chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-AUG-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-APR-2016, the patient was treated by a physician at the medical group facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Around midnight I got severe chills, and felt extremely cold. I bundled up but my husband said I felt extremely hot and I was shivering. Feverish, achy, headaches all night and day. Mild nausea and dizziness. Overall fatigued. I called in sick to work this morning.
difficulty breathing,  hoarseness, fever, dizziness, weakness, nausea and vomiting, sweeling and redness at the side of injection
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if patient had other medication in 2 weeks. Patient had received anti-viral as a treatment for COVID-19; started on 01Jun2022 and treatment stopped on 05Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
They diagnosed that it was a spasm; severe back and nerve pain; severe back and nerve pain; This is a spontaneous report from a contactable consumer. A 45-year-old male received BNT162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 45 years) as single dose for COVID-19 immunisation. The patient's medical history included bipolar 1 on an unspecified date. The patient's concomitant medications were not reported. The reporter was calling for her son. On 20Jul2021, the patient was in the ER (emergency room) two days ago with severe back and nerve pain and she clarified as lower back nerve pain. They diagnosed that it was a spasm and gave him a muscle relaxer and a few pain meds. the patient got the second Pfizer vaccine just a couple of weeks ago. The patient's body metabolizes things differently because he has bipolar 1. The outcome of the events back pain and neuralgia were recovering, muscle spasms was unknown.
Narrative: This is a 64-year-old male with a history of COPD, on 1.5 L nasal cannula of oxygen at night and as needed during the day, who presents to the emergency department with worsening shortness of breath over the last 10 days. He reports since getting his COVID-19 booster, he has felt more short of breath. He has had a lot of phlegm in his throat with productive cough, but has not noticed any wheezing or fevers. He denies runny nose or sinus congestion, denies any known allergies. He denies nausea, vomiting, diarrhea, or sick contacts. The patient does continue to smoke. He denies any chest pain, except occasionally with coughing. The patient denies any falls or trauma, no known anemia or blood in his stool. He has noted shortness of breath with exertion, but no chest pain or lower extremity edema. He denies any known heart problems, no history of thromboembolic disease. The patient does use a motorized wheelchair when he is out of the house, but has been ambulatory within his house. His shortness of breath seemed progressive, thus he presents for evaluation. The patient is immunocompromised due to Biologics (Humira) for arthritis/ankylosing spondylitis.
Info has been received from a physician concerning a 12 year old female who on 3/25/99 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 5/5/05 the pt developed breakthrough varicella which resolved spontaneously. Medical attention was not sought. No product quality complaint was involved. Additional info is not expected.
1) Low-grade fever (101 deg F) for a few hours - Treated with Tylenol 2) Sudden onset of thick, yellow/green nasal and chest congestion starting at 8PM 8/29/14 and lasted for 3-4 days - Treated with Amoxicillin. 3) Excessive fussiness from around 8PM 8/29/14 to 10AM 8/30/14. 4) Excessive sleepiness from 8/30/14 to 9/1/14. 5) Weak Appetite from 8/29/14 to 8/31/14.
received his second dose, 7 months before he would have turned 16, with no adverse event; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 15-years-old male patient who received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concurrent conditions and family history were not provided.  On an unknown date, the patient received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE  (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site for prophylactic vaccination  The pediatrician was asking whether a male patient should be re-dosed. He was given a booster vaccine in less than 4 years from the prior dose. He received his first Menactra on 19-Oct-2016, which he was 12-year-old at that time. When he came in on 22-Aug-2019  (latency unknown), he received his second dose, 7 months before he would have turned 16 (inappropriate schedule of product administration). The pediatrician asked if they should re-dose now that he was over 16. The patient Information not obtained. An attempts were made to obtain the patient information but the pediatrician was unavailable.   It was an actual medication error case due to product storage error.  At the time of reporting, outcome was unknown.  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 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. There will be no information available on the batch number for this case.
also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid; also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: reporter was mentioning her partner, who was on Paxlovid, also had the same number of vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
I had these side effects. They began around 15 hours after the vaccination and lasted for approximately 12 hours. They appeared in this order:  Soreness at injection site Fatigue Low-Grade Fever (99.9) Joint Pain Chills Severe Headache Nausea
Area of swelling  2 inches wide by 3-4 inches long on upper left outer arm below but not including aea where DTaP administered.  But does involve area where IPV given.  Area red, warm to the touch temp 98.1 orally.  Seen by Dr @ Health deaprtment
Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tumeric, multivitamin, vitamin d, lexapro and adderall.          On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection.   On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock.   Treatment for the event included was given steroids, benadryl, and prescription antihistamine.    Action taken with mrna-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
This case was considered medically important. Information regarding Hib-Titer Vaccine was received from an attorney regarding a 4-year-old male patient who experienced autism spectrum disorder, autism, ADHD, neurological damage, neurodevelopmental disorder and mercury positioning. The patient received the fourth dose on 13-Aug-1997. The patient also received the first dose of Varivax and the fourth dose of DTP on 13-Aug-1997. On 13-Aug-1997, patient received a fourth dose of Hib vaccine along with other childhood immunizations. In February of 2000, at the age of 4, patient was diagnosed with severe communication disorder/autism spectrum disorder (autism spectrum disorder). On an unspecified dates, the patient was also diagnosed with mercury poisoning and neurological damage and neurodevelopmental disorder. In May of 2001 additional diagnoses of autism with an overlap of ADHD were then diagnosed as well. Blood lead (results: 4 ug/L was done on 23-Nov-1999. No additional was available at the time of this report.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Concurrent medical conditions included rotator cuff tear and arthritis. Concomitant products included Pravastatin, VALIUM, JANUVIA, LYRICA and NEXIUM. On 26th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site cyst and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site cyst were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the injection site pain, injection site warmth, injection site erythema and injection site cyst to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left arm. The patient received Multivitamin concomitantly. The patient experienced pain, redness and heat at the injection site. The center became mushy inside, like a cyst. Her arm became so sore that she could hardly do anything. The symptoms continued for several weeks, but the pain, heat and mushiness eventually resolved. At the reporting time, the patient had a red area about the size of a small pancake on her arm around the injection site. It was not quite as red as before, but still very distinctive. The contact details of the physician was provided. Follow up information received from physician on 14th June 2018: The 70 to 80 percentage of people experienced mild reaction. Sender's Comments: US2018087748: Previous VAERS submission in paper format.
Massive headache; soreness in the arm; Aura in left eye; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0153, NDC number and Expiry Date: Unknown), via an unspecified route of administration, administered in arm right on 10Apr2021 (at the age of 66years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes, obesity and asthma (diagnosed when she was a baby). No family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not take concomitant medications. There was no investigation assessment. Prior Vaccinations (within 4 weeks) was 1st COVID vaccine. No AE following prior vaccinations. The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0153, expiration is unknown), via intramuscular route administered in Arm Right on 20Mar2021 at 11:51 as DOSE 1, SINGLE for COVID-19 immunisation. On 13Apr2021 10:30, the patient experienced aura in left eye, on 14Apr2021 11:00 massive headache and soreness in the arm on 14Apr2021. She had second dose on Saturday of this past week, 10Apr2021. Today is 14Apr2021. Yesterday, she experienced some kind of an aura in her eyes and it went away. Today, she had the same thing and now she has a massive headache. She would like to know if these are possible side effects that could occur at this date. She later clarified that it was only her left eye that she had the aura in. She wants to report it if she is within the time frame that this headache could be a possible side effect. Aura improved yesterday, but today it is worse. No ER or physician's office required. No relevant tests were conducted as a result of events. Therapeutic measures were taken as a result of massive headache, She took an Aleve. The events outcome for aura in left eye and massive headache was reported as not recovered. The event outcome for soreness in the arm was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Student came in to my office 5/15/09 1350 to report neck stiffness and head pressure that started 5/15/09 PM.
4 hours after, high temperature. 6 weeks of catastrophic fatigue. Sleep 12-18 hours a day.
Information has been received from a pharmacist and an assistant director of nursing concerning an 86 year old female nursing home patient who on an unspecified date was vaccinated by a licensed practical nurse with PNEUMOVAX 23 (lot # 658072/1416U) and developed severe adverse reactions including redness and swelling.  The nursing director reported that on 16-SEP-2008, the patient was hospitalized because the patient's level of consciousness had decreased, and for injection site redness and swelling "all the way to the neck."  The patient improved and on 17-SEP-2008 was discharged from the hospital.  The nursing director reported that the patient's redness and tenderness at the injection site were less, but the swelling was the same.  This is one of several reports received from the same source.  Additional information has been requested.
I was taking oxycodone because my doctor damaged my urethra. I usually take 1 pain pill a day. Within a week of the vaccine my pain increase 100%. I saw my doctor within a week to increase my pain medication and he told me that I needed to see a pain specialist. About a month later I did schedule an appointment with the pain specialist and he increased my pain medicine dosage from 7.5mg 22mgI was taking 2-3 pain pills a day. I also suffer from IBS, but my IBS got so much worse after the vaccine that I lost 20 lbs. within two months and have not been able to gain the weight back.
Severe joint pain lasting 12 hours moving throughout the body especially in areas known to have arthritis.
The patient came in today for her first COVID vaccine today.  I reviewed her forms with her, and she confirmed she did not have any allergies to her knowledge.  Her vaccine was administered somewhere around 12:30pm, and I advised her of the 15 minute waiting period.  She requested to stay in the immunization room instead of moving to the waiting area because she said she felt light-headed. I asked if she had eaten anything, and she said no, except for some crackers she just ate.  I asked if she had any gum or a piece of candy in her purse, and she said she didn't have anything. I said it would be okay to stay in the immunization room for the observation period, but that I would return to check on her. (I removed the SHARPS container and Moderna vial prior to leaving).   Within a few minutes, someone we believed to be her boyfriend came around to get in the door to the immunization room to see her.  My tech, went around to let him in, and then let me know I needed to check on the patient now. I went in the immunization room, and she was sitting in the chair with her eyes closed.  She still was responsive, but somewhat slow to answer questions.  I asked her boyfriend to go get her some orange juice, thinking she may be hypoglycemic. Before he came back, she started to vomit, and also urinated on herself.  He returned, and I watched her closely and picked up an epinephrine injection box.  I then advised against her having anything by mouth anymore.  She didn't have any swelling of lips, could still breath, and there wasn't any redness/swelling at the injection site, but I went ahead and called emergency services on my cell phone.  They couldn't make out what I was saying due to bad reception, so I had to call from the pharmacy, and stretch the phone back to the room. One of the questions they asked was if she was having any abdominal pain, but she said it was just her back.  (Whether she realized it or not, I'm thinking she had something else going on before she even received the vaccine, even though she indicated on her consent form that she didn't have an illness going on).   The paramedics came, and I let them know I didn't administer any epinephrine.  Before they left, they told me she was fine. I notified the customer service manager about the paramedics and emergency services call, and she was aware.  Then I asked for a biohazard clean up of the immunization room.
Intermittent fever with chills started 24 hours after vaccine and lasted for 3 days. tmax 101 hives started 48 hours after vaccine and required Benadryl every 6h for hive/ urticaria management
on 4/5/98 pt devel ``mild varicella-like rash w/assoc mild upper respiratory infect type sx p/ recv vax in 3/18/98
Very sore arm.  Extreme chills , body aches, headache, foggy brain.
Approximately 5 minutes after receiving imm., patient became pale, clammy and had a syncope episode that lasted for a few seconds. Staff layed patient on soft mat on floor and raised her feet above her heart. Her vital signs were normal (B/P 90/60, heartrate 80). Patient had not had breakfast..staff gave her apple juice. When patient felt well enough to sit up, she was also given peanut butter and crackers. Staff continued to monitor patient's condition and vitals. Seemed back to normal around 10:30 and patient discharged.
BODY ACHES; HEADACHE; LOSS OF APPETITE; CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced extreme fatigue. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, loss of appetite, extreme fatigue, chills, body aches, and headache. This report was non-serious.