chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 16 October 2014. A male patient had received a dose of Influenza vaccine (Manufacturer and batch number unknown, expiry date and dose in series was not reported) intramuscularly in left deltoid on an unspecified date in 2013. The patient's illness at the time of vaccination includes COPD had alpha tripsin deficiency. On an unspecified date in 2013, 7 days post vaccination; the patient developed a fever and a productive cough. He was productive he had the flu. The patient was sent to emergency room 3 times and was evaluated by doctor. Laboratory details and corrective treatments were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Seizures, abnormal MRI finding consistant with acute demyelinating Encephalmyelitis (ADEA). Hospital discharge states pneumonia and fever.
She talked to PCP and he said to not get Pfizer again, due to allergic rx last year...they spoke about Novavax and decided that would be good to get. Per Dr benefits of getting shot outweigh risks from getting COVID disease due to obesity and  age. At 10:50am  Novavax was administered. 11am she felt good. 11:13 am Staff let me know that Patient was starting to "stiff" in her nose and tingly lips and tongue, no trouble breathing at all. Benadryl administered from emergency kit. BP 130/80. Client recovered and went home around 11:55am. She stated she felt better. I recommended she call PCP today to follow up.
he was sick for a day; chills; body aches all over; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over). At the time of the report, ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-371356, MOD-2021-369390.
Seen by Dr. on 3/6/13. 6x8 mm indurated warm to touch area. Mlid low grade fever. Not tx with anything. Advised to observe the area and call back if sx worsen.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump and injection site warmth to be related to SHINGRIX. Additional details were provided as follow: This case was reported by a medical assistant (MA). The patient experienced injection site reaction of large red and swollen lump around injection site which was warm to the touch. It disappeared after 4 days post SHINGRIX injection. The reporter did not agree to be followed up.
Spinal Cord swelling, numbness and tingling in hands, arms, feet and legs. Onset within 5 days of vaccination.
I woke up with a migraine. I had extreme pressure in my head. It didn't go away for 4 weeks. I started having ringing in my right ear. It was very loud and horrible. That is still going on, but it's not quite as loud as it was. The migraines still come and go. I went to urgent care and they treated me for an ear infection. I did not go to the doctor until the first week of month. Our doctor's office was only doing virtual appointments and I finally got in with somebody.  I went back and they performed a CAT scan (03/15). I went back a 3rd time on 03/28 because I was still having all the same problems. They put me on a prednisone to try and control symptoms but it didn't help.  I had 3 more doctor visits after that. I was sent to a head, nose, and throat specialist. They still can't explain my symptoms. I feel like I am never going to get back to normal.
Began having altered sensation in limbs in April 2021. Endorses right hand numbness which progressed to bilateral lower extremity, left hand, and across the chest numbness. Symptoms improved in August 2021 except for right hand numbness. On November 14, 2021 she noticed vision changes in her right eye (described as blurriness). Initiated high-dose IV steroids followed by oral steroid taper.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   relevant concomitant products usage were not reported by the reporter.treatment details not included.
I had been exposed to COVID-19; I went in to get test at an Urgent Care that came back positive. I had extreme fatigue, a very bad headache, really bad coughing, I was given the antiviral Paxlovid that I started taking on December 28, 2022, I did over the counter cough medication. It took me a month to get over everything I had. My doctor told me when I did get into see her that I had brain fog and confusion. I am still dealing with symptoms from having had COVID-19, extreme fatigue, shortness of breath, coughing, neurological and cognitive problems. I will be having tests run to rule out any biological issues.
trouble swallowing, itching, nausea, and memory is not good anymore, dizziness
The day after vaccination the child's hands and especially fingers were covered with clear fluid filled blisters. Hands now peeling.
Currently 15 weeks pregnant  Swollen area and lymph node right above right clavicle...very tender to touch
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced induration on thigh after receiving multiple immunizations at site. The patient received the first dose on an unspecified date. The patient experienced induration on thigh after receiving multiple immunizations at site. The induration was so severe that it requested plastic surgery to repair. Outcome was unknown. See related case (s): US-WYE-H03552408 (adverse event, non-expedited). No additional information was available at the time of this report.
expired ADACEL was given to a 16-year-old male patient with no reported adverse event; Initial information received  on 09-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old male patient who was administered expired diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra) for Immunisation; and polio vaccine INACT 3V (vero) (Ipol) for Immunisation.  On 08-Feb-2023, the patient received an expired 0.5 mL dose 4 of suspect diphtheria-2/ tetanus/5 AC pertussis vaccine, suspension for injection (lot: U6922AA; expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired adacel was given to a 16-year-old male patient with no reported 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, Arthralgia, fatigue, Narrative:   Other Relevant History:
Slight case of chickenpox, lasted 1 week. Shingles-like rash across back, lasted 3-4 days with high fever and seizures, lasted 1 week. Seizures hopefully will not return.
11 year old otherwise healthy female received 1st dose of Pfizer/BioNTech COVID-19 vaccine on 11/22/2021.  On Friday, 12/3/2021, she noticed her left palm/hand felt swollen along with her left thumb.  Hours later, that went away and she got hives on her chin.  Over the course of the next 5 days, this inflammatory process traveled around her body and came and went.  Other locations included: left ear lobe was swollen, cheeks were a bit swollen with hives, hives on her torso, ankle/foot felt swollen.  All non-serious, but noticeably bothersome and uncomfortable and all subsided or moved to a different location in a few hours.
24 hours after vaccination patient was running a fever of 102, fatigued, and had body aches. Injection site was sore and armpit was sore and slightly swollen. Managed symptoms with tylenol and ibuprofen and cold packs. About 48 hours after vaccination we noticed more  swelling and redness at injection site and a lot more swelling and redness underarm and in armpit and it was hot to the touch. Over the next several hours the redness and swelling continued to get worse, and redness was spreading to chest and back from armpit. Area was hot and swollen and uncomfortable. Patient was around 100 all day. Symptoms were managed with ibuprofen and cold packs. That evening we went to an urgent care facility to make sure there was not an infection. They suggested monitoring closely and watching for more spreading or swelling. By following day fever was gone and redness had not gotten worse. 96 hours after vaccination redness and swelling started to go away.
Pt recv vax on 2/11/99; post vax pt exp local red swelling of upper LA; tx=ice, elevation, Benadryl PO
Muscle pain all over body, specifically glutes, lower back back, and arms.   Fever above 99° F   Chills and sweats at the same time  Headache with pulsating nerve pain on sides and ears.  Dryness in mouth no matter how much water intaked   Treatment: tylenol and bed rest
The evening following the vaccination (1/29), my arm was sore, red, and swollen. The following morning on 1/30, there was a 2-3 inch circle that surrounded the injection site that was hot and hard to the touch, but this subsided.  One week following my vaccination, I noticed red area that looked like welts/hives appearing on my face (around my eyes mostly). On 2/9, there were new hives appearing in my armpits and abdomen which were very itchy. The next morning the same sensation of itching and hives appeared on my hips and upper thighs. The rash and itching would appear in one place on my body and if I put calamine lotion on it, it would subside but then appear on another part of my body. The areas ranged from my scalp, ears, face, neck, chest, arms, abdomen, back, and thighs. I did a telehealth visit and was prescribed prednisone 20mg on a taper (40mg for 3 days, 20mg for 3 days, and 10mg for 3 days), along with triamcinolone 0.05% cream/ointment, and Benadryl 25-50mg as needed for itching. These medications helped with the itching, but the red spots continuously appeared. After completion of the steroid taper, the hives have subsided, but my body still gets itchy. If I scratch anywhere on my body, a few minutes later it appears as a raised red area (almost like a welt). My heart rate is also something that has seemed to be higher during this entire time.
Patient's spouse called and said patient was complaining of pain and swelling ("like a balloon") in the left arm. Also said patient had a headache, no hives or rash at this time.
Case number PHEH2015US019407, is an initial spontaneous report from a nurse received on 29 Sep 2015. This report refers to a 36 years old female patient. Medical history and concomitant medications were not reported. On 28 Sep 2015 the patient received intramuscular dose of FLUVIRIN, (batch number: 157102) that reached 65F inside refrigerator for 12 hours before administration. It was reported that the patient had been administered the vaccine after first temperature excursion. No adverse event was reported.
swelling of her left foot/tremendous swelling in left hand; diarrhea; difficulty sleeping; chills; headache; fatigue; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of her left foot/tremendous swelling in left hand), DIARRHOEA (diarrhea), INSOMNIA (difficulty sleeping), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Anxiety. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), IRON, POLYCARBOPHIL CALCIUM (FIBER), VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and TRAMADOL HYDROCHLORIDE (TREMADOL) for an unknown indication.    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 PERIPHERAL SWELLING (swelling of her left foot/tremendous swelling in left hand), DIARRHOEA (diarrhea), INSOMNIA (difficulty sleeping), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PERIPHERAL SWELLING (swelling of her left foot/tremendous swelling in left hand), DIARRHOEA (diarrhea), INSOMNIA (difficulty sleeping), CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included water pill, thyroid medications and anxiety medications (unspecified).  Treatment information was not provided.
Patient rec'd the vaccines at approx 1200 noon, waited approx 10-15 minutes sitting in exam room.  Return to waiting room and said she was going to pass out.  Her forehead hit a chair, she was unconscious for about 15 seconds, was helped up to the chair.  Eyes were open then her head flopped and she began to have slight jerking movements.  She appeared to be post icthal and the decision was made to transport to local ED via ambulance.
Extremely intense headache that lasted approximately 10 hours. Headache caused nausea, sensitivity to light and sensitivity to sound.  I took naproxen 500mg and 1000mg tylenol and neither did anything for the pain.  I also tried ice and heat, neither of which helped with the pain either. Pain reached intensity of 7.5/10.  This was by far the worst headache I've ever experienced.
Prolonged bleeding after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 030M20A and 027A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included TESTOSTERONE and FISH OIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster). On 05-Nov-2021, VACCINATION SITE HAEMORRHAGE (Prolonged bleeding after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: low (Low) Low.         No treatment information was provided.  After vaccination, the patient was bleeding a little and placed a band-aid on the site.  On 05-Nov-2021 morning, patient took the band-aid off and had a lot of blood on the band-aid. The bleeding finally stopped. Patent self administer Testosterone shots weekly and had never bled that much except one time. When bled after Testosterone injection, testosterone lab levels were low. Because of the bleeding, the Testosterone injection did not work.
Pain at the injection site; Tiredness; feeling unwell; This is a spontaneous report from contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration to his left arm on 22Mar2021 at 3:30 PM for COVID-19 immunisation. Medical history and concomitant medications of the patient was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 21:00 PM the patient experienced pain at the injection site which began several hours after injection, leading to intense stabbing pain whenever the upper arm was moved, tiredness and generally feeling unwell. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse event. The clinical outcome of the event pain at the vaccination site pain, tiredness and feeling unwell was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
30-36 hrs p/flu shot pt had sx that mimicked & strengthen (enhanced) nerve tingling sensations in feet & hands; swallowing was also very difficulty; these sx disappeared on Wednesday 2NOV;
arm pain, left arm very weak, difficulty standing up (legs weak), difficulty walking (balance), headache, fever, chills, no sleep, left side of body warm/hot, right side cold/normal
First Dose Heplisav-B Second Dose Engerix; Initial Report Received on 14-Jun-2021  A licensed practical nurse reported that a 22 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported. The patient did not have any allergies.  No relevant concomitant medications were reported.   On 14-May-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and site were not reported) at a different facility (unspecified).   On 14-Jun-2021, the patient received the second dose with Engerix (Lot #9P9B5, expiration date 07-Feb-2022).   At the time of reporting, no other information was provided.   Company Comment:  The company assessed the event as non serious.; Sender's Comments: The company assessed the event as non serious.
Myalgia, NauseaVomiting, KNOT IN ARM AT INJECTION SITE Narrative:
Pt was admitted for acute systolic CHF with an EF of 20 to 25% and has a life vest.  The pt was scheduled for a TAVR at the facility on May 19.  Prior to transfer to the facility he was tested for COVID and was positive with a CT value of 39.1.  He was previously positive for COVID in December 2021.
Healthy pregnancy with no concerns, due 07/25/2021. Child born on exact date at 7lbs 8oz.   Adverse event was severe chest pain, which gradually worsened over the first day. Felt painful to breathe deeply. Pain most severe when lying on left side. So severe that I could not tolerate that position for more than a second. Then chest pain resolved the following day for normal upright positions but continued when laying on left side until 03/11/2021. Initially, the cause of the pain was written off as heartburn. But I now believe it was pericarditis, due to the onset following vaccination and never experiencing anything else like it again for the duration of pregnancy.
Her heart was beating faster; Part of her face was flushed; Her chest and arms had a rash; Blotches all over; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/lot number was not reported), via an unspecified route of administration on 23Feb2021 (at the age of 75-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included family history of Bell's palsy (her mother had it). The patient's concomitant medications were not reported. The patient got the first dose of BNT162B2 on 23Feb2021. After 15 minutes, the patient noticed her heart was beating faster. She didn't know whether it was because she was nervous or what. When she got home, she happened to look in the mirror for some reason and she saw that part of her face was flushed, her chest and arms had a rash, and had blotches all over. The patient called and explained it to her doctor, the doctor told her that she could take an antihistamine before the second dose or skip it. The patient reported that she looked online, and she read that one should not take antihistamine as it could affect the efficacy of the vaccine. The patient was scheduled for the second dose on 16Mar2021. The patient will be 76-years-old in a couple of weeks, she lives alone and doesn't know what to do if she should she take an antihistamine before the second dose. In reading some literature, the patient saw that there's a slight possibility for Bell's palsy, her mother had Bell's palsy and she watched her face get worse and worse. The patient mentioned that she may not go back to get the second dose, and wonders what the efficacy of the first dose alone is. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.