chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doctors reporting the patient developed rapid, shallow breathing with chest heaviness. Patient had facial flushing with a blood pressure reportedly at 212/90. However, a second opinion from another doctor stated they were unsure if true anaphylaxis. Epi pen was administered LOT 0FM498 and patient left in ambulance to go to ER.
I woke up in the middle of the night with this feeling that I could not hear. It felt like someone was covering my head and making it to where I couldn't hear, this was in my left ear. From that point I had this loud high pitched ringing sound in my left ear, it felt as if there was water stuck in my ear. I ended up seeing an Audiologist and we did a hearing test which showed I could not hear, then we treated with prednisone and retested I could hear back at normal levels.
Around 6:30 pm on 9/22/2020 I started becoming very congested and it got much worse during the night. By 10:00 pm the itch began all over my body (no rash) and did not begin to subside until early evening on 9/23/2020.  It was the kind of itch where you wish you could have stepped outside of your skin for awhile.  I did take Benadryl tablet form 25 mg.  I contacted my primary physician.
Felt dizziness within approximately 1-minute of injection. Lost consciousness/ seizure. Regained consciousness within 1-minute. Tingling/ numbness in back/ spine lasting up to 3-hours afterward. Weakness in left hand currently (day 4).
Patient complained of racing pulse, anxiety, dizziness during 15 min observation time.  BP elevated 175/91, HR 120-130.  pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises.  Vitals started to come down (153/71, HR 96).  Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again.  911 called to patient to go to ER for evaluation.
Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe
Myalgia malaise. Inidially following injection, she had red face, hot & stayed 1 hour. During the a.m., earlier same day she had an MRI w/contrast. Narrative:
Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of PROQUAD, lot # M037011, expiration date 21-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments:  US-009507513-1701USA013126: US-009507513-1701USA013127:
The night of 08/02 and morning of 08/03 wasn't feeling well. Tested positive on 08/03. Called PCP and was put on PAXLOVID. Was febrile off and on for 10 days. The first couple days I had cough, congestion, fatigue, sore throat. Went to PCP on 08/23 went back to PCP due to continued fatigue and increased anxiety. Ran lab work and increased BUSPAR. Repeated lab work and liver enzymes had improved but were still outside normal limits.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 12:00 as dose 4 (booster), single (Lot number: Unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Lot number: Unknown), as dose 2, single (Lot number: Unknown) and as dose 3 (booster), single (Lot number: Unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: three negative tests; Negative, notes: three negative tests; Negative, notes: three negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: No. the patient received COVID 19 Treatment with Paxlovid from 09Dec2022 to 13Dec2022. Recurrence of COVID symptoms 4 days after medication series was complete. The followed improved symptoms and three negative tests. Known allergies: No. Other medical history: No  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.
Acute swelling and pain of left upper arm, axilla and into neck area, is red and warm to touch.
Moderna 8/2/21, 8/30/21, 3/4/22. Positive on 8/18/22
I experienced body aches and exhaustion. I am breastfeeding. My baby developed diarrhea following my vaccination.
Patient with two Moderna vaccinations, last dose 05/21 who admitted with altered mental status, fever, and positive COVID test.  Provider discharge summary below:  "patient presented with AMS superimposed on dementia found to be covid positive, febrile, and neutropenic. Procalcitonin was mildly elevated so he was also presumed to have superimposed bacterial pneumonia though this seems less likely with quick resolution of hypoxia, fever and mentation. He was treated with decadron, cefepime with improvement in mentation, transitioned to Augmentin and did well with this. Due to dementia quinolone was not used, weighing risk of worsened AMS for covering pseudomonas. Neutropenia is chronic and did not improve. He was afebrile x 48 hours prior to discharge. lumbar puncture to evaluate for infection and causes of his progressive (rapid) dementia was essentially negative with a few outstanding labs at time of discharge, to be followed up on.   He needs to follow up with his oncologist out of network for bone marrow biopsy and further work up of his neutropnia. Peripheral smear unremarkable. He has low normal b12/folic acid levels and replacement was started."
I had major vertigo the day after my second shot followed by fever and flu-like symptoms. The following February I got covid and from that point on was told I had an autoimmune disease it was told I had to see a specialist. I have had ongoing fatigue loss of strength weight gain thinning hair lack of sleep my migraines have doubled. Joint swelling, muscle stiffness.
fatigue( 5 days- slept and did nothing but lay on the couch)  , whole body muscle aches ( 2 days), left arm itchy and red bumps(2 days put cold compresses on it) , very sleepy( slept on couch-3/4 days) , serve headaches (3 days- took Advil every 8 hours and drank 64 ounces of water daily)
Family care giver given Moderna vaccine.  Visitor is only 16 years old. No symptoms or side affects reported post vaccination.
sz 2 hrs p/vax; 5 mins tonic-clonic; no fever irritable; given PB; EEG was not performed;
Two weeks after vaccine swelling of feet and hands begin to turn purple and black and her feet were swollen and numb
This patient received FLUZONE HD from pharmacy on 8/30/16. She reports symptoms of weakness and pain in (L) arm starting 9/1 lasting approximately 10d. Then weakness and pain (R) arm. She presented to clinic on 9/21/16 and I referred her to ER. Pt stated she has received flu shots x 35 years and never had any problem.
Swelling and achy in my injection arm  in my armpit or possibly lymph nodes.  Uncomfortable, particularly during my morning jog.  I felt like I had another breast under my arm.
This spontaneous report was received from a Medical Assistant, referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. It was reported that, PNEUMOVAX23, was exposed to multiple excursions, for more than 2 cycles, below 32 °F, the coldest cycle being reported was 26 °F. Nevertheless, the vaccine was not exposed to any pervious temperature excursions. Data logger was not involved. Furthermore, no adverse event was reported and no product quality issue was involved. Additional information has been requested.
Chills for 12 hours (no fever), mild headache the day after, rash starting 2 days after
Severe left upper extremity edema and erythema  (extended from the shoulder to arm and hand) with  small bullae and weeping on forearm. Progressive acute onset over the course of a week.  Started on oral clindamycin, however superimposed cellulitis was NOT suspected but oral antibiotics are low risk. Limited to left arm, showed no signs of systemic illness (afebrile). Had no signs of neurovascular compromise, was able to move hand, sensation intact and notable pulse.
terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report received from a contactable consumer (Patient). A 84-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 14:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation and drug hypersensitivity. The patient's concomitant medications were not reported. On 10Feb2021 at 22:00 patient experienced terrible thirst, fever 100.3, achy pain everywhere, no energy and chills. The patient underwent lab tests and procedures which included body temperature as 100.3 on an unspecified date. Treatment received with aspirin and loads of fluids. The outcome of the events was recovered.
Patient received a second dose of moderna bivalent on 10/18 and received a dose on 9/4. patient has not experienced any symptoms
inadvertently administered dose of Pentacel from the late shipment to a patient/temperature excursion it was less than 24hours/ no AE; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 29-Apr-2019, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Suspension for injection) lot UJ123AA, expiry date- 29-Sep-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  Caller states problem with late shipment has been resolved and the office will be receiving replacement vaccines. Caller states vaccines were put in refrigerator immediately after receiving shipment, but she is unsure of the exact temperature of the vaccines at that time. Caller confirms that cool packs were still in place and believes if there was any temperature excursion it was less than 24hours. Caller reports nurse inadvertently administered dose of Pentacel from the late shipment to a patient.  None adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Inflammation of previous knee injury; This is a spontaneous report from a contactable other HCP (patient). A 26-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration in right deltoid on 27Jan2021 around 15:20 at SINGLE DOSE for covid-19 immunisation. Medical history included Prediabetic from Feb2019 and ongoing, obesity from 2021 and ongoing (thought he just turned the corner to obesity this year), previous knee injury. Family history included diabetes only. There were no concomitant medications. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as 'None'.  The patient experienced inflammation of previous knee injury on 27Jan2021. He reported onset of inflammation of previous knee injury around 15:35-15:40 which was ongoing. He called to ask if this event was known to be associated with the vaccine; if it was normal, just an inflammatory response of old injuries that was expected or not. Inflammation of previous knee injury: Described as knee was probably about 25% bigger than normal, swollen and painful, ballooned up a bit with swelling. Noted when he started walking back to the vehicle and knee just started hurting real bad to bend the knee; Described as a bad knee, previous knee injury was an old high school injury where he tore the meniscus and a few other things in the knee. The bad knee normally did not hurt or bothered him, but flared up if he got sick. The swelling was only in his knee, not in his throat or anything else. The event did not require a visit to Emergency Room and Physician office. The outcome of the event was not recovered (reported as worsened).
Rash all over body-developed day after she received DTAP, PREVNAR, HIB.
I've started to have migraines much more than usual since my vaccination. I used to have them two or three times a year but since my vaccination in March, 2021 (I had a Moderna booster in January 22), I've had between one and four a month, and my doctor put me on sumatriptan, 100mg as needed. Lately I've been struggling to remain headache free.  I don't have any reason to believe there's a causal connection, but as it was a major change in health, I reported it in my v-safe check-in and received a request for further details.
-within a month of getting the vaccine the patient started getting winded with exercise progressively getting worse, she came to us in  2/2022 and as specialists started working it up after a wait to get in the Echo came back abnormal and then got the medical records from previous  obgyn with normal echo only thing new was the covid vaccine
8 cm area of induration and erythema (L) deltoid. Decreased ROM of (L) arm due to pain. No adenopathy palpated in axilla and cervical regions. C/o nausea, headache and photophobia. Afebrile, VS stable. No nuchal rigidity. Denied fainting, dizziness, seizure, vomiting.
excessive sleeping; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) 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 for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired). At the time of the report, HYPERSOMNIA (excessive sleeping) and FATIGUE (extremely tired) 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 for the event was provided.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 10:45 (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation. Medical history included bell's palsy in Dec2009. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EB8731) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that he had history of Bells Palsy and it occurred in Dec2009. Similar symptoms of Bells Palsy started on 29May2021 at 7:00 AM, 2 weeks after the Covid 2nd dose. The patient consulted his physician and on medications (Steroid and Anti-infamotroy(inflammatory)) now. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.
Local reaction/cellulitis - treat with antibiotic. Small vesicles - thigh.
Covid19 breakthrough.  1st vaccine received on 01/05/2021.  91 y/o PMHx Dementia, Alzheimer's, AFib, HLD, Mesenteric artery embolization, massive CVA with Right hemiparesis presents from SNF with progressive SOB and increasing O2 requirements.  Pt on O2 at 6L NC, CT mild ground glass opacities, afebrile.  Pt started on IV steroids and Remdesivir.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 88-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Co-suspect products included BOOSTRIX (batch number 4P9CL, expiry date 1st December 2020) for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and BOOSTRIX (intramuscular). In August 2018, 2 days after receiving SHINGRIX and BOOSTRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: Two days later the patient developed a rash from the front of her neck down to her legs.
Member received Anthrax # 5 2Nov08. Contacted clinic 4Nov08 C/O fever, sweats, H/A, and lethargy. Member advised to follow up with Provider for care. Member did not feel the need at the time to see their provider. Member contacted the clinic 6Nov08 C/O edema, erythema, pain & tenderness non-localized to injection site. Patient instructed to proceed to nearest appropriate medical facility for Tx. Patient received Dx of cellulitis.