chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bloody stools w/mucous daily for 6wk;no tx;no effect on appetite;no illness detected;no fever;no apparent pain. This patient had some blood stools - trace of blood for approximately 3 weeks afte receiving Rotateq. He has thrived since and is quite healthy, without any known adverse effects. No further studies were done.
Hot flashes, fatigue(lasting 24 hours), drowsiness (slept for 18 hours the next day), lower back pain,
Patient had hives, itching, swelling, mild pain, tender, warm, inflamed, No SOB. Patient got Triamcinolone 0.1% ointment today for the rashes.
had an axillary t102. h/a, stiff neck & vomit x 1;adverse rxn started 17JUL97 @ 10AM denise any hx of problems w/prev DTP;given advil was seen in ER by MD;was unable to determine if vax cause rxn or a virus;
Feb 12, post nasal drip and drainage and that evening I had insomnia. Woke up Feb 13 with sore throat. Woke Feb 14 feeling very poor with all classic COVID-19 symptoms. That evening I had a low grade fever but it registered at 103.7 fever. Tested negative each of these days. Feb 15 before I went to walk in clinic I tested positive on at home test and later tested positive on PCR test. Symptoms improved dramatically by Feb 18. Symptoms appeared to resolve completely by Feb 22. Tested negative on Feb 26.
Information has been received from an 80 year old female consumer who in August 2009, was vaccinated with a dose of PNEUMOVAX 23.  After the vaccination, the patient had a severe allergic reaction with hives and swelling throughout her body.  Unspecified medical attention was sought.  The patient was given PREDNISONE for the allergic reaction.  At the time of the report, the patient's outcome was unknown.  No further information is available.
Pulse: 56 after shots. Pt states felt sweaty and had blurred vision. Received 5 vaccines today on both arms. 10 mins after pt. states feels a little better. Did not pass out. Not nauseated just light headed. Pt. states gets this feeling mostly after giving blood. and Pulse 15 mins later: 68
Patient visited pharmacy on 09/28/18 to report bruising and redness on arm.
Shingrex vaccine given in a subcutaneous region on underside of left arm below armpit
Dizziness started in the morning of 12/02/22 accompanied by right center chest pain. Chest pain is even present during rest. I had no dizziness of chest pain prior to this vaccine
One week after the vaccination it started itching at the site of the vaccination. The next day it became red . Diameter around 3 inches
Patient was vaccinated with her second dose on 12/8/21 at 4:45pm, by 12/11/21, she had a rash on her back, raised and very itchy.  By 12/12/21, she complained of a headache and a tummy ache.  The head and tummy pain has lasted from then until NOW, 12/19/21. On 12/18/21, she woke up with hives on her body.  She had 3 on her left arm, 1 on her right arm, 1 on her lower abdomen, and 1 on her lower back.  The entire week prior, she has complained she is cold (has the chills), has head and tummy pain, and incredibly itchy.  The doctors here in Westford say there is no correlation to the vaccine, but she had a reaction to the first dose as well.  I am worried I vaccinated too early from her being positive.  But i was advised otherwise.  I am also worried this will affect her long term, as she is not over this yet.
Regarding FLUZONE, I had never had one before so I was not aware that there was anything unusual about the after affects. I did feel somewhat like after a tetanus shot-sore at the site of the injection, muscles sore-unable to lift arm above shoulder level, and tired and achy all over. That went away after four days, but then came back a day later for three more days. Now I just have some muscle soreness left.
Patient received her Moderna COVID-19 as her 1st dose on 4/11/21 and Pfizer COVID-19 inadvertently as her 2nd dose on 5/21/21. Denies any significant issues from this, but it was brought to her attention by someone else after looking at her COVID Vaccine Card. Patient noticed the error and called the clinic on 7/14/21.
Morbilliform rash slowing forming over the span of a week 4/6-4/13 that is painful, dry, and itchy.  Rash covers face, neck, back, chest, and on 4/16 starting moving down upper torso. Some small spots are forming on arms. It has been over two weeks since vaccine and the rash is still present and new spots are showing up. Face has cleared up but some red blotches still exist.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of PROQUAD, lot number L003221 expiration date 30-JUL-2016, lot number L007228 expiration date 03-SEP-2016 and lot number L014401 expiration date 23-OCT-2016 (route of administration and anatomical location were not reported). There were not concomitant medications provided. No adverse effects were reported and there was no product quality issue involved. This is one of several reports from the same source. Additional information has been requested.
Patient received the vaccine @ 1510. At 1520, she developed a huge rash and hives on her right arm. She reported "not feeling good". Placed patient on a cot with head raised at 45 degrees. She was massaging her neck, saying there was a "knot" in her throat. Shallow, rapid breathing @ 25-30 per minute, and swelling of the lips noted. BP=130/80, HR @ 95-101 per minute.  @ 1522, Epinephrine 0.5 mg. administered at L vastus lateralis IM. 911 was called per protocol. At 1533, patient reported no relief and swelling of the throat noted. Placed in the left lateral position. At 1539, EMS arrived. She was wheeled out via stretcher to be taken for further evaluation and treatment. Patient was conscious and coherent when she left the building with the EMTs in an ambulance.
moderna vaccine was given to patient age 17 yrs 10 months old.  no current symptoms noted at this time
Myalgia, Fever, inj site sore, warm to touch x1 day; fatigue, body aches, fever 101F x5 days Narrative:
Fever of 102.4; Headache; Full body chills; Then cramping in both hands; This is a spontaneous report from a non-contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: A7485) via an unspecified route of administration in the left arm on 10Aug2021 at 20:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 20:45, the patient experienced full body chills and cramping in both hands. On 11Aug2021 at 01:15, five hours after vaccination, the patient also experienced fever of 102.4 (units unspecified) and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 full body chills, cramping in both hands, fever of 102.4 and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (primary immunization, manufacture unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had not received other medication in 2 weeks. Adverse event Rebound infection started 2 days after completing treatment. Treatment was reported as, from 01Apr2022 to 05Apr2022 as anti viral medications (unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M042170, expiry date: 22-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
pt reports lt arm (shoulder to elbow) began itching & eventually entire area became red, swollen, hot & had a hard area to rt of inj site;pt states roof of mouth became itchy & bumps devel;seen by MD;prescribed oefadroxil, hydroxyzine;
pt recv vax 22JUL97 & 1AUG97 pt exp chickenpox consisting of 20-30 spots around the inj site, head, face, & chest;pt recovered by 7AUG97;
I think I am having a bad reaction to my covid shots.  The first shot was 1/31; a week later on 2/7  I started having headaches that travel around my head: some are behind my eyes and my teeth ache;  some more like migraines that go up the back of my head; some more on the top of my head or on the side.  My sense of taste changed.  My second shot was 2/27.  The day after I slept all day.  The headaches continued (I have had a headache of one kind or another since 2/7).  I had a tooth that broke off last June and was removed on March 8.  I thought the tooth was infected and part of the headache problems, but since then I have been having really bad fibro pain and for the week of 3/8- 12 I ran a fever, had chills and more headaches.  I was on amoxicillin from 3/8 to 3/14, but the tooth was not that badly infected and is healing well.  The headaches do not seem to relate to the tooth.  I have had a headache every day since 2/7 of various intensity and in different areas of my head.  I am extremely fatigued and need to nap some days.  My fibromyalgia symptoms are worse than they ever have been and some nights keep me awake.  I also muscle stiffness and spasms in my neck occasionally.  This is not normal for me. I saw a ARNP on 3/16 and she tested me for neurologic symptoms. Here are her notes:  NEUROLOGIC: negative findings: speech normal, mental status intact, cranial nerves 2-12 intact, gait, including heel, toe, and tandem walking normal, Romberg negative, muscle tone normal, muscle strength normal, rapid alternating movements normal, finger to nose normal, reflexes normal and symmetric   I have a video appointment with my primary care provider 3/26 to discuss this further
Nausea that lasted until around 7:30 pm. Also..on 12/17/2009 I started having whole body itching.
She was kind of panicky, she ended up not being able to breathe too well; She was kind of panicky, she ended up not being able to breathe too well; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for a unknown female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. An contactable consumer (who was caller as well) stated that on an unspecified date the time she got done standing in line, the girl in front of them had a problem, she doesn't know what it was. Caller states everybody seemed fine that went ahead of her, but she doesn't know if she was kind of panicky, she ended up not being able to breathe too well, she had to have water and kind of had to sit in the chair and relax and of course the patient was there when she left. Caller states she guesses she's doing better now, but she doesn't know if it was panicky, or she reacted to the vaccine. Caller confirms the pharmacy was giving out Pfizer Covid vaccines. Caller declines to complete a report for the girl who was in front of her receiving the Pfizer Covid vaccine, stating she doesn't know her situation at all, she doesn't know what happened whether it was because of the vaccine or whether she got panicky, she has no idea. Caller states the pharmacist would know more than her, she just knows she was given an orange juice and water and she was sipping on them and she seemed to be better. The outcome of events was unknown.    Information on the lot/batch number has been requested
This spontaneous report was received from a consumer concerning her son of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported). On an unknown date, after getting the injection, her son experienced extreme fatigue and hair loss. After receiving the vaccine, her son had behavior changes, eye swelling, felt agitated, and "didn't feel right." She said her son's hair loss was severe. It was unclear if caller's son also has arthritis. She stated that her son was so fatigued he could "barely see". It was unclear where in the regimen the doses were received but her son would not continue with GARDASIL. Patient sought medical attention. The patient has seen HCP. The outcome of the events were reported as not recovered. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Allergic reaction, hives, itchiness, dizziness, problem swallowing,  my face was swollen, to this day my headache doesn't go away, I feel very nervous i can't sleep. Anxiety and stress reaction.
Pt reported that he experienced swelling of the lips on the day that he received vaccination 11/21/14 but did not report at that time. He has again experienced swollen lips after that and now in addition itching at night. Rxn reported on 1/23/15.
Information has been received from a physician concerning a 13 year old female who on an unspecified date, was vaccinated with the first dose of GARDASIL. The patient was concomitantly vaccinated with VARIVAX (MSD) and tetanus toxoid. The patient fainted after receiving GARDASIL and had a brief seizure. The patient sought unspecified medical attention. The patient has recovered. Upon internal review brief seizure was determined to be an other important medical event. Additional information has been requested.  12/30/2009 PCP office note, telephone encounter records and immunization record received for DOS 09/17/1997-11/17/2009. DX: Well infant/child exam, URI Patient presented with no complaints. Examination revealed oropharynx and tonsils mild red, not swollen, no exudate. Received Varicella #2, TDap (Adacel), HPV#1 and Influenza 3+ years. After office visit, mother reported patient passed out in parking lot, appeared to have a seizure but was fine and did not need to be seen.
Had shot on Wednesday. Didn?t even feel the injection. Took Tylenol for mild headache and soreness. Thursday felt fine. Friday had sore elbows and a noticeable mild flare up in my right pointer finger. (Normal for me this time of year to a flare up) by Saturday morning I felt pain in my elbows while doing yoga. By Saturday afternoon my elbow had swollen up and turned bright red - excruciating to the touch. Went to urgent care they said ?bursitis? and gave me prednisone- will follow up with rheumatologist Monday.
The day after the vaccine, my arm was sore, but not unbearably so.  8 Days after I received the vaccine, my arm started swelling and itching.  It was very sore for the day.  I took Benadryl 3 or 4 times yesterday.    It was better today.  The swelling has gone down.
Pt had abdominal pain and same day fever chills. "Pt was scared " per mom.
No reaction to the vaccine. I had general fatigue, headache, tested twice for COVID-19 and it was negative, I called the doctor because I did not feel good, and he prescribed methylprednisolone on 4/06/2023. Then, a week went by wasn't feeling good, I called the doctor again and he gave me another prescription, an antibiotic for infection. 10 days' supply which I have finished now. During this period, I lose my sense of smell and taste, but I still tested negative for COVID-19.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), BENAZEPRIL, ATORVASTATIN CALCIUM (LIPITOR), MIRTAZAPINE (REMERON), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (Fatigue). On 01-Apr-2021, FATIGUE (Fatigue) had resolved. Not Provided          Patient has taken blood thinner, high blood pressure, cholesterol medicine as treatment.
Felt sick; Nausea; Headache; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, headache and fever. On an unknown date, the outcome of the sickness, nausea, headache and fever were recovered/resolved.   It was unknown if the reporter considered the sickness, nausea, headache and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR013107  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient heard how awful the shingles was.  The patient got a dose of Shingles vaccine and felt sick for a week after each shot (nausea, headache, fever), but patient guessed it was better than getting shingles. The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR013107.
Patient brought to the ED by EMS on 12/4/22 for increasing shortness of breath and right anterior lateral chest wall pain. He reportedly tested positive for COVID on 11/29/22. He additionally has had increasing productive sounding cough over the past few days. Patient arrived to the ED on 4L O2 NC. Ultimately, he was admitted 12/4/22 - 12/9/22. During his admission, his O2 needs were up to 10L, however he was weaned to 4L O2. On 12/6/22, respiratory culture was performed which resulted positive for COVID-19. During admission, patient was managed for COVID-19 pneumonia/community-acquired pneumonia with sepsis. Patient has received the COVID primary vaccine series.
redness; soreness; discomfort; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 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, unknown after receiving Shingrix, the patient experienced erythema, pain and arm discomfort. On an unknown date, the outcome of the erythema, pain and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the erythema, pain and arm discomfort to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced redness, soreness and arm discomfort with the first dose. This case has been linked to US2020002546, reported by the same reporter
No pain initially after vaccination. But pain at injection site (R Deltoid) began 4 days later and has persisted until now (5/13/11) and continues to persist. Pain interferes somewhat with job duties. He is able to perform them but needs ibuprofen to complete them pain-free. He has not seen a physician yet but is considering follow-up soon if pain does not subside.
03/30/21 09:35 AM - Vaccine administrated 05:00 PM - Uncontrollable shaking/shivering and dizzy 06:00 PM - Uncontrollable shaking/shivering, very dizzy, fever of 101 07:00 PM - Uncontrollable shaking/shivering, less dizzy but still, fever 102.5 08:00 PM - Shaking stopped, dizziness stopped, chills started, fever 103.5, nausea, very sore muscles in legs and lower back 09:00 PM - Chills, fever 103.9, worse nausea and vomited once, very sore muscles in legs and lower back, headache begins  03/31/21 08:00 AM - Chills gone, fever 101, nausea worse, headache much worse, sore muscles in legs and lower back 10:00 AM - Fever 101, nausea and vomiting, headache very bad, sore muscles in legs and lower back 10:30 AM - Took Imitrex (sumatriptan succinate) for the headache and fell asleep 2:00 PM - Fever gone, nausea and vomiting better, headache better, back and legs muscles feel better, arm soreness starts  04/01/21 - Light headache persists and arm soreness. All other side effects subsided.
Patient developed redness and skin became hard to the touch surrounding injection site about 2 hours after immunization was given. She developed chills later on at night and her arm was still swollen and sore for a few days after the injection.