chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; sleepiness (hard to keep his eyes open); confusion; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension and Diabetes.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue) 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.   Concomitant medication information was not reported. Treatment information as not reported.
Breakthrough COVID infection. Symptom of shortness of breath and cough. Admitted to hospital 11/07/2022. Had prior admission 10/09/2022 - 11/02/2022 for COPD exacerbation and pneumonia. Positive COVID test collected 11/08/2022. Began inpatient hospice 11/16/2022. Expired 11/18/2022
Patient called 7 days after vaccination to report that, since his vaccination, he has experienced shortness of breath and racing heart rate. (He has not taken his heart rate, but says that he "Can feel it racing". He further reports that on the day of his vaccine he felt almost drunk and woozy. It should be noted that he was very upset (boarding on angry) that he had to get the vaccination because his employer required it.
Area shot and red, rash, flat - Lt. arm. Upset stomach last night. Tx: BENADRYL, Hydrocortisone cream 0.2%.
Going to bathroom constantly, arm sore and swollen with a big knot/ more like a circular bruise, fever as if I had covid19 again, weak
Skin rash with small blisters primarily on my hands, arms and legs. (red, itchy, coarse skin with small blistery patches)
pt recv vax & 2wk post vax pt exp decreased WBC, dec hemoglobin & dec hematocrit;the reporting MD noted that pt is doing diagnostic tests;pt exp leukopenia & anemia;dx w/leukemia;
Body aches, stomach cramping, rash on abdomen, arms.  Start of period early (last period 12/22). Itchy all over
Extreme headache; 102 degree fever; joint pain.  Extreme pain in arm at injection site-red, swollen, fever in arm.  Treatment: shot of antibiotic & shot of steroid for cellulitis 11/19 pm.
It was reported that a 39 year old female received Fluzone SV on 10/4/99 and experienced "pain at injection site immediately, generalized muscle aches and fever to 101F and fatigue for 24 hours. Pt now had joint pain." No further information at this time.
Patient received ADACEL, MENVEO and GARDASIL today. 30-45 seconds after receiving GARDASIL, she began jerking and passed out and fell out of her chair. She was given juice and a cool towel for her head. She woke up confused and pale but was alert. She was observed for 20 min and released to go home.
Spotty rash. Somnolence. 10 days after vaccine. No treatment.
All vaccines were administered at 1355, MMRV vaccine as administered on the L leg. 5 minutes later, at 1400, pt experienced a small reaction including redness around injection site and three small hives clustered together near injection site. The patient primary care provider was notified of the reaction and came to assess the patient. Primary care provider ordered a dose of diphenhydramine to be administered to the patient with no other treatments needed at the time.
On the evening of vaccination (9/20/20) the patient developed an inflamed area about 3x3" ~3" BELOW the administration site. She stated the area was warm to the touch and sore. She confirmed that the vaccination was given in the middle of her deltoid and it was not noticeably painful during administration.  The inflamed area persisted through 9/24. Her physician was notified and initially diagnosed it as cellulitis. However on 9/25 she had an in person visit and the appearance shifted a bruise. Starting on 9/25 she also reported pain in all of her joints (shoulder, elbow, wrist, and knuckles) on her left arm. Her physician had her discontinued her bactrim and started a prednisone taper.
Breakthrough case admission after 3 vaccines Pfizer 3/10/21 lot# EN6205;  Pfizer 4/1/21 lot# Ew0150;  Moderna 12/18/21 lot# 060H21A
FLUCELVAX LOT NUMBER 1740874 GIVEN TO PERSON LESS THAN 18 YEARS OLD.  NOT FDA APPROVED FOR PATIENTS AGE.  NO IMMEDIATE ADVERSE OUTCOMES REPORTED.
Suspected vaccination failure/I had both shots and I did not have a light case.; I certainly did not have a light case! don't want it again; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had both the shots and his/her provider said he/she certainly did not have had a light case. The patient stated he/she was sorry to say that this was an adequate description of some of the pain. The patient stated please god did not want them again. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Additional Details: PATIENT RECEIVED VACCINE AT 11AM. AROUND 2-5 MINUTES AFTER INJECTION PATIENT LOSS CONSCIOUSNESS ACCORDING TO WIFE AND PASSED OUT. HE FELL OUT OF CHAIR AND HIT HIS HEAD. ONCE I WENT OVER PATIENT WAS SHAKING BUT CONCIOUS. I HELD PRESSURE TO THE CUT ON HIS HEAD AND HAD TEAM MEMBER CALL 911. EMS ARRIVED AND CHECKED HIM OUT. THEY DECIDED TO TAKE HIM TO ER TO RULE OUT SEIZURE. PATIENT LEFT THE STORE AROUND 1125 AM.
Ongoing had vaccine 09/07/2022 that evening and overnight body aches and chills. Next day over exhaustion and fatigue following day experienced dizziness for 5 days.
Pt vaccinated with DTP dx of pertussis based on clinical symptoms. 3 doses DTP given 2, 4 & 6 months.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JUL-2016, the patient was vaccinated with PEDVAXHIB injection, lot # L038502, expiration date 16-AUG-2018 (strength, dose, route and anatomical location of administration were not provided), along with a dose of PENTACEL; "which has Haemophilus influenza as a component". No adverse reactions were reported and no product quality complaint was involved. Additional information has been requested.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: Patient had rash all over the right side of the body, itchy at times, with numbness. Felt very tired and lethargic. Even felt tingling. Patient was unable to sleep.
Migraine with  nausea and vomiting that lasted approximately 7 hours and did not respond to typical treatment with Excedrin Extra Strength.  Less severe events have been intermittent feeling of light-headedness that started an hour after vaccination and are still occurring 48+ hours later.
She had a headache and fatigue the day after the vaccination; She had a headache and fatigue the day after the vaccination; In the evening on Wednesday she said it hurt to breath deeply for a few hours (about 7 to 10pm); Described it as a stabbing pain in chest; This is a spontaneous report from a contactable consumer. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via intramuscular route of administration in the right arm on 20Apr2021 at 14:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, norgestimate (TRI-SPRINTEC); both for unknown indication, and acne medicine; all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via intramuscular route of administration in the right arm on 31Mar2021 at 16:45 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had a headache and fatigue on 21Apr2021 at 08:00, the day after the vaccination. On 21Apr2021, in the evening on Wednesday the patient said it hurt to breathe deeply for a few hours (about 19:00 to 22:00). The patient described it as a stabbing pain in her chest. By Thursday her symptoms were gone. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and fatigue the day after the vaccination; in the evening on Wednesday the patient said it hurt to breathe deeply for a few hours (about 19:00 to 22:00); the patient described it as a stabbing pain in her chest; by Thursday her symptoms were gone was resolved on 22Apr2021.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 24-Dec-2013. It was reported that the patient received expired FLUMIST which started on 24-Dec-2013. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
Patient reports a 3-4 inch diameter red area below where the vaccine was administered starting the day following vaccination. This read area was also hot to the touch. She also had a 5 day headache that started the day after vaccination and resolved on its own.
On March 26th 2019  patient  cancelled second dose of SHINGRIX, stating he had a bad reaction to the  first one. Reports he had high fever, achy muscles & was unable to sleep for 2days following 2/2019 SHINGRIX administration. There are no previous reports on his medical record regarding reaction to the vaccine and he did not mention any lingering adverse reaction.
10/31: Vaccines administered  (Hep A and flu) Fevers started that evening Rash developed on 11/3 - right arm and then progressed to other extremities/face - spared trunk. Hand and foot swelling and pain. Irritability and itching.  Evaluated on 11/4 - rash consistent with hives along with swelling of hands/feet. Started on oral prednisolone once daily x 5 days for SSLR. No recent antibiotic use or illness. Strep exposure 1 week prior - Rapid strep negative. (2 days later Group A strep culture negative)
Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Severe itching). At the time of the report, PRURITUS (Severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided. No concomitant medication information was provided.
PATIENT IS ONLY 60 YEARS OLD AND RECEIVED THE HIGH DOSE FLU VACCINE.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (lot # not reported). The physician reported that the patient received from the complete series of GARDASIL and tested positive for HPV DNA 16 and 18 following cytology testing. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
PRONOUNCED REDNESS/SWELLING/PAIN AT INJECTION SITE- INFORMED PHARMACY A COUPLE OF DAYS AFTER INJECTIONS. ADVISED PATIENT TO PUT ICE ON THE AREA FOR 10-15MINS AT A TIME, TRY BENADRYL PO, OR GO TO A DR TO BE SEEN. PT STATED THAT THE SYMPTOMS STARTED THE DAY AFTER THE INJECTION
Fever of 100. Patient instructed to take TYLENOL or other fever reducing medication and monitor.
The patient briefly lost consciousness a few minutes after receiving the vaccine. The patient quickly regained consciousness and appeared to be alert. The event occurred in the hospital and the patient was taken admitted for further evaluation.
Severe flu symptoms, weakness painful gut hard red vaccine site, skin rash. Day 11, severe cold symptoms, inflamed sinuses, infection in lungs. Seriously considered hospitalization
Skin feels like it?s crawling with bugs. Bodily Weakness. Headache. Alternating between hot and cold. No fever present. Sleeplessness. Increased urination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 08Nov2022 as dose number unknown, single (Lot number: 010422A) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative, notes: Covid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient was treated for COVID-19 with Paxlovid from 05Apr2023 to 06Apr2023 having lot number GE3011. After taking Paxlovid, patient had one negative covid home test. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165379 Same patient, different product;
Client vaccinated in their own home through partnership with local EMS. Day of vaccination, the EMS noted tachycardia and severe swelling of the lower extremities, but client was alert and oriented. Appox 24 hours later, client was slow to respond and her coloring was "gray." Ambulance called and client hospitalized. Client found to have GI bleed of unknown cause. Providers involved in her care do not believe it is related to the vaccine.
Sweats; Fever; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills). On 19-Apr-2021, HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) had resolved.            No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.  Reporter stated daughter missed 2 days of work due to the side effects from the second dose of vaccine.   This case was linked to MOD21-082785 (E2B Linked Report). This case was linked to MOD-2021-091829 (Patient Link).; Sender's Comments:  MOD21-082785:
pt recvd vax & 1wk later devel a red, raised rash on back which lasted 3 wks;required MD visit;pt recovered;
Pt recv vax on 1/27/99; on same day pt exp weak feeling, shaky, sore legs, lethargy, cold sweats, nausea, unclear thinking, dizzy, barely able to walk
No adverse effect; patient was inadvertently administered an expired dose of MMRII; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneously, lot # N009171, expiry date 20-MAR-2019 (exact dose and site of administration were not reported) for prophylaxis. There was no temperature excursion. No adverse effects were reported.
Information has been received from a physician concerning a female pt who on 6/28/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/11/06, thirteen days after vaccination, the pt developed a rash and fever. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
can i take anti-inflammatories after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (can i take anti-inflammatories after taking the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (can i take anti-inflammatories after taking the vaccine). At the time of the report, PAIN (can i take anti-inflammatories after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
2 day after injection, left upper arm with edema, erythema, and pain. Treated with KEFLEX 500mg TID x 5 d, antibiotics. Redness, pain resolved; left with forearm & upper arm paresthesias & mild edema.
Rash that moved all over my body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that moved all over my body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced RASH (Rash that moved all over my body). At the time of the report, RASH (Rash that moved all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
pt recv vax 31OCT96 & 12NOV96 lt hand became numb & unable to move;adm to hosp on 18NOV d/ 23NOV96;MD dx GBS;c/o bumps on soles of feet;
Heart palpitations/pounding heart; shortness of breath; Chest pain on right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2022 13:15 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "Heart palpitations/pounding heart"; DYSPNOEA (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "shortness of breath"; CHEST PAIN (non-serious) with onset 28Jan2022 01:00, outcome "not recovered", described as "Chest pain on right side". Therapeutic measures were not taken as a result of palpitations, dyspnoea, chest pain.  Additional information: Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. No other medications in two weeks. AE does not result in physician office visit or emergency room visit. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 79 year old male patient. Medical history and drug reactions/allergies were not reported. On 26-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # H022280 expiry date 16-JUL-2014 (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 20 year old female who on 18-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658100/0525U) injection in the upper deltoid. On 19-JUL-2007 the patient woke up with hives generalized over her body. The hives continued to get worse and she sought medical attention at an urgent care facility. At the time of reporting the patient had not recovered from the hives. No further information was given. Additional information is not expected.
Nausea, feeling hot, decreased vision. BPs 99/44 (pulse 63), 109/69 (pulse 66).