chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received two immunizations (ZOSTAVAX and ADACEL) on 7/11/17. Today, July 13, 2017, the patient called and said she was having an injection site reaction. She stated that there was a clear 1-2 inch mark induration surrounding the injection site (SQ Injection in the back of the arm) that was hot to the touch, swollen, and appeared to have some blisters around the site. I asked that she come in so I may take a look to give her further advice, but she declined stating she was about 40 minutes away. I then gave the options to go to an urgent care to be seen or to give it another day or two and continue taking ibuprofen and to ice the area. The patient states that she will continue her watchful waiting and if the area worsens or stays the same, she will go to an urgent care. Linda said that she has been icing the area and medicating with ibuprofen for the past day. I asked that she call either way to let me know the outcome.
Eight hours after the vaccine was administered had a 104° temperature severe bodyaches severe headache nausea dizziness vomiting. Went to the hospital after 48 hours for dehydration and was treated with Zofran and fluids. Three days later a cooling sensation as if icy hot was on the body was all over back and legs and fingertips were prickling. Blurry vision and unsteady vision gate started four days after and are still occurring.
Patient developed a bloody nose a few minutes following her 2nd Pfizer covid shot. Bloody nose resolved within 5 minutes
Around 3 p.m. today I was putting on makeup and noticed that there was a droop to the left side of my face, which was confirmed by my next door neighbor who is an RN. I was advised to go directly to an emergency room to make sure it wasn't a stroke, although I'm in my 30s and healthy. I was then diagnosed with Bell's Palsy (mild facial droop) at the ER. The left side of my face is mildly droopy, with my left eye slightly more closed than my right. I can still move my forehead just fine and as of now, the symptoms are mild. I'm beginning a course of Valtrex and if symptoms get worse (they haven't, but this is only six hours since onset) I'll begin prednisone.
Diarrhea and sore arm after first shot. Swollen lymph nodes under right arm, shortness of breath, headache that I can?t get to go away, positive d dimer, and bronchitis after second shot
no additional adverse event reported; Administration of improperly stored vaccine / temperature 47 F; This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 10-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose unspecified, orally, lot # T033812, expiration date 29-DEC-2021 for prophylaxis. The administered dose of the vaccine was stored in a temperature of 47 degrees Fahrenheit (F) for 1 hour. There was no previous temperature excursion reported. Digital data logger was not involved. No adverse event (AE) was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004039: US-009507513-2106USA004087: US-009507513-2106USA003971: US-009507513-2106USA004335:
focal seizures; heart enlarged; pulse spikes to 158; sick; was given one Moderna then the Pfizer shot; This is a spontaneous report based on the information received by Pfizer on behalf of Moderna Therapeutics, Inc. (Manufacturer Control No: MOD-2021-244840) from a contactable consumer (patient).   This case described the occurrence of Partial Seizures (focal seizure). Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) in a patient of an unknown age and gender who received mRNA-1273 (Moderna Covid-19 Vaccine) via unknown route of administration for Covid-19 immunisation. The occurrence of additional non-serious events in a detail below. Co-suspect product included product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration for COVID-19 immunisation. No medical history information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna Covid-19 Vaccine) (unknown route) 1 dosage form and dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced Partial Seizure (focal seizures) (seriousness criterion medically significant), Cardiomegaly (heart enlarged) (seriousness criterion medically significant). Heart rate increased (pulse spikes to 158) (seriousness criterion medically significant), Interchange of vaccine products (I was given one Moderna then the Pfizer shot) and Vaccination complication (am still sick). At the time of the report, Partial Seizures (focal seizures), Cardiomegaly (heart enlarged) and heart rate increased (pulse spikes to 158) outcome was unknown. Interchange of vaccine products (I was given one then the Pfizer shot) had resolved and vaccination complication (am still sick) had not resolved. Concomitant products use was not provided. Treatment information was not provided. This report refers to a case of Interchange of vaccine products for mRNA-1273 with associated AEs. All reported events were assessed as possibly related due to temporal association, however very limited information preclude proper medical assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 4SEP98 & devel fever that lasted 3 days;rash started raised red & sl raised remains;
Within 1 minute of pt receiving the HPV #1, then getting her finger pricked for a blood test, the pt fainted was clammy, unresponsive for approx 1 min, (R) arm jerked for 30 seconds and pt was incontinent of urine.
Small lump in armpit, slightly painful and uncomfortable when lowering the arm.  The lump comes and goes and so does the pain and discomfort.  This started the morning after the vaccine and is still continuing on day two post vaccine
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL, start date: 01Dec2022; LISINOPRIL; METFORMIN ER; and multivitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (17Mar2023) and all described as "Treatment of COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 17Mar2023. After completing Paxlovid on 17March, the patient tested negative for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to an approximately 63-year-old male patient. The patient had no pertinent medical history, drug reactions, allergies or concomitant medications. On 31-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L036823, expiry date December 2016, (dose, frequency, site and route of administration were not reported). On an unknown date in April 2016 (reported as within two weeks of the administration of the ZOSTAVAX), the patient experienced muscle pain in the shoulders which radiated to his thighs, hips and back. The reporter noted that the patient was basically "paralyzed" due to such severe pain. The patient has been seen by several different physicians for this condition as well as hospitalized (at an unknown hospital on an unknown date in 2016 for an unknown length of time). The reporter noted that the patient walked into the pharmacy on 07-JUN-2016 and stated that he was recently diagnosed with "PMR"-polymyalgia rheumatica by a physician at a hospital. He stated that the diagnosing physician associated the polymyalgia rheumatica with the ZOSTAVAX. The reporter was unaware of the treatment for the polymyalgia rheumatica, although the patient just had a prescription filled for 10 mg prednisone (manufacturer unknown) on 03-JUN-2016. No further information was provided. The outcome of polymyalgia rheumatica was reported as ongoing. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of polymyalgia rheumatica was considered to be medically significant. Additional information has been requested.
One week after injection woke up with a blood clot in left calf.  No history of clots.  No injury or muscle strain, etc.  Just happened out of no where.
Patient had multiple episodes of vomiting but has a history of dysphagia, patient also reported generalized weakness in bilateral lower extremities. Was sent to the ER and discharged
Following vax w/DTP/HIBTITER, pt devel a rash @ each inject site which spread over both legs; this resolved p/several days; Not seen by the MD; Mom reports a similar rash, although smaller & less intense, following 1st inject;
Patient said she has pain in arm since then she received the flu shot for almost 18 days.
LEFT LEG SEEMS TO BE GETTING SWOLLEN; 1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021). On an unknown date, the patient experienced PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN). At the time of the report, PERIPHERAL SWELLING (LEFT LEG SEEMS TO BE GETTING SWOLLEN) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 01-Mar-2021 and 2nd dose on 15-Mar-2021) outcome was unknown.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event(s) of LEFT LEG SEEMS TO BE GETTING SWOLLEN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
A report has been received from a Health Professional concerning a 12 year old, male subject, who had been receiving FLUMIST QUADRIVALENT.  FLUMIST QUADRIVALENT started on 23-OCT-2014. It was reported that expired FLUMIST QUADRIVALENT was administered to two patients. The outcome of the e vent EXPIRED FLUMIST QUADRIVALENT administered to two patients is unknown. The report was considered to the non-serious.
pt recv vax JUN96 & JUL96 & 31JUL96 pt found to have acute renal failure & a low heart rate & was adm to hosp;tx IV fluids & monitoring;addtl info requested;
On 7/4/00, the pt's arm started itching after swimming in the ocean at the injection site. It was an area the size of a dime. It is red, swollen and the size of a 1/2 dollar. Treatment was cold compresses and Benadryl.
Left side of his body the side where he got the injection got itchy and it never stops itching; Also has bumps; bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over; bumps on my legs are getting worse and worse; hives are getting bigger and bigger; sore arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), CONDITION AGGRAVATED (bumps on my legs are getting worse and worse), URTICARIA (hives are getting bigger and bigger), PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen arm). On 23-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps). At the time of the report, SWELLING (bumps under and behind my knees,bumps all over my body,below my knees I have bumps all over), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (Left side of his body the side where he got the injection got itchy and it never stops itching) and VACCINATION SITE SWELLING (Also has bumps) outcome was unknown and CONDITION AGGRAVATED (bumps on my legs are getting worse and worse) and URTICARIA (hives are getting bigger and bigger) had not resolved.      Patient reported concomitant medications as Diabetes medication,High blood pressure medication,Around 30 different medications (did not want to share all). No treatment medications were provided .   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up  received contains concomitant medications, New events added and anatomical location, patient date of birth updated
UNSTABLE ANGINA 1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a medical assistant and refers to a 3-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Almost a week after injection, after initial injection site pain had been gone for days, the injection site became slightly swollen and painful again.redness in area as well. Lasted 3 days approx then subsided.
Rash on left arm, numbness and tingling of the left arm, swelling at the injection site left arm. Denied fever.
Feeling some nausea almost daily.   Feel like marbles are between my skin (like on my foot, hand, underarm, head) but cannot feel them it just feel like something is there.  High allergic reaction to my cat.  (have had my cat for 6 years, now got hives).   Just overall not feeling well.   Feel itchy like I'm about to have a reaction.  Like heightened response to allergens.
expired vaccines was inadvertently left in the refrigerator and was administered to 2 children, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA262370 (same reporter).  This case involves a four years old male patient who received 0.5 ml dose of expired vaccine QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (lot UT6375LA, Exp. Date 30-Jun-2019) via intramuscular route in the left vastus lateralis on 13-Sep-2019.  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 expired vaccine used.  It was reported that a box of expired vaccines was inadvertently left in the refrigerator and was administered to 2 children on 9/13/2019.  At the time of reporting, no adverse reactions were reported.  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.
Next day, when I woke up I experiment strong dizziness. Since then I am have dizzeness every day.
lt deltoid-swollen, sm ant erythema-achiness lt arm, neck, & acorss shoulders & down to wrist, top of buttocks; low grade fever; general malaise, pain @ inject site w/in the hr;
Rough time breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Rough time breathing) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included End stage COPD and Sleep apnea. Concomitant products included PREDNISONE for an unknown indication.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Rough time breathing). The patient was treated with PREDNISONE for Dyspnoea, at an unspecified dose and frequency. On 07-Mar-2021, DYSPNOEA (Rough time breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 20 May 2021, the age was corrected to 71 years.
Pt has blistery rash over entire body, scalp,face, consistent chicken pox rash.
Frequent Chest pains, high fevers every 10-14 days for 3 months, scintillating ocular migraines
had shingles on face and up the side; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (had shingles on face and up the side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Contrast media allergy (Injectable MRI dye).    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (had shingles on face and up the side). At the time of the report, HERPES ZOSTER (had shingles on face and up the side) outcome was unknown.            No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-367149 (Patient Link).
Patient given third (booster) dose of Pfizer, but original series (#1/#2) given with Moderna.
The patient cant walk move his arms and in a rest home; The patient cant walk move his arms and in a rest home; Initial information was received on 07-Nov-2020 regarding an unsolicited valid serious social media case from a consumer via social media.  This case involves a 69 years old male patient who cant walk move his arms and in a rest home (walking disability) (movement disorder), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient could not walk(walking disability), move his arms(movement disorder) and in a rest home  (unknown latency) following the administration of INFLUENZA VACCINE. These events were leading to disability.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events were unknown at the time of reporting.  There will be no information on the batch number for this case.; Sender's Comments: This poorly document case received from Facebook concerns a 69 years old male patient who cant walk move his arms and in a rest home, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Patient reported cough, congestion, and some chest tightness/wheezing and watery eyes the day following.  Self resolved over next several days.
Pt did not devel "protective titers" p/3 injects of Engerix-B; "Plan to revax" pt; Reporter states the non-protective titer can be possibly disabling and/or life threatening "if the person contracts Hepatitis";
Received vaccine on 1/30/21.  Noticed a red, swollen, hard lump about 3?x1? radiating heat at the injection site late afternoon on 2/7/21.  The injection site had been sore for the first 3 days but then did not bother me again until recently.
Pain lasting longer than a few days, seen at immediate care due to primary care doctor being out of the office, after 2nd wk, received MEDROL dose pack and no pain, completely fine now.
Enlarged lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes). At the time of the report, LYMPHADENOPATHY (Enlarged lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.