chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got sick with flu like symptoms on 10/24 around 1PM, went to hospital with trouble breathing around 9PM, was pronounced deceased at 1AM on 10/25.  10/27/09 ER and hospital records received service date 10/25/09. Assessment: Death due to septic shock secondary to infection of unknown source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea, tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive, hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome. End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of head and extremities. Overwhelming sepsis and septic shock. Patient expired. 11/02/09:  Primary Care Records received for date of service 10/9/09.  Seasonal flu vaccine record received VAERS updated.  Assessment:  Presented with vaginal bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding.  Also presented with a cold that started 5 days prior, afebrile at visit.  Seasonal Flu vaccine given.  11/05/09 Diagnostic/lab results received.  IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis.  Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia.   Special stains: Scattered gram-positive cocci in lung, heart and liver.   Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus.   PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus.  PCR for penumoniae pending.   12/14/09 Autopsy Records receivedI. DOD 10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic Anemia with Splenectomy.  Additional information abstracted: Arteriovenous malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus pneumonias.
Dismissed after waiting 30 minutes.  On drive home, swallowing felt somewhat restricted.  Within 2 hours of vaccination, I had an itchy rash where my bra straps touch my body and in the left armpit.  Itching  and rash spread to elbow of opposite (right) arm, scalp, face back, and right leg by the time 2 1/2 hours had passed.
it was still sore from the first dose; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry Date were not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her first vaccine dose on 11Mar2021 and her second dose on 31Mar2021. She had to request her second dose be in her opposite arm of the first dose because it was still sore from the first dose, and now (as reported) the muscle in her arm still hurt when she rotated it 360 degrees. She stated that it also hurt when she extended her arm backwards. She asked if other people have had this or should she go see a doctor. She also asked which healthcare professional (HCP) should go to. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Headache, Myalgia, SKIN HURTS/RUN DOWN Narrative:
Approximately 5 days following injection, I developed a raised, firm pruritic and erythematous area, measuring about 5 x 3 cm, located about 3 cm below my injection site.  It lasted about 5 days and resolved without treatment.  No similar reaction seen following dose 2.
had some stiffness and soreness; had some stiffness and soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness). On 02-Oct-2023, MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had some stiffness and soreness, and she was not able to play on Sunday but on Monday, 02-Oct-2023, she was okay. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743553 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743553:Wife patient case
Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-047965 (Patient Link).
Information has been received from a nurse concerning a 68 year old female with concomitant medications and pertinent medical history reported as unspecified, who on 15-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, 0.5 mL, IM in the right arm (Lot# 658673/0990U), it was unknown if this was the patient's first or second dose. The patient developed an injection site reaction consisting of pain and redness at the site. The patient was seen in the emergency room due to the pain, she was not admitted. The patient was then seen by the physician on 17-APR-2008 and she was still complaining of discomfort to the right arm. At the time of the report, the patient was noted to be recovering. No product quality complaint was involved. Additional information is expected.
After administration of HPV#1 vaccine, patient felt faint, thought she was going to vomit, had to lie down.
PATIENT REFERS 4 DAYS AFTER VACCINATION RASH AND MACULES APPEARED IN TORSO.
Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 10Mar2021 (age at vaccination: 57 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea on Mar2021.Therapeutic measures were taken as a result of diarrhoea was Imodium (Loperamide 2mg). The outcome of the event diarrhoea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
THIS REPORT SHOULD REPLACE REPORT # 868907. Patient had a vaccine administration error on her first dose, NOT second dose ( 6/10/22).No adverse reactions have been reported for this patient. The Pfizer pediatric Orange cap vial  ( ages 5-11) administered was not diluted. The vaccine should have been diluted with 1.3 mL sterile 0.9% Sodium Chloride. The amount of vaccine administered was  0.2mL of undiluted serum, resulting  in a dose 3 times more concentrated than the advised dose.  This patient was 1 of 6 individuals to have received improperly diluted vaccine.  Only one staff member that was responsible for the errors, but all staff were retrained on storage, dilution, and administration of the vaccine. Chart audits were preformed to identify affected patients.
This spontaneous report was received from a physician via a field representative, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date, the patient received ZOSTAVAX (lot #, expiration date, strength, dose, route of administration and anatomical location were unknown by the reporter), for prophylaxis. It was reported that the vaccine was administered in two separate visits, which was not indicated on the Prescribing Information for it. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
pt recvd vax 14OCT92 & had mild URI; 2 hrs later fever & began shaking & eyes rolled back; t101; convulsions;
Extreme headache, lethargy, stomach pains, chills, hot flashes, nausea
Immediately Saturday: spacey and throat feels strange; afternoon: body is cold/tired. Sunday: felt great! lots of energy until during a walk at 3pm started to feel spacey (hands feel weird) and spiked a short term fever. Tired and cold. Monday: tired, bottom of lungs burning like I inhaled campfire smoke for a week straight, stumbling over words. Tues: tired, more burning lungs but sensation moving to mid chest (NOT heartburn), feeling like I needed to cough but nothing in lungs, still tired, still struggling with full sentences, irritable. Weds: felt hot but temp was below normal, lungs burning. Took Covid test (negative), incredibly tired, got the spacey feeling and hands felt weird-lasted 30 mins. Thurs: tired, irritable, left side hurt, started having to clear my throat every 20-30 minutes, cold. Fri: still tired, felt like I needed to cough but didn't reduce the pressure in chest/burnin/aching. Slept 14 hours. Sat: woke up feeling awful. Short of breath, clearing throat all day. Went to urgent clinic. Lab/chest x-ray and EKG all negative. Dr:"Nothing we can do for you. This vaccine is too  new and you are likely having a reaction. Come see us if it gets worse." I almost cried. When he had me take 4-6 deep breaths to check my lungs with his stethoscope I almost passed out. Now I'm home stuck on the couch under an electric blanket feeling like crap with no relief in sight. Hoping no one else has this ever.
Patient complained of a headache immediately after injections. Had water/rest. No complaints after 20 min.
Pt recvd 2 doses of Engerix-B & 10 days p/2nd inject exp loss of pinprick sensation & light touch; seen by MD;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K018959, expiration date 15-OCT-2015, dose and frequency were not reported), which was improperly stored. No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
pt recvd vax & 6FEB96 pt exp a severe local rxn w/severe swelling & very red on side of arm the pt was vaxed on;pt also devel fever of 106 & had a sz as a result & was subsequently hospitalized;
Three knots developed on right testis. After waiting a week with no improvement scheduled an appointment with a Urologist. Went to see the urolgoist on 10/18/21 about the knots. I had a testicular ultrasound (10/18/2021), a CT of the Pelvis (10/20/2021) and another testicular ultrasound (10/21/21). The urologist recommended surgery to remove the 3 cysts off the epididymis. He said that they would not resolve on their own and would continue to get worse.
Employee reported hives arms and chest, no shortness of breath 10/3/2023 @ approx. 1500. Employee reported taking 4x Benadryl last night and  1 this morning and hives down to about 50% of body this morning.
I get a lot of itching like a itching rash and I haven't been experiencing it until I got the COVID shot So, number one, I want to report it; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration (in muscle), administered in arm left on 24Apr2021 09:30 as 1st dose, single dose for COVID-19 immunization. Age at the time of vaccination is 53 years. The patient medical history and no concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0165; Expiration Date: 31Aug2021) dose 2 via an unspecified route of administration (in muscle) in arm left on 15May2021 11:15 as 2nd dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient experienced I get a lot of itching like a itching rash and I haven't been experiencing it until I got the covid shot so, number one, I want to report it on an unspecified date with outcome of unknown. Treatment medications included allergy medicine like Zyrtec or something, I think it was like the generic allergy relief Loratadine, an anti-histamine that seems to give me some kind of relief. Outcome of the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore Arm Injection Site Post Second Dose; Arm hurts a little Post Second Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
No additional adverse event reported; a patient received a fourth dose of Gardasil 9; This spontaneous report was received from a physician concerning a 16-years old male patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On unknown dates, the patient was vaccinated with the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strengths, routes of administrations, anatomical sites of injections, lot numbers, and expiration dates were not reported).   On 28-OCT-2020,  the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse event reported, nor product quality complain involved.
Information has been received on 18-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other related complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Severe hips/shoulders pain, stiffness; in Dec 2022 diagnosed with polymyalgia arthritica.  4 month duration.  Relieved with course of prednisone.
experiencing severe diarrhea and today it is worse; her daughter also had diarrhea at 10pm the day she received the 1st dose, 13Jul2021/experiencing severe diarrhea and today it is worse; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 20-year-old female patient (reporter's daughter) that: A 20-years-old Female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 13Jul2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration in Arm Left on 03Aug2021 as dose2, single for COVID-19 immunization. Medical history included ongoing coeliac disease Diagnosed in 2015 or 2016 , arthritis from 2019 and ongoing. The patient's concomitant medications were not reported. Previously patient received Tdap and experienced Injection site erythema (red arm after getting a booster shot for TDap, when she was 13 or 14 years old, was in 2013. They gave her a topical steroid to put on it). Reporter on behalf of daughter, aged 20, received her second dose of the Pfizer BioNTech Covid 19 vaccine on 03Aug2021. Yesterday she started experiencing severe diarrhea and on 04Aug2021 (today) it was worse.  In the clinical trials how long did the side effect of diarrhea last. She noticed that her daughter also had diarrhea at 10pm the day she received the 1st dose, 13Jul2021, but it wasn't as bad as it was now. Stated that she called because she just wanted to find out from the people who experienced diarrhea in the clinical trials, how long did it last. States that her daughter was a college student, so she was 20 years old, and caller doesn't have her card to be able to provide her Lot numbers. States that the diarrhea started yesterday, 04Aug2021; she had it all day. Today the diarrhea was worse. States that she hasn't even eaten anything, so there isn't anything left to come out, so it's just like water; she is in the bathroom like every 30 minutes. She took Imodium yesterday but it didn't help. The outcome of the events was not recovered.     No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (low grinding headache right across forehead) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced HEADACHE (low grinding headache right across forehead). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (low grinding headache right across forehead) outcome was unknown.  Treatment information was not provided.
Injection site was sore as expected, but that evening I woke up around 2:30am because my body was so sore. I took a drink of water and then almost vomited.  The nausea lasted for a couple hours.  I got a little sleep, but in the morning the body aches were extremely strong... much like for a bad flu.  To the point I just needed to lay down and do nothing.  Mid way through this day the headache started getting worse and I had a bad headache for the remainder of the day, mostly near the temple areas.  This body ache and head ache lasted for 2 days total.
1 or 2 days p/vax pt devel a fever of 102 & an inj site rxn characterized by swelling & redness which extended from shoulder to elbow;rxn looks like a bee sting;pt was seen by MD who prescribed APAP & DPH;
She presented to Hospital for Johnson and Johnson Covid vaccine on 5/14/2021. Janssen vaccine was given at 1330. She was instructed by LVN to wait 30 minutes in the waiting area to be monitor for any allergic reactions. At approximately 1550, she presented to LVN reporting tingling sensation in the mouth, lips and tongue, stating "feeling funny". Then she was evaluated by an RN and Benadryl 50 mg was given by mouth at 1553. Her symptoms were increasing.  911 was called at 1606 and she was injected with EpiPen at 1610.  Paramedics arrived approximately at 1618 and transported her to the Emergency Department. Patient remined alert during the entire encounter.
Due to forming bad shortcut habits during covid nurse gave the wrong vaccine after relying on the system and not her own knowledge and normal processes for screening patients.  Nurse gave the first chickenpox vaccine when it was supposed to be his second shingles vaccine.