chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash all over the body.  Red pimples and streaks of red welts.
Extremely agitated today; Feels like crap; Headache; Muscle pain; Chills; Fever (internal); Pain on injection site; Difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis and Cystic fibrosis. Concurrent medical conditions included Iodine allergy, Penicillin allergy and Allergy to chemicals (Sulfate). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CLONAZEPAM for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (Difficulty swallowing), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site). On 18-Jul-2021, the patient experienced AGITATION (Extremely agitated today). At the time of the report, DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site) outcome was unknown.        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 treatment information was provided.
her husband's skin is breaking out; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer-sponsored program. An 82-year-old male patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 14Jan2021 as Covid-19 Vaccine. The patient's medical history and concomitant medications were not reported. The patient's skin was breaking out (onset date not reported). He took a medicine: diphenhydramine for relief. Reporter was advised by their doctor that his husband can't take the second dose and caller was asking what their option was and asking why he can't take the second dose. The outcome of event was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
No reactions on first dose. After second dose started to feel weak, feverish, stayed in bed for 12 days, chills, no appetite, constantly  vomiting,  itchy hives on arms, back, chest, and the back of thighs.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age.  Initial information was processed along with additional information received on 10-MAY-2021. 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: Unknown) dose was not reported, 1 total administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAY-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. It was reported that, the patient trying to find out if there was anything else that might need to be done after she recover from Covid and was there any impact on her vaccines effectiveness. She was not fully vaccinated at the time of covid-19 infection due to the timeframes (6 days elapsed between vaccine and test).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178967 The suspected product quality complaint has been confirmed to be voided due to no PQC identified within the complaint record.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
I was in the hospital for another issue. I was having excessive mucus and going through so many tissues that the nurse on duty suggested that I get a COVID-19 test, that came positive. One it came positive I was given Mucinex to help clear up the excessive mucus. I decided that the Paxlovid would not really benefit me since I was fully vaccinated. Today, 01/03/22 is the first day that I started to feel better. I feel that it may be a combination of being in the hospital for the other issue on top of getting COVID-19. I do feel this case of COVID-19 is very mild compared to the first time I had it before the vaccines.
Narrative:  67 yo male with h/o htn, gi reflux, depression, etoh depence, died on 8/14/21 post covid vaccinations on 2/14/21 & 3/13/21. Of note pt was seen in outside ER on 7/12/21 for chest pain, but pt left AMA. Likely death not related to vaccinations considering possible undiagnosed heart issue & length of time from vaccine administration.
5 hours after injection I had facial andoral numbness; oral numbness; throat irritation/throat hadburning sensation.; Following morning ate a protein barand mouth, tongue and throat hadburning sensation.; tongue burning; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 11Apr2021 at 12:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamin d nos (VITAMIN D), ascorbic acid (VITAMIN C), and calcium (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 17:00, the patient experienced facial and oral numbness and throat irritation. Following morning she ate a protein bar and mouth, tongue and throat had burning sensation. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with BENADRYL. The clinical outcome of the events facial and oral numbness and throat irritation, and mouth, tongue and throat had burning sensation was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient called and stated she had first COVID vaccine on 2/27/21, and had tenderness and redness at injection site. She stated the area now feels warm, and the redness had changed to a darker color. She stated it was like a bruise but not the purplish color of one. She also stated it is getting itchy now.RN asked if she took any Tylenol or Advil to help with tenderness, but she stated she did not. RN suggested she try a cool compress at the area. RN also advised to call her provider and let him know as he/she can give an antihistamine to help with itchiness. She denies any other symptoms. She did not have any other questions,
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 12 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
APPROX. 11AM PATIENT STARTED GETTING A HEADACHE, TIRED AND SORE THROAT. STATED SHE "DOESN'T FEEL LIKE SELF AT ALL". BP 131/80; PULSE 95; TEMP 97.8;respirations 20 w/o difficulty. @ 2:25pm Benadryl 12.5mg, 2 tsp. given PO after notifying parent. @ 2:45pm patient indicated she was feeling better and throat was much better.
Suspected vaccination failure; developed an outbreak of Shingles; body aches; Fatigue; Malaise; High Fever; Injection site pain; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, general body pain, fatigue, malaise, fever and injection site pain. On an unknown date, the outcome of the vaccination failure, shingles, general body pain, fatigue, malaise, fever and injection site pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the general body pain, fatigue, malaise, fever and injection site pain to be related to Shingrix.  Additional information was received as follows: The patient's age at vaccination was not reported. The patient received 2 doses of Shingrix and after receiving the 2nd dose they developed body aches, fatigue, malaise, injection site pain (3 days post injection) and then developed an outbreak of Shingles with a high fever. The reporter did not consented to follow-up.
Red Bump; Pain on left arm when touched; Redness; Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red Bump), DIARRHOEA (Diarrhea), HEADACHE (Headache), VACCINATION SITE PAIN (Pain on left arm when touched) and VACCINATION SITE ERYTHEMA (Redness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 10-May-2021, the patient experienced VACCINATION SITE MASS (Red Bump), VACCINATION SITE PAIN (Pain on left arm when touched) and VACCINATION SITE ERYTHEMA (Redness). On 05-May-2021, DIARRHOEA (Diarrhea) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE MASS (Red Bump), VACCINATION SITE PAIN (Pain on left arm when touched) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient reported severe stomach upset that last 12 hours. Severe pain indicated almost going to the hospital for pain
01/09/21, 25 minutes after I got my 2nd dose, I felt heart palpitation. I my heart rate was 109 at sitting. I feel my heart beats stronger than normal. my heart palpitation didn't improve overnight. 01/10/21 I feel shortness of breath with talking and walking. My chest hurts. My head hurst. I call my hospital and talked to an RN urgent line. She suggested me to go to Urgent Care or ER. I went to Urgent Care at 1500 that day. At check in my blood pressure was 160/110 (my normal BP is around 120/90 or less) heart rate was 112. EKG was done, result no concern. Urgent Care Doctor sent me home with no medication. He said what I experienced is the reaction of my body with the Covid vaccine. He told me to go to ER if my symptoms get worse. I went and see my primary doctor ( bloods tests was done ) and Cardiologist after with EKG and ECHO done. I was off from work during that time. I feel back to normal after 10 days.
10/31/2022 late in the evening noticed leg swollen quite large.  11/1 Saw the doctor who ordered an ultrasound of the area on the right leg.  US Venus Doppler Scan, right common femoral vein compression, but right superficial vein, Popliteal Vein and Posterior Tibial Vein all had thrombosis in them.  Prescribed Eliquis starting at 10 MG 2x a day, then after 2 weeks it was reduced to 5 MG 2x a day.  12/29 follow up with doctor determining swelling is down and progress is going satisfactorily.  Will have another follow up Doppler Scan in February of 2023.
Erythema to injection site (left deltoid) progressing to urticaria and hives along left arm, left chest, left side of back treatment: Kenalog 40mg IM, Benadryl 25mg PO.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 08-SEP-3025, the patient received an improperly stored dose of ROTATEQ by oral route, lot # K005396, expiration date 28-FEB-2016 (dose and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
No additional  adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to  a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.
Date: 3/22/2021  Problem: Tongue Feeling Funny Notes: Client States it feels like her tongue is swelling. Upon assessment. Client oxygen level is 98% RA. No swelling noted to clients face, neck, or tongue. T 98.9 P 86 R 18 BP 140/88. Client monitored for 30 mins. No longer c/o tongue swelling. Client states she feels fine. No swelling to face/ neck/tongue noted. T 98.4 BP 140/82 R18 P 70 O2 98% RA. AAOx3 Client left facility via Personal vehicle.
Pain, swelling, redness, and itching at injection site left arm. Also, been getting a fever.
Patient's Mother describes reaction as a pus filled boil/rash in various areas of the body. Looks similar to suspected MRSA that was previously diagnosed.
Came to clinic 5/28/10 at 11am c/o pain in rt arm, 8m, bruise at deltoid area. (excessive pain and numbness).
03/22/2000, at 1.5 hours post vax, 11:30, initial onset of feeling warm, red scattered rash on checks and temples occurred. No rash or redness at injection site(s). Instructed to take Benadryl 25 mg. At 3:30 pm, slight facial swelling (still at work) ahd not taken Benadryl. At 4:00 PM, broke out in hives all over trunk and back. Instructed to go to ER. 03/23/2000 call to home, spoke with wife who states that pt was back at work. Received Cortisone shot at ER a
Information has been received from a physician concerning a 22 month old female patient with no known recent exposure to herpes zoster who on 10/13/98 was vaccinated with the first dose of varicella virus vaccine live, 0.5cc IM in the right deltoid. Concomitant vaccination that same day included the first dose of MMR in the left arm. There was no post-vaccination rash. On 4/15/1999, she presented with herpes zoster on her left lower torso. It was noted that most of the torso lesions had dried up, but the child developed one fluid filled lesion on her abdomen. She was afebrile and it was reported that her pain was a 3 on a scale of 1 to 10. On 5/13/99, the patient recovered. No further information is available.
The following morning I had a headache and felt significant muscle fatigue and loss of appetite. This lasted until I woke up from a nap around 5:30pm.
Patient was given his 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported). On an unknown date, the patient experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Severe chest pain, tightness of breath, wheezing, cough with phlegm. Chills and fever (up to 40 degrees C) pain at muscle site joints. Patient came to EOHS with a slip from urgent care. Patient state he did the flu shot at EOHS on Mon noon. A cough of his later restarted experiencing chest pain and sob. This was followed with hot/cold sweats into the evening after dinner. He called the triage nurse at emergency room. She advised him to go to the urgent care - he did this. A copy of the report is in file. "Vaccine Adverse Reporting System." He said the Dr on the slip said this was a reaction to the flu shot. Patient said however eh had a sore throat and cold for 2 wks prior to getting the flu shot. At Urgent Care he had blood test done which he indicated his white blood count was very high. He was put on an antibiotic and state he felt better after taking this. He had coughing with phlegm prior to the flu shot. Advised since he is on antibiotic he should follow-up with his PMD before the antibiotics is gone as if needs to cont. with antibiotic and be evaluated. 11/25/05 call patient -  completed medications but was unable to talk on cell phone will call me back to discuss current health state. 11/28/05 Symptoms 2 wk prior to when rec'd flu vaccine includes cough, mild sore throat, felt fine the day of vaccinations. Advised patient to consult PMD concerning future vaccines and allow them to administer if still recommended. 11/28/05 no symptoms. 11/29/05 Appt with Primary MD.
RINGING IN LEFT EAR.  LEFT EAR AND SIDE OF FACE NUMB.  MY HEAD FEELS LIKE A BAD SINUS INFECTION BUT WITHOUT ANY MUCOUS IN THE NOSE.  DRY SCRATCHY THROAT AND CONTINUED COUGH.
This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 59-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included tegretal allergy. Concurrent medications included DIOVAN, ATENOLOL, Baby aspirin, METFORMIN, MELOXICAM, KDUR, Vitamin D, Vitamin B Complex, FLONASE, ZOCOR, PRILOSEC and Fish oil. On 17 September 2010 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 19 September 2010, 2 days after vaccination with FLULAVAL, the subject experienced flu like symptoms, diarrhea and low grade temperature. The healthcare professional considered the events were disabling due to the subject "was in bed all day due to the adverse events." On an unspecified date in September 2010, the flu like symptoms, diarrhea and low grade temperature were resolved.
slept all day; low fever; Tired; Patient got his 2nd dose on 41 day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day), HYPERSOMNIA (slept all day), PYREXIA (low fever) and FATIGUE (Tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day) and FATIGUE (Tired). On 18-May-2021, the patient experienced HYPERSOMNIA (slept all day) and PYREXIA (low fever). On 17-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got his 2nd dose on 41 day) had resolved. On 19-May-2021, HYPERSOMNIA (slept all day), PYREXIA (low fever) and FATIGUE (Tired) had resolved.            No concomitant medications were reported.  Treatment Medication includes: Antibiotics and steroids   This case was linked to MOD-2021-155509 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-Jul-2021 contains no significant information. Contact information updated, email added.
Reason for Hospital Admission (Admitting Diagnosis): AHRF 2/2 COVID; 64 Y male with history of HTN, subclinical hypothyroidism, pre DM, and COVID + (5 days ago) who presents to the ED w/ AHRF 2/2 COVID PNA. Please see hospital course below by problem: 1. AHRF 2/2 COVID PNA, Recent dx COVID 5 days ago. Febrile on admission 100.9F. CRP, D-dimer elevated. Symptoms of cough and body aches started 8/7 and tested positive on 8/11 and 8/15 on admission. On 2L NC at present. Received 4mg PO Decadron x 1. Consider PE given elevated D-dimer and COVID, however breathing comfortably on 2L NC and HR 80s. No signs of fluid overload on exam to suggest HF. CXR w/ bilateral insterstitial opacities. Less likely ACS given EKG changes more consistent w/ LVH when compared to prior and Troponin 0.02. No urinary sxs and no abdominal pain. No focal deficits on neuro exam. Breathing on 1L NC comfortably. Inflammatory markers trending down. S/p Remdesavir 5 doses. -Continue Decadron and Pepcid for 5 more days until 8/25 -Self isolate until 9/3 (20 days) -COVID kit provided to patient w/ home O2 monitor  -Home O2 delivered -F/u PCP via telephone or following self isolation. 2. Atrial Fibrillation - New  Patient with intermittent atrial fibrillation seen on telemetry.  On 8/18 a.m., patient went into atrial fibrillation with RVR (HR 115-160s) S/p PRN Metop and Dilt. H/o stroke per family. Rate controlled and sinus rhythm on day of discharge.  -Continue Metop 25 mg PO BID -Continue Pradaxa BID -E-consult placed for outpt TTE; 3. Gram Positive Rod Bacteremia; 8/15 blood cx w/ 1/2 GNR. No speciation as yet. Unclear source. No abdominal pain and clean UA. Started on Ceftriaxone ovn. Discussed w/ ID. CT abd/pel w/o acute intraabdominal pathology. Patchy bilateral lobe densities. Per lab, report of blood cx w/ GNR is actually Gram positive rods (Bacillus sp, not Anthracis). Likely contaminant. No further abx.  4. Hyponatremia - Resolved; Na 130. Likely 2/2 poor PO intake in the setting of acute illness w/ fatigue and body aches at home. Cr WNL. 1L Isolyte x 1. 5. HTN; SBP 178 on admit, SBP 140s on DC. -Add 5mg Amlodipine for HTN-Continue PTA Losartan; 6. Pre DM; Last A1C 5.9. BG 195. -Monitor BG