chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; pounding head; low-grade fever; doesn't feel fine; "horrible" muscle aches particularly around the low hip area but also "all over"; feeling dizzy; elevated BP 155/100; This is a spontaneous report from a contactable consumer for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), Intramuscular in Right upper arm on 04Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included seasonal asthma as a kid and as she got older, it got worse. There were no concomitant medications. She reports the following AE's: "horrible" muscle aches particularly around the low hip area but also "all over", feeling dizzy, elevated BP 155/100 in Jan2021, "pounding head", low-grade fever, body aches 05Jan2021. She received the first COVID vaccine on 16Dec2020 and then the second vaccine yesterday. Now, she doesn't feel fine. The caller clarifies further with the first vaccine, she was fine. She had a sore arm and that's it. With this second vaccine, she doesn't feel fine. She didn't start feeling bad until around 1 a.m. She received the second vaccine yesterday, 04Jan2021. Around 1 a.m., she started feeling not so hot. She confirms she started to experience body aches, making the comment " it's ridiculous, it's my entire body". Also, a headache and low-grade fever. She states these symptoms didn't get really bad or worse until 10 this morning. Outcome of event feeling unwell was recovered on 05Jan2021, of headache, low-grade fever, body aches, was not recovered, of others was unknown.
Delayed side effects; Pain in hands; tingling in feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed side effects), PARAESTHESIA (tingling in feet and hands) and PAIN IN EXTREMITY (Pain in hands) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (tingling in feet and hands). On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed side effects) and PAIN IN EXTREMITY (Pain in hands). At the time of the report, VACCINATION COMPLICATION (Delayed side effects) and PAIN IN EXTREMITY (Pain in hands) outcome was unknown and PARAESTHESIA (tingling in feet and hands) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  No Treatment medications were provided by reporter. Vaccination facility type was Public health clinic.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up recieved contains no new information.. On 14-Aug-2021: Follow up recieved contains no new information. On 10-Sep-2021: Significant follow up received includes Patient demographic details, Patient's historical condition,  1st and 2nd dose  details, Vaccine facility information  and new events Tingling and pain in extremity are added.
No adverse reactions noted at this time. Pt and father advised of a heightened immune response due to receiving the 2nd dose Pfizer 1 week early.
Information has been received from a nurse concerning unknown number patients who were vaccinated with GARDASIL vaccine (yeast). The nurse reported that about 80% of her patients who received GARDASIL vaccine (yeast) experienced injection site pain. The outcome was unknown. It was unknown if the patients sought medical attention or not. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
fever; swelling was bigger than 1st day; Painful; painful; Vaccination site hot to touch; Injection site swelling; Injection site pain; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site pain), PYREXIA (fever) and VACCINATION SITE SWELLING (swelling was bigger than 1st day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Crohn's disease, Hashimoto's thyroiditis, GERD and Ulcerative colitis. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain). On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch), PYREXIA (fever), VACCINATION SITE SWELLING (swelling was bigger than 1st day), VACCINATION SITE PAIN (Painful) and PAIN (painful). At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot to touch), PYREXIA (fever), VACCINATION SITE SWELLING (swelling was bigger than 1st day), VACCINATION SITE PAIN (Painful) and PAIN (painful) outcome was unknown and VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) had resolved.        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 medications were not provided.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. The registered nurse reported that the hepatitis b vaccine (recombinant)(manufacturer unknown) was given too early, and asked what could be the next course of action. No adverse effects were reported. Follow up information has been received from the reporting registered nurse on 03-JAN-2017, referring to a 10 week old male patient. On 29-DEC-2017, the patient was vaccinated with the third dose of RECOMBIVAX HB lot number: N009802, expiration date: 19-DEC-2019, for prophylaxis. The nurse informed that the interval between second and third dose was less than recommended.
Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), LORAZEPAM, ATENOLOL, PAROXETINE, ROSUVASTATIN CALCIUM (CRESTOR), QUETIAPINE, CLONAZEPAM, MOMETASONE FUROATE (NASONEX) and LEVOCETIRIZINE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
A non-serious spontaneous report of patient was given FLUMIST that expired two weeks ago was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 04-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
woke up with heart palpitations. felt chest pain and pain in right arm from shoulder to wrist
maybe her arm hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1, Vaccine Lot Number: EWO186, left upper arm), administration date: 22Sep2021, when the patient was 64 years old, for Covid-19 immunization, reaction(s): "experienced something really strange", "state her hair started coming out". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "maybe her arm hurt a little bit". The event "maybe her arm hurt a little bit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated the first dose of her Pfizer COVID Vaccine was administered on 22Sep2021 and her patient card has the lot number of EW and she does not know if it was a zero or V and then 186 written for the lot; states the 2nd dose was administered on 13Oct2021 and the patient card does not state the lot or have it written on it. After that, reporter stated that, she had a correction for the Pfizer COVID Vaccine 1st dose lot number and it was the letter O so the lot is EWO186. Vaccine Administered at Vaccination Facility Type:  health clinic. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect and no Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patients Medical History (including any illness at time of vaccination) and no Family Medical History Relevant to AE(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101573822 same reporter/patient/product, different dose/event.
Body aches, fatigue, sleeplessness, restless, uncontrollable shaking, feeling cold,, sore and tender at injection site, headache (full band front and back), fever, sweating, heavy feeling in chest, occasional cough.
About 10 minutes after the injection i started feeling that my throat was tight and I was nauseus.   I got checked out by medic personnel and all of my vitals were normal.  As the time passed about 30-40 minutes after the injection, I started feeling very weak and my face was flush.  The medical personnel decided I needed to be transported to the ER.  The whole time my vitals were within normal ranges.  Upon arriving to the ER the oncall dr evaluated me.  She decided to treat it as an allergic reaction and fave me IV steroids and benadryl.  This caused me to sleep and after a few hours I felt much better.  The next day my body was achy but that went away as the day went by.
This case was reported by a other health professional via call center representative and described the occurrence of muscle spasm in a 26-year-old female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 23rd September 2018, the patient received FLUARIX QUADRIVALENT. In September 2018, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced muscle spasm, pain in arm and weakness of arms. On 23rd September 2018, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the muscle spasm was recovering/resolving and the outcome of the pain in arm and weakness of arms were unchanged and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the muscle spasm, pain in arm and weakness of arms to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by the healthcare professional for herself. The FLUARIX might have been administered too high above the deltoid to the patient, which led to vaccine administered at inappropriate site. Afterward the patient experienced pain and difficulty in lifting anything heavy with affected arm which persists till the time of reporting. Muscle spasms of left side of neck and jaw was also developed after two days. The patient has denied permission to contact their physician.
pt states about an hour after vaccine her right arm started swelling.  Arm hard and had fever. Her right arm is scarred from the injection site to about half way to elbow after blisters formed.  She started running 102 fever.  Pt went to urgent care on 10/3 and 10/4/23 and was treated by doctor. She went to be treated for the  burning sensation and developing of blisters on right arm.  The urgent care popped the blisters. They prescribed her clindamycin, levocetirizine and prednisone. She went to her PCP and was given Silva dyne. Pt states she is still using the Silva dyne and her blister are healing but her right arm is scared.  Pt will contact PCP if further treatment is needed.
Pt arrived as a walk-in to clinic on 10/9/19 c/o (L) distal upper arm swelling/discomfort. SX started yesterday (10/8/19). Pt reports redness/warm to touch but is improving.
Burning immediately when the needle entered her arm before the vaccine was injected; difficulty raising her arm and opening the dishwasher since- loss of range of motion and weakness 1 week out.
Patient came to pharmacy to state that left arm was swollen and painful to touch. No other symptoms noted.
sore arm; nosebleed; achy; had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EPISTAXIS (nosebleed), PAIN (achy) and PYREXIA (had a fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), EPISTAXIS (nosebleed), PAIN (achy) and PYREXIA (had a fever). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 14-Feb-2021, PYREXIA (had a fever) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), EPISTAXIS (nosebleed) and PAIN (achy) outcome was unknown.            No concomitant medication was reported. Treatment medication included antidepressants Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Patient described that they had a racing heart beat the night following the shot and had trouble sleeping.  The side effects just lasted that night.
Breakthrough case admission after three vaccines Pfizer 3/19/21 Lot# ER8727; Pfizer 4/21/21 Lot# EW0164;  Pfizer 12/3/21 Lot# 33030BD
Dizzy ness, fainting, vision blurred, foggy mentally, overall terrible feeling since receiving first dose of Vaccine
In the middle of the night I felt sick, with headache, chills ,body aches, felt like fever.
Patient began feeling a tightness in their throat shortly after leaving the observation area at the vaccination clinic at 4:30 pm, but was not noticing any difficulty breathing or swallowing. After two hours, the patient was experiencing some lightheadedness as well, and requested assistance from a local urgent care clinic, where it was advised the patient should come in and be checked out. At 7:30 pm, the patient's vitals were tested and all appeared in the standard range. The patient was administered some Benadryl, Pepcid, and Decadron, all orally. An Epipen was prescribed in case of a flare-up over the next 24 hours, however after an overnight rest the symptoms have disappeared.
Skin around the bump is hard; Bump right on the crease of her behind; Feel a little sore when she sat down; Rash; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021. The most recent information was received on 15-Jul-2021 and was forwarded to Moderna on 15-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bump right on the crease of her behind) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEIN #3) for Back pain, VERAPAMIL for Blood pressure management, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 5:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced SWELLING (Bump right on the crease of her behind) and RASH (Rash). The patient was treated with CORTISONE (topical) ongoing from 03-May-2021 at a dose of 1 dosage form once a day. At the time of the report, SWELLING (Bump right on the crease of her behind) and RASH (Rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 117/77 mmHg (Low) 117/77.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.  Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Updated the address of the secondary reporter. Added the patient details which includes height, weight, race and ethinicity. Added lab data which includes Blood pressure. Added the reported indication and dosage regimen for concomitant medication Tylenol-Codeine #3 and Verapamil. Added the concomitant medication multivitamins along with the dosage regimen. Added starting date of the events. Updated the outcome of the events from  unknown to not recovered.
For first shot of covid moderna vaccine- late period (my cycle is always very regular), fatigue, sore arm 2nd shot- period came early
Received a seasonal flu shot 10/13/09. States injection was given in left shoulder instead of deltoid. 30 minutes later shoulder was swollen. Put ice on and off, took ibuprofen for 5 weeks - can not left arm backward without pain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2011, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
heard a loud bang in my brain; blacked out for an instant; tired and wobbly; Did not get my balance/wobbly; 1,Day after the vaccine, I had violent projectile diarrhea; This is a spontaneous report from a contactable consumer (patient). An 83 year-old elderly female patient received first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration from 20Jan2021 20:30 at single dose in the right arm for COVID-19 immunisation. Medical history included small cell lung, 2cm, no follow -up treatment necessary. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), and losartan potassium. One day after the vaccine administration on 21Jan2021 10:00, the patient had violent projectile diarrhea. Two days after the vaccine, she blacked out for an instant and heard a loud bang in her brain. She was tired and wobbly for over one week. She did not get her balance back for nearly 3 weeks. The events resulted in Disability or permanent damage. Treatment for the events was unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 outcome of the events was not recovered.
Varicella given 7/16/04. Child's mother reported a small number of chickenpox covering body - very sporadic. No illness reported.
After receiving the vaccine, I waited in the office for 15 minutes.  Then I left with husband (who also received the vaccine).  A few minutes later I was dizzy and had rapid heart beat.  I had to sit for 5-10 minutes for this to pass.  A few hours later I realized that my upper arm is red and hot to the touch and the injection area is very swollen and painful.  This lasted for about a week.
Left UE injection site soreness 4 hours post. Severe vertigo approximately 10 hours after, lasting about 4 hours.
Patients mom stated son had asthma attack and sore throat after pfizer pediatric vaccine and flu shot
I experienced headaches, nausea, severe swelling and redness in my arm, itching. When I saw my provider the same day I received the vaccine, and tests were done. A week after my provider called to tell me I was positive for syphilis and prescribed doxycycline, and a penicillin G injection. I was given a "magic mouthwash" by the provider when my tongue swelled due to stress which the provider stated was attributed to the syphilis which in truth did not have. I was given unnecessary treatment due to a false positive on the syphilis rapid test due to a reaction with the Covid19 vaccine. The same day of initial positive the TTPA confirmatory test was negative proving I in fact never had syphilis and the provider misread the results. I am still getting migraines, and experiencing nausea from the vaccine periodically.