chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recieved Engerix -B 1st and 2nd Dose, 3rd Dose Received was Heplisav-B and Expired; Received Expired Dose; Initial Report Received on 20-Apr-2023  A pharmacist reported that a 65-year-old female patient (race and ethnicity unknown) received Engerix-B for the first and second dose and was given an expired dose of HEPLISAV-B (hepatitis B vaccine) as the third dose for hepatitis B immunization.    Medical history, allergies, and concomitant medications at the time of vaccination were not reported.    On an unknown date in Oct-2022, the patient received Engerix-B as the first dose (no details provided).   On 18-Nov-2022, the patient received the second dose of Engerix-B (no details provided).   On 20-Apr-2023, the patient received an expired dose of HEPLISAV-B vaccine as the third dose (Lot # 935844, expiration date 04-Nov-2022, and NDC # 43528-003-05) intramuscularly in the left deltoid. No adverse reactions were witnessed. No concomitant medications were given to the patient.   No additional information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Woke up next morning approximately 15 hours after Shingrix injection with fever, headache, chills, and nausea.  Symptoms lasted approximately 24 hours.
Red rash and swollen spot at injection site .   I'm reporting at the 5 day point, redness still apparent, swelling is gone.
Approximately 8 to 12 hours after receiving the Hep B Vaccine, patient's body began to swell and with red hives and dark purple spots.  We took him to the ER.  He was kept for observation over night.  He was very sick, weak, would not nurse, his tongue, face lips, eyes were severely swollen. His body was covered in red welts and purpura spots.
This spontaneous report as received from a license practical nurse and refers to a patient of unknown age and gender. The reporter stated that the patient was in the office (on 25-SEP-2014) to receive GARDASIL injection (0.5 ml, intramuscular, anatomical location, lot number were not reported) as the second dose in the vaccination schedule. The patient received the first dose of CERVARIX (reported as CEVARIX) on 18-JUN-2013. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB lot # K006682, expiration date 17-DEC-2015 (dose, frequency and route were not reported). No adverse experiences were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Rash, swelling, pain on right. Arm a few hours after receiving PNEUMOVAX. Pt used MOTRIN, CLARITIN and ice. Pt getting better after 2 days.
Administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB60AA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 01-Apr-2022 Reporter's Comments: The reporter stated that the patient was administered an expired dose of Bexsero and want to know what side effects to expect. No additional details were available. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
PER CONVERSATION WITH PATIENTS MOTHER, "NO FEVER, BUT INCONSOLABLE FOR LONG PERIODS OF TIME, CRYING/SCREAMING, IRRITABLE, RASH STARTED ON FACE AND NOW SPREAD TO BODY, DECREASED PO BUT STILL VOIDING PLENTY, INTERMITTENT SCREAMING."
Post vax, the pt developed pains, muscle aches, fatigue, episodic malaise, and pain at the injection site that radiated up to her neck and down to her middle three fingers as well as parasthesia in those fingers. She was hospitalized.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II lot # L001336, expiration date: 13-JAN-2017 (dose and route were not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same source. Additional information has been requested.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 immunization: Moderna Covid-19 vaccine (dose 1 batch:027A21A) on 05-Mar-2021, Moderna Covid-19 vaccine (dose 2 batch:019B21A) on 02-Apr-2021, Moderna Covid-19 vaccine (dose 3 batch:307B21A) on 12-Nov-2021 and Moderna Covid-19 vaccine (dose 4 batch:058A222A) on 28-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.   On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Vaccinations on 5/24/2011. Onset redness at vaccine site 5/25/11. Redness & induration & warmth increasing on 5/26/11.
c/o of blurred vision; blackout, SOB, handover pt. to the paramedics.
Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers; It is affecting patient from shoulder blade to their fingers/can't lay down in my arm; can't sleep; severe pain in the arm/The 'terrible pain' in the arm is still going on; could not rise my arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm), INSOMNIA (can't sleep) and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (First dose (J&J, no lot number) and was reported.) on 17-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Hypercholesterolemia, Hypertension and Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm), INSOMNIA (can't sleep) and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on). The patient was treated with MELOXICAM (MOXICAM [MELOXICAM]) at a dose of 15 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm) and INSOMNIA (can't sleep) outcome was unknown and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on) had not resolved.            Concomitant medications includes stomach pill, cholesterol medicine, blood pressure medicine, heart medicine.
This medically confirmed spontaneous report (initial receipt 13-Nov-2014) concerns a 77 year old female patient. On the 09-Nov-2014, the patient received AFLURIA (batch number T51208) 0.5mL annually in an unspecified arm. On the 09-Nov-2014, the patient developed redness at the injection site. On the 10-Nov-2014, the patient received her ZOSTAVAX vaccine (batch number not reported) in the opposite arm as the AFLURIA injection. On the 11-Nov-2014, the injection site redness worsened so the patient visited her primary care provider who diagnosed her with cellulitis and was being treated with cephalexin (dose and duration unspecified). The doctor specified that the AFLURIA injection was given below the deltoid which may have caused the cellulitis. The pharmacist stated that the injection was given in the deltoid. Outcome was reported as not yet recovered.
Developed Covid Arm.   Red itchy circle at injection site approx 2 inches in diameter with firm lump underneath.   The date I first noticed it is approximate.  It?s almost gone and it?s been approx 4 days.   Did not need any treatment.
Didn't get the second dose.; Residual effects about every 2-3 weeks; Chills; vomiting; Painful excruciating gut pain; cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.), GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) and CHILLS (Chills) in a 66-year-old male 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.     The patient's past medical history included Chemotherapy (Platinum-based chemotherapy). Previously administered products included for an unreported indication: Flu vaccine in November 2020. Concurrent medical conditions included Prostate cancer since 11-Jan-2017, Drug allergy (Allergic to cholchicine), Bladder cancer since 11-Jan-2017, Bone cancer since 11-Jan-2017, Acid reflux (esophageal) and Blood pressure high. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), FLUTICASONE for Allergy, SIMVASTATIN for Cholesterol, BROMELAINS (BROMELAIN) for Digestion impaired, ATENOLOL for Hypertension, PEMBROLIZUMAB (KEYTRUDA) from August 2018 to June 2021 for an unknown indication.    On 05-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 11:00 PM, the patient experienced GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, GASTROINTESTINAL PAIN (Painful excruciating gut pain), COLD SWEAT (cold sweats), CHILLS (Chills) and VOMITING (vomiting) had resolved with sequelae. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose.) had resolved and SYMPTOM RECURRENCE (Residual effects about every 2-3 weeks) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient refused to get his 2nd shot  Patient stated that he gets residual effect about 2-3 weeks for the past 5 months and it has not given up. Patient reports he experienced very similar reaction after receiving the flu vaccine in November, not as severe,  but same timing, no residual effects since last year.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Updated patient demographics, updated medical history, added concomitant medication, events were added, outcome and causality of events were updated.
I had a frozen embryo transfer on May 24th. The embryo was 5 days and PGA tested. It was successful. I had 3 really good HCG measurements with the last on June 8th being  2500 mIU/ml. An ultrasound was performed on June 20th, the embryo measured 4mm. There was no heart beat yet. A second ultrasound was performed on June 27th. There was no heart beat and the yolk sac was gone. It was considered a missed miscarriage. A third ultrasound confirmed that growth had stopped at 6 weeks 2 days.
Information has been received from an RN concerning a 76 year old patient who in November or December 2007 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine, lot #657626/1084U. The patient commented that the injection was painful and 1-2 days later developed warmth and localized hives at the injection site. The patient also reported pain from the shoulder to the breast area. Medical attention was sought. The patient was recovering. The nurse indicated that 2 additional patients had identical adverse experiences from pneumococcal 23v polysaccharide vaccine, lot #1084U, and requested a lot check to ensure the product was safe to use. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
I developed a small hive/bite looking spot around the injection site. It began as about 1inch and has grown to cover the whole upper arm. It is red around the outside and lighter in the middle. Is seems to be growing, it is warm to the touch, and slightly itchy. Not other side effects
sore arm for 2 days, headache ever since, extreme insomnia (inability to sleep for 6 days), brain fog
Severe itching & redness @ injection site X 3-4 days. Progressively worsened & then resolved
Patient was seen with her child who was to receive the MMR vaccine.  During injection, the child struggled and the needle came out of the arm while it was being plunged.  The vaccine was inadvertently sprayed into mother's right eye. Eye was flushed with water and mother advised to follow up if any further symptoms.  Mother returned on 1/29/14 with symptoms of burning and itching on lateral aspect of eye.  Treated with Tobradex and advised to return in 1 week if no improvement.  Mother has appointment with optometrist on 2/5/14 for additional follow up.
Experiencing high levels of anxiety along with psychoses (auditory) and  paranoia  the very next day following the second covid-19 shot (pfizer).
Patient developed hives covering entire body 24 hrs after receiving Tdap, MENACTRA, and GARDASIL 9.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 26May2022 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunization; 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. Concomitant medication(s) included: SERTRALINE [SERTRALINE HYDROCHLORIDE], start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022, outcome "unknown", described as "Interchange of vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (26Dec2022) Negative; (28Dec2022) Negative; (31Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment details Anti-viral details: product COVID 19 Treatment, brand Paxlovid, treatment start date 19Dec2022, treatment stop date 23Dec2022, indication Treatment of COVID-19.
About 24 hours after my shot I got a fever that ran from 101-103 degrees, the chills and could barely stay awake. It lasted about 8-10 hours total and then I was fine again.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain. On 26th September 2018, the outcome of the dizziness, general body pain and bone pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the diarrhea and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, diarrhea, dizziness, upset stomach, injection site pain, general body pain and bone pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the arm. The next day she had redness and pain at the injection site. Every bone in her body hurt, she felt dizzy and she had an upset stomach and diarrhea. She spent the day in bed. By that evening the body aches and dizziness were resolved. The redness resolved after about one week and the pain a little after that.  She has continued to have an upset stomach and diarrhea since getting the injection.
pt recv vax 9APR98 & 20min later exp swelling of nares resulting in difficult breathing;pt had an allergic rxn resulting in hives & a rash  on rt arm;
Lightheaded or dizzy; Dry heaves; Very warm; Charley horses in both legs; Chills; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm, on 26Jan2021 at 13:15 (01:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a doctor's office or urgent care facility. On 26Jan2021 (reported as 12:15 AM; pending clarification), the patient woke up lightheaded or dizzy, with dry heaves, very warm, and with Charley (reported as Charlie) horses in both legs, then she got the chills. This morning (27Jan2021), the patient felt fine. No treatment was administered for the adverse events. The patient was not tested for COVID-19 post vaccination. The patient recovered from the events on 27Jan2021.
Ring of erythema, warmth, swelling, hives 2-3 around injection site (MMR) Lt thigh immediately after shot administration. Resolved after 30 mins w/ Benadryl 10mg orally.
Information has been received from a licensed practical nurse concerning an 8 year old healthy female who on 10-FEB-2000 was vaccinated with Varivax. On 06-MAR-2007 the patient experienced breakthrough chickenpox and was exposed to wild type at school. The patient had 0-25 lesions and was afebrile. No treatment was ordered. Patient outcome was not reported. 2/11/10 In follow-up received 17-APR-2007, the nurse noted there were 20-25 chicken pox spots over patient's trunk and extremities that looked papular. One lesion on the lower abdomen looked vesicular. There were no relevant diagnostic testm or laboratory data. It was unknown if there was any illness at the time of the vaccination. Patient outcome was unknown. No further information is available.
Administration error: Patient incorrectly given Moderna as first dose  on 2/5/21 despite being <18y/o. Error was detected when patient presented for second dose. Patient given Pfizer at that time due to age <18y/o which resulted in a mixed-dose series.
GENERAL WEAKNESS IN THE LEGS AND ARMS; ODD KIND OF TINGLING THROUGHOUT BODY THAT KIND OF WENT INTO HEAD AS WELL; HEADACHE; HEAVY HEART BEAT; HOT FEELING IN FACE AND SAME HOT FEELING DOWN INTO LEGS/GENERAL WARM KIND OF FEELING; CLAMMY KIND OF FEELING; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced heavy heart beat. On 19-OCT-2021, the patient experienced hot feeling in face and same hot feeling down into legs/general warm kind of feeling. On 19-OCT-2021, the patient experienced clammy kind of feeling. On 19-OCT-2021, the patient experienced headache. On 21-OCT-2021, the patient experienced general weakness in the legs and arms. On 21-OCT-2021, the patient experienced odd kind of tingling throughout body that kind of went into head as well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from heavy heart beat, hot feeling in face and same hot feeling down into legs/general warm kind of feeling, odd kind of tingling throughout body that kind of went into head as well, general weakness in the legs and arms, and clammy kind of feeling. This report was non-serious.