chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; one dose of improperly stored GARDASIL 9 was inadvertently administered to the one 11-year-old male patient; This spontaneous report was received from a healthcare business professional referring to a 11 years old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.    On 12-JUL-2019, the patient was inadvertently vaccinated with one dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602283, expiration date: 16-AUG-2021, but upon internal validation established as 18-AUG-2021 (dose, unit, and route were not reported) for prophylaxis (Product storage error). There was no previous temperature excursion. The vaccine was exposed at the temperature below 2 degree Celsius (C) (-0.6 C) for 50 minutes. Data digital logger was involved. No adverse effects were reported.
Dizzy; Shortness of breath; major headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), HEADACHE (major headache) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 044A12A) for COVID-19 vaccination.     Concomitant products included ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), HEADACHE (major headache) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), HEADACHE (major headache) and FATIGUE (Fatigue) outcome was unknown.            Treatment medication were not reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with the additional information received on 05-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 08-AUG-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. It was unspecified whether patient had experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total administered to left arm on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced fever of 99.8 F, aches, fatigue and cough (coded as suspected covid-19 infection). Laboratory data included: covid-19 rapid diagnostic test (NR: not provided) positive (coded as suspected clinical vaccination failure). It was reported that the symptoms went away on 02-JAN-2022. The patient currently had scratchy throat and fatigue. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000210193.; Sender's Comments: V0: 20220104880-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Heart palpitations, rapid heart rate, chest tightness, chest pain, lightheadedness/dizziness, nausea. Symptoms varied over the course of approximately two weeks.
pt recv vax 21AUG96 & 10SEP96 pt devel a good number of spots/lesions on face & trunk;according to patient's father some of the spots/lesions had a water head;
PATIENT BECAME LIGHT HEADED, FELT LIKE SHE WAS GOING TO PASS OUT.
MMR (ProQuad) 1 week after vaccine erythema to face/conjuntival injection/discharge bilateral eye resulted in resolve without intervention.
First vaccine: sore arm x 3 days Second vaccine: pain, weakness, joint pain, myalgia, aching, headache, eye pain, fever, foggy brain starting 9 hours after injection to present (0710: 2/11/22)
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Mild, Systemic: Weakness-Medium
Sore arm by 4 pm on day of shot, almost gone at 3 pm the next day. Headache during night one. Body aches on the morning after.  Took Advil and symptoms nearly gone.
About 6 weeks after getting the shot my arm, I began to extremely hurt between the injection site and my elbow. I went to the doctor and they tried a hot compress. The pain went away on its own after 2 months.
Cluster of small erythematous papules R upper chest and RUE lateral to axilla, worsened over next week with extension down R upper arm.
Left leg became really swollen to the point the skin was stretching; Leg was numb; Gums became very sensitive; Developed a rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm). At the time of the report, PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment drugs include Steroid for 7 days for an unknown indication.
EYE PRESSURE; BLOODSHOT EYE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 179 pounds, and height was not reported. The patient's pre-existing medical conditions included patient's race. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021 21:00, the subject experienced bloodshot eye. On 15-APR-2021, Laboratory data included: Intraocular pressure test (NR: not provided) 2-3/10 pressure, 1/10 pressure. On 15-APR-2021 07:00, the subject experienced eye pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bloodshot eye, and eye pressure. This report was non-serious.
Patient developed bleeding in his left eye the day after the injection. He saw a doctor who could not diagnose it. Patient said he had bleeding in his eyes several times but this time was bad.
Four days after vaccine administration, I developed sudden onset of fatigue, dizziness, headache and severe myalgias, had to leave work early.  Had bad chills, diarrhea and loss of appetite on day of onset, no fever.  A day later had severe chills and shakes that were so bad I could not stop them, my wife called an ambulance.  My vital signs were normal, no fever, I did not require hospitalization, I self-medicated with tylenol and ibuprofen, mainly for myalgias and severe headache.  After four days, I am back at work but still have a mild headache.
1/22/21- began having dizziness and Nausea, then had emesis x5. On 2/1 /21 developed positional dizziness which worsened with time, unable to work 2/1-2/5. Seen by my oncologist and urgent care. Now symptoms resolved.
Adverse Reaction Notes; 0920 Throat tightness. Hx of allergies. BP 151/87, HR 66, Resp 17 unlabored, Sats 98%. Refused epi injection reports he has epi pin at home. Stated "it's not that bad". 0930 left ambulating for home accompanied by his son. Stating "if it was going to be bad it would have gotten worse by now". Educated on S/S to seek immediate care for. He verbalized understanding.
Muscle twitching in entire body but mostly in legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs) in a 25-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 (No medical history provided).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs). At the time of the report, MUSCLE TWITCHING (Muscle twitching in entire body but mostly in legs) outcome was unknown. Not Provided      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 concomitant medications were provided Treatment include magnesium.
3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'.  'ALSO NAUSEA AND FEELS DRUNK'.  NO SOB/DYSPNEA. 7:16PM PLACED IN W/C TAKEN TO MEDIC TENT & PLAACED ON CARDIAC MONITOR: NSR NOTED. 7:25PM STATES 'DECREASED NAUSE AND NO CHEST APIN NOW - STILL FEELS DRUNK'. PT DECLINES JUICE AND CRACKERS - STATES SHE WANTS TO WAIT AND TAKE HER DIABETIC MEDS BEFORE SHE EATS'.  7:30PM 'FEELING BETTER' TO EXIT PER W/C TO BE DRIVEN HOME PER DAUGHTER. 3-12-21 1PM TC: STATES 'NO CHEST PAIN , STILL HAS A LITTLE NAUSEA'.
103 fever,, dizziness, weakness, unable to walk or lift arms, shortness of breathe , severe headache  Stayed at doctors office for 1.5 hours, took ibuprofen to lower temp and had to have my husband leave work to come and get me as I was unable to drive.  Woke up in the middle of the night with same symptoms and had to take more ibuprofen
Pt was given vaccines in clinic according to hospital records. Approx 1/2 hour later mother was at home and noticed he became leghargic and apneic, was taken to ER by EMS, is currently in NICU on ventilater. (Mother did not have pink card and didn't know that baby had received immunization in the hospital -- thought we were giving 2mg shot.  Diagnosed with seizures, bradycardia, anemia gastroesopageal reflux, encephalopathy, respiratory failure, R upper lobe atelectasis
Cold sore on outside of lip. It has been over 3 years since I developed a cold sore.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored M-M-R II (lot # K007107, expiration date 16-MAY-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Patient was not feeling well with symptoms starting on 2/8 after receiving 1st Moderna dose on 1/23/21.  On 2/10 the patient's wife had him taken to the hospital for repeated ?falls? and once he was in the hospital, he tested positive for covid-19.  The patient's wife remarked he had tested positive back in December as well while in the hospital.
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of M-M-R II 1 dose, lot number lot M044351 and expiration date 04-NOV-2018 (Albumin status rHa) (strength and frequency were not reported) for prophylaxis which was reconstituted with a sterile diluent (manufacturer unknown) that was not undergo a temperature excursion. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1710USA001694: US-009507513-1710USA001901.
Pain on site of shot. Red rash , itchy. Still have rash  12 days later . Tired
Patient went blank about 2 minutes after receiving vaccine, stated he could not see and was clammy.  Slowly came out of it, was confused Seizure was suspected and EMT was called.  Person with patient stated he had same issue with another vaccine three years ago.  On Immunization questionnaire patient answered no to seizure, brain or nerve problem.  Patient declined EMT, they checked all vitals and they were within normal limts (BP, pulse, respiration etc)
extreme fatigue next day after 2nd dose. lasted about 10 hours. change in smell of urine & feces still continuing. Reporting at doctor's recommendation.
Pt called pharmacy reporting severe arm pain that radiated from shoulder to hand.  She said this pain started in the car on her way home from the pharmacy, approximately 10 minutes after receiving the vaccine.  Pt said pain was so severe she could not grip anything with her hand or even type on the computer. The pain subsided the following day to what she said was an "expected level" for the flu shot.
Client received vaccine around 3:40 PM and at around 3:45 PM said he had left chest and shoulder tightness. At 3:48 PM we called EMS to come check him out. At 3:50 pm his oxygen saturations were 97%, heart rate was 102, and blood pressure was 136/88. EMS arrived around 3:55 PM, provided oxygen, did a quick exam, and transported him to the hospital for further evaluation.
Pt reports numbness on the left side of his face and the fingers on his left hand. He reports this feeling lasted "most of the day, but is better now." He reports he continues to have significant soreness in his left deltoid and states "I can't raise it as high as I was able to before." He denies bruising, but reports a "knot" at the injection site.
Burning and tingling in hands and feet, associated numbness in some distal areas too Occurred two weeks after Moderna vaccine
Pt became short of breath and began to itch and rash. Sent to ER for treatment and evaluation.
Shaking chills, nausea, vomiting, fever 102.6, sudden onset.
employee started to complain of feeling "itchy" about 15 minutes after receiving first dose.   Benadryl 25mg provided and continued to monitor employee.  About 10 almost 15 minutes after the Benadryl, employee continue to complain of feeling "itchy" and stated that he was starting to feel light headed and developing a headache.  MRT (medical response team) was called and the employee was taken to the emergency room.
Patient received an expired vaccine; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine).    No concomitant medication was reported. No treatment medication was reported.
Rash on his chest and neck; This case was reported by a pharmacist  and described the occurrence of rash in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient said a rash occurred on his chest and neck following the first dose.  The reporter said that it sounded like the event occurred within a day or two but she could be certain.  The patient had received the first dose at a different pharmacy therefore the reporter's information was limited. The reporter consented to follow-up but stated that she did not have any additional information to provide.
When shot received it caused pain, unlike the 1st dose, and within 1/2 hour nose was congested and running.  By 6:00 PM,  I could hardly move my arm due to the intense pain.  At 10:30, I was beginning to not feel well overall so I went to bed and by 5:00 A.M. when I woke up, I was feeling worse but thought it would improve since everyone said it was about 4 hours of discomfort before subsiding.  When I reached work at 7:00 A.M., however, I started feeling as though I had the flu.  I had to ask for coverage and to leave (I am a teacher).  I returned home and by 8:30, I had full-blown flu-like symptoms:  high fever, body aches/pain, nausea, headache, chills, very congested and running nose, difficulty breathing, dizziness, pain riveting up my arm into the shoulder, and I had no appetite.  I got the shot on Wednesday and didnt't start to feel better until Saturday.  However now (today, Saturday), I still can't raise my left arm over my head without bad pain and my glands under the same arm are very tender making it further difficult to use my arm while the headache is still lingering as well.  Tylenol has not helped!
On 11/22/00 the results of the tuberculin test were reportedly positive following the receipt of flu shield.
Like a gout attack; Soreness all over; Sweats; Chills with fever/ Fevers; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 2 tablets. On 05-May-2021, GOUT (Like a gout attack), PAIN (Soreness all over), HYPERHIDROSIS (Sweats) and PYREXIA (Chills with fever/ Fevers) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-416215 (Patient Link).
Awoke 12 hours after injection with severe chills, sweating, muscular pain, headache, slight nausea, weakness.  Awake the rest of the night, and had symptoms the next day, Began to abate in the evening.  Mostly gone the second day.
Respiratory issues  Chronic cough after first injection  Swollen lymph nodes near armpit and left breast  Sore throat   This started 3/20/2021. Went to  Care on that day. They gave me prednisone. Had to go back 3/29/2021 with Swollen lymph nodes under my armpit and laryngitis due to coughing.
Patient stated day after vaccines she  developed very heavy bleeding vaginally.  She had her period 1 week prior. her  doctor put her on high dose birth control pills and said if did not work to go to hospital  bleeding did eventually stop
Information has been received from a M.S. concerning now a five year old female who in September 1996 was vaccinated with one dose of varicella vaccine. On 11/23/2000 the pt experienced breakthrough varicella. Subsequently, the pt recovered from breakthrough varicella. Other patients were reported with similar symptoms. No further info is available.
Redness & pain where shots were given. Muscles aches. High fever for days & sweating heavily at night. Severe dry cough with difficulty of breathing, fast heart beat, wheezing, dizziness. Blisters, paleness. Lost of appetite. Sleeplessness. Still have chest congestion with very tick.
Very sudden onset of fever, grunting, crying, lethargy, went to ER. Child f/u in ofc - doing well, no fever, stable.
Sustained high fever (up to 106), severe dehydration, chills, diarrhea, loss of appetite, headache, body aches, joint pain, muscle weakness, swelling and pain at injection site. All symptoms started 12 hours after shot and lasted for 48 hours, with some symptoms (headache, pain, loss of appetite, etc) continuing weeks later
My son was running a fever for approximately 12 hours before event occurred. I had been treating with TYLENOL and his fever was never recorded above 101. At 430 am I was changing his diaper and he started having a seizure that lasted approximately 2 minutes. EMS was called and his condition was stable, so he was transported by us to the emergency room. They concluded this was a febrile seizure likely cased by the varicella vaccine. He was discharged to our care and treated with an alternating TYLENOL/Ibuprofen schedule for 24 hours after discharge.