chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER2613), at the age of 39, via an unspecified route of administration, left arm, on Apr 12, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history included long QT syndrome and major depression. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient previously took lamotrigine on an unknown date for an unknown indication and experienced allergy. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 39, via an unspecified route of administration, on Mar 22, 2021, at 10:30, single dose, for COVID-19 immunisation. Concomitant medications included potassium, nadolol and desvenlafaxine; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 12, 2021, patient experienced nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site. No therapeutic measures taken as a result of the events. The events did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not been tested for COVID-19. The outcome of nausea, brain fog, dizziness, some cotton mouth, malaise, fatigue and pain in injection site: not recovered (at the time of this report). No follow-up attempts possible. No further information expected.
Pt went to the ER on 10/13 immediately after receiving the booster shot because of severe pain the left leg. He was admitted to the hospital on 10/13 and had vascular procedures completed on left leg. During transfer on 10/15 from ICU to cardiovascular floor Pt complained of difficulty breathing, the ICU respiratory team was called and Pt was readmitted to the ICU floor and place on high-flow & bi-pap machines to assist with breathing. CT scan & Chest X-rays were performed and results indicated pulmonary edema in both lungs. On 10/16 he was taken off bi-pap due to discomfort and placed on high-flow temporarily to relieve the discomfort and was ultimately put back on the bi-pap the same day. On 10/17 another CT scan was performed and on 10/18 results indicated "ground glass" in the lungs and patient was moved to COVID isolation, COVID test was performed and results were negative. After 3 hours of isolation along with negative COVID test patient was moved out of the isolation room and transferred back to the previous ICU room  on the high-flow machine. On 10/19 he was still in ICU and had a chest scope procedure to determine the cause of "ground glass" since COVID test was negative. On 10/20 patient was discharged from ICU to cardiovascular floor. On 10/21, general antibiotic was started for unknown infection in the lungs on 10/22 E Coli/Pneumonia was identified and new antibiotic treatment was started. On 10/23 no change patient was not complaining of anything so hospital team called it an "observation day". On 10/24, low oxygen level & blood pressure and overall lethargy with trouble breathing again and Rapid Response Respiratory team was called and patient was placed back on the bi-pap machine to assist with breathing. On 10/25 a shot of Rocephin (for infection) was given along with a steroid to attempt to "open the lungs". On 10/26, hospital team started to "wean off" the oxygen and by the evening he couldn't breathe again and rapid response team was called and he was transferred back to the ICU in the overnight of 10/26-10/27 and he was placed back on the bi-pap in ICU. On 10/27 another chest x-ray was performed and showed that the "ground glass" had spread more throughout the lungs and more procedures were ordered once the patient was discharged from ICU. On 10/28, he was on the high-flow machine while in the ICU and was stable so the hospital team discharged from ICU to the cardiovascular floor but kept him on the high-flow machine in the room.  At 2am on 10/29 his oxygen level dropped and the rapid response team came to the room they couldn't restore oxygen levels and his heart stopped, the team performed chest compressions and other life-savings procedures; at 3am he was pronounced deceased by the medical team.
My daughter was given her two month shots on 9/22/03 and on 11/07/03 she had two Grand Mal seizures within one hour of each other.  She was then sent to the hospital where they did every test under the sun including several EEG's, a CAT Scan,MRI, and several blood tests. All of them came back negative except for the EEG's which showed infantile spasms (the worst form of childhood seizures)we have been in and out of the hospital for three months. She has gone through 5 anti-convulsant drugs(Phenobarbitol,Dilatin,Adivant,Topamax,& ACTH)none of them worked, she is now on Zonegran, which has helped control some of the seizures. Today she had a cluster of 8 break through spasms so it looks like the 6th drug might be failing.  The EEG shows that a lot of seizure activity is not seen, so she very well could have had unseen seizure activity soon after recieving her first series of shots. Her neurologist does not want her to receive any vaccines until we know more. When he feels that it is safe to get her shots her primary doctor has special ordered shots without the   Pertussis vaccine.  I had a normal and healthy pregnancy and a normal delivery. Before she got her shots she was a healthy baby. The discharge summary received on 2/26/04 states reflux. Follow up information 05/04/2004: She is still having seizures and as a result her development is delayed. She is still on two anti-epileptic medications Topamax and Zoneglan. She is still being seen by a neurologist.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA ACUTE ST ELEVATION MI, ANTEROSEPTAL ACUTE NON ST ELEVATION MI
Information has been received from a physician via a company representative concerning a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. The patient fainted after she received her GARDASIL vaccination. The outcome of the event was unknown. Causality between event and GARDASIL was not reported. Additional information has been requested.
This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain and joint swelling, weakness, fatigue, rashes, decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Initial medical records received on 30 April 2009 indicated that three doses of LYMERIX were administered to the subject with dates August 1999, September 1999 and August 2000.  A form completed on 23 November 2005 and signed by a podiatrist indicated that the subject had polyneuropathy secondary to LYMERIX vaccine.
Strep throat on Monday, 6/5/00 and missed work on 6/6/00. Examined by family doctor on 6/8/00. Still recovering.
No adverse effects ?.. Moderna accidentally given to patient under the age of 18....see previous description of event.
Patient noticed 2.5 inch circular rash around the injection site a week and a half after injection. The rash does not itch often but the skin is irritated. She has not tried anything for the rash yet.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.26  .  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34,35 degrees Fahrenheit from 09:00 AM to 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
12 hours of flu symptoms: fever, sweating, chills, body aches, headache, stomachache, nausea.
Severe headache and flu like symptoms for 5 days. On the sixth day 1-11-21, I was left with a slight headache and dizziness (from 1-10 about a 3) 24 hours a day.  On 2-17-21 around noon, I felt i was going to pass out.  speaking, thinking were difficult. A nurse took my blood pressure it was 180 over 90.  I couldn't stand and was taken to the hospital via ambulance. from noon to nine pm,  (my time in the er) i felt was was going to loss all conscientiousness  eleven times.  I now have an appt to see a neurologist Thursday 2-25-21.  I have not felt like i was going to pass out since 2-17-21.  I am still left with a headache and dizziness 24 hours a day.  i have had 3 appointments with a doctor to address my headache and dizziness along with my emergency room visit via ambulance.
tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right calf, repeated vomiting, constipation
Day after vaccine, headache up my neck and into my head on the left side where I received the shingles vaccine, body ache, dizziness and overall body flu symptoms. Second day after the vaccine, those symptoms were gone but then I started having a red rash on my neck and throat that itched but if I touched or scratched it it burned. The skin in that area has continued to have those symptoms and the skin is scaley, damaged. I also became numb on part of my lower lip and have some scaliness ness peeling on my lower lip. the numbness is mostly gone but the scaliness continues. Besides the rashes I sometimes feel like my skin is irritated and touch sensitive.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (The every year the patient gets the flu vaccine and she gets a sore arm). On 28th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced headache, stomach pain and stomach burning sensation of. On 28th September 2018, the patient experienced pain in arm. On 29th September 2018, the patient experienced fatigue, fever and weakness. On 30th September 2018, the patient experienced swelling arm, skin warm, erythema of extremities and itchy upper limbs. The patient was treated with EXCEDRIN unknown. On an unknown date, the outcome of the pain in arm, fatigue and fever were recovering/resolving and the outcome of the headache, weakness, skin warm, erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the stomach pain, stomach burning sensation of and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, stomach pain, stomach burning sensation of, fatigue, fever, weakness, swelling arm, skin warm, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were reported as follows: At 16:00, the patient got 1st dose of SHINGRIX on 28th September 2018. The patient arm was sore that day. The patient woke up around 2 am on 29th September 2018 with a headache and stomach pain. It felt like her stomach burned inside. Later that morning on 29th September 2018, when the patient woke up for the day, her stomach felt better, but the headache was worse. The patient treated it with 1/2 an EXCEDRIN tablet and treated it continuously for the next day or two. That day on 29th September 2018 she also had fatigue, fever and weakness. On Sunday morning (30th September 2018) she noticed her arm was starting to turn pink and by that evening there was a large pink area, and her arm was swollen and warm to the touch. It was also a little itchy in the red area. The patient had started feeling better, but most of the symptoms had not completely resolved.
Patient presented to the ED and subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. 2/18/21 and 3/21/21.
Developed a fever that ran as high as 103.0. Felt nauseated and head was spinning H/A. Symptoms began at 6:30pm on day that vaccine was given 1/22/16 and resolved by 8:30pm the following day 1/23/16.
Injection site soreness; headache; general fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 10:30 (Lot number: EP6955) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EP6955, administration time: 10:30, vaccine location: Left arm), administration date: 27Mar2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Apr2021, outcome "recovering", described as "Injection site soreness"; HEADACHE (non-serious) with onset 18Apr2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 18Apr2021, outcome "recovering", described as "general fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.  Additional Information: The facility where the most recent COVID 19 vaccine was administered at a workplace clinic. Prior to vaccination the patient was not diagnosed with COVID-19 and has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. The events were reported as non-serious and did not result in death, was not life-threatening, caused/prolonged hospitalization disabling/Incapacitating nor congenital anomaly/birth defect. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
My arm felt like I got hit in the arm with a bat.  My arm swelled and is red.  The redness of my arm is as big as a softball. It feels hot and hard to the touch and it hurts to move it or even touch it.  My arm is lumpy. My temperature has been up to 103.  I have been on Advil for 2.5 days straight and even on the Advil my temperature is at 101.  I had to miss 2 days of work. My body aches and I have gotten the chills.
I have a red raised hot and itchy patch at vaccine site for 2 days after vaccine.
No symptoms reported; patient who was administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 19-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W031813, expiration date 05-OCT-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown days, the suspect vaccine experienced a temperature excursion of -14 degrees Celsius (C) up to -10 C for 4 hours and 15 minutes and -8.33 C/-10 C up to 8 C for 7 hours 45 minutes. No symptoms reported. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Local area in the shape of a two inch pink heart with swelling over a slightly larger area. Twenty four hours later area remains pink with a total four inch area slightly swollen.
t105.4 sponged bathed & given APAP temp lasted <24 hrs;
they administered an act-hib vaccine that was a couple of days out of date,with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 months old female patient and it was reported that they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination; and hepatitis A vaccine(Hepatitis  A) for Prophylactic vaccination.  On 02-Nov-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection (batch number: UJ603AAA) (strength and expiry date: unknown) via intramuscular route in the right thigh.  On 02-Nov-2022, the patient developed a non-serious event they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Lab data not reported.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was unknown for the event they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
36 hours after vaccination had Severe tiredness and bad stomach ache fever of 100 and  muscle aches  on left side. Continued for 9 days getting less pronounced after day 5 but not abating. Rash on inside of both knees starting on day 8 the same day as muscle aches  on left side of chest and back area  ,sharp chest pain on left side.  felt tired for two more weeks , had trouble completing daily tasks without rest. The tired feeling is better but not a energized as I am normally even now.
Patient was given Pfizer Covid monwalent vaccine instead of Pfizer Covid bi-valent vaccine for booster dose
This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received MENVEO. Previously administered products included Pneumococcal Vaccine (adverse events) and influenza vaccine (no adverse events). Concomitant products included Flu Seasonal TIV Dresden (Influenza vaccine unspecified) and Pneumococcal vaccine. On 19th October 2016, the patient received MENVEO. On 19th October 2016, less than a day after receiving MENVEO, the patient experienced chills. On 20th October 2016, the patient experienced fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the chills and fever were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the chills and fever to be possibly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. On Wednesday 19th October 2016, the patient received MENVEO on right arm, at the age of 61 years, which led to inappropriate age at vaccine administration. The patient received Pneumococcal vaccine right arm and Flu Seasonal left arm. The reporter does not know the manufactures of the products or the names. The reporter stated that, because she has had a flu vaccine and pneumonia vaccine in the past, she only believes the side effects are related to the Meningitis vaccine. One day after receiving Meningitis vaccine, the patient experienced fever. The patient received Meningitis vaccine at the age of 61 years, which led to inappropriate age at vaccine administration. The patient had not notified her physician of the events, but was encouraged to do so.
SHAKING; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 16-MAR-2021, the subject experienced shaking. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, headache, and nausea on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210420008.
No adverse event at time of vaccination.  Report submitted due to patient age.  Patient is 16 years old and received Moderna vaccine which is only approved for 18 years of age and older.