chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever , body aches , legs buckled and almost fell over , arm twitched a few times , nausea, eyes completely bloodshot & glassy looking , extreme fatigue
Extreme bodywide itching, hives. The slightest contact with my skin creates welts and becomes warm.
Approximately 30 minutes after administration of Covid vaccine in left upper arm patient complained of a tingling sensation down the entire arm and into the palm.  She then began noticing a sensation that she needed to clear her throat and cough.  Reports it started to feel tight.  No facial edema no oropharyngeal edema visible.  Lungs clear to auscultation. Blood pressure and pulse remained normal throughout the visit.  anaphylactoid reaction 1. 9:28 am given Epinephrine 0.5mg/0.5ml given IM, in the left thigh; administered by: healthcare professional: ( lot #344615; exp. 01/2022; Par Pharmaceutical )  2. 09:31 am given Diphenhydramine 50mg/1ml given IM, in the right upper arm; administered by: healthcare professional; ( lot #070101; exp. 07/2022; west-ward )   Epinephrine was administered followed by Benadryl.  Patient was observed for another 30 minutes and noted the throat symptom disappeared and was feeling back to her normal self.  9:45am felt better, 10:00am discharged Discussed with patient anaphylactoid reaction.  She is well versed in anaphylactic reactions having had them in the past.  Has an in date epinephrine pen on her at all times.  Is being driven home by friends and has family members at home to help observe her.  Discussed rare cases of delayed second reactions up to 12 hours later.  She will observe for this.
Information has been received from a registered pharmacist concerning her 17 year old daughter with no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL.  There was no concomitant medication.  On an unknown date, the patient developed heart arrhythmia after getting the third dose of GARDASIL lot # was not provided.  The patient sought unspecified medical attention.  At the time of reporting, the patient had not recovered.  Additional information has been requested.  7/10/09 Cardiology consult rec'd for DOS 5/12/08-6/5/09 with final dx: Wolff-Parkinson-White syndrome with supraventricular tachycardia.  Pt initially presented 5//12/08 with ~ 1wk hx of episodes of palpitations which begin and end suddenly. Also reporting joint pain in the wrists, knees and ankles.  Syncope with vomiting 7/2008.  Episode of palpitations 5/26/09 at school and RN noted HR between 200-300.  Sent to ER where the WPW dx was made.  Cardiac ablation scheduled.  7/14/09 MR recd from PCP with vax info. Several OVs 4/2008-6/2008 r/t c/o  fatigue and irregular heart rate. One episode ~2/2008. Referred to cardiologist (above). Dx: Fatigue, malaise, arthralgia, palpitation, irregular heartbeat, heart murmur..Seen 7/5/08 in f/u to sycopal episode on 7/4/08. Several month hx of fatigue, muscle aches, palpitations. Wearing a heart monitor which registered HR 32 during event. Dx: fainting.  7/15/09 ER record rec'd for 2 ER visits 6/7/08 and 5/26/09 as well as a heme/onc consult from 11/2008. Initially presented on 6/7/08 with c/o sudden onset of palpitations lasting~5 minutes. Resolved on arrival.  ..  To f/u with peds cardiology (above). Heme/onc consult 11/20/08 in f/u for von Willebrand.   Reports sensation of heart racing and fatigue, but vW in good control. ER visit 5/26/09 with dx: Wolff Parkinson-White syndrome.  SVT.   EKG abnormal-see above.
This spontaneous report as received from a physician, reporting on himself, a 58 year old male patient with hypothyroid and no drug reaction/allergies. On 08-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength was no reported) lot # J014851, expiration date 24-OCT-2014, 0.65 ml, subcutaneous injection. Concomitant therapies included SYNTHROID. The physician experienced a 4 cm, circular, red, swollen skin reaction on 09-MAY-2014, after receiving ZOSTAVAX. Physician reported on 10-MAY-2014, there was deep purple tracking down to left elbow; skin around injection site was tense. Physician became concerned and contacted unspecified infectious disease physician and was advised to start KEFLEX. Physician reported that there has been improvement with color, erythema, tracking was gone and area was less tender following the KEFLEX, cold compresses and heat. At the time of the report the outcome was recovering. Patient received as treatment heat, cold compresses and KEFLEX. No lab diagnostics studies were performed. Additional information has been requested.
pt presented with mother for 2nd dose of pfizer. She was upset it wasn't the 1st dose rph..was very anxious..mom tried to calm her down. Rph told pt to sit..she refused.. mom held her up while rph gave vaccine. As Rph was cleaning up, pt was still standing with mom and the patient fainted in her mom's arms. Mom gently layed her on the ground. Rph asked tech to call for 911. Pt came to within seconds not knowing what happened. Gave patient water and then she felt nauseous and vomitted in garbage. Officer arrived then pharmacy gave him the ok to leave. Kept pt in observance for 15-20 minutes with juice and snacks.
Started with profuse eye tearing. Woke up with extreme headache, teeth aching, non stop runny nose, it felt like aching golf balls in my left breast, armpit and upper back. (lymph nodes) Extreme fatigue, could not eat for 23 hrs. As of 5 days later I still am having pain and swelling in my armpit. Dizziness.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-337484 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up -ADR form received, Medical history provided, Gender added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-337484:MOD21-148785
EXTREME pain at injection site after 4 hours. Cannot lift arm after 52 hours due to continued intense pain. Extremely limited mobility in arm where injection given. Believe vaccine was not administered properly.
R arm soreness- mild to moderate on 4/29, 4/30. Fever TMax 102 F Max on 4/29/2021,  2 PM onwards.  TMax 99.7 F on 4/30/2021. Temp normal from 5/1/2021 onwards.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned that he had seen and heard a lot of his older patients complain about redness and swelling. Some said it has become the size of a bug bite - some have seen their whole triceps get enlarged, some people have treated it like a skin infection and one (the patient) went to the hospital and was in the hospital for three days. The outcome was unknown. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and event details description including event location and time lag between the onset of the event and vaccination date of PREVENAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Severe stomach cramps, headache, dizziness, low heart rate. Child was taken by ambulance to local hospital.
Patient developed a rash on back. Medical Provider told patient that she got shingles from the vaccine. This information was given by the patient and her husband, not the medical provider.
Pt describes as having radiating nerve pain at the local site of injection on the left arm for about two weeks starting shortly after receiving the shot.
Tachycardia, metallic taste, warm flushing. Waited 5 minutes before alerted nurse, by the time she arrived heart rate had slowed to 98. Physician checked BP it was OK. Waited an extra half hour before leaving.
Bivalent Moderna vaccine was given as the primary dose instead of a monovalent vaccine. Patient is instructed to go to another pharmacy (location given) to get the monovalent vaccine at her earliest convenience.
Flu; This is a spontaneous case initially received from other non-health professional on 28-Aug-2019, concerning a male patient of an unknown age..  The patient's relevant medical history included epilepsy (Grand mal seizures and Jacksonian seizures well controlled since starting medication at 14 years old).  The patient's concomitant medications included Trileptal (oxcarbazepine) and Depakote (valproate semisodium); the both were indicated for epilepsy.  On an unspecified date, the patient was administered Flu vaccine [influenza vaccine, dose, route of administration, anatomical location, batch number, expiration date: not reported] for unknown indication.   On an unspecified date, after vaccination the patient started experiencing flu with no other side effects.  The outcome of the event influenza was not reported by the reporter.  This case is linked to 201904420 and 201904525, concerning the same patient.  Company Comment: The patient experienced influenza on an unspecified date after vaccination with Flu vaccine. Chronology is unclear but plausible. No diagnostic findings were provided. Causality was confounded by therapy with concomitant medications Trileptal (oxcarbazepine) and Depakote (valproate semisodium). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced influenza on an unspecified date after vaccination with Flu vaccine. Chronology is unclear but plausible. No diagnostic findings were provided. Causality was confounded by therapy with concomitant medications Trileptal (oxcarbazepine) and Depakote (valproate semisodium). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.
Severe diarrhea that lasted three days until 6/29/2016. And this happened last year as well but I was not sure of the cause last year. But since same thing happened this year reaction was confirmed.
Moderate pain, pain increased severity to 8/10 (Pain on entire arm and hand); Arm and hand are slightly swollen; Barely able to sleep due to pain; Felt like my entire arm and hand were having an arthritic flare, were blown up; Hand was cold to touch; palm looked red-blue; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0151), via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to latex, intravenous contrast, soft shell crab, various medications, bee stings; as well as seasonal allergies, arthritis, increased blood pressure, lipidemia, chronic pain related to several injuries. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included colecalciferol (VIT D), atorvastatin calcium (ATORVASTIN), buproprion, varenicline tartrate (CHANTIX), mirabegron (MYRBETRIQ). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6199) in the left arm on 17Mar2021 at 10:30 for COVID-19 immunisation. The patient did not receive any other vaccinations within 4 weeks. On 08Apr2021 at 15:00, several hours after injection, the patient experienced moderate pain to the entire arm and hand which increased in severity to 8/10. There was no response to ice, paracetamol (TYLENOL). The pain was so severe that the patient took tramadol to help diminish the pain. The arm and hand were slightly swollen. The patient was barely able to sleep due to the pain. It felt like the entire arm and hand were having an arthritic flare, were blown up. The hand was cold to the touch, the palm looked red-blue. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events was not resolved.
Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives; Itching; Tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives), PRURITUS (Itching) and FATIGUE (Tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Developed allergies this year). Concomitant products included ATORVASTATIN and LISINOPRIL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRURITUS (Itching). In 2021, the patient experienced FATIGUE (Tired). On 10-Nov-2021, the patient experienced URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives). At the time of the report, URTICARIA (Had the booster and they got a bunch of/ welts rae red, itchy bumps, itchy bloches/Hives) and FATIGUE (Tired) had not resolved and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  treatment  medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up documents contains additional new events and reporter details. On 17-Nov-2021: Follow up received and Secondary reporter information was added. On 17-Nov-2021: Follow-up received and Patient details and events added.
3 wks later pt came in & a sterile abscess was dx on lt thigh secondary to vax; tx consists of warm compresses to affected area
Burning, redness and swelling like a balloon. Put ice on it 3/9/2017; went to dr and they diagnosed with infection. Treated with cephalexin better after 2 weeks; 4/20/2017 pain started; wrapped it in ice; red mark returned and it felt hot; fever, arm swelled; headache, went to hospital - now on bactrim Ds and  cephalexin.
PATIENT REPORTS LOW GRADE FEVER, SORENESS AT INJECTION SITE, AND LOSS OF FUNCTION BELOW THE WRIST
Right arm started hurting 2 hours after shot by the end of the night he couldn't lift his arm from his side. Pain is constant, hurts when he uses it. Not sleeping since shots. Was getting shooting pains up his arm. Hot & ice packs, stretching & ibuprofen
Adverse effects 12 hours after 2nd dose: Body pain Fever Skin Rash Eyes irritation Joints pain Headache Arrhythmia These Symptoms lasted for 12 hours
Patient's partner called reporting that the patient was experiencing severe nausea and facial swelling. Patient immediately instructed to go to emergency room ASAP and follow up with providers office ASAP. Called the patient today @04:05pm with no answer.  Left voicemail asking patient to call me back ASAP. Provider and Practice Administrator notified of adverse reaction.
He had a cough and fever (102.1). He wasn't able to walk due to his Parkinson's disease. His Parkinson's symptoms got very severe.
Patient's mother did not disclose that patient already had its booster dose. Booster dose was completed at a pharmacy and not entered into patient's chart. This equated to the patients 4th dose.  Staff discovered it was an extra booster when mother handed over vaccine record card that showed the three previous doses. Patient was monitored for 40 mins in office and mother was explained situation too. Patient and mother had no concerns. Told to contact office should symptoms arise. No contact has been made dose 1: 6/25/21 dose 2: 7/16/21 booster 1: 1/14/22 booster 2: 6/8/22
given the second dose on day 21 instead of day 28; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment information not provided,
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9262), administration date: 23Jan2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EL9266), administration date: 13Feb2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: EW0217), administration date: 15Sep2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot: FK9894), administration date: 16Apr2022, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered". The event "tinnitus" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination.
Information has been received from a physician concerning a female patient who was vaccinated on 05-MAR-2009 with an unspecified dose RECOMBIVAX HB intramuscularly. On 17-MAR-2009, The patient was inadvertently given an other dose of RECOMBIVAX HB. The patient developed a rash on her arms on 17-MAR-2009. The patient sought medical attention at the office. No labs were performed. On 18-MAR-2009, the patient recovered from rash on her arms. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 18-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. Within one month after receiving the ZOSTAVAX, the patient began experiencing sudden and severe headaches, intermittent shooting pain and tingling in his right eye and sudden horizontal bilateral diplopia. The patient was diagnosed with sixth nerve palsy, zoster opthalmicus, hypertropia of right eye, and diplopia. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, sixth nerve palsy, and zoster opthalmicus were determined medically significant. Sixth nerve palsy, zoster opthalmicus, hypertrophia of right eye, bilateral diplopia, and tingling in his right eye were considered disabling. Additional information has been requested.
Information has been received from a physician concerning a 14 year old female with asthma, seasonal allergy, penicillin allergy and allergy to erythromycin who on 31-AUG-2007 was vaccinated with her first dose of GARDASIL, 0.5ml IM. There was no concomitant medication. Several hours after receiving the vaccine, on 31-AUG-2007 the patient experienced injection site reaction with redness and swelling at the injection site and fever which lasted for 24 hours. She has been taking TYLENOL, ADVIL, BENADRYL for the symptoms. The patient's injection site reaction and redness at injection site and swelling at injection site persisted. Additional has been requested.
Her eye is bruised in between the eyelid/ Black eye; Her eye was hurting; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 (at the age of 54 year old) (Batch/Lot Number: EW0186) as single for covid-19 immunization. The patient's medical history and concomitant medications were reported as no. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 7May2021 (at the age of 54 year old) (Batch/Lot Number: EW0167) as single for covid-19 immunization and experienced no adverse event. Patient reported upon waking up this morning (28May2021) her eye was bruised in between the eyelid, also her eye was hurting. She was no Narcissistic so at first she didn't look in the mirror. She was trying to figure out why her eye would her. When she went to wash her face and get ready, that was when she saw the black eye. Investigation assessment was reported as no. The events were reported as non-serious. The outcome of both events was unknown.  Information on the batch/ lot number has been requested.