chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Headache; Injection site soreness; General malaise; This is a spontaneous report received from a contactable consumer (Patient herself). A 25-year-old non pregnant female patient previously received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 11Jan2021 at 07:00 as first single dose for covid-19 immunisation and second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in arm right on 01Feb2021 at 07:00 as second single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported, and concomitant medication included insulin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for covid-19 since the vaccination. On 02Feb2021 at 12:00, the patient experienced fever, chills, headache, injection site soreness and general malaise. The case classified as non-serious. No treatment was received for adverse events. The events were recovered on 02Feb2021.  No follow-up attempts are possible. No further information is expected.  Follow-up (09Feb2021) and (09Feb2021): New follow up spontaneous report received in response to mail trail sent for query regarding confirmation of Pfizer receipt date. This report included that: the receipt date would have been Tuesday 02Feb2021.  Follow-up (09Feb2021): This follow-up contains no new medically significant information.  No follow-up attempts are possible. No further information is expected.
Similar to the first two shots, I experienced numbness of various parts of my face, teeth and tongue. No swelling or drooping. No problem with respiration. Onset just a few minutes after receiving the injection. Duration a few hours then  also more numbness lasting shorter periods up to 20 minutes over the next three days. Late on day 3 started to show a rash/hives on my neck then upper chest. Day 5 some redness on face while neck is still rashy. These effects in addition to more common mild fever with muscle and body aches on days two and three in the evening/nighttime. Advil taken for fever/discomfort.
Woke up the next morning ready to puke but stomach was empty; Headache; Fatigue/ Tiredness; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old adult of unspecified gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 09:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included narcolepsy and high blood pressure. The patient received unspecified medication within two weeks of vaccination. The patient has no known allergies to food, medications or other products. 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 19Mar2021, the patient experienced headache, fatigue/tiredness and sore arm which wiped out by early afternoon and on 20Mar2021 next morning she was ready to puke but stomach was empty. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, fatigue and sore arm was resolved on 19Mar2021 and ready to puke but stomach was empty was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
5,OCT,2008 reports to clinic with malaise/fatigue and chills. Pt states symptoms developed 4,OCT,2008 afternoon. Experienced N/V/Chills. Woke up vomiting 3 to 4 times last noc. Cannot keep food or liquids down today. Reported to clinic 09:15 5,OCT,2008.
Extreme exacerbation of bilateral tinnitus; Extreme exacerbation of bilateral tinnitus; This is a spontaneous report from a contactable Nurse. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: no reported, Expiry date: not reported) via an unspecified route of administration, administered in right arm on 31Mar2021 at 13:15 (59-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included hypothyroidism, irritable bowel syndrome and constipation. Concomitant medication included lithium (LITHIUM), quetiapine (QUETIAPINE), gabapentin (GABAPENTIN), levothyroxine sodium (SYNTHROID), linaclotide (LINZESS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested covid post vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took Resperidone and experienced hypersensitivity. On 31Mar2021 at 12:00, the patient experienced extreme exacerbation of bilateral tinnitus. The patient did not receive any treatment for the event. The clinical outcome of the events was not recovered at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Tinnitus, Condition aggravated cannot be completely excluded.  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.
right dominant arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right dominant arm got sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043a21am and 005c21a) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, CURCUMA LONGA (CURCUMA), MAGNESIUM, METOPROLOL, METFORMIN, LISINOPRIL, ALLOPURINOL, SITAGLIPTIN PHOSPHATE (JANUVIA), VITAMIN D3 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE PAIN (right dominant arm got sore). At the time of the report, VACCINATION SITE PAIN (right dominant arm got sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included as Diabetes medication and Vitamin 12.
Patient was noted by mother to have difficulty breathing and lethargy. Patient was brought to ER and noted to some difficulty breathing and lethargy. A septic wrkup was performed and patient was given IV rocephin pending lab cultures.  Temperature upon admission to ER was 95.3 but repeat temperature before transfer was 98.1.  Patient was transferred to another Hospital for admission for difficulty breathing.  During hospital stay, patient continued to recieve IV ceftriaxone.  Within 24 hours, patient was back to baseline level, tolerating feedings without vomitting.  Patient remained afebrile during hospital stay.  Patient was discharged from hospital 05/15/2011.
patient received the diluent portion of the Pentacel vaccine, and did not receive the lyophilized powder portion; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four years old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UI953AA and Exp. Date 30-JUN-2020) via intramuscular route in the right vastus lateralis on 28-Jun-2019.  The patient's past vaccination(s) included first and second doses of Pentacel (first dose was Jun2015, second was Aug 2016).  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunization.  It was an actual medication error case due to inappropriate reconstitution technique as the patient received the diluent portion of the Pentacel vaccine, and did not receive the lyophilized powder portion.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow up information received from an other health professional on 17-Jul-2019.  No new information was reported.  List of documents held by sender: none.
left arm blisters and pain lost shoulder use  as of now blisters are drying up  arm still not useable 10-1-2020
Started having g side affect that night. Aches and pains. Nausea. Headache.
Onset of fever 9/10/11 - rash all over body appeared 9/13/11. Adv. parent to use Aveeno lotion for itching.
Tired after the First dose for a week. Next Sunday after the vaccine I woke up with a very large swollen lymph node on my armpit. Left arm. Same as vaccination.  After a week the swollen lymph is still there . It is harder and smaller.
Noted tongue starting to swell on 12/24 at 1030. Started on left side, then progressed to right side. No SOB, difficulty swallowing or breathing, but staff noted difficulty understanding her speech. Presented to ED at 1300. 50mg Benadryl given IV on 12/24 at 1328 and 125mg solumedrol given IV at 1327. Pt reported improvement in tongue swelling at 1630.
Chest pressure; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest pressure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Oct-2021, the patient experienced CHEST DISCOMFORT (Chest pressure). The patient was treated with PREDNISONE for Chest pressure, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest pressure) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient who was also a nurse received her booster shot on 23-Oct-2021. Beginning the evening of 24-Oct-2021 patient started having chest pressure. On 27-Oct-2021 she went to emergency room because the chest pressure would not stop. ER took several tests and cardiac labs, and the results came back normal. Patient was put on Prednisone for 5 days, and as of 01-Nov-2021, she still has chest pressure.  Action taken was reported as not applicable.  This case concerns a 43-year-old female patient with no relevant medical history who experienced non-serious unexpected event of Chest discomfort. The event occurred one day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the third dose. Patient's diagnostic test results were within normal range, however, very limited information regarding clinical course of the event has been provided at this time. It was reported that the patient was treated with Prednisone, however, at the time of the report, the event was still ongoing. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 43-year-old female patient with no relevant medical history who experienced non-serious unexpected event of Chest discomfort. The event occurred one day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the third dose. Patient's diagnostic test results were within normal range, however, very limited information regarding clinical course of the event has been provided at this time. It was reported that the patient was treated with Prednisone, however, at the time of the report, the event was still ongoing. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Red spot on the injection site (on the vaccination date) Pt felt warm and little pain on the area (from vaccination date) Pt applied ice bag and took tyrenol (from vaccination date) Pt still has a 4-5 inches round circle (7th date from vaccination) Pt said red spot got bigger and still painful.
Patient had syncope at 10:00 AM, family health clinic called EMS, arrived at 10:20 AM. Brought to emergency room.
In the first 15 minutes after the vaccination, I experienced reduced nerve sensation in the arm of the vaccination site. Following, I experienced short term heat in my ears. At 17 minutes or so, my right arm nerves became amplified. The sensations passed and I continued on with my day. At some point, I noticed itching at the injection site. At 7:30 pm I arrived home from work and experienced chills. I took a hot bath for hours as hot as I could make it I was woosy and pale. After tylenol and food I went to bed. Friday morning, my arm was hot, hard, and swollen at the injection site. At nearly 10 pm 12/4 the red circle around injection site (2.5 inches in diameter or so) is still present
Heart rate slowed and  arrhythmic, numbness in the chest area followed by headache and fatigued.
I received my shot on 8/26. Sunday the 1st my anxiety got triggered and caused me to have a night of insomnia (which is very abnormal for me). Monday the 2nd I felt okay during the morning, but then my anxiety got triggered again and since the following days have been the worst anxiety I've ever felt. I've had to skip work and go get on medication to try to help. I've been crying none stop, I wanna crawl out of my skin, my whole body feels electric at times, and I feel out of it. I've struggled with anxiety before but I've never, ever felt like this. At first I thought it was a culmination of a lot of things and I'm sure they're contributing, but then I looked into if the vaccine could have caused this and I found several other people experiencing the same things as me after their first dose, some after their second. Of course I'm not sure if it's the vaccine, but my experiences were lining up so much with the other people. When I went to see my family doctor I hadn't thought of this connection yet so I hadn't discussed it with him, but I plan to at my follow up.  At the end of the article, past the ads, there's comments of all sorts of people with severe anxiety side effects.
This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 29-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) immunization series (dosing details were not reported). No concomitant medications were reported. On an unknown date the patient developed shingles when she was in fifth grade. The outcome of the event was reported as recovered/resolved. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint reported. Additional information has been requested.
fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician.  A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered.  The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Swollen tongue, tingling tongue and lips, Tightness in throat, lightheadedness, weakness and heaviness in both legs.
Bilateral Pulmonary Embolsion  on 8/11/21.    Shortness of Breath, then Head rush and passed out.   Ambulance called, spent 8 days in the hospital Cardiac Arrhythmia Cardiac Amyloidosis
Case previously recorded as MA2009-4582. Initial case report received from a physician on 17 NOV 2009. A 3-year-old or younger patient was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m. on 13 NOV 2009. Reference no: NA09-008308.
1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021). At the time of the report, COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter.   She had Regeneron antibodies when she had COVID. Company comment:This spontaneous case is concerning a female patient of unknown age with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-199 (with SARS-CoV-2 test positive). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a female patient of unknown age with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-199 (with SARS-CoV-2 test positive). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Ringing in ears.  Feels like it is emanating from the center of my head.  The ringing persisted from Monday the 26th through Thursday the 29th (of July).  The ringing stopped completely on Friday the 30th and then started again on Sat am 7/31/21 at 10:30 and has not stopped (with the exception of a few minutes) since.
This spontaneous report as received from a medical assistant (M.A) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (route of administration default to oral, dose, lot# and expiration date were not specified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
He received modern a COVID-19 vaccine at 17 years 10 months of age by mistake.  He started having runny nose and left arms own as the next day.  2 days later he started having fevers.  He did not check the temperature initially.  T-max went up to 102°.  He took over-the-counter acetaminophen, ibuprofen and take will.  Fever improved this afternoon.  He has nasal congestion, fever, body aches, myalgias.
Patient received a 3rd COVID vaccine in error on 3/24/21. Patient received this 3rd vaccine at an extended-care facility. No adverse events have been noted.
Diarrhea; Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer in 2015. The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medications were not reported. On 22Apr2021, the patient experienced diarrhea and severe tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 diarrhea and severe tinnitus was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP became fussy, temp 104.6 (R), body shaking, eyes rolled back while in car seat lasted 30-45 secs. Stopped when mom picked up pt. 24hrs later temp 101.4 no sz activity or sequelae noted on f/u exam.