chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a virus; Missed appointment for second dose; This is a spontaneous report from a non-contactable consumer (patient's husband). This consumer reported similar events for 2 patients (himself and wife). This is the 2nd of 2 reports. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 29Mar2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a virus (viral infection) (medically significant) on an unspecified date with outcome of unknown and missed appointment for second dose on 19Apr2021. The reporter stated they were told they will be rescheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021471065 Same reporter/event/drug, different patient
Fever starting after immunization given, same day, and on 2nd day fever peaked to 103.6 degrees and had questionable febrile sz. Same day, fever peaked to 104 and (R) and had witnessed febrile seizure. To ER via EMSA x 2. following day (day 3) , developed diambes along and continued fevers , low grade.
4 year old male patient was inadvertently administered an expired Quadracel, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four year old male patient who was vaccinated with an expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] inadvertently (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 15-Sep-2020, the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (single vial) (lot C5560CA and expiry date: 16-Aug-2020) via an unknown route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (same day latency).  At the time of report, no adverse reactions 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.
One side of heart was not pumping right; Nauseous; Patient was not feeling well; Loss of appetite; Increased heart rate; Pale; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (One side of heart was not pumping right) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC DYSFUNCTION (One side of heart was not pumping right) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing). The patient was hospitalized from 09-Mar-2021 to 19-Mar-2021 due to CARDIAC DYSFUNCTION. At the time of the report, CARDIAC DYSFUNCTION (One side of heart was not pumping right), NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included diuretic medications.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
No adverse reaction noted to patient. Vaccine was administered over 12 hrs after vial was punctured
Two days after shot I noticed redness at injection site.  No soreness at this time, some itching.  No fever no other symptoms.  As of today (1/4/21)redness it still there and area seemed to expand, still  little itching.  Arm does not appear swollen.  No other symptoms. Received i injection on 12/23/20.  Concerned about length of time this is still present.
Pt experienced headaches, depression, multi-system problems, pain in muscles and tendons within three days post vax.  Pt also developed arthritis in right shoulder, knee and hips, increased fibromyalgia, back, neck and body pain.
The vaccine comes with to components a powder and liquid that should be mixed. The MA that admistered vaccine did not mix the two. Pt was only given the liquid portion of the vaccine. No reactions noted per the administering ma. No treatment was needed before pt leaving clinic.
1/2 hr post vaccine - odd sensation of tongue. 1 hr post vaccine - throat felt like something stuck in it. 2 hrs post vaccine - sclerosis bilateral bright red in color. 2 hrs post vaccine - barky type of cough.
Hypothermia; Full body muscle ache; Tinnitus; This is a spontaneous report from a non-contactable other hcp (patient). A 36-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on 02Apr2021 13:15 (Batch/Lot number was not reported) unknown dosage #, single dose for COVID-19 immunization. Medical history included thyroid disorder and food allergy (artificial color shrimp mango some preservatives) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient experienced hypothermia for few hours, full body muscle ache and tinnitus on 01May2021 with outcome of recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.  Medical history of thyroid disorder may provide a plausible alternative explanation for the events.  The case will be reassessed if additional information becomes available.  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.
Vomiting at 2am Nausea, chills, fever More vomiting over the course of the day (vomited about 7 times from hours 12 to 36), couldn't keep liquids down. Caused resurgence of recurring stomach acid issues.
Start of first menses; abdominal cramping; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 19:15 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Vaccine Administration Time: 07:00 PM), administration date: 07Oct2021, when the patient was 12 years old, for COVID-19 Immunisation. The following information was reported: PREMATURE MENARCHE (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "Start of first menses"; ABDOMINAL PAIN (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "abdominal cramping"; NAUSEA (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 06Nov2021 08:00, outcome "recovered", described as "vomiting". The events "start of first menses", "abdominal cramping", "nausea" and "vomiting" were evaluated at the physician office visit. Therapeutic measures were taken as a result of premature menarche, abdominal pain, nausea, vomiting.  Additional information: Start of first menses, abdominal cramping, nausea, vomiting that was not treatable with anti-emetics. Lasting 3 days post shot. Prior to vaccination,the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever for 55 hours.  101.1 to 103.4,last temp 4pm Sunday 99.8.  vomiting , severe body pain, chills, shaking, no taste, weak, sweating .  took tylenol and advil.  called my pcp she said it should last about 24 hours.  As of  tuesday 4/6/21 still very tired.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent, which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Lock jaw; Upset stomach; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills). At the time of the report, TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Who received both doses of the Pfizer covid vaccine early on and they all got covid 19; who received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the 4th of 5 reports.   A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (at the age of 45-year-old) (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (at the age of 45-year-old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received both doses of the Pfizer COVID vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient
Large red area, covering arm (side to side) 3 inches by 6inches, below the injection site. The red area was hot to the touch. Feels sore/ bruised. Began fading after 4 days.  Used topical Triamcinolone 0.5% ointment, and took allergy medication.  3 days after injection, began getting blister type rash on lower opposite arm from vaccination site. Today 07 June, 6 days after vaccine, large red area  almost gone, no longer tender, but more blister type bumps appearing on lower right arm, and a few are now beginning  to show on lower left arm (injection arm).
first dose of Shingrix on 10/16/2019 / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 16th October 2021, batch number K9L3M and expiration date-29th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Headache, body chills and aches, swollen lymph nodes, fever up to 104.5 at 2 AM, fever down to 100.6 by 6:30 AM  Advil taken at 7 am
Large red area around where vaccine given on arm (about 4 inch diameter) warm to the touch and painful. Sent pt. to ER. Onset was approximately 12 hours after vacc. given.
Pfizer covid vaccine given without diluent, therefore resulting in higher than authorized dose (0.3ml of undiluted of pfizer vaccine given) Client notified of error. Discussed potential for local and systemic adverse side effects. Spoke with client on 11/3/2021 at 12:15pm, client stated she was lightheaded overnight, and feels fine today (11/3/2021)
Hyperhidrosis in joints; Joint pain; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Narrative:  Developed chills, low BP, low O2 after Pfizer COVID vaccine. Did not receive vaccination at facility. Per patient report.
1 day after 2nd shot had  fever, abdominal pain, chest pain, shortness of breath, tachycardia..  Was seen in ER.  Fever. abdominal pain resolved in 2-3 days.   Chest pain still present, and shortness of breath 5 days after
administrated with Infanrix instead of Boostrix; 11 years old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7km94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The health care professional that a patient was administered with Infanrix instead of Boostrix. No adverse event was reported. The reporter consented to follow-up. Additional supportive information: The patient was administered with Infanrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
liver enzymes were not good; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME ABNORMAL (liver enzymes were not good) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Kidney disorder. Concomitant products included INSULIN ASPART (NOVOLOG), LOSARTAN and ATORVASTATIN for an unknown indication.    On 06-Mar-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME ABNORMAL (liver enzymes were not good). At the time of the report, HEPATIC ENZYME ABNORMAL (liver enzymes were not good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
Vomiting; Headache; Nausea; Case reference number BN-2021-002406, initially downloaded on 08-Nov-2021, is a spontaneous case received from a consumer/non-health professional via health authority (Safety report ID 1670637-1) and concerns a 22-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details included Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetaimne saccharate, dexamfetamine sulfate) and birth control (not specified).  On 03-Sep-2021, the patient received first dose of Rabipur (Inactivated Rabies Virus Vaccine, Batch no. ARBA851A) at unknown dose intramuscularly in left arm for unknown indication. On the same date, the patient developed nausea, vomiting x3 events and mild headache.  At the time of this report the outcome for the events of nausea', vomiting' and headache' was unknown.  The reporter assessed events as non serious and the causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 22-year-old female patient received the first dose of Rabipur for unknown indication. As reported, on the same date, the patient developed nausea, vomiting and headache. The events of nausea, vomiting and headache are listed for Rabipur according to the local Datasheet V6. The patient's medical history was not provided. The patient's concomitant medication details included Adderall. The outcome of the events of nausea, vomiting and headache was unknown. The patient's use of concomitant medication could have confounded the causality for the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of nausea, vomiting and headache is assessed as related to the suspect vaccine, since contributory role of Rabipur cannot be excluded. This case is considered non-serious.; Sender's Comments: The 22-year-old female patient received the first dose of Rabipur for unknown indication. As reported, on the same date, the patient developed nausea, vomiting and headache. The events of nausea, vomiting and headache are listed for Rabipur according to the local Datasheet V6. The patient's medical history was not provided. The patient's concomitant medication details included Adderall. The outcome of the events of nausea, vomiting and headache was unknown. The patient's use of concomitant medication could have confounded the causality for the events. However, due to suggestive temporal relationship and known vaccine safety profile, the causality for the events of nausea, vomiting and headache is assessed as related to the suspect vaccine, since contributory role of Rabipur cannot be excluded. This case is considered non-serious.
family states pt has had fever since receiving vax; lt deltoid hot, swollen, red; no fever;
Started period on 6/5/21. Had excruciating period cramps pain in low abdomen on 6/5/21 and again throughout that week. Never have cramps before in general and especially never this bad.  Cramps again on 6/14/21- 6/17/21.
Symptoms - Severe shivering and chills, severe muscle pain and headache.  The symptoms started about 12 hours after the first shingles shot and lasted 12 to 16 hours.
Patient reports progressive fatigue and lightheadedness beginning the day after vaccination (4/10/21). He also reports headache and nausea with decreased oral intake. Patient found to have AKI in ED and is being admitted to the hospital.
Pt arrived with a fever, cough, and shortness of breath. He also has a suprapubic catheter in place. He was found to have myocarditis and an NSTEMI. He was found to be COVID positive and admitted due to undifferentiated shock, septic versus cardiogenic.
swollen left arm extending to shoulder and elbow, about twice normal size, dizziness, slight chills, immobile, painful - began the day after vaccine administered,in the am. Treatment - MD put pt. on tetracycline and benedryl.