chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I got the vaccine I was fine until the next morning when I woke up and I didn?t feel too bad and was just sleepy and achy but mostly sleepy. I woke up at 10 AM and I went and had breakfast and then went back to bed and slept until 3:30PM. My arm was sore but just achy and if you touch it, it hurt but I went right back to bed and slept until 10 PM. I then got up and took a shower, went back to sleep. Next morning I got up and did the same thing but I was able to get up and do what I had to do and I drank a lot of water. Saturday and Sunday was the same thing. Monday I was supposed to work up at 7 but I didn?t get up until 10 AM. I ended up going to the Doctor with back ache and I figured it was from sleeping so much. I ended up having a kidney infection and she said it was probably from the shot and it would go away and as of today (09/16/21) it has went away. It was hurting last night but not excruciating. Each day got better and I've been drinking a lot of water and kept moving. Sleepiness went away Monday afternoon (09/13/21). My body ached a little bit but I wasn?t sure if it was because I was sleeping so much.
This spontaneous report as received from a pharmacist refers to an unknown number of patients (unknown age and genders). The pharmacist reported that the patients at another clinic were vaccinated with ZOSTAVAX (lot#, exp date,dose and route not reported) stored at temperature of about 19F for an unknown period of time up for 6 months. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 20-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Had first shot in september, had same symptoms at that time.  An achiness and fatigue throughout body. so first shot 9/?/22,                                                                                                                                                                                                                                           second shot 03/04/23
received 2nd shot on 2-4-21.  Sleep during the night was restless.  Upon awakening, felt aches and discomfort.  Upon arrival at work on 2-5-21, symptoms continue and left work and went home to sleep and took measures usually done with cold or flu symptoms occurred in the past.
day after vacc #1 Pt. developed Atrial flutter,  hx Afib for 20 years,   over last1-2 years no problems after ablation,  only one episode of Atrial flutter during suspected Covid +in Aug, 2020 Current Atrial flutter event required conversion,   4 days later develped slight rash around pelvic area, very local  read article it is nano partilcles of polyethelene glycol causing issue. not questioning taking second vacc.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose.
While giving the injection it was noticed that the needle was not tightened onto the syringe enough which resulted in some of the vaccine leaking out and the patient not receiving the full dose.
Within 5 seconds of receiving 0.5ml of influenza virus vaccine, the patient had an episode of syncope. Fortunately the patient's mother and I (pharmacist) was able to catch her fall. The patient regained consciousness soon after the fall.
Shortness of breath beginning 4 days after vaccination. Pacemaker was checked per wife and it was fine.
This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 4 August 2012 the subject received unspecified dose of BOOSTRIX (unknown). Less than one week after vaccination with BOOSTRIX, the subject experienced injection site pain, swelling injection site and injection site redness. The pharmacist reported that the subject complained of pain, swelling and redness at the injection site; the subject received BOOSTRIX seven days prior to this report. At the time of reporting the outcome of the events were unspecified.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 23 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
SUDDEN, SEVERE PAIN, WEAKNESS AND UNABLE TO USE ARM, FOLLOWED BY ATROPHY. PHYSICAL THERAPY IN JUNE AND CONTINUED AT HOME. INJECTION SITE ARE WAS KNOTTED INITIALLY, MORE THAN NORMAL.
Right arm with blisters (vesicles), started with one large centralized vesicle & several smaller ones day after with pain.   Right arm shoulder to elbow redness & swelling.
RIGHT ARM SWOLLEN 3cm X 4cm wide. Red feverish spot. Bruise in the arm. At site of injection, you can feel a knot in the muscle. Patient had fever of 101, nausea, and headache for three days after shots received. Took Motrin for pain for 3 days after.
12 years old patient received Flublok Quadrivalent on 18Oct2019 during a Vaccine Visit only no side effects; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1939, expiry date: 30-Jun-2020 via intramuscular route in the left  deltoid, on 18-OCT-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse 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 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.
This patient had an IPV in the right lower thigh, now swollen, 4 x 4 1'/2 inch, Also red and irritated.
I've felt tired and slightly nauseated, with loose stools, ever since two days after the injection.
Patient came into clinic. Lt. arm had whelps from injection site to elbow, swollen, red, and warm to touch.  c/o being achy and headache. States glands in neck are swollen.
Information has been received from a nurse practitioner concerning a female who was vaccinated SC with a 0.5 ml dose of PROQUAD. It was reported that the patient developed rash after vaccination. The patient's rash appeared on her injection site. Unspecified medical attention was sought. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one several reports received from the same source.
A few hours after receiving vaccine arms and legs were weak, got dizzy, couldn't think clearly. Lasted approx. 12 hrs.
W/in 12 hrs p/DTP/OPV/HBOC, pt exp fever 102-105 R & a local rxn which lasted for 3 days; Seen in MD office next day; Blood work-up ordered to rule out illness; tx included APAP;
overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; overlying skin with faint hyperpigmentation and feels like sandpaper on palpation; cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm; This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), second dose, intramuscular, administered in left arm on 19Feb2021 17:00 as single dose for covid-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder), obesity, allergic rhinitis, penicillin allergy (rxn in childhood - suspect not actually allergic). Concomitant medications included Fluoxetine, Bupropion, Adderall, Cetirizine and Ibuprofen. On 19Jan2021 11:00 patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) Lot number=EL9264, intramuscular on left arm. In the hours following the second injection patient developed a cutaneous/subcutaneous reaction at the site of the first injection - pruritic, erythematous, indurated, warm, size approx 12mm x 5mm, minimal depth below skin surface. Itching waxed and waned in intensity, was worst early on, but still had some occasional itching two days later at which point lesion was sort of like a pin-point sized scab in appearance. Induration gradually resolved but was still detectable the day after the injection. Currently (4 days after injection) overlying skin with faint hyperpigmentation and feels like sandpaper on palpation, no warmth, induration, or erythema. (Healing, non-concerning, is sort of like a not-quite-a-scab, 8mm x 1mm - though I did not note any abrasions or watery exudate while it was symptomatic. On an unspecified date the events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
abdominal cramps in both ovaries, swelling of ovaries, pain in abdomen treated with acupuncture - some relief
Muscle or body aches  Headache  Sore throat  Congestion or running nose
My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping; My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping; lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EY0584) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 19Aug2021, outcome "not recovered" and all described as "My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping"; LETHARGY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, lethargy.  Additional information:Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Adverse event: My once normal Menstrual Cycle is erratic and coming every two weeks or less accompanied with cramping. Feeling fatigued, lethargic. Fatigue began 2 weeks after the second dose. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination: [covid test type post vaccination, Nasal Swab, covid test name post vaccination=Pcr, covid test date=16Sep2021, covid test result=Negative]. No Known allergies.  Follow-up attempts are completed. No further information is expected.No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient was treated with 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-202200966852 same reporter/patient, different drug/AE.;
having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; having "allergies" with symptoms including pain in her ears, throat, and has red eyes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced having allergies with symptoms including pain in her ears, throat, and has red eyes. It was reported that the patient has been scheduled for an appointment for her second dose of vaccine today ( day of reporting) but her allergies were really bad. She has red eyes and other symptoms, she wanted to know if she can go ahead and get the second dose (3weeks) or should she wait an get it next week. The patient also wants to know if she can change her appointment to Tuesday. The outcome of events was unknown.   Follow-up attempts were needed, further information was expected.
Patient describes feeling "heart racing" after vaccine administration.  Patient's vital sign established  and within normal limit. Patient reported "feeling better". Patient vitals reassured and found within normal limits. Vital signs record: 11:51am: BP 135/94, HR 94 bpm, RR 14, SpO2 100%, Temp 97.1 degree F. 12:06pm: BP 129/92, HR 92 bpm, RR 12, SpO2 100%, Temperature 97.1 degree F.
swelling at injection site; slight nausea; red and swell at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (red and swell at injection site) and NAUSEA (slight nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red and swell at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and NAUSEA (slight nausea). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (red and swell at injection site) and NAUSEA (slight nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information regarding medical history or concurrent conditions was provided. On an unspecified date, the patient received ZOSTAVAX (lot # not provided). On an unspecified date two years later, the patient developed shingles that radiated from the right torso down the right leg. The outcome of the event was unknown. Additional information has been requested.
08/20/2021 I had a headache, sore throat, cold symptoms, runny nose, cough, body aches, lost taste and smell, very tired.
Excruciating pain for several days at injection site. Unable to lift R arm over head to this day 9 months later. Spent thousands of dollars on PT, steroid injections, imaging and pill packs. Pain specialist, Walk in clinics and orthopedic surgery visit. Told I have a tendinopathy.
Shortness of breath, arrhythmia, palpitations and tachycardia over 150.
On 11/30/11, noticed swelling, soreness and redness. On 12/01/11 swelling, soreness and redness continued, with additional "fevered" feel at the injection site. Site looked like a large "knot" with increased redness and soreness.
Infanrix had expired on 9/16/2023 and was administered on 10/02/2023. Manufacturer was contacted and reported that the vaccine is effective 30 days after expiration. CDC recommends a repeat vaccine. Patients mother was informed and encouraged to speak with patient's physician. Mother reports she is not worried about it at this time.
Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 03-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
At 1:45pm approximately 30 minutes after receiving vaccine symptoms included: throat tightness, slightly difficulty swallowing which proceeded mostly until about 5:15pm. Symptoms progressively improved slowly over time continuing although minimal at this current time. This writer was in route home and pulled over at 2:15 to a Health clinic for this concern. Advised to be monitor. Vitals all stable, no other signs of repository distress. Stayed at clinic until 5:15pm.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003594: US-009507513-1803USA003814.
About two months after receiving the Moderna Bivalent Booster, I tested positive for Covid-19. I started to show symptoms of coughing, decrease in appetite and feeling flushed. I took a Covid-19 test at home on 12/30/2022 and it came back positive. I called the doctor's office on 01/02/2023, they told me that I wasn't able to get the anti-viral because I was five days out from showing symptoms. I started to take OTC medications and vitamins and stayed hydrated. I finally tested negative on 01/20/2023. I still feel winded when I walk too much and I'm still feeling fatigued, but I am able to return to most of my activities prior to testing positive.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had an unspecified allergy to aspirin. On 14-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014812, expiration date 20-FEB-2015, 1 vial, subcutaneous). Concomitant therapy was not reported. The patient reported to the pharmacist that she developed bumps on her stomach and legs on an unspecified date in June 2014 after receiving ZOSTAVAX. No lab diagnostics studies were performed. The patient did not seek medical attention. Outcome of the event was unknown. Additional information has been requested.
Woke up the next morning with the worst headache and extremely tired for the next 9 days