chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after waiting for 20 minutes after first vaccine, she started to develop one hive on chin and a couple of hives on the back of her head. She also complained of a tightness in her neck. She was not having any shortness of breath. She was offered zyrtec. She drove home and took some benedryl. She was feeling better within 1 hour of taking benedryl at home. she did not have any other symptoms.
Patient was inadvertently given the Moderna vaccine which is not indicated for use in children under the age of 18.
Inofrmation has been received from a pharmacist referring to a female patient of unknown age with allergies to codeine and KEFLEX. Pertinent medical history was not reported. On 15-SEP-2015 the patient was given a dose of ZOSTAVAX, lot # L021602, expiration date 10-SEP-2016 (dose and route were not reported), on an unspecified location on her left arm by an unspecified physician. Concomitant therapies included oxycodone, gabapentin, losartan, furosemide and cyclobenzaprine hydrochloride. Then the next day, 16-SEP-2015, the patient started to experience unspecified right sided torso pain. On an unknown date in 2015, the patient confirmed with the physician that she did not develop a rash. At the time of reporting, the patient did not recover. The causality was not reported. Additional information has been requested.
The site was inflamed, pink/red and tender. Had fever of 104.  Given same antibiotic , Cephalexin 500 mg. Same healing time, but sicker than I was with first dose.
severe flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved.   The reporter considered the flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's sister in law. After receiving Shingrix, the patient experienced severe flu-like symptoms. No further details were collected. Reporter provided limited information. This case was linked with case US2020223073, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223073:same reporter
Patient received vaccine on 11/5/02.  Returned with erythema and enduration at vaccine site 15*10 cm.  Very tender.  No fever.  Patient does complain of Headache.
Here for c/o left arm-deltoid muscle-after 10/2023 No xrays at urgent care Immediate pain after injection Never bump, but red & warm, no swelling Massage therapist-knew her-January-reduced neck  Rigth handed  Seteroid 2/7-10 mg x 5 days Muscle relaxer
PT CALLE D IN 8/23/21 @ APPROX 2:30PM_ PT EXPERIENCED DELAYED REACTION OCCURED 11 DAYS LATER AFTER VACCINATION. PT EXPERIENCED ONSET ON SATURDAY UPON WAKING UP IN THE MORNING.       WARM TO TOUCH (APPROX 99.5 DEGREES) ;  NOTICABLY SWOLLEN LEFT ARM; REDNESS & PAIN AT INJECTION SITE. PT ALSO DISCLOSED THAT COVID VACCINATION WAS DONE ON ARM THAT  HAD A ROTATOR CUFF PROBLEM. HOWEVER, THAT WAS NOT DISCLOSED TO VACCINATING RPH .  UPON COUNSELING TODAY, PT WAS ADVISED TO TAKE TYLENOL TO HELP WITH PAIN & WARM ARM REACTION, & TO SOAK ARM WITH EPSOM SALT & WARM WATER. MONITOR FOR 3  DAYS IN NO IMPROVEMENT CALL BACK PHARMACY & FOLLOW-UP WITH PT'S PCP. PT UNDERSTOOD .  PT WAS ALSO NOTIFIED TODAY THAT DELAYED REACTION AFTER SEVERAL DAYS/WEEKS CAN OCCUR FOR SOME PPL. PT UNDERSTOOD.
This spontaneous report as received from a Licensed Practical Nurse refers to a three children of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On 18-MAR-2015 the three patients were vaccinated with VARIVAX (Merck) (dose, route of administration, lot# and expiration  date not reported). The VARIVAX (Merck) was improperly stored. There were no adverse effects reported. Additional information has been requested.
the patient got infected with COVID/once was about Dec2021; the patient got infected with COVID/once was about Dec2021; This is a spontaneous report received from a contactable reporter (other HCP) from Medical Information Team. A male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose number unknown, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) with onset Dec2021, outcome "unknown" and described as "the patient got infected with COVID/once was about Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) positive. Clinical course: The patient got infected with COVID; he has been exposed to COVID and he got very sick once was about Dec2021.   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 known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201198081 same patient/product/event, different vaccine dose;
8/7/12 Mom - called clinic to report patient has 104 degrees fever & is vomiting. Mom states "he & all my kids do this with every shot they get". Mom states is using TYLENOL & Ibuprofen to help with fever, giving fluids, etc. No plans to see PCP unless "it gets a lot worse". Denies any local site reaction. Advised mom to call if she contacts PCP or has concerns.
No adverse event; 6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine).    Reporter stated that relevant medical history conditions, allergy, concomitant diseases and risk factor were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717776 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717776:Master case
Mild local injection site reactions of both thighs.  Started the day after vaccines were administered.  Recommended supportive care with cool compresses and Tylenol as needed.  Expect full recovery with no negative consequences.
Patient reports feeling "fine" after receiving the vaccine and before leaving the clinic. About 4 hours later, patient reports feeling very, very cold and faint. 911 was called and patient was taken to the emergency room where her initial blood pressure was 40/20's.
Patient reports 7 days post vaccination raised, hive-like area. w/o pruritis that flattened over time and now presents as reddened area. Pt did not take any Benadryl for reaction. Pt concerned about second required series due 1/30/21 to where she will rcv medical advice.
have them, have shingles; got shot years ago, not booster; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient stated that he/she was vaccinated with Shingles vaccine a few years before reporting and did not know he/she needed a booster. The patient had shingles at the time of reporting. Additional Supportive Information: The patient missed the booster dose of shingles vaccine, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
Erythematous, edematous right thigh in vastus lateralis. Mother given instructions to use Tylenol and apply ice to local area.
31 year old walking patient stands in observation area. Reports to the paramedic of feeling nauseous after the vaccine administration. We proceed on taking her vital signs BP 130/80, pulse 76min, Spo2 99%, glucose 71mg/dl. Patient reports not having eaten anything all day. 4oz of juice is given to her. Vitals are re-evaluated BP 130/80, pulse 87, Spo2 99%, DEXTROSE 113. Patient reports not having any nausea and feeling good and proceeds to leave the vaccination center.
pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a spontaneous report from a contactable Non-healthcare Professional. This Non-healthcare Professional reported that a 44-years-old female patient received bnt162b2 (BNT162B2;  brand=Pfizer COVID; lot number=EL3302) second dose, via an unspecified route of administration at Left arm on 20Jan2021 11:30 AM at SINGLE DOSE for covid-19 immunisation.  Medical history included lymphocytic colitis from an unknown date and unknown if ongoing, diagnosed with covid-19 prior to vaccination. No Allergies to medications, food, or other products. Historical vaccine included received first dose of Pfizer COVID 19 vaccine (lot number=EL3246) on 30Dec2020 at left arm for covid-19 immunization. Concomitant medication included budesonide and OTC vitamins.  The patient experienced pain and swelling in arm pit of left arm on 22Jan2021 08:00 AM with outcome of recovering. No treatment received. The events reported as non-serious.The patient was not pregnant and not Pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19.
Patient developed redness, swelling and fever at injection site on left arm Friday afternoon. Developed nausea and vomiting on Sunday. And overall does not feel well. The injection site was doing better when the phone call was received on Monday 11/25/2013.
6 days p/vax pt devel an inj site rxn characterized by redness & warmth;pt was seen by MD & instructed to take DPH & apply ice to inj site pt recovered;
Case number PHEH2014US024287, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 17 year old male patient. His medical history and concomitant medication were not reported. His previous vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in left deltoid on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 01Apr2023 to 05Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health professional referring to 1 year old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 15-JUN-1999, the patient was vaccinated with the first dose of M-M-R II and the first dose of VARIVAX, on 06-OCT-2003, the patient received the second dose of M-M-R II and on 04-JUN-2007, the patient received the second dose of VARIVAX all of them for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date, an unspecified test was performed and the results showed titres were 0. Nevertheless, the patient did not receive treatment to the aforementioned event. On 01-OCT-2018, the patient was vaccinated with PROQUAD (Captured in MAARS # 1810USA000670). At the time of the report, the outcome of antibody test negative was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and vaccination with M-M-R II and VARIVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA000670.
developed pain after the administration; dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint; dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 922yf, expiry date 07-MAY-2025) for prophylaxis.   On 29-SEP-2023, the patient received the 2nd dose of Shingrix. On 29-SEP-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint) and vaccine administered at inappropriate site (Verbatim: dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint). On an unknown date, the patient experienced pain (Verbatim: developed pain after the administration).  The outcome of the pain was not reported and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 3-Oct-2023 Pharmacist reported that the patient developed pain after the administration. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received a dose of Shingrix and the dose was administer to high in the deltoid muscle, probably subcutaneously or in the shoulder joint, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site.
Pain starting within several hours of vaccine. No redness, warmth or swelling. Just pain that extended into head neck and became so severe patient considered going to the ED. Pain then began to fade and within 12 hrs of pain starting it went away and has not returned.
Large rash over six inches in diameter and associated swelling around injection site. Some tenderness to touch and return of muscle ache around the injection site . Onset six days after vaccination and ongoing.  Appears to be what is commonly referred to as Covid-arm.
rash/fever; pt was treated clinic on 11MAR95 for ear infect; 13MAR95 mom called pvt MD & clinic;
Sinus Congestion; Runny nose; Felt miserable; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable). At the time of the report, SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial report received from a health care professional on 13 January 2011. A 44-year-old female patient received on 07 December 2010 a left deltoid intramuscular injection (dose 1) of FLUZONE, lot number U3788AA. The patient had a history of heartburn, reflux and anxiety. He had an allergy to FLOXIN and penicillin. The patient had no illness at the time of vaccination and received no other vaccines within 4 weeks of the FLUZONE. the patient's concomitant medications included XANAX, omeprazole, potassium and PHENERGAN. The patient received no prior influenza vaccines. On 09 December 2010, the patient developed nausea, red palms, red circle around injection site, swelling of hands and "achy". The patient took BENADRYL. The outcome was not reported. Follow-up information was received 18 February 2011 from a health care professional. Allergy testing had not been performed and the reported events did not require any additional treatment medications except for BENADRYL. According to the reporter, the patient recovered (date not reported). Documents held by sender: None.
57-year-old male with history of diabetes, presented to the emergency room department due to worsening shortness of breath and hypoxia, patient was diagnosed with COVID-19 infection about a week ago, he denies any sick contacts at home, he has not received COVID-19 vaccination, his symptoms have been progressively worsening over the past couple days, he checked his oxygen levels at home and was 88%, he denies any associated chest pain, nausea, vomiting, dizziness or focal weaknesses.  He denies any productive cough or chest pain.  He had a fever 100.9 in the emergency department.  Chest x-ray showed multi focal pneumonia, he received IV antibiotics per ED provider and currently admitted for further evaluation.  He is currently requiring 3 L O2 via nasal cannula
Patient thought she had Moderna for 1 & 2, but she actually had Pfizer.  Patient was fine with the switch, she was just unaware of it.  We only administered 1 MRNA vaccine today:  Moderna.
Fatigue; 103 degree fever; This is a spontaneous report from a contactable consumer. A male patient of unknown age received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 the patient experienced fatigue and 103 degree fever. Therapeutic measures were taken as a result of fatigue and 103 degree fever included treatment with acetaminophen (MANUFACTURER UNKNOWN). On 30Apr2021, the patient underwent body temperature and the result was 103 degree fever. The clinical outcome of the events fatigue and 103 degree fever was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about the lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information:Patient's Initials updated as unknown, Country captured,Supplier to safety updated to measurable supplier other and Protect Confidentiality unticked in general tab.
presented on 10/2/99 w/vomiting & lethargy, 10/3/99 had surgery @ hosp for intussusception;
Moderna COVID-19 Vaccine EUA: seven days after vaccination patient developed painful, pruritic rash at injection site that spread to chest, stomach, back, limbs, lips, and scalp. Initially seen at an urgent care where administered methylprednisolone, initiated prednisone, and symptoms worsened.  Patient subsequently went to a dermatologist that initiated Valtrex and mupirocin. One day later patient presented to emergency department because rash continued to worsen and become more painful. No fever, chills, nausea, malaise, oral erosions, or ocular symptoms and vital signs within normal ranges. Patient admitted and diagnosed by dermatology with erythema multiforme (dusky, targetoid appearance with central blister, pale ringe of edema, and peripheral erythematous halo) secondary to herpes labialis. Initiated antivirals, topical steroids, oral antihistamines, and moisturizing cream. Patient discharged to home one day later improved and medically stable with dermatology follow-up in place.
Information has been received from a healthcare worker concerning an approximately 56 year old male with no pertinent medical history who in early April of 2009, was vaccinated with PNEUMOVAX (lot # 661529/0868X) (dose and route unspecified). The patient experienced persistent pain at the injection site for two weeks after the vaccination, and he went to the office to seek some medical attention. At the time of reporting the patient was not recovered from the event. Additional information has been requested.
03/18/2010 patient noted left arm sore, swelling, et. redness present.  Swelling extending to left wrist eventually.  Patient was seen by MD at Health Center on 03/20/2010 et and treated with antibiotic.  1 week later 5X improved and almost completely gone.