chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/3 - Evening of shot - developed severe swelling, soreness and stiffness of arm. Pain was great enough that I was unable to sleep at all that night. 4/4 - Next day I fell asleep finally for a nap and when I woke, my arm was still sore and stiff, but arm was a big more mobile and I was able to resume light housework, etc. 4/8 - I woke up with severe pain and tightness in my left trap. 4/9 - I woke up with my left deltoid swelled up again and in pain close to the level after the injection on 4/3. 4/10 - The swelling persisted and then a developed a rash below the injection site. The rash and swelling lasted for 2-3 days and then all side effects were gone.
arm was sore; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was sore".  Additional information: The patient received both doses of the Pfizer vaccine. She received the second dose on 17Feb2021. She stated that she received the second dose "12 days past the 21 days". She stated that she had "no antibodies when they checked". She got an antibody test: they pricked her finger and said she had no antibodies ("negative IgC and IgM). They advised her to come back in 1 month to test again. She stated that after the first vaccine, her "arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273309 Same patient/drug, different dose/event separated in time;US-PFIZER INC-2021273352 Same patient/drug, different dose/event separated in time
Case number PHEH2016US027672, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, batch number: not reported) at an unknown dose on an unknown date. On an unknown date, the patient experienced cellulitis at injection site after injection. The outcome, seriousness and causality of the events were not reported. The seriousness assessment of vaccination site cellulitis was upgraded based on the information provided in the source document.
Dizziness in bed during the night- Complete vertigo in the morning- unable to stand or walk unassisted- nausea- went to doctor- had high blood pressure and was sent to Medical Center.
After dose 2 of COVID-19 vaccine I began having symptoms never experienced before. My symptoms were fatigue, exercise intolerance, lightheaded, high heart rate, and low blood pressure. I did several tests at the cardiologists. I ended up in the Fall of 2021 doing autonomics testing, a tilt table test. I met the criteria for POTS, Postural Orthostatic Tachycardic Syndrome. I was diagnosed with thyroid disease. I began taking levothyroxine. There was concern for my cortisol. Fall of 2022 I went through testing for Adrenal Insufficiency. My body no longer produces cortisol. ACTH Stimulation test fall of 2022. I am now on steroids for my lifetime. I now carry an emergency kit with an injectable steroid in case of accident or high stress situation. I am also on fludrocortisone. Even though I met the criteria for POTS, it's likely that what I had all along was Adrenal Insufficiency. Also, on February 1, 2023, I tested positive for COVID-19. This was after dose 4 on 12/26/2022. My symptoms were nasal congestion, headache, wet cough, slight fever, fatigue and mild body aches. I didn't visit the doctor for care. I did home remedies for comfort. This is day 3 and I feel about the same.
Patient received vaccine on 11/17/23 and felt fatigue later that evening. She experienced fever, chills and fatigue the following morning and said she kept drinking a lot of water. The next day her symptoms improved
A report from a healthcare professional via VAERS concerns a 39 year old male patient. His medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). On an unspecified date, the patient developed asthma exacerbation. At the time of reporting the outcome of the event of asthma exacerbation was unknown. According to the reporter the adverse event of asthma exacerbation was considered to be serious as an important medical event and according to company physician, the adverse event was at least possibly causally related to the suspect drug.
At night started with cough. When to ER. MD administered antibiotic and prednisone. Discharged to home from ER.
started feeling fatigue, tired; dizziness; pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; She usually gets spasms but now they are more intense.; This is a spontaneous report from a contactable consumer or other non-health care professional (pa-tient), from a Pfizer-sponsored program. A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspeci-fied route of administration on 10Aug2021 as dose 2, single for COVID-19 immunization. Medical history included covid-19 from May2021 to an unknown date she had COVID in May2021 and recovered fi-ne, but was treated in the hospital because she had COVID Pneumonia , cushing's syndrome, pre-diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, and then out of the blue about 3 weeks ago the patient experi-enced started feeling fatigue, tired, dizziness, pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes, a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes and she usually gets spasms but now they are more intense. It was fur-ther stated that Caller was not sure if her symptoms that she has been having over the past two weeks now almost a month are almost a repeat of COVID. She does go to the Doctors because she does have Cushing's syndrome and is a pre-diabetic and on medication for that. She stated she was just trying to marrow a few things down, Had a sudden onset did not have these symptoms all along, just does not feel the same. She usually gets spasms but now they are more intense. And now why did this red bump appear a week later after getting the second vaccine and the itchiness at the site, like she just got the vaccine, is this a possible side effect? Stated she does have an appointment with her neurologist et up and her Cardiologist mentioned to her that she might be experiencing COVID long hauler. The patient underwent lab tests and procedures which included blood test: fine, comput-erised tomogram: fine, ultrasound scan: fine on an unspecified date. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up
10 days after the 1st vaccine my lip and tongue started swelling and I took benadryl.  Spoke to an allergist and they did not think it came from the vaccine .  2nd vaccine which I had on Tuesday, early Thursday morning I woke up with itching and tingling all down my legs which is still continuing.
THROAT FELT SWOLLEN; TONGUE FELT SWOLLEN; clammy; EXHAUSTED; MUSCLE PAIN; nausea; JOINT PAIN; CHEEKS FELT PUFFY; DIZZY; HEADACHE; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, dizzy, headache, throat felt swollen, tongue felt swollen, cheeks felt puffy, clammy, exhausted, muscle pain, joint pain, nausea.  The patient's medical history was  provided asthma for current condition. No relevant concomitant medications were reported.  On 18 Feb 2021 , prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A)  for prophylaxis of COVID-19 infection.  .  Treatment information was provided Benadryl and albuterol inhaler.  Action taken with mRNA-1273 in response to the events was unknown  Outcomes of the events were unknown..
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Post-acute COVID-19 syndrome.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  This case contains information about patient 17 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Feb2021 (at the age of 79-years-old) (Batch/Lot Number: EL9262; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism taking levothyroxine. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism, start and stop date were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 on 22Jan2021 (at the age of 79-years-old) (Batch/Lot Number: EK9231; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. Consumer stated, he was not sure but he thought he had a reaction to the Covid shot. He had his second shot and had rashes that have come out on his thighs and his wife said, he had them on his, just above his waistline and on his right shoulder blade and they were approximately of a size of a dime and they were pink but they were not raised and they donot itch. The patient did not receive any treatment for the event. Outcome of the event was unknown.
At  5 p.m. (about 8 hours after my second Pfizer shot) on March 31, 2021, I suddenly had ringing in both ears). I went to sleep about 10 p.m.  The next morning, it had disappeared. At about 10:30 p.m. on April 3, 2021, the ear ringing returned in both ears (I think it was louder than before). When I woke up this morning (April 4, 2021) at 7 a.m. when the phone rang, it was strong in both ears, and especially the left ear.  I could barely hear the phone ringing and my hearing reduction is especially strong in my left ear. It is now 8:26 a.m., and conditions have not changed. It is Easter Sunday and I will not contact my physician until tomorrow (the questions below do not yet apply).
It was brought to my attention that shortly after this patient was administered FLUZONE, she walked to the front of the store to shop, but had to sit down on the register table to rest because she was having severe back pain. A team-member called EMS and they arrived, but patient refused medical care at that time.
Pharmacist did not realize that patient was only 17 years old at the time of vaccination. Mother accompanied patient and thought that the patient qualified for the booster. It wasn't until other pharmacist went to bill after administration that it was discovered that patient was not yet 18 years old. Pharmacy spoke directly with the mother and explained the situation, noting that it was an eligibility error, not a safety concern. Mother and patient were satisfied and patient was not experiencing any side effects. Mother knows to contact the pharmacy if the patient develops any issues.
A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old female vaccinee inadvertently received 0.25ml Fluvirin on 12/3/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
Skin problems/eczema; started gaining weight.; Period problems/hormonal problems; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder (She has had already a year-round of hearth problems).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems). At the time of the report, ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  It was reported that patient was prescribed medication for the symptoms started one month after receiving the first dose of the Moderna Vaccine.   This case was linked to MOD-2022-649986, MOD-2022-649987 (Patient Link).
Vomited 2 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/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: VOMITING (non-serious) with onset 13Dec2021, outcome "recovered" (Dec2021), described as "Vomited 2 times". It was unknown if therapeutic measures were taken as a result of vomiting. Additional information: Prior to vaccination, was the patient diagnosed with COVID-19?:Unknown, Since the vaccination, has the patient been tested for COVID-19?:Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5NOV96 severe h/a-dull-felt like allergic h/a;6NOV felt icky-stayed home from work;15NOV h/a gone completely;
This case was reported by a healthcare professional and described the occurrence of swelling arm in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), influenza virus vaccine (Flu vaccine). There were no concurrent medications. On 22 December 2009 the subject received 2nd dose of HAVRIX (unknown, right arm) and 3rd dose of Flu vaccine (unknown). Within a couple days of vaccination with HAVRIX, at an unspecified time after vaccination with Flu vaccine, the subject experienced swelling in the right arm and swelling of the chest. He was admitted to the hospital for a couple of days while he received treatment with antibiotics. The physician questioned the flu vaccine as co-suspect, but noted the HAVRIX vaccine was the vaccine given in the right arm. The reporter did not know if the physician felt this incident was disabling, life threatening or jeopardized the subject. The events resolved.
Pt vaccinated with DTP/OPV developed systemic hives, felt warm to touch, temp not measured. Also developed wheezing.
Headache, Myalgia, Fever,  Fatigue, chills Narrative:
A few hours after the vaccines, patient developed rash and purple discoloration of both his legs. He was also crying inconsolably and had a low grade fever of 100.3.  The symptoms self-resolved after about one hour.
Initial and follow up information has been received from a licensed practical nurse concerning a 29 year old white male with type I diabetes mellitus for 22 years.  On 03-OCT-2006, at 4:15 PM, the patient was vaccinated intramuscularly in the right arm with the first 0.5 mL dose of PNEUMOVAX (lot #651320/1008P).  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 03-OCT-2006, the patient developed extreme pain at injection site and muscle weakness in right arm at "h.s" (previously reported as could hardly move his arm).  It was very painful but there was no redness or swelling.  On 04-OCT-2006, at 4:00 AM, the patient went to the emergency room.  The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) for pain and released.  No lab studies were performed.  On 06-OCT-2006, the patient had recovered from the events.  Additional information is not expected.
Weak knees; Dizzy; Shakes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills). At the time of the report, MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy), TREMOR (Shakes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
Lymphadenopathy of the axillary, pectoral, and epitroclear regions.
Patient came in on 7/31/2019 to report bruising from her Shingrix shot. She was bruised from the site of her shot on her left upper arm to her elbow.  Her bruise was very dark and patient reports it being tender to the touch.
Facial Flushing; throat constriction; feeling faint; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, lot number: EJ1685, intramuscular in the left arm, first dose on 28Dec2020 07:45 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial flushing, throat constriction, and was feeling faint on 28Dec2020 at 07:45 AM with outcome of recovered on an unspecified date. The patient received treatment for the events with diphenhydramin, methylpred and famotidine. The patient had no covid prior to vaccination nor was she tested post vaccination. The events was reported as non-serious. The events resulted to emergency room/department or urgent care.
Pt received one dose of the Moderna vaccine, then tested positive for COVID-19 on 5/22/2021 and was ill enough to be admitted for inpatient treatment.  She is still currently in our inpatient Gen med unit.
Anaphaxis response:  flushing,respiratory distress approximately 1 hour after Tdap given. ER: Benadryl and steroids. ER records attached.
Received vaccine at 1:10pm.  At 1:30pm, while in observation lot,patient complained of chest pressure  8/10 and appeared ashen and diaphoretic.  Paramedics from the vaccine facility immediately responded to the patient.  Patient stated these were the same symptoms she has had in the past when she has an allergic reaction, and stated she has reactions to 10 different "things".  Patient carried an epi pen but stated she usually went to the ER and was treated there.  On-site paramedics gave 0.5 mg IM to Left deltoid.  Patient stated chest pressure went down to a 3/10, and she felt better.  Ambulance arrived and patient was transported to Hospital.
Vacine was 01/11/21 one week later 01/18/21  at approximately 6 PM, I started to itch around primarily on my left side and all around my chest.  After checking with my shirt off there was light pink (rash or hive) no blister or bumps.   I took two Benadryl tablets at around 8 pm.   By late morning and  one other pill the itch and  pink (rash or hive) was gone.