chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the office as a walk-in complaining of arm swelling and mild pain. Arm from left side below injection site was red and warm to touch. Home care instructions provided. Denied fever or any signs of infection.
About 7 hours after vaccine I began shivering. I assumed it was a fever (normal side effect).  I became so cold my teeth were chattering. I put on thermal fleece long Johns and was wrapped in 2 down comforters and a fleece blanket. A couple of hours later when I stopped shivering I took my temperature and it was 96.1. thinking the thermometer wasn?t reading right, I used a 2nd thermometer and it read 96.2.   I took one Tylenol hours before when I started shivering (forgot to note that on the previous screen).   This morning my temperature was back to normal.
Intense fatigue, continuous pain in left arm of injection site, burning in arms, severe mood swings, folliculitis, recurrent cold sores around entire mouth continuing for 2 months, depression, inability to report to work and complete job duties, headaches, nausea, dizziness, brain fog, loss of memory, confusion, tingling throughout body on a continuous basis, hot flashes, inability to sleep, irritability, lack of motivation, loss of appetite, some shortness of breath, diarrhea.  All these symptoms were severe and lasts 8 weeks on a daily basis.
diarrhea; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and FATIGUE (extreme fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and FATIGUE (extreme fatigue). At the time of the report, DIARRHOEA (diarrhea) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.     Reporter did not allow further contact
Immunization given on 8/16/03, shot site swollen tender and oozing up to 6 months after the immunization, course of antibiotic given recently 2/22/03 (Keflex).
Patient called us 2.5 months after she had the vaccine stating that about 2 hours after the vaccine she had an episode of blurred vision and numbness in tongue and mouth. Episode lasted 10 minutes.
diverticulitis; sick in his stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (diverticulitis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DIVERTICULITIS (diverticulitis) (seriousness criteria hospitalization and medically significant). On 04-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick in his stomach). The patient was hospitalized for 3 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis) and ABDOMINAL DISCOMFORT (sick in his stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient's diverticulitis did not have anything to do with the vaccine and he had no history of diverticulitis. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
drug ineffective; COVID-19; SORE ARM AFTER COVID VACCINE; Psoriasis flare-up; Fatigue; 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-163-4398413-00 (FACILITATED COLLECT).  A 27-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 26 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "SORE ARM AFTER COVID VACCINE"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare-up"; FATIGUE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "drug ineffective", "covid-19" and "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "sore arm after covid vaccine" and "fatigue" related to BNT162b2.  Additional information: Solicited report from a consumer of an adult male with events of non-serious Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid with Humira (Adalimumab). There was no reported medical history. On unknown date, the patient experienced Sore arm after Covid vaccine, Fatigue, Occasional Plaque Psoriasis flare and Covid. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if Patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue, Occasional Plaque, Psoriasis Flares And Covid was not provided. Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran):  The reporter's causality for the event(s) of Sore Arm After Covid Vaccine, Fatigue was reported as Possible whereas for Flares And Covid was Not Reported.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19  and psoriasis flare-up,pain in arm,fatigue.
Patient stated two weeks after his first dose, he experienced chills, body aches, fatigue, and dizziness. This lasted two days.
Bicep swelled up and hives on the face.  Hives resolved and swelling has decreased.  Physician prescribed steroid dose pack pharmacy is awaiting receipt of prescription as of 2/12/22.
a friend who got both doses and she was unable to get out of bed; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date and received second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that she had a friend who got both doses, and she was unable to get out of bed, caller had to do everything for her, like food shopping, caller was trying to get her to go to a doctor but she was refusing. Caller was wondering if anyone at Pfizer has heard of an experience like the one she was having. Caller stated that she was having a delayed side effect. Caller stated that she got her Pfizer COVID vaccine at the end of March or early April, and she had nothing at all in terms of side effects. Caller stated that starting late May, or in early June, she started having strange side effects. Caller has a doctor's appointment today, but the doctors don't know anything about this, she has already asked her primary care and no one knows what she is talking about. Caller would like to speak with someone who could answer side effect questions for her. Caller was looking to see if there is any information about delayed side effects. The outcome of event was unknown.  Information about lot and batch number was requested.
Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands began shaking and eyes were moving erratically. Patient would not respond to verbal commands so called 911. The patient came responsive about 1 minute later and had no recollection of the event. Pharmacist checked bllod pressure and it was low (97/46 ) and upopn recheck in 3 minutes it was high (199/90). Paramedics arrived and patient said he felt fine at that point but he would still go to hospital to get checked out.
Burning inside of left arm; Raised bump at the injection site size of 50 cent coin; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Burning inside of left arm), VACCINATION SITE MASS (Raised bump at the injection site size of 50 cent coin), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03682IA) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Burning inside of left arm), VACCINATION SITE MASS (Raised bump at the injection site size of 50 cent coin), FATIGUE (Tiredness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Burning inside of left arm), VACCINATION SITE MASS (Raised bump at the injection site size of 50 cent coin), FATIGUE (Tiredness) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
I have an auto-immune disease, which I checked on the vaccine form as immuno-compramised. Within a week after vaccine, experienced swollen ankles, muscle at joints pain, heart muscle pain. I already had Covid in Feb 2020, after the normal 2-3-week cold/sinus /coughing in bed watching tv, and was totally fine after. I only got the JnJ shot to go to an event in June requiring it, but wish I hadn't! My natural immunity was probably compromised by the vaccine. Being on Humira for previous 10 years (another mRNA-style maintenance drug), probably complicated/worsened my current post-vaccine symptoms. Humira website says the combo isn't tested yet.
I felt extremely dizzy after getting the shot. It was about an hour after. I could not walk or think straight. I felt like I wanted to pass out.  My stomach was sick for a week.
Shortness of breath and chest pain began on Wednesday  02/10/2021 (2 days after vaccine given), Breathing and chest pain severe enough to go to Emergency Room  on Saturday 02/13/2021 ( 5 days after vaccine given).   CT scan in Hospital showed  blood clotting in both lungs. Was kept overnight in hospital and released  on 02/14/2021 with prescription for Eliquis (blood thinner).
Nurse reports an adult male patient was administered a dose of Engerix-B on 08Aug2023 from lot number F73DG, which had an expiration date of 03Jul2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 08-AUG-2023, the patient received the 1st dose of Engerix B. On 08-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Nurse reports an adult male patient was administered a dose of Engerix-B on 08Aug2023 from lot number F73DG, which had an expiration date of 03Jul2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 At the time of reporting, a repeat dose had not been administered of Engerix-B. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Redness, lump at site of Pvax 23. Gave prednisone  and suggested Tylenol, motrin and ice on 9/2/2020. Sent picture of site on 9/10/2020. Much worse, dark spot in center with pain. Sent in RX for Keflex, pt to come in 9/11/2020. Came to office, redness spreading, mild discharge from site. Concerned about necrotic tissue, made immediate appt at surgeon for same day. 9/11/2020
Beginning right after the shot my arm was tingling and I reported it to the physician giving shot. Later that night my left arm was tingling all the way to my heart for a period of 12days and slowly got better my head and body felt weak and would get tired out of no where my head was numb, I would get cold and hot I had trouble sleeping my vision was blurry. My arm also had red dots looked like bursted blood vessels.
Patient received the vaccine in her arm. Then at the 12 min mark, she felt her lips tingling, dry mouth, light headed, flushed, and nauseated. She was taken to the Emergency Dept where she was given a Zofran and still vomited once. Then she got a Benadryl and Solumedrol injections. Then she was observed for an hour and a half. Her temp did go up to 99.2 from around 98.4. HR 90-100s. O2 sats normal.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 29.85.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15- Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
"sweating" BP: 117/76 HR: 60 Sp02: 98% Seen and cleared by EMS
Next  day diarrhea  all morning,   imodium , he was  cold, clammy, wet with sweat, week pulse at 40 , in profound shock,  Stimulated him by shaking and hitting and had him take deep breaths . Pulse was 120/82 pulse up to 60 20 minutes into the event he was stable and alert .
Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Patient got one and two [Pfizer COVID vaccinations] but not going to pollute her body with any more boosters. One and two let the flu get her sick. It's best to rely on her immune system.  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) :PFIZER INC-202201384889 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: about 10 minutes after pfizer covid vaccine administration, pt reported feeling slight dizzy. I said I would call 911 and asked if she has touble breathing. pt said no it is not serious. another 2 to 3 minutes later, pt got up and said she is feeling completely fine. I asked her to stay a little longer, but she said is no longer dizzy and she is able to go home and did not want to stay in the store any longer. I did call her about half hour later and she is completely fine.
Vaccinated 2/26/2021, 1/29/2021. Hospitalized for COVID 11/21/21
Tested positive for COVOD-19 using a rapid antigen test on 13Jul2022; Tested positive for COVOD-19 using a rapid antigen test on13Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 24Jun2022 as dose 4 (booster), single (Lot number: FP7153) at the age of 57 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported as no other vaccine in four weeks and no covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jul2022, outcome "recovering", described as "Tested positive for COVOD-19 using a rapid antigen test on 13Jul2022"; COVID-19 (medically significant) with onset 13Jul2022, outcome "recovering", described as "Tested positive for COVOD-19 using a rapid antigen test on13Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Moderna COVID-19 Vaccine EUA; On 12/30/2020 I began experiencing soreness in my left arm along with a short period of chills and body aches. The next day, 12/31/2020, I noticed the injection site had a small, thumb-print sized red area around it. It seemed to have faded over the course of the next week however on the morning of 1/4/2021 I noticed soreness under my left arm pit. On 1/6/2021, the redness around the injection site increased and a second, distinct red spot developed on my left arm,  close to the injection site. Both spots are raised and hard but not itchy.  I put Cortizone cream on both spots and am monitoring its progress.
2am chills,achiness,shakes, temp 100  3am temp 100.7 no change 4am no change took advil  no change all day 12/23 shooting pains level 8 ,chills  body aches. no fever. no change all day will see employee health in AM
Swollen, painful, itchy welt starting 24 hrs after shot, lingering, persistent nausea 6+ days post-shot.
Patient's left arm instantly swelled up at time of injection. A small lump could be visualized but patient stated she "felt fine" and she denied being in pain.  Pharmacist requested for her to stay in the waiting area for at least 20 minutes after immunization.  After 20 minutes (11:37am), pharmacist examined injection site and it appeared to look the same as 20 minutes prior.  Patient's daughter called pharmacy around 3pm stating the lump had resolved.
Lt eye swelling /w rapid progression on 31Dec. Taken to ER & subsequently hospitalized /w orbital cellulitis. Blood cultures showed hemophaelis influenzae
Patient got AFLURIA on 11/17 evening. 11/18 morning she woke up with swollen lips, swollen eyes and red eyes. Took BENADRYL felt little better.