chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself).  This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick.  The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.
Swelling of face, tongue and lips.  dizziness, shortness of breath, shaking all over.  Emergency room -push iV predisone and Benadryl plus anti nausea drug.  Followed by four days of Prednisone and Benadryl by mouth
Arm pain starting 1 day post vaccine lasting 3 days. Extreme fatigue starting 3rd day post vaccine lasting  8 days. Starting 3rd day post-vaccine, I felt like my entire nervous system was being electrified (tingling in neck, hands, feet, finger tips, tip of nose) that lasted 5 days.  I also received the seasonal flu vaccine in the opposite arm at the same time as the Shingrix vaccine.  I do not know the manufacture of that influenza vaccine.   I had the shingrix booster on 2/12/2020 with mild arm pain and mild fatigue lasting two days.
Symptoms reportedly started the evening after vaccine given/early the following day - symptoms include - fatigue, headache, myalgias, arthralgias (shoulder), nausea, dizziness, tinnitus, eye discomfort (pulse/twitching behind (R) eye), local reaction with redness, tenderness.
Within two days of receiving patients covid 1st dose, injection site swelling and redness started. When patient presented to clinic on 3/30 to be evaluated. injection site had a red ring that was warm to the touch and raised. Diameter was 7-9 cm.  Patient stated this has not gotten any better. patient also complains of severe 'arthritic' pain in her knuckles.  Patient was seen at clinic for evaluation and treatment with prednisone for allergic reaction to covid 19 moderna vaccine. patient requested report to be made.
It began with soreness, pain, redness. The next day I felt tired, sick. I couldn't sleep because both my arms hurt from the 2 vaccines. My left from my last Moderna vaccine which I had the day before, 4/12/22, and my right from the Pneumonia vaccine 4/13/22. I contacted my doctor 4/14/22 because I felt like I was having an allergic reaction to the Pneumonia vaccine. I said it was the worst reaction I've had to any vaccine. He, through his nurse, wrote that I had an exaggerated reaction and I could apply ice to help get rid of the inflammation. I felt physically better after getting a nap sitting up, but on 4/17/22 I noticed pink color all around my arm and greater swelling. I went to urgent care on 4/17/22 but they were closed because of Easter. I took a Benedryl thinking that might help. It didn't. I went back to urgent care 4/18/22. They diagnosed it as an allergy unspecified. I was told to take anti-inflammatories for the swelling and pain, and to use ice. The ice pack I was using was barely cold because of the cloth-like envelope you are supposed to use with it. Frozen peas or ice in a towel was recommended. The person who examined my arm didn't think there was any infection present. I was asked to show both my arms to compare which is something I did myself by accident  and it alarmed me to see the difference. I still have some pain when I raise my arm but it is greatly reduced. The rash (?) was about 5"W x 7"L. I did not want to get this pneumonia vaccine so close to the 4th covid vaccine. It was sprung on me. At my doctor's office, I had seen the nurse first who asked me questions required by insurance. When she finished, my doctor came in and we talked about 30 min. As he walked out the door, I barely heard him say something about a pneumonia vaccine. I thought he meant sometime in the future but the nurse came in again with the syringe in her hand. I knew I wouldn't be able to sleep with both arms sore because I sleep on my side. I didn't feel I could say no since the syringe was ready. I am not the kind of person who dodges vaccines. I believe in preventative medicine. This doctor will not pull that on me again because I will be getting any future vaccines from my pharmacy where I have received most of my vaccines. I am not sure I will ever go back to this doctor at this point. Also, from what I can tell, my first pneumonia vaccine was 11/10/11 and then a booster 8/6/13. I am not positive about these dates but I am sure that I had two previous pneumonia vaccines and had given all the dates of my vaccines, etc. to my doctor. The urgent care people were exceptionally nice and caring and told me to return if I had any concerns, fevers, redness, swelling, discharge, or increased pain in the wounded area.
High grade fever 104, chills, severe myalgias, nausea despite Tylenol RTC
patient received a dose of TYPHIM VI today (15Jul2021) that had expired on 10May2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00683910) and transmitted to Sanofi on 15-Jul-2021.  This case involved 82 year old male patient received a dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] today (15Jul2021) that had expired on 10May2021 (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 15-Jul-2021, the patient received 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A264M and expiry date: 10-may-2021) (Frequency = Once) (Strength = Standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Pharmacy resident states that she is calling to report an adverse drug event. Pharmacy resident asking what the next steps should be and if they should give the vaccine to the patient again".  It was an actual medication error case (Expired vaccine used) (latency same day)  At the time of reporting, no adverse event  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 the 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.
My Period/menstruation started  Not sure if in relation to getting my vaccine today.  Period is  a week early and got vaccinated earlier today
Numbness tingling down both legs pain like legs fell asleep for 4 months first 2 weeks sick with flu cough runny nose congestion fever Body aches Severe pain in muscles Down legs for another 5 months Still tingling sensation nerve pain Nerves on back in spine & left shoulder Tingling feet Tingling legs upper Body tingling Muscle weakness Gate walk Problem coordination Weak arms & legs Body Fatigue High blood pressure (Never had before) abnormal Heart Rhythm Difficulty speaking Facial muscle weakness Shortness breath Difficulty swallowing Slow reflexes Uncomfortable Burning being Soar Nerve pain Pins needles hands Swelling legs Severe back pain Left shoulder pain on injection sight (left arm) still hurts to this day 5-1-20 My skin hurts (Sensitive) Doctor prescribed 300mg Gabapentin 3x Day told me Im young and active it will subsid in year I will investigate further due to few vaccines are known to carry coronavirus I now have problems with other parts of organs I will continue until I prove flu shots are dangerous. Still active pins Needles Nerve pain only Thing That helps it is prednisone 20mg day with Gabapentin All Joints Now hurt Leg Nerve pain increased Going to have Nerve specialist evaluate & Treat I can not (ever) get
Mild muscle pain; Mild joint pain; Mild headache; Bodyaches; Fevorish at and around the injection site; Swelling at and around the injection site; Redness at and around the injection site; Soreness at and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain) and INJECTION SITE SWELLING (Swelling at and around the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (Nyquil/Dayquil allergy), Drug allergy (Aspartame allergy), Fibromyalgia since 1995, Osteoarthritis, Irritable bowel syndrome since 1991, Overactive bladder since 1981, Mitral valve prolapse since 1991 and Acid reflux (esophageal) since 1996. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, COLECALCIFEROL (VITAMIN D 3) for Deficiency vitamin, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Fibromyalgia, FISH OIL and GARLIC [ALLIUM SATIVUM] for Heart disease, unspecified, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Osteopenia, OXYBUTYNIN for Overactive bladder.   On 13-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Fevorish at and around the injection site), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site) and INJECTION SITE PAIN (Soreness at and around the injection site). On 14-Mar-2021, the patient experienced PAIN (Bodyaches). On 14-Mar-2021 at 10:00 AM, the patient experienced MYALGIA (Mild muscle pain). 14-Mar-2021 at 10:00 AM, the patient experienced ARTHRALGIA (Mild joint pain) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) 14-Mar-2021 for Headache and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site), INJECTION SITE PAIN (Soreness at and around the injection site) and HEADACHE (Mild headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours after injection, lasting  approx 29 hours.  Approx 48 hours after injection swollen, tender area approx size of golf ball under left arm ( injection arm) and conintues to be there on 3rd day
- severe body aches - high fever (102.6 peak before taking Tylenol)  - headaches  - tingly sensation in skin  - muscle soreness
Initial misuse report received from a nurse on 14-October-2013. The 5-months-old patient had received FLUZONE. No adverse event was reported. List of documents held by sender: none.
Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 22-JUL-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168: US-009507513-1612USA005169.
tooth fell out today; A spontaneous report was received from a consumer concerning  her husband, a 76 year male patient  who was administered Moderna's vaccine  has experienced tooth fall. The patient's medical history was not provided. No concomitant medications were reported. On 20- Jan-2021 prior to the onset of events, the patient received  1st dose of mRNA( batch no.-013L20A) for prophylaxis of COVID-19 infection. The patient's tooth fall out.Treatment drugs were not reported. Action taken was unknown. The event outcome was unknown.
Immobile pain on left shoulder, chills, nausea, intense pain, can't sleep, pain started 6 hrs after injection.  12-3 pain persist around the injection site.
Moderate to severe pain at injection site, fever, chills, headache, extreme fatigue, GI upset, decreased appetite. All started the day after the 2nd injection and lasted for approximately 48 hours. OTC medications and oral fluids at home were the only treatments.
Patient received Pfizer COVID 19 vaccine on 12/21/2020. Patient felt fine that day and all day of 12/22/2020. Around 2AM on 12/23/2020, Patient woke up with a headache and started to have nausea, vomiting, and diarrhea.
swollen in injection site; red ring in injection site; fever in injection site; soreness of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (soreness of arm), VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (soreness of arm). On 19-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 16-Apr-2021, MYALGIA (soreness of arm) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on concomitant medications on birth control shot every 3 months.
A non-serious report of positive influenza A test has been received from a registered nurse concerning an eight-year-old female subsequent to FLUMIST. The patient received FLUMIST before onset of the event given in October 2008. On 19-May-2009, the patient was tested for influence A and had clinical symptoms of influenza. Outcome of the event was not provided by the reporter.
Patient arrived for booster of Pfizer vaccine. Given Moderna instead. Patient PCP notified and follow-up to be conducted.
(Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (flare up on the knee). At the time of the report, ARTHRALGIA (flare up on the knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
PATIENT PRESENTED WITH SHORTNESS OF BREATH AT ABOUT 4:15.  SHE WAS GIVEN 50MG OF BENADRYL AND ONE DOSE OF EPI-PEN 0.3MG IM. PARAMEDICS WERE CALLED AND ARRIVED WITHIN ABOUT 5 MINUTES.  PATIENT WAS TAKEN TO HOSPITAL FOR OBSERVATION.
On 07/24/2001 the site of the injection was sore. On 07/25/2001 the patient's arm at the site of the injection was sore, red swollen and hot to the touch.
4 cm x 3.5 cm erythematous raised lesion on (R) thigh. Prescribed BENADRYL cream to be applied TID for 5 days. Area has improved as of 12-8-17.
cessation of menstrual period at the time of this report 64 days since LMP, no pregnancy, no prior similar episodes.
Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.   The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline.   On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk.   Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain.  The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.  Further information have been requested.
Per caller, patient did not have any adverse reactions.; Nurse calling from HCP office to report that a duplicate dose of PROQUAD was accidentally administered to a 4 year old patient on 8/20/2020 that had already received their dose on 12/16/2019.; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-DEC-2019, the patient received the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided); on 20-AUG-2020, the patient accidentally received a duplicate dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S005880, which has been verified to be valid, expiration date reported and validated as 25-AUG-2020), due to the first dose did not show up in the recording system for vaccines which was the reason for duplicate administration (duplicate therapy error), both vaccines were administered as prophylaxis. The caller reported that, the patient did not experience any adverse reaction (no adverse event).
This spontaneous report was received from a medical assistant refers to a 48 years old female patient with no pertinent medical history and not drug reaction or allergies who on 02-JUL-2012, was vaccinated subcutaneously on right upper arm with a single dose of ZOSTAVAX (lot number 672676/0069AE, Exp. Date: 03-APR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included: progesterone cream. The medical assistant reported that on an unspecified date, in approximately July 2012, the patient developed redness at the injection site. The injection site reaction resolved in four days without requiring treatment. No lab diagnostics studies were performed. At the time of the report, the patient recovered (date not provided). The patient came to the office for a routine exam on 13-AUG-2012 and reported reaction at that time. The relatedness for redness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
shots given 11AM, cried uncontrollably 2PM-9PM-slept 15mins stretches, unconsolable upon waking;
Excessive crying 12-9-2008 after PREVNAR vaccine 12/10/2008 Phone call-  cried himself to sleep.  No fever. Settled dwon 45minutes.