chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer and spouse (representative of estate of decedent) regarding a case in litigation concerning a female patient (Decedent) of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 27-JAN-2014, the patient (Decedent) was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient (Decedent) suffered from focalized left chest wall tenderness, shortness of breath, pleuritic chest pain and chronic chest pain requiring hospitalizations. The patient (Decedent) was diagnosed with pneumonia and acute systolic congestive heart failure. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the decedent suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 02-APR-2014. The husband of decedent claimed wrongful death of Decedent. As a direct and proximate result of the ZOSTAVAX vaccine, the decedent suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required healthcare and services; the patient incurred medical and related expenses; and the patient suffered mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of pneumonia and acute systolic congestive heart failure was considered to be unknown. The causality assessment was considered related. The cause of death was not reported. It was unknown if an autopsy was performed. Upon internal review, pneumonia, acute systolic congestive heart failure and death were determined to be medically significant events. Pneumonia and acute systolic congestive heart failure were considered to be disabling. Additional information has been requested.; Reported Cause(s) of Death: Death.
Slightly swollen arm, itchy, moved to soft spots in both legs the next 2 days. Slightly swollen arm, swelling and itchiness moved down arm; next 2 days moved to soft spots in legs and buttocks; 4th day woke up with swollen eyes and cheeks. By evening swelling and itchiness moved to chin. Woke up at 2:30 AM with hugely swollen chin/throat and tongue. Couldn''t swallow or talk. Went to the ER.
per mom on 16MAY94 rash on leg high fever & convuls during noc 15MAY-16MAY & bad leg pain; advised mom of pt to have pt f/u w/regular MD;
Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; My lip just stated to tingle again; Rest of the mouth feeling weird; Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; This is a spontaneous report from a contactable nurse (patient reported for herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years-old, dose 3 via an unspecified route of administration, administered in Deltoid Left on 01Oct2021 06:45 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included depression, blood pressure abnormal, anxiety and sleep disorder. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single and dose 2, single for COVID-19 immunization. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for depression; lisinopril taken for blood pressure (abnormal); buspirone hydrochloride (BUSPAR) taken for anxiety; nortriptyline (NORTRIPTYLINE) taken for sleep disorder; all start and stop date were not reported. The patient experienced had an anaphylactic reaction to the third booster shot. The events occurred on 01Oct2021, within 24 hours after the vaccination. The patient received epi-infusion, Benadryl, Steroids and 'tester'. The patient was in the hospital from the morning from 5 to 9, she had an epi drip gone for little bit and some steroid and some Benadryl (treatment). Her lip just stated to tingle again, and rest of the mouth was feeling weird. The patient wanted to know the half-life of the suspect drug. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the unlisted events Oral discomfort and Oral Paraesthesia and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Next morning (4/27/2021) after receiving the shot (@ approx. 8:00 AM), tenderness was felt in the left armpit (same side shot was received).  After examining armpit with fingertips, I felt what appears to be swollen lymph nodes.
Rt arm sore after few hours. About 8-9 hrs after injection started with headache, sweating, sharp pains throughout body. Vaccine given 10/14 in AM. Pt called 24 hours later to report events and stated she stil had HA and general achiness. Wasn't sure is she had fever. Arm not red or swollen.
patient came in today to receive booster for moderna. stated that he noticed he started getting a purple marking on his wrist/lower arm in the same spot on and off since receiving the first dose of the vaccine. he cannot confirm that vaccine is related and doesn't know if something else is responsible but stated that he noticed it started happening about a month after vaccine 1st dose. referred the patient to a primary care provider to further evaluate the condition to determine causes and possible treatments if needed. Patient did not receive booster dose today and will wait on direction from provider
Client received Zoster vaccination by subcutaneous route to back of left arm at 11:00 am on 04/09/2014.  Morning of 04/10/14 at 9:00 AM client noticed itching and redness to the site.  By morning of 04/11/14 client noticed increased itching from upper arm to elbow, increased redness around injection site, and a lump at the injection site. Left arm painful with ambulation. Observation by this RN: Lump at injection site measures 35 x 35 mm, warm to touch.  Redness extended beyond size of lump by approximately another 35 mm. Client denies symtemic symptoms of fever or illness. Counseled on signs of increased infection, comfort measures, and encouraged her to consult with her provider about reaction, which she did.  Her provider obtained blood test for signs of infection.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's medical history included "cancer" and "shingles in the left eye area". On 27-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous injection in the left arm). Concomitant therapies included PRILOSEC, glipizide (manufacturer unknown), glipizide/metformin hydrochloride (manufacturer unknown), LOSARTIN, gabapentin (manufacturer unknown) and tamoxifen citrate (manufacturer unknown). On 02-JUN-2013 the patient returned to the pharmacist to report that she is experiencing "pain and burning around her left eye area". The pharmacist is unsure of how long the patient has been experiencing these symptoms. No treatment was given. The patient previously experienced a case if shingles (date unspecified), in the same "left eye area". The outcome is not reported. It was reported therapy with ZOSTAVAX was not discontinued.
Around 3pm on 6/18 I noticed a red rash on my upper left arm a good 3-4 inches away from injection sight so I thought I may have been bit by a spider. The rash was itchy and raised and my throat felt tight. I applied a cold pack, put on equate triple antibiotic ointment plus to sooth the itchiness. The area of the rash was hot to touch, no pain. Today, 6/19, I woke up around 5 am and realized the redness got bigger and the area around my injection is a light pink. Still itchy but throat was scratchy. I went to walk in and they noticed there's a little bruising around the rash area. It was suggested to me to take an allergy pill and I got a prescription for an ointment to help the itching (don't know the name). The allergy pill has helped a little (took around 11 am) still waiting for the pharmacy to call about my ointment to help with the itchiness. Was told by the walk in if symptoms  escalate then to come back in and they'll try prednisone or if I feel as though I need further medical help to go to the ER.
Information has been received from a medical assistant referring to a patient of unknown age and gender. It was reported that the patient were administered a dose of improperly stored ROTATEQ (lot# J013587. EXP date 03-JUN-2015) (dose, route not reported) on 11-MAR-2015. This is one of the several reports with the same reporter. Additional information has been requested.
t102 w/in 8 hrs of vax w/severe tenderness, difficulty walking & swelling of thighs;
Administered incorrect dosage per Moderna vaccine guidelines. patient received 0.3 mL instead of 0.5mL. Per CDC if more than half the dose was given, do not repeat the dose. If less than half the dose was given, then repeat the dose. in this case more than half the dose was given based on CDC guidelines. Incident reported to patient by clinics Doctor.  Reviewed  the 5 rights of medication administration to ensure incident will not happen again.
Fever at night. Woke up next morning complaining of pain in (R) leg - refused to walk for 2-3 hours and resolved. Completely normal exam in clinic.
My left arm was very swollen play under arm had about a 3 to 5 inch oval ball that was red and eight but the swelling filled up the cavity of my under arm it a few days later I got the flu shot on my right arm and the same thing happened. Comfortable swollen and red and now I have symptoms of a cold and I?ve had a headache since November 29 when I got the shot it?s still ongoing and I?ve had a dry nosebleed as well  The date formatting in this form is very difficult to fill out you need to figure out a better way for customers to fill out this form it?s enough to give up
c/o swollen from shoulder to elbow; tender @ site of inject feels more like tiredness is painful w/movement able to raise arm above shoulder unable to lay on that shoulder; soreness extended into shoulder blade;
Patient began to have a headache (4/10 pain top of the head) and dizziness immediately after being vaccinated. Notified medical observation nurse after her 15 minute observation period was over. Vitals obtained, patient assessed, given water and observed for an additional 15 minutes.
12/04/21@500am, feeling unwell, fatigued, sore arm, headache, nausea, severe diarrhea 10-12 times throughout the day, feeling similar to a Cdiff infection, treatment Xtra strength Tylenol 2 tabs q 6-8 hours, pedialite, bone broth. 12/05/22 Same as above 12/6/21 feeling unwell, upset stomach, mild diareah, fatigue Tylenol pedialite, arm no longer hurts 12/7/21 headache, little fatigue, 2 bouts of diarrhea  12/8/22 little fatigue, 2 bouts diareah
Patient wife came in stating adverse reaction to same vaccine. She had a bright red circular injection site type reaction that was 3 to 4 inches in diameter. Stating that it was itchy. It was 3 days post vaccination. Was given 6/16 patient did not come in until 6/19. The wife came in but stated her husband, this patient, had same reaction but spot was larger. Recommended to call MD, take Benadryl, and place ice pack on area. I tried calling md's office but they closed early at noon this day and patient came in at 330.
PATIENT PRESENTS WITH COMPLAINTS OF PAIN TO THE LEFT SIDE OF HER FACE, LEFT EYE AND LEFT EAR PAIN-SCORED AT 5. ALSO C/O BUZZING IN LEFT EAR. RASH TO LEFT FACE
pt recvd vax on 7OCT92 & nest morning mom reported red bummps on stomach; mom brought pt to cllinic 16OCT92; rash is fine, red, raised; dry yellowish patch over nose; fussier;
Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizziness.
RN noticed the client experiencing emesis in the parking lot around 10:55AM. The client was accompanied by his mother and sister.   The client ambulated to underneath the canopies and sat down on a chair. RN noted pallor on the client's face and that he appeared diaphoretic. The client stated he felt better and denied any symptoms at that time. The client denied any headache, dizziness, blurry vision, chest pain, or shortness of breath. Client's mother stated the client ate a "burrito and slushy" prior to receiving the vaccine today. Vitals obtained at 11:00 AM via pulse oximeter were as follows: HR 138, O2 97%. Manual right radial pulse obtained by RN  was 100 BPM. Manual blood pressure obtained by RN was noted at 85/60 with faint auscultation. The client's mother stated the client reported nausea while in observation, but the family did not alert staff on site. The client then walked outside the building into the parking lot and experienced an episode of emesis. The client's mother reported the client has a history of asthma, but does not currently take any medications. The client's mother denied any known allergies for the client. The client denied any symptoms. Client was provided water by staff and drank some. The client had no known history of emesis after receiving any medications. The client and his mother denied the client experiencing any adverse reactions after receiving the first COVID vaccine Pfizer. Vitals obtained via pulse oximeter at 11:05 AM were O2 99% and HR 134. Manual right radial pulse obtained by RN was 116 BPM at 11:07 AM. Automatic BP obtained at 11:09 AM was 125/83. RN noted decreased pallor of the client's face. RN recommended the client stay for 30 minutes after the onset of symptoms. The client's mother stated she wanted to take the client home and that he looked better. RN educated client and his mother on possible adverse reactions and when to seek medical care. The client's mother voiced understanding of this education and elected to leave against medical advice.
The next day after vaccine was given, I got vaginal spotting/breakthrough  bleeding. I am postmenopausal and on HRT and have been for 14 years and have not had any spotting after menopause and HRT was started. This highly unusual. Today, I also got a little spotting in the afternoon, like yesterday. So this is the second day in a row. I do not have any discomfort. I contacted my doctor late today and left a message for her. I do hope she will contact me tomorrow. I have heard that there are some new symptoms  reported in the UK regarding female gynecological  side effects like changes in  menstrual cycle, which would not apply directly to me, but maybe similar symptoms?  I am hoping the spotting will stop soon.  The question is, would a 2nd dose be advised or not?
4/1/2021 Shivers/Shakes at about 10pm, Fever was high 102+, after midnight began  vomiting for along period and until empty. Chills continued with fever thru the night. 04/02/2021: The next day had severe headache and fever all day. Went to bed at 10pm and woke the next day feeling  much better. 04/03/2021 Weak all day but headach was gone. Had some shortness of breath for almost a week.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
Day after imm. pt developed redness swelling (L) arm site of inj. Had chills and back pain.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M032148, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
maculo-papular rash on neck and trunk with itchy skin; maculo-papular rash on neck and trunk with itchy skin; This is a spontaneous report from a contactable physician reported for herself. A 52-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration at left arm on 18Dec2020 20:00 at single dose for covid-19 immunzation at workplace clinic.  Medical history included seasonal and dust allergies, allergies to medications doxycycline and erythromycin. Concomitant medication included acetaminophen and ibuprofen.  The patient experienced maculo-papular rash on neck and trunk with itchy skin on 19Dec2020 10:00 with outcome of recovered in Dec2020. No treatment received for the adverse events. No COVID prior vaccination, no COVID tested post vaccination. The was seriousness was reported as no.
At 4:00am I developed a nasty headache and generally felt awful.  Felt very low on energy that day and spent half the day in bed.  The next day, today, I still feel below normal and am unable to do work requiring much physical effort.  I suspect tomorrow I will be back to normal.  No medical professional was contacted.  I did not feel like I had a fever, and did not take my temperature.
Patient received vaccines at 7 weeks of age. That evening patient develop fever and was described by mother as being lethargic and feeding poorly. Admitted to Hospital, septic work-up done and started on antibiotics. History: At time of vaccine patient was diagnosis with URI; Presenting complaint: afebrile, history cough, congestion, sneezing. Phy exam: Normal exam except nasal congestion. Vital signs normal. 7/25/06 Received medical records from hospital which reveal patient experienced right upper lobe pneumonia confirmed by x-ray.  Had cold signs & Symptoms 2-3 days prior to admit.  Had been seen by PCP on day of admission for the immunizations and then developed fever up to 103.6 at home.  Septic w/u was neg.  Rapidly improved on IV antibiotics & d/c home 4/27 on oral antibiotics./ss
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Oct2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (08Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received covid treatment. Patient tested negative on 5th day of taking medication (paxlovid) with no symptoms. On 08Apr experienced some "brain fog" and tested positive. Patient did not have any known allergy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148681 same reporter/patient, different drug/event;
This spontaneous report was received from a medical assistant concerning a 25-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
After the second  dose I developed clogged ears and severe vertigo that would occur every week or so for several months, gradually getting better and less severe.  It finally resolved and then  I received the third shot and in less than a week had severely clogged ears and now tinnitus which has lasted for a full week now.
Pt recv vax on 8/12/98; on 8/12/98 pt exp fever,  red/warm/ painful vax site; tx=Zyrtec
Patient c/o throat swelling and itching after getting covid vaccine; received epi and benadryl
High fever, shivers, dizziness, aches and pains, flu-like, all night.
Pfizer pediatric shots were received on 07/29, 10 weeks would be 10/7.   Recall notice was received on 10/13 for LOT FL2757 that this lot was expired per manufacturer's expiration of 09/30. Information has been received that the manufacturer indicating that the stability data supports the use of this product through 10/19
Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female non-pregnant patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly in the left arm on 17Feb2021 11:00 (Lot Number: EL9266) at single dose for Covid-19 immunization. Medical history included asthma, mitral valve prolapses, gastroenteritis and leiomyoma. (Two weeks after receiving BNT162B2) the patient's concomitant medications included Calcium, Vitamin D3, Cranberry capsules and Turmeric. The past medications included Penicillin, Vancomycin, Levaquin, Ceftin and experienced known allergies to Penicillin, Vancomycin, Levaquin, Ceftin. Prior vaccination with BNT162B2 the patient had not experienced any covid symptoms. The patient reported that she was not on any other vaccine till four weeks after receiving BNT162B2. No Covid test were conducted post BNT162B2 vaccination. On 17Feb2021 19:00, the patient experienced mild pain at injection site, slight headache, mild fatigue. At the time of report, the outcome of the events mild pain at injection site, slight headache and mild fatigue was recovered on an unspecified date of 2021. The patient had not taken any treatment medications for the experienced events.