chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LETHARGIC; FELT PAIN IN HIS ARM INSTANTLY; HEADACHE; PAIN BEHIND EYES WHEN LOOKING  LEFT AND RIGHT/STRAIGHT; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced pain behind eyes when looking left and right/straight. On 02-JUL-2021, the subject experienced felt pain in his arm instantly. On 02-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and felt pain in his arm instantly on JUL-2021, and headache on 04-JUL-2021, and had not recovered from pain behind eyes when looking left and right/straight. This report was non-serious. This case, from the same reporter is linked.
I did not have a reaction to the vaccine. On 09/26/2022, I started not feeling well with a stuffy nose and fever. I tested positive with a home test for COVID-19. The fever lasted for three days and on the second day I lost my sense of taste and smell. After COVID-19 I have had a lot of inflammation in my knees and my hands swell. I never had those symptoms before.
Patient received Flu High dose by error instead of Flu IIV4 standard dose at this visit. No adverse event occurred, only medication error.
High fever, chills, headache, cough; High fever, chills, headache, cough; The caller received the first vaccine on 28Jan2021 and tested positive for Covid on 02Feb2021.; High fever, chills, headache, cough; High fever, chills, headache, cough; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: 31May2021) via an unspecified route of administration in the left arm on 28Jan2021(at the age of 66-years-age) as a SINGLE DOSE for covid-19 vaccination. Patient medical history included hypertension, diabetes, cholesterol and patient reported that, he does take medications for hypertension, diabetes, cholesterol.   The patient stated that back on 28Jan2021, he had first dose of Pfizer Covid vaccine, he got a terrible reaction, had fever and chills and eventually they sent him to get tested and found out that he tested positive for coronavirus, had just contracted the coronavirus before he got the vaccine. When probed for the adverse reactions, the consumer stated, "High fever, chills, headache, cough". Second dose was scheduled for tomorrow morning he said, should he get that or put it off, he still had cough and headache from coronavirus. Caller, the patient clarified he was tested on 01Feb2021 and got positive results on 02Feb2021. Treatment received by the Consumer (patient) was reported as, "Just a little over the counter, Acetaminophen, Aspirin, cough syrup". The outcome for the events covid-19, headache, cough were not recovered and the outcome for fever, chills were recovered on 12Feb2021.
intestine was swollen; cold; kidney surgery; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4477013-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162590) at weekly (citrate free, weekly (1 in 1 wk)), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL SURGERY (medically significant) with onset 27Jun2022, outcome "recovered" (2022), described as "kidney surgery"; GASTROINTESTINAL OEDEMA (medically significant), outcome "unknown", described as "intestine was swollen"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The action taken for adalimumab was unknown.  The reporter considered "kidney surgery", "intestine was swollen" and "cold" related to BNT162b2.  The reporter's assessment of the causal relationship of the events with suspect product (Bnt162b2) for renal surgery, Intestinal edema and cold was possible.  The reporter's assessment of the causal relationship of the events with the suspect product Humira (adalimumab) for renal surgery, Intestinal edema was no reasonable possibility and for cold was not assessable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information in the case , the reported events intestinal edema and kidney surgery is most likely due ot intercurrent medical condition and not related to the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
@ this time pt is living w/aunt; pt had welts (hives) that would move around body for 4 days; reported this on 14SEP92;
The area around my right eye was tended approx 18 hours after my 1st shot.  Approx 36 hours after the shot, the area surrounding my right eye is noticeably bruised, very tender, with a large welt under my eye.  I feel a lot of pressure in my eye but my vision is good.
Fever / Low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received Shingrix. On 17th August 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix on the day of reporting in morning The patient asked Should patient take Tylenol with the fever at the time of reporting had a low grade fever if 99.3, but if patient get a fever of 101 or higher, was it okay to take Tylenol.
Injection site pain within 5 minutes. Minor pain grew to bothersome soreness within an hour prompting the first Tylenol which dulled the pain. Around 12 hours later pain returned at bed time and a second Tylenol was taken. However that night had chills, sweats, and extreme shivering/tremors in jaw and in abdominal muscles. The muscles were left painfully sore that night due to the contractions.  Sweating and extreme fatigue for two days. Fatigue tapering off over two days after that as activity level grew to normal along with normalizing food intake. Chest pain a persisting symptom that takes longer to dull but seemingly everything back to normal after a week.  However chest pain, sweats and minor fatigue returning unexpectedly in the middle of the night a full week later as this report is being typed.
KNOCKED FLAT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced knocked flat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knocked flat was not reported. This report was non-serious.
The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration.; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; The first dose received on 18Dec2020 and the second dose received on 06Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 06Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of  BNT162B2 on 18Dec2020 for  COVID-19 immunization. The patient did not receive other vaccine in four weeks of vaccination. No known allergies. The patient had Hemolytic Anemia with symptoms starting within the first 24 hours of vaccine administration on 06Jan2021. The patient had emergency room visit and physician office visit. No treatment was received (as reported).  Outcome of event was unknown. The event was assessed as serious with serious criteria: Life-threatening, disability.    Information about Batch/Lot number has been requested.
It was about 4:00 PM, I experienced high heart rate. Couldn't control my heart rate and blood pressure. At 1:00 AM, stopped breathing. After care from the hospital, I went to see PCP and since then, I've had ongoing cough that I cannot get rid of. Tried every cough syrup, antibiotic, capsule, it won't stop. I've had an X-Ray and MRI of my lungs, and we can't figure out anything. High blood pressure has not been in control for a while. Increased Metoprolol to see if that would help but nothing has helped with controlling blood pressure, 149/110 with a pulse of 115. Severe abdominal pain since the first vaccination and it will just not go away. Ongoing exhaustion and memory issues (short term memory loss) affecting my work.
the day following vax pt exp arm pain/swelling, entire lt arm red, warm, tender. resolved in 5days w/ice & motrin
Patient began experiencing nausea and faintness approximately 2-3 minutes after vaccination. She had either a brief fainting episode or a near-fainting episode, and her head drooped while still sitting down. Patient's mother was present and held her steady. Immediately after this episode, patient vomited on the floor.  Patient was moved from an upright chair to a reclining chair and monitored for the next 30 minutes. She was given cold water and an ice pack for her forehead. Blood pressure was checked twice during monitoring and was 93/64 the first time, and approximately 112/74 before leaving. Patient reported feeling better but still tired and weak. She said this has happened to her once before with a flu shot, but it was "years ago." She also said she had not eaten since the morning that day.  Upon leaving, she was accompanied to her mother's car by her mother and aunt. Instructions given to the mother to report to ER or medical office if condition worsens.
The patient requested a bivalent booster. The RPh on duty administered a primary series for ages 6-11 instead of the bivalent booster. The patient is aware of what happened and is reporting no other adverse events at this time
Damage to her stomach; Heart and chest felling like burning/burning on the left side of her heart; Fogginess in her mind/wanting to disappear; Severe depression; Shingles on the left side 3of her mouth; Not being able to open her mouth; Diarrhea; Falling; Bbig ball in the injection site; Very high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression) and HERPES ZOSTER (Shingles on the left side 3of her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CARVEDILOL, VIT D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN E NOS for an unknown indication.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Damage to her stomach) had not resolved and CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high blood pressure medicine. Treatment also included tea, ice pack and antibiotics.   This case was linked to MOD-2021-358984.
Case number PHEH2016017632, is an initial spontaneous report received from pharmacist on 12 Jul 2016. This report refers to a 31 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly in left arm at a dose of 0.5 ml on 14 Jan 2016. On an unspecified date, FLUVIRIN that had been exposed to 8 to 10 temperature excursions was administered to an unknown number of patients. No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received from a nurse on 13 Sep 2016: Updated patient demographics (age and date of birth), suspect drug information (left arm and vaccination date).
patient has red area to the right thigh. patient states that there is no pain or trouble bearing weight. Pt leg warm to the touch. Mom advised to ice, ibuprofen and benedryl.
Within 15 minutes of vaccination, developed mild headache. Was resolving when left observation area. Employee reported at 1:45 had developed right sided face and arm tingling and numbness and lips numb and tingling. Consulted with ED provider -Dr Plan to observe by Employee Health  and refer to ED triage if symptoms do not improve. . Symptoms improving. Employee observed by Employee health  and symptoms had resolved by 2:15 . No admission to ED
Havrix pediatric administered to adult; Havrix pediatric administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the pediatric dose of Havrix vaccine was administered to the adult patient. The reporter wanted to know how to proceed. The reporter did consent to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Information has been received from a registered nurse (R.N.) concerning a 14 month old female with no relevant medical history or past drug history who on 03-FEB-2009 was accidentally vaccinated intramuscularly with a 0.05 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 663199/1551X).  Concomitant therapy included MMR II , PREVNAR and VAQTA(manufacturer unknown) were given on 03-FEB-09.  On 03-FEB-2009 the patient experienced inappropriate schedule of vaccine administered.  It is unknown if there is any relevant laboratory data.  It is unknown if the patient had experienced any adverse effects.  Follow-up information was received from the R.N. which reported that the intended dose was VARIVAX (Oka/Merck) (MSD).  It was confirmed that the patient was given a dose of ZOSTER vaccine live (Oka/Merck), and VARIVAX (Oka/Merck) (MSD) was not administered after ZOSTER vaccine live (Oka/Merck).  It was reported that this was an error in the office and since then both vaccines are now stored in separate locations to avoid future confusion.  Additional information has been requested.
pt recv vax 28AUG96 & was dx by MD on 6SEP96, confirmed had chicken pox from vax;about 30 pox @ that time;cont to multiply by 16th day had 300 to 400 chicken pox;tx w/meds;
Neurological Disfunction - mild temperature relieved by Tylenol. Felt better in late afternoon so went outside to sweep with a broom debris off of floor of  outside patio. Took two sweeps effortlessly and then on 3th attempt was unable to move my arms, shoulders, hands to sweep although attempting as best I could both physically and mentally. Was scared and knew something was wrong so immediately went back inside. Fever resumed, had chills, and immediately went to lie in bed under covers at 5pm. Next thing I remember was waking up 12 hours later the next morning and felt fine.  No issues since. Suffered a bout of vertigo 8 years earlier after benign prostate surgery. Although 98% recovered lingering effects include having to stabilize balance when standing up after sitting for long periods of time.
pt had rash genl macular over hands & face & sl on trunk w/t100; It was self limiting & MD did see pt;
Severe rash on feet, 2 inches long on left foot and spotty on the right
Vaccine given at school vaccine clinic. Patient felt nauseated about 20-25 minutes after receiving the vaccine.  No itching, swelling, hives of mouth, lips or tongue, or anywhere else.  Pt did not vomit.  VS stable.  ER precautions reviewed with school nurse.  Parents were called and pt will wait in nurses' office until they come to pick him up.
"Pfizer-BioNTech COVID - 19 Vaccine EUA"   Developed a rash approximately one day after the injection.   Worse on the top half of my body.  But itchy everywhere.  Upper chest and lower next is a visible rash.   The rest I can feel bumps and they itch but not visible to the eye.  Itching is worse on my face and neck, including my eyes and nose.   I do not appear to have any other symptoms besides site pain.
Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain).   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt.  On 17 Jan 2021, her temperature was 95 F.  On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea.  On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain.  On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided.  The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048848, expiration date 09-AUG-2018 and lot# M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Bell's Palsy symptom, face drooped on left side, diagnosed at ER on 3/18/2021 after several tests run to rule out a stroke. Was given anti viral meds and steroids for 7-10 days. Physical therapy for face.  Treatment for 2 mos.  Ongoing at home treatment on face and speech therapy.