chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle started 4-5 days early (07-28-2021-day1). Cycle was unusually heavy and lasted until 08-07-2021( 12 days).  Normal cycle lasts 5-6 days and begins around day 26/27. Missed next two cycles.  Light spotting on 09-29-2021 is first since 08-07-2021.
Immediately after vaccination, pt. wouldn't make eye contact and was staring off into space. She didn't cry or make any sound for hours. I gave her a detox bath in bentonite clay, fulvic acid, and essential oils. After 30 minutes of soaking she started to make eye contact and smile. Shortly after, she started arching her back and screaming inconsolably and refusing to drink her bottles. I took her to a chiropractor for an adjustment and she slept 13 hours straight. She was extremely lethargic and didn't want to eat or move. She drank a total of 7 ounces in the 24 hours after her vaccinations. We did several detox baths in the next few days and slowly her appetite and crying got better. However, she kept the strange ear piercing cry - she still cries that way when upset to this day, but the other negative effects seem to have waned.
pt recv vax 16FEB98 & 12 to 16hr p/vax a large area of lt deltoid became very sore;
Went in for IPV for both of my two girls ages 2 and 3 1/2 years old. MA said that they no longer have the IPV as a vaccine by itself, but have a DTaP-IPV combo (later finding out it was KINRIX). I agreed even though I was opposed as I am giving vaccines on an altered schedule and spacing them out. Neither have had all DTaP or IPV doses needed and I understand this is a booster. Both age and times the vaccines were administered were incorrect. Not sure what recourse I have, but am scared as it isn't recommended for their age group and the 3 1/2 year old, her arm has been swollen, puffy, red and hard for a week. Called the Dr. and he said that sounded like a mild reaction and to give her comfort measures such as Ib or BENADRYL.
G47.33 OBSTRUCTIVE SLEEP APNEA 6/20/2022 ACUTE PANCREATITIS
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced rash on abdomen spreading to generalized rash all over body and skin peeling, knees, hands and feet. At 15 months of age, the patient received the first dose on 12-MAY-2010. The patient also received the third dose of DPT (manufacturer unknown) and the third dose of HIB (manufacturer unknown) on 12-MAY-2010. On 13-May-2010, on or about 0600, the patient experienced a rash on his abdomen spreading to a generalized rash all over his body. On 14-May-2010, he was evaluated by a physician. Treatment was not reported. On an unspecified date in May he recovered from the rash. On 16-May-2010, on or about 1400, the patient experienced skin peeling on the knees followed by skin peeling on his hands on 20-May-2010 and in May-2010 from his feet. On 21 and 28-May-2010, the patient evaluated at a physician's office for the event of skin peeling. A complete blood count and sedimentation rate were performed and found to be "normal". A "strep" culture was negative. No treatment was reported. As of 01-Jun-2010, the event of skin peeling had not recovered.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-SEP-2010, the patient was inoculated with the ZOSTAVAX vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at an urgent care facility by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
The HCP who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection; The HCP who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection; the plastic part by the plunger of the VAXNEUVANCE syringe was broken off on the circular ring while administering the vaccine; This spontaneous report was received from an registered nurse and refers to a 27-year-old non-pregnant female who refers to herself.  The patient's concurrent conditions included drug reaction/allergy to amoxicillin and erythromycin. The patient's medical history and concomitant therapies were not reported.  On 08-SEP-2023, the plastic part by the plunger of the 15v conj vaccine (crm197) (VAXNEUVANCE) (lot #X019197, expiration date: 30-AUG-2025) syringe was broken off on the circular ring while administering the vaccine. The nurse who administered the vaccine got a "little scratch" on her right hand due to the breakage of the syringe while administering the injection (scratch, Injury associated with device, Syringe broken ). There was no vaccine exposure to the skin. The vaccine with the product quality issue was administered to the patient (captured in MARRS # 2309USA004099). Sample was not available for retrieval as it was discarded prior to the call.  The nurse sought medical attention but did not receive treatment for the event. On 11-SEP-2023, the nurse recovered from little scratch.  The relatedness between the event of little scratch and 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.  This is one of two reports received from the same source. ; Sender's Comments:  US-009507513-2309USA004099:MSD
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 05Apr2021 as dose 2, single (Lot number: EP7533) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for covid-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient has received other medication within 2 weeks. Patient received treatment for covid-19, started on 27Jul2022 and stopped on 31Jul2022. Known allergies: Yes.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
severe flu like symptoms for 3 days starting 12 hours after shot; slight fever; chills; night sweats; body aches; severe chest pain; fatigue; persistent, throbbing pain in my right temple area; This is a spontaneous report from a contactable consumer(patient) reported that: A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EN6208) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included obesity from an unknown date and unknown if ongoing , hypothyroidism from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing , sleep apnea syndrome from an unknown date and unknown if ongoing , headache from an unknown date and unknown if ongoing and hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, cetirizine (CETIRIZINE) taken for an unspecified indication, sertraline (SERTRALINE) taken for an unspecified indication, ethinylestradiol, ferrous fumarate and norethisterone acetate (AUROVELA FE 1.5/30) taken for an unspecified indication.  The patient previously took vicodin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. After 2nd shot, the patient experienced severe flu like symptoms for 3 days starting 12 hours after shot. These include slight fever, chills, night sweats, body aches, severe chest pain and fatigue on 05Apr2021. Symptoms abated after day 3. At about 2 1/2 weeks later she donated blood. Three days later she developed persistent, throbbing pain in her right temple area. This continued for days, not helped by migraine medication, todarol nsaid shot, acetaminophen. TMJ and migraines were ruled out by doctors. Eye exam came back normal. Primary care ordered bloodwork and started me on steroids. Bloodwork indicated high blood sedimentation rate and high C-reactive protein which, combined with persistent temporal pain (2 weeks so far) and sensitivity to touch in temple, are highly indicative of temporal arteritis. Sars-cov-2 test: Negative on 13Apr2021. This is very abnormal in someone my age (32). She is waiting on approval for an MRI (insurance denied 1st request) and possible temporal artery biopsy to confirm. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The event outcome was Not recovered.
On Sunday I started coming down with headache, dizziness and fogginess. I took a PCR and rapid test that were COVID Positive. I took a rapid test from a different manufacturer and it came back positive. I had a fever all that week, 100 to 101 until that April 1st. Initially my symptoms were still fever fatigue, dizziness, and headache. In a few days I started developing a runny nose and cough. By the that next week my fever broke, it's been stable at 99.5. Right now I still dealing with the same symptoms they come and go. But I do feel better than I did last week. I took Dayquil and alternated with Ibuprofen, Mucinex and I was prescribed with a cough suppressant, DM Promethazine for cough symptoms. I took another rapid test on last Saturday, it still shows positive.
virus in my left eye; This case was reported by a consumer and described the occurrence of eye infection viral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced eye infection viral. On an unknown date, the outcome of the eye infection viral was unknown.   It was unknown if the reporter considered the eye infection viral to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and got a virus in his/her left eye just a month after. The follow up would not be possible as no contact details were available.
Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010421A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 07-Mar-2021, PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided Treatment information was not provided   This case was linked to MOD-2021-207658 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow-up added. 2nd dose information were added.
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a two years old patient who was vaccinated with ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that reporter gave a ADACEL to a 2yrs old and is looking to see what to worry about with side effects. It was unknown whether patient experienced any adverse reaction. 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. Documents held by sender: none.
sore throat 09/12/2011 PM sore throat, cough, sore muscles and joints, fatigue on 09/13/2011 AM
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a Manager of Pharmacy Operations for doctor's offices.   Concomitant medication of the patient was not reported.  The reporter reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. Doses were administered to 20 patients from these expired vials. The vials expired on 08-Oct-2021 and were left in the refrigerator past that date. The reporter reported that that no adverse reactions had been reported by the patient from the 3rd dose.  No treatment information was provided by the reporter.
I developed a site reaction 7 days after the vaccine. Initially after the vaccine, I just had some arm soreness for a couple of days, as to be expected. Day 7, I started noticing soreness returning. That evening, it started itching. The site had developed a hive. It was red, swollen, painful, hot to the touch, and itchy. The redness and swelling increased over the following ~36 hours, then started decreasing. Now, on day 10, it?s starting to look like it?s almost resolved again.
I had my second COVID shot at 10:30AM on March 28, 2021, at 4:30AM on March 29, 2021 I woke up with chills, body aches and fatigue. I felt like I had a fever. Body aches lasted for about 4 hours. The chills only lasted for a few hours but the fatigue I had lasted 24 hours from the start of the symptoms.  After the 24 hour period I was mostly back to normal. I did feel a bit more tired for about one more day.    Note: At the time of second vaccine, I was 35 weeks pregnant. My due date is April 27, 2021 but I'm scheduled for a c-section on April 20, 2021. At 36 weeks pregnant, the baby was estimated to weight 7 lbs 9 ozs.
I have not had my period since February 2020. 24-48 hours after I received my first dose of Pfizer vaccine I started feeling cramps and PMS type symptoms. I thought it was  stress related and disregarded.   This morning I woke up to find I had started my period overnight. I've seen there have been reports of post-menopausal women bleeding after receiving vaccine.
received covid vaccine last January/got covid in October with mild symptoms; received covid vaccine last January/got covid in October with mild symptoms; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "received covid vaccine last January/got covid in October with mild symptoms". Clinical course: He did not have the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 the drug ineffective(LOE) cannot be ruled out.
No adverse event.  Medication Error:  Too little diluent 1.3ml diluent mixed with adult Pfizer Covid-19 vaccine when correct dosage should have been 1.8mL.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 14:45 (Lot number: EN6203) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EN6203; on 25Feb2021 at 02:45 PM administered in the left arm), administration date: 25Feb2021, when the patient was 45 years old, for covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "Body ache"; HEADACHE (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "chill". Therapeutic measures were not taken as a result of pain, headache, chills. Additional information: The vaccine was administered in the workplace clinic. No other vaccine in four weeks. No covid prior vaccination and not covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
20cm x 6cm local reaction, erythema, itching, chills and fatigue reported by patient. Patient saw physician and was given prescriptions for Benadryl and Prednisone.
C/O dizziness, weakness, nausea, & headache. Symptoms started 7/8-7/13/2020.
first dose 24Sep2019, forgot to get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 24th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The pharmacist reported 65-year-old female patient received first dose of Shingrix 24th September 2019 and forgot to get the second dose.  The patient presented to pharmacy 13th July 2022 requesting second dose.  The first dose was given at a different location, so reporter did not have the lot number and expiration date of the first dose. The reporter gave permission for follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
reactive arthritis in both hands; heart palpitations; booster; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Right at the age of 29-year-old on 06Oct2021 (Lot Number: FE3590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included none (other medical history: No). Prior to vaccination, the patient was not diagnosed with COVID-19. No Known Allergies. Patient was not pregnant. The patient's concomitant medications were not reported.  The patient previously took first dose BNT162B2 (Batch/Lot No: Ez0140, Location of injection: Arm Right) at the age of 28-year-old on 28Dec2020 for COVID-19 immunization, second dose BNT162B2 (Batch/Lot No: EL3248, Location of injection: Arm Right) at the age of 28-year-old on 18Jan2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had experienced reactive arthritis in both hands since the day after receiving patient's booster. Patient also had heart palpitations that were occurring consistently post vaccine, but now only happen intermittently. The reactive arthritis has not lessen in intensity or frequency. Adverse event start date 07Oct2021. AE resulted in: [Disability or permanent damage].  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Oct2021 (Nasal Swab).  No treatment received for events reactive arthritis in both hands and heart palpitations. The outcome of events reactive arthritis in both hands and heart palpitations was not recovered. The outcome of event booster was unknown.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event Immunisation, Arthritis reactive, Palpitations cannot be totally excluded. ''The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.