chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm calling my arm swell like; My bones I can hardly move are swollen; My hands and I can hardly move; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164) via an unspecified route of administration in left arm on 20Apr2021 (at the age of 54-year-old) as dose 2, single for COVID-19 immunization Patient medical history include congestive heart failure myopathy (heart patient). Concomitant medication includes ACETYLSALICYLIC ACID (ASPIRIN) Batch/lot number: Unknown), Unspecified medication (Isotropin (Not further clarified hence captured as Unspecified Medication in tab), Batch/lot number: Unknown. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E46198) via an unspecified route of administration in left arm on 30Mar2021 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. On unspecified date she had side effects after 2nd shot in April. Patient had her arm swell like and bones hardly move as they are swollen. Her hands and she can hardly move. Patient states Isotropin and Aspirin, I'm allergic to those. I cannot take those. Patient have allergy to 'Isotropin' and Aspirin. The clinical outcome of the event was unknown.   Follow-up (05Jul2021): Follow-up attempts completed. No further information expected
The injection itself was extremely painful; Burning feeling, while it was being administered; This case was reported by a nurse and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and burning sensation. On an unknown date, the outcome of the injection site pain and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain and burning sensation to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that the injection itself was extremely painful, in addition to a burning feeling, while it was being administered. The nurse giving the injection stated that this vaccine is always extremely painful to patients. The patient wanted to know that neither  Z-track method or changing the needle after reconstituting the vaccine was mentioned in the Shingrix video or insert also will lyophilized antigen Ig used to reconstitute Shingrix interfere with an IgE blood level test which was drawn the same day?
Site of MMRV presented to Dr 4/30/15. Dr. considers it side effect, no adverse event. Fever, rash, swelling.
Pt. states that after receiving the 3rd dose of Pfizer 08/30/2021, started experiencing symptoms that evening of arm soreness with neck pain continuing to current. Ear ache lasting 3 weeks before subsiding. No noted Primary visit/communications.
fainted; lost consciousness; weakness; concussion; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6198) on 09Feb2021 in left arm at single dose for COVID-19 immunisation. Medical history was none, unknown if known allergies. No covid prior vaccination. Concomitant medications were none (no other medications in two weeks). No other vaccine in four weeks. The patient was not pregnant, was not pregnant at time of vaccination. No covid tested post vaccination.  The patient received first dose on 09Feb2021, on 28Feb2021 05:00 PM, experienced weakness fainted, lost consciousness, diagnosed with concussion. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Unknown if treatment for the events. Outcome of the event was not recovered.
severe pain in body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe pain in body) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (severe pain in body). At the time of the report, MYALGIA (severe pain in body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to MOD21-084369 (E2B Linked Report).; Sender's Comments:  MOD21-084369:
Pt fell down after receving the flu vaccine on the righ arm. Fell down on  his face, pt felt lightheaded right after receiving the flu vaccine. "Nurse observed shaking of patient's body described as like having seizure".
Nausea for roughly 6 hours, arm extremely sore and stiff for about 24 hours, headache for about 8 hours.
Injection site swollen with redness, itching & site pain. Swollen area feels hard underneath & painful to touch. Redness in a circle on arm with injection site in the middle. Redness area feels warm to the touch, like feverish.  Noticed day after vaccine injection. Was 2nd dose of Moderna vaccine. This did not happen after 1st dose.
After 10-11 weeks of my 4th dose I came down with Sinus infection. In the morning around 8:00AM I had headaches, severe sinus congestions/ pressure, slight fever, runny nose and immediate laryngitis. My voice came back to normal on Jan 03/2023. I did a telehealth with my doctor on 12/28/2022. I was prescribe with doxycycline, fluticasone, and a decongestant for 10 days.
Patient admitted on 5/1/2021 for centrilobular emphysema within 6 weeks of receiving COVID vaccination.
Appox. 35 days after receiving second Moderna vaccine I developed severe headaches.  No hx of headaches in the past.  The headaches continued every day.  I was seen multiple times by urgent care and my doctor and treated for various things as they didn't know what was causing the headaches.  Then on June 1 I lost sudden onset of vision on the bottom of my right eye.  Then one week later lost vision in my left eye.  I was seen by retinol specialist and dx with new onset NAION in both eyes. TIA July 11, and full CVA on July 12th admitted to hospital with confirmed CVA.    I now have left sided weakness and my vision will never return according to my retinal specialist. I am having to do physical, speech, and occupational therapy multiple times per week.  Multiple visits with neurologists/retinal specialists/primary care.
It started out as a sore throat the night before and became like a sinus infection the next day. I was feeling extremely tired and I felt like I was not in my body. I was stiff all over, hard to walk around. Lack of appetite and I was very thirsty. It gave my mouth a metallic taste and I had a sick feeling in my stomach. I lost my sense of smell and taste. I was extremely tired. Once I started the PAXLOVID I slowly started getting my sense of smell and taste back. I've lost about 13 pounds since I had COVID-19. I was also coughing up a lot of phlegm.
11 year old received adult dose of vaccine ( for pts 12 and older) instead of vaccine approved for pts under age 12.   Pts father stated that he has not had any adverse effects.
PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21.  After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours.  Did not see doctor or other healthcare provider.
Left thigh swelling, erythema begun within 24hr of injection.  Seen in clinic 8/27 concern for Cellulitis and Rx'd Cephalexin
Information has been received from a physician concerning a 15 year old female who on 15-SEP-2009 was vaccinated with her first dose of GARDASIL (lot # not provided). The physician stated after receiving the GARDASIL, within 10 minutes the patient was limp and had an ashy, pale color. The patient was monitored in the office for a short period of time and seemed to have fully recovered. Additional information has been requested.
bilateral lower extremity weakness and difficulty with gait. Numbness of feet and hands. Received intravenous immunoglobulin (IVIG) and improved in her weakness and ataxia. Sensory changes persisted. 2 months later, developed involuntary movements of her arms (pseudoathetosis). Received another course of IVIG and the pseudoathetosis improved.
I noticed I was itchy right below the injection site on my arm in the morning. I was itching it like it was a bug bite. I left it alone for hours, but it is larger and red, a little swollen, and a little bit painful. I took ibuprofen.
Allergic reaction to flu vaccine. Nodule formed within sec. pt was sweating, dizzy, passed out - sweating profusely - called 911 administered EPIPEN 1 shot.
This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 20-APR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 mL, intramuscular, lot # J008799, expiration date 16-APR-2015). Concomitant medications were not provided. No adverse events were reported. Additional information has been requested.
Experienced vasovagal syncope after standing, resulting in fall; Experienced vasovagal syncope after standing, resulting in fall; Awoke with severe chills; nausea; body/muscle aches; body/muscle aches; left arm pain; extreme thirst; fatigue; This is a spontaneous report from a contactable consumer. A 44-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 08Jan2021 14:30 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered was in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021 01:30 am, patient woke with severe chills, nausea, body/muscle aches, left arm pain, nausea, extreme thirst. Patient experienced vasovagal syncope after standing, resulting in fall. Worst symptoms were lasted about 30 minutes, muscle aches and fatigue continue about 16 hours later. All events were reported as non-serious. No treatment was received for these events. Outcome of all events were recovering.
excruciation pain swollen, red shoulder that is itchy red itchy band around arm really itchy redness comes and goes red circle that itches is right below the injection middle of upper arm is itchy
Headache right after for 5 or 10  minutes and it went away. Following day, I had a low grade fever, little body aches. Pretty bad pain in the arm. I couldn't have used my right arm for those two days but I had those two days off.
Child was given Pentacel at age 7 years 5 months - Pentacel is not indicated for this age group.  Our local Health Department was notified of the error by a different pediatric office who the child was transferred to.  We will notify Medical of the error and provide education.
Fatigued, sore muscles, fever of 101.3, chills Only lasted from around 9:00am to 9:00pm.
After the vaccine was given I had a sore arm for a day or two. That was all I had directly from the vaccine. On November 4th I had blood in my urine. I was unable to urinate. I had went to an urgent care. They said it was a bladder infection. I was given antibiotics. On November 7th went back to the urgent care and I was diagnosed with Supraventricular Tachycardia. They sent me to Hospital for 3 days. That cleared up on its own. Because I had blood in my urine I had a cystoscopy so the doctors could look in my bladder. I went to another doctor and had surgery done to remove the tumor on December 15th. After that surgery I started having bronchitis. December 19th I went to urgent care and was diagnosed with bronchitis. I have been taking cough medicine benzonatate up to 200mg and liquid cough syrup Hydrocodone-Homatropine  5mg/1.5mg  of 5 mL syrup at bedtime. I was also prescribed  albuterol sulfate HFA inhaler and depressants. I have recovered from the SVT but I am still having chemo treatments for bladder cancer. I still have a little cough but I'm feeling better.
Mother stated child was at home in bathtub at approximately 08:00pm 06/22/2003 and observed an appropriate 2 x 3in. inflamed area on right upper arm.  Area warm to the touch.  Approximately 3 vesicles present.  Ecchymotis approximately 1cm in diameter noted 2 finger widths below shoulder in deltoid muscle.  Patient treated with antibodies.
Rash on arm near injection site. Pruritic, erythematous rash that appeared 1 day after patient was given a booster shot (3rd does) of Moderna COVID vaccine. Evaluated 4 days after vaccination by virtual visit. Seeing improvement after applying cool compresses, taking an antihistamine, and using a topical steroid cream.
Pt was admitted to hospital on 6/21/2013 to 6/24/2013. Pt had intussusception and no surgery was needed.
Mild fatigue started 4 hours post injection.  Moderate muscle and joint pain with nausea and mild fever started approximately 60 hours after injection and lasted 24 hours.   Mild nausea persisting at time of reporting.
Significant swelling, redness, and tenderness of right arm where Pneumovax was administered IM. Fluzone Quadrivalent was also administered in the same arm. Significant swelling of both upper and lower extremity. Warm to touch. Symptoms appeared soon after receiving vaccine. Per pharmacist advice, patient has been treating with intermittent ice pack and acetaminophen. Symptoms have not improved or worsened as of 10/2/2016.
tested positive for COVID-19; tested positive for COVID-19; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Dec2021 (Lot number: FD7218) at the age of 18 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 17Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing). No known allergies. No COVID prior to vaccination Concomitant medication(s) included: INFLUENZA VACCINE taken for immunization, received within 4 weeks of BNT162B2; ESCITALOPRAM; VYVANSE; TRI-SPRINTEC. The following information was reported: IMMUNISATION (medically significant) with onset 19Dec2021, outcome "unknown", described as "Booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: QuickVue at Home COVID Test: (01Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
pt recv vax; 2 hr p/ vax, fever to 104.2; tremulous, lethargic, cyanotic, fast respirations; possibly post ictal;
I developed a red mark at the injection site that was hard to the touch, hot, and red.  Based on information on the CDC website, it seemed that was expected and that it should not continue to grow past 24 hours post shot.  We circled the red area at 24 hours and again at 51 hours, since in doubled in size during that time period.  It is continuing to expand out of its borders at 70 hours post shot.  It is currently 4 inches in diameter.  Have been taking ibuprofen and applying ice packs.
Patient complains of the following side effects starting 7 days post vaccination: Tinnitus, tingling sensation in ear, and deafness, no pain. Patient was seen by local physician. Prescribed methylprednisolone dose pack and iron.
Client reports the day after her first Shingrix vaccination, she experienced local arm soreness and vertigo sx that began on 12/6/19 and lasted 3 days. Symptoms resolved after 3 days. Per CDC, vertigo is not a contraindication to getting future doses of Shingrix. Informed client it would be recommended for her to complex the Shingrix series. Client agreed to follow-up with dose #2. No further follow-up needed.
Case number PHHY2011US26136 is an initial spontaneous report received from a healthcare professional on 29 Mar 2011. This report refers to a patient of unknown age group and gender. This patient was not given the MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number 024011) on 21 Mar 2011. The vaccine was administered intramuscularly. No other adverse reaction was reported.
At 3:00 pm MST nurse called to waiting area/observation where patient was feeling lightheaded.  Patient sitting up and slightly lethargic, lips and skin palor pale, and eyes closed.  Parents and sisters at patient's side.  Patient able to ingest a juice box while sitting up.  Patient helped onto mat on carpeted floor with second nurse and legs elevated and put on chair.  Smelling salt used to ilicit stronger response from patient.  Patient able to open eyes, converse, and drink second juice box.  Parents stated that patient often feels dizzy after receiving vaccinations, and asked to inform nurses/providers in advance of future vaccines.  After 10 minutes lying on floor, legs lowered off chair.  Patient more conversant and color in lips and face pink and normal.  Patient able to sit up on own without dizziness, and drink a bottle of water and eat a snack (granola bar).  After 5 minutes able to stand up and walk without dizziness and stated he felt 'normal'.  Patient discharged to care of family (parents and 2 sisters) at 3:25 pm without incident.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medication was not provided.  It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 51 doses from Lot AS7140C were administered.   Treatment information was not provided.
SITE OF INJECTION APPROXIMATELY THE SIZE OF A FIST BECAME RED AND WARM TO TOUCH BY 2ND DAY AFTER INJ. PT SAID FIRST DAY AFTER SHOT SMALL REDNESS AT SITE. WORSE ON 2ND DAY AFTER AND LASTED FOR APPROXIMATELY 1 WEEK.
Client was here on 3/14/04, with an interpreter.  She was complaining of pain in her left shoulder.  Stating that this pain started since she received her Flu shot dating 12/17/03.  On arrival, she demostrated limited range of motion in left arm and unequal hand grips with weakness to the left hand. Client did recieve Td (RA), MMR, IPV on 1/15/04.  And the recieved the same shots on 9/30/03(with TD in LA).
1541-patient developed itchy/dry throat, flushed face and upper chest noted Vital signs taken BP-151/104, HR 102, 100 % on RA symptoms persisted-benadry; 50 mg po given as advised MD 1600-patient symptoms improved ,D/C home
Red raised rash at injection sight with blisters. Very painful. needed to sleep with arm raised. Treated w/numbing topical agent. Joint pain , muscle pain, swollen glands.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.96 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Pt complain of pain at injection site since date of injection (9/24/13). She claims pain interrupts her sleep. Also claims that her doctor has done various tests to find out reason for pain.