chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/09/2018 patient was accompanied by mother for immunizations was given dtap+hepb+ipv on the right vastus lateralis, with no complications, on 3/10/2018 mother stated that there was localized rash, erythema and swelling, and palpable lump under the skin which lasted until 3/20/2018. Mother did not bring child in for evaluation until 3/22/2018 and was seen by provider at that time. The exam was normal, without any sign of edema, rash, erythema or lump under skin of right or left upper thigh. All symptoms are based on mother's recall. Child had no reaction to the birth Hep B vaccine.
Chills, low grade fever up to 100.4, muscle aches, flushing red skin of neck and chest.
Patient had history of allergic reaction to percocet per  pt. Had EpiPen in her purse. Asked pt to remain after shot, She become "warm" and anxious, described feeling as having too much caffeine.  Also said she was light headed, she remained seated for a while longer with a cold compress on her forehead.   She later reported feeling her lips tighten and arms and feet tingling. Asked if she was ok to take benadryl, she was, so we gave 10cc of benadryl liquid and asked her to lay day behind the cash wrap area. We elevated her feet and seemed to make her feel better.  We  called 911  and EMS arrived. Patient was still alert and conscious.
Started to feel sick a few hours after the shot was administered.  Turned into fever, felt like my head was going to explode, face felt like it was on fire, but hands and feet where frozen, body aches, stiff neck, labored breathing, hands itching. No treatment sought, suffered through, felt better next day.
psoriasis got significantly worse; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 06May2021 (Lot number: EW0168) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis; "arthritic problems from psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL [LISINOPRIL DIHYDRATE]; ASPIRIN (E.C.); METFORMIN [METFORMIN HYDROCHLORIDE]; ATORVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot ER8737), administration date: 08Apr2021, when the patient was 81 years old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "psoriasis got significantly worse". The event "psoriasis got significantly worse" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis.  Additional information: The patient reported that she had psoriasis her whole life, she was diagnosed at 6 or 7 years old. The patient had some arthritis in relation to her psoriasis. The patient was unsure if this was a serious or not. The patient reported that she took two injections of the COVID-19 vaccine and shortly after this, her psoriasis became significantly worse. The patient reported that psoriasis was under pretty good control until this. The patient's psoriasis was breaking out on her hands and it had not done this before. The patient's psoriasis worsening was significant enough she had to go urgent care and was given Prednisone which helped. The patient did not want to take the steroid because she was a diabetic and the cortisone did not help her blood sugar. The caller's psoriasis was under pretty good control until this. The caller knows another person with psoriasis and they had the same thing that happened to them. The caller is unsure of the serious criteria as it wasn't life threatening or anything. The patient reported that it was more of an irritation and it itches. The patient was asking if Pfizer had any evidence of psoriasis worsening after getting the vaccine.  Follow-up attempts are completed. No further information is expected.
A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST (INTRANASAL), 0.2 Millilitres (frequency not reported), for INFLUENZA. Concomitant medications included METHOTREXATE. FLUMIST (INTRANASAL) started on an unknown date for INFLUENZA. The reporter stated that mistakenly FLUMIST was administered to immunosuppression patient. The outcome of the event of FLUMIST MISTAKENLY GIVEN TO IMMUNOSUPPRESSED PATIENT is unknown. The report was considered to be non-serious.
administered with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were 9 patients instead of 10 as initially reported. All of the patients were administered with the 1st dose,  0.5ml, intramuscular on the left deltoid. Lot number 032N20A, expiration date 27Aug2021. This case is for the 3rd patient.  No concomitant medications reported. No treatment reported.   This case was linked to MOD21-141642, MOD21-141643, MOD21-141644, MOD21-141645, MOD21-141646, MOD21-141586, MOD21-141427, MOD21-141647, MOD-2021-314573, MOD-2021-314570, MOD-2021-314517, MOD-2021-314545, MOD-2021-314555, MOD-2021-314793, MOD-2021-314805, MOD-2021-314793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information. On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information.
Site: Pain at Injection Site-Medium, Additional Details: pt arrived at the pharmacy 3 days after administration and complained of shoulder soreness that affected his ability to raise his arm.
This may just be coincidental, but developed polymyalgia rheumatica within one month after the second dose. Diagnosed with PMR on June 12, 2021. ESR 40 mm/hr, CRP 87.3 mg/L. Severe pain in hips and shoulders in the morning. Very difficult to get out of bed. Some stiffness in hands. Some stiffness in legs. Pain fades in late morning.  Had been doing very high level of work/exercise during 3 months previous.   Also got Shingles vaccine in January 2021.  Currently on Prednisone 25mg/day. Pain reduced from level 7-8 to 2-3.
Lightheadedness. "Floaty feeling. Some weakness.  Vision slightly skewed. Told nurse-they called EMT and paramedics took my blood pressure which was slightly elevated. Blood sugar was normal. They gave me the option since I am pregnant to go to the hospital, but I opted to take the doc's advice to eat a substantial meal, go home and rest, and stay hydrated. Slept and felt better. Feel better-may have just been that I didn't eat a lot of protein earlier that day. AM 6.5 months pregnant and they were just being cautious which I really appreciate. The follow up by DOH, and the EMT's was really impressive and I am really thankful. 10/28/2009 routine prenatal visits
Went in for flu shot, (medical device sales, need shot for credentialing) on Monday 9/18/2017. Not sure of which actual type of flu shot received. On Wednesday (9/20/2017) morning felt ill. Chills, severe body aches, pain when touched or bumped, sore throat, tonsils swollen, extreme fatigue.  By Wednesday evening symptoms severe enough to frighten me, had third party take me to Clinic ER.
the evening of flu shot had rash, unable to sleep by morning c/o rash on stomach & back;hands swelling denied diff breathing or swelling of throat;instructed to ER;9NOV95 phone call feeling better, given DPH & 2 other meds, 1 ATB
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Bladder cancer" (unspecified if ongoing), notes: Verbatim: Bladder cancer, I don't know exact date but you can take a year.; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure abnormal. The following information was reported: HEADACHE (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: This report was not related to a study or programme. ATENOLOL (Pill, 25mg, once a day). He had Covid shot on 25Mar2021 and for a last two days had been having headache. He took Advil and 2 Tylenol last night (guessed it was 250 but took 2 so its 500 mg, yesterday, he took a twice yesterday and had not taken any today) for it but the same still lingering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had difficulty walking; had mild pain in his right knee, the pain was severe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 10Aug2022, outcome "unknown", described as "had mild pain in his right knee, the pain was severe"; GAIT DISTURBANCE (non-serious) with onset 11Aug2022, outcome "unknown", described as "had difficulty walking". Additional information: On 10Aug2022, the patient had mild pain in his right knee. But on 11Aug2022, the pain was severe and had difficulty walking at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Woke up at 1 AM  sweaty and heard pounding. Got up and checked heart rate and it was varying 130-180 bpm. Had my husband take me to ER. They determined that I was in afib. They gave me some meds and my heart went back into rhythm after an hour or so. I had fever and headache for 3 days and then cleared up. I have had the afib episodes 2 more times since then. I had never had heart issues before getting the vaccine.
Pt reported to Immunizations Clinic to receive one vaccine, meningococcal, but received varicella. A system indicated that pt required varicella. Titers were not drawn to confirm necessity,  Pt has had no adverse physical effects. Discrepancy was discovered on 8 Sep22 when pt inquired about meningococcal date.
Some fatigue for a few days; Very light lip swelling; Very light lip swelling and sensitivity.; Slight itching on forearms and scalp.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 11:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma. Concomitant medications included escitalopram (ESCITALOPRAMUM), clonazepam (MANUFACTURER UNKNOWN), dexamfetamine (DEXTROAMPHETAMINE) and naproxen sodium (ALEVE) for unknown indication from an unknown date. The patient previously received rituximab (RITUXAN) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced some fatigue for a few days, very light lip swelling and sensitivity. The patient also experienced slight itching on forearms and scalp. 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 events some fatigue for a few days, very light lip swelling, lip sensitivity, slight itching on forearms and scalp were recovered on an unspecified date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Approximately 2 hours after injection, pt exhibited coughing, sneezing which progressed to runny nose, chills, eye tearing, fever, severe body aches at 6 hours after injection. Pt medicated himself with Tylenol 700mg every 4 hours without relief.
1. and 2. Diarrhea and constipation - days 3-8 post vaccination.  Vaccination on 2/12/2021 and diarrhea and constipation began 2/15/2021 and lasted until 2/21/2021 3. A lump where I received the vaccination from 2/12/2021 until 2/20/2021 4. Warmth around the injection site (4 cm in diameter) from 2/12/2021 until 2/20/2021 5.  Extreme muscle spasms as a side effect of my vaccination 2/12/2021.  They came on Monday 2/15/2021) but subsided Tuesday. Pain came back Wednesday and then Thursday I had to go home early and take 4 hours sick time.  I then took 4 hours sick time on Friday in order to see the Nurse Practitioner. NP diagnosed as muscle spasms and prescribed Tizanidine 3 x day.  I took two doses of Tizanidine (4mgs) on 2/19/2021 4pm and midnight and one dose 2/20/21 and muscle spasms are now resolved.   The pain on Monday was on left and right flank (lumbar) but migrated to thoracic level by afternoon.  On Tuesday it was not there. On Wednesday it was on left and right flank all day.  On Thursday it was worse. The pain was an 8 on a scale of 0-10 with 10 being equivalent to labor pain. (Natural labor x 2, each 8 hours in 1994 and 2000). The pain 2/19/2021 was so severe that I left work in order to go home and made an appt with the medical provider for the next day.  I saw the NP on Friday 2/19/2021 at 10.30am.   Pain was worse when seated. Pain was extremely bad when driving. Pain lessened if I could press the area with my hand. Possible confounder is that I pushed a boat with arms outstretched on a trailer over uneven ground with my spouse on 2/13/2021 about 3 feet to its resting place. However, I was on the boat in particularly frigid weather outdoors for two hours prior to pushing the boat to its resting place.
SARS-CoV-2 RNA Resp Ql NAA+probe~2019 Coronavirus SARS-CoV-2 test performed for patient on 07/09/2021 and came back positive. Case investigation interview with case has not been performed at time of this note.
Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN; Dose-1-21-APR-2021 and Dose-2-28 May-2021; PAIN AT THE INJECTION SITE; Loose stools/ INCREASED FREQUENCY LOOSE STOOLS; LOT OF STRESS; Inflammation; Fatigue; Headache; Fatigue/ EXHAUSTED; Vaccination site pain/ SORE ARM AT INJECTION SITE; General body pain/ FULL BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain/ FULL BODY ACHES), STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) in a 22-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced PAIN (General body pain/ FULL BODY ACHES), VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AT INJECTION SITE), HEADACHE (Headache) and FATIGUE (Fatigue/ EXHAUSTED). In August 2021, the patient experienced STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DIARRHOEA (Loose stools/ INCREASED FREQUENCY LOOSE STOOLS) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) and INJECTION SITE PAIN (PAIN AT THE INJECTION SITE). In 2021, PAIN (General body pain/ FULL BODY ACHES), STRESS (LOT OF STRESS), INFLAMMATION (Inflammation), DIARRHOEA (Loose stools/ INCREASED FREQUENCY LOOSE STOOLS), VACCINATION SITE PAIN (Vaccination site pain/ SORE ARM AT INJECTION SITE), FATIGUE (Fatigue), HEADACHE (Headache) and FATIGUE (Fatigue/ EXHAUSTED) had resolved. At the time of the report, DEVICE ISSUE (Device issue/ HAD A HUMIRA PEN MISFIRED AND GOT MEDICATION ON SKIN), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1-21-APR-2021 and Dose-2-28 May-2021) and INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) had resolved.      It was reported that on an unknown date, the patient had a Humira Pen misfired and got medication on skin (device issue) and which cause the pain at the injection site.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna.  There was no reported medical history.   Concomitant medication was not provided.  No information regarding treatment medication was provided.
A week following the injection, there was a welt, redness, and itching at the injection site that lasted about 3 days.
The patient's right arm had a red circle and she said it was very itchy, hot, and hard. This is the place where she received her ZOSTAVAX injection.
pain in lt thigh on walking mild limp on lt leg & tender on thigh flexion rite of IM inject, no edema, no redness;
Dizziness, fainting, weakness in legs, numb feet, unable to stand on own, nausea, dehydration, tingling in legs, pain in legs, low blood pressure, double vision, difficulty breathing, light headed.
Patient became lightheaded and began sweating profusely. Had patient lay down and monitored pulse ox, heart rate and blood pressure. All WNL. Patient began to feel better and sweating subsided after about 5 minutes in supine position. Upon sitting up, patient did experience a drop in pulse ox to 90 and heart rate to 50. However, immediately began to climb to normal limits. Patient reported history of passing out with previous vaccines, once even resulting in a concussion. Patient did not feel necessary to seek additional medical assistance. Continued to observe for another 15 minutes and patient experienced no other symptoms.
Headache C/O muscle cramp left arm and left side of neck, left earache,left armpit lymph node ache,fatigue,injection site reddness  Narrative:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Severe headache"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Feeling sick, She is not doing well"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "I just vomited like five times"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain". The event "pain" was evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the morning after the shot I experienced itching of the face and neck which has continued to this date. I am also experiencing diarrhea.
Patient received their COVID-19 Pfizer booster at 12:50PM and reported feeling fine.  The Influenza (Fluarix) vaccine was administered at approxiametly 1:05 PM into the same arm. After 10-15 seconds, I noticed the patient's head had tilted to their left and they had slumped in their chair (leading me to believe they had syncope). After receiving no verbal response for 3 seconds, I made sure the patient was stable in their chair and rushed to advise the pharmacist on staff of the incident (I called 911 while Dr. checked on the patient). The patient had regained consciousness and reported feeling dizzy, faint, and hot when he awoke about 30 seconds after initially losing consciousness. Police and EMT's arrived within 4 minutes of the incident and confirmed vitals were stable before transporting the patient into their ambulance for transport to the ED.
Had a bad accident and fell; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FALL (Had a bad accident and fell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced FALL (Had a bad accident and fell). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FALL (Had a bad accident and fell) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Itching all over began night of and continued for almost two days after vaccine. Mild symptoms, didn't need Benadryl or anything.