chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old patient (gender was not reported) who received a dose of vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about 2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   In or about 2015, the patient presented shingles. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, she suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, she had incurred significant expenses for medical care and treatment, her injuries and damages were permanent and would continue into the future.   The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EM9810, AE(s) following prior vaccinations: States any vaccines her arm is sore), administration date: 04Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "AE(s) following prior vaccinations: States any vaccines her arm is sore"; BNT162b2 (Dose 2, lot EN6200, AE(s) following prior vaccinations: States any vaccines her arm is sore), administration date: 24Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "AE(s) following prior vaccinations: States any vaccines her arm is sore"; Shingles (States the last one was shingles a couple of years before.), for Immunization; Flu shot (States she had more soreness with her last flu shot), for Immunization, reaction(s): "soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  No follow-up attempts are possible. No further information is expected.
The flu shot put me in 9 dka comas .. I hate the flu; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media serious case received from patient.  This case involves an unknown age and gender patient who experienced 9 dka (diabetic ketoacidotic hyperglycaemic) comas, after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed 9(dka) diabetic ketoacidotic hyperglycaemic coma (diabetic ketoacidotic hyperglycaemic coma) (latency: unknown) following the administration of Influenza Vaccine.   Reportedly, flu shot put patient in 9 dka comas.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 23-Oct-2023: This case involves an unknown age and gender patient who experienced 9 dka (diabetic ketoacidotic hyperglycaemic) comas, after receiving Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
A few hours after vaccination patient began feeling intense pain, swelling and increased temperature at the site of injection. Pain got worse and patient felt that it was radiating down to her elbow. Swelling and redness also got worse. On June 2, 4 days after injection, patient was given a prescription of Oral cephalexin.  A day later symptoms began to improve. On follow up, on June 5, day 8 after injection, patient's symptoms are 85 % improved. there is only mild tenderness on site. Full range of motion of left arm/shoulder.
Information has been received from a medical assistant concerning a 21 year old female, weight 190, high 5'7" with no drug reactions or allergies, a history of migraine, who on 06-Oct-2008 10:30AM was vaccinated with the first dose of GARDASIL (intramuscular, lot # 661044/C548X) at right deltoid at private doctor's hospital. Concomitant therapy included Butisol, YASMIN 28, fexofenadine. On 06-Oct-2008 10:30AM, immediately after withdrawing the syringe, the patient's arm turned red and the redness spread down the arm and became swollen. Ice was applied and the patient was given a prescription for Benadryl and Prednisone. The patient sought medical attention at office. No further information was reported. Follow up information was received: Patient had side effects of erythema and mild edema of the injection site extending to lower right arm. Patient was given Zantac, Prednisone and Benadryl: On 09-Oct-2008, the patient's swelling was better. Additional information has been requested.
I became physically stronger. As of today can lift up to 100 lbs with ease. Before I would struggle with 50lbs. Can also push, pull with my left arm, before only my right. Not as tired, wasn?t tired before but now sleep at night. (Work 2 full time jobs. Also have a more positive/renewed zest for life.
husband has a very sore arm; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen). At the time of the report, PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Pt eval  for 4 day hx of progressively worsening headache, sudden in onset, with assoc. photophobia, fever, chills, night sweats, fatigue, nausea and vomiting.  Mildly elevated temp.(100.7) and tilt positive.  Pt transported to Hospital for further eval at that time.  Pt's condition improved with 1L NS fluid bolus and APAP during the ED stay.  CBC- WBC 8.7, H/H 14.2/41.5, Plat 239.  Pt diagnosed with Viral Syndrome and Acute Cephalgia(resolved), and was discharge back to Command with f/u at BAS.
not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter stated that her mother received a single dose of Shingrix in 2019 and never received her second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Injection was painful in upper left shoulder.  By evening, had pain lifting arm above shoulder or overhead.  Pain has continued to date; especially painful in morning and overhead.
Pyrexia, Staring, Tremor, Dyskinesia, Oedema periphereal. This case was reported by a healthcare professional via a company. and described the occurrence of high fever in a 4 year old male subject who was vaccinated with combined diptheria, tetanus acellular pertussis and inactivated poliomyelitis vaccine (Kinrix, GSK) and seasonal influenza vaccine (non-gsk) (FLUVIRIN) for prophylaxis. Concurrent medical conditions included autism spectrum disorder. On Sept 14 2009 at 10:30 the subject received 4th dose of KINRIX (intramuscular, right arm), 1st dose of FLUVIRIN (intramuscular, left arm). On Sept 15 2009 1 day after vaccination with FLUVIRIN and KINRIX, the subject experienced high fever, staring, unusual shaking, jerking of arms and legs and swelling arm. Relevant test results include body temperature of 104 at night on September 15 2009 and another body temperature of 103 at 15:00 on September 15, 2009. The healthcare provider stated that the  mother reported a high fever occurring during the night with a rectal temperature of 104. The subject was staring not focusing, shaking and then had jerking extremities. The mother reported slight swelling at the deltoid with no redness noted. At 09:27, this morning the subject was more himself, eating and drinking and making eye contact with his mother. At 17:00, the healthcare provide called to check on the subject. The mother reported that the subject was doing better but spiked a temperature of 103 at 15:00. On Sept 15 2009, the high fever, staring, unusual shaking, jerking of arms and legs and swelling arm were resolved.
Pt received PPV 5 on 9/18 on 9/19 11:30 AM noted swelling, redness at injection site, by 3:00 PM felt unwell with body aches, HA, increased swelling at injection site.
Pt began having headaches that were described as throbbing at her temples b/l. Initially the headaches were relieved with Tylenol or Motrin. Over the next 3 days the headaches worsened in severity and were not relieved with Tylenol or Motrin alone. Pt also began developing photophobia and N/V when pain was severe. Headaches would wake her up from sleep. Basically she developed neurological symptoms of ataxia, dysmetria, hyperreflexia, urinary retention, AMS, and weakness and was found to have ADEM on 10/25 MRI.
Got her 3  rd dose of the Moderna COVID-19 Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 048A21A and 011D21A) for COVID-19 vaccination.     The patient's past medical history included Lung transplant.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine). At the time of the report, INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Antibody test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Antibody test: negative (Negative) Negative.         Concomitant product included several unspecified medications.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: regulatory authority FU- No new information
Narrative:  Pt is a 77 yo M who received COVID-19 vaccine on 1/30/2021. Pt was in hospice with h/o Parkinson's disease, dementia, and prostate cancer w/mets. Does not appear that vaccine caused/contributed to death. Autopsy was not performed.
pt recvd vax;fever 101,muscle aches,joint pain, redline from inject site to arm pit;very painful red raised area 6" in diam around inject site,started on sat eve;advil to take & cold compresses;11jan95 arm still sore but no fever/red line;
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female 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 11Apr2021 at 15:30(at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any allergies to food, medications or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), venlafaxine hydrochloride (EFFEXOR), paracetamol (TYLENOL), alprazolam (XANAX) and levonorgestrel (MIRENA); all for unknown indication and start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021 at 23:00, the patient experienced diarrhea. The patient did not receive any treatment for the event. The clinical outcome of the event diarrhea was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received injection and then approximately one day later developed a fever with aches. Called to report to pharmacy. Largely resolved after an additional day.
the wrong vaccine was listed on the record. I documented on the info and consent form as a moderna dose and documented Pfizer on the covid-19 vaccination record card.   I know that I gave Pfizer.  I was rushing myself and was documenting after shots given later in the day, and had placed this form wrong stack.
Severe body rash Headaches for 5 weeks after vaccine like I had with the Covid virus Still currently having headaches.
Red rash covering large portion of arm over injection site and extending down approximately five (5) inches. Mild itching. Began to resolve on third day. Day five rash is barely visible but some itching remains at furthest portion of rash from injection site.
Within minutes after the injection, patient became dizzy, and nearly fainted. Pharmacy Manager caught patient from falling. Pharmacy Manager stabilized patient and took blood pressure. Blood pressure was normal after stabilizing.
Myocarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging heart: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Myocarditis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057464 Same article/drug/ event; different patient;
Fever over 101 for 17 consecutive days, shortness of breath ongoing 30 post vaccine, body aches ongoing 30 post vaccine, fatigue ongoing 30 days post vaccine, hypertension with no history post vaccine ongoing.
she felt the bruise at the COVID-19 Vaccine injection site; she felt like she was going to throw up, but didn't/making her feel nauseous; she also had a thing going on with her head, clarifying it as a headache type of thing; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered on arm left on 28Mar2021 19:00 (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. Medical history included food allergy, abdominal bloating, and thought her hernia was acting up because she had a lot of bowel movements (as reported). Concomitant medication included cefalexin (CEPHALEXINE). On Mar2021, the patient experienced that she felt the bruise at the COVID-19 vaccine injection site, felt like she was going to throw up, but didn't, had a thing going on with her head, clarifying it as a headache type of thing. The events led to emergency room visit on 29Mar2021 (for the symptoms she was experiencing before she had the COVID-19 vaccine, trying to figure out what was making her symptoms happen, as reported). The outcome of the events was unknown.    No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
pt recvd flu vax & 1 of 5 pts devel influenza & was hospitalized;
Gave me Covid 49 days after ?vaccination? of this experimental drug, which not in order to keep my job
Dizzy; Weakness; Arm was still sore; Chills; Muscle aches; Headache; No rash but Itchy from head to toe; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 16Jul2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, meniere's disease, TMJ syndrome and fibro. 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 COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine sodium (CYTOMEL), potassium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. The patient previously took prednisone (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. On 16Jul2021 at 10:45, the patient experienced day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events day 3 arm was still sore, chills, muscle aches, weakness, headache, dizzy, no rash but itchy from head to toe was not recovered.
It started with a post nasal drip and a cough. The next day the coughing had gotten much worse with green phlem. I did take some tussin and that did help temporarily. On 06/06/2022 I did take a rapid home test and it came back negative. I decided to call my doctor's PA and she called into the pharmacy and prescribed Benzonatate and Azithromycin. It did help a bit. I'm not coughing now, but I don't feel like I have fully recovered.