chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine didn't work for me; Patient received first dose of vaccine on 05Mar2021 and 2nd dose on 16Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received dose1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) on 05Mar2021 (batch/lot number: EN6203) and on 16Mar2021 (batch/lot number: EN6208), both the doses via an unspecified route of administration as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took immunosuppressants for chronic condition. It was reported that the patient received both the doses of vaccine first dose on 05Mar2021 and second dose on 16Mar2021 and stated that the vaccine didn't work for him/her. The reporter mentioned that he/she was looking at the list of studies for COVID 19 and wanted to participate in and stated that he/she takes immune suppressant info for a chronic condition and mentioned that he/she had no detectable level of antibodies after receiving both the doses of vaccine. Patient also stated that when people stopped wearing mask makes the world more difficult for him/her. He/she wants to be a part of a trial for a booster shot for those who has conditions like him/her. On an unspecified date the patient underwent lab tests and procedures which included blood test which result came back negative for anti-bodies for the IgG and IgM. The outcome of the events was unknown.  Any other additional information provided (sample size, etc.). Contact consent was obtained.
The patient reported that her chest was feeling tight and she was feeling dizzy. The tightness in the chest persisted and got worst. The patient then reported that her tongue went numb. Vital signs were taken (BP: 129/90; HR: 98; R: 17; T: 99.1; O2: 100% RA).  EMS were called, Paramedics assessed the patient  and heart monitoring and then transported the patient to ER for further treatment and observation.  the patient  remained alert and consciousness during the entire time.
Right popliteal DVT and Pulmonary embolism Needed oxygen and anticoagulation
Vial initially stored in the refrigerator on 9 Jun 2023, bud date was 9 Jul 2023 and shouldn't have given it past the 9 Jul 2023 and administered vaccine on 12 Jul 2023; No adverse event; Caller reports they mistakenly gave 3 clients expired Moderna vaccine on the 12th; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Caller reports they mistakenly gave 3 clients expired Moderna vaccine on the 12th), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 9 Jun 2023, bud date was 9 Jul 2023 and shouldn't have given it past the 9 Jul 2023 and administered vaccine on 12 Jul 2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Caller reports they mistakenly gave 3 clients expired Moderna vaccine on the 12th). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 9 Jun 2023, bud date was 9 Jul 2023 and shouldn't have given it past the 9 Jul 2023 and administered vaccine on 12 Jul 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Caller reports they mistakenly gave 3 clients expired Moderna vaccine on the 12th), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 9 Jun 2023, bud date was 9 Jul 2023 and shouldn't have given it past the 9 Jul 2023 and administered vaccine on 12 Jul 2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Caller reports they mistakenly gave 3 clients expired Moderna vaccine on the 12th) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 9 Jun 2023, bud date was 9 Jul 2023 and shouldn't have given it past the 9 Jul 2023 and administered vaccine on 12 Jul 2023).    Concomitant medications were not reported.  Caller reported that they mistakenly gave 3 clients expired Moderna vaccine on the 12th. The bud date was the 9th of July and shouldn't have given it past the 9th the July.  2 doses were there. Vial size was reported as Blue cap.  Date the vial was initially stored in the refrigerator was 09-Jun-2023.  The vial did not undergone any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-733172 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733172:
Sore throat within 12 hours. Fatigue and muscle aches within 24 hours. Elevated heart rate with light activity within 48 hours. All previous symptoms worsened over 48-72 hours. Moderate to severe congestion within 72 hours. Dizziness and nausea within 72 hours.
Weakness; Cold sore; This spontaneous case, initially received from other non-health professional on 15-Oct-2018, concerns a 32-year-old, adult male patient.   The patient's historical conditions included hyperthyroidism and sleep issues. The patient's concomitant medications included doxycycline and Zyrtec (cetirizine hydrochloride) for unknown indications.  On 10-Oct-2018, the patient was administered with Afluria Quadrivalent (Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39508, and expiry date: 30-Jun-2019) [explicitly reported as Afluria Trivalent] for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.   On 11-Oct-2018, 1 day after vaccination, the patient experienced cold sore and weakness. On an unspecified date, the patient made an emergency room visit for cold sore and was prescribed with Valtrex.  On 13-Oct-2018, the patient had recovered from the event weakness. On -25-Oct-2018, the patient had recovered from the event cold sore.  The reporter assessed this case as non-serious.  Follow-up received on 01-Nov-2018: Expiry date of the suspect vaccine was added in the product tab. Stop date of the event cold soar was added in the event tab and the outcome of the same was changed to recovered. Narrative was amended accordingly.; Reporter's Comments: A 32-year-old, male patient experienced cold sore and weakness, 1 day after vaccination with Afluria Quadrivalent. The company assessed the causality of the event weakness as related due to plausible temporal relationship between event and suspect vaccine and cold sore as not related, due to infectious nature of the event.
tested the patient for HPV, which was positive; Patient received a dose in March 2012 and February 2013; This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On an unknown date in March 2012, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), injection, 0.5 milliliter, intramuscularly (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On an unknown date in February 2013, the patient received another dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, 0.5 milliliter, intramuscularly (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis(inappropriate schedule of vaccine administered).    On an unknown date (reported as recent), the patient underwent human papillomavirus (HPV) test, which was positive for an unknown strain or strains of the virus. The patient's mother sought medical attention and called health department. The patient did not receive any treatment. The outcome of the event was reported as not recovered.   The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
3/21/23  I had been  exposed to COVID. I began having a scratchy throat and I took an at home COVID Test that was negative. I called my doctor, they said to let it run its course.  On 3/22/23, I had full body aches, chills, general aches that hurt everywhere and a fever that I had trouble controlling. My rapid COVID test was positive.  I called the doctor back and told me the parameters to go to the Emergency Room if my fever got too high. From 3/21/23 ? 3/28-23 I had general cold symptoms, congestion, fatigue and did not feel well.  I also had a lingering positive COVID test.    My delivery date was at 38 weeks. No complications. The baby?s birthweight was 7lb12oz.
Suspected vaccination failure; I've had it; Sick/Ended up in the ER both; two shingles shots made me sick/Ended up in the ER both; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I've had it), sickness (Verbatim: Sick/Ended up in the ER both) and sickness (Verbatim: two shingles shots made me sick/Ended up in the ER both). The outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was not reported and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient had shingles and it was awful.  The patient stated that two Shingles shots made him/her sick for two weeks.  The patient ended up in the emergency room (ER) both times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
HEADACHE, FEVER, CHILLS, NAUSEA, DIAHRREA,  BODY ACHES, PALPITATIONS, CHEST PRESSURE
patient received covid pfizer monovalent vaccine in error and was supposed to get the covid pfizer bivalent vaccine
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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 complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "There is a patient who has developed neuralgia/neurological issues"; MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "muscle weakness after receiving their third dose". Additional information: Additional information: Pharmacy student had called to see if there was any data on how many patients who have received the adult formulation of the Pfizer BioNTech COVID 19 vaccine have developed neuralgia or muscle weakness after receiving the third dose. There was a patient who has developed neuralgia and muscle weakness after receiving their third dose approximately a month ago. The age and gender of the patient was unknown by the caller. (She believes it was the gray cap formulation because it was given a month ago but knows for certain it was an adult formulation of the vaccine.) What was the incidence or rate at which patients develop neuralgia or muscle weakness after receiving the third dose of the Pfizer BioNTech COVID 19 vaccine, gray cap formulation?. States they are just looking for a percentage of how often this has been reported to see if they can rule it out for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received the vaccine on 1/27/21. That evening, the patient began to have an increase in heart rate. It seemed to decrease/normalize the following two days.  On Saturday (1/30/21), her heart rate became elevated again. Other symptoms the patient experienced included: feeling a sense of burning inside, nausea, shaking and sometimes short of breath. Patient went to the ER on Saturday and treated for an allergic reaction. On 2/1/21, the patient started developing a rash and became itchy. Patient followed-up with PCP and again prescribed medications for an allergic reaction. It was also recommended for patient not to receive the 2nd dose of the Moderna vaccine.
Swollen arm down into hand.  Throbbing/pain in arm and hand.  MD stated reaction needed to be reported. Pt had had influenza vaccine every year for the past several years.  Pt had a liver transplant approx 5 years ago.
Swelling, redness: rash at injection site - BENADRYL given and cold compress.
About 4 days after the first shot, I started to get rash and bumps all over my body.  Bumpy areas were itchy but it went away couple of hours later.   The system continued to occur today after 3 months later.
Initial unsolicited report received from a consumer on 23 January 2015. A 50-years-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number U4870BA, expiry date 3-OCT-2016 and route of vaccination was not reported) in the right deltoid on 07 Nov 2014. The patient had received eleventh dose of FLUZONE (batch number, expiry date and route of vaccination were not reported) in the right deltoid on an unknown date within four weeks prior to ADACEL dose. The patient had allergies to Apples, Cherries and penicillin (PCN). On 10 Nov 2014 i.e. 3 days post vaccination the patient had a palpable lump at the injection site, pain in arm and she hurts to use the arm at times. The patient had no illness at time of vaccination. The patient does not have any birth defects and relevant medical conditions. The patient does not have any laboratory data and corrective treatment was not reported. At the time of this report withink one week the patient was recovered from the event palpable lump at the injection site and the evens pain in arm and still hurts to use the arm was not recovered. The patient required ER visit. Documents held by sender: none.
Pfizer 3/12/21, 4/2/21, 12/13/21. Positive on
Headache, Myalgia, Arthralgia, Diarrhea, CHILLS
This case was reported in a literature article and described the occurrence of Systemic Lupus erythematosus flare in a subject of unspecified age and gender who was vaccinated with influenza (unspecified manufacturer). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of influenza (unknown route and injection site, batch number not provided). 12 weeks after vaccination with influenza unspecified, the subject experienced systemic lupus erythematosus flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using XMAP technology. SLE patients who exhibited disease flare had significantly (p <0.01) higher levels of BL pro-inflammatory mediators, including Th1, TH2, and TH7-type cytokines compares to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (BF/SNF) compared to SLE flare and HC, TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased a BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanisms of flare, therapeutic selection or development.
Pt. sat in room for 7-8 mins post vaccine. Went to sit in lobby for rest of time. Front desk person states that after sitting she noticed, pt. head go back and he began shaking all over for 5-10 seconds. Nurse brought pt. back to room where he lied down and was given ice pack to cool down. Father stated - Pt was fine, but felt sick to his stomach and was light headed. Pt father stated he was fine and wanted to leave. We had patient sit for 10 mins longer until he and father stated he felt better and were ready to leave.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, lot #, and expiration date were  not provided). It was reported that the vaccine did not prevent shingles as intended and the patient subsequently in 2013 contracted a severe vesicular rash, which was diagnosed as a persistent strain condition of herpes zoster or shingles, which was treated by a physician. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, on an unknown date, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. At the reporting time, the outcome of the events was unknown and the causality assessment between ZOSTAVAX and the events was considered related.
Edema is hands and ankles X 2 days, numbness in hands X 3 days, rapid heart rate (100 on 8/25/21, 90s on 8/26/21, 80 on 8/27/21), increased blood pressure X 2 days, itching in injection site arm on 8/28/21.
10/29 fever of 101, severe joint pain, joints warm to touch, chills again on 11/8 chills, fever of 101-102, lots of sweating, body aches, sore joints, sore lymph nodes in neck.
Systemic: Dizziness / Lightheadness-Severe, Additional Details: She passed out momentarily and fell out of chair.  Hit her head on floor & slight bleeeding from side of ear from earring.
Patient reports feeling spacy, difficulty focusing, light headed. Has been happening since he woke up at 3:25 am the day after getting the vaccine. There seems to be a lot of confusion for the patient. No fever present any day after getting the vaccine. Patient reports that he feels "High as a kite."
right VI cranial nerve palsy Narrative: ER visit diagnosed with VI right cranial nerve palsy, see above for timeline
pt recv vax 19AUG98 & T104 ax;pt seen in local ER & released in 3hr p/temp improved;
I had a horrific rash after my second dose.; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient need a list of vaccine ingredients for shingrix as the patient had a horrific rash after second dose. Ingredients were not forward facing on this site.