chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINGLING IN LEFT ARM FROM LEFT ELBOW TO LEFT HAND; WEAKNESS; DULL NERVE PAIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced dull nerve pain. On 01-JUN-2021, the subject experienced tingling in left arm from left elbow to left hand. On 01-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and tingling in left arm from left elbow to left hand, and the outcome of dull nerve pain was not reported. This report was non-serious.
Complaining of itching and warmth which started 3-4 days after receiving first dose of Moderna vaccine.
Received fourth Anthrax vaccine on 4/5/99, pt began to experience pain in right elbow on approximately 5/15/99. Evaluated by MD and thought to be tendonitis.  Sx's improved but not completely resolved
FEVER, CHILLS, MYALGIA, ARTHRALGIA, HEADACHE, NAUSEA, DIZZINESS, INJECTION SITE PAIN, EYES MATTED, RED AND BURNING  Narrative: Temperature 102.5, all symptoms described as severe by patient: took acetaminophen 1000mg alternating with ibuprofen 400-600mg; missed 2 days of work Patient had a similar, but less severe reaction to the first dose of Moderna COVID vaccine on August 17, 2021 (see previous report)
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of MENACTRA (batch number, expiry date, dose, route and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. Documents held by sender: none.
Pain at injection site, itchiness at injection site, redness at injection site on left arm.   Fully resolved of issues.
On that Saturday, I had hives on my back, tummy and right shoulder. I found some Benadryl and peppermint oil for symptom relief. The Benadryl didn't help but the doctor said to try Tagamet. On Feb. 3, I reached out to the doctor and told her it wasn't working and she prescribed a Medrol dose pack and told me to keep taking the other medication as well, as long as I didn't have problems with it. It started to get better but I still had hives after the medication. I was no longer as miserable as I was. The doctor also said to add Samotidine to the cetirizine that I already take and I did that until it went away.
17 days after receiving this vaccine I developed Dermatographia. I'm having hives and dark red scratches show up on my neck, stomach, and back. For example, I'll wake up in the morning with itchy red hives all over my neck from my shirt pressing against it. Even pressure from my clothing will cause it.   I treat the hives with hydrocortisone ointment and benadryl. But they still keep coming back day after day. I'm very worried the symptoms will continue to persist.
Pt presents at clinic today for second Pfizer vaccine, pt states to vaccinator RN after first vaccine she did experience itching after she left clinic, she self treated with Benadryl po for two days at home, symptoms were relieved. Pt was in monitoring setting and notified this nurse she was beginning to itch. Standing order received from pharmacy @ 9:34 Benadryl 25mg po x1 dose given. Pt monitored, no other s/s noted. Pt states@ 9:49  she wants to leave with family, she has husband as driver, she was educated on adverse reactions and instructed to go to ER if s/s worsen, pt acknowledged and agreed. Pt left clinic ambulatory with family. lpn
Metallic taste in my mouth; Mild face swelling; This is a spontaneous report from a non-contactable other health care professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL9265 Exp Date:not reported),via an unknown route of administration in right arm (at the age of  39-year-old) on 27Jan2021 at 4pm at a single dose  for COVID-19 immunization. Medical history included asthma, obesity and post-traumatic stress disorder, all from an unknown date and unknown if ongoing. Patient has allergies with bee stings from unknown date and unknown if ongoing.  It was also reported that prior to vaccination, the patient was not diagnosed with COVID-19. Patient was also reported not to be pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and ibuprofen (MOTRIN), both taken for an unspecified indication and start and stop date were not reported.  Patient previously received Hepatitis A vaccine and had allergies. The patient experienced mild face swelling at 4:45pm (about 45 minutes after injection, as reported) then she had a metallic taste in her mouth that started about 6:30pm (about 2.5 hours after injection) and lasted until about 8 pm. She reported that she could still taste the food. Patient  has not been tested for COVID-19 since vaccination. The outcome of mild face swelling  was recovered on an unknown date while metallic taste recovered on 27Jan2021 at 8pm.   No follow-up attempts are possible; information about lot/batch number already obtained
diarrhea; sore stomach; sore injection site; heart started to beat like crazy; started to get harder to breath; A spontaneous report was received from a consumer who is a 73-year-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site soreness, difficulty breathing, increased heart beat, diarrhea, and stomach soreness.  The patient's medical history was not provided. Concomitant medications included losartan, acetylsalicylic acid, hydrochlorothiazide, pravastatin, amlodipine, and combination of amoxicillin trihydrate, clarithromycin, esomeprazole magnesium.  On 15-Feb- 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15-Feb-2021, the patient experienced the events injection site soreness, difficulty breathing, and increased heart beat. On 16-Feb-2021, the patient experienced the events, diarrhea and sore stomach.  Treatment details included bismuth subsalicylate.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events injection site soreness, difficulty breathing, increased heart beat, diarrhea, and stomach soreness was considered resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sore arm, fatigue, weakness, muscle pain, joint pain, back pain, chills, sweats nausea
This spontaneous report was received from a field representative and refers to a 11-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. The patient had blood drawn on 17-AUG-2018, prior to receiving vaccination. On 17-AUG-2018, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). After the vaccination, the patient reported feeling lightheaded and laid down in the unspecified office for 30 minutes. No treatment was given for the event. The patient had recovered on the same day, 17-AUG-2018. The causality assessment between the event and GARDASIL 9 was not reported.
fever 105-0130, irritable, sore legs; pt recvd vax 1115AM mom gave 1 dose of APAP @ same time; pt irritable & feverish through afternoon & evening per mom;
After patient was given booster, pt felt light headed and eyes rolled back. Eventually passed out and regain consciousness after 1 minute. 911 was called and paramedics came and evaluated pt. pt decided to go to the hospital.
About 1 hour after injection, i had a small bump at the injection site. That evening it was swollen and warm to the touch and the bump was larger. I went to bed and woke up the next day and the bump was larger, red, swollen feels a little hard. This is my 3rd day and the bump grew in size again but now its itchy around the outside of the bump.
he still has a pretty good cough; fatigued; he tested positive on August 10th; chest congestion; we thought it was a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (we thought it was a sinus infection), COVID-19 (he tested positive on August 10th), CHEST DISCOMFORT (chest congestion), COUGH (he still has a pretty good cough) and FATIGUE (fatigued) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus, DULAGLUTIDE (TRULICITY) for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced SINUSITIS (we thought it was a sinus infection) and CHEST DISCOMFORT (chest congestion). On 10-Aug-2021, the patient experienced COVID-19 (he tested positive on August 10th). On 19-Aug-2021, the patient experienced COUGH (he still has a pretty good cough) and FATIGUE (fatigued). At the time of the report, SINUSITIS (we thought it was a sinus infection), COVID-19 (he tested positive on August 10th), CHEST DISCOMFORT (chest congestion), COUGH (he still has a pretty good cough) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID. On an unknown date, Oxygen saturation: 95 (normal) 95.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Three         Large red areas underneath injection site.  First one on February 9, second one February 10 and third one February 11.  No swelling or heat.  No itching
Redness, hardness, and warmth in the area of the vaccination (upper left arm)
Patient began severe itching with redness to left arm, across chest and going up neck. Mom administered Benadryl 50mg po at 10:06 AM. Child presents back to health department.  Benadryl 25mg po at 10:25 AM.  Red rash to neck, arms, chest, abdomen and back. No whelps or difficulty breathing noted.
Information has been received from a physician concerning a male patient who was vaccinated SC with a dose of Zostavax. It was reported that the patient "broke out in a rash" after vaccination. Patient was treated with valacyclovir hydrochloride (VALTREX) by another physician. The reporting physician did not think that rash was shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
had received doses from vials that had exceeded the 30 day refrigeration limit/  Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had received doses from vials that had exceeded the 30 day refrigeration limit/  Received Expired Dose of Vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (had received doses from vials that had exceeded the 30 day refrigeration limit/  Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (had received doses from vials that had exceeded the 30 day refrigeration limit/  Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
DONOR FELT PAIN IN HIS LEFT ARM AT THE INJECTION SITE ON 05-09-19, WHEN HE RUBBED HIS ARM  HE FELT A KNOT.  NO TREATMENTS HAVE BEEN DONE. DONOR STATED THAT HE WILL GET IT CHECKED OUT THIS WEEK.
PFIZER COVID VACCINE #3 GIVEN 8/24/21, LOT #FD8778; pt had a positive COVID test; 10/5/21 pt admitted to hospital with progressive dyspnea and left sided chest pain, no radiation; given O2, Decadron, ABX, DVT left subclavian vein; O2 requirements increased; given Remdesivir, baricitinib; CXR showed worsening bilateral infiltrates; placed on Optiflow; transferred to ICU; required NRB in addition to maximum Optiflow; condition worsened; hypotensive; significant hypoxia with movement; comfort measures instituted; suffered cardiopulmonary arrest and passed away in the hospital
Pt fainting after influenza injection. Passed out approximately five times within a 20 minute period. Called 911 and paramedics took patient to hospital.
Red, hot rash spreading from the vaccination site up/down arm.  Started 2nd day post-vaccine. Continued to get worse, so called doctor on 7th day. First doctor prescribed antibiotics thinking it was cellulitis. Seemed to get better, then started spreading again on 10th day. When it started spreading again, second doctor had me take Benadryl + Famotidine. Finally seemed a bit better 14th day, but did not fully clear up until 21st day.
Patient returned to pharmacy on 9/1/21 stating she had the following symptoms evening following vaccination:  extreme swelling, red,  large knot at injection site (size of golf ball).  Patient states that symptoms started to improve after one week.  As of today, small amount of swelling remaining.
On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE RASH ((Rash ) Injection Site). At the time of the report, VACCINATION SITE RASH ((Rash ) Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
7min p/vax pt c/o dizziness;BP 76/50 (pt states nl BP 80/50) P52, 02 sat=100%;pt called MD 6hr later c/o throat closing sensation;pt states tingling in lips & h/a began w/in 30min of inj;pt did not seek medical attention;
swelling on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on my left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on my left arm). At the time of the report, PERIPHERAL SWELLING (swelling on my left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information include antibiotics.
Urticaria (on back of neck, bilateral arms), upper lip swelling and scratchy sensation in throat. Consistent with anaphylaxis.
Itching of chest, arms and back about 10 min after Fluzone vaccine. Benadryl 25mg PO given. Episode resolved 30-45 min after Benadryl.
Loss of appetite; high fever; chills; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient had no history of COVID-19 diagnosis.  Concurrent medical conditions included Type 2 diabetes mellitus, Mitral regurgitation, Irritable bowel syndrome, Blood pressure high, Drug allergy (codeine allergy), Drug allergy (Miralax allergy) and Drug allergy (magnesium citrate allergy).    On 27-Oct-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received previous Moderna doses first Dose: 17-FEB-2021 Lot 071F21A, second Dose: 17-MAR-2021, Lot 044A21A. It was reported that the patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F. She would stay at home and in bed when she did not feel well after the vaccinations. Patient received fourth dose on 20OCT2022, Lot: 049D22A and fifth dose on 26-OCT-2023, Lot A02920B. No treatment medication reported.   This case was linked to MOD-2023-747880 (Patient Link).
Left upper arm pain, swelling, Erythema and tenderness 2 days after immunization.
initial shot 3/9-diarrhea began the day after vaccination and is still occurring today. Rashes began appearing  on both breasts as well as arm pits and arms. The rashes are gone but the diarrhea is occurring daily. Arm pain in both injection sites is still occurring but not daily or constantly, only on occasions.
redness; itchy; inappropriate age at vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 44-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erythema of extremities, injection site itching and inappropriate age at vaccine administration. On an unknown date, the outcome of the erythema of extremities and injection site itching were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the erythema of extremities and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received their first dose of Shingrix a few days ago and developed a red and itchy area in the injection site, and the redness has spread down her arm.  The redness on patients arm was receding a bit on her arm, but the symptoms around the injection site had remained the same since. The provided date of birth of the patient also indicates that the patient was younger than indicated, which led to inappropriate age at vaccine administration The reporter consented to follow up. The lot number was uncertain (wasn't available in documentation). A possible lot number 4257F was provided. The reporter gave Permission for follow-up.
Pain in the arm radiating to the fingers, right chest wall tightness, vision went "yellow" with fatigue for about an hour.  After the vision returned to normal, experienced fatigue with sedation and nausea and loose stools the next day.  She reported feeling hot, but did not have a thermometer.  She was evaluated by me the day after the event with some mild residual fatigue, loose stools, and soreness at the injection site with inability to lift arm over shoulder height.  Symptoms improved from the day of the injection.  BP 110/80, P 60 R 14, lungs clear, mouth moist, no local induration or erythema at site of injection. Pt instructed to return for follow up next drill weekend - end of August, and to see primary care provider sooner if worsens, or fails to improve in 1-2 weeks.
Patient called one week after receiving vaccine and reported that about 4 hours following her dose she started experiencing some swelling of the neck and face that lasted about 45 mins before subsiding.  States she also developed a fever and "felt crappy".
Decreased appetite; 16 year old patient was accidentally administered the 1st Moderna Vaccination; Developed low grade fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Decreased appetite), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was accidentally administered the 1st Moderna Vaccination) and PYREXIA (Developed low grade fever) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DECREASED APPETITE (Decreased appetite), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was accidentally administered the 1st Moderna Vaccination) and PYREXIA (Developed low grade fever). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was accidentally administered the 1st Moderna Vaccination) had resolved. At the time of the report, DECREASED APPETITE (Decreased appetite) and PYREXIA (Developed low grade fever) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.