chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm to the touch at the injection site; Knot at the injection site; Red knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE MASS (Knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. uknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE MASS (Knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE MASS (Knot at the injection site) and VACCINATION SITE ERYTHEMA (Red knot at the injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 01Jul2021 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's relevant medical history included: "asthma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I sincerely want to thank all of you for Saving my Life! I received my first dose of the COVID-19 vaccine as soon as it was available to me on 01Jul2021 (after returning). I received my fourth Pfizer vaccine on 10Jun2022. My wife and son were also vaccinated but he brought the virus home with him after school began in August. I have underlying health conditions including asthma so when we got Covid I used Paxlovid, Thank you and thank GOD.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Vaccine administered after use by date. Efficacy study done by Moderna, and vaccine deemed effective and no re-vaccination needed. Moderna Case ID Unknown.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally, lot # L008034, expiration date: 05-AUG-2016 (dose was not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Follow up information was received from the physician on 21-NOV-2016. The patient was vaccinated at the private reporter's office/hospital. The reporter did not have any additional information to provide for the patient. Additional information is not expected, as no further information is available. Sender's Comments: MERCK 1609USA007571:Mfr number.
Site where was injected developed a large 1 inch (very soft) scab, that came off revealing raw pink skin / Felt something like a bug and rubbed shoulder, but there was no bug it was the skin which came off with a booger like consistency; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 at 13:30 (Lot number: FJ8762) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Administration Location: Left Arm; Route of administration: Unspecified), administration date: 25Mar2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0172; Administration Location: Left Arm; Route of administration: Unspecified), administration date: 22Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 13:30, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE SCAB (non-serious) with onset 09Jan2022 at 22:30, outcome "unknown", described as "Site where was injected developed a large 1 inch (very soft) scab, that came off revealing raw pink skin / Felt something like a bug and rubbed shoulder, but there was no bug it was the skin which came off with a booger like consistency". Therapeutic measures were not taken as a result of vaccination site scab.  Additional information: The patient did not scratch the injection site. The patient reported the events as they were happening. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
a patient has accidently administered a 2nd dose of vaccine without adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Medical Information (Reference number- 00372235) and transmitted to Sanofi on 25-Nov-2020.  This case involves a 65 years old male patient who received QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (Extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included pneumococcal vaccine polysacch 23V (Pneumovax 23).  The patient was given two doses of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Lot numbers: UJ500AA, UJ555AA) via an unknown route for prophylactic vaccination on two separate occasions. On the first visit on 30-Sep-2020, the patient was given 0.7 ml of the product in the left deltoid. No other vaccinations or medications were given on that visit. On 19-Nov-2020, the same patient was given 0.7 ml of the product in the right deltoid. It was reported that the patient had accidently administered a 2nd dose of vaccine (Extra dose administered).   It was a case of actual medication error due to Extra dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
4:00 p.m. Diarrhea, abdominal pain; 1/19/2011 2:30 a.m. strong abdominal pain, cramps, nausea; 3:30 a.m. vomiting; 9:00 a.m. continued abdominal pain
Left leg 2.5 2.5 cm, red painful. Cellulitis.
Severe nausea and vomiting set around 3 hours post vaccination. Unable to keep food or liquids down for 4 additional days. This also brought on severe anxiety and panic attacks, including elevated heart rate.
Pt called by phone 05/02/2000 to acquire information, pt the revealed right arm swollen, itchy, and couldn't move. Left arm was fine. Pt reports applying ice, alcohol and using Tylenol on 5/2/2000. Pt reported right arm improving with less swelling, less itching and able to move
Got shingles vaccine, then shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:01-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingle vaccine and then the shingles again. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Nausea, vomiting & diarrhea the night of the 3rd dose; pt exposed to the saliva of a racoon that bit pt's dog;
Woke up with Bright Blue Palms on second treatment.  ON first treatment had swollen lymph nodes
Low grade fever and rhinorrhea for 2 days after administration.  Developed reddish brown area around site of injection, which persisted 8 days post injection.
28jan90 pt vax hepta B. for an accidental needle stick.  6 hrs later, pt ex chills, temp of 101 F., nausea, vomiting, and flu-like sx.  29jan90 vomiting resolved.  pt recovered.
Patient received Moderna Covid Vaccine Lot 028A21A, Expired 04/28/2021. The patient did not report any adverse events.
This spontaneous report was received from a healthcare worker via a company representative and refers to a 70 year old female patient. The patient's concurrent conditions and medical history were not provided. On 02-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unspecified date, in November 2015, the patient had blood in her stool. On 04-NOV-2015, the patient had an appointment for an ultrasound for an unspecified reason. The results of the ultrasound were not provided. At the time of the report; the outcome of haematochezia was unknown. The reporter considered haematochezia to be related to ZOSTAVAX. Additional information has been requested.
pt recv vax FEB97 & pt mom stated child has had only 3 menstrual periods since MAY97;Jul97 recvd third dose c/o itchy red rash
Within 24 hours, tinnitus/ringing/high pitched screetching in ears.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medicine were reported. No treatment medicine were reported.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023:
pt recvd vax p/well baby check; pt afebrile but had a sl cold; immun occured that am;that evening devel fever up to 104,cont'd off & on thru noc & next morning,some diarrhea & very cranky, wanted to be held all noc; pt checked 20OCT94;
Rash over arms, chest, legs & back arms sore - no swelling, no fever itching - started out with small bumps then turned red. Went to Dr & he gave steroid shot - better.
Patients wife called the pharmacy and said that patient was in the hospital with a severe reaction to the vaccination and would not be getting the 2nd dose.
I broke out in hives head to toe. This went away with Benadryl. However I have been having a red itchy hand for weeks now that will not subside with antihistamine.
This spontaneous report as received from a medical assistant refers to a 5 week and 2 day old patient of unknown gender. On 29-AUG-2013 ("today") the patient was vaccinated with ROTATEQ (lot # H016251, expiration date 26-MAR-2014), (dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
I got shingles rash started on 3/6/21 and it still hasn?t cleared up.
bladder infection; blood in urine; high bilirubin count; had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Mar2021 09:30 (Lot number: EN6202) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "gastric bypass", start date: Oct2000, stop date: Oct2000. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; CRANBERRY; PROBIOTIC [BIFIDOBACTERIUM LACTIS], and unspecified multivitamins. Past drug history included: Codeine, reaction(s): "drug allergy", notes: Possible. Vaccination history included: BNT162B2 (1st dose; Lot number: EN6201 at 09:30 in the left arm), administration date: 15Feb2021, when the patient was 48 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: CYSTITIS (hospitalization) with onset Mar2021, outcome "unknown", described as "bladder infection"; BLOOD URINE PRESENT (hospitalization) with onset Mar2021, outcome "unknown", described as "blood in urine"; BLOOD BILIRUBIN INCREASED (hospitalization) with onset Mar2021, outcome "unknown", described as "high bilirubin count"; OLIGOMENORRHOEA (non-serious) with onset 29Apr2021, outcome "unknown", described as "had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021". The clinical course was reported as follows: The patient got her period from 29Apr2021 until 21May2021 and it stopped only for a few days and started again from 24May2021 until 08Jun2021. She also ended up with a bladder infection at the beginning of Jun2021 in which she ended up in the hospital for. She felt my symptoms back in Mar2021 after the 2nd vaccination, but doctor did not find any signs of bacteria then. She did have blood in the urine and a high bilirubin count. Urologist exams, computerised tomogram (CT) scan, and unspecified antibiotics were given for treatment. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; sars-cov-2 test: (18Mar2021) negative; urological examination: (unspecified date) unknown results; blood bilirubin: (Mar2021) high.
Patient started with fatigue, cough, and shortness of breath.  Was found to be hypoxic at an Urgent Care and was referred to the Emergency Department.  Patient was hypoxic and remained on supplemental oxygen during ED stay.  CTA of chest shows "bilateral extensive segmental an sub segmental pulmonary artery embolus.  CT evidence of right heart strain."    Treatment: supplemental oxygen, IV heparin  Outcome: ICU admission on 1/10/2023
915AM pt recvd vax & approx 920AM mom had pt in arms who was limp, gray, lips were cyanotic, non responsive; pt was breathing BP 60/40, apical pulse 56 weak; ambulance called; vomiting;
Systemic: Fainting/Unresponsive-Severe, Systemic: Irregular breathing-Severe, Additional Details: Paramedics were called and patient transported to hospital. Later released and patient seemed to have recovered.
Fully vaccinated patient admitted to hospital with positive COVID PCR test.  Patient seen in ED for headache and increasing shortness of breath, and occasional (chronic) cough, abdominal pain.  Denied chest pain, nausea, vomitting, change in bowel habits, vision changes, weakness, paresthesias.  Denied known sick contacts.  Patient was in A fib with RVR and PVC's.  Rate 114 per EKG.  US showed gallstones, labs showed elevated liver enzymes and bilirubin of 4.5.  Patient seen by GI no intervention recommended at this time as patient reported all symptoms had resolved on day after admission.  Patient to follow up with PCP and d/c'd from hospital.
she has bronchitis; tested positive of Covid; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose on 04Apr2021. The patient stated that she had bronchitis; and tested positive of Covid last Wednesday, 14Apr2021. The patient wanted to cancel her second dose appointment on 02May2021, and she asked if bronchitis was a reaction to the vaccine. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Narrative: 74 y/o M found to have low grade fever 99.9F on 1/6/21 at 10:00am. This was attributed to COVID-19 vaccine administered on 1/4/21 at 11:51 am. Patient received scheduled APAP 650mg PO q6J and fever subsided.
7/10 - around 8 pm client noticed itching; 7/11 - large raised erythematous area (3" x 3.5"), firm & warm to touch.  Warm compress & Benadryl 7-11 pm;  7/12 - am- less red, less warm; 7/13 - statess a little better
Within seconds, the injection site started to itch.  Within about a half-hour, I developed a severe headache that has continued unabated for over five hours.  I have a slight fever as well - 2.5 degrees above normal for me.
I had Covid early in 2020, before we/CDC/WHO knew what Covid was. I tested positive for antibodies for over a year.  I had been experiencing headaches since having Covid, but they were getting better. Now since being forced to take the vaccine, I am having headaches again. I cannot get a medical exemption from my primary physician because she states headaches is not considered an adverse reaction to the Covid vaccine. Well, I think it is! I?m the one living with them after being forced to take the vaccine.
This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # K004773, expiration date 22-FEB-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
swollen lymph nodes above collarbone after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No lab results /concomitant medications were reported.    Reporter did not allow further contact
Hot flushes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flushes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (Hot flushes). At the time of the report, HOT FLUSH (Hot flushes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.