chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient states that last Thursday she had the COVID vaccine in her left arm.  Friday night her back, hips and knees started hurting bad.  she contacted Maderna who told her that no complaints have been made regarding this type of reaction and to see her pcp.  her daughter states that on Friday the patient did a lot more walking than normal and she started hurting after that.  patient states that the pain has not easeed up since and that it has gotten worse.  pain described as throbbing. in both hips and across the lower back. pain level when sitting in office 7-8/10 while standing or walking 10/10 adds that the pain eases up slightly when sitting
Presented to ED with sore throat, fevers, diarrhea, and fatigue. 1L IVF, Decadron, Albuterol, Rocephin, Remdesivir, Vapotherm, baricitinib, vitamins
Area of redness left anterior thigh 9 X 10cm.  No induration, warmth or tenderness.
Nothing happened for the first few days, other than a sore arm.  Then a small rash appeared at the injection site and it has steadily grown so not it is as big as my hand, it itches, has welts and feels warm. My lymph nodes under that arm are also tender.  I also developed a cold sore/fever blister on my lower lip.  I have not had one of those in years. I showed it to my Dr. on 3/8/2021 and she prescribed Triamcinolone Acetonide to be applied 3 times a day until the rash is gone.  She suggested I go back to the facility where I had the shot and speak with them about it.  I did that today 3/10/2021 and she suggested that I take Benadryl at night.
I had diarrhea, stomach pain. This lasted for about 9 days. I had to go to the ER, and they gave me morphine for pain and sent me home with TYLENOL 3. The next day my primary doctor and they thought I had food poisoning and they treated me with hyoscyamine. I had a follow up appointment with an ER physician, and they treated me with pantoprazole, but nothing helped. They did a CT scan, but it didn't show anything. I also have a Colonoscopy scheduled soon.
PATIENT REPORTED AN EXACERBATION OF HIS RECURRENT PERICARDITIS TRIGGERED BY THE ADMINISTRATION OF HIS FIRST DOSE OF SHINGRIX VACCINE ON 6/24/19.  SYMPTOMS BEGAN 60 HOURS (5 DAYS) FOLLOWING THE VACCINATION AND INCLUDED BURNING CHEST PAIN AND EXTRASYSTOLE.  I (THE PHARMACIST HE SPOKE WITH, NOT THE ADMINISTERING PHARMACIST) ADVISED THE PATIENT AGAINST A SECOND AND FINAL DOSE
localized reddness, swelling, & itchiness OT  injection site. No pain Patient took OTC Benadryl with relief, but experienced  side effect (i.e. grogginess), So Rx changed to  cetirizine 10 mg PO QD., x 7 days
Cramping of uterus constantly; Swollen and sore breasts; Sore breasts; Water retention; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 03May2021, the patient experienced cramping of uterus constantly, swollen and sore breasts and water retention. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cramping of uterus constantly, swollen and sore breasts and water retention was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received the vaccine shot at 10:30 in the morning. That same night at 9 PM became tired and started shaking. Had violent chills and hot episodes. Woke up at 2:15 AM and couldn?t move. My arms and hands and feet were completely paralyzed. Couldn?t speak or call out. Slowly started attempting to move fingers and feet and head. After several minutes was able to roll over on stomach. Could not move. After several minutes of attempting movement was able to push myself up and grab a piece of furniture. After several more minutes was able to get legs to move sufficiently to walk to bathroom by holding onto furniture and leaning against walls and door jams. Still feeding feeling feverish with chills. My son took my temperature with a forehead scanning thermometer and it registered at 100.3. He said my skin felt extremely hot. Took 1000 mg acetaminophen.  Finally was able to go back to sleep around 4 AM and slept for a couple more hours. Woke up just before 7 AM and was able to stand and walk with some effort. Currently 9:30 AM and still have aches and pains and difficulty walking.
He has had recurrent urticaria only at the site of injection (L) arm off and on for 4 weeks.
Exacerbation of asthma - vaccine date 3/20/15 - respiratory infection started 3/21/15 - asthma exacerbation started 3/30/15
there's a little bump now.; The patient reports getting a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (there's a little bump now.) and PAIN IN EXTREMITY (The patient reports getting a sore arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Last Moderna booster) in December 2021 and Moderna COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.  On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (there's a little bump now.) and PAIN IN EXTREMITY (The patient reports getting a sore arm). At the time of the report, SWELLING (there's a little bump now.) had not resolved and PAIN IN EXTREMITY (The patient reports getting a sore arm) had resolved.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant or treatment medications were reported.  The patient reported getting a sore arm. It's not sore now, but there's a little bump now. The soreness is gone now.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with MMR II, subcutaneous (dose not reported). No other concomitant therapies reported. On an unknown date the patient was tested negative for rubella. The outcome of negative for rubella was unknown. The causality of the event was unspecified. The case as been linked with the cases (same reporter link) # 1406USA008681 and 1406USA012138. Additional information has been requested.
Fatigue; Headache; Fever; Chills; Body aches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatment were not reported.   This case was linked to MOD-2021-032628 (Patient Link).   Reporter did not allow further contact
No symptoms noted on day of vaccination 3/29/2018. The vaccine was given in the left deltoid muscle without an complication. On 3/30/2018, a sore swollen left deltoid muscle was noted with waking at 5am. By around 8 pm, the discomfort extended toward a reactive lymph node in the left axilla along with tender slightly raised red streaks. My urine began to display a pink tinge. On 3/31/2018, Dr. evaluated me at the Medical Walk In unit at about 9:30 am. The streaking of skin over the shoulder hadn't progressed significantly, and the tenderness was unchanged. Throughout the day the streaks faded and the swelling/tenderness subsided. My urine darkened significantly, appearing like red wine by evening. I didn't display any edema or swelling. I had no dysuria or urinary frequency or incontinence throughout the episode. On 4/1/2018, my arm and axilla were back to baseline. My urine was dark red and foamy. On 4/2/2018, my PCP Dr. evaluated me.  My arm discomfort and discoloration was not present. My urine had begun to clear a bit although there was a tinge of pink. On 4/3/2018, my urine appeared to be back to normal.
weakness, chills, headache, blurred vision, uncontrollable itching from a rash covering my entire torso. Rash was bright red, small dots and extremely uncomfortable, it did not start subsiding until after 24 hours
Vaccine was expired for 4 days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
no additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 14-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660112, expiration date: 18-OCT-2020, orally for prophylaxis. There was no additional adverse effect reported. Administered dose of vaccine was stored below 2 Celsius degrees (1.28 Celsius degrees) for 2 hours and for 30 hours as recorded by digital data logger.  Previous temperature excursion was not noted.
Inability to move arm without severe pain where injection occurred since morning after vaccine a week and a half ago. Last doctor visit on January 24, also was informed of high blood pressure. Faint red spots around injection side as well.
expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 19-MAY-2023, the patient received Engerix B. On 19-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter consented to follow up via email. The patient received a dose of Engerix B, which was already expired, which led to expired vaccine used.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable other hcp. The other hcp reported same events for two patients (herself and her coworker). This is the first of two reports, for herself.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date in Jan2021 (either 06Jan2021 or 07Jan2021) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was calling about herself and another coworker. They both received the first dose of the COVID vaccine either 06Jan2021 or 07Jan2021 and they both tested positive for Covid-19 this past weekend (Jan2021) and reporter wanted to know if they should still get their second dose or what do they recommend for that. Reporter is asymptomatic and currently quarantining.  The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is available.,Linked Report(s) : US-PFIZER INC-2021072822 Same reporter/drug/AE, different patient
Very sore arm after 2nd dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine) outcome was unknown.            Reporter did not allow further contact
Pt has a approximately 5x5 size rash on left upper arm. Pt complains of lots of pain, swollen + hot to touch arm + also rash. Pt states that she feels fine except for her arm. States she "hasn't done much of anything at all". I, called PCP. Person from office called me back to let us know pt is going to be seen in the office today. Pt came back through drive through. MD gave her Clindamycin + is checking in with her. Patient has antibiotic now + will follow up with doctor. Pts arm is outlined by MD so that they will be able to identify if the rash is spreading.   - called manufacturer (closed) will follow up this week (Friday) + let staff RPH aware thursday (512).   - pt states she received this Monday April 29th around 9pm. Started noticing a reaction the next morning Tuesday April 30th.
Information has been received from a registered nurse concerning an 11-month-old female, who in December 2006, was vaccinated with a dose of VAQTA. Suspect vaccination included PROQUAD (Oka/Merck upgrade process) (MSD). It was reported that the patient developed swelling in her extremities, hives and rash and was hospitalised for five days. The patient's status was unknown. No product quality was involved. This information is one of several reports from the same source. Additional information has been requested.
Severe Headache, Exhaustion and Confusion- No strength in muscles, could not stay awake or carry a conversation
Pain in the arm within an hour of Fluzone vaccine; 7/10 on pain scale over (L) upper arm, shoulder, axilla, and chest. Bone pain in hand as well. (+) nausea
On 30 Nov 2021, the patient had Covid-19.; On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days.; Pain in extremity; Low back pain; Sinus pressure; Cold; Fatigue; dry cough; stuffy nose; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206386-00 (AbbVie).  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19."; SUSPECTED COVID-19 (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in extremity"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Low back pain"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 2021, outcome "recovered", described as "Sinus pressure"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "Cold"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "stuffy nose". The patient underwent the following laboratory tests and procedures: pyrexia: (unspecified date) 102.0; sars-cov-2 test: (30Nov2021) unknown. The action taken for risankizumab was unknown.The reporter's causality for the event(s) of COVID-19, pain/soreness in feet, hands and legs, pain/soreness in lower back, sinus pressure, fatigued and cold with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19, pain in extremity, back pain, paranasal sinus discomfort, nasopharyngitis, fatigue, cough and nasal congestion with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Lower lip swelling. Itchy tongue. 911 called. Children's antihistamine 12.5 mgm given.
Patient presented to a vaccination clinic on 10/05/2022 @1200 patient was given a Covid Pfizer Monovalent vaccine by accident. The intended vaccination was Covid Pfizer Bivalent vaccine. No adverse reactions were noted, patient educated on the need for revaccination with correct Pfizer Bivalent vaccine, two months after incorrect dose.
L arm and neck became swollen, red and itchy after #3 Hep B on 1/28/02. Symptoms resolved with Benadryl. Denies yeast allergy.
I became numb from head to toe. I developed severe tinnitus in both ears. My blood pressure became elevated since the vaccine to the point I needed to be on medication. I am on anti anxiety medication now due to the anxiety I have developed over this. It has been over 5 months now and I still experience light headedness, dizziness, heart palpitations. My activities are reduced because I am more secluded to the house because I am afraid to drive, to walk long, to even shower alone, because I fear I will faint. All tests done to me all came back normal. They think this is a hyper immune response to the vaccine. I was always pro these vaccines, until it happened to me. These vaccines are not safe.
PATIENT CLAIMS SHE HAD A FEVER, CHILLS, ACHES AND PAINS, HEADACHE, NO APPETITE FOR 3 DAYS
This case was reported by a physician and described the occurrence of fatigue in a 40 year old female subject who was vaccinated with Twinrix for prophylaxis. On 9/13/06, the subject received 1st dose of Twinrix (unk). At an unspecified time after vaccination with Twinrix, on or prior to 9/29/06, the subject experienced fatigue, myalgia, metallic taste, tingling to arm, and pain to neck. The subject required a visit to her doctor as a result of these events. The physician considered the events were clinically significant or requiring intervention) (OMIC). At the time of reporting the outcome of the events were unspecified.
Awakened by " bubbling" sensation in muscles of legs and arms which got progressively more severe and uncontrollable. I could not walk. Developed a severe frontal headache with nausea and vomiting. NO fever. Lasted approx 2 hrs and then extreme fatigue and slept for 12 hours. WILL NEVER PUT THIS INTO MY BODY AGAIN!!
Presents to EC 05/23/2021 "with a chief complaint of lightheadedness, difficulty sleeping, and SOB"; PMH " aortic stenosis, CAD, hyperlipidemia, HTN, and MI"; on 6/17/21 transferred to rehab; D/C'd Home on 07/01/2021.
Began to experience unexplained weight loss in October-December which plateaued in January (10lbs in 3 months). Went in for my annual well check and had my A1C drawn. Results showed A1C of 12.1. Aside from the weight loss there were no symptoms which made me seek treatment sooner. Further testing found autoantibodies and I was diagnosed with adult onset Type 1 Diabetes. Weight loss was directly attributed to my high blood sugar. Direct trigger of the autoantibodies is unknown tho timing seems to indicate correlation with my vaccination.
Information has been received from a pharmacist referring to a 68 year old male patient without any drug reactions/allergies. Information about concomitant medication and pertinent medical history was not provided. On 12-OCT-2017 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route unspecified) for prevention of shingles with sterile diluent (manufacturer unknown) (lot#, expiration date, dose, frequency and route unspecified).    On 17-NOV-2017, the patient developed bruising around the injection site (unspecified arm) after administration of vaccine. No treatment and no lab diagnostic/ studies were performed. The patient sought medical attention via calling the pharmacist. At the time of the report, the pharmacist reported that the patient had the bruising for the past 6 weeks and it was not resolving. The causality was not provided.
appt reminder call reveals pt had unknown rxn to IZ, to the point that his state dept (National Security) trip to the middle east was cancelled per Dr. recommendation and appt cancelled for further boosters.Unknown if previously reported.Other details unknown.
Initial misuse report received from a healthcare professional on 12 September 2013. It was reported that DTaP-IPV from the PENTACEL vaccine was administered to a child without ACT-HIB. No adverse event was reported. List of documents held by sender: none.