chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was red and burning; Arm was red and burning; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning). At the time of the report, ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Seizures/tremors multiple times every day beginning 30 hour after vaccination.  On first day of seizures transportation via ambulance to local Emergency Room  was required.  Treatment was prescription of Levetiracetam 1000 mg twice daily, Lorazapam 0.5 mg twice daily, and Potassium Cl 20 meq twice daily.  Outcome is continued seizures multiple times throughout the day, including while sleeping.  Severe headaches, muscle aches, nausea, fatigue (sleeping up to 20 hours a day), unsteadyiness, forgetfulness, and general overall not feeling well.
20-30 red papules- (L) axilla, biceps, groin, thigh- 4-6 more erupted in the following 2 days.
Hospitalized on 3-23-23. COVID 19 was one of the diagnoses. Died in the hospital on 4-10-23/
she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.
the patient did fall asleep; A HCP called and reported an AE where a dose of VARIVAX was administered to a patient after it was improperly stored.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 29-SEP-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 ml (lot number W017551, expiration date reported as 01-JUN-2024) for prophylaxis (strength, and route of administration were not provided) after it was improperly stored (product storage error). The patient did fall asleep shortly after the injection (somnolence). At the time of this event, the outcome of the event somnolence was unknown.   The causality between the event somnolence and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not reported.
8/14 symptoms started mild sore throat progressed to nasal congestion and headache that evening.  8/15 tested positive with an At Home COVID-19 test.  Positive.  Went to urgent care, saw a PA who prescribed remdesivir.  8/15 I had a fever was on and off, spiked at 100, lasting about 3 days.  Started Remdesivir on 8/16. Used Robitussin to treat cough.  Tested Negative on an AT Home COVID-19 test 8/21.  8/23 symptoms, nasal stuffiness, returned, and 8/24 tested positive on an At Home COVID-19 test.  Tested Negative on an AT Home COVID-19 test 8/28.  Cough lasted until 9/8.
CRAMPS IN TOES; LITTLE COLD; SORE LEGS, SORE FEET; SORE KNEES; SORE THIGHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cramps in toes. On 13-MAR-2021, the subject experienced little cold. On 13-MAR-2021, the subject experienced sore legs, sore feet. On 13-MAR-2021, the subject experienced sore knees. On 13-MAR-2021, the subject experienced sore thighs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore legs, sore feet, cramps in toes, little cold, sore knees, and sore thighs. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, fever and pain. On an unknown date, the outcome of the swelling arm, fever and pain were unknown. It was unknown if the reporter considered the swelling arm, fever and pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The physician reported that the patient experience bad side effects after SHINGRIX. The patient had been seen at the physician's office everyday for 10 days due to a severely swollen arm, fever and pain. The reporter gave consented to follow up. Emergency room visit was required. The contact details of the healthcare professional's assistance were provided for contact or if follow up required. This has been linked to the case US2018199468 reported by the same reporter.
On 05/17/2021- my left side of my chest started to hurt near my shoulder at that point I thought I over did it, or a muscle strain and it would go away on its own, but it did not. The pain continued and became worse toward the weekend. I started to feel dizzy, heart racing, my left arms started to feel numb, I thought I might be having a heart attack and I decided to go to the emergency room. On 05/22/2021, I went to the ER. At the hospital: blood work done,  EKG- abnormal, chest x-ray, cardio CT scan of the heart-they came back normal.  They administer Advil and ibuprofen. Diagnosis:  Pericarditis,  inflammation outside the heart muscle The EKG pinpointed the pericarditis.  I went to the ER at 12:30 AM, 05/22/2021,  I was kept for emergency observation  till 9:00 PM  05/23/2021.  I saw the cardiologist, they sent me to do a cardio function MRI, on 07/14/2021-  identified I did not have pericarditis. It identified I had myocarditis.  I cannot exercise. I am on restriction. The MRI showed whatever caused the inflammation was no longer there. I just need to wait for the inflammation to go down and let it heal.
Pt developed hives 11/1/01. He was seen by MD and given Benadryl. The hives lasted on and off until 11/6/01. Note: Pt had eaten foods with eggs before immunizations. "No problems" per mother.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. In September 2016, the patient was vaccinated with the first dose of VAQTA 50 U/ml injection (route, lot and expiry date not reported). The patient was then inadvertently administered their second dose of VAQTA (lot M031806, expiry date 30-MAR-2018, route and dose not provided) in February 2017, five and a half months after the initial dose. No adverse effect was reported. There was no product quality complaint (PQC). Additional information has been requested.
The morning after I started running a fever. I run normally a 97.1 temp. I checked it was 98.6. I felt weak tired and not hungry. I laid down to sleep. The arm and injection site was sore swollen and congested. Like it was full. The next morning I went to bed early and ate light. I felt better, but my arm was still was red and swollen. The redness moved down my arm toward my elbow. Comparing two arms my upper arm was really hot. I called the nurse line and they said it sounded it cellulitis, and it was confirmed at the ER; and I received two prescribed antibiotics.
generalized exfoliative rash on body - scalp, upper trunk, arms and thighs.
Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post second Pfizer vaccine.   was diagnosed with a STEMI heart attack and then coded on April 26, 2021.
Thank you for asking me to evaluate this 34-year-old female with right biceps cellulitis. History: Patient is a 34-year-old female who had a PNEUMOVAX and tetanus vaccination on 7/21, and on 7/22 she noticed an area of erythema about her right bicep at the area of the vaccination. Over the next 24 hours, there was significant progression of erythema and she presented to the ER yesterday evening. I did discuss with the ER MD and we considered adding clindamycin to cefazolin initially but decided to go with cefazolin alone. She has a history of splenectomy at age 8 for hereditary spherocytosis. She has never had cellulitis in the past. The erythema is not really any better according to her and her husband and has extended beyond the margin distally. She has been afebrile this admission. She did have some chills on 07/24. She also had some shaking chills and fever 07/22 in the evening. She had been seen previously in urgent care, where she got ceftriaxone.
Progressive upper and lower extremity weakness felt to be Guillain Barre Syndrome. Please note patient is pregnant. Given IVIG, found to have DVTs left lower extremities, now receiving Gamunex (different type of IVIG) with full dose Lovenox. Slight improvement in upper extremity strength but patient extremely weak in lower extremities 3/5 strength at hips.
pt recv 1 dose of varivax & included 1 dose mmrII 8/19/96 & in early 4/98 pt dx with chickenpox, no fever, no itching was noted
Welt on arm approx 4 inches in diameter, swollen and hot to the touch, sore, lasting approx 6 days, starting 4 days after injection. ?Covid arm?
Patient recieved flu shot at approximately 6am on 9/15/09.  Approximately 2-3 hours later (per the patient) both arms became red and blotchy from elbow to wrist only.  Itch got progressively worse as day went on.  Patient washed with soap and water and covered with hydrocortisone cream.  At approximately 2pm patient visited with nurse who came in to administer flu shots for afternoon group.  Nurse verified that patient did have red, blotchy skin and some discoloration but patient reported that itchiness was gone by 2pm.  I spoke with patient on 9/16/09 and she stated that all discoloration was gone as well as itchy sensation.
was restless the noc of 22APR92 & had temp of 102 off & on for 3 days; fever controlled w/APAP; seen by MD who said probably from HEp B no signs of illness;
Information has been received from a Medical Assistant referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K008679, expiration date 05-MAR-2017; lot # L009649, expiration date 29-NOV-2017; dose and route were unknown). The vaccines were stored under 33 F for 24 hours, and were cumulative 33 F for 48 hours. There was no previous temperature excursion. It was not called because of a "data logger". No adverse effects were reported. Additional information has been requested.
This spontaneous report received from a licensed practical nurse refers to two unspecified patients of unknown age and gender who on unknown date were vaccinated with two improperly stored of (Oka/Merck) VARIVAX (dose, lot #, expiration date and route of administration were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Follow up information has been received on 05-MAR-2015 from a licensed practical nurse refers to a male patient of unknown age. On 26-JAN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K09758, expiration date 26-JAN-2016) that had experienced a temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 101-102 x 3 days. Crying 1/2 hours for 4 days. Wide eyes, red face and jerking but not seizures.
pt recv vax 11OCT95 & pt devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax
Came back to clinic after going down to the first floor. C/o legs feeling tingly. VSS. Left with steady gait
This spontaneous report as received from an office manager (healthcare worker) refers to a 15 months old male patient. The patient was vaccinated with a dose of M-M-R II (lot # reported as 667245/0961Z, expiration date 21-JUL-2012) on 31-JUL-2012. It was reported that the patient was vaccinated with expired M-M-R II. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (manufacturer control number: NUS2018US020679). A contactable consumer (spouse) reported for a 31-year-old patient experienced allergic reactions to the pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein). Clinical outcome was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Information has been received from a Nurse practitioner (N.P.) concerning a 15 year old female who on 01-OCT-2008 was vaccinated with a 0.5 ml dose of GARDASIL (lot # 0947X).  01-OCT-2008 the patient experienced uncontrollable bladder symptoms and wet the bed overnight after receiving the vaccine.  The patient recovered 24 hours after receiving the vaccine.  It was reported that therapy with GARDASIL was discontinued on 01-OCT-2008.  The patient sought unspecified medical attention.  Additional information has been requested. Follow up information was received from an other health professional concerning the 15 year old female patient with sports induced asthma who on 10-JAN-2008 at approximately 1;00 pm was vaccinated in the left arm with he rfirst dose of GARDASIL. At the night of injection, the patient had uncontrollable bladder. She peed the bed and severe frequency that lasted into the next evening. The syndromes lasted approximately 24 hours. The patient was recovered 24 hours later (02-OCT-2008). Her mother confirmed the adverse event. The patient sought unspecified medical attention. No further information is available.
Vertigo akin to benign positional vertigo which started about 36 hours after injection, initially in bed, later with any rapid movement to the left/over-extension of the head associated with nausea  leading to fall without injury. Profound fatigue. Fatigue settled within 24 hours, vertigo gradually subsided over 7-10 days. No other obvious neurological symptoms. Initially I thought this was just coincidence and nothing to do with the vaccine (although I have never had vertigo in my life), but similar symptoms occurred this morning after I received the vaccine yesterday (03/06/2021 at 12.15 PM). I will report separately how long symptoms lasted for the second vaccine.
This spontaneous report as received from a physician via field employee referred to a 25 year old female patient. On 19-FEB-2013 the patient was vaccinated with GARDASIL (lot # H010915, exp date as 13-FEB-2015, dose/frequency and route were unspecified). Patient felt "queasy" following the vaccination on 19-FEB-2013. It was not known which dose in the schedule the patient received today's vaccine. Patient did not seek medical attention. No treatment was given for the event. The outcome of felt "queasy" following the vaccination was unknown. The relationship was not provided. Additional information is not expected.
possibly blood in my stool; redness; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient went to the bathroom past 2 times and reported redness and possibly blood in his stool. Patient received the vaccine at 1 and around 4pm next day he went to the bathroom and it happened again.   As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, patient was asked to consult with doctor/healthcare provider. There is information on Diarrhea but not about "bloody stools" under: 6 ADVERSE REACTIONS. Outcome of the events were unknown.
Client states she experienced flushed face after received her vaccine.  Vital signs obtained by EMS  BP 169/98, HR 62, O2 sat 97%. Client states she feels better.  Client advised to be transported to the hosp.  Client denied.  Client discharged home by EMS.
5 minutes after Pt received vaccines, fainted LOC lasted about 5 seconds then pt dizzy and lightheaded for about 5-10 min and relieved by 10 min resting supine then 5 min sitting and drinking gatorade/eating cheese crackers.
Patient had colicky abdominal pain and vomiting the week after having immunizations including 2nd dose of RotaTeq.  Symptoms were progressive and patient followed up  with urgent care without appropriate evaluation or treatment.  Patient began to have bilious emesis and bloody diarrhea and so was seen at ED 24 Jan 2022 with US diagnostic for intussusception.   Non operative reduction was unsuccessful and patient required surgery with excision of 5 inches of bowel.
12 month old female with local erythema since injection and worsened to show 3 large nodules on Left Anterior/Lateral thigh.
This spontaneous report as received from a Registered Nurse refers to one of 18 years old female twins. The patient was testing "low" for anti-HBs after having received doses of an unspecified RECOMBIVAX HB (manufacturer was unknown, lot # was unknown) on the following dates: 18-Mar-1994, 18-Apr-1994, 14-Dec-1994. The nurse reported that the patient was going to college and blood titers for the anti-HBs were below the acceptable range. The patient did physical examination for medical attention. No other adverse event had been observed and reported. This is one of the several reports received from the same source. Additional information has been requested.
No adverse events. Patient states she has had no issues but 2nd COVID shot was administered 1 day early. 2nd injection should have been given on 8.14. First dose was administered on 7.24.21
Right leg parasthesia starting behind knee to ankle, constant. Feels as if leg is mildly ?asleep.? Very mild parasthesia to right wrist. I mostly notice it in right leg.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a neonate male patient who received ENGERIX B pediatric for prophylaxis.  On 15th January 2019, the patient received the 1st dose of ENGERIX B B pediatric (intramuscular) 10 µg. On an unknown date, less than a month after receiving ENGERIX B pediatric, the patient experienced injection site erythema, injection site swelling and injection site induration. The patient was treated with phytomenadione (Vitamin K). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to ENGERIX B pediatric. Additional details were provided as follows: The batch number was not reported. The physician reported that the patient received hepatitis B pediatric on date of birth 15th January 2019. She was not sure of where it was given, as it wasn't documented. The doctor believes it was given in the right thigh because Vitamin K was given in the left thigh. The doctor stated that she called the hospital and it was noted the product given was ENGERIX B. It was unknown when the events started, but the physician states she was 1st made aware at the 1 month well checkup visit.  The patient has been seen again in the office for these events on 4th March 2019 and has a follow up appointment also. Emergency room (ER) visit was required.
dizziness; This is a spontaneous report from a contactable consumer. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on 13Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included pernicious anemia from 2019 and ongoing (gets B12 shots). There were no concomitant medications. The reporter's mother had the Pfizer COVID vaccine at 3 o'clock in the afternoon of 13Jan2021. At 1 o'clock on 14Jan2021, she started experiencing dizziness. The caller's sister is with the patient as this time. The past 4 hours the patient has experienced dizziness. As she tried to get up, it gets worse. Outcome of the event was not recovered.
This spontaneous report as received from a registered nurse refers to a 14 year old patient (unspecified gender). On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and unknown gender. No information regarding the patients pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 02-NOV-2018, the patient was vaccinated with M-M-R II injection, lot # M039914,albumin status: rHA (recombinant Human albumin), expiration date: 26-SEP-2018, 1 dosage form, intramuscularly(Incorrect route of product administration) for prophylaxis. The reporter stated that the patient received an expired dose of M-M-R II, also reported that product as well as sterile diluent was stored properly. No adverse effects were reported. No further information provided.