chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left side swollen lymph nodes; total of three Shingles on set just started meds; This is a spontaneous report from a contactable other hcp. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (at the age of 42 years) (Batch/Lot Number: Ew0168) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included thyroid, Diabetes Type 2 from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to Penicillin, Sulfa. 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 four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 17:00 (Batch/Lot Number: Ee0171) as DOSE 1, SINGLE for covid-19 immunisation. 04Jun2021, the patient experienced, Left side swollen lymph nodes total of three Shingles on set just started me. The events resulted in visit to Physician office. The patient received treatment for the events. The clinical outcome of the events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
pt recv vax;exp low grade fever, tiredness and soreness under rt arm;exam by MD revealed axillary nodes but sl tenderness on dorsum of rt hand at second and third MCP joints;
Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing progressed to right ear; tinnitus is so loud that it wakes me up at night and makes falling asleep difficult
Confidential called on behalf of HCP to report a rash after receiving ZOSTAVAX/ a unilateral zoster rash at different locations once a month for 3 years; This spontaneous report has been received from a physician, regarding to herself, an 80-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date (reported as many years ago), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection, as prophylaxis (strength, dose scheme, route and anatomical location of administration, lot number and expiration date were not reported).  On an unreported date (reported as years ago), the patient experienced a unilateral zoster rash at different locations (Rash vesicular), which was reportedly treated with valaciclovir (VALTREX) if the rash was bothersome and it would go away, but that continued to appear once a month for 3 years.  By the time of the report the patient was recovered.   The causal relationship between rash vesicular and zoster vaccine live (ZOSTAVAX) was not reported.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that an 85-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had allergies with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Information has been received from a health professional concerning a quality issue regarding a pre-filled syringe of GARDASIL (lot # 655327/1287U). It was reported that the syringe's safety mechanism released before it can be given to the patient . No adverse events were reported. Additional information has been requested. The SB# is 1-3060667927.
No adverse effect reported; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; first dose of GARDASIL 4 Valent on 09-AUG-2011 and second dose of GARDASIL 9 on 25-JAN-2019; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.  On 09-AUG-2011, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported).  Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 25-JAN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), batch/lot # R025725 and expiration date: 25-MAY-2019, for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (inappropriate schedule of product administration (onset date: 10-AUG-2012), interchange of vaccine products and wrong product administered). No adverse effect was reported. The outcome of inappropriate schedule of product administration, interchange of vaccine products, wrong product administered was unknown. No product quality complaint (PQC) was involved.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 16 months old. The patient demographics were updated. On 08-JUN-15 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
permanent brain damage; recurrent seizures; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (NA).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant, life threatening), outcome "unknown", described as "permanent brain damage"; SEIZURE (medically significant, life threatening), outcome "unknown", described as "recurrent seizures". Therapeutic measures were taken as a result of brain injury.  Clinical information: It was reported that as many feared when these jabs were rushed to the market largely untested, it was only as time passes that some of the effects become more obvious. One example was the case of a 12-year-old girl who participated in Pfizer's pre-release safety study. In a presentation of families who had been injured by Covid vaccines (Name withheld), (Name withheld) mother said she was now confined to a wheelchair as a result of getting the jab. In addition to suffering from permanent brain damage and requiring tube feeding, she had been experiencing recurrent seizures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration Error 07/23/2021 : Received Phizer as 2nd dose 07/23/2021 prior Moderna 06/25/2021, Pharmacist (Supervisor) 09:51am administered 2nd dose Phizer. No noted symptoms.
Foot and ankle inflammation and swelling. It started out with my left foot/ankle but it is now impacting my right foot/ankle also. Currently, it has gotten to the point where I essentially can?t walk. I am having similar symptoms with my knees and right index finger but they are not as severe and not as debilitating.  I am currently waiting for an appointment with a rheumatologist.
Had some headache, fatigue, and fever within 12 hours of the vaccine, but that mostly stopped after 36 hours. Now experiencing mild discomfort when breathing in, feels like tightness in chest.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  It was reported that number of doses/vials were 4 vials (15 dose) 44 doses.  It was reported that the date the vial initially stored in the refrigerator 24-Sep-2021. It was also reported that the date of administration of vaccine was 24-Oct-2021 to 27-Oct-2021. The vial did not undergo any temperature excursions.
Pt received Covid vaccine on 2/10/2021. Pt stated she began having headache, fever, chills, body aches, and nausea on 2/11/2021. And today (2/18/2021)Pt stated she is having chills, body aches, and headache. Today Pt c/o chills, body aches and headache. Pt was seen by her Provider yesterday and no medications were prescribed. Pt was seen by Provider here at the clinic today and advised Pt to go home and rest and drink plenty of fluids and eat light.
Lock down for dementia after first dose; A spontaneous report was received from a consumer concerning a female patient was participating in the mRNA-1273 Emergency Use Program and experienced lock down for dementia after first dose / dementia.  The patient's medical history not provided. The patient's concomitant not provided.  On 30th JAN 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient was in lock down for dementia.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event, lock down for dementia after first dose, was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Right arm swelling, felt warm, took Naprosyn with relief of pain. Two days later very swollen, went to ER. The ER physician diagnosed as cellulitis and treated with IV Leviquin for 3 days then po for 7 days. Also had blisters. Saw dermatologist 5 days after the incident for routine check up, he felt that patient had had an allergic reaction to the vaccine.
BLURRED VISION; LEFT EYE HAS BEEN ACHY; LEFT EYE HAS BEEN SENSITIVE; PERSISTENT HEADACHE/DULL HEADACHE RIGHT BEHIND FOREHEAD; DULL ACHE IN LEGS /PAIN IN LEGS; CHILLS; FEVER; HASN'T BEEN ACTIVE; SWELLING IN LEGS; PURPLEISH LARGE PATCH ABOUT SIZE OF NICKEL OR QUARTER ON BOTH SHINS UNDER THE SKIN/ WORSE WHEN STANDING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: varicose veins, dark spots on right shin, and tiny bit of blurriness in left eye regardless as an underlying issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced swelling in legs. On 30-JUL-2021, the patient experienced purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing. On 30-JUL-2021, the patient experienced hasn't been active. On 30-JUL-2021, the patient experienced dull ache in legs /pain in legs. On 30-JUL-2021, the patient experienced chills. On 30-JUL-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced blurred vision. On 02-AUG-2021, the patient experienced left eye has been achy. On 02-AUG-2021, the patient experienced left eye has been sensitive. On 02-AUG-2021, the patient experienced persistent headache/dull headache right behind forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache/dull headache right behind forehead, blurred vision, left eye has been achy, and left eye has been sensitive, and the outcome of fever, swelling in legs, purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing, chills, dull ache in legs /pain in legs and hasn't been active was not reported. This report was non-serious.
Injection site swollen; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site sore) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site sore). The patient was treated with LISINOPRIL ongoing since an unknown date at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with hepatitis b vaccine (recombinant)(HEPATITIS B VACCINE (RECOMBINANT)) for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.  The reporter considered incorrect product storage and no adverse event to be not related to Hepatitis B Vaccine (Recombinant)(HEPATITIS B VACCINE (RECOMBINANT)). This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1707USA000510: US-009507513-1707USA000509: US-009507513-1705USA009596: US-009507513-1707USA000508:
Intense disabling lower back pain Fever after 36 hours, lasted 6 hours and relieved back pain Then fever disappeared and intense back pain returned
Heart attack; Appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; APPENDICITIS (medically significant), outcome "unknown". Clinical course: Reporter wanted to know if there was a product that can alleviate the symptoms, or she enquired it just pushing the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm swollen, area hot to touch 3" x 3". KEFLEX 500 Bid, BENADRYL Bid Hydrocortisone Cr.
I had a large lump that formed in my under arm near my breast. My entire under arm became swollen, painful and red. Other spots under the arm became swollen and inflamed. I attempted to care for it on my arm but it did not heal. I went to the doctor and she prescribed medication NYSTOP top powder to treat a yeast infection that did not help. I had a mammogram on May 25 due to concerns. I had a UTI that consisted of me having to get my bladder scanned and having some urine test (April 29, 2021). I had to have more films via ultrasound on June 04, 2021. I had an additional mammogram and ultrasound which was also abnormal. There was no mass but it appears to be benign cyst that were not there before. I have to return for a regular checkup in 6 months.
Excessive bleeding while it is not her regular periods; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID vaccine breakthrough case. Also boosted, less than two weeks ago. Booster shot - Moderna 012H21B on 12/29/2021
Patient visited the hospital after 2 month shots as well as after her 4 month shots. In September shortly after her 4 month shots were given the mother brought in patient. Patient was vomiting and had not had a bowel movement in several days. Baby was sent to hospital and was diagnosed with failure to thrive. Since this that baby has lost weight, not gained very much at all, experienced seizures, had vomiting and constipation. Patient was placed on a feeding tube.
Redness, swelling from site of injection to elbow. Pain in arm radiating to elbow. Says there is an ache in his upper back. It's not like chest pain. Has went to ER 3 times. Today 9/29/2011 the swelling is down some. He was given Prednisone 20mg, amoxicillin, Vicodin 5/500. Is still having restless sleep from pain at night.
Severe hair loss that started one month after shot and continues to fall out and with no end in site. Saw dermatologist and they said there is nothing they can do.
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health professional (office staff). This case involves a female patient of unknown age who received vaccine FLUZONE QUADRIVALENT (batch number, expiry date, dose, dose in series and route  were not reported) via subcutaneous route as hematologist had ordered that a patient of their get her flu injection subcutaneous to avoid undue bleeding on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to incorrect route of administration. It was not reported that if any adverse event was experienced or not. 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. List of documents held by sender: none.
Pfizer 3/3/21, 3/31/21, Moderna 11/8/21. Positive on 1/29/22
Patient had vaccine administered after published expiration date. Moderna company analyzed lot 007B21A and advised vaccine  maintained the activity necessary to protect against covid 19 at time of administration.. Patient did not call in to report any adverse events.  This is an administration error without adverse events.
Dupuytren's disease of palm (2 nodules), patient noticed 3 months after booster. Mother had similar reaction. Referred to PT, dietary changes.
A ball formed in my collarbone on the left side and my neck and arm hurt a lot and when I drive the seat belt rubs ( I had a swollen gland and my head hurts a lot and I feel very exhausted.
pt recv vax & exp h/a which persisted for 3 days;pt then had a grand mal sz & was hosp;analysis of CSF obtained from LP led to the dx of mild encephalitis;pt was disch from hosp &  as of 12FEB was recovering slowly;
RIgors starting approximately  15 hours after dose administration and continuing for 3-4 hours
Revaccinated from 8/31/14 compromised vaccine. 12/29/14 Fever, vomiting, generalized body pain to touch.
I had chest congestion, nasal congestion and a cough started the next day. I started coughing up some green flam because I have a sinus infection. I called my doctor and he thought it was bacterial more than viral so he called in an antibiotic for me.