chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported.  No treatment medication was reported.  This case pertains to the 48th patient of the total 190 patients.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
Awoke with nausea and myalgias.  Nausea and myalgias progressed.  Fever and chills within a few hours.  Very weak and fatigued.   Myalgias became severe.  Severe rigors and fever >102 about 26 hours post vaccine.  Fever, myalgias, anorexia, nausea lasted approximately 30 hours. I felt like I had COVID all over again (I had it in July).
NEGATIVE REACTION TO VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced negative reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction to vaccine was not reported. This report was non-serious.
1 day post vax w/2nd dose pt exp urticarial rash around site of deltoid inject which was associated w/pruritus, h/a, nausea, & myalgia; 24OCT90 rash & nausea resolved & on the following day h/a resolved; 26OCT90 myalgia resolved;
Developmental regression-loss of speech-fever, eye tic-eyes rolling back for few seconds periodically-lasted 1-2 weeks then resumed normal speech progression
Client complained of numbness down left are and pain at injection site. in the evening after 3rd Gardasil vaccine. Arm is still numb this AM. Called MD this AM and was told to apply ice for 10 min at a time every 2 hrs. Suggested Ibuprofen also. Mother to call back Monday with update.
Contracted Covid; Contracted Covid; This is a spontaneous report from a contactable Other Health Professional (patient). A 59-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration at left arm on 21Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient received the unspecified concomitant medications within 2 weeks of vaccination; patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was contracted COVID on 29Dec2020 20:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient received the treatment Monochrome antibiotic for event. The patient received the COVID test post vaccination on 29Dec2020. The COVID test type post vaccination was Nasal Swab, COVID test name post vaccination was RNA, COVID test result was Positive. The patient was not COVID prior vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the vaccination with BNT162B2 in this patient cannot be completely excluded.
12 hours after vaccine- chills and body aches relief with Tylenol  15 hours after vaccine - fatigue, slept on and off for over 24 hours, alternating Tylenol and Advil when awake for body aches  36 hours after vaccine - nausea and fatigue  72 hours after vaccine - slight fever 99.5 orally and fatigue, nausea and food aversions
Headache; influenza-like symptoms; feeling abnormal; This case was reported by a consumer via call center representative and described the occurrence of headache in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR238304).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, influenza-like symptoms and feeling abnormal. On an unknown date, the outcome of the headache, influenza-like symptoms and feeling abnormal were unknown.   It was unknown if the reporter considered the headache, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional information was received as follows: The patients had the second dose of Shingrix and experinced flu like symptoms and feeling out of it.
Coughing; nausea; SOB; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient not pregnant, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in arm right on 10Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Patient received the first dose of BNT162B2 on 20Jan2021 08.30 AM, intramuscular, administered in arm right. Medical history included asthma, cervix carcinoma in remission, allergy to shellfish.  The patient's concomitant medications included albuterol.  On 11Feb2021 05:00,  patient experienced coughing, nausea, shortness of breath (SOB). Therapeutic measures included continued care with albuterol. Outcome of events was not recovered.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and to side of the nose. It lasted until I went to bed. Symptoms had disappeared by the time I woke up the next day
Myalgia, ErythemaMultiform, NauseaVomiting, neck and arm pain Narrative:
Arm sore and is very bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a multiple patients (8 patient) of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The reporter stated that "I caught it from my vaccinated wife who caught it at a party where everyone was vaccinated. 8 of them caught it. My son and I both caught it and had mild symptoms. No loss of taste or smell or even a cough. No vaccines, and I have multiple issues that probably should have made me very ill at least. My vaccinated wife got very sick and lost taste and smell for 4 months. I see vaccinated people every day coming down with covid. Most tell me they were at least very ill. They're not telling you the whole truth. I was definitely less sick than most people tell me about their personal experience with vaccine side affects" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220230393. This report was associated with product quality complaint: 90000217220; Sender's Comments: V0: 20220230277-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Client received shot on 10/22/07, noticed soreness of left arm on 10/23 and by 10/24 upper left arm was red and edematous. Client did report that the afternoon of the shot he went to wrestling practice.Instructed to use alternating warm and cold compresses and take Ibuprofen. Referred to MD for evaluation
Pt developed edema and erythema extending to elbow.  Developed macular rash, no urticaria.  Lethargy, flu-like symptoms.  Symptomatic treatment with diphenhydramine.
Vaccine administered from a vial greater than 12 hours post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control.  On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture). On 12-Oct-2021, PRODUCT STORAGE ERROR (Vaccine administered from a vial greater than 12 hours post-puncture) had resolved.      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.   No treatment information was provided.
Feels like my blood is clogging up inside me; Flu shot it burns; Initial information received on 02-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who feels like his/her blood was clogging up inside him/her and flu shot it burns while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious  event "feels like my blood is clogging up inside me" (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event " flu shot it burns" (injection site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Flu shot it burns, Feels like my blood is clogging up inside me).  At time of reporting, the outcome was Unknown for the event flu shot it burns and was Unknown for the event feels like my blood is clogging up inside me.
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of Shingrix and experienced adverse drug reaction.
Patient's wife reported the adverse event to  me today 6/27/22 along with her husband.  Patient received both Pfizer 2nd booster and Shingrix in left arm at approximately 4 pm 4/19/22.  When he woke up in the morning 4/20/22 when walking from bedroom to the kitchen he fainted and hit his head.  I was not dehydrated.  They called 911 and was taken to the Emergency Room.  The ER doctor did an EKG and xrays and they didn't find any other cause for the syncope.  The MD said it was not a good idea to get shingrix and covid vaccines in the same day. The patient was discharged from the ER 3 hours later.   The patient was a little tired the next couple of days. Did not have a concussion and no further problems reported.
On 03-17-08, Mother reported that patient had received a chickenpox (2nd dose) and Tdap booster in her right arm on Friday, 03-14-08, about 4:30pm. On Saturday, 03/15/08, about 2:00pm patient complained of redness, swelling and discomfort at the Chickenpox injection site. No problems were noted at the Tdap injection site. She also complained of a headache and had a temp. of 99.5 degrees. Mother gave patient Advil for the fever and discomfort every 6 hours. On Sunday, 03/16/08, patient's Mother stopped the Advil and about 2:00pm patient's temp. went up to 101 degrees.  Patient's mother gave her another dose of Advil and her temp returned to normal within 30 minutes. Patient also had increased redness, swelling and discomforted  at the  chickenpox injection site. Today 03-17-08, patient was sent home from school complaining of nausea and dizziness. The swelling, redness and discomfort at the chickenpox inject site has gotten worse. The chickenpox injection site has a bull's eye type area of redness and swelling totally approx. 4 inches in diameter. It has a center area of dark redness  approx. 2 inches in diameter that is surrounded by a 1/2 inch ring of whitish discolored that is surrounded by another 1/8 ring of pinkish discoloration. One chickenpox pox is noted in the area of discoloration, swelling and discomfort. Patient mother states she is planning on taking her to the doctor. She was encouraged to do so, push fluids and instructed not to give any Aspirin products.
Full body hives began 4 days post shot, spread from torso to extremities; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient had no allergies to medications, food or other products. Concomitant medications included tadalafil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 13:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 , four days post shot the patient experienced full body hives which began to spread from torso to extremities and lasted roughly four days. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event full body hives which began to spread from torso to extremities was resolved on 09Apr2021.   No follow-up attempts are needed. No further information is expected.
Within 10 min, after receiving shots, client pale, diaphoretic, dizzy. BP low 80/54. Provided emergency management for syncope -shock position. Vital signs, hydration. Recovered. Was anxious prior to shots and had not drank today. BP WNL at recovery 100/72. Pulse 72 regular.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknow, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "slowly I lost my eyesight". Clinical course: I had your COVID vaccine and it was good but slowly I lost my eyesight. I don't know what should I do. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (lot# L008059, expiry date 18-DEC-2016 and lot# L010844, expiry date 16-NOV-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (kids) of an unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 06-DEC-2022. The patient's weight, height, and medical history were not reported. The patients previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number and expiry dates were not reported) dose was not reported for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sick (dose number in series 2). It was reported as "My entire fam has had 1,2,3 xs. On my side adult niece her kids- All jabbed- All sick now".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000261962. The suspected product quality complaint has been confirmed to be voided (no product quality issue and there was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210446, 20221210598, 20221210980 and 20221210961.
Vaccine was given to right deltoid.  Immediately after completing vaccine, patient bruised and began to swell.  A provider was notified and assess the vaccination site.  Applied ice to site for 10 minutes.  Swelling did go down and stayed at about 5cm X 4cm.  Pt's whole deltoid was swollen immediately following injection.  Pt. declined the need for Benadryl as swelling did go down after icing for 10-15 minutes.  Called patient the following day, 10/27/22, pt reports there is some bruising and just a little bit of swelling still.  No other symptoms.
All of a sudden the pt developed a high fever and generalized tonic/clonic seizure-type movements on his way to the hospital. On the Wednesday before admission, he received immunizations. Quickly resolved his respiratory distress with frequent nebulizer treatments with albuterol, as well as, Atrovent, with 48 hours with Claforan IV. Also, IV methylprednisolone. Discharged home on albuterol 1/2 vial every 8 hours, Atrovent 1/2 vial ever 9 hours by nebulizer. Will continue Augmentin 3 1/2ml po every 12 hours X 10 days (200 mg/5ml), Prelone 2 1/2ml, 7 1/2mg po twice a day for 3 days. Mother to follow-up on Monday. Dx on discharge; febrile seizure, status post respiratory distress, status post crisis.
A little over 12 hours after I received the first dose I woke up with the worst cramps I?ve ever had in my life then started my menstrual cycle four days early. It?s extremely heavy which is not normal, nor is the intense abdomen pain I felt after the shot.
Immunized with Moderna at facility in Fab 2021, missed second dose. Immunized with Pfizer product by Healthcare ER in Aug 2021