chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Before the vaccine I experienced a mild headache and pain in the sinus area of the face and assumed I had a mild sinus infection. On the morning of vaccination I had no temperature. Shortly after the vaccine the pain in my head and face area became unbareable. I went to a local clinic and was diagnosed with shingles.
Starting at 8:30 the morning after the injection, i got chilled to the bone and could not warm up, had a bad headache, no fever, and nauseous.  Was ok the day after those symptoms occurred.
Chronic constipation followed by intense bouts of diarrhea, chronic fatigue, joint pain and memory loss. Treated with OTC laxatives, Pepto-Bismol, energy supplements, Chondroitin Sulfate and Ginko Biloba.
Approximately 3 weeks post vax and every 3 weeks since pt has had varicella lesions reoccur around neck, associated with temperature of 100.4.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 30-JUN-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Moderna vaccinated x2 patient - last dose 05/1/21 - who admitted to hospital inpatient with COVID pneumonia and subsequently died.  Discharge note below:  "63 YO female w/ history of persistent asthma, prior cardiac arrest, depression, seizure disorder, polypharmacy presented to ER due to worsening confusion. She was found to be COVID 19 positive with pulmonary infiltrates on CXR. She was subsequently admitted to inpatient hospital but later transferred to another hospital due to increasing oxygen requirements.    Due to worsening respiratory status, she was transferred to ICU where she was subsequently intubated. Her hospitalization stay was further complicated by VRE UTI where he was started on Unasyn. She underwent tracheostomy and PEG placement 01/18/22 and then transferred to regular inpatient floor. She remained critically ill with ongoing encephalopathy therefore Palliative care met with family members who then elected DNR/DNI with care limitation code status (transition to comfort care if she is to deteriorate.  She remained critically ill and subsequently passed early morning of 01/27."
Case PHEH2016US025949, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 44 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618521) at a dose of 1 ml intramuscularly on 26 Sep 2016. The nurse stated that, she discovered that 9 patients received 1.0 ml of FLUVIRIN rather than 0.5 ml. No adverse event was reported after this maladministration (accidental overdose). The case was lost to follow up at initial.
the white particles were noticed floating in each of these vials, five (5) patients received the Daptacel vaccination; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown age and gender of five patient who received a dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot C5281AA expiry date: 05-Oct-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   It was as an actual medication error case due to deteriorated drug administered.  There were thirty Daptacel vials each have one white particle floating in each of the vials. Reporter stated that, before the white particles were noticed floating in each of these vials, five patients received the Daptacel vaccination with this lot number.  Reporter was unaware of any adverse effects experienced by the five patients.  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.  List of documents held by sender: none.
As of disease investigation on 8/23/21 case reported onset of symptoms as 8/16/21 which included subjective fever, chills, rigors, muscle aches, runny nose, sore throat, new olfactory disorders, headache, fatigue, cough, wheezing, shortness of breath, nausea, abdominal pain, diarrhea and loss of appetite.
had a sore arm for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm for 5 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a sore arm for 5 days). At the time of the report, PAIN IN EXTREMITY (had a sore arm for 5 days) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
After both shots I had chronic chest pains for 3 weeks.  They went away on their own after the 3 weeks. I called my pcp and reported each time.
Was given Covid vaccine error, 3 other siblings in room. No adverse reaction. Follow up call to mom, with interpreter, no answer, voice mail asking mom to return call next business day to schedule appointment. Call to mom with use of interpreter, mom states child is ok and not able to come to appointment today, appointment scheduled next day, Tuesday. Error was immediately reported to clinic manager
Chills; sore Arm; headache; sore throat; high resting heart rate 90bpm & low heart Rate variability 8ms; high resting heart rate 90bpm & low heart Rate variability 8ms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 09:45 (Lot number: ff8841) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore Arm"; HEADACHE (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "headache"; OROPHARYNGEAL PAIN (non-serious) with onset 29Oct2021 20:00, outcome "recovered with sequelae", described as "sore throat"; HEART RATE INCREASED (non-serious), HEART RATE VARIABILITY DECREASED (non-serious) all with onset 29Oct2021 20:00, outcome "recovered with sequelae" and all described as "high resting heart rate 90bpm & low heart Rate variability 8ms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain in extremity, headache, oropharyngeal pain, heart rate increased, heart rate variability decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has tested for COVID-19. Patient recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.
At 9:30 A.M. on 2/23, I noticed that I had a slight headache.  My left arm was, as I had expected, painful and red near the injection site.  As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4).   I felt listless and nauseous by dinnertime.   By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that.  By the morning of 2/25, I began feeling better and stopped the Tylenol.  My symptoms gradually continued to improve through 2/28.
Vomiting; High Fever; Cough/ Lingering cough; Congestion/  lingering cough/congestion for additional 5 days.; Major Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 24Sep2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) scleraderma, migraines, rynauds, hoshimotos, allergy to iodine, allergy to bees and allergy to shellfish. 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 etanercept (ENBREL), escitalopram oxalate (LEXAPRO) and propranolol (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received methotrexate (MANUFACTURER UNKNOWN), ketorolac (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) for unknown indication on an unknown date and experienced drug allergy. On 25Sep2021 at 08:00, the patient experienced vomiting, high fever, cough, congestion, major headache for 7 days and also reported as lingering cough, congestion for additional 5 days. It was reported that the patient missed 5 days of work and doctor wouldn't let go back. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events cough and congestion and included treatment with albuterol sulfate (ALBUTERAL) inhaler. Since the vaccination, the patient had been tested for COVID-19.  On 27Sep2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events vomiting, high fever and major headache were resolved with sequelae on 02Oct 2021; while that of the events cough and congestion resolved with sequelae on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
10/4/08 - rash, fever, diarrhea, leg cramps, lymphadenopathy (mild), sx's resolved 10/9/08.
w/in 48 hrs of vax pt died-17FEB94; preliminary autopsy report indicates SIDS (brain and heart nl).  culture are pending; grandparent states that pt had 2 episodes of flu during the 4 wks prior to immun & had recvd 2 courses of ATB;
5x5 cm induration, red, warm, itchy right deltoid. Tx: prednisolone 15 mg/5 ml 6.5 ml daily x 5 days.
Had been asleep for 15 minutes. Older sister noted color was bluish-white ("like a porcelain doll"). Mom picked her up, had foam at the mouth, opened her airway, noted patient was breathing, eyes rolled up, unresponsive, whole body limp, lasted 25 minutes. Went to ER. Color improved by time of arrival at hospital. No fever (temp 37.7 in ER). Had not received acetaminophen after immunization. No shaking of body or stiffening.
At 1045 patient started experiencing eyes swelling and mild hives. 5/1/21 in morning had severe hives head-to-toe and swollen eyes worse. Took Benadryl 2 tabs, which totally resolved symptoms. This morning, 5/3/21, reoccurrence of hives and eye swelling. Taking Benadryl currently to manage symptoms.
Received vaccine on 7/16/2020. On 7/17/2020, noticed hives on left armpit. By 7/18/2020, hives and itchiness all over body. Went to walk-in clinic, dx as allergic reaction. Tx with Prednisone 50mg x1 daily for 5 days. All sx resolved by day 4 of medication.
Experienced chills, frontal headache, fatigue and joint pain for the 3 days following 2nd dose of Moderna vaccine (20april2021).    Frontal headache lingered for about 10 days along with general fatigue.  Also experienced elevated hear rate on runs by +20bpm compared to same runs prior to second dose.  Since the second dose dose, I?ve experienced monthly episodic frontal headaches requiring ibuprofen to treat and some issues with blood glucose levels. These events are some what transient in that they resolve within a day.  Prior to second dose, I rarely experienced headaches, NMT 1/yr and rarely requiring treatment with NASAID.
administered vaccines that were 27°F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Havrix, Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Havrix, Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that patients had been administered some vaccines that were exposed to to a minimum temperature of 27 degree F for 44 min, which led to incorrect storage of drug. The vaccines in the temperature excursion were Menveo, Kinrix, Boostrix, Havrix, Engerix-B and Infanrix. The HCP did not have any information on how many patients had received the vaccines, nor did he have any information on which patient received which vaccine at the time of the reporting. No further details were provided. The vaccine administration facility was the same as primary reporter. The health care professional consented to follow-up by phone so as to complete the patient and vaccine information missing at the time of the call.
Pain injection site; Headache; Tiredness; Muscle pain pills; Joint pain; Fever; Nausea; Not feeling well; Decreased appetite; Diarrhea; Vomiting; Arm pain; reminisce injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 at 12:00 (Lot number: unknown)at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. Concomitant medication included: WELLBUTRIN.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Pain injection site"; HEADACHE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Tiredness"; MYALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Muscle pain pills"; ARTHRALGIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Joint pain"; PYREXIA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Not feeling well"; DECREASED APPETITE (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Decreased appetite"; DIARRHOEA (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Vomiting"; PAIN IN EXTREMITY (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "Arm pain"; VACCINATION SITE REACTION (non-serious) with onset 10Jan2022 at 13:15, outcome "not recovered", described as "reminisce injection site".  Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue, myalgia, arthralgia, pyrexia, nausea, malaise, decreased appetite, diarrhoea, vomiting, pain in extremity and vaccination site reaction.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
pt woke up 11PM & had a hard time breathing;felt tingling in spine;weird, scary sensation;uncontrollable shaking;lasted for about 1/2hr;pt husband took pt to ER;
Chronic lung condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CHRONIC RESPIRATORY DISEASE (non-serious), outcome "unknown", described as "Chronic lung condition".  Additional information: The reporter was just wanted to know if and when she will be able to get the new Comirnaty vaccines. She said that patient and her husband both received the COVID booster in June of this year on to be exact June 8th of this year and they are just enquiring about a timeframe or when they can receive the new Comirnaty vaccine. Patient had a chronic lung condition. She has taken all of the COVID vaccination booster so far, the last one she had was 08Jun2023. Her husband is 96 and the same goes for him. He does not have the same health issues that Patient do. The question is, are we now both due for the new vaccine booster that is out or do we wait.  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.
She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Allergy to antibiotic (Allergic to erythromycin.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand). At the time of the report, HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On Mar-2020, Patient tested COVID positive. On Mar-2022 patient went to the hospital that said that it was a bad period, but in the article, patient read that after COVID shots, woman had experienced bad bleeding. Also patient mentioned that she bleed through 10 pairs of panties, and patient bleed from the 21-Jan-2022 until 24-May-2022 and again on the 13July2022 . Treatment details was not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-609273 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-609273:Same reporter
This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unkonwn age and gender. Medical history and drug allergies were not reported. On an unknown ate, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot# J014235 with expiration date 07-MAY-2015 dose, frequency and route of administration were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sweats and headache for the day following the jab. Slept most of that day.
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient had Moderna vaccine and had complaints of being tired.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.