chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication was reported.  Vial size was reported as 10 dose vials. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at the time of report. The second potential lot was confirmed to not be used.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Initial soreness at the side of the injection, subsided after 48 hours. After 72 hours, developed soreness in left armpit. After 96 hours,  began to experience soreness and tenderness  in upper arm area (both left and right), across rib cage, and mid back.
Beginning 4 to 5 hours after vaccine shoulder pain and stiffness continues to worsen over 5 days before improving with Ibuprofen. Shoulder pain worsened again after increased use 1 week after injection  became difficult to move due to pain and stiffness. Has improved again with consistent use of Ibuprofen.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 56-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site bruising and injection site swelling. On 15th August 2018, the patient experienced injection site itching, lip swelling and facial swelling. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and epinephrine (Epi Pen). On an unknown date, the outcome of the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site itching, lip swelling, injection site swelling and facial swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient had the SHINGRIX vaccine and immediately experienced bruising and a big large swelling at the injection site. Overnight the patient experienced facial and lip swelling. The patient also experienced itching at the injection site. On the day of reporting, the patient went to the doctor and had series of cortisone injections and an epi pen.
Child began screaming inconsolably and nonstop for over 2 hours (no history of colic and has never been a fussy baby).  Gave .6mL of infant Tylenol at 4pm but did not appear to help.  Her body was very stiff during the long screaming episode.  She was fussy the remainder of the night and was very bothered by movement but was better by the next morning.
I noticed that I had pain in weakness in my upper outer deltoid in the muscle from the injection site.  This pain continues since the vaccine every time I use that muscle.
Narrative: COVID infection following COVID vaccine series 01/28, Pfizer, dose #1 Agency Facility 02/06, Pfizer, dose #2 (PHARMACY) 08/12 08/23 08/26 COVID swab , result: not detected 08/16 08/23 08/26 COVID swab , result: not detected 08/19 08/23 08/26 COVID swab , result: not detected 08/23 08/26 COVID swab , result: not detected 08/26 COVID swab , result: detected 08/26 SARS-COV-2 Variant Sequencing results: pending 08/27 pt cognitively impaired admitted to nursing home COVID unit for quarantine and supportive care. 08/27 pt cc: unable to verbalize exposure: unknown 10/03 pt deceased
Rash at injection site right deltoid (1) day after injection was given.  Seen by Dr. 2 day after c/o rash and itching BENADRYL was prescribed by Dr.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 48, and 40 hours, with the lowest recorded temperature of 33, and 34 degrees Fahrenheit (0.55, and 1.11 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented for 2nd dose of Pfizer vaccine.  RN was the nurse to administer the vaccine.  Prior to administering the vaccine, she began the documentation.  That is when a warning popped up saying the patient had already received maximum doses of vaccine.  RN excused herself and found the clinic lead.  I queried the patient and noted that she received Pfizer vaccine on 3/16/21, 4/6/21, and 4/30/21.    I asked the patient if she received a first and second dose, and she responded "yes".  I asked if she received a 3rd dose with us and she responded "yes".  I asked if she was wanting a 4th dose of vaccine today, and she responded "yes".  I educated the patient that she was considered fully vaccinated after 2 doses of the vaccine and that she didn't not need any further doses.  She responded that she is immunocompromised and wants to receive more than 2 doses.  She understands in other countries they are giving 3rd and 4th doses to patients similar to herself.  I explained that in this country, we are only authorized to give 2 doses 3 weeks apart and that I would not be giving her another dose today.  I told her I would need to report this error.  She asked if she had just gotten us in trouble, to which I responded "no".  I also reassured her that she was not in any trouble, but that she shouldn't continue to seek more vaccines.  At this point she shared that she works at a university and the first 2 COVID cases on campus occurred in the lab that she works.  Next week, things on campus are "going back to normal" and she is nervous.  I told her that it's ok to be nervous and scared, especially after everything we've been through in the last year.  I reassured her that she is fully vaccinated and that she can continue to wear her mask (she had on 3) as long as she felt comfortable.  I reiterated that I would not be administering a 4th dose of vaccine today, and she verbalized that she understood and left with her driver.  Throughout the entire encounter, she was very calm and forthcoming.  I contacted department head and discussed the situation.  She advised me to complete a VAERS report, which I will do.  The patient didn't report any adverse side effects to her 3rd dose.
On Thursday morning, pt's mom says the pt woke up with a swollen left arm from shoulder to elbow. By today the swelling is worse and spreading down the arm. Advised mother to contact the pediatrician to be evaluated soon as possible. On 04/29 follow-up mother states that the pt is much better.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (orally) from 01Dec2022 to 06Dec2022.  Clinical information: Patient didn't received other medication in 2 weeks. The patient didn't taking any other medications/products within 2 weeks of starting COVID-19 treatment. Known allergies was NKDA. Serious: No. Seriousness criteria-Results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect was no.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Patient received Janssen COVID-19 vaccine on March 5, 2021. She had reported she never received a COVID-19 vaccine in the past and the dose was given. Patient had no reaction in 15 minute wait period.
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Beginning that evening the patient experienced headache causing nausea and very sore arm where vaccine was administered. Headache continued thru the next morning. After headache subsided patient experienced daytime fatigue/sleepiness which is not normal for him. All side effects had subsided by noon today, just some arm soreness remaining.
Immediately after receiving the shot, felt tightness across my chest.  2 hours later, began to experience flu like symptoms.  Started running a fever and shivering in the bed.  highest fever was 102.  symptoms lasted 24 hours.    Other symptoms were slightly labored breathing, elevated blood pressure, and fluctuating O2 levels.  Tightness in the chest remains after fever and other symptoms have dissipated.
Information has been received from an office assistant and a nurse concerning a 9 month old patient who on 28-JUN-2010 at less than 12 months of age was vaccinated intramuscularly with the first dose of 0.5 mL dose of VAQTA (LOT# 667261/0261Z, expiration 19-DEC-2012). The patient was not experiencing any known symptoms. No further is available at this time of reporting. Follow-up information has been received from a registered nurse concerning the 9 month old female patient with no illness at time of vaccination and no pre-existing allergies, birth effects and medical conditions who on 28-JUN-2010 (also reported on 29-JUN-2010) at 11:30 was vaccinated intramuscularly at quadriceps of right arm with the first dose of VAQTA. It was reported that the patient was given hepatitis A vaccine instead of hepatitis B vaccine at 9 months of age. Patient experienced no adverse reactions. There were no relevant diagnostic tests and laboratory data. No further information is available.
I had no reaction immediately after the injection. It started about a week later, I developed a rash on the back side of my left knee and some random spots on my arms and legs. I assumed it was just an eczema flare and didn't even think that it might be related to the vaccine because I felt fine after both injections. The rash behind the knee got worse. I was given a steroid shot by my physician when I went in to see him and a Medrol dose pack with some Clobetsol cream. As soon as I finished the steroid, the rash came back and spread to different spots. I was then given Prednisone and the same thing happened and continues to happen as soon as I stop the steroid. I went to the dermatologist and they biopsied it and it came back at an allergic reaction but no one will test or can test to see if it's to the vaccine I am told because it's so new. I went to the allergist and they didn't test. The rash had caused a malar flush and for a minute they thought I had developed Lupus and nothing to do with the vaccine. I have now had blood work that has ruled out lupus but I will be finishing the 5 round of steroids soon and still have no answer. I do not know if it's related to the vaccine but that is the only new thing I have been exposed to. I am afraid that this is related to the vaccine and no one will tell me how long it will or can last since it's so new and nothing is known. I don't want to keep taking steroids but as soon as I stop, it comes back. I am not even sure that filing this out is the right thing to do.
fever to 108, diarrhea x8, floppy, tachycardia, sz, AHOC, tachy-status eplipticus, died;tx APAP, 02, Motrin, Rocephin, Ativan x3, Phenobarb;
Narrative:  79 y/o male w/ PMH significant for HTN, Anemia, PAD, HLD, BPH, T2DM, CKD, PAF, seizures and recent diagnosis of Parkinson's Disease. Pt presented to ED on 05/19/22 w/ decreased oral intake, weakness, cough and multiple falls. Pt admitted to hospital for failure to thrive, COVID 19 positive, anemia and AKI. Failure to thrive with increasing tremors in association with worsening Parkinson's Disease and possibly secondary to COVID. Pt with mild symptoms of COVID during hospital stay, mild cough. Pt received supplements of zinc and MVI during hospital stay. Pt improved and discharged to home on 5/31.
Severe ulnar nerve neuropathy.  Could not move LUE for 2-3 days due to pain.
Rash Narrative: developed well circimscribed ~6x6cm well circumscribed area of pruritis, swelling, and erythema under site of injection 7 days after vaccination. States are remained itchy/red for ~10 days after it developed. Staff applied OTC lotion and rubbing alcohol. Issue self-resolved, denied other symptoms that would be concerning for immediate allergic reaction.
Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day
Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator:29NOV2021 Date of administration: 17-DEC-21 -1 vial, 28-DEC-21 -1 vial, 14-JAN-22- 2 vial, 28-JAN-22- 2 vial.  No concomitant medications were reported. No treatment medications were reported. -   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow up received contains non-significant information. On 03-Feb-2022: Follow up received and contains non significant information (reporter added)
Information has been received from a health care professional concerning a 42 year old female nurse who on 5/19/99, was vaccinated with 1 dose of Hep-B vaccine recombinant and within a few minutes, post vax, she experienced neck stiffness and a slight headache. Approximately 2 hours later, she experienced an episode of diarrhea. She was taken to the ER and treated with Benadryl IM. The treating physician noted a "possible allergic drug reaction." Subsequently, the pt was discharged from the ER. No further information is available.
High fever (103.8 degrees). On 03/12, dr visit. Patient put on Amoxicillin for possible sinus infection. On 03/21 at 8:00am, patient covered with hives. Dr visit at 10:00am. Told to use antihistamines. On 03/22 at 8am, dr visit. Hives are worst. Patient prescribed Prednisolone for 3 days.
Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID; Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 4-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 1, single (Batch/Lot number: unknown), in Jun2023 as dose 2, single (Batch/Lot number: unknown) and in Aug2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 4 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Treenuts" (unspecified if ongoing). Concomitant medication(s) included: MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE taken for immunisation, on 24Aug2023 as dose number unknown, single. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The patient had no covid prior vaccination. There was no other vaccine in four weeks and no other medications in two weeks. The patient received all the 3 doses of the vaccine within the specified timeframe for her age and all doses administered appropriately. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Aug2023, outcome "not recovered" and all described as "Developed symptoms of high fever, runny nose, abdominal pain on 24Aug2023/ tested positive for COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) high fever, notes: Developed symptoms of high fever; SARS-CoV-2 test: (25Aug2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Tylenol & Motrin for fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Four hours after receiving my second vaccination shot on September 4 I started noticing a small batch of hives around the injection site. After about eight hours they disappeared and a hard red bump appeared the size of a Pea. My arm became very painful over time getting worse and by the second day was not functioning at 100%. By Sunday afternoon the Pea size lump had expanded. It had grown to the size of a golf ball was hard hot to the touch and read. It also became extremely itchy. By Monday around noon, the lump grew to the size of a lime still hard red itchy and hot to touch. Tuesday the redness had minimized but continued to be warm to the touch hard the same size and itchy. Wednesday no change in lump status but severe diarrhea has ensued with no change of diet. Nausea follows an extreme bout of diarrhea. From the date of injection fatigue and sleepiness has been present but not extreme lethargy.
Moderna COVID-19 Vaccine EUA Fever (100.5), body aches, sore/uncomfortable injection site.
Pt. received immunizations on 4/23. On 4/29, she developed loose stools.  On 5/1, she developed hematochezia x2.  She then went 1 day without any stools, and then had a nonbloody stool on 5/2.  No fevers, but she did have a mild increase in spitting up.  She also has been more irritable with prolonged crying episodes (45min 3-5 times per day).  No rhythmic episodes to suggest intussusception and she is completely content between these episodes.  Her exam on 5/1 was completely benign.  Treatment consisted of changing from soy to elemental formula for 3-4 days.
Febrile seizure 21 hours after vaccine. Total time = 1 minute, generalized tonic-clonic movements. Fever was 102.7 degrees F prior to seizure. Full recovery after 30 minute postictal phase. No residual deficits. Family all had vomiting & fever; maybe rotavirus.
About 1 or 2 a.m. after having the vaccination. Thursday had a lot of pain. Friday gotten worse. Called doctor. Friday and Saturday applied ice on it. Went to Urgent Care on Saturday and was given Prednisone. It seemed to help a little bit. Still having pain and can't sleep. Still applying ice and heat throughout the day.
Last night child started running fever of 102 degrees - 103 degrees with no other symptoms. Mother administered TYLENOL every 4 hours. Mother states fever dies break then spikes back up at the 4 hours mark. Pediatrician recommended mother continue TYLENOL. 10/20/09 - Dad states she ran a fever for 2 days - Did not go to ER or see her MD - State she is back at school - now no problems