chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started getting some Covid symptoms on the 18th and was tested yesterday and am positive; Body ache; pain on the injection site; This is a spontaneous report from a contactable nurse (patient) received from a Pfizer sponsored program CoVax US support. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration on 15Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication included vitamins. Nurse stated, I got the Pfizer first dose on the 15Feb2021, then I started getting some Covid symptoms on the 18Feb2021 and I was tested yesterday and I am positive i.e. on 23Feb2021. Now I am supposed to get the second dose on the 08Mar2021. Is there any contraindication for me to not get it on the 08Mar2021? I want to know if it is safe for me to get it on the 08Mar2021. Causality, Nurse stated, Well I do not know because on unspecified date Feb2021 after I received it like 3 days later or 4 days later I had body ache, I had pain on the injection site but then I never had Covid, I do not know if it is the vaccine or the Covid because my mother got the Covid too and my uncle got it too. Treatment, Nurse stated, well after I was feeling really bad I am taking Tylenol flu. Patient wanted to know since she tested positive after her first dose of the covid vaccine is she still able to take the second dose of the covid vaccine. The outcome of events was unknown. The patient underwent lab tests and procedures which included tested positive for COVID: positive on 23Feb2021.  No follow-up attempts are possible. No further information is expected.
back hurt; stomach hurt (she doubled over); rash on nose; arm hurt; shoulder hurt; bad headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurt), ABDOMINAL PAIN UPPER (stomach hurt (she doubled over)), RASH (rash on nose), VACCINATION SITE PAIN (arm hurt) and ARTHRALGIA (shoulder hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach discomfort (Motility issues in stomach), Stroke (3 stroks (1991, 2002, 2006).), Endometriosis, Psychiatric disorder NOS and High cholesterol. Concurrent medical conditions included Allergy (Allergies include all of the "lipitor class", all stomach medications.) and Allergy to sting (Allergy to bee sting). Concomitant products included CLONAZEPAM (KLONOPIN), CLOPIDOGREL BISULFATE (PLAVIX), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), VITAMINS NOS, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ALFUZOSIN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced BACK PAIN (back hurt), ABDOMINAL PAIN UPPER (stomach hurt (she doubled over)), RASH (rash on nose), VACCINATION SITE PAIN (arm hurt), ARTHRALGIA (shoulder hurt), HEADACHE (bad headache) and FATIGUE (tired). At the time of the report, BACK PAIN (back hurt), ABDOMINAL PAIN UPPER (stomach hurt (she doubled over)), RASH (rash on nose), VACCINATION SITE PAIN (arm hurt), ARTHRALGIA (shoulder hurt), HEADACHE (bad headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.   This case was linked to MOD-2021-263735, MOD-2021-263805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-Significant follow up appended: No new information
No additional AE; vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-JAN-2022, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # U022321, expiration date: 15-JUL-2023 (route of administration was not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of -14.1 degrees Celsius for 12 minutes. There were no previous temperature excursions reported. No adverse event was reported.
This case was reported by a consumer via call center representative and described the occurrence of possible fibromyalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 14 days after receiving SHINGRIX, the patient experienced fibromyalgia, injection site pain, muscle pain, joint pain and difficulty sleeping. On an unknown date, the outcome of the fibromyalgia, muscle pain, joint pain and difficulty sleeping were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the fibromyalgia, injection site pain, muscle pain, joint pain and difficulty sleeping to be related to SHINGRIX. Additional details were reported as follows: The patient stated she had a reaction to the SHINGRIX vaccine received on left arm. The patient experienced pain at the injection site which lasted for about a week. About 2 weeks after receiving the vaccine the patient experienced muscle pain and joint pain on both sides of the body which was worse at night. Due to the pain the patient was not able to sleep at night. The patient thought she might had fibromyalgia but she had not been diagnosed with it. Since her symptoms were similar to what fibromyalgia could cause. The reporter consented to follow up. No further details were provided. The patient did not have her doctor's information but she would call back to provided that information. The patient did not have her physician's information but she would call back to provided that information.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Nausea-Mild.
PFIZER COVID VACCINE #3 GIVEN 10/26/2021, LOT #FF2590; pt had a positive COVID test on 1/19/22; 1/23/22 pt brought to ED with SOB, slurred speech, AMS; test revealed no evidence of CVA; positive for COVID; Pneumonia due to COVID; pt's condition worsened throughout hospital stay; DNR; pt passed away in the hospital
On the 05/16 I started experiencing extreme itching on 05/17 it progressively got worse. On  05/18 I had hives all over my body. I started taking Benadryl. I also have seasonal allergies so I am not sure if this is in reaction to the vaccine. I was prescribed Methylprednisolone. I also reported to smartphone tool that I noticed that I had swelling under my arm and breast area on the left side. I noticed swollen lymph nodes.
36 hours - extreme sensation of cold as though running a high fever - went to bed. Fatigue. 48 hours - sensation of heat and pain at and around injection site [radius 3"]  day 3-7 pain at injection site migrated down arm and across upper shoulder into back of neck. Sharp pain in back of neck one day. Overall flu like symptoms [ headaches, body aches, fatigue, etc.] Contacted Dr's office on day 5 - no action - patient told that this was within the range of normal reaction.  Day 8 awoke to swollen face, puffy eyes - unable to work.  Seen by Dr. who started a medrol dose pack. Day 9 Only minimal relief. Was started on 20 mg prednisone 3x day for 3 days, 2x day for 3 days etc. until symptoms were gone. Total duration of symptoms was approximately 2 weeks.
Narrative: Decrease oxygen sats, SOB, cough, HA, body aches, fatigue Hx of obesity, DM. Received azithromycin and steroids with no improvement. Then received remdesivir and dex. d/c home. Moderna #2. Covid+
Confirmed Breakthrough Case   COVID-19 (Moderna) 1  03/02/2021 Hospital Moderna 015M20A   COVID-19 (Moderna) 2  04/17/2021 Hospital Moderna 018B21A
already vaccinated for first and second dose but still tested positive for covid a week before his booster.; already vaccinated for first and second dose but still tested positive for covid a week before his booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "already vaccinated for first and second dose but still tested positive for covid a week before his booster.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still tested positive for covid a week before his booster.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Pt examined on 1/19/06 per request of mother.  Developed fine rash on trunk and extremities.  R leg injection site slight edematous mom reported baby could not stand.  Upon exam by physician baby able to bear weight and move all extremities full range of motion with difficulty.  Instructed to use Tylenol/ Ibupropren as needed.  Mom took baby to local ER with visit in office of same symptoms.
First dose / on 5/6/2019 / has not had a 2nd dose yet /  First dose / on May 16, 2019 / never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detials were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details for 1st dose were updated. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137218:Same reporter
pt recv vax 7NOV97 230PM stating was covered w/hives on torso, arms, legs & foot;states has been taking DPH per MD;18NOV97 to clinic;PMD states all hives have cleared up & denies any resp problems;
Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The healthcare professional (HCP) wanted to know whether the patient should revaccinate or not.  The vial was initially stored in the refrigerator on 10-Jan-2022.  The vials did not undergo any temperature excursions.  No treatment medications were reported.
Body aches; chills; headache; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, chills, headache, fever on an unspecified date. Events took place after use of product. The outcome of events body aches, chills, headache, fever was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant referring a 79 year old female patient. The patient's pertinent medical history included vaccination with Prevnar (manufacturer unknown) on an unspecified date in 2015. In addition, the patient's drug reaction or allergies information were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml, intramuscularly (dosage schedule, lot # and expiration date were not reported) for prophylaxis (reported as "the patient was due to receive PNEUMOVAX23 because the patient received PREVNAR in the past"). Concomitant medications were not provided. It was mentioned that on the same date, upon administration, the medical assistant noted "a little blood return in the syringe". No treatment was given for the treatment of the adverse event. No laboratory test were performed. This is one of the several reports of the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA007183.
Headache; Body pain; Joint pain; Chills; Sensitive skin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 20Mar2021 at 16:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 03:00, the patient experienced headache, body and joint pain, chills and sensitive skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body and joint pain, chills and sensitive skin were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
arm pain x 3 days, diarrhea x 1 day, increased urination x 1 day
Received 1st DTaP on 12/10/1998.  Cried for 48 hours and had a seizure on 12/12/1998 at which time he stopped breathing and went limp and his eyes rolled back into his head.  This lasted for approx. 30 seconds. We took him immediately to the ER and followed up with our family dr the following day.  We took him to a pediatric neurologist within that week where it was determined that his seizure was a direct result of the pertussis component of the DTaP.
No additional AEs were reported; patient received smaller than recommended dose of VARIVAX due to the needle being slipped out of the patient due to a human error; This spontaneous report has been received from nurse concerning a 12-month-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 28-OCT-2022, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number w018831 with expiration date 14-JUN-2024 (dosage regimen and route of administration were not provided). According to the reporter, the patient received a "smaller" than recommended dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) since the needle slipped out of the patient due to human error (Accidental underdose). No additional adverse event was reported (No adverse event).
Swollen lymph nodes; MARKETING PROGRAM NOT AVAILABLE  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-163-4256835-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 vaccination. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 2021, outcome "recovered" (2022), described as "Swollen lymph nodes". The action taken for risankizumab was unknown.  The reporter considered "swollen lymph nodes" related to BNT162b2.  Additional information: The patient had swollen lymph nodes off. After her second covid vaccine booster she noticed her lymph nodes stayed swollen for about one month just like they did after her first vaccine booster. She know that the lymph node swelling was related to Covid booster and not the Skyrizi. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Change History On 18May2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of Swollen lymph nodes is now considered serious. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event (s) of Swollen lymph nodes with SKYRIZI (RISANKIZUMAD) was no reasonable possibility.  Suspect product information: Drug: SKYRIZI(RISANKIZUMAB) 1)Swollen lymph nodes: (Lymphadenopathy) Causality as per reporter (Drug/Vaccine): Not related Drug:  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)  1)Swollen lymph nodes: (Lymphadenopathy) Causality as per reporter (Drug/Vaccine): Probable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Patient had miscarriage after 1st dose of COVID vaccine. Vaginal bleeding and cramping started after routine check at her OB clinic 4/22 showed fetal demise , Miscarriage complete 4/22/21. Seen by provider for pregnancy care per patient. Was around 16 weeks at time of 1st moderna vaccine-  G4P1031. ER visit 4/22 reports she was supposed to be 17 weeks on that date but US confirmed fetal demise at 12w6 days. RH positive
Patient had only received 1 dose of primary series, Pfizer so should have been scheduled to receive monovalent vaccine. Patient received Pfizer bivalent dose instead of monovalent dose.
Patient in office with mother to receive vaccines. Mother accepted offer for Tdap, HPV, Meningitis. Patient given Tdap and Meningitis and did well. After RN injected HPV vaccine around 4:15pm patient face turned pale, and he then fainted. His arms stiffened as he was fainting, and he was then unresponsive for about 20-30 seconds. RN laid patient back on table during event and called for help.  Additional nurse responded and helped RN to raise patient?s legs and place cold rag on patient forehead. Patient then came to and was able to tell nurse his name and explain that he was feeling shaky. Initial blood pressure about 4:20pm BP 109/89 HR 89. Patient given juice due to fact that child states that he has not eaten all day. BP check 4:30pm 90/66. Patient stated after drinking juice that he felt nauseous and vomited.  BP check 4:40 89/59 HR 74. Patient reported feeling better although his face was still pale. Mother decided to take child home. RN advised mother if patient fainted again, she should take him to ER. Mother voiced understanding. Patient walked down the hall with mother and then sat in waiting room until checked out. Mother walk out the door with child in stable condition.
feel tired for a few hours; I think the administer of it the way the guy gave me the shot it wasn't too cool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset Sep2022, outcome "unknown", described as "I think the administer of it the way the guy gave me the shot it wasn't too cool"; FATIGUE (non-serious) with onset Sep2022, outcome "recovered" (2022), described as "feel tired for a few hours".  Additional information: Patient received the Bivalent shot way back last Sep. And patient though the administer of it the way the guy gave the shot it was not too cool. Patient stated didn't have an issue with the Bivalent, never had anything happen to patient, patient wasn't happy with the person who gave the shot. Patient felt tired for a few hours and that's the end of it.  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.