chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, and her arm was sore for a couple of days and continued to be sore.  It got worse and worse, muscles got weak and could not do things with her arm.  She started having problems with her legs, and stopped, they were stiff.  She now has front and back stiffness of her legs, it takes her a while to start walking.  The arm is hurting when she's reaching, trying to cover with a blanket.  It's a mobility situation, but does have pain when she tries to reach and try to cover herself and not able to do that.  The legs are a mobility issue not pain.   She saw her doctor for her symptoms, who wanted her to get an x-ray as that time she did not have the right arm involved, but only the left  The day she went into her her legs did not hurt her.  Her arm was x-rayed all the way up to the shoulder, no arthritis, the bones looked okay, the AC joint had some space, but nothing too concerning.  She wrote her and told her that she was not doing well, and she has an appointment for FU this week.  She cannot pick anything up off the floor due to the stiffness in her legs.  She is very active, she is in a pool 3 days a week for an hour with water aerobics, she is also doing dance, and does something every single day.  She was possibly going to be sent for PT, but due to her activity she did not know if she needed it, and says what's the sense of it as she is going these other things.  This affects both arms, back and front of legs, cannot walk and has to wait to walk after she sits.  She forces herself to get going, and night is terrible.  Trying to turn in the bed and covering herself is severe.  She cannot do her arm movements much a far as dancing.  She has a stretch out flap and stretches herself real good to be able to dance.   Getting dressed is very difficult.    She went online and found us and found Guillian barre syndrome, and has not gone into her yet with these.    She went this past week to have a message thinking it would help her, which did not help her.  She does take Tylenol from time to time and helps with mobility.  She is not in pain, but has slowed her down considerably.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:14 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 27-Feb-2021 Age of patient was reported as 58.28 and on 27-Mar-2021 age of patient was reported as 58.36. On 27-Mar-2021 at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 27-Mar-2021, and at 10:00 Am the  temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration At 8 AM: 33, 9 AM: 36, 10 AM: 35, 11 AM: 35, 12 AM: 35, 1PM: 35 2 PM : 46, 3 PM: 34, 4 PM: 34 and 5 PM : 35.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
received, today 9 AM, an expired dose of Boostrix.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 429H5, expiry date 7th February 2021) for prophylaxis.   On 30th March 2021 09:00, the patient received Boostrix. On 30th March 2021 09:00, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received, an expired dose of Boostrix, which led to expired vaccine used. No further information reported. The reporter consented to follow up.
administered acthib that was reconstituted with expired diluent with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered hib (prp/t) vaccine [ACT-HIB] that was reconstituted with expired diluent with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect hib (prp/t) vaccine powder and solvent for solution for injection (expiry date - 30-Nov-2022, Diluent - 29-Oct-2022) lot number not reported via unknown route in unknown administration site (strength, dosage, frequency: unknown) for Immunization.  On 08-Nov-2022 the patient was administered hib (prp/t) vaccine that was reconstituted with expired diluent with no reported adverse event (expired product administered) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Dec2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201213034 Same patient, different drug, different AE;
Patient received second dose on day 16, which is less than the minimum required 17 day spacing between dose 1 and dose 2 of Covid vaccine.    Dose one was received on 12/28/2020 Dose two was received on 01/13/2021
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 25-FEB-2016, the patient was vaccinated with a dose of RECOMBIVAX HB injection, lot # L025738, expiry date 14-AUG-2017 (dose, route of administration and anatomical location were not specified). The administered dose of RECOMBIVAX HB underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
severe head pain-back of head-ear to ear across bottom of hairline; began evening of shot-severe pain-lasting approx 2 wks; ASA taken daily for relief some sl cold sx began @ same time;
itches; injection site pain; cant raise arm 90 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cant raise arm 90 degrees), PRURITUS (itches) and VACCINATION SITE PAIN (injection site pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced LIMB DISCOMFORT (cant raise arm 90 degrees) and VACCINATION SITE PAIN (injection site pain). On 21-Apr-2021, the patient experienced PRURITUS (itches). At the time of the report, LIMB DISCOMFORT (cant raise arm 90 degrees), PRURITUS (itches) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.        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 concomitant medications information was reported. No treatment medications were provided.
PATIENT STATES SHE HAS REDNESS AT THE SITE OF INJECTION, SMALL BLUE SPOT WHERE THE NEEDLE WENT INTO HER ARM, LOW GRADE FEVER/CHILLS. STATES THAT AT THE TIME OF INJECTION SHE DIDN'T FEEL ANYTHING.
I have got a little head cold/I got cold; I have got my sinus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have got a little head cold/I got cold"; SINUSITIS (non-serious), outcome "unknown", described as "I have got my sinus".  Additional Information: Consumer stated, "I have got an appointment this morning at 9:00 and it is 07:30 here, I made an appointment last week, I have got a little head cold, this is normal. So, I was wondering, will they stop me from getting my shot? I am taking my booster shot today at 09:00." (Head cold-captured as event since further clarification about if consumer was experiencing head cold after getting first and second vaccine shot was unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
STABBING PAIN BEHIND RIGHT EYE.  NON-VERTIGINOUS LIGHT HEADEDNESS.  NO CHANGE IN VISUAL ACUITY.  NO CHANGE LASTED FOR 5 MINUTES.  RESOLVED SPONTANEOUSLY.
Seven days post vax, the patient developed a fever of 103F and a prominent rash that looked like measles. The rash went away after 6 days. It was itchy and uncomfortable. The patient was treated with Motrin.
Pt recvd vax 2SEP92 devel sweating, chills, fatigue & swollen glands which resolved in 6 hrs w/o treatment;
c/o of increased HR and seems anxious.  P=124; O2=98.  resolved.  P=89
Cluster of varicella lesion at site of injection with swelling and erythema approximately 4-5 cm treated with cephalexin.
Soreness and swelling at injection site, low grade fever, muscle aches, joint pain (mostly on the left side),  headache transitioned to a migraine today. Severe fatigue throughout.  Mild nausea.
Body aches, extremely sore arm/muscle (hurt to elevate), redness and extreme tenderness at and just under injection site, chills, headache for 18 hours (starting 7 hours after vaccine).  Treatment: bed rest, limited activity. Outcome: all but arm redness gone within 24 hours.
Out of the blue I started having severe chest pain then numbness throughout left side of body, slurred speech, confusion. It was either a mini stroke or transient ischemic attack. I will be seeing my Dr tomorrow morning
my niece got a shot, a spoon stuck to her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown dose as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that on an unknown date after shot her niece experienced a spoon stuck to her arm. The outcome of the event was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up#1 (8Sep2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101110877 Same reporter, different patient, same drug/event (split);US-PFIZER INC-202101110375 Same reporter, different patient, same drug/event (split)
Information has been received from a physician and a licensed practical nurse concerning a female who was recently vaccinated with the second dose of VARIVAX (Oka/Merck). The physician reported that the patient experienced injection site reaction after receiving the vaccine; on follow-up the nurse reported that the patient experienced redness and swelling at the injection site. At the time of the report the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information hs been requested.
About 5 minutes after vaccine, patient noticed mild itching at injection site, small area of redness around injection site and injection site is warm.  Denies pain.   Offered Hydrocortisone Cream for topical administration to injection site, but patient declined.  Patient stated she had some at home that she would apply if needed. Patient waited a total of 30 minutes.  Site did not appear to change.  Patient denied any further allergic symptoms.
When child woke up had fever of 101, child slept for approximately 15 hours, arm where vaccine was received felt hot and there was redness from shoulder to elbow, it was raised, looked like he was burned with an iron. Child was also talking while sleeping, not common for him. Child taken to the doctor. They recommended Dimetap and to watch out for fever and bring him back by Friday however mother gave child Tylenol, Motrin and Benadryl instead. Redness has decreased.
This spontaneous report as received from a Nurse concerning to a 5 years old child male patient who was vaccinated with a 2 and final dose of VARIVAX (Merck) (dose, route and lot # not provided) "injection" in "late" August 2012 approximately on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that in the end of September 2012, approximately on 30-SEP-2012, the patient developed "chickenpox" about 3 to 4 weeks later" after being administered the vaccine. The nurse also stated that the patient went to unspecified "urgent care" facility for an unspecified duration and was diagnosed with the chickenpox there. The patient saw the physician a couple of days later and he confirmed the diagnosis. At the time of the report, the patient's chickenpox had improved. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of tremor in a 10-year-old male patient who received HAVRIX 720 Junior (batch number MG4R9, expiry date 30th September 2018). On 20th July 2017, the patient received the 1st dose of HAVRIX 720 Junior. On 21st July 2017, 1 days after receiving HAVRIX 720 Junior, the patient experienced tremor and dizziness. On an unknown date, the outcome of the tremor was unknown and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the tremor and dizziness to be related to HAVRIX 720 Junior. Additional details were reported as follows: No other concomitant vaccine was given. The patient's parent brought the patient to the emergency room and had full workup of EKG (electrocardiogram), BP (blood pressure) which showed normal results. The patient then followed up with PCP on 24th July 2017. The blood work was examined normal and reported that the only time the patient felt dizzy was when he bent down to tie his shoes when he was getting weighed. The patient still complained of dizziness at the time of reporting and had to leave camp after 1 hour.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # K025006, expiration date 22-JUL-2017, exact doses and route of administration were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist via company representative, concerning a male patient of currently 66-years-old. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 plaque forming units (PFU) (dose, route, frequency, lot number and expiry date were not reported) for prophylaxis. It was reported that the patient has had a burning sensation in his arm where the injection was for about a year (not specified), also, that he was nervous for the injection site stinging that had not gone away. The patient wanted to know if he should move along with the SHINGRIX shot. The outcome of burning sensation was not reported. The causality assessment between ZOSTAVAX and burning sensation and injection site stinging was not provided.
My adverse event started on 01/29/2023 in the late afternoon. I had chills and felt like I had the flu. I did a Flu test at my doctor's office on the 1st week of Feb which was negative. I was sick for 2 weeks with the viral infection. On the 16th or 17th  day I went back to my doctor's office on 02/15/2023,  where they  diagnosed me with  Pneumonia. My doctor prescribed me with 2 Antibiotics for 10 days.
On 5/4/13 pt c/o fever in am, some swelling body aches. Seen in ER - c/o SOB on 5/6/13 pt seen in clinic - 102 and hot red arm.
Patient presented to this Immunization Clinic on 8 May 2006 at 1300 hours stating PA-C had advised her to receive a Pneumonia Vaccine.  Therefore, patient was vaccinated with Pneumovax(adult formulation)0.5ml given SQ over the right deltoid without any reaction noted at time of vaccination.  Patient contacted this Immunization Clinic on 10 May 2006 stating she had localized redness, swelling, and heat at the injection site on her right arm and was advised to see a provider for further evaluation.  Patient presented to PA-C for this evaluation at 1430 hours on 10 May 2006.  PA-C documented patchy, mild redness, and edema of the right upper upper arm from the inner aspect of the mid-humerous to the lateral aspect of the upper deltoid area with no significant redness or edema at the injection site.  Patient was positive for tenderness at injection site with no systemic symptoms.  Patient stated the site was improved from the previous day.
5 hours post vaccination broke out with a hive on my face, felt lightheaded and heavy in the chest but not short of breath.  went to bed around 10 that evening and slept well. felt fine the next morning, hive stayed for about 2 days.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot # 650084/0605P). Subsequently, the patient developed a fever, heat and swelling at the injection site and had difficulty moving arm. The patient was treated with an unspecified antibiotic. Subsequently, the patient recovered. Heat and swelling at the injection site, difficulty moving arm and fever were considered to be other important medical events. Additional information has been requested.
Erythema at injection site 3in wide by 2.5in long. Very sore (7 out of 10) at injection site with shooting pain sometimes. Decreased ranged of motion with pain when moved.
I developed joint pain approximately 8 hours after vaccination, at 10 PM, beginning in the hips and spreading throughout the entire body.  Around 11 PM, I began to experience chills. Around midnight, I developed a pounding headache. Around 1 AM, I began to experience muscle pain. Around 2 AM, I began to experience nausea and sweating. Around 3 AM, I experienced tachycardia, with a pulse rate of between 110 and 120 beats per minute while lying down. Throughout the time, I was lying in bed but not sleeping. I was unable to work the next day and spent most of it in bed.
Patient was administered vaccine at an off hospital site. Patient acknowledged anxiety prior to vaccine administration. Following administration of vaccine, paatient reported that felt tingling in both hands, followed by lightheadedness, tunnel vision, dampening of hearing; was then moved from post vaccine observation area to an exam room. Patient complained that tongue felt swollen and numb and complained of difficult breathing  Patient received Epinephrine 0.3mg SQ by the Physician Assitant;  ambulance then requested.  Stated that she felt relieved after receiving Epi pen, but heart racing and shakiness. Evaluated by paramedics; BP134/80 HR 85 spo2 100% and transported to local ED for suspected panic attack.
1 day after vaccination, the patient developed symptoms of severe fatigue, nausea, and malaise. The following morning, the patient awoke complaining of shortness of breath and chest pain. He also developed a red, angry rash that spread to cover most of the surface area of his upper arm around the injection site. The rash persisted for about 7-8 days after vaccination.