chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash was getting progressively brighter red; looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water; rash around her bronchial/chest area; bruising at the injection site; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water), ERYTHEMA (rash was getting progressively brighter red), VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (Chronic Obstructive Pulmonary Disorders.) since 11-Aug-2021. Concomitant products included Zatidor eye drops for Allergy, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE FUROATE (ARNUITY ELLIPTA), MONTELUKAST, CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) and LORATADINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness). On 05-May-2021, the patient experienced ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water) and RASH (rash around her bronchial/chest area). On 20-May-2021, the patient experienced ERYTHEMA (rash was getting progressively brighter red). In April 2021, VACCINATION SITE BRUISING (bruising at the injection site), HEADACHE (headache) and FATIGUE (tiredness) had resolved. At the time of the report, ACNE (looked like blood vessels had popped and turned into little red pimples that hurt/stung when touched or came in contact with water), ERYTHEMA (rash was getting progressively brighter red) and RASH (rash around her bronchial/chest area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.         She was allergic to thimerosal and also She had numerous allergies.  She was prescribed a steroidal cream by the dermatologist on 05/Aug/2021. She was only to use it for 2 weeks. Since starting the cream, a lot of the deep redness was going away. No one knew what caused the rash or exactly what it was. They described the diagnosis to her as little baby spider veins that when touched explode and become a red dot. patient saw the pulmonologist yesterday and he poked the rash and created a red spot. Her next step was a biopsy.   This case was linked to MOD-2021-283915 (Patient Link).   Reporter did not allow further contact
Chills, Body aches, Head aches, fatigue began evening of 12/22 and lasted 24 hrs
About 60 hours after vaccine developed elevated heart rate (into 90s) and irregular beats.  This lasted 6 hours and resolved.
received a dose of expired Daptacel; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 2 months and 17 days old male patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] VACCINE lot C5202AA via intramuscular route in the left thigh on 24-Jun-2019.  The patient's medical history not reported and concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) via oral route for unknown indication.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
had Large swelling on the opposite armpit; large swelling underneath the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (had Large swelling on the opposite armpit) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Swollen lymph nodes.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (large swelling underneath the site of injection). On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (had Large swelling on the opposite armpit). At the time of the report, PERIPHERAL SWELLING (had Large swelling on the opposite armpit) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Computerised tomogram: swollen lymph nodes (Positive) which revealed swollen lymph nodes on the same area but he mentioned that this is unrelated as he has other medical conditions..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-396542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: The follow-up document contains No New Information.
I awoke in the evening and walked to the bathroom. I could not walk a straight line! This happened twice, and I awoke and was still dizzy. About noon it got better, but I did not feel well - could not function as normal, until evening.
Redness, warmth to area, redness size about 2" in size elongated. Had some hives go down her arms no fever. Took some BENADRYL for hives.
VACCINE GIVEN 3-9 MINUTES AFTER THE 6 HOUR OF IT BEING PUNCTURED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-DEC-2021, the patient experienced vaccine given 3-9 minutes after the 6 hour of it being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given 3-9 minutes after the 6 hour of it being punctured was not reported. This report was non-serious.
screaming episodes lasting 2-3 hrs, evening & noc p/vax; began 1 1/2 hrs p/vax over 48 hrs; temp remained between 103 R, 104 R w/APAP;
Approx 24 hrs after immunization had prolonged (15 min) afebrile, generalized seizure required meds, intabatin, ICU admission. 12/8/08-records received for DOS 11/13/08-presented to ED with C/O multiple seizures. Tonice-clonic seizure and multipe seizure per EMS. Unarousable. Intubated. DX: Status epilepticus. UTI. transferred.  1/23/09-records received for DOS 11/13-11/14/08-DC DX:New onset afebrile seizure. Post-ictal and intubated due to deteriorating mental status and poor airway protection. Agitated, vomited. Subsequently extubated. Sleepier day of vaccination.
5 x 7 cm area of erythema & induration. Serous d/c from injection site. No systemic fever. Tx: steroid cream, ice, ADVIL.
Patient death from COVID after full vaccination series of COVID vaccines ? Vaccines o 03/03/2021 Pfizer Lot EN5318 o 03/24/2021 Pfizer Lot EN6204 o 11/18/2021 Pfizer Lot FH8028
Patient with no history of urticaria began having chronic severe, random urticaria 1 month after finishing the pfizer covid series.  The urticaria has continued for 5 months and is not abating.
On 28 April he received Anthrax vaccine (dose #10) in his left deltoid and approximately 24 hours he noted redness, swelling, and warmth surrounding the vaccination site which extended from his shoulder over his bicep. He denies fever/chills, fatigue, malaise, arthralgias/myalgias, painful/swollen joints, generalized rash, pulmonary symptoms, GI symptoms, and neurologic symptoms. He feels the redness is improving. He says no reaction to prior vaccination.
Fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:00 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Caller says that her Pfizer COVID-19 vaccine card is handwritten and does not provide NDC/EXP. Caller says she got her first dose 04Mar at 10:00AM injected in her left arm. She says that her body aches started this past Monday, she thought it was the weather, and then last night she had a fever that did not last very long, and today she is fine. She says it had gradually progressed over Monday and Tuesday from body aches to something else, then she had a fever last night and that did not last too long. She says that her temperature was about 100 degrees Fahrenheit, though it may have been a little over. She says on Monday, Tuesday, and Wednesday she took Tylenol for the body aches. She says for the fever she tried not to because she wanted to see if it would leave on its own, so she did not take Tylenol during the night and when she checked her temperature it was back to normal without Tylenol, then she didn't take Tylenol today. She says that the dosage for the Tylenol she took was two normal Tylenol over the counter, she does not know dosage, it is the normal stuff. Tylenol UPC/LOT/EXP: Not provided. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit on. Therapeutic measures were taken as a result of body aches (pain). Caller says she did not see any information on the website, which that is the reason she called today, to ask is this normal or has anyone else had this. Caller says she does not wish to answer any more report questions. No further details captured, reported or documented at this time. Outcome of the events was recovered on unspecified date of 2021 No follow-up attempts are possible; no further information is expected.
About 4-5 hours later, spiked low grade fever, she felt SOB, chest heaviness, right arm heaviness, swelling and weakness. She traveled via ambulance and admitted for 7 days Symptoms: FEVER, UNSPECIFIED, CHEST PAIN, UNSPECIFIED.
Sore arm; Significant fatigue; Muscle aches; A spontaneous report was received a nurse concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity, significant fatigue/fatigue, muscle aches/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event(s) sore arm, significant fatigue, muscle aches which lasted for 6 days.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   On 4 Feb 2021, the outcome of event(s), sore arm, significant fatigue, muscle aches was resolved.
Arm was sore to move. Site of injection became swollen and hard. A red bullseye the in about a 1" diameter formed in a rash like manner around injection site. Was hot to the touch and very painful.
weakness in arm and legs occurred 12 hours after the vaccine and lasted for approximately 10; weakness effected the left leg the most; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in arm and legs occurred 12 hours after the vaccine and lasted for approximately 10) and ASTHENIA (weakness effected the left leg the most) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arm and legs occurred 12 hours after the vaccine and lasted for approximately 10) and ASTHENIA (weakness effected the left leg the most). On 11-Mar-2021, MUSCULAR WEAKNESS (weakness in arm and legs occurred 12 hours after the vaccine and lasted for approximately 10) and ASTHENIA (weakness effected the left leg the most) had resolved. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   This case was linked to MOD21-053599, MOD-2021-044549 (Patient Link).
Excessive ear wax production; acne; immense pain at injection site and in shoulder of that arm; nausea; excessive hunger; feeling/acting inebriated
Patient received DTaP+IPV after age 7 when she should have received Tdap
Pfizer vaccine was administered outside of our facility - reported by patient  I21.19 ACUTE ST ELEVATION MI, INFEROLATERAL WALL 7/5/2021 ST ELEVATION MI INVOLV OTH CORONARY ART INF WALL
Information has been received from registered nurse concerning her 16 year old daughter who had no significant medical history or allergies who on 7/31/01 was vaccinated with the first dose of hepatitis A virus vaccine inactivated. There was no concomitant therapy. The patient's mother indicated that her daughter was vaccinated with a dose of hepatitis A virus vaccine inactivated from a recalled lot (lot # not provided(. The patient's mother reported that on 10/10/03, her daughter's hepatitis A titer was negative. Unspecified medical attention was sought. A repeat hepatitis A titer was again negative. At that time, a two shot series of hepatitis A virus vaccine inactivated was restarted. At the time of this report, the outcome is unknown. The RN also reported that she and her other daughter were also vaccinated with a dose of Hepatitis A virus vaccine inactivated from the same recalled lot, but have not had titers drawn. No further information is available.
Fatigue,  aching joints, headache,  slight fever, sensitive skin. Slept most of 36 hours, then was fine.
Patient's parent documented DOB as 11/25/2008 on consent form. Patient's true DOB is 11/25/2009. Patient received Pfizer 12+ about 3 weeks before 12th birthday. Error discovered months later by web server. Phoned patient's father to confirm true DOB. He reported patient did not experience any adverse effect. Noted that the purpose of the call was to close the loop to document the error and confirm no adverse event occurred, noting the possibility of myocarditis.
sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The reporter (patient's wife) stated that she felt a sting when the needle went into her arm, but she did not feel anything else stating her husband had a sore arm. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.; The pain at the injection site was more severe than the others; I had mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.), INJECTION SITE PAIN (The pain at the injection site was more severe than the others) and VACCINATION SITE PAIN (I had mild soreness at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (I had mild soreness at the injection site). On 25-Sep-2021, the patient experienced INJECTION SITE PAIN (The pain at the injection site was more severe than the others). On 27-Sep-2021, the patient experienced TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.). At the time of the report, TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.), INJECTION SITE PAIN (The pain at the injection site was more severe than the others) and VACCINATION SITE PAIN (I had mild soreness at the injection site) outcome was unknown.            No Treatment medications were reported. Events included: (1) The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation  (2) As I move them around, it seems like the blood starts circulating again.   This case was linked to MOD-2021-333396 (Patient Link).
Pt vaccinated on 10/20/03. Received PCV-7 to RL and Fluzone to LL. Pt RTC on 10/22/03 with localized reaction on right thigh. Onset of reaction was 10/21/03. Mom stated it was swollen, red and warm to touch 1 day after PCV-7. Dr made aware of reaction after shot. No recommendation given states parent. 10/22/03 observation: noted 5cm x 2cm reddened area on right thigh. Not warm to touch. Child no c/o pain with examination of area. Advised warm compress to site, seek MD recommendations on Benadryl. Exam performed by RN.
Patient felt weak, blurry vision, low blood pressure starting 10 minutes after vaccination and for the following 10-15 minutes.  Patient rested in a chair, was given juice and recovered.
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 20-JAN-2022, the patient was vaccinated with improperly stored (temperature -14.1 Celsius degrees, time frame: 12 minutes) varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023 (route of administration were not provided) for prophylaxis, (Product storage error). No additional adverse event was reported (no adverse event).
FIRST ONE NO SIDE EFFECTS SECOND ONE - WOKE UP AT 2:00 AM TERRIBLE HEADACHE & FEVER CHILLS & SHAKING - 102 HORRIBLE ACES WRIST, FINGERS, ARMS, BACK, LEGS, FEET TOES, NECK & HEAD RIBS & STOMACH MUSCLES, COULD NOT WALK OR SIT UP LOST CONTROL OF BLADDER & BACK EXTREMELY BAD NO CONTROL OVER LEGS & ARMS TOOK THURSDAY 3-11-21 10:30AM THRU SUNDAY 3-14-21 TO RECOVER   2 DAYS IN BED IT WAS SO AWFUL IF I HAD KNOWN WOULD NOT HAVE DONE!
Patient received SHINGRIX vaccine on 11/15/2018. The next morning she awoke with chills and nausea and feeling her head was heavy. She then had a syncopal episode. No cardiac or neurologic symptoms, no other new meds. Pt was found by housekeeper and EMS was called. They evaluated her and told her glucose and EKG was fine- they advised ER visit which she declined. I evaluated her in office but by this time was completely asymptomatic. She has never had a prior syncopal episode.
Info has been received from a physician concerning a 32 year old male with a history of a renal and pancreas transplant and renal failure who in 5/06, was vaccinated with a dose of MMRII. Two weeks later, in 6/06, the pt developed fatigue, fever and viral syndrome and was hospitalized. The pt was discharged on 6/21/06. On 6/27/06, the pt was admitted to a different hospital where he remains with fatigue. There was no product quality complaint involved. Additional info has been requested.
Left arm extremely sore (interfered with sleep, feels like a significant shoulder/arm injury). Extreme headache. General muscle soreness and joint aches and pains. Significant nausea. Pain going down left leg. Fever/chills. Curled up on couch sobbing from pain.
Patient reported on April 4, 2011 experiencing "difficulty raising her arm, tingling, and discomfort" starting the same week as receiving the vaccine.  She stated she has applied ice/cool compress to the area and has taken acetaminophen since without relief.  She also states she has seen a Chiropractor who told her he thought a nerve may have been affected at the injection site.  She reported temporary relief from the Chiropractic visit but the problem persists.  I advised contacting her primary care physician and keep me aware of any developments.
On 2/25/21, two days after receiving this 2nd COVID injection, he developed right leg pain/discomfort (medial thigh and medial posterior calf), which lasted for 10 days, then developed a right foot drop that worsened for one week (worse at about 19 days after the vaccine where he had trouble walking because he could not keep his foot dorsiflexed due to weakness - not pain), then gradually improved.  By the time I saw him on 3/23/21 the leg discomfort and foot drop had mostly resolved but was still present.  Denies trauma or any other sxs. [ Of note, he had is first COVID vaccine on 1/14/21 and 10 days later was admitted to medical center with hypoxia and DOE, dx with acute hypoxic respiratory failure due to COVID pneumonia and requiring HFNC, discharged after one week.]
Vesicular rash to right wrist and both knees. Itching, no fever, no sign of pain, no breathing difficulty. Slight rash to both thighs near vaccine administration site.
Within a week of the vaccine, the back of my left knee started to hurt, and I had a really sharp shooting pain in the back of my calf muscle that shot down into the calf muscle. It felt like it split into pieces. It's still hurting behind my knee. I am having trouble walking on my left leg. My mobility is not what it used to be. I started trying to do massage therapy on my leg, but it did not help so I scheduled to see the orthopedic doctor. Tomorrow I have a massage therapist coming to my home to complete a massage. The doctor said there were no tears in my meniscus, but he did see fluid under my kneecaps.
Flu-like. Soreness, exhaustion, fever. Spent all day in bed, for two days after vaccine. (Strongest time period was between 48-60 hours after vaccination)