chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We received a call from public health saying that we had given a Jansen dose to a patient who had already received a single Pfizer dose. The Pfizer dose was given at a different facility back March 2021. The patient signed up for a vaccine at our store online. on the form they indicated that they requested the Jansen shot and denied that they had had any other Covid vaccines. I called the patient and confirmed that they had had not adverse reactions to the shot. He also explained that this was done intentionally and that he wanted only a single dose of the Pfizer and Jansen.
Pt was in usual state of health until 10/17 when she endorsed upper respiratory tract infection. Pt states that 2 days later she had numbness in her feet bilaterally. Pt states that over the course of a week, the numbness had spread to her proximal lower extremities. Pt denied having bowel or bladder incontinence during that time. Pt went to see PCP the Friday prior to admission and patient had MRI to rule out cauda equina syndrome which was negative. Over course of two to three more days pt endorsed more pronounced numbness of proximal lower extremities with weakness. Pt noted that she was having more trouble with her balance and was constantly tripping on herself; however, she never experienced a traumatic fall. Pt denied fevers, chills, shortness of breath, trouble breathing, upper extremity weakness/numbness, or troubles with speech or swallowing.  Of note, the patient states she had shingles in early October immediately after she had her flu shot distributing from lateral left ankle to lateral knee. Pt was given oral antiviral regimen for this.  Pt also endorses repeated tick exposure and comments that she's always pulling ticks off her body 11/3/2009 ED records for 10/28/2009. patient with c/o's bilateral LE weakness and numbness. Neuro decreased DTR's with patellar and ankle jerks. Tx: LP, Telemetry Patient offered EMG/NCV studies but declined. Patient had just started taking Methotrexate for her Psoriatic arthritis and MD felt this could be the cause of numbness. DC Dx BLE numbness, ? due to Vit B12 or folate deficiency from MTX.
received expired dose of vaccine. had a sore arm and took tylenol to resolve side effects. recommended to repeat vaccine
Received vaccine at about 11AM, developed pain and swelling of site at about 4PM. Swelling improved but pain progressed with radiation down arm and inability to move shoulder joint.
Patient vaccinated on 8/16/05 with Menactra (lot U1766AA).  Culture confirmed meningococcal disease on 7/6/06.  Blood culture was positive for Neisseria meningitidis serogroup C.  2/5/09 Received hospital medical records of 7/7-7/13/2006. FINAL DX: septic shock due to gram neg type C meningococcemia w/known type 1 DM.  Also hypogammaglobulinemia. Records reveal patient experienced neck pain, low back pain, bilateral shooting leg pain, low blood pressure, fever & elevated blood sugar x 1 day.  Admitted to PICU.  ID consult done.  Tx w/IV antibiotics, IVF.  Improved & d/c to home w/immunology & encocrine f/u. 2/24/09 Received vax records from PCP for 8/16/2005 which confirms as reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, concurrent condition and concomitant medication were not reported. On 18-MAR-2016 the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # L006382, expiry date 25-MAY-2016. The vaccine had a temperature excursion of temperature of 30 F for 12 hours. The patient experienced no adverse event. There was no previous temperature excursion and the call was made because of data logger. There was no product quality complaint. Additional information has been requested.
tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient).   An 87-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right at the age of 87-year-old on 03Feb2021 at 13:45 as single dose for covid-19 immunization. Medical history included 10-year cancer survivor, 2016 mild heart attack, thyroid imbalance, dust mites, mold, mildew. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. 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 vaccination. On 07Feb2021 02:15 the patient experienced tiredness, headache, muscle pain, joint pain, nausea, feeling unwell. The patient did not receive treatment for the events. The outcome of events was recovered on an unspecified in Feb2021.  Follow-up attempts are completed. No further information is expected.
vaccine were exposed to 19.8 Fahrenheit and were out of range for 2 hour and 16 minutes/no ae; Initial information received on 10-Sep-2021 regarding an unsolicited valid  non-serious case received from a other health care professional via under Medical Information Inquiry Number: 00764523.  This case is linked to case US-SA-2021SA303376(CLUSTER).  This case was considered as non-valid due to no involvement of patient.   This case involved vaccines IPV (VERO) (lot number: R1F973M and expiry date: 10-MAR-2021), (lot number: T1E871M and expiry date: 10-OCT-2022), (lot number: T1D482M and expiry date: 25-FEB-2022), (lot number: R1F97 and expiry date: 10-MAR-2021), (lot number: T1E87 and expiry date: 10-OCT-2022) HIB (PRP/T) VACCINE (lot number: UJ661AAA and expiry date: 05-JUN-2022), (lot number: UJ526AAA and expiry date: 06-MAR-2022), (lot number: CC5788BA and expiry date: 14-OCT-2022) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5829BA and expiry date: 03-JAN-2031) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ528AAA and expiry date: 07-OCT-2022), (lot number: UJ435AAA and expiry date: 17-MAY-2022), (lot number: UJ421AAA and expiry date: 03-AUG-2022) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: CC5788BA and expiry date: 07-OCT-2022) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6951AA and expiry date: 06-JUN-2022) that were exposed to negative 19.8 degrees Fahrenheit degree for an undetermined period (product storage error).  It was potential medication error case due to product storage error temperature too low.  It was reported "Caller stated they had a temperature excursion of unknown cause".  At the time of reporting, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
01/13/2022, 15 Minutes after I received the shot you felt weird. Almost like the feeling when I have COVID in 2020. It was like something coming over my body. I almost did not leave the store, but pushed through it. By the time I got to the house I worse. I went back into AFIB. I had heart palpitations, chest pains and shortness of breath. I am still experiencing heart palpitations and shortness of breath, it is not as bad, but better. Chest pains are gone. I had a cardioversion to get my heart back in rhythm. The doctor was concerned about the chest pain, she prescribed an echocardiogram. The doctor said the EKG and Echocardiogram suggest I have pericarditis which I have never had before. I have an appointment with my cardiologist May 23, 2020, because she is concerned.
Headache Grade 2; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune esophagitis. The patient was allergic to seafood. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 16:00, the patient experienced headache grade 2. Therapeutic measures were taken as a result of headache grade 2 and included treatment with ibuprofen po (MANUFACTURER UNKNOWN) on an unknown date. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache grade 2 was resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swollen with grape size lump (lymph node maybe) on right side of neck in between neck and shoulder, feeling of swollen throat on right side. Neck ache. Didnt notice lump until about a week or week and a half after first covid dose. I am only thinking this is from the shot because I had NO previous problems until the shot,no reactions to any shots ever. I do receive a flu shot every year with no problems. I am pretty healthy besides high blood pressure.
Day 1-dizziness directly after the vaccine Day 2-light dizziness, severe fatigue (slept all day), constant medium headache, body aches, fever between 99.4-100  F, severe brain fog, medium nausea and vomiting, very stuffy nose. I stayed in bed all day. Day 3- severe fatigue but less than Day 2, mild body aches and headache, fever of 100 all day, severe brain fog. I stayed in bed all day again.    Talk about brain fog - it took me 10 minutes to type this, and I typing is a big part of my job.
Light pink erythema noted entire right deltoid area with voiced discomfort by the resident. Area invoved warm to touch. Ice applied.
Patient admitted as observation on 7/15/22 then upgraded to inpatient status on 7/16/22 due to Left leg cellulitis.   Tested positive for COVID upon admission to Hospital.
Rolling over in bed, with vertigo.; Im feeling nauseous; headache; headache and intermittent spinning; I also feel tired; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206) via an unspecified route of administration in the left arm 11Mar2021(at the age of 64-years-old) at 12:00 as a single dose for COVID-19 immunisation. Medical history included Celiac do (as reported), hypothyroidism and hypertension. The patient was allergic to gluten, avelox and amoxicillin. The concomitant medications included vitamins (unspecified), thyroid medicine (unspecified) and amlodipine (MANUFACTURER UNKNOWN). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, two weeks after receiving the vaccine, the patient woke up at 02:00 after rolling over in bed, with vertigo. It had been 3 days and the patient was feeling nauseous, had headache with intermittent spinning that stopped only after closing the eyes. The patient also felt tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, nausea, headache, head spinning and tiredness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Arthralgia,  Fatigue, chills, injection site pain and swelling Narrative:
he had a fever of 100.9 F/fever of 101.3 F; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (he had a fever of 100.9 F/fever of 101.3 F) and CHILLS (chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced CHILLS (chills). On 28-Apr-2021 at 5:00 AM, the patient experienced PYREXIA (he had a fever of 100.9 F/fever of 101.3 F). At the time of the report, PYREXIA (he had a fever of 100.9 F/fever of 101.3 F) and CHILLS (chills) outcome was unknown.       It was reported that the patient took acetaminophen for the adverse events.   This case was linked to US-MODERNATX, INC.-MOD-2021-095036 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095036:Case for dose 1
On 10-17-01 grandmother reports fever of 103.6 then rash developed - red, raised. Rash worsened over time  and when in heat. Took to ER for evaluation, unsure if vaccine RX or 3 day measles. Rash and fever still present.
Bells Palsy; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported same events for three patients. This is a 3rd of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, also reported as Comirnaty), via an unspecified route of administration on an unspecified in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Healthcare worker reported that 3 nurses who work in her facility received Pfizer's COVID vaccine last week (Dec2020) came in with Bells Palsy. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519118 same reporter, same drug, same event, different patients;US-PFIZER INC-2020519105 same reporter, same drug, same event, different patients
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      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.  Date of refrigeration was 07-MAY-2021.
itchiness around the injection site; rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (rash around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (rash around the injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness around the injection site) and VACCINATION SITE RASH (rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ringing in his ear on the left; This is a spontaneous report from a contactable Physician(patient).  The 37-year-old male patient received first dose of vaccine BNT162B2(Batch/lot number: EK7530, Expiration date: unknown), via an unspecified route of administration on 18Dec2020 at single dose for prevention of Covid.  Medical history included gastrooesophageal reflux disease(GERD).  Concomitant medication included omeprazole for GERD.  The patient stated in the hospital, he had the Covid vaccine 2 hours ago and he just want to report a possible side effects, about hour after the vaccine he had ringing in his ear on the left on 18Dec2020. No treatment was received. It was not that bad. It was improving. Outcome of event was recovering.
This case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, pain localized, local swelling and adverse reaction. On an unknown date, the outcome of the localized erythema, pain localized, local swelling and adverse reaction were unknown. It was unknown if the reporter considered the localized erythema, pain localized, local swelling and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized redness, swelling, pain, and general complaints. The reporter did not have any other information to report about the patient or vaccine. The reporter did not speak to the patient till the time of reporting.
Severe stomach pain, no nausea, pain like a severe side ache; severe chest pain; headache.   Chest pain, left sided stomach pain, and headache persisted through the night.  I was able to get some relief by takin a 325 mg Aspirin and an Advil every 2-3 hours through the night.  The chest pain was pretty bad, considered going to the ER, but persisted to fight it through to the morning.  In the morning, around 6:30 am I was exhausted, but the worst of the pain was over.  I did take another Aspirin and Advil around 8:00 am and stopped after that.  I did run a low grade fever off and on of 99.7 to 100.4.   I felt better on Saturday, but by noon I was feeling generally run down and again started to run a low grade fever off an on the rest of the day.  Sunday - what a joy to feel totally well!!
Systemic: Other- lightheaded, dizzy, tingling of roof of mouth, chest tightness, tongue felt swollen-Severe
Patient is a 48 year old male received lower than authorized volume of Pfizer COVID19 booster 0.2mL, instead of 0.3mL on 11/09/2021 at approximately 11:00am. He did not received a repeat dose. He was observed for 15 minutes after the vaccine, without any adverse reaction.  He was contacted today morning via phone and denied any adverse reaction.
Patient went to hospital with COVID symptoms on  01/10/2021 and passed away on 01/22/2021
Swelling of thigh (circumference 2" larger than other thigh) with patchy light redness.
KINRIX GIVEN INSTEAD OF ADACEL FOR 9 YR OLD TETANUS.
2/22/21-Office visit for c/o severe lower back pain 10/10 since woke 8 hours after #1 Moderna Covid vaccination. Radiation to hips/thighs/knees, but not to feet. No pain in arms or neck. Pt tried motrin, up to 800mg w/o relief. Unable to walk to mess hall d/t pain. Also c/o bilat leg weakness. H/o L foot drop; R patellar reflex intact; BIL dorsi/plantar flexion intact. + Tenderness on palpation of muscles of upper legs and lower back. Telemed to Emergency Room; etiology unclear; not typical Guillan Barre; cont. to monitor. lipitor held 2/23/21--No worsening of pain or weakness. Bowel/bladder intact. Labs ordered 2/24/21--Pain still severe; pt feels legs are weaker. Unable to elicit patellar reflex on R. Sent to ER.
This spontaneous report was received from a physician via a sales representative, referring to a female patient on her 60's. The patient had no medical history, drug reactions/allergies or concomitant medications to be reported. On an unknown date in 2015 (reported as "about 2 years ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously, for prevention of shingles (dose, lot # and expiry date were unknown). On an unknown date, reported as "shortly after injection", the patient developed a "zoster-like rash" at the injection site. The physician stated that the rash "cleared up by itself" (date unknown). Neither treatment nor laboratory diagnostics were performed. The patient's outcome for rash vesicular was reported as recovered. The causality assessment between the ZOSTAVAX and the aforementioned adverse event was unknown.
pt recv vax & devel n/v, diarrhea & cramping w/in 3 days of vax;this is 1 of 6 pt, out of 30 vaccinees from this facility to exp this rxn;
no additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications was not provided.  On 22-MAY-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W032370, expiration date 10-OCT-2024, route of administration and anatomical location were not provided) for prophylaxis (Improper storage of product in use).  On unknown day, the suspect vaccine experienced a temperature excursion of 19.2 degrees Fahrenheit for 8 hours and 20 minutes. There was no reported previous temperature excursion. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No additional information provided.; Sender's Comments:  US-009507513-2305USA007880:MSD
This case is a cluster of three patients who experienced adverse reactions following administration to DAPTACEL, lot number C4006AA. The other two patients were captured in cases 2012-03355 and 2012-03356. Initial report was received from a health care professional on 23 March 2012. A female patient had received a dose four intramuscular injection in the right arm of DAPTACEL, lot number C4006AA on an unknown date and the second day after the vaccine the patient experienced swelling, tenderness and redness of 5-10cm at the injection site. Medical history, concomitant medications, illness at the time of vaccination and any other vaccinations within four weeks of DAPTACEL were not reported. The patient's sister experienced the same adverse reaction to DAPTACEL where she experienced swelling, tenderness and redness of 5-10cm at the injection site, which was captured in case 2012-03355. The patient's outcome was not recovered. Documents held by sender: None.