chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lethargic; Right arm pain; body aches; tingling both arms and face; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for himself. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL0140) via intramuscular in right arm on 17Dec2020 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient had no known allergies or other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced right arm pain, body aches, tingling both arms and face, lethargic, flu like symptoms on 17Dec2020 23:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of events was recovered in Dec2020.
not feel well; shingles; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feel well) and HERPES ZOSTER (shingles) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced MALAISE (not feel well) and HERPES ZOSTER (shingles). At the time of the report, MALAISE (not feel well) and HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Headache, Myalgia, Fever & CoughWheeze Narrative: Pt reported Body aches, fever, chills, fatigue, headache, cough after 2nd covid vaccine dose. Pt treated with ibuprofen & tylenol.
For a few days after the 2nd dose I had the normal arm ache, after one day of no symptoms my whole left arm from my shoulder to my elbow, it really hurt, it was like a very deep ache. Then it went away and about 3 weeks later my left knee started feeling kind of weak, I could not put any weight on it and it got progressively worse. It started getting swollen like 3 times bigger than my other knee, it was very painful. It was limited to my left knee but a few times at night my whole tight had that same kind of ache as in my arm, like a very deep ache and it was so painful it would wake me up at night. I had a hard time going back to sleep. That lasted about 2 or 3 nights. That thigh ache went away so now I just have the swollen knee. Around 06/06/2021 I went to get an x-ray so I must have called my doctor about 2 days before that. After that I was told to go to the ER and they just gave me crutches and prescribed some anti-inflammatory medicine, then a few days after I went to the ER again and they kept me overnight and they removed fluid and they tested it and they are still doing testing, they gave me a different anti-inflammatory medicine and told me to stop taking the first one.
Admitted to the hospital in AFIB RVR. Positive covid test in the am.
Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.
Expired Twinrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 24-APR-2023, the patient received the 1st dose of Twinrix. On 24-APR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that the patient inadvertently received an expired dose of Twinrix yesterday. No further details available at time of call, but pharmacist consented to follow up. The use of Twinrix, which was already expired on 1st January 2023, which led to expired vaccine used.
My first dose swelled; sore; was hot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling, pain and feeling hot. On an unknown date, the outcome of the swelling, pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the swelling, pain and feeling hot to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that his/her first dose swelled and was hot and sore. The second dose nothing. It was fine. The follow-up could not be possible as no contact details were available.
I've developed nerve pain in my left shoulder.  Initially it was just when raising it laterally, but in the past two weeks it's worsened so that it hurts when I move it in multiple directions. It doesn't hurt all of the time or at all angles, but it's become chronic. I haven't lifted any weights in over 5 weeks. I've visited the chiropractor and done stretches, but I still experience pain.   I've also started getting numbness and tingling in the middle finger of my left hand. Never had that until the vaccine. In the past few weeks it's become more frequent.
This spontaneous report was received from a pharmacist referring to a currently 18 year old female patient. The patient had no pertinent medical history, concurrent conditions or known allergies. Information regarding the patient's concomitant medications was not provided. On an unknown date (reported as "shortly after the patient was born"), the patient was vaccinated with RECOMBIVAX HB dose (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. The patient stated that, on an unknown date (reported as "recently"), she had hepatitis B titers drawn and the titers were negative. The patient then called the reporting pharmacist, to query about the recommendations for revaccination, but otherwise she did not seek for any medical attention. At the time of the report, the outcome of hepatitis b surface antibody negative was reported as not recovered. Additionally, the reporter did not provide for causality between the adverse event and vaccination with RECOMBIVAX HB.
While waiting the 15 minutes, I noticed that the left side of my body went numb. I was told that it was okay and that I could go home. 3 days after the shot, I called the local health dept. and was told to wait and that it would resolve. 2 days later my I couldn't grip with my left arm couldn't grip and my left leg also went numb. Went to the ER 1 week later and had some tests done.
Patient reports having fever for 2 days post vaccination when I talked to her on 7/27/2019. Also her arm swelled up to the point were she could not move it for 2.5 days. She visited her doctor and her doctor suggested not to proceed with the second series of the dose. She used OTC compresses and pain medication to help.
sore arm, pain in the right hand, fever, body aches. nausea, redness. swollen, hot at the red spot zone of the injection.
Patient was ending her menstrual cycle on the day of her 2nd Moderna vaccine. She then started to bleed heavy again and has been bleeding now for almost 2 weeks. Her menstrual cycles are always regular and last no more than 4-5 days.
patient has been feeling ill since he receieved the vaccine. he also has swelling in his legs
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headache injection site/arm soreness, very fatigued, chills Narrative:  Very fatigued, arm/injection site soreness, chills, elevated temp. Took Ibuprofen OTC, headache is subsiding.
Received the vaccine on Aug 1, 2022.   On 8/12 developed slight cough,  slight mucus in throat, by 8/13 symptoms persisted/worsened to lethargy and headache also.  Home covid test immediately positive.  ( I cared for covid patients in nursing homes through 2 waves of covid 2020-21 and in elementary school in 2022 priding on not testing positive as of yet, till now).   I messaged dr, advised follow CDC guidelines, quarantine 5 days then mask days 6-10.  Today Aug 17 is day 5 of quarantine.  For the past 2 nites, days 2 and 3 of quarantine have had excruciatingly painful muscle/joint pain, migratory in nature, left posterior back(scapular) to left flank to bilateral hips,abdomen, thighs, a burning, tearing type pain, "8"/10.   Worsened on lying down.  Eases up at times, intensifies at night. Late last night, I took 2 ibuprofen, 400 mg total, and the pain was relieved, for now.   I had similar thigh tearing pain after cholecystectomy in 2015, attributed to perhaps the anesthesia or lying flat,  the surgeon thought perhaps a blood clot and something similar after statin therapy which was discontinued, but this was on a larger area of my body and weirdly migratory.   As I am on quarantine still, did not seek medical attn, will notify my dr of the muscle pain.   I recently stopped wearing a mask in public, I had faithfully worn one up to this point.
Resident began with all over itching, progressing into hives, that then ended with facial swelling. She required an initial dose of Prednisone, then began a Medrol dose pack, with PRN Benadryl ordered.  She proceeded to experience episodic hives over her arms and torso for almost a week.
diffuse, 2-3cm circular patchy flat erythematous lesions scattered in extensor surfaces of arms;no blanching w/pressure;appeared 1 day p/flu shot;stiff present on 27OCT97;pt used hydrocortisone;
On 10/16/2023 MA gave expired dose of Pentacel to patient on Left Thigh. I have contacted the manufacturer company to receive information and indications about vaccine. Dr. has contacted parent to notify about the incident. Mother of child stated patient is doing fine and will just keep a close eye on him and was very understanding. I have also contacted the compliance department of the company to notify them about incident that occured and incident is also recorded in patients chart.
One day post vax, the pt had a quarter sized area of induration and redness. Pt seen in clinic 3 days post vax, induration and redness measured 5 X 8 mm.
Patient noticed Edema/Erythema that night when undressing (reports increasing radius). Patient also describes throbbing pain throughout entire left arm immediately following vaccination which is getting worse as time progresses.  Patient denies nor shows symptoms of any respiratory reactions or further dermal irritation/discoloration. Erythema/Edema marked with time and date, patient told to see provider if size increases or if there are any further issues. Patient being seen by onsite HCP to determine if further care is indicated.
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction. On an unknown date, the outcome of the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a number of adverse events after her 1st dose of SHINGRIX that lasted for 2 weeks. Consented to follow up.
Each vaccine after the vaccine I had an adrenal insufficiency episode.  Since it happened with the first dose I took stress doses of steroids before the second dose,  I also had COVID 10/2/20
Hives appearing on torso and at injection site of VZV. Redness at site of HPV. Reported 7- 8 hrs after immunizations given. Child was administered wt. appropriate dose of Benadryl. No facial swelling or respiratory involvment noted. Moc reported child doing well and hives  had dissipated after Benadryl given. Moc noted that child had also been to nail salon  to have artificial nails applied after office visit and shots administered. Unknown if this event could have caused this reaction.
Lightheadedness, like vertigo when she stands up; Cannot get out of bed; Extreme Fatigue; Fever; Sweat; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METFORMIN for an unknown indication.   On 08-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) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Sweat), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 16-Mar-2021, the patient experienced DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed) and FATIGUE (Extreme Fatigue). At the time of the report, HYPERHIDROSIS (Sweat), DIZZINESS (Lightheadedness, like vertigo when she stands up), SOMNOLENCE (Cannot get out of bed), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Extreme Fatigue) and PYREXIA (Fever) outcome was unknown.            Other concomitant medications included Alavert for allergy, Herbal Supplement, Asthma medication.  No treatment information was provided.
No redness, warmth at injection site. States under the arm, a vein hurts, runs down his arm, it looks bruised. Started hurting day after injection.
ASSESSMENT AND PLAN: 1. Palpitations (Primary) Assessment & Plan: Next step would be to take 1/2 dose metoprolol for any Bp <100/70 but pt doesn't want to do that at this time. Will cont asprin prophylaxis and will check tsh given concurrent fatigue. Will call with results. If normal thyroid, will f/u in 6 months or sooner should condition worsen   Orders: -     TSH, Reflex Free T4; Future -     aspirin 81 mg EC tablet; Take 1 tablet by mouth Daily.  Dispense: 90 tablet; Refill: 3   2. Essential hypertension Assessment & Plan: Well controlled at present. Limited by palpitations t hat are controlled by metoprolol but when controlled with metoprolol also occasionally cause some low bp and fatigue of unknown etiology. Will cont for now but may need to decrease metoprolol to 1/2 dose for any Bp  <100/70 inf uture.    Orders: -     metoprolol tartrate (LOPRESSOR) 25 mg tablet; Take 1 tablet by mouth 2 times daily.  Dispense: 180 tablet; Refill: 3   3. Fatigue after COVID-19 vaccination Comments: suspect much of fatigue is related to covid 19 vaccination. will monitor   4. Gastroesophageal reflux disease without esophagitis -     omeprazole (PRILOSEC) 20 mg capsule; Take 1 capsule by mouth Daily 1 tablet before breakfast .  Dispense: 90 capsule; Refill: 2   5. Seborrhea Comments: refilled chronic medications Orders: -     desonide (DESOWEN) 0.05 % lotion; Apply 1 Application topically Daily as needed (itch) Apply once daily to prevent ear seborrhea. .  Dispense: 59 mL; Refill: 3 -     triamcinolone (KENALOG) 0.1% lotion; Apply small amount to affected area(s) two to four times daily as needed: avoid face and groin areas.  Dispense: 60 mL; Refill: 3
Chills; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Mar2021, the patient experienced chills and fatigue and was lasted for 1-2 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Pt is a 72 YO male with PMH of a flutter, DM2, PVD, HTN, GERD, CAD, head & neck cancer, HLD, bradycardia, peripheral neuropathy, TIA, and EtOH dependence. The agency was notified of the patient's death by his son. No additional details provided.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased and hyperthyroidism. Concomitant products included Atorvastatin. On 15th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth were recovered/resolved. Reporter considered the pain in arm, injection site inflammation, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. No diagnosis dates were provided for reported medical history. The reporter did not have lot number or expiration of vaccine. Arm pain described as a painful to sleep on arm and painful in pressure applied to arm. The patient was receiving thyroid medicine for concurrent medical condition hyperthyroidism. The patient was recovered completely after two or three days, exact resolution date was not provided. The reporter denied emergency room or physician visit, or hospitalization to treat reported events. The reporter declined to provide mailing address. No diagnosis dates were provided for reported medical history. The reporter noted that the patient did not need to contact or consult with his healthcare professional for reported events. This case has been linked to the case US2018GK054615, reported by the same reporter.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K023432 and expiry date: 18-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.