chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient received Moderna COVID #1 on 2/5/21 and #2 on 3/5/21. On 4/7/21, a note was entered that indicated he was in the hospital and may need hospice care when discharged. No scanned records of why he was hospitalized. It appears he was on home hospice on 4/10/21 when it was recorded that he passed away. No autopsy report available. Time from date of second vaccine to date of death was 36 days.
pt recv vax; RN reported multiple patients have devel nodules at tetramune site; she notes that "they do not aspirate" prior to inject and postulates this may be an etiology of the above rxn;
I tested positive for Covid-19 on January 19, 2023 I experienced runny nose and fatigue I was prescribed Paxlovid for my symptoms.
productive cough with yellowish green phlegm; productive cough with yellowish green phlegm; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who experienced productive cough with yellowish green phlegm (Productive cough and Phlegm discoloured), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included Hypersensitivity, Epstein-Barr virus infection, unspecified Cardiac disorder and was hospitalized 6 times in the past. At the time of the event, the patient had ongoing Asthma, Arthritis, Hypothyroidism and use of cannabis. The patient's past medical treatment included Levaquin for productive cough. The patient's past vaccination(s) included INFLUENZA vaccine last year and FLU VACCINE VII (flu shot of High dose) the year before the influenza vaccination.. The patient's past family history was not provided.  On 29-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On 29-Oct-2019, the patient developed a non-serious productive cough with yellowish green phlegm (productive cough and Phlegm discoloured), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was productive cough with yellowish green phlegm.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for productive cough with yellowish green phlegm.  Information on the batch number was requested.
She mentioned that she had a little pain for 2 days and then it was all good.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nut" (unspecified if ongoing), notes: walnuts, nuts and pecan. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no -1). The following information was reported: PAIN (non-serious), outcome "recovered", described as "She mentioned that she had a little pain for 2 days and then it was all good."  Additional information: The patient had received both doses of the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe pain in was my side sort of on my back thing; cannot walk with that pain; my side were it is almost impossible to stand up on a sitting position; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation.  Medical history included kidney cancer and kidney were removed 15 years ago. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, (lot number:EN6206) for COVID-19 immunisation.  The patient stated on 08Apr2021, "I had my second Pfizer shot on last Wednesday on 07Apr and Thursday morning I woke up and I am having severe pain in was my side sort of on my back thing, my side were it is almost impossible to stand up on a sitting position. I cannot walk with that pain and I just report it on, like through the whatever that portal is but it's been five days so, I don't know if I should go to the doctor or not or I should just wait it out. I did have kidney cancer and that exactly where it is hurting. I had kidney cancer, my kidney were removed 15 years ago. So, could it be like information from the shot?" The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A week after getting the vaccine I had a weird unexplainable sweet taste in my mouth. It would come and go. But after 2 days it was constant. About a week of that it went away but then I could not stop salivating. From day to night. That lasted for about 12 days. Then it just stopped. I saw my PCP and he said other people had reported the same thing. He did not do any medical tests or prescribed any medications.
Mother called clinic 1 day following vaccines. Mom stated 1 hour after vaccines child vomited  1 days. Second started with fever greater than equal to 101 (fever reduction with the use of Motrin and Tylenol.) and also nose running. Morning following vaccines child awoke with eyelid, under eye and nasal edema. Erythema at site of Dtap injection. Mom states "swollen to her elbow." After discussion of side effects from vaccines and review of VIS Forms child taken to primary hospital and mom told she "was" in fact having an allergic reaction to vaccine. VAERS form sent.
Menstrual blood clotting for every month since first dose administered, Uterine cramping after second dose. Blood clotting has occurred in 4/4 monthly cycles.
Itchy; Blister spot where she was injected/ half inch long skinny blister; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister) and VACCINATION SITE PRURITUS (Itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN B NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Rash on upper left arm, raised surface with increased redness and warmth measuring 2 inchx2 inch, bean 12 hours after, continuing to increase in size and worsen, swollen lymph nodes under L arm.
Second dose: soreness underneath her armpit/ache under her arm; Second dose: no appetite/doesn't feel hungry; Second dose: bruise at the injection site on her left arm; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 26Apr2021 at 10:20 (at the age of 53-years-old) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included  sciatica nerve pain from an unknown date and unknown if ongoing. Concomitant medication(s) included tizanidine (TIZANIDINE) taken 4 mg for spasms (She hasn't taken any since maybe about 2 weeks ago). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7533) via an unspecified route of administration, administered in right arm on 05Apr2021 at 15:30 (at the age of 53-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any prior to vaccination within 4 weeks. Patient reported that she had received her second Covid 19 vaccine and it left a bruise on her arm on 24Apr2021. On 29Apr2021, patient reported she's having soreness underneath her armpit and she has no appetite. Having no appetite started this morning on 29Apr2021. She normally wakes up early and goes to work at 6:00AM. She hasn't eaten yet today. She could smell fine, she just doesn't feel hungry. Patient reported the time of onset of AE(s) as 2 days. Patient did not had any AE(s) following prior vaccinations. AE(s) did not require a emergency room or physician office visit. The outcome of the events were not recovered.   No follow-up attempts are needed. No further information is expected
Pt was given  5-11 y/o dose of 0.2ml instead of 12 and older of 0.3ml. No adverse reactions notedd
2 doses of Pfizer vaccine in Feb 2021, no booster, admitted to ICU for COVID PNA
I did not have any adverse events excepts sore arm; 1st dose 09Feb2021, 2nd dose 30Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Mar2021 12:45 (Batch/Lot number: EB8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2005 (ongoing), notes: Taking medication; "Allergies", start date: 1979 (ongoing), notes: got allergy shots + take medications; "arthroscopic surgery", start date: 27Jan2021 (unspecified if ongoing), notes: Left knee. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time:1:30pm, Anatomical site of injection : left upper arm, Route of administration: Intramuscular, Batch/lot number: EL9267), administration date: 09Feb2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I did not have any adverse events excepts sore arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose 09Feb2021, 2nd dose 30Mar2021". Relevant laboratory tests and procedures are available in the appropriate section.  Verbatim: Consumer was traveling to (City name) and she was in (City name). Consumer will not be able to get her second dose on 02Mar. Consumer would like to know if she can reschedule her appointment or if she gets the second dose in (City name) also asking if it's fine if she will get the second dose more than 3 weeks. Upon receiving further information, Consumer (Withheld), got the first dose of vaccine on 09Feb2021, and the second dose was scheduled on 02Mar2021. (Withheld) said she missed the second dose, and she was advised that she can get it within 6 weeks from her first dose. (Withheld) is trying to get an appointment and asking if she will start again from the first dose. Prior vaccination: None. Concomitant drugs: None. Anatomical location: Left upper arm.  Information about lot/batch number has been requested.  Followup#01 (09Apr2021): Upon receipt of follow-up information on 09Apr2021 this case is now considered valid. This is a follow-up spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) reported in response to HCP letter sent via follow-up letter. Updated information included patient age, dose description, event details.  No follow-up attempts are possible. No further information is expected.
the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses; the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses; arm is a little sore; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (mother) reported that a 12-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Jun2021 (age at vaccination: 12 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Jun2021, patient experienced the vaccine administered to his son was not diluted/undiluted vaccine administered is equivalent to 3 shots or 3 doses, arm is a little sore on Jun2021. Caller is a mother of a (withheld) year old male who received 1st dose of Pfizer BioNTech Covid19 Vaccine on Friday 25Jun2021. 1 hour after the vaccine was administered, they got a call from the vaccination site informing them that the vaccine administered to his son was not diluted and the woman who called said that the undiluted vaccine administered is equivalent to 3 shots or 3 doses. The people working on the vaccination site had been calling them since 27Jun2021 and 28Jun2021 to check the boy how's he's doing. As per the mother, his son's arm is a little sore. She talked already to the pharmacist and reported this event and she called the health department and they are already in the process of reporting it. Their doctor recommends not to get the second dose of the vaccine, but she wants to know Pfizer's recommendation, if his son should get the 2nd dose of the vaccine. The outcome for the events was unknown. Information about batch/lot number has been requested.  Follow-up (19Jul2021): Follow-up attempts completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added event Product concentrate not diluted.
Low grade fever, headache, raised erythematous area at site of injection (left deltoid).
An hour after receiving vaccines the patient experienced a 10/10 headache.   She also experienced nausea, vomiting, abdominal pain, and shivering.  She went to the emergency room where she received zofran and ibuprofen with relief of symptoms
Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 2nd of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Sudden onset and contiued to day 4 now, nausea and loss of appetite.
Patient was feeling fine before the vaccine was administered. After administering vaccine, patient suddenly collapsed briefly from a sitting position to the ground. Patient wasn't responsive at first but then was able to verify his name and birth date. Blood pressure was taken and it was 93/60. Patient rested on the ground until his BP normalized and was given a cup of water.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported.  Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 34 and the higher was 50 degrees Fahrenheit for 46 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.   Follow up information was received from the physician on 16-OCT-2017 and on 27-OCT-2017.  This report refers to 16 months old patient.   On 26-AUG-2017, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).   This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1710USA015222: US-009507513-1710USA015223: US-009507513-1709USA012770:
Diagnosed with high blood pressure and Afib at GP?s office on 10/25/21.  Cardiologist appointment confirmed on 11/2/21.  Cardiac ablation specialist seen on 12/9/21.  Cardiac ablation done on 1/5/22.
Within 15 minutes I felt tightness in my chest and throat,  35 minutes after the vaccine I developed a metal taste in my mouth.  Soon after I started getting a nasal drip and when I blew my nose I could smell metal.  My head has felt "foggy" and dizzy ever since.  It is now over 36 hours since the vaccine.  I have been drinking plenty of water and woke up dehydrated, my mouth is dry and I have this awful taste.  The metal taste is even worse and even tastes like chemically.  It is very unpleasant and I can taste my food, but my coffee is tasting weird and the food is too.  I still have headaches, slight nausea, but the worst, most unpleasant and worrisome condition is this metal/chemical taste and sensation in my mouth and nose. What is this???
Pt recvd vax 10NOV92 & 8 to 10 hrs following vax & exp a fainting episode, nausea & dizziness; seen in ER 11NOV92 where lab eval revealed a nl CBC:
Rash started around injection site arm and spread on back and torso, itchy, burning at site area. Duration 5-7 days. Took benadryl 1 tab.
10/28/22 presents to ED for "fever, chills, shortness of breath, weakness". PMHx of "atrial fibrillation, hypertension, hyperlipidemia, hypothyroidism".
Information has been received from a health professional concerning her 16 year old daughter who on 21-FEB-2007 was vaccinated with a first dose of Gardasil. On 21-FEB-2007 the patient experienced a bad headache. She was given two ADVIL and her headache went away the following day. On 21-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Child cried constantly and was unable to be calmed from approximately 11:00 AM 6/12/03 to 5 PM 6/12/03. Child calmed 30 minutes after given Motrin 1/2 tsp and 1/4 tsp Benadryl.
Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective). On 07-Sep-2021, COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) had resolved. At the time of the report, DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-311270 (Patient Link).; Sender's Comments: This case concerns an 50-year-old, male subject medical history of asthma, who experienced the non-serious unexpected events of COVID 19 and Drug ineffective. The event occurred approximately four months after the second dose of Spikevax. The event Drug ineffective was considered as related to the product per the reporter's assessment. Rechallenge was unknown since there's no information. The association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.  The benefit risk relationship of spikevax is not affected by this report.
Muscular pain at site, day of shot and day after.  Runny nose, 2 days after shot, ongoing.  Extensive sneezing, 2 days after shot, ongoing.  Nausea, 3 days after shot, ongoing.  No medical visits scheduled currently. Patient began taking DayQuil 60 hours after shot, and has taken a dose approximately every 6 hours subsequently.
Extreme pain first day with red swollen injection site. Pain lessened next few days. Pus filled bump on injection site with patchy red hot rash surrounding. Arm still tender to move a week after.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of VAQTA (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Broke out into a full body rash somewhere between 2-3 hours after the vaccine. I only noticed it about 3 hours after getting the shot. The rash started out on my chest and stomach, it looked like I had the chicken pox. And there were red and pink patches all over the rest of my body. I felt extremely warm, and was sweating profusely. My chest felt tight, and my throat hurt, but I had no trouble breathing. I went to bed after calling the hospital, where a lady told me I should be fine, and to call my provider in the morning. When I woke up the rash was almost completely gone. And my chest no longer felt tight, and my throat felt fine. I had a few patches of pink dots across my stomach. But after taking Benadryl today (8/3 at 9am), the rash is almost completely gone (current time:3:30pm). And other than typical Flu like symptoms, I feel fine.