chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a case in litigation from a physician concerning a 20 year old female patient who in 2001 at the age of 12 year old was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated in 2001 with the second and third doses. The reporter mentioned that in the following weeks after the first vaccination the patient had intermittent hives. Similar outbreaks followed subsequent vaccinations. After the third vaccination, she developed pain in her upper legs, which grew worse over the following months until she had trouble walking across the room. The physician had diagnosed the patient with a lupus-like illness. The patient's rheumatologist said the development of arthritis after the vaccine "is well recognized". Although the vaccine's connection to lupus is "less clearly demonstrated". In May 2003, the patient consulted rheumatologist who attributed her symptoms to dermatomyositis, juvenile rheumatoid arthritis, lupus or mixed connective tissue disease. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the RECOMBIVAX HB had caused systemic lupus erythematosus. Upon internal review systemic lupus erythematosus (SLE) was considered to be an other important medical event. Additional information has been requested.
Unexplained death.   Patient was found dead near his front door with car keys still in his hand.  Pacemaker had recently been checked and was working fine, so it was not a heart attack.
The pt was sitting at a table and suddenly stopped talking and fell forward without trying to break his fall. Eyes initially closed and then seemed fine. The pt was never stiff and did not experienced any shaking.
8/11/2021 BILAT LEG, ANKLE, & FEET SWELLING. PAIN UN LEFT SHOULDER BLADE 8/12/2021 LEFT ARM PAIN AND SWELLING, SWELLING TO BILAT LEF, ANKLE & FEET CONTINUED 8/13/2021 SWELLING CONTUNYED TO LOWER EXTREMITIES 8/14/2021 SORE THROAT STARTED 8/15/2021 SORE THROAT CONTINUED 8/16/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE 8/17/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE GETTING  WORSE 8/18/2021 SAME 8/19/2021 SAME 8/20/2021 VIRTUAL VISIT SAME WITH COUGHING
Case number PHEH2012US022485 is an initial spontaneous report received from a pharmacist on 09 Nov 2012: This report refers to an adult male patient. He was given only MenCYW lyophilized conjugate component of MENVEO (batch number: X11082) intramuscularly on 09 Nov 2012 without being re-constituted with MenA. No adverse event was reported following this administration error.
Developed wheezing, shortness of breath, hives starting a little over 30 minutes after vaccination and progressing to severe enough illness pt took her epipen and quickly get better, also took benadryl before vaccine.  Within an hour after using her epinephrine, she felt back to normal.
Patient had unresponsive episode of approximately 5 minutes. Dusky skin and lips, poor tone, unable to be awaken, slowly return to normal self over 5 minutes. No interventions necessary.
On Friday, Jan. 30 I noticed that the site of the vaccine was red and swollen and warm to the touch
Stiff knees; Inappropriate schedule of vaccine administered; Headache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062620A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache). At the time of the report, JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) blood pressure is also a little more than it usually.         Concomitant medication information not provided.  Treatment information not provided.  Patient stated that when he sits down for a period of time and gets up, the top of his left knee cap is stiffening. He experienced a slight headache at night. His blood pressure is also a little more than it usually. He thought he might have COVID-19 but was not tested yet.
Diagnosed with psoriasis in 2017, treated with topical halobetasol ointment. Went into remission after treatment with topical halobetasol ointment.  Following my Jynneos vaccine, roughly a week after receiving it, I began to develop small red spots on my arms, legs, and chest/stomach. The spots were not painful, but were red and scaly. I was able to confirm this was guttate psoriasis and it is treatable with topical halobetasol ointment, but it has not yet gone back into remission. Given the timing of the flareup and the complete remission over the past 4+ years until receiving Jynneos, I am certain that Jynneos caused the flareup of my psoriasis.
Gillian Barre syndrome. My husband is on a ventilator in ICU. Flu like symptoms 36 hours after flu shot received. 12 days later paralysis.
PT REQUESTED TO VACCINATE TO RIGHT THIGH INSTEAD OF ARM D/T MEDICAL CONCERN OF HIGH RISK OF BILAT LYMPHADEMIA. VACCINE WAS GIVEN IN RIGHT THIGH AS REQUESTED.
Why I'm reporting: My period started May 3 and was unusually light and short.  Otherwise, I was extremely exhausted and in bed for a week, though as mentioned, I did have a mild cold going into it. I also had a fever and chills, but I can't say if it was the cold or shot. Since I was still ill after a week and a half, I visited Urgent Care to make sure it wasn't COVID or bronchitis and got the all-clear.
Recurring GI / nausua episodes for 3-4 months. Chest pain, inability to recover from physical activity.   Recovery at around 5-6 month mark.
Typically have 1-2 episodes per year with dizziness and balance issues. Also, tinnitus is somewhat regular throughout the year. Shortly after receiving the 2nd dose of Covid vaccine, my left ear regularly feels full  which leads to dizzy spells and balance issues which has continued now for months. The tinnitus has gotten worse with each episode. Not sure there is any relation to the vaccine as maybe it?s all coincidence, but makes me concerned that it is related. Bodice and Dramamine have typically been taken as needed, but the last few months has seen a constant need to take and keep on my persons.
Within 2 hours both pt and husband (also same vaccine) describe fever with pain, swelling at injection site.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: cough-Medium
The morning after I received the second dose, I started having severe chills and excruciating pain across my back. I was sitting in my house with blankets on and freezing, but it was like summer outside. This last for two days. On the third day, the chills and pain went away, but I felt a little off. I was sitting down and went to stand up and black out. It seemed to only last a couple of seconds, but I fell on my floor. I stayed on the floor until I got my bearings back and pretty much stayed there the rest of the day. A day later, it seemed as if it had passed. I didn't contact my doctor because I feel that no one took me seriously after my first vaccination. The hospital didn't even face the fact that it could have been from the vaccination. My doctor was the same way.
HEADACHE; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 20:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.7 F. Treatment medications included: ibuprofen. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) low grade, 100.4 F. On 18-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 18-JUN-2021, and had not recovered from headache. This report was non-serious.
Developed cough, congestion on 10/17 and fever of 102 on 10/19. Fever/cough continued thru November 8. Cough and congestion remains. CXR showed pneumonitis. WBC's elevated (increased monocytes).
sore arm; Potential drug interaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic reaction" (unspecified if ongoing), notes: Rash; "Rash-hives" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone; Kanalog. Vaccination history included: Bnt162b2 (Dose 1,), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Potential drug interaction".  Additional Information: Reporter would like to know if there was no interaction between steroids and the vaccine either injected (Kanalog) or oral (Prednisone therapy), if the use of steroids take away the protection from the vaccine. Reporter had not received a steroid yet, however she might have to get one of them after she visited her dermatologist because she had an allergy rash "hive-rash" that started a week ago (6-7 days) it was prior to the second dose of the vaccine, she received it last Thursday, 2 days ago. Even before the first dose of the vaccine like 13 months ago she had the first allergy, they are related to the weather or stress (has not received a test yet). Reporter stated that the only side effect she experienced with the first and second doses of the vaccine was a sore arm, it was very sore she felt like someone punched her really hard, she couldn't lift her arm but it was manageable an lasted around day and a half. She further stated she had her 1st dose of the Pfizer Covid-19 vaccine on 24Mar2021 and was scheduled for 2nd dose on 14Apr2021 but she chose to reschedule it to 15Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Sulfa allergy) and Penicillin allergy.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) had not resolved. Not Provided.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  No concomitant medications were reported. The patient did not received any medications/products within 2 weeks of starting COVID-19 treatment. The patient reported rebound symptoms on 27-May-2022 and was not recovered at that time. The device date was 29-May-2022.  Company comment-This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 22nd May2022. She had a rebound symptoms 5 days after completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 22nd May2022. She had a rebound symptoms 5 days after completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pain in arm, decreased mobility, could not sleep, hot and cold flashes with fever 101.6. Patient took  ibuprofen and temp was down to 99.8 in the morning. The next day he stated he still feels bad.
Severe joint pain 8/10 in knees, hips, lower back, shoulders and neck which lasted until 11/21/21. Ongoing joint pain more than normal at 6/10.  Normal joint pain is 2-4/10 due to osteoarthritis. Severe nausea which is still ongoing. Severe fatigue/malaise which is still ongoing.
At night all of a sudden I got chills, shaking from the chills, 103 temp, body aches, and a headache the next day.
minor pain at the injection site; 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 DYSPNOEA (minor pain at the injection site) 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 is reported by reporter.     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 DYSPNOEA (minor pain at the injection site). At the time of the report, DYSPNOEA (minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
3PM recvd vax devel rash 3 hrs later on legs & face;
Chest pain and hurting in both arms. Congestion and hurting all over body. Sleeping all the time. Loss of apetite and bad taste in mouth.
approx 4hr p/vax pt devel pain, swelling, erythema @ site;did not respond to DPH; hosp; tx for cellulitis; MRI revealed a possible cyst @ site;
pt recvd vax; 28 days later exp rt facial palsy;sxs progressed to vestibular neuritis & rt hearing loss; to er; tx steroid & famvir X2;
Sore arm (expected) than the next morning I reported on Saturday 09-12-2020 for work by 7am as a nurse and noticed I felt tired; than by 10:30 am I became extremely fatigued which increased as my shift continued; I was unable to eat anything, and all I cared about was finishing my shift safely   which I was able to do; I focused on driving myself home which takes 20 minutes, I handed my uneaten lunch to my youngest son (20 years of age) and informed my family that I was retiring for the night; I slept from 4pm until 4am (awakening twice to urinate and able to return to sleep very quickly). I am widowed so I do not have the luxury to stay home without good cause. I felt much better on Sunday 09-13-2020 without any fatigue ; only noticeable sign was the continued soreness/redness at the injection site, by Monday Sept 14, 2020 injection site is still tender.
Received 2nd shot on April 14.  He was functioning normally until he woke up on April 25.  Symptoms were chest pain, trouble breathing, lethargic, very pale, cold to the touch, vomiting with blood in vomit. PT was taken to the ER where he passed away later that night.
Received covid and GlaxoSmithKline Fluarix quadrivalent  Lot # 95Z42 at 8:40 and 8:45am. Was at dinner in a restaurant at 5:30PM when his eye was swelling noticeably. Went home and noted his opposite eye swelling, "felt like my eyes were exploding" Present to and ER where he reports being admitted and treated for anaphylactic reaction with IV steroids.  He does report eating escargot and oysters.
chills; achy; flu-like symptoms; fever; sweating; weakness/Very Weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 11May2021 at 13:55 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19, He had a history of covid infection 6-7 weeks ago for which he was hospitalized for rehab and quarantine, Verbatim: Covid 19 Virus. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines within four weeks prior. No adverse events following prior vaccinations. There were no concomitant medications. On 12May2021, patient experienced chills, flu-like symptoms, achy, fever, sweating and weakness/Very Weak. It was reported that last night (12May2021) was rough and he is still chilling today and sweating. Therapeutic measures were taken as a result of fever included acetaminophen. The events did not result in emergency room or physician office visit. The outcome of event weakness was not recovered and rest all events was recovering.  No follow-up activities are possible. No further information is expected.
Myalgia, Diarrhea, NauseaVomiting, Chills, fatigue, earache, loss of appetite Narrative:
2-3 days after injection,  started to have swollen lymph nodes around his ears bilaterally and initially thought it was a zit but is having purulent drainage from the preauricular area on the right side and cervical lymph nodes also are now enlarged.
I remained at the site for 15mins.  Everything seemed fine.  I was driving home and my left side started to feel numb from my neck down to my foot.  As the evening went on my left hip & back became very sore and my legs to the point where I couldn't walk.  I took Tylenol and Advil with little relief.  This has continue since I got the vaccine.
Rash at injection sites within 24 hours, then facial rash at 12 days.
Right arm swelling, tenderness after vaccine. History of Present Illness: Patient received BEXSERO vaccine on 6/21 - Right arm. Started on 6/22 with pain swelling to right arm. The next day had pain under arm. Now with pain to inside of right arm from axilla to forearm. Arm feels tight, tender. No redness noted. Pt being seen in office for second time today, 7/2/18, for continued site pain and tenderness.
25 minutes after vaccine given, pt. development hives, whelps, severe itching over entire body.
pt recv vax; became dizzy & fainted;had sz type movements while unresponsive;pupils fully dilated during episode;was unaware of sz, just remembered feeling sick & dizzy;
Initial unsolicited report received from a Non health care professional on 27-Oct-2017. This case was linked with cases 2017SA211778, 2017SA244642, 2017SA244729, 2017SA244854, 2017SA244856 (same reporter). This case involves a child patient (age also reported as 4-10 years of age, gender not reported) who was vaccinated with 0.5 ml dose of FLUZONE (dosage form: injection) (batch number: U1856AB, expiration date, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination patient had a severe, localized reaction, injection site swelled to baseball size, was very red and painful. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
1. 1st Moderna Injection on 2/26/21 (Lot 013A21A) 2. 3/17/21 - Unknown Bleeding around the left eye causing dark bruise 3. 2nd Moderna Injection on 3/26/21 (Lot 008B21A) 4. 5/18/21 - collapsed  5. week of 6/7/21 - legs felt weak, 6/12/21 - arms felt weak - went to emergency room 6. 6/12/21 - admitted to hospital mild heart attack 7. 6/12/21 - the night admitted to hospital - stroke 8. 7/11/21 - died
Dementia; cognitive decline; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 67 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis and allergies Sulfa. Concomitant medications included atenolol; methotrexate sodium; and leucovorin [folinic acid]. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EW0108) in arm left on 12May2021 at age of 67 years old for covid-19 immunisation; erythromycin, and clarithromycin (MACROBID) and experienced allergy. Patient experienced cognitive decline, rapid onset and moderate, concerning. Memory, recall, concentration. "Dementia" like symptoms, previously nonexistent. No treatment was received for both events. Events onset date was 14Jul2021. The outcomes of events were not recovered.   Follow-up attempts are completed. No further information is expected.
Swelling under eye on 3/23 and then also very swollen bottom lip on 3/24
Information has been received from a physician concerning a female (age unknown) who on an unspecified date was vaccinated with a 0.5 ml dose of Gardasil. Subsequently, on an unspecified date, the patient passed out. The patient sought unspecified medical attention. subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.