chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via field employee refers to a 2 year old patient of unknown gender. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 03-AUG-2016, the patient was inadvertently vaccinated with dose 3 of oral ROTATEQ (dosing details not provided) via oral route. Physician reported that the patient had previously received two doses of oral ROTATEQ on unknown dates at the age of 2 months and 4 months, respectively. No adverse effect was reported. Additional information has been requested.
Received Flu shot. Few hours after shot started having hives, itching, tightness in back. heart fluttering and left arm pain. Still itching from shot inside and out .
the morning post vax pt arm where recv inj started to itch & become sore & hot area was from the elbow to the shoulder;evening the arm started to swell;next morning pt arm swelled big enough that it was noticeable;black & blue;
30 minutes after the shot was administered, patient experienced sudden swelling of the tongue, irritation of the throat, coughing, profuse drooling, and slight wheezing.
3 hours after vaccine, I started experiencing lighning bolts in right eye and am now seeing one floater in same eye.
Significant loss of hearing in left ear. MRI & MRA performed with negative results. Now wearing a hearing aid, with continuing tinnitus.
Period cramps and spotting; Period cramps and spotting; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salmon oil (MANUFACTURER UNKNOWN), docosahexaenoic acid (DHA), ergocalciferol (VIT D), ascorbic acid (VIT C) and multivitamins (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 03:00, the patient experienced period cramps and spotting. The patient was very regular and track her period using an application. It was reported that the patient was not expecting to get her period until 08May2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period cramps and spotting was resolving at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Skin rash, intestinal issues, constant cramping and nausea. All started within a month and continues to this date 2-21-2018.
This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reaction/allergies and concomitant thereapy were not reported. On unspecified dates in 2016 (reported as starting on or after 08-FEB-2016) the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L010595, expiry date: 12-NOV-2016; lot # L016959, expiry date: 12-MAR-2018). Nurse stated that the mentioned lot numbers of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. Nurse also reported the details of unspecified vaccine administered to unspecified patients: lot # L040458 (expiry date: 04-FEB-2016, lot # L048236 (expiry date 31-MAR-2018; temperature excursion at -1.2 degree Celsius for 23 hours 20 minutes) on 23-MAR-2016, lot # L040458 (temperature excursion at -1.2 degree Celsius for 22 hours 33 minutes) on 24-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) on 25-MAR-2016 and 28-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes on 24-MAR-2016 and 28-MAR-2016, lot # L048236 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) on 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. Additional information has been requested.
- heart palpitations lasting approximately 2-3 months post injection - itching and thickening of the skin of the right hand (persistent)
A report has been received from a Health Professional concerning, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced full dose of FLUMIST given in each nostril which started on 17-SEP-2013. The outcome of the event of full dose of FLUMIST given in each nostril is unknown. The report as considered to be non-serious.
I had no immediate symptoms of any kind after the 3rd (booster) shot.  Several weeks later, I developed a rash on both of my legs and plaques on my scalp.  They would not go away.  I was taking Leuflonimide for my rheumatoid arthrtis, which was new, so I asked the Doctor if I could stop taking it and she said yes (Dr. with Hospital).  I made an appointment with Dermatology and was told it was excema on my scalp and given Clobetasol ointment and liquid.  I also had abscesses in my groin which were drained - this was totally new as well and a uti.    All have resolved except for the sores (psoriasis) on my legs and the scabs on my scalp, which resist all.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported an unspecified number of patients received improperly stored GARDASIL (lot#, dosage and route unknown) on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Pfizer COVID vaccine on 1/17/21 and 2/7/21. Patient tested positive for COVID at her AFH on 3/14/22 and was transferred to our inpatient facility with ambulance. Main admission diagnosis: acute hypoxemic respiratory failure due to COVID-19. Patient was in CCU from 3/14/22 to 3/16/22 and currently in med/surg unit from 3/16/22. Earliest anticipated discharge is 3/21/22 pending caregiver availability.
7/13 Presented w/ 2 day h/o fever Tmax 104.2F, fussiness, rash, decreased appetite. Multiple contacts at daycare w/ similar sxs. 7/15 Cont'd fever, worsening rash (sever, diffuse, maculopapular). Pharyngitis and exudates on exam Pt started on Amoxil.
Patient received 12 month series vaccinations on 3/5/2019. On 3/8/2019 he developed a severe rash consistent with Erythema Multiforme. He was seen in a local ER on the evening of 3/8/2019 and treated for an allergic reaction with BENADRYL and oral prednisone. Symptoms worsened in the early morning hours of 3/9/2019, returned to same ER and received more treatment for an allergic reaction. Patient was discharged with prescription for diphenhydramine and prednisone. Mother was traveling. She was stopped for the evening to rest. During the night she noticed the child's face and eyes had become more red and swollen and she brought him to another Hospital for evaluation. Upon arrival to the ER, patient had an episode of vasovagal syncope requiring the administration of epinephrine.
Friday night: soreness at the injection site, body aches, fever, lethargy. Saturday morning: continued body aches (less severe), lethargy, soreness at the injection site, swollen lymph node - left underarm. Saturday throughout the day and night: soreness at the injection site, swollen lymph nodes - left underarm, lethargy. Sunday: lethargy, swollen lymph nodes - left underarm, slight soreness at injection site.
Nausea Achy Chills Headache Sore arm at site Fatigue
Information has been received from a pharmacist concerning a 63 year old female with no drug allergies, who in November 2007 or December 2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. In February 2008 the patient received a second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced a sore arm. The patient sought unspecified medical attention via the pharmacist. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Patient reported swollen, hot, painful injection site reaction also tenderness, swelling, and pain face and arms two days following administration. Doctor diagnosed it local adverse reaction.
pt had sx of shingles w/in 2wk of two vax;the shingles devel completely @ 16 days;it was a severe case fever didn't exceed 100;shingles lasted ten days;
HR 70 SaO2 96% BS 94  R 20 BP 132/78 Not feeling well; dizzy very soon after getting the vaccine and sitting down in chair. Checked by EMT. Sat for 25 more minutes and still feeling somewhat dizzy. Checked by EMT again BP taken.  Felt better and went home.
Experienced 3-4 days of Fever above 100 deg, Cold Chills, Body Aches, Left Arm (swollen,red, hot), severe back spasms, drowsiness. Continued 4-5 days of tiredness. Was given Acetaminophen (Tylenol), Ketorolac (Toradol) & Orphenadrine (Norflex).
Patient reported severe erythema, soreness, and touch sensitivity post injection. Area was also extremely warm to the touch. I examined it 3 days post administration. Still red, patient taking analgesics, and slightly warm to touch. But otherwise improving.
Right deltoid became red, swelling in area 3x3 inches, patient complained of shortness of breath 10-15 minutes after vaccine administered. Received oxygen, diphenhydramine 50mg orally, methylprednisolone 125mg IM, Pepcid 20mg orally.
Pt was COVID-19 negative on admission to inpatient psych, but due to exposure was retested and found to be COVID positive.
This infant has onset of vomiting lasting about 12 hours, followed by diarrhea. Inset within 4 hours of vaccines.
10/30/21 COVID vaccine dose #1 12/03/21 PCP note: He has had chest pain for the past 6-7 weeks after his covid vaccine. He got covid vaccine 2nd week of October, 6 hrs later, having chest pain, mid sternum (acute, sharp) & left side of chest (dull). The night of his COVID vaccine, he woke up with chest pain. He pointed to left chest, he said he has "acute pain" in the sternum. The left sided chest pain worse by lying on left side, caffeine and stress made dull pain worse. 12/17/21 Cardiac ECHO showed small pericardial effusion (<1cm), left ventricle mildly dilated, EF 55-60% 12/23/21 Secure msg from pt: "Within six hours of receiving my Covid vaccine my chest pain started. I went through 3 weeks of significant chest pain and 66 days later the pain persists although to a lesser degree.
Information has been received from a physician concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who in May 2008, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The patient passed out within 5 minutes of receiving the first dose of GARDASIL vaccine (yeast) at the office. She was sent by ambulance to the hospital and was diagnosed with vasovagal. The patient recovered on the same day. This is one of several reports from the same source. Additional information has been requested.
Sore upper arm, swelling, difficulty sleeping due to pain, hot to touch. Area still sore this date.
within 24 hours of vaccine, minor swelling of left upper eyelid and upper lip, lasting around 12 hours. Two weeks after vaccine, minor swelling of lower lip, lasting around 12 hours.  Just under 4 weeks after vaccine, minor swelling of lower lip, lasting around 12 hours.
Felt the vaccine run down her arm; Was more SQ instead of IM; Hard lump around injection site; Red hard lump around the injection site; A spontaneous report was received from a nurse concerning a 42-year-old female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and felt the vaccine run down her arm, was more subcutaneous (SQ) instead of intramuscular (IM), red hard lump around the injection site.  The patient's medical history and concomitant medications were not provided.  On 07-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 011J20A) via left deltoid subcutaneously for prophylaxis of COVID-19 infection.   The registered nurse (RN) who vaccinated patient reported that some of the dose of vaccine had dribbled out and patient felt the dripped vaccine ran down her arm. When HCP looked at the injection site of patient, RN stated that she went to high and the administration was of more subcutaneous than intramuscular. Patient also had red hard lump at the left deltoid around the injection site. No treatment information was provided for the event.   Action taken with mRNA-1273 in response to the events was not provided.   The events felt the vaccine run down her arm and was more SQ instead of IM were considered to be resolved on 07-Jan-2021. The outcome of event red hard lump around the injection site was unknown.; Reporter's Comments: This report refers to a case of a 42 year-old female patient who experienced non-serious event of felt the vaccine run down her arm, was more subcutaneous (SQ) instead of intramuscular (IM), (Incomplete dose administered; Vaccine given subcutaneously, Vaccine administered at inappropriate site)   and event of red hard lump around the injection site. (lot # 011J20A), Exp date-unknown). The event of red hard lump around the injection site is temporarily associated with the administration of mRNA-1273 vaccine, hence a causal association cannot be excluded. The events of felt the vaccine run down her arm, was more subcutaneous instead of intramuscular are considered not applicable
After receiving the vaccine, the same day, I started to feel weird, the first extreme symptom I experienced was trembling and shaking. I was shaking so much I could not hold my hands still. I went to bed and went to sleep, and I woke up in the night and I woke up in the middle of the night with a fever of 103 F. I also was experiencing a very bad headache. The thing that was very extreme was this rash I got across my abdomen from one side to the other, the rash was fiery red. I decided to call the doctor's office and I did a health visit, and they prescribed a steroid for the rash for a course of 5 days.
rash s/p vax recvd vax 100PM approx 8PM devel hive-type rash all extremities, changing to mac pap rash
Nausea, fatigue, and redness with swelling on left deltoid. Will begin taking Loratadine 10 mg daily.
Fever and aches and pains.  Then next morning about 5:00 AM blisters under tongue and swelling in my mouth.  This continued and additional symptoms of facial swelling occured about 11/11/13.  Still have raw mouth and facial (lips) swelling and some mild itching.
Treated for cancer after the first shot / diagnosed with cancer after / 1st / vaccine; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient received first shot two years ago from the reporting date. The patient was diagnosed with cancer after receiving 1st dose. The patient asked, if get treated for cancer after the first shot, should you start over after 2 years, as she just received one more shot. The patient was advised to not get second shot during treatment. The consent to follow-up was requested.
Sickness; Fever; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], ATENOLOL, TRAZODONE and TRAMADOL for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE). On 21-Apr-2021, ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment medication was not provided.   This case was linked to MOD-2021-057764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Reporter details, patient details, medical history, lab data, suspect drug dose details, concomitant products and events added.
The patient received a dose of RECOMBIVAX HB on 03-APR-2017 and 18-APR-2017; This spontaneous report was received from a physician, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 03-APR-2017 and 18-APR-2017, the patient was intramuscularly vaccinated with the first and second doses of RECOMBIVAX HB injection (dose, frequency, lot # and expiration date were not reported), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Shingles vaccine received 5/29/15 AM. Pain and swelling started 12 hours later, swelling, pain and redness entire upper arm extending to elbow. Medical attention 5/31/15, antibiotics, antihistamine and cold compress.
Urticarial rash consisting of 2-3 mm red papules on trunk and upper extremities starting 48 hrs after immunizations administered. Decreased appetite, low grade fever yesterday.
Redness, swelling, sharp nerve pain-lasting for 6 days-required doctor's visit. Redness/swelling extended all the way down arm 6" past elbow. Treated with Benadryl/Claritin and Allegra.
This spontaneous report was received from a Registered Nurse refers to 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Additional information has been requested.
Arm soreness the size of a half dollar area at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy in 2017.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm soreness the size of a half dollar area at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient had not taken any treatment medication. No relevant concomitant medications were reported.   This case was linked to MOD-2021-070116 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow up received on 05-APR-2021. Outcome updated and history added,; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Flu; Initial information was received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient 62 years old patient who had the flu (Influenza), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, patient had the flu (Influenza), (unknown latency), following the administration of INFLUENZA VACCINE. It was reported (I m 62 never toke the flu shot but one time [ guess what got it ] don't take them can't remember the last time I had the flu)  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Hive developed at injection site one week after injection. Rash spread over upper arm. Was red; bumpy; itchy and sore.
Headache, ErythemaMultiform & UrticariaPruritus Narrative: p vaccine fatigue, tired. 12/31/2020 fatigue body ache no fever,temp 99. redness soreness ejction site c hard bump. HX of migraines. 1/4/2021 itchy ness at injection site. 1/5/2021migrain to R side of head, R ear pressure, itchy ness, redness, swelling, warm to touch at injection.
Pruritic  morbilliform  rash upper chest and bilateral arms , shoulders to hands. Eventually  spreading to pretibial region. Treated with OTC Claritin, Pepcid, Benadryl and eventually 0.5 % Triamcinolone cream. Rash resolved in same pattern that it appeared -chest arms and legs over a two week periord.