chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore left injection site arm/felt achy; tired; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 029L20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 18-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever). On 18-Sep-2021, VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-353240 (Patient Link).
Approx. 2-3 minutes after vaccine administration, child stepped off exam table-+ LOC-fell to the ground in exam room-hit right frontal forehead and back of head. Patient awoke spontaneously-asking what happened. Examination done by Dr. Pt c/o headache, dizziness alert and oriented. Sent to hospital for observation and evaluation v/sign stable.
cannot lift that arm; pain in her left arm; This case was reported by a other health professional via call center representative and described the occurrence of injected limb mobility decreased in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxab2az, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 28th July 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injected limb mobility decreased and pain in arm. The action taken with Bexsero Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 provide are as follows: The case was reported by Medical assistance. The reporter reported that patient was administered with Bexsero in left arm and started feeling pain in her left arm and could not lift that arm. All the symptoms were in the arm that the vaccine was administered. The patient still present the symptoms, at the time of reporting. The reporter consented to follow-up.
Pain in right arm; mild itching all over; neck pain opposite of injection site; joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7533) via unspecified route of administration in the right arm on 27Mar2021 at 17:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. Concomitant medications were not reported. It was unknown if the patient had any known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 10:00, the patient experienced pain in right arm, mild itching all over, neck pain opposite of injection site and mild joint pain. 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 reported events. The clinical outcome of the events pain in extremity, pruritus, neck pain and arthralgia were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Foggy, slow brain. Started 6 days post injection. Made worse with dehydration and low blood sugar. Still having it 11 days later now.
Patient developed a bump at the injection site. Painful to the touch, bump is about 1-2 cm in size. Slight temperature in the am, that subsided through out the day. No other symptoms reported.
earache; slight lock jaw; pain; all over body weakness; redness and swelling that the injection site; swelling that the injection site; cannot eat; red line traveled from the injection site up his arm to a swollen lymph node on the left side; swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of weakness generalized in a 46-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   On 18th March 2021, the patient received the 1st dose of Boostrix (intramuscular). In March 2021, less than a week after receiving Boostrix, the patient experienced unable to eat, erythema diffuse and enlargement of lymph nodes. On 18th March 2021, the patient experienced weakness generalized, injection site erythema, injection site swelling, lockjaw and pain. On 24th March 2021, the patient experienced ear pain. On an unknown date, the outcome of the weakness generalized, injection site erythema, injection site swelling and pain were recovering/resolving and the outcome of the ear pain and lockjaw were not recovered/not resolved and the outcome of the unable to eat, erythema diffuse and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the weakness generalized, injection site erythema, injection site swelling, ear pain, lockjaw, pain, unable to eat, erythema diffuse and enlargement of lymph nodes to be related to Boostrix.  Additional details were provided as follows: The reporter was the patient's wife.   The patient received Boostrix in the left arm and experienced all over body weakness and redness and swelling that the injection site.  The red line traveled from the injection site up and arm to a swollen lymph node on the left side.  The patient also had slight lock jaw.   The symptoms started to resolve but except for the lock jaw which had become more severe in the last 48 hours.  The patient cannot eat and presented earache. The batch number of Boostrix was reported as 3652S, it was corrected to 3E52S as per sales data sheet. The reporter consented to follow up.
Arm pain at injection site. Fatigue and muscle aches for 24 hours. Swelling in armpit/lymph nodes on injection site arm.
heart stopped for about 30 seconds and then flatlined in ER; had a seizure within 10 mins; This case was reported by a consumer via  interactive digital media and described the occurrence of asystole in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than an hour after receiving Meningococcal B vaccine, the patient experienced asystole (serious criteria hospitalization and GSK medically significant) and seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the asystole and seizure were recovered/resolved.   It was unknown if the reporter considered the asystole and seizure to be related to Meningococcal B vaccine.  Additional details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the Meningococcal vaccine and had a seizure within 10 minutes and then her heart stopped for about 30 seconds and then flatlined in emergency room and off to hospital. The reporter stated that the patient was fine and mentioned that just no more vaccines for the patient. The follow-up would not possible as no contact details were available.
I felt extremely dizzy at 5 PM and checked my blood glucose.  It was extremely high, 283.  I checked again in minutes to be sure the meter was functioning properly and it was 280.  The meter was accurate enough.  With my meds over the past 2 years it has NEVER been this high!  I did not eat or drink anything that could have caused this spike.  I had a healthy lunch at noon.  I began drinking a LOT of water and went for a 20 minute aerobic walk.  At 6 PM glucose was down to 195.  At 7:30 PM glucose was down to 135.  Dizziness began to subside this whole time period.  I will continue to monitor glucose closely.
Numbness and pins and needles in left side of face (cheek and around mouth) 20  minutes after vaccine. Traveled to left leg and right cheek approx. 8 hours later.  No treatment. Symptoms went away by 11 am the next day.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who received vaccines MENACTRA instead of the provided diluent and ACT-HIB. At the time of the event, the patient had ongoing Asplenia. Concomitant medication not reported. On 05-Oct-2018, the patient received 0.5 ml single dose of suspect HIB (PRP/T) VACCINE lot UI957AA via unknown route. On 05-Oct-2018, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that medical assistant went to administer an ACTHIB vaccine to an adult, who is asplenic, but used MENACTRA to reconstitute it instead of the provided diluent. No adverse event occurred. 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.
Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved.            Concomitant medication was not reported.  The patient was sick for a few days after taking the Moderna COVID booster. Patient received all three doses of vaccine from Moderna. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: CALLED 911. AMR MONITORED PT FOR 30 TO 40 MINS AND RELEASED HER TO GO HOME AFTER THEY DID TALK TO HER MOM.
12/06/2021 Vaccination, 02/22/2022 Ringing in ears, 02/25/2022 Ringing became '24-7', 02/28/2022 Saw my primary Dr. Health Center. She referred me to an ENT. 03/24/2022 Diagnosed with Tinnitus 04/04/2022 Audiogram  *It started sporadic, in 1 ear. It moved to both ears. Primarily L ear. Pitch changes, usually higher and louder or sometimes and E sound or crickets.
Papular erythematous rash began on his chest, then spread to his abdomen, extremities and face within 72 hours
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 03-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
She thought she might die; Felt a bit strange and wasn't sure what she was feeling.; feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest.; This is a spontaneous report from a contactable consumer (patient).  A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 16:30 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 0.3 ml, single dose for covid-19 immunisation at the age of 79-year-old. Medical history included ongoing diabetes, ongoing joint injury, She had a need for knee surgery. The patient has never had any vaccines in her life, not the flu shot or measles or anything. There were no concomitant medications. On 06May2021, the patient felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest and thought she might die.  The events felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips were recovered on 06May2021, outcome of thought she might die was unknown. The events didn't result in visit to Emergency Room or Physician Office. She received the dose 2 (Lot EW0182, EXP date Aug2021) on 27May2021.  The clinical course was reported as: after she received the vaccine she stayed around 30 minutes and seemed ok so she left. She received her shot at 4:30 pm and after she got home she decided she wouldn't know what to do if she had side effects so she decided to lay down on her bed. She states she thought she felt a bit strange and she wasn't sure what she was feeling. After 3 and half hours, while laying on her back, she describes feeling her heart beating really hard she felt it from her hips to the trunk, up to breasts/ chest. Her heart was beating so hard, like thump thump thump, it did not get fast or slow, it was just steady. It was beating so hard that she could feel is shake the bed that she was laying on. The patient stated the doctor has already been informed about her events. She states she didn't call anyone because she thought she might die and she was afraid to move to call. She told herself to just relax, relax, relax so the stress wouldn't bother her. She states the events lasted 3-4 hours but scared to pieces and she was to scared to reach for the phone. she did not go to the doctor about it but told her doctor about it during her check up a couple weeks later and she did routine labs but not for that. She states she is a diabetic. She states she lives alone and is a relatively new widow. The patient stated she has never had any vaccines in her life, not the flu shot or measles or anything.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Fully vaccinated, not boosted.  COVID breakthrough infection and an inpatient hospital stay.
Severe left shoulder pain for 24 hours. Could not raise arm to wall light switch or reach forward very far by evening. Could not lay on left shoulder without significant pain. At peak of pain arm was swollen at injection site and muscles were sore down to wrist. Also had chills that evening from 9:00p to 4:00a next day. After 24 hours have better mobility but still sore around injection site only. The PPSV Vaccine information sheet indicated less than 1 out of 100 have this reaction so this is the reason for reporting.
The Immunizing Tech ask me to look at patient's arm after giving an injection. I took a look it was swelling at the injection site. I monitored for about 10mins to see if swellingwould go down & it wasn't, then I administered 1 tab Benadry Spoke with customer on 3/30/31 swelling mostly gone down she just had soreness at the site
Skin rash started almost 2 days after 2nd Moderna vaccine.  Started off as small rash on stomach in the morning and spread to whole stomatch, chest, and back by afternoon.  Does not itch.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with GARDASIL (lots # reported as K008931 exp date 04-MAR-2017, K010215 exp date 05-MAY-2017 and L033347 exp date 23-JUL-2017) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient admitted as observation on 12/27 due to encephalopathy, metabolic. Patient was tested for COVID-19 and was positive on 12/27.
Patient administered MMRII vaccine on 7/20/23 that expired 7/15/23
Patient phoned pharmacy 11/11/09. Arm pained and patient has difficulty raising arm and rotating.
she had a reaction to ZOSTAVAX. The reaction is itching and swollen eyelids; she had a reaction to ZOSTAVAX. The reaction is itching and swollen eyelids; ear infection; she had pain at the injection site; This spontaneous report has been received from a currently 61 years-old female consumer concerning herself. The patient's concomitant therapies included rosuvastatin calcium (CRESTOR), fish oil, ezetimibe (manufacturer unknown), aspirin, probiotics and milk thistle. The patient's concurrent  conditions included a shellfish allergy. The patient's historical drugs and medical history were not reported.     On an unknown date,  the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dosage regimen, Lot # and expiration date were not provided)for shingles' prophylaxis.      On an unknown date, the patient experienced pain at the injection site, swelling of eyelid and itching (pruritus).      On 09-SEP-2020, the patient started using ear drops called hydrocortisone (+) neomycin sulfate (+) polymyxin B sulfate) otic suspension, 3 ear drops, twice per day, Expiration date June 2022 for an ear infection.  On 14-SEP-2020, the patient experienced the same aforementioned reaction.  On an unknown date, the patient underwent a blood work ( name of the laboratory test, units and results were not reported) and the patient was planning to visit her health care provider.  At the time of reporting, the patient had not recovered from pain at the injection site, swelling of eyelid, itching and the ear infection.    The consumer  considered injection site pain, swelling of eyelid and pruritus were related to zoster vaccine live (ZOSTAVAX). The causal relationship between zoster vaccine live (ZOSTAVAX) and the ear infection was not reported.
tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Severe abdominal cramps, severe chest pain, neck pain and headache, severe joint pain, muscle aches and weakness and shakiness. Started 6 hours after receiving vaccine and is ongoing at 30 hours post vaccination.
chills, fever up to 105, severe headache, severe back ache, dizziness, weakness, fatigue
Adverse events on 4/22 was arm pain, fever and headache Adverse events on 4/23 was arm pain, headache, change in urine color Adverse events on 4/24 was red rash near injection site
Full body rash/ Still experiencing a rash; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore arm), RASH (Full body rash/ Still experiencing a rash) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and CHILLS (Chills). On 06-Apr-2021, the patient experienced RASH (Full body rash/ Still experiencing a rash). The patient was treated with PREDNISONE for Rash, at a dose of UNK, cyclical and FLUOCINONIDE (topical) for Rash, at a dose of 0.05 %. On 01-Apr-2021, LIMB DISCOMFORT (Sore arm) and CHILLS (Chills) had resolved. At the time of the report, RASH (Full body rash/ Still experiencing a rash) outcome was unknown.            Lab data - Biopsy  No concomitant medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received contains significant information. One event is not recovered. On 03-Aug-2021: Non-sig follow-up added.
Severe mitral regurgitation and chronic obstructive pulmonary disease with (acute) exacerbation. ED visits and hospitalization within 6 weeks of receiving the COVID-19 vaccine.
No adverse event. Med error. Bivalent Moderna given for dose # 2 in the primary series. Repeated with monovalent Modera per CDC guidelines.