chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wonky and lightheaded; Felt weak and lacked energy; "Cold cold chills then got hot hot hot."; Hot, itchy, cold all the time, and sick to the stomach; Coughing a lot and also has a running nose.; Coughing a lot and also has a running nose.; Having the flu; Itchy all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach) and COUGH (Coughing a lot and also has a running nose.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.). At the time of the report, DIZZINESS (Wonky and lightheaded), ASTHENIA (Felt weak and lacked energy), BODY TEMPERATURE FLUCTUATION ("Cold cold chills then got hot hot hot."), ABDOMINAL DISCOMFORT (Hot, itchy, cold all the time, and sick to the stomach), COUGH (Coughing a lot and also has a running nose.), RHINORRHOEA (Coughing a lot and also has a running nose.), INFLUENZA LIKE ILLNESS (Having the flu) and PRURITUS (Itchy all over her body.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included none
Please check with her doctors. I know she mentioned Myocarditis.  She was vaccinated I am correct, on March 8 and April 6, 2021
Exposed to neighbor with varicella zoster. Approximately 30 pox lesions noted on 5/2/2000 PM, now getting smaller, less red, not pruritic. Afebrile.
Pfizer Dose 1 2/5/21 (lot not listed in system) Pfizer Dose 2 2/26/21 (lot not listed in system) COVID Positive 9/2/21  9/2/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA  He presented with SOB, non productive cough and fever . he also endorses abdominal pain and being fatigued  He denies sick/ COVID contacts but says wife also has similar complaints 3 days after his illness started  He is COVID vaccinated  In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen  CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates.  CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation.  The appendix is not visualized, indeterminate for appendicitis. However patient states his appendix has been removed  CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable . Blood cultures sent in the ER  He received tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER  9/17/21: Patient is a 77 yo male with medical history of CAD , Parkinson disease, Prediabetes, HLD, OSA who presented with SOB, non productive cough and fever.  He is COVID vaccinated.  In the ER vitals remarkable for fever and elevated SBP 140- 170 with RR 30s and requiring 2 L supplemental oxygen.  CXR showed mild bilateral airspace disease in the lower lobes, may represent atelectasis or infectious infiltrates.  CT abdomen done showed mesenteric stranding in right lower quadrant and a trace amount of free fluid, suggesting adjacent infection or inflammation. CBC, CMP were wnl, VBG was wnl, trop negative , UA unremarkable , PT/INR unremarkable.  COVID PCR returned POSITIVE.  He received Tylenol 650, Duoneb, 2g IV Ceftriaxone, 2.7 L LR , 4 mg IV Zofran in the ER.  Pt was subsequently admitted to the hospitalist service for further evaluation and management.  Pt was started on Dexamethasone and Remdesivir.  Ceftriaxone was continued. Pt with increasing O2 needs ultimately requiring 100% OptiFlow.  Pulmonology was consulted at that time.  Pt was started on Actemra.  Pt also developed enteritis during admission was was treated with a 7 day course of Flagyl. Pt with fluctuating O2 needs.  Pt did not desire intubation. Ultimately pt and family decided on comfort cares and home hospice.   9/20/21: Patient deceased.
Case number PHHY2012US037523 is an initial spontaneous report received from a physician on 30 Apr 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that she received inadvertently two doses of MENVEO (batch number: not reported) intramuscularly on to unspecified site about one month apart on 06 Apr 2012 and 29 Apr 2012. No adverse reaction was reported following the maladministration.
I received the vaccination on 1/5/21 approx 2pm in the afternoon.  Approx at 7pm that evening I started with left arm/shoulder discomfort and heaviness.  By 9pm I had complete immobility to my left arm/shoulder.  It felt as though my shoulder was dislocated and no matter how hard I tried, I was unable to move it.  It's like it was out of socket.  That went on for 2 days.  On the 3rd day, I had pain that radiated into my left scapular area.  The pain was a achy/pressure pain in that area for 1-2 more days.  On the 5th day, I was awoken around 4 in the morning with crushing chest pain.  It felt as though I was having a heart attack.  It was like something was squeezing my heart/lungs.  It was difficult to breath.  It just felt like the pain and/or inflammation went from my arm into my left back area and then around into my chest/lungs, is the only way I can describe how the progression felt.  Had I not just received the injection, I would have thought I was possibly having a heart attack.  However, since the chain events led back to the shot, I just treated my symptoms throughout those days with Tylenol, Motrin, steam showers and warm compresses.  By day 7 all symptoms had resolved.
Received dose at 2pm, started with general discomfort, local pain in the left arm, feverish feeling at 7pm, proceeds to take oral ENANTYUM. At midnight with chest tightness without dyspnea and proceeds to use Salbutamol inhaler with another intake of oral ENANTYUM. Associated with #2 vomiting, consultation the next day (09/15) at 9 am with BP: 124/076 mmHg T: 38 c So2: 98% room air. Eupneic, cardiopulmonary without added noise, no foot edema. Sg Levine (neg) Tietze (neg) .
I experienced extreme fatigue, chills (but no fever), and body aches for a period of 10 hours.  I treated it with Tylenol.
Burning itch over upper body, extremities + bottoms of feet. Felt very "hyper" "wired". Difficulty sleeping that night, diarrhea, sweats, swollen axillary lymph nodes. Symptoms resolved after 72 hours.
little bit of nausea; Feeling of Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 15:00 (Lot number: FF2590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1st, Start Date: 26Jan2021, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: EL3247), administration date: 26Jan2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose:2nd, Start date: 16Feb2021, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: EN5318), administration date: 16Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 13Oct2021 06:30, outcome "recovered" (Oct2021), described as "little bit of nausea"; PAIN (non-serious) with onset 13Oct2021 05:30, outcome "recovered" (Oct2021), described as "Feeling of Aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Lot number: FH8030) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported and also reported that patient had other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive for COVID; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, included Paxlovid (Lot number: GA2851) started on 07Jul2022 and stopped on 11Jul2022. Clinical course was reported as, Coughing and Phlegm returned. Still testing positive for COVID on 12Jul2022. No treatment received for symptoms and patient was recovering from symptoms.  No follow-up attempts are possible. No further information is expected.
fifteen minutes p/inject pt walked home for lunch very hot day (light-headed-laydown briefly); could not hold pen in hand, hand weak; t98.2, BP 118/70, 76HR; taken to hosp;
Right hand went numb for approx. 5 minutes; A hot, flushed feeling.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cyanocobalamin (VITAMIN B-12) for unknown indication on unknown date and unknown if ongoing. The patient previously took cefalexin (KEFLEX) for unknown indication on unknown date and experienced drug allergy. On 14Apr2021 at 13:05, 5 minutes after receiving vaccine in left arm, right hand went numb for approximately for 5 minutes followed by a hot, flushed feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right hand went numb and hot, flushed feeling was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pneumonia; Thrombus; Incoherent; dehydrated; threw up; Fever; A Spontaneous report was received from Consumer concerning 73-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fever, incoherent, threw up, dehydrated, blood clot and he was diagnosed with Pneumonia.  The patients relevant medical history included. The concomitant medication was not reported.  On 28 Jan 2021, prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 012M20A, Expiration date: not provided) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On same day, after vaccination patient experienced fever, incoherent, threw up, dehydrated.  Few days later he went to the hospital because of shortness of breath, the hospital diagnosed him with a blood clot (on 31 Jan 2021), Then on 09 Feb 2021, he went to see his family doctor because he still did not feel well and he was diagnosed with Pneumonia.  Treatment was included as Eliquis and Antibiotic.  Action taken with the mRNA-1273 in response to the events was not provided.   On 29 Jan 2021 the outcome were recovered for fever, incoherent, threw up, dehydrated. The outcome were unknown for pneumonia and shortness of breath.  On 01 Feb 2021 the outcome blood clot was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of pyrexia, vomiting, dehydration , incoherent and thrombosis, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of pneumonia is assessed as unlikely related. Further information has been requested.
Patient was very anxious about getting her vaccination. After a couple minutes of receiving the vaccine, the patient went to stand up from the chair she was vaccinated in and became light headed. She then put her head on the table and began shaking. She was safely lowered to the floor and placed on her back. 911 was called and paramedics arrived within 10 minutes. The patient was lucid and responsive, but breathing quickly and shaking. She was taken to the hospital by paramedics and discharged shortly after arriving.
This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included a properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of VAQTA from lot numbers N005605 and N008823; with expiration dates on 08-APR-2018 and 26-MAY-2018, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA012973.
After dose 1 on Jan 27, 2021, only soreness in left arm around the site of the shot which abated by the end of the 2nd day.   After dose 2 on Feb 24, 2021, soreness in right arm around the site of the shot, headache, neck ache, lower back ache which abated by the 3rd day.  HOWEVER, my very mild pre-existing tinnitus became much louder and has not dissipated.
patient had a low grade temp 99.3 Vomiting diarrhea body cramps stiffness
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310708 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was 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.
Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth.  Sharp pain in collar bone around during the 15 min waiting period of after injection.
From time of imm  through the following day left arm painful, swollen. and hard. Difficulty moving. Better Friday and Saturday. Sunday redness started at injection site and began spreading. Worse today. Area patchy red; measures 8 1/2 inches long 5 inches wide painful upon palpation ot 98.2 degrees F.
On 28JUL90 (48 hrs aftr DTP/OPV immunization), the infant experienced a fever of 104, the following day, infant was fed 8 oz of formula and 2 hrs later expired.  Taken to ER was pronounced dead on arrival.
Child reports back to clinic after leaving and presents with swelling/itching on right eyelid and erythema around right eye. Mother gave 25 mg of Benadryl po. Swelling and itching resolved by 1:00PM.
Information has been received from the father of an 18 year old female with a penicillin allergy noted as rash and fever. On 16-JAN-2007, the patient was vaccinated intramuscularly in the deltoid, with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 18-JAN-2007, the patient developed epigastric pressure and discomfort. On 19-JAN-2007, the patient was examined by her physician and was prescribed famotidine. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning an overweight 18 year old female with a penicillin allergy noted as rash and fever, acne, smoking, a history of an appendectomy and a family history of the mother (age 45) with ovarian cancer (currently undergoing chemotherapy). On 16-JAN-2007, at 6:32 P.M., the patient was vaccinated intramuscularly in the left deltoid, with the first dose 0.5 ml of GARDASIL. Concomitant therapy included topical medications for acne. On the 16-JAN-2007 the patient had a Pap test done with reflex HPV. On 17-JAN-2007 (previously reported as 18-JAN-2007) the patient complained of a week history of a band of abdominal pain across her abdomen which was associated with chest pain. She denied any burning or back wash of food or fluid coming up in her chest, although occasionally she had this chest pain. There were no foods that aggravated her and she followed a healthy diet. The patient had normal bowel movements and her last period was 2 weeks prior. On examination, the patient was in no acute distress; her abdomen was soft, non-tender, nondistended; no hepatosplenomegaly or masses. The physician's impression was abdominal pain/possible mild viral gastritis. The patient was prescribed famotidine (MSD) 20 mg, twice a day. She was to avoid caffeine and acidic foods or large meals before bed. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information is not expected.
Hcw from Dr office called to say patient, who received Janssen Johnson and Johnson COVID 19 vaccine here on 7/16/2021 was not expected to live. Hcw continued to say that patient was in good health prior to the vaccine. Patients organs started shutting down soon after receiving the vaccine. I deduced that she had been in the hospital longer than one week ( not exactly sure ). Hcw said patient is an employee. Patient is at a Hospital. She had been Life Lined there. Patient was having blood clots and uncontrolled bleeding. Hcw was letting us know of patients condition and cautioned use of that specific vaccine.
pt recvd vax JUN92 & 2 days later devel stiffness in the neck & shoulders; No further details were provided;
A report has been received from a Pharmacist concerning an 11 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 27-Nov-2013. The pharmacist reported that inadvertently administered expired FLUMIST QUADRIVALENT to a patient on 27-Nov-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious. Summary of significant follow-up information received by AstraZeneca/MedImmune on 03-Dec-2013 from a Pharmacist: Product lot number ane expiry date added with updation of start date for FLUMIST. Event start date updated. Patient details updated. Reporter details updated.
Daughter had covid vaccine. She had bad reaction.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter had first-hand knowledge of the patient and was reporting on a specific patient. Daughter had Covid vaccine. She had bad reaction. Outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
sudden constant eruption of cystic acne on chin, back, and chest; not alleviated by any OTC medications.  Menstrual cycles, post-vaccine, pain/longevity/heaviness incredibly increased.
Systemic: Confusion-Medium, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Systemic: Seizure-Medium.