chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Lack of efficacy; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08FEB2021 and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is a spontaneous case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE The events occurred 324 days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2021-432829 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: follow-up received and contains non-significant information; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE The events occurred 324 days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
He got his vaccine, didn't really feel bad, went to bed.  In the middle of the night all of a sudden he woke up shivering, which would come and go.  He also noticed that he the ringing in the ear that he has is more prominent this morning.  He also seemed like he was feeling more feverish and he turned on some fans close to him to try and cool him down, which seemed to ease his feeling of fever that he might have been having.    He did have to watch his step as he was still having chilled feeling, he has prostate issues and has a urinal and felt a littler jittery while holding the container.    He has had the flu vaccine before and has had no reaction to it.   He seemed to be having the feeling of the flu.
Narrative: Patient contacted provider on 3/31/21 indicating he had received his second COVID-19 Moderna vaccine on 3/29/21 and was experiencing fever/chills and treating with ibuprofen and acetaminophen alternating between the medications. Was followed-up with and indicated the fever had broken and he was feeling much better, with only slight fatigue noted.
Patient presented after being found unresponsive, he had one episode of vomiting he was diagnosed with  1. Dehydration  2. Acute hyperglycemia  3. Acute metabolic encephalopathy  4. Bilateral paralysis due to old stroke (HCC)  5. Sepsis due to pneumonia (HCC)  6. Acute hypoxemic respiratory failure (HCC)  7. Antibiotic long-term use  8. CRP elevated  9. CVA, old, dysphagia  10. Diabetes mellitus type 2, insulin dependent (HCC)  11. Elevated ferritin  12. Elevated LDH  13. Elevated liver enzymes  14. H/O tracheostomy  15. Passive smoker  16. Pneumonia due to COVID-19 virus
Pt had dizziness, paleness, diaphoresis, slight trouble breathing and weakness 3-4 hrs after receiving the flu vaccine. Went to ER treated and released same day.
Information has been received from a physician concerning a patient who was vaccinated with a first or second dose of Rotateq. Subsequently the patient developed diarrhea. It was reported that the physician did blood work and tested a stool sample from the patient. No other information was provided. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to multiple unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# L015047, expiration date 29-APR-2017; lot# I003775, expiration date 04-FEB-2017; lot# k005425, expiration date 15-APR-2016; lot# I006385, expiration date 25-FEB-2017; lot# I012035, expiration date 07-APR-2017; lot# I013067, expiration date 14-APR-2017; lot# L017143, expiration date 13-MAY-2017; doses, site and route of administration were not reported). No adverse effects reported. Additional information has been requested.
arm was sore and red; sore arm; blister; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blister), VACCINATION SITE ERYTHEMA (arm was sore and red) and VACCINATION SITE PAIN (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced BLISTER (blister). On 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was sore and red) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BLISTER (blister), VACCINATION SITE ERYTHEMA (arm was sore and red) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            No relevant concomitant medications were reported.
Woke up at 3:00 AM 04/12/05 with difficulty breathing, swollen tongue, large hives on entire body, eyes swollen. Called  911 Taken to ER for TX.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BASAGLAR; NOVOLOG; NOVOLIN R. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about Covid treatment. Other medication in 2 weeks. Anti-viral details: Paxlovid (Treatment start date: 16Dec2022, Treatment stop date: 20Dec2022). Extreme high blood sugars I have been type 1 diabetic for 20+ years with excellent control. Upon starting Paxlovid, my blood sugars shot into the 300s and higher. I worked with my endocrinologist and had to triple the calculation on all my insulin doses during Paxlovid use to bring my blood sugars under 200. Upon finishing Paxlovid, my blood sugars returned to normal approximately 12-24 later and I was able to resume my normal insulin dosing. For reference the only medication I took was paxlovid during this 5 day period. Nothing over the counter and only insulin as prescribed. I also continued to test positive for 5 days after completing paxlovid so the virus itself cannot be blamed for the high blood sugar as it was present in my system when paxlovid was not and I maintained stable blood sugars after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Morbilliform rash 48 hours after injection across my upper body, sparing my face. Started at injection site and spread. Injection site red, itchy, hot, and swollen.
double vision (cleared in ~10 minutes); numbness in left arm, left hand, left side of face; extreme sleepiness (made it home then slept for ~ 14 hours - still sleepy the next day; diarrhea; rash on face and hands appeared (still clearing); pain at injection site only lasted 2 days and it wasn't all that bad (did NOT take any over the counter drugs until March 31, 2021)
From initial info received on 10/14/03 from a health care professional regarding an adverse event occurring, it was reported that a 56 year old male pt received Fluzone SV '2003-'2004, lot U1268AA on 10/10/03 at 12:30pm. One hour later, the pt's legs "felt funny" and he had difficulty breathing. The pt used albuterol inhalers. He developed a harsh cough throughout the evening and experienced progressive weakness on 10/11/03. The pt went to the ER and was given Benadryl, epinephrine and prednisone. The pt returned to the ER on 10/12/03 after experiencing difficulty breathing and was admitted to the hospital. The recovery status of the pt was not reported. The reporter of this case is also the reporter of case 2003-02308. A 15-day follow up report received 10/23/2003 adds: From additional info received on 10/17/2003 from a health care professional, it was reported that the pt felt achy and weak one hour after receiving the vaccine. 4 1/2 hours later, at 5:00 PM, the pt began coughing and left work to go home. At home, he noted his arms and chest were red and he also experienced chest tightness. He became red all over and was achy. He ate dinner and went to sleep. The following day, the pt stated that he felt a little better, but was still red all over. He went to the ER that night, where he was given Benadryl, prednisone and respiratory therapy for his wheezing. He was then sent home. The next day, 10/12/2003, the pt experienced increased respiratory difficulty and cough and once again went to the ER, where a chest x-ray showed a right upper lobe infiltrate. The pt was admitted to the hospital with a diagnosis of pneumonia. It was not reported whether the pt recovered. Follow up on 05/19/04 states: "No further information is anticipated, this case is considered closed."
Approx. days post injection, pain started  in top of left foot ; pain  intensified and lower left leg became red and warm to touch. saw primary physician the following week -  steroid injection and pain injection in buttocks and doppler performed on left leg - no relief, gabapintin 100 mg began on 10/19 and rapidly inreased to 300 mg at bedtime to sleep...intense pain in top of left foot and toes..physical therapy assessment and one session...(did not help and unclear on issue) only relief is when standing with pressure on foot  Numbness and tingling in both foot and both hands began ..Nov. 1, saw podiatrist - steriod injection given in peroneal nerve area - some resolution with this and continued gabipentin.  Primary feels symptoms are coincidential.  Podiatrist thinks may be vaccine related.  Spoke with pharmacist who felt sysmptoms were related to vaccine and advised to complete this form
CLIENT RECEIVED 3RD/BOOSTER DOSE AT 5 MONTHS - ONE MONTH EARLIER THAN SUGGESTED BY CURRENT CDC/MANUFACTURER GUIDELINE  NO ADVERSE S/S IDENTIFIED AS OF THIS DATE/TIME
Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021; Expired Vaccine Used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 18-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
A few hours after receiving the vaccine, I became very tired and I had to lay down. I started to get chills and a high fever. For 2 days, my neighbor had to come stay with me because I couldn't do anything for myself and I don't remember anything. My children came down as well, and after the fourth day, I felt fine. I am still feeling fatigued since then. A couple weeks later, I started to realize that I wasn't able to really eat or drink anything. I went to three different Urgent Cares within about 12 days. The first Urgent Care told me that I probably had an infection of some sort. They gave me a shot of prednisone and gave me a prescription for a 5-day Z-Pack. They told me to take it within 3 days. After 3 days, I did not feel any better. I wasn't able to be seen at the second Urgent Care. At the third Urgent Care they said they thought I had strep throat. A friend of mine gave me something called "magic mouth" to numb my tongue so I could drink something. I had to miss a couple days of work and I'm now going on two weeks without really eating anything. I went to a medical facility. At the ER, they gave me fluids and they did a CT scan on my head to rule out a stroke. They drew a lot of blood. I have seen the Doctor twice and he wants to do a CT scan on my lungs. I have gone to an ENT and there is something going on in my throat. There are damages that have been found, but they still need to come up with a treatment. I keep having moments where I'm repeating myself. I'm going to be going to a neurologist to find out if there is any issue with my brain.
got a little light headed; wobbly; had a strange feeling of weakness; had a strange feeling of weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 09:00 (Lot number: ENG205) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, single, lot number: EL9266, administered in Left arm), administration date: 07Mar2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Mar2021 14:00, outcome "not recovered", described as "got a little light headed"; GAIT DISTURBANCE (non-serious) with onset 29Mar2021 14:00, outcome "not recovered", described as "wobbly"; FEELING ABNORMAL (non-serious), ASTHENIA (non-serious) all with onset 29Mar2021 14:00, outcome "not recovered" and all described as "had a strange feeling of weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The vaccine was administered in an outside clinic. The patient thought she was being hypoglycemic since she has diabetes but she checked her sugar and it read 146 (no unit provided). The patient did not want to feel panicky but the reaction hasn't gone away and kept on reoccurring. The patient wanted to know if this was effect of the vaccine. Events did not result to emergency room or physician office visit but she was planning to go to her doctor.  No follow-up attempts are possible. No further information is expected.
LIGHT HEADEDNESS; SWEAT; POSSIBLE VOMITING; NAUSEA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced light headedness. On 2021, the subject experienced sweat. On 2021, the subject experienced possible vomiting. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headedness, sweat, nausea and possible vomiting was not reported. This report was non-serious.
Rash all over body, started on chest and progressed. No fever. Slight decreased in appetite. ? body aches.
As I was administering the vaccine in her arm, the syringe and needle separated causing the vaccine not to be administered completely. Vaccine was re-administered.
Fast heartbeat; Dizziness; Trouble seeing; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated he was calling about the Pfizer COVID 19 vaccine, stated he had the first vaccine and immediately after had a fast heartbeat, dizziness, and trouble seeing which could be a sign of a severe allergic reaction which he saw on the FDA website, also stated he was scheduled for the second dose today and had read if one has experienced a severe allergic reaction it may not be best to get the second dose so he was wondering what Pfizer would recommend for him to do and stated he talked to his primary doctor and the doctor said it should be fine for him to get the second dose. The patient underwent lab tests and procedures which included heart rate which was fast on an unspecified date. The events were assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, exhaustion, vivid dreams, joint pain in sockets of hip and shoulder frequent urination. stayed in bed for 3 days. have not sought medical attention, still not feeling 100% well at the time of this report.
Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Various sxs from high fever 103.1, body pains to complete spine, hips, various toes and left lower back over kidney felt sore.. Now shoulders hurt. Asked job for FMLA forms.
The patient is 17 years old but received a pfizer booster shot which is only approved in 18 years or older. No adverse events occurred.
As reported by the patient's mother: 4 days after vaccination patient experienced extreme headaches, vision changes, slurred speech, difficulty walking, nausea, prickling skin and numbness. She had three ER visits. She was admitted to a psychiatric facility due to concerns of self harm.
This pt is from another country and no shot record is available. On 2/18/15 mother reported that the day after the child received vaccines on 9/24/14 she broke out in a "red raised itchy rash head to toe and had swelling in her throat". She denied fever or other symptoms. The rash lasted one week. They did not seek medical attention.
Information has been received from a physician concerning a 23 year old female patient with penicillin (PCN-rash) and anesthetic (nausea and vomiting) allergies who on 18-AUG-2010 was vaccinated with a second dose of series of 3 of GARDASIL (Lot# unknown). The physician stated that two days after vaccination on 20-AUG-2010, the patient reported having canker sores in her mouth, swollen lymph nodes and cold sores on her lips. The outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
16 hours post vaccine, persistent hypoglycemia to 30-40. Took multiple glasses of orange juice and sugary foods to get the blood glucose up. He?s not a diabetic and had no fever or other symptoms.
Presented with SOB, cough  x 10 days, + Covid 8/24; hypoxia: admit with Covid PNA; tx with rocephin, steroids, remdesivir, zinc, Vit C, zithromax, singulair, supplemental O2
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported by reporter.