chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 on an unknown date at a single dose for covid-19 immunization. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. The he denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received antihistamines as treatment for the event until stable to go home and follow up with. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Left arm is red from elbow to shoulder; Elbow to Shoulder Inflammed; Sweating; Extreme chills; Uncomfortable; hard to go back to sleep; Body started Warm Up; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Uncomfortable), INSOMNIA (hard to go back to sleep), FEELING HOT (Body started Warm Up), HYPERHIDROSIS (Sweating) and ERYTHEMA (Left arm is red from elbow to shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported Adverse Event.).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced DISCOMFORT (Uncomfortable), INSOMNIA (hard to go back to sleep), FEELING HOT (Body started Warm Up) and CHILLS (Extreme chills). On 24-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On 25-Mar-2021, the patient experienced ERYTHEMA (Left arm is red from elbow to shoulder) and INFLAMMATION (Elbow to Shoulder Inflammed). At the time of the report, DISCOMFORT (Uncomfortable), INSOMNIA (hard to go back to sleep), FEELING HOT (Body started Warm Up), HYPERHIDROSIS (Sweating), ERYTHEMA (Left arm is red from elbow to shoulder), INFLAMMATION (Elbow to Shoulder Inflammed) and CHILLS (Extreme chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment Information includes Acetyl Salicylic Acid.  Action taken with mRNA 1273 in response of events is Not Applicable.
No adverse event reported. Patient received a 4th dose of HPV vaccine on 09/02/2022 (HPV 9-Gardasil). As per Shots she received the previous ones on: HPV 4 03/28/2011, HPV 4 09/24/2012, HPV 4 04/22/2013.
Injection site was warm, erythematous and mildly tender. + pruritus. Some improvement over the next day. Did also get several scattered mosquito bites the evening of 8/30/16 prior to noticing this reaction. No other symptoms. Was seen in clinic on 8/31/16 ~3:00 PM. Area of swelling, erythema and warmth on left upper arm at site of previous injection measuring ~15.5x12.5 cm. Subsequently saw an allergist - no workup done.
COVID arm; Felt like it was a little hard/harder than the other the arm; COVID arm/ quarter size of a cell phone; Light red in color; Pain all along/pain to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Felt like it was a little hard/harder than the other the arm), VACCINATION SITE PAIN (Pain all along/pain to the touch), VACCINATION SITE RASH (COVID arm/ quarter size of a cell phone) and VACCINATION SITE ERYTHEMA (Light red in color) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus (on medication).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain all along/pain to the touch). On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Felt like it was a little hard/harder than the other the arm), VACCINATION SITE RASH (COVID arm/ quarter size of a cell phone) and VACCINATION SITE ERYTHEMA (Light red in color). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE INDURATION (Felt like it was a little hard/harder than the other the arm), VACCINATION SITE PAIN (Pain all along/pain to the touch), VACCINATION SITE RASH (COVID arm/ quarter size of a cell phone) and VACCINATION SITE ERYTHEMA (Light red in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medication for diabetes.  Treatment information was not provided
This spontaneous report was received from a pharmacist and refers to a 8 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Local reaction- redness and swelling over right lateral bicep. Mom gave TYLENOL then gave ibuprofen. Patient had decreased appetite and stomach ache.
Only liquid portion was used; Only liquid portion was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The pharmacist asked about information of the event, date of vaccination, patient details, vaccine batch number or expiration date but information was declined because health care professional comment the event had occur at a different facility and did not had access to the requested information. The reporter did not consent to follow-up. Additional supportive information: The patient only received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Polymyalgia/ran tests that pointed to polymyalgia; Achiness around injection site; Shoulder pain; pain in arm/pain  then moved to my right arm; This case was reported by a consumer and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high (was on Spironolactone for high blood pressure), female pattern hair thinning (was on Minoxidil 0.5 tablet for female pattern hair thinning) and polymyalgia rheumatica (was on Prednisone for polymyalgia rheumatica). Concomitant products included spironolactone and minoxidil.   On 9th December 2022, the patient received the 1st dose of Shingles vaccine (intramuscular). On 18th December 2022, 9 days after receiving Shingles vaccine, the patient experienced injection site pain, shoulder pain and pain in arm. On an unknown date, the patient experienced polymyalgia. The patient was treated with prednisone. On an unknown date, the outcome of the injection site pain, shoulder pain, pain in arm and polymyalgia were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, pain in arm and polymyalgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's comments: The patient received a dose of Shingles vaccine in left arm and had achiness around the injection site on her left arm which the spread up into her left shoulder and then moved to her right arm and shoulder. The patient did not have to go to the hospital but saw her physician who ran tests that pointed to polymyalgia and prescribed prednisone which had worked to stop the pain. The patient was in the process of tapering off the prednisone.  The reporter consented to follow-up.
Extreme fatigue, chills but not a fever, joints very achy, headache, nausea
Rash on neck that shot pain to jaw.  Was prescribed Famvir 500mg tid.
Confusion; Mentally slow; Like I was in a dream and woke up yesterday but I remember everything; Delirium; Mental FOG; Detached from reality; A spontaneous case report was received from a physician concerning a 32 year old male patient, who received Moderna's Covid 19 vaccine and experienced events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly on 24 Dec 2021. On 21 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced confusion and mentally slow. He was sent home from work because he was not normal. He explained it as, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state. He went to the ER (emergency room). Relevant laboratory results included unspecified lab tests and results were negative. Treatment details was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, like I was in a dream and woke up yesterday but I remember everything. Almost like neuropsychiatric effect: delirium, mental FOG, detached from reality, in a dream state was considered resolved on 26 Jan 2021.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
some site tenderness in left deltoid; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (some site tenderness in left deltoid) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Urticaria. Concurrent medical conditions included Asthma and Autoimmune disorder (was diagnosed in her 20s). Concomitant products included MONTELUKAST and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Asthma, SIMVASTATIN for Cholesterol, AZITHROMYCIN for Flu, MELATONIN for Sleep disorder NOS, MULTIVITAMIN [VITAMINS NOS], CALCIUM, GLUCOSAMINE & CHONDORITIN, ASPIRIN [ACETYLSALICYLIC ACID], ALBUTEROL [SALBUTAMOL], OXYMETAZOLINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (some site tenderness in left deltoid). At the time of the report, VACCINATION SITE PAIN (some site tenderness in left deltoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-300242 (Patient Link).
have a big bump on the shot site, knot; have a big bump and redness on the shot site; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 14Jun2021 (Lot Number: EW0180; Expiration Date: Aug2021) as dose 2, single at the age of 58-year-old for covid-19 immunization. Historic vaccine was bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 23May2021 (Lot Number: ER8736; Expiration Date: Jul2021) as dose 1, single at the age of 58-year-old for covid-19 immunization and experienced sore arm. Medical history included rheumatoid arthritis from 2010 to an unknown date (Diagnosis date: 2010), asthma from an unknown date. The patient had not had no wheezing and it might had been about 2 weeks ago. There was no prior vaccinations within 4 weeks. Concomitant medications included diclofenac sodium (topical gel), prednisone, and hydrocodone, all taken for rheumatoid arthritis; salbutamol (ALBUTEROL) taken for an unspecified indication, all start and stop date were not reported. The patient just had one concern. She got the Pfizer, her second shot yesterday (14Jun2021) and today  (15Jun2021) she had a big bump and redness on the shot site. Was that a normal reaction? After the second shot. The first shot, the patient just had sore arm. The second shot she was experiencing this knot and redness. The patient was still experiencing the issue, It's a knot and its red. Therapeutic measure were not taken as a result of events. The outcome of events was not recovered.
Information has been received from a physician concerning a 6 month old female who was vaccinated PO with her third 2.0 ml dose of ROTATEQ (lot# 658379/1388U).  Subsequently the patient experienced "loss of appetite."  The patient sought unspecified medical attention.  No labs or diagnostic studies were performed.  The outcome was unknown.  It was noted that there was no adverse event with the first two doses of ROTATEQ.  There was no product quality complaint.  Additional information has been requested.
Found not breathing that night. Taken to ER, transferred to another hospital. Pronounced dead at 3:00 am.
Notified by HR Specialist of the clinic that patient had a reaction to her shots via email.  "Our Director of Compensation and Benefits had a reaction to her shots. She then went to her doctor who said the pneumonia and flu shot should never be given at the same time. She wants to make sure at the future clinics these 2 shots are not given together. Do you have any clinical data on this?" No further information was reported after inquiry.  Provided HR Specialist with information and data requested.
Right Arm Immobilized in Shoulder Joint with extreme pain if arm moved in any way.
The pt developed significant and cutaneous and oral lesions (100-200). Complicated with streptpogenes pharyngitis. Required IM antibiotics. ER visit for dehydration and decreased oral intake.
Product temperature excursion issue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided. She stated that when they received the vaccine, she looked at them and they looked frozen so she placed them in the freezer.  HCP stated that it was brought to her attention that the data logger was not set properly and thus it was not alarming when the temp got below -15C.  The data logger was set to alarm if it went above 7C, it was set for refrigerator.  HCP stated that looking back at the temp data logger, the highest temperature the freezer reached is -11C for a period of approximately 3 hours. The vials remain in the freezer quarantined. 4 doses were administered since receipt of vaccine, two on 16Sep2021 and two on 09Sep2021.
Patient states that she starting experiencing extreme chills and was very cold in the middle of the night, the day she received the shot that lasted into the next day.
3 days after 2nd HPV (2/28/08), she had a syncopal episode.  She was also ill at time, seen in clinic and diagnosed with bronchitis.  3 days after 3rd HPV (7/1/08), she was sitting in a chair, said "I don't feel well", then mom saw her eyes roll back.  She had LOC.  Mom noted brief jerking of arms and legs.  Within 1 minute she was alert and coherent.  Felt tired rest of day.  No illness.  Felt was prior two days.
pt recv vax & devel severe pain w/needle insertion; nausea, dizzy x 2-3 days then dec endurance, visual changes, balance problems, h/a;since then can't do what she used to do
10 minutes after receiving vaccination, patient complained of feeling very tired and weak.  Blood pressure elevated at 165/95.  Patient referred to primary care doctor for blood pressure management
About 5 hrs after receiving shot, muscles started to ache & spasm. Spasms lasted about 5 hours. Alternated between sweating & chills for 2 days. Slight chest itch for few hours. Bad headache & body (joints, legs, back) aches for 3 days. Nausea for 2 days.
VACCINES ADMINISTERED ON 4/24/06.  MOTHER REPORTS HE SOON DEVELOPED A LARGE SWELLING IN THE RIGHT UPPER ANTERIOR THIGH AT THE INJECTION SITE.  DESCRIBED AS GOLF BALL SIZE WITH SOME PAIN AND TENDERNESS AND AN ASSOC. LIMP OF THE RIGHT LEG. PARENTS THOUGHT THIS WAS PROBABLY A HEMATOMA SECONDARY TO VACCINATION.  NEVERTHELESS, THERE WAS NO FEVER AT THE TIME, NO RASH, OR OTHER SYMPTOMS OF NOTE.  SLOW RESOLUTION OF THE SWELLING IN THE RIGHT ANTERIOR THIGH WITH FINAL RESOLUTION.  AT THIS POINT HE WAS NOTED TO HAVE A WELL-CIRCUMSCRIBED DEPRESSED ARE OF APPROXIMATELY 5 CM IN DIAMETER AT THE INJECTION SITE.  THIS HAD A SLIGHTLY BLUISH-PINK DISCOLORATION.  ASCENDING FROM THIS LESION WAS A LINEAR DEPRESSION EXTENDING TO THE PUBIC SYMPHYSIS SUGGESTIVE OF MUSCULAR ATROPHY.  LESIONS ARE NON-TENDER AND GAIN IS NORMAL.  NO OTHER SYMPTOMS OF NOTE. OF NOTE OLDER BROTHER ALLEGEDLY DEVELOPED SIMILAR LESION FOLLOWING AN INJECTION (NOT VACCINATION).
Pt lethargic, fever, loss of appetite and localized pain at site of injection on day after vaccine (Td) in left upper arm, IM, 12-2-09 3:00pm.
Received 1st Vaccination on 2/4/21. Started to get severe back pain on left about a week after 1st injection about 2/11/21. Received 2nd Pfizer Covid-19 injection on 2/25/21. On 3/3/21 was sent to ER by my PCP  based upon abnormal Blood Work on 8/26/21. Found to have Staph infection in lower back and Sepsis.  Had fver for several days after admission, don' know temperature. Treated with antibiotics and had drain inserted into my back. Release from hospital on 3/11/21. Was treated with injection of Cefazolin 3 times per day for 6 weeks until 4/23/21. Drain was removed on 3/23/21 at hospital.
sore arm post vaccination/ injection arm soreness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm post vaccination/ injection arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19; and since the vaccination, it was also unknown if patient has been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Events took place after use of product.  No follow-up activities are possible; information on the batch/lot number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Medium
I noticed tinnitus in my left ear within 2 hours of receiving the vaccine in my left arm.  Today, one week later, it continues.  It is a high pitched ringing in my left ear.  This is not normal for me at all.
25APR96 cold sx, low grade fever;26APR96 recv vax & arrived @ ER 3AM on 27APR;had 2 probable sz @ home w/stiff posture, eyes rolling back in head, gentle quivering x 20sec;t106.5 R in ER; confirmed w/2nd thermometer; lt OM;
I had a sore arm after receiving the vaccine and it was warm to the touch. On 12/04/2022, I began feeling sick with cold like symptoms with a sore throat.  My symptoms stayed the same for several days and I had a terrible cough.  I went to an urgent care and received a prescription for Zithromax and a steroid. I went to my doctor on 01/03/2023 because I could not smell or taste. I was sick for six weeks, but I never tested positive for COVID-19.
Severe headache  withe fever chills body ache. Vomiting  diarrhea. 2nd day skin felt like needles all over. Pain in neck over collar bone fever gone. 3rd day severe pain and swelling  under right arm pit and breast. 4th day same 5th day much better.
No adverse reaction happened following administration or follow-up period Patient was given a vaccine that had expired on 9/30/22 on 10/7/2022