chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild soreness in arm; Mild headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A male patient received bnt162b2 (BNT162B2) (Lot number: ER8734) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild soreness in arm"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: The patient's wife reported that her husband, the patient, experienced mild soreness in his arm and a mild headache following the Covid-19 vaccine. She declined to complete safety report for the patient, stating that the mild soreness in her husband arm and mild headache were not serious and were expected with a vaccine. She reported that he received his Covid-19 vaccine from the same lot number that she provided for her product details.  No follow-up attempts are possible. No further information is expected.
Nausea and fatigue 4 days so far. Getting better. Wish I wouldn?t have taken the second shot. No problems with the first shot.
Pt received vaccinations 8-21-19. On 8-23-19 in morning, Pt noticed both arms were swollen with "golf ball sized" bumps where vaccine was injected RPh counseled pt to use benadryl to help w/possible allergic reaction.
Soreness in her arm,where the injection site was; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received first dose of bnt162b2 (BNT162B2), on 14Jan2021 (Lot Number: EL3247) as SINGLE DOSE in Arm Left for covid-19 immunisation.  Medical history included ongoing thyroid, diagnosed when she was 40, so 33 years ago, she has some immune thing, diverticulitis in Dec2020, and they did have to put her in the hospital because the thing perforated and they had to give her IV antibiotics, so she was on antibiotics for 2 weeks after that. Prior Vaccinations within 4 weeks was None. Concomitant medication included levothyroxine sodium (SYNTHROID) 75 mcg taken for thyroid disorder; thyroid (ARMOUR THYROID) 30 mg taken for thyroid disorder, both ongoing, just orally in the morning everyday by mouth.  She experienced soreness in her arm on 14Jan2021 where the injection site was and pretty much nothing more, no fever, no tiredness, no nothing. and lasted for about 2 days,was gone by 16Jan2021. she has recovered completely, she didn't have lasting effects.  No follow-up attempts are needed. No further information is expected.
Patient was given HPV first dose along with MCV and Fluarix. Patient was asked to wait in the waiting area for 15 min to take blood pressure, minutes  after that patient  had a convulsive syncope Dr. and nurse came to patients aide as patient regained conscious, patient was observed for an approximate 45-min to an hour until vitals where stable.
feels like garbage; headache in back of head; entire body was tremoring, body shaking non stop; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021. The most recent information was received on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (entire body was tremoring, body shaking non stop), FEELING ABNORMAL (feels like garbage) and HEADACHE (headache in back of head) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced TREMOR (entire body was tremoring, body shaking non stop). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (feels like garbage) and HEADACHE (headache in back of head). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (entire body was tremoring, body shaking non stop), FEELING ABNORMAL (feels like garbage) and HEADACHE (headache in back of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up was received on 31 mar 2021.Event description updated. She claims that her spleen has been taken out and she gets the pneumonia vaccine and flu vaccine yearly but she has not had this kind of a reaction.
This spontaneous report as recovered from a 77 year old female patient with allergy to LEVAQUIN and penicillin (unspecified) refers to herself. The patient had no pertinent medical history. In approximately 2012 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, route and site of administration were not reported). In approximately February 2015 (reported as last week), the patient noticed her right leg was getting sore and discovered a rash. In approximately February 2015 (reported as over the weekend), the rash evolved to splotchy stuff going down the right side of her right leg and blisters. The reporter stated that it looked like ring worm and was the size of a silver dollar. The patient also said that it looked like a "light case" compared to shingles pictures she saw. The patient sought medical attention. No lab diagnostics studies were performed. The patient was treated with methylprednisolone 4 mg dose pack, acyclovir 800 mg and methocarbamol 750 mg. The outcome of events was not reported. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Temperature 104F to ER. Tylenol given with instructions again. Chest x-ray normal, blood cultures OK. CBC ok.
Vaccinated on sunday and today (tuesday) woke up feeling itchy all over; Severe diarrhea after vaccination; Also vomited about twice; This is a spontaneous report from a contactable consumer (Patient). This 30-year-old male consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Fc3181) dose 1, Via an unspecified route of administration, administered in left arm on 22Aug2021 at 16:00 (at the age of 30-year-old) COVID-19 as dose 1, single for Covid-19 immunisation at Pharmacy or Drug Store. Patient medical history was none. Known allergies to past drug Amoxicillin. The patient concomitant medications were not reported. Patient has not received any other vaccine in four weeks and not received any other medication in the last two weeks. The patient was not diagnosed covid-19 prior to vaccination and not tested for covid-19, post vaccination. The patient experienced severe diarrhoea. Had to run to use restroom every 30 minutes to an hour for about 9 hours day after vaccination. Also vomited about twice on 23Aug2021 at 01:15. Vaccinated on sunday and today (tuesday) woke up feeling itchy all over. The patient did not received treatment for the events. Outcome of other events was recovering.  No follow-up attempts are needed. No further information is expected.
About 4 days post dose, my ear began to ring loudly and I lost some hearing in that ear. The problems continued for at least a week and then began to be intermittent.
developed infection in all body piercing; developed gingivitis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INFECTION (developed infection in all body piercing) and GINGIVITIS (developed gingivitis) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INFECTION (developed infection in all body piercing) and GINGIVITIS (developed gingivitis). The patient was treated with CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency. At the time of the report, INFECTION (developed infection in all body piercing) and GINGIVITIS (developed gingivitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment drug for the event included Cephalexin antibiotics.
Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient tested positive for Covid 19 with mild cold like symptoms, headache, cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The clinical course is as follows: the patient tested positive for Covid 19 after taking an at home rapid antigen test. The patient experienced mild cold like symptoms, headache, cough. The patient was vaccinated with the Moderna Covid-19 vaccine for his 2 dose primary series and then received a booster dose of the Pfizer/BioNTech Covid 19 vaccine on 11Nov2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Delayed hypersensitivity type reaction with large local swelling, redness, vesiculation 9 x 9 cm.
woke up in middle of night to my ears itching severely, again few minutes late. Then my hands and arms started itching. I got up and to see what was going on. My fingers had hives on the and the hives/rash had started down both arms from my hands to my elbows.  I immediately started taking a homeopathic remedy Apis. I took four doses within 6 minutes of each other, then another dose half hour later and another dose an hour later. the itching had stopped but the hives were still there. I sat up for another hour and then went back to bed. at 6 am the hives were much lighter and completely gone 2 hours later.  I had a hard lump at the injection site that stayed for a couple of days.  On March 3 my arm started hurting again with a much larger hard lump and a red hot spot on it. I put ice on it several times a day.  After 3 days it was only a small lump.
4OCT91 pt recvd Engerix-B on the morning of 5OCT91 devel hypotension which continued for about 1wk or so; Event resulted in an ER or MD visit & pt is reported to have recovered;
Pt is currently incarcerated. Had his first Moderna vaccine at 12:15pm on 2/2.  Reports that he "worked out" doing squats (without weights), lunges, and lifts that night at 10pm.  Next day noted coke-colored urine, throughout the day became bloody/red colored.  reported red colored thighs, weakness, and leg and arm pain. Reported to staff and brought to ER on morning on 2/4.  At outside ER had mild weakness on exam but could walk/bear weight.  Initial CK of 81,300, renal function normal.  given multiple liters of IVF's. Repeat was >100,000.  Transfered to our facility for ongoing management.  Had total of 8L of fluids over the course of 40+ hours, his CK here was down to 0, renal function normal. and by afternoon of 2/5 on admission here, his strength to him felt normal, muscle pain completely resolved.  He was discharged back to prison on morning of 2/6.
Had been responding to check-in every day with on symptoms to report but they stopped checking on day 7.  Delayed response to injection.  Arm had a rash, was red and itchy.  Began on day 8 following vaccination.  Spread and reddened for two days and is now starting to clear up.
This spontaneous report has been received from a consumer refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 30-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On 31-AUG-2017, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that the unspecified patient was late for her third dose of GARDASIL 9 (approximately on an unspecified date in January 2018). No adverse events were reported.
Right arm swelling and erythema next day after the vaccine.  The reaction resolved 6 days later.  Treated with Benadryl.
Localized redness & pain, on 04/20/11. Two day of minor pain at injection site, then developed worsening redness and pain with tender lump 2 wks after injection 10 cm x 10 cm erythema with 7 x 5cm nodule.
Itching really bad Injection Site; Rash on Injection Site; Pain in the left leg (All the way to her calf); Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), VACCINATION SITE PRURITUS (Itching really bad Injection Site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE RASH (Rash on Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), HEADACHE (Headache) and CHILLS (Chills). On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad Injection Site) and VACCINATION SITE RASH (Rash on Injection Site). On 29-Mar-2021, PAIN IN EXTREMITY (Pain in the left leg (All the way to her calf)), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching really bad Injection Site) and VACCINATION SITE RASH (Rash on Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines were not included  Treatment drugs were  not provided,  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-126068, MOD-2021-126068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI. Email.  2nd dose case created.
Since the shingle shot administration in Feb 2016. Pt has had tingling and buzzing sensation of left arm.
Patient was fine during the day, but then woke up with arms and legs weak and hurting all over her body. She then fell and had to be taken to the ER.
Vaccine was given, patient stood up and was talking to her sister when she all of a sudden fell face first onto the floor. She was unconscious for less than 1 minute, 911 was called. She was placed on her back on the floor. she regained consciousness and was alert, talking to mom and dad. EMS arrived and she was taken to a nearby hospital for treatment.
This is a spontaneous report from a non-contactable consumer (patient herself). A 39-year-old (non-pregnant) female patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE (age at vaccination 39 years) for covid-19 immunisation. Medical history included herpes zoster from 2018 to an unknown date Previously had shingles in 2018. Patient had codeine allergies from unknown date and unknown if ongoing. Other medications in two weeks concomitant medications included fluoxetine hcl (FLUOXETINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine for drug hypersensitivity. Patient had not diagnosed covid prior to vaccination and had not been covid tested post vaccination. On 06Apr2021 (1 week ) after 1st vaccine injection into left arm, patient experienced a bruise-colored but raised circular patch appear under my right arm (in armpit area). Patient did not received treatment for event. Adverse event resulted patient visited Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.
pt recv vax;had chills & devel hives;pt called;had dph at noon;improvement noted;cont to be achy; did not go to work; hives were flat, nearly gone on 19apr95;
Spoke with patient, she received the 1st vaccine at vaccine site in the cafeteria they had there.  She is unsure if it was from the HD or actually Integris.  She received it on 02/26/2021.  She states that it was the Moderna Vaccine.  She states that she started noticing the hives at 18 hours and the breathing issues were at 24 hours.  She said that the "difficulty breathing" was more like someone was sitting on her chest.  States that the hives lasted approximately 1 week.  States that the chest heaviness lasted approximately 12 hours.  States that the swelling of her hands lasted approximately a week too.
Pt. states that after receiving the 1st dose of Phizer 08/06/2021, started experiencing symptoms 08/08/2021 of muscle spasms between the hips and knees. Primary visit 08/18/2021 no recommendations, Pain Management visit 08/2021 recommended visit with Back Specialist 10/2021 no abnormalities. Recommendation for Follow-Up with Neurologist.
Moderna 2nd shot. one week later I had pain in joint near knuckle of my ring finger in  left hand.  For the next two days the pain was so bad, swelling near knuckle, that I could not use my hand. Also in my palm about half inch under the ring finger I can feel a small bump in the palm like a nodule.    I called doctors office to ask for recommendation for hand specialist but i would wait to see if it improved after weekend.  I took advil then switched to aleve on 3 rd day of pain.  The next day it was much better, only slightly swelled and painful.  Today is 5 th day since pain began but much better but not normal yet..   I never had this before.  so i thought i should report this.  Two days after injection I did have a rash that was warm at injection site  but it went away the next day.
Patient given 2nd dose of Pfizer at 11:25 am patient alerted staff numbness and tingling in right arm, neck, and jaw. Had patient wait additional 15 minutes. Symptoms did not worsen. Advised patient if problem continues, is more troublesome, or becomes worse to call physician or got to ER. No medication was administered. Patient left facility with minor symptoms. patient stayed 30 minutes after symptoms initiated then chose to leave. Patient did not want to go to ER. No further action/intervention  required.
Alternating sweats/chills and headache beginning ~10 hours after vaccine administration, followed shortly by 100.2 degree fever lasting until ~21 hours after administration. Body fatigue/weakness for most of the next day. Tylenol taken ~27 hours after vaccine administration, which helped headache subside. All symptoms went away ~30 hours after vaccine administration.
Rash began on patient's face and body on 4/15/04, without other signs or symptoms. Patient was seen by pediatrician on 4/16/04 and only had fine papular rash on her legs, without other symptoms.  No treatment was given.  Doctor thought it was either a viral or a contact rash.
1st intradermal shot did not create a wheal. 2nd intradermal injection created wheat. Pt left in no distress from injection.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 25-year-old male patient who received BOOSTRIX (batch number 45MH5, expiry date 11th February 2017). Concurrent medical conditions included gun shot wound and hospitalization. Concomitant products included fentanyl, KEPPRA, mannitol, NURCURON, Rocephin and VERSED. On 19th April 2015, the patient received BOOSTRIX .5 ml. On an unknown date, the dose was an unknown dose. On 19th April 2015, less than a day after receiving BOOSTRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to BOOSTRIX. This was one of the 2 cases received from the same reporter. Additional details provided as follows: The patient developed a localized rash (caller does not know if this rash was at the injection point, but believes it may have been). The rash lasted about 30 minutes and no treatment was given for this rash.
Patient developed a raised, red rash to left thigh after the injections were given. Patient also developed a fever and severe nasal congestion which lead to him becoming hypoxic at 82% on room air.
stomach cramping; brain fog; headache; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Hay fever.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), FEELING ABNORMAL (brain fog), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD21-085094 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Contact Information Updated; Sender's Comments:  MOD21-085094:follow up - contact information updated - name , email , address.
2min p/vax passed out mouth clenched shut x 1min-forehead warm to touch-hands cold-vision blurred-afeb;IV fluids given @ hosp;