chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 23:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: I am overweight, and I have a heart murmur.; "heart murmur" (unspecified if ongoing), notes: I am overweight, and I have a heart murmur. Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE; FLUOXETINE; ZOCOR; PROZAC. Past drug history included: Betadine, reaction(s): "allergy", notes: I have a betadine allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), 2 months 5 days 12 hrs 45 min after the suspect product(s) administration, outcome "recovered", COVID-19 (medically significant), 2 months 5 days 45 min after the suspect product(s) administration, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101; SARS-CoV-2 test: (25Nov2022) Negative, notes: I had taken a COVID test on 25Nov2022 because we were going to be seeing other people in the coming days, and that test was undeniably negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product- COVID 19 Treatment, Paxlovid: Treatment start date: 15Nov2022, Treatment stop date: 20Nov2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Ongoing fatigue, brain fog and nausea  that is still present one month after the second injection.  Occasional chest tightness and shortness of breath.  This has disrupted my daily activities and made it difficult for me to work and care for my child.  It has been a scary experience.  If I was single parent, I don't think I would feel safe taking care of my child by myself due to the side effects of this vaccine.
Noticed a low grade fever the morning after. Never went above 100.4. Had headache chills and strong body aches. After 30+ hours those symptoms subsided on that Wednesday. The next morning I noticed itching with a few bumps on right arm.. by the end of the day I had erupted in hundreds of itchy very red bumps all over body. Most on stomach and legs with some on arms and a fe on back. Was intense itching and burning for hours. I couldn?t wear clothes. It eased some but the bumps never went away. Friday afternoon another flare of intense itching and burning for a couple hours. Again could not wear clothes. It?s now been 6 days and no resolution of rash. It does not look at all like hives. I can not get in to see my family doctor or dermatologist any time soon. I went to the emergency room on 10/16 and they wouldn?t test it. I was able to get them to run a shingles blood test even though the er nurse practitioner and I do not believe it?s that. So far no help from any doctor after me telling them it could possibly be a reaction from vaccine.
Localized inflammation; Elevated temperature of 102; Itchiness in the injection site; Swelling/ Injection site is slightly raised; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Localized inflammation), VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised), VACCINATION SITE ERYTHEMA (Redness in the injection site) and PYREXIA (Elevated temperature of 102) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     The patient's past medical history included Bone marrow disorder and Chemotherapy (8 years ago). Concurrent medical conditions included Blood pressure abnormal. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and VACCINATION SITE ERYTHEMA (Redness in the injection site). On an unknown date, the patient experienced INFLAMMATION (Localized inflammation) and PYREXIA (Elevated temperature of 102). The patient was treated with CORTISONE at a dose of UNK dosage form. On 23-Mar-2021, VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) had resolved. At the time of the report, INFLAMMATION (Localized inflammation), VACCINATION SITE SWELLING (Swelling/ Injection site is slightly raised) and PYREXIA (Elevated temperature of 102) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication use included unspecified blood pressure medication. Patient stated that she has a complex history as she had chemotherapy eight years ago for a bone marrow disorder but that she sees a hematologist and oncologist and that everything was stable.   This case was linked to MOD-2021-069888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received included past medical history, suspect product details, concomitant medication details and outcome. On 06-Jul-2021: additional event and contact info added
For the first week the patient was nauseous, dizzy, and  experienced joint aches, then after a week patient experienced inflamed muscle pain in the back of his head.  After a week afterwards the patient noticed his lip was numb, and then a day later patient had paralysis on the left side of his mouth.  The patient first went to an urgent care, and was then refered to the ER where he was diagnosed with Bell's Palsy.  The date of the diagnosis was 5/27/21
One week after receiving injection patient developed an erythematous pruritis area on the arm measuring 7 x 9 cm and swelling and pain extending into the left SCM muscle.
Can't walk, Pain in left leg, shaking, sweating. Steroids (prednisone 20mg) and norco, vicodin, ibubrofen for pain.
pulmonary embolus; This is a spontaneous report from a contactable physician.  A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 13Apr2021 (at the age of 72-year-old) (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Relevant medical history included coronary artery disease (CAD), diastolic congestive heart failure, obstructive sleep apnoea (OSA), morbid obesity and hyperlipidaemia. The patient's concomitant medications were not reported. On an unspecified, the patient experienced pulmonary embolus. The event required Emergency Room/department or urgent care visit and the patient was hospitalized for 2 days. Corrective treatments taken as a result of the event included anticoagulation. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported pulmonary embolism  and the use of BNT162B2 cannot be fully excluded.  The patient's underlying condition may also contribute to the risk for the reported event. As there is limited information available to further assess the case, the case will be assessed further upon receipt of new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient received second booster on 12-Apr-2022. Vaccine expiration date 27-Mar-2022.
An hour or so after receiving my first Moderna shot, I was aware of an unusual feeling in my lower right abdomen.  Knowing this to be a potential problem area for Appendicitis I paid attention to it for the next day and there was no change.  Two days after receiving the  vaccine shot this sensation got worse and I was visibly bloated.  I went to an Urgent Care where a doctor referred me to the closest ER due to the area of pain and bloat in my body.   After several blood tests and an MRI at the ER, it was determined that my appendix was inflamed and I was admitted to the hospital for surgery ASAP.   Luckily the appendix was stable, never burst and was successfully removed the following day in the early afternoon.   I am currently at home recovering successfully.
Red flat round lesion at injection site. Started about 3in. grew to about 5in.  Was itchy first day only and gradually faded away by day 5. I didn?t use any  treatment, just watched for increased size or symptoms.
Sore arm and injection site x 48hrs and fatigue, following vaccination. After 48hrs, swollen lymph node and pain under left underarm developed.  Left underarm continues to be painful on the 3rd day of vaccine, as well as fatigue.
Patient had rash on left arm (from armpit to elbow) starting the night he received the vaccine. He reported a rash, fever, chills, and heart palpitations.
Within a few hours a severe pulsing headache appeared, similar to a migraine. The headache lasted about 4 days. About 4 hours after the vaccine, I experienced severe muscle aches and pains throughout my body, similar to the flu. This was accompanied by severe nausea and fatigue. These symptoms lasted for about four days as well. After receiving the vaccine, frequency of having difficulty breathing increased to several times a week.
chills; high fever; really severe vomiting; massive headache; injection site pain; fatigue/she still feels fatigued; muscle pain; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache) and VACCINATION SITE PAIN (injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 026B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS and Arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting), HEADACHE (massive headache), VACCINATION SITE PAIN (injection site pain), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous). On 01-Sep-2021, CHILLS (chills), PYREXIA (high fever), VOMITING (really severe vomiting) and VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, HEADACHE (massive headache), FATIGUE (fatigue/she still feels fatigued), MYALGIA (muscle pain) and NAUSEA (nauseous) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for her blood pressure, thyroid, arthritis.  Patient gets infusions and is immunosuppressed.  Treatment information was not provided.
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 6-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Patient developed low grade fever & erythema/pain/swelling in subcutaneous tissue of left upper arm.  Her erythema, pain and swelling increased as of 04-12-07 & she presented to clinic with significant cellulitis of left upper arm, intense pain with any movement, and a temperature 102° Blood culture drawn, started on IV antibiotics:  vancomycin & ceftazidime; Ultrasound of left arm; CBC and CHEM7.                                   After 48 hours of IV antibiotics, she began to have resolution of that site.  There was some concern as to whether or not it was an actual cellulitis or a local reaction to her immunizations however, with resolution of her symptomatology during this hospital admission, she was discharged home with no additional antibiotic therapy and instructed to monitor that area for progression of swelling, erythema and/or pain. 4/7/08-records received for DOS 4/12-4/15/07 DC DX: Resolving left upper arm cellulitis likely related to immunizations. Received immunization sooner than scheduled. Developed low grade fever with erythema and pain at site of her injection. Fever to 102. Cellulitis at injection site.
I don't know if this constitutes an "adverse reaction" or not. I had headache, body ache, fever (100 degrees F), fatigue. I feel better today (2 days post injection) but am still achy. I feel like these are "side effects" more than "adverse reactions" but wanted to share the experience I had.
PATIENT PRESENTED TO THE CLINIC FOR A HEP A VACCINE (PEDIATRIC DOSE).  CLINIC STAFF ADMINISTERED ADULT HEP A VACCINE INSTEAD.
I was exposed to both oral and genital herpes on 10/22/2021. I had sores in my mouth, couldn't eat, had a fever for 3 days; had genital sores that were very painful, and muscle aches form 10/31/2021-11/4/2021. I called my doctor on 10/31/2021 thinking it was just a UTI and then called on 11/1/2021 and made an appointment to come in and was prescribed antibiotics. Then I went to the ER and was treatment for all STI's with multiple rounds of antibiotics and antivirals. I am starting to feel better but don't have all the results back yet. I believe the COVID-19 booster inhibited my immune system from fighting the herpes.
I have been experiencing tachycardia since  0700 am 1/27/21  heart rate reaching 130 just standing and walking from one door to the next it was 153 ,   Also I have been experiencing muscle spasms all over as if 1/28/21 and as if today 2/1/21 I?m still experiencing the same two reactions .
anxiety was exaggerated; feels anxiety day and night and wakes up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Mental disorder NOS.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night). At the time of the report, ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
lt arm still swollen, red, hot to touch & really sore on 7JUL93;
Lungs hurt when deep breathing; discomfort in bronchial area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: ENC 207), via an unspecified route of administration on 18Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril 25mg (MANUFACTURER UNKNOWN) and sertraline hydrochloride 75mg (ZOLOFT), for unknown indications from unknown dates. The patient previously received penicillin (MANUFACTURER UNKNOWN), cefadroxil (DURICEF), doxycycline (MANUFACTURER UNKNOWN), nalidixic acid (NEGGRAM) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 16:00, the patient's lungs were hurting when deep breathing and the patient had discomfort in bronchial area. The patient did not receive any treatment for the events lungs hurt when deep breathing and discomfort in bronchial area. The clinical outcomes of the events lungs hurt when deep breathing and discomfort in bronchial area were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Pt presented to clinic for 2nd Moderna Vaccination today. Patient reported to vaccinating RN Hx of anaphylaxis to NSAIDs, Hx of covid infection resulting in multi-week hospitalization in December 2020, reports that she is a "covid long hauler." Additionally, pt reported that she experienced "throat scratchiness/tickle" and "dry throat" immediately following Moderna vaccine dose #1 on 3/16/2021, which resolved after drinking water. Pt was instructed by her physician to bring her personal epi-pen with her when receiving 2nd dose of Moderna. 2nd dose vaccination administered today,with pt agreeing to stay in observation for 30 minutes.  10 minutes post vaccination at 10:24am, Pt reported that she was getting the same scratchy tickle in throat she experienced following 1st dose.  RNs brought pt into clinic room five for closer observation.  10:33am, Pt reported feeling dizzy, was visably shaking, and reported tightening in her chest. At 10:33am, pt was laid down on floormat, and 0.5L Oxygen was administered via mask. 10:35am, HR 77, RR 24, Oxygen was increased to 1.0L. 10:36am, pt reported decreased chest pressure, decreased dizziness, stated "this feels better." 10:40am, pt reported tightness in chest had resolved completely,  denied dizziness, denied itching, however, throat still "tickles." 10:48am, patient remained supine, O2 at 1L, B/P 138/90- pt reports resolved throat itching, states she feels "much better." 10:52am, RNs assisted pt to sitting position, pt states she feels "way better," denied tight chest, dizziness, throat tickle. 10:55am- HR 66, pt given water. 11:00- pt moved to standing position then sitting position in chair, and O2 was removed. 11:10- pt reported breathing and throat feel normal, denied dizziness. 11:16am, pt walked to observation to wait for daughter to pick her up and drive her home. 11:38am, patient's daughter arrived at clinic to drive her home. RN provided education on s/s of anaphylaxis reaction vs expected s/s following vaccination to patient and daughter. RN instructed patient not to drive today and have someone remain with her for at least 4 hours. Instructed not to take benadryl as it may mask symptoms of anaphylaxis. Instructed to go to ED if she experiences difficulty breathing, rapid onset of symptoms such as tight chest, SOB, throat swelling & dizziness. Both patient & daughter verbalized understanding before leaving clinic.
At the time the patient received  pneumonia vaccine with us, the recommended Prevnar 20 was not available, so she received Prevnar 13
pt recvd vax; exp a rash consisting of 15 lesions on both hands;
pt recv vax 25OCT96 & 25OCT96 pt devel swelling in hand & a hard area on arm;w/in a few days pt recovered from sx;
Pt received vaccine in left upper arm. He was bleeding immediately more excessive than a usual bleed  after shot.   no medications history. he felt faint also.  applied cold compress to head and mom applied pressure to arm with paper towel. bleeding stopped and he was feeling better . Checked in with mom on patient at home and he was feeling better
Patient's father brought in patient to get walk in 2nd covid shot and presented a agency card (1st dose  was given elsewhere, confirmed it was at pharmacy via MD). Birthdate but not age was written on consent form. Patient previously got a flu shot here in September. Patient was administered 30 mcg dose from Pfizer 30 mcg/0.3 ml via left store. While looking through vaccine rejects later in the day noticed that rejection message said vaccine wasn't approved for under 12 (patient is 1 yr, 10 mos, 26 days). Contacted patient's father by phone  about the age/dose error and counseled on sxs of myocarditis/pericarditis as the primary risk