said at first felt her throat was tighting for just a second.  Recovered with 10 minutes
The pediatric Pfizer vaccine was not diluted prior to administration, resulting in a higher than authorized dose.
Feeling tired and constantly sleeping; Feeling tired and constantly sleeping; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping). At the time of the report, SOMNOLENCE (Feeling tired and constantly sleeping) and FATIGUE (Feeling tired and constantly sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
1/28/21 11:10 AM  Sinus Headache, Fatigue 1/29/21 9:00 PM  Asthma Attack - Tightness in Chest, Wheezing, Fatigue 1/30/21 1:00 AM Asthma Attack, Congestion, Fatigue 1/31/21 4:00 PM  Asthma Attack - Tightness in Chest, Congestion, Fatigue  Asthma treated with Albuterol inhaler Congestion treated with Theraflu Fatigue treated with rest and liquids
Started with a fever that lasted about 3 days, loss of appetite and a few diarrhea diapers. On 7/28/2012 a rash appeared on the face and by the next morning it spread to the body.
Patient was visibly nervous. Patient also stated that she has fainted previously. Vaccine was administered and she then fainted while going to sit in the waiting area. Pharmacist got orange juice and a ice pack and elevated the patient's legs until she felt ok to sit up. EMS responded shortly after.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 07-AUG-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at 8.88 Celsius Degrees for 24 hours, 15 Celsius Degrees for 56 hours, 9.44 Celsius Degrees for 168 hours, -1.11 Celsius Degrees for 80 hours and 8.33 Celsius Degrees for 416 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Narrative:  Per CPRS info from reporter: "per patient, thrombocytopenia happened with booster in 10/2021. Admitted to outside hospital with severe thrombocytopenia"
Localized reaction, redness, firm started to spread, treated for possible cellulitis 2nd to vaccine administration.
Tingling, itching and hives all over hands only. Started evening after receiving vaccine and has not gone away since (dose on 10/11, todays date 10/26).