chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; They had COVID twice after receiving Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (They had COVID twice after receiving Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 032L20A, 016M20A, 939901 and 013G22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced COVID-19 (They had COVID twice after receiving Moderna.). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (They had COVID twice after receiving Moderna.) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive. In December 2022, SARS-CoV-2 test: Negative. On 20-Dec-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient was going to get the other Moderna booster shot the second week of January. No treatment medicine were reported.   Reporter did not allow further contact
Episode of high pitched screaming for four plus hrs; also two witnessed apnea episodes; pt was hospitalized for 3 days & UGI, EEG & Pneumogram was done; everything was nl; 14FEB t97 ax, no local rxn;
Dose was adminstered outside of the 6 hour timeframe from the first puncture of the vial; A spontaneous report was received from a healthcare facility administrator concerning a patient who received Moderna's COVID-19 (mRNA-1273) Vaccine and experienced expired product administered.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020, a vial containing Moderna's COVID-19 Vaccine was thawed, and the vial was punctured. Afterwards, the vial was placed back into refrigeration overnight.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection from the same vial. The dose given was outside of the six-hour timeframe from the first puncture of the vial.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event, expired product administered, was not provided.   The event, expired product administered, was considered recovered/resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history is not provided.  The event occurred 31 Dec 2020 during administration of the first dose of mRNA-1273. This report refers to a case of out of specification product use where, mRNA-1273 was given outside of the 6 hour timeframe from the first puncture of the vial.
Frequent Aching of Trapazoid muscles after 5th Anthrax shot received Mar 2004 while deployed. Frequent knee joint pain in both knees  seemed to get worse after 5th and 6th anthrax shot. 6th received Sept 2004.
got at 11:00 Am and around 6:00pm i got chills and ran a slight fever and just felt bad. this morning, i feel cold but don't feel too bad.
Fever (100.4-101), severe headache, body aches, fatigue, injection site pain
a few red dots on left arm, and  on torso. Showed up about 10 days in. Still there as of today.
101.2 fever, rigors, body aches, exhaustion, enlarged lymph nodes under right arm, partially numb upper lip
5 minutes after receive the dose, patient complaint not feel good.  Her BP was normal.  No rash. She coughed, felt nausea and throwed up.  We monitor her closely, and then she stared shaking and felt so cold.  At that time we gave her 2 tablets of 500mg acetaminophen.   10 minutes later, she complain of difficult of breathing, and felt something in her throat, we call 911 and administer 1 dose of epi-pen. 10 minutes later, EMT arrived and took her to the hospital .
Fever  was 99.8 when I woke up then. Spike to 100.9. Dropped to 98.6 then back up at 99.9 .  Body chills  Body aches  Weak  Nauseous  Headache   Took Tylenol  every six hours  which was 4times of a dose of 2pills . Drank lots of fluids.  And rested all day .   Next day body aches  temp was 99.4
1-15 minutes after receiving vaccination, pt complained of left arm numbness and tongue numbness. BP 170/100, HR 100 and felt sick and flushed. Eval by MD.
I had some symptoms the day of I just felt tired and then a headache but then Within 48 hours I?ve been very exhausted for months now. I've been to doctors, and I've been to urgent cares. They've done every test in the book. It's been this extreme fatigue with joint pain, but I don't know if it's related, and it comes and goes. I've seen urgent care, primary care, endocrinology, neuroendocrinology, allergist, immunology and none of them have been able to help. I had kidney stones and I had a severe UTI 2 weeks after I got shot and they did a CAT Scan and the CAT Scan showed a nodule on my lung and a stone on my kidney which they thought was strange because I've had tons of scans prior, but they figured they'd just repeat the scan and my insurance has to approve it so I had to reschedule it for October 12.  I?m still dealing with fatigue.
Patient had swollen eyes, red cheeks and fleeting/evanescent urticaria on face.
Fever: 104 F after injection.  Lasted 24 hours.  Swelling on arm 2 x 2 in. with redness lasted 24 hours.  right arm.
no other issues or concerns noted; improperly stored Varivax had been administered; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot #U020238, expiration date: 28-JUN-2023 (formulation, strength, dose, frequency, site and route of administration were not provided) for prophylaxis (product storage error). The vaccine experienced a temperature excursion of 41 degrees Fahrenheit for 45 minutes. No previous temperature excursions were reported. No other issues or concerns noted.
Patient received ZOSTAVAX on 5/17/12. Came in to store on 5/18/12. Her arm was red (circular shape) where shot had been given. It was size of small pancake. Said it didn't hurt but was hot to touch & felt like a knot was under the skin.
This case was reported by a pharmacist and described the occurrence of local reaction at injection site (induration) in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cased include A0947071A, A0947173A, A0947174A, A0947176A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to product complaint investigation results reported by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
3 inch long red itchy area at the injection site; 3 inch long red itchy area at the injection site; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 17Feb2021 11:30 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis", start date: 2018 (ongoing); "a ton of allergies to medicines" (ongoing). The patient took concomitant medications. Vaccination history included: Flu vaccine, administration date: Nov2020, for influenza immunisation, reaction(s): "No adverse effects". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 25Feb2021, outcome "recovering" and all described as "3 inch long red itchy area at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus. Additional information: The patient received cortisone-10 cream as treatment for the events on 26Feb2021 (only once), but did not use it again as she said that it didn't help and it wasn't unbearable that she needed to continue using it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On September 26, 2017, four days before having my third baby by cesarean section, I had facial paralysis, which culminated the following month, without noticeable scars on the face, but yes, some sensitivity to cold or sudden changes in temperature .  After applying the vaccine, I felt slight body heat and they warned us that we were going to have pain in the arm and possibly cramps, no more. But, the day after the application, I began to feel the flu, cough, muscle pain, slight headache, but on the fourth day of the application, the flu had almost disappeared and I began to feel the same sensation in my body as when I had facial paralysis, I have two fingers slightly numb on my left hand and one finger from my right hand, cramps in my face. My question is what should I do in this case? Do I apply a second dose, can I cancel, what consequences will I have if I apply the second.  I know that apparently nobody forces you, but if you have family in another part of the world, you will NEVER be able to see them again, because it is mandatory to go but vaccinated, in fact while they administered it to me, and before applying it, I thought I HAD BEEN SOLD ON IT TOO EASILY, I WANT TO SAY I AGREED BECAUSE I DIDN'T WANT TO STOP SEEING MY FAMILY, but now I think that if something happens to me thanks to this vaccine, I may not be able to see them for a long time or ever.
Redness and swelling from injection site in shoulder down to elbow. Pt did not report fever or other symptoms.
Vaccine was given 7 days past beyond use date. Their data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
I has body shivers, spiked fever- this lasted around 12-18 hours. Later in the day the shiver went away but had sharp abdominal in the right upper quad, just below the rib area. This pain comes and goes, some days its ok and some days it's painful.  I did go to the ER and they stated it was constipation but I know it's not and they just haven't ruled out what it may be. They did administer Morphine but only lasted 10-15 minutes.
No adverse event; Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 years old.  No treatment medications were reported.  This case contains information for the 1st of 4th adult patients described by the reporter.
Severe arm pain into the joints; Severe arm pain into the joints; Inability to lift arm; This is a spontaneous report from a contactable other hcp (patient).  A 26-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm right on 04Sep2021 12:30 (Batch/Lot Number: Fc3184) (at the age of 26-years-old) as SINGLE for covid-19 immunization at Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Patient medical history included pre-hashimotos from an unknown date and unknown if ongoing. Patient concomitant medication(s) included dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021 at 14:00, The patient experienced severe arm pain into the joints and had inability to lift her arm. The patient did not received any treatment for the events. The outcome of events was not recovered.
injection site/ arm pain with numbness of 4th and 5th digits on that side Narrative:
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Since 23-MAY-2014 (approximately in 2014, exact date was not reported) unspecified number of patients were vaccinated with unspecified number of doses of VARIVAX (Merck) (lot#H015136, expiration date: 09-AUG-2014) (dose not reported) that were exposed to temperatures outside of range on 23-MAY-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
ACHES; LOW GRADE FEVER; This spontaneous report received from a patient 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced aches, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and low grade fever. This report was non-serious.
Approx 1 hour after receiving vaccine, I began to have stomach or abdominal pain, followed by nausea (did not vomit), light-headedness, headache, very noticeable sweats, & overall discomfort. The symptoms were bad enough I went to lie down, but the discomfort was bad enough that it was difficult to find a position to lie down in. I had some shortness of breath but I believe that was caused by discomfort (& possibly also worry). I did not experience difficulty getting breath in or out. I had pain in my neck & stiffness (& mild numbness) in my arms. My son (11 years old) said I felt hot but I did not feel hot myself. No fever found with thermometer. About 1 & 1/4 hours later the symptoms went away leaving me fatigued & light-headed, & a little uncomfortable but nothing I would remark upon. The following day I was fatigued, & got light-headed as I got more tired. This continued but also lessened the two days thereafter.
Fever to 99.9, then down to 97.6 (my normal for my life is 97.4), then today back up to 98.9.  Vaccine on Thursday, April 1st, on Sunday, April 4th had severe dizziness which subsided a bit, today, Monday the 5th I can hardly walk I'm so dizzy.  Can't think of anything that would cause it except for the vaccine.
This case was reported by a other health professional via sales rep and described the occurrence of injection site redness in a patient who received PEDIARIX (batch number 33E9E, expiry date 16th November 2018). This case was associated with a product complaint. On 24th August 2016, the patient received PEDIARIX .5 ml. In August 2016, less than a week after receiving PEDARIX, the patient experienced injection site redness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site redness and pharmaceutical complaint were unknown. It was unknown if the reporter considered the injection site redness to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that they were concerned about this particular lot of PEDIARIX because they had three patients who experienced adverse events within a 2 day period of vaccination. This patient experienced injection site redness. They had used PEDIARIX and never experienced this type of problem so they are concerned that the lot was defective and do not want to use any further doses from it. They had 6 full boxes and then some partial boxes but the field representative did not have an exact total. There was no other obvious defect with these vaccines but reporter advised him that he would register a complaint. The reporter advised the representative that GlaxoSmithKline did not credit or replace for this situation but if the quality department did decide to retrieve some from this lot and found a defect upon investigation, then credit could be arranged. The field representative asked that someone contacted him to provide follow-up regarding how GlaxoSmithKline was proceeding with this complaint. The representative did not have further information. The healthcare professional was supposed to call medical information with additional information. This is one of the 3 cases reported by the same reporter.
Nausea, extreme fatigue, soreness, muscle ache, headache, onset appx 3 hours after injection, lasting about 36 hours.
All symptoms of my long COVID went away at end of March 2021 (had been present for 7 months).  Started to get back to regular function; exercising, full work, minimal brain fog and stuttering).  Felt good until mid July 2021 when my legs began to be fatigued particularly right above my knees along with pain and aching in my kneecaps.  At times had to hold myself up due to the fatigue.  As September 2021 started the joint pain and muscle fatigue spread up to my upper body.  I've seen Rheumatology and Neurology at two hospitals.  Particular pain emanates from the back of my neck over the last couple of months.  These symptoms are present everyday, severity in body parts ebb and flow each day, and they are present in the upper and lower part of the body as well as the left and right.  It has been 9 months of these symptoms and almost everything else has been ruled out.  I am currently waiting on a response to see if a third hospital will see me based on a referral from my doctors.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-DEC-2017, the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX 19400 PFU vial, 0.65 ml/once, lot # M037654 and expiry date 29-NOV-2017, for prophylaxis reconstituted with properly stored, unexpired sterile diluent, lot M044950 and expiry date 30-MAY-2019. No adverse affects were reported.
Complaining of "stomachache" and dizzy. Denied difficulty breathing or rash.
Muscle aches, 102.4 deg fever, vomiting starting 1/29/2015 7:00 AM; administered ibuprofen 1/28/2015 9:00 PM and again 1/29/2015 10:00 AM. Fever reduced to 100.8 deg, muscle ache reduced by 1/29/2015 2:00 PM.
Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot). In 2021, PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot) had resolved.            Concomitant and treatment drugs were not provided   Reporter did not allow further contact
pt did not think was pregnant @ time recv vax, has now confirmed that is pregnant;pt given info re: risk;referred to PMD;
About 3 days or so ago I noticed my arm was itching. Yesterday I noticed it was warm and I decided to check it in the mirror and it is about 3 inches in diameter reddened area.  I was going to call my doctor today.  It was more blotchy yesterday and today it is more of solid red.
PT PRESENTED WITH COMPLAINTS OF CHILLS, BODY ACHES, JOINT PAIN, HEADACHES, VOMITTING X 3 DAYS. PT DIAGNOSED WITH URI AND GIVEN 1 BAG NS, NAPROXEN, SUDAFED, SIQ X 24HRS.