chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to an unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       On 03-DEC-2019, The nurse identified that on an unknown date, 8 unspecified patients were vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020), and 5 unspecified patients with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) both vaccines for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). The temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. It was reported that the call was due to data logger. No adverse symptoms were reported.  This case was determined as non-valid due to lack of patient identifiers.  Upon receipt of follow-up information from nurse on 08-JUN-2020, it was determined that the case is now valid as the patient identifiers were reported.   The patient was 18 years-old. The suspect product of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was deleted. On 15-NOV-2019 (previously reported as 03-DEC-2019), the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) and on 18-DEC-2019, the patient was vaccinated again with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) both for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-2006USA003314:same reporter
Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 5 patients; 0.25ML/3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients), ACCIDENTAL UNDERDOSE (0.25ML/3rd dose) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and ACCIDENTAL UNDERDOSE (0.25ML/3rd dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 06-Apr-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) outcome was unknown. At the time of the report, ACCIDENTAL UNDERDOSE (0.25ML/3rd dose) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14-Mar-2022. The vial did not undergo any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
Routine ADT after repair knee laceration. Developed pain, swelling, redness, induration at site of injection 3 days after given. Resolved with local heat. Only induration persists now.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
onset of raised, itchy hives on lower lt leg approx 30min p/vax;no tx for hives;no other areas of body affected by hives;no local rxn @ inj site;
admitted to the service of Im at Sh BL on 7/26/2021 with SOB secondary to COVID pneumonia, acute hypoxemic respiratory failure. PMHx significant for CKD III, DM II, CAD, GERD.
Localized erythema with induration 80 by 60 mm. Treated with Benadryl and Motrin.
Mild Tenderness of Nose; Slight Swelling of Nose; This is a spontaneous report from a contactable Other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), intramuscular from  05Jan2021 10:00 at single dose in the right arm for COVID-19 immunization. There were no medical history and concomitant medications. On 06Jan2021 16:00, the patient experienced mild tenderness of nose and slight swelling of nose. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Ouchiest arm ever; Scarcity made #2 a year out; Annoyingly got 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced pain in arm, product supply issue and extra dose administered. On an unknown date, the outcome of the pain in arm, product supply issue and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Jan-2023. Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that annoyingly, got three and first then scarcity made 2 a year out.  The pharmacist said start over so the patient did. The reporter stated that ouchiest arm ever for a vaccination and got 2 more all good. Additional supportive information: The reporter stated that scarcity made 2 a year out which lead to Product supply issue. The patient annoyingly got 3 shots which leads to extra dose administered. The follow up would not possible, as no contact details were available. Note: Due to insufficient information for pain in arm hence link with all three suspect.
Numbness and tingling in the left arm.  Pain accross the shoulders and below the shoulder blades and starting to make the left arm tingle and feel numb.  Mild headache.  Feel very tired.
I am having this weird pain in my arm, since I had the first dose of the moderna vaccine. It starts at the injection site and goes up my arm into my shoulder. It has lasted now for seven days. I get some relief when I ice it or take some Tylenol.
High pulse; Raised BP; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (High pulse) and BLOOD PRESSURE INCREASED (Raised BP) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced HEART RATE INCREASED (High pulse) and BLOOD PRESSURE INCREASED (Raised BP). On 01-Mar-2021, HEART RATE INCREASED (High pulse) and BLOOD PRESSURE INCREASED (Raised BP) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Heart rate: 108 (High) 108.         No concomitant medicines were reported.  No treatment information were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
I had a sinus issue that lasted for months on and off, after the vaccine experiencing fatigue and would not subside. 3/30/2021 Sought care from PCP . Naturopathic treatment of mushroom formula that supports adrenal and fatigue called 3 Defenders.  4/20/2021 EBV profile, CMV, Hemochromatosis tests. Endocrinologist for Hypoglycemia, Low insulin. Referral found that her insulin issue was not causing the fatigue. Monthly appts. to address the fatigue.
got the flu shot he got the flu right after; Initial information regarding an unsolicited valid non-serious case received from a non-health care professional (patient's son) via Digital Media through social media on 24-Nov-2020.  This case involves an adult male patient of unknown age who got the flu right after (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown), the patient got the flu (influenza) following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome was unknown .  There will be no information available on batch number for this case .
Patient came to a Outreach Program on 3/27 and received Moderna COVID19 vaccine. He denied vaccines in the last two weeks and other COVID19 vaccines, however, he had received his first covid19 vaccine on 2/20/2021 and it was the Pfizer vaccine.
chills; neck and shoulder pain; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; neck and shoulder pain /  intermittent joint pain in her left elbow, right shoulder, knee, and back; fatigued; nausea; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 27Jan2021 (at the age of 76-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she has pulmonary fibrosis at baseline. Concomitant medications were not reported. It was reported that, patient is 76 y/o female. She received her first dose of the Pfizer Covid vaccine on 27Jan2021. 3 hours after her shot, she started to experience intermittent chills that last about an hour then go away, neck and shoulder pain - was hard to turn her head due to the pain. Then intermittent joint pain in her left elbow, right shoulder, knee, and back. She felt fatigued and had an episode of nausea and cold sweats. She states she has pulmonary fibrosis at baseline. She is concerned that the side effects have been lasting for a while and wants to know if that's normal. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Redness at the injection site, itchy, very hard lump.  It lasted over the next 3 days or so, then began to resolve.  She has improved significantly at this point.
The day after my shot I got hives all over my body. They were giant hives. I started to take allergy medication to help with the irritation but it wasn't going away. I then called the place I got the vaccine and they hadn't reached back out to me in a timely manner so I did a virtual appointment. I then was prescribed some sort of Steroids for 5 days. I still have the hives mostly on my back and stomach. The hives are very hot but not ichy, just hurt to touch.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4511566-00 (Agency).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: Z-PAK. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was unknown.The reporter considered "covid-19" related to BNT162b2. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility.  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 available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events "Drug ineffective and "Suspected covid-19".
After receiving vaccine - within 20 minutes I became weak and numb on my left side. Went to GP and she said may be Guillain Barré (GB). Went to ER, admitted to hospital for tests. Neurologist ruled out GB, said live virus attached weakness on left side (pre-existing).
Pt presented to clinic on 9/28/22 for a Pfizer injection.  She should have been given Pfizer bivalent but was mistakenly given Pfizer monovalent.
No additional AE reported; a dose of GARDASIL 9 was administered to a pregnant patient in error instead of lu vaccine on 12-DEC-2022; a dose of GARDASIL 9 was administered to a pregnant patient in error instead of lu vaccine on 12-DEC-2022; This pregnancy prospective spontaneous report was received from a healthcare business professional and refers to a 16-weeks-pregnant, 28-year-old female patient. Number of fetus was defaulted to 1. Last menstrual period (LMP) was estimated as 25-AUG-2022, date of delivery was estimated as 01-JUN-2023. At the reporting time, pregnancy outcome was pending, fetal outcome was unknown. The patient's medical history included gastric bypass. The patient's concurrent conditions included diabetes. The patient's concomitant medications included iron tablet. The patient's drug reactions/allergies were unknown by a reporter.  On 12-DEC-2022, the patient was vaccinated in error with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in pre-filled syringe, injection, lot #: W002963, expiration date: 06-OCT-2024 (strength, site and route of administration were not provided) for prophylaxis instead of influenza vaccine (reported as flu vaccine) (exact dose, strength, formulation site and route of administration were not provided, lot #, expiration date and indication were not provided) (maternal exposure during pregnancy; wrong product administered). The patient had not experienced any symptoms. It was unknown whether any treatment was given to the patient. No additional adverse event reported.
1st shot, she experienced nausea and pain; 1st shot, she experienced nausea and pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. An 85-year-old female patient received first dose of bnt162b2, Solution for injection (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced nausea and pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk.  Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
Positive for covid-19; Shortness of breath / difficulty breathing; Can't talk much, has trouble with her voice; Diarrhea; She got sick; Ongoing cough; Experienced chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea) and ILLNESS (She got sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills). On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: (Positive) Covid-19 rapid test positive was reported..     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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the event COVID-19 positive is unlikely related to mRNA-1273 .
a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome.  Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events.  Information about Lot/Batch number is requested.
This spontaneous report was received from a Nurse Practitioner refers to a 67 years old female patient with allergy to penicillin, allergy to MACROBID, endometrial carcinoma and hemochromatosis. On 07-DEC-2012, the patient was vaccinated subcutaneously (SQ) with a 0.65 ml dose of ZOSTAVAX (lot # not reported). No other co-suspects were reported. Concomitant medications included: COLACE. The Nurse practitioner reported that a patient who received ZOSTAVAX had developed a rash on her abdomen and back. It was on both sides of the body (it was not limited to one side). The patient had a hysterectomy on 12-JAN-2013 and the rash developed approximately 2 days after the surgery (approximately on 14-JAN-2013). Patient's outcome was reported as recovering. The patient was treated with BENADRYL. The patient sought Medical Attention by visiting office. No lab diagnostics were performed. The Nurse Practitioner said the rash looked like contact dermatitis and she did not think it was related to ZOSTAVAX. The relatedness for hysterectomy was unknown for ZOSTAVAX. Upon internal review the event hysterectomy was considered to be medically significant. Additional information has been requested.