chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201) at the age of 53 years, in left arm and on 15Mar2021 as dose 2, single (Lot number: 7534), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 032F21A), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "morbid obesity" (unspecified if ongoing); "high blood pressure (mild and under control with medication)" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: ASACOL, start date: Jan2002; VYVANSE, start date: Jan2016; LISINOPRIL; DESVENLAFAXINE; PRISTIQ; SPIRONOLACTONE; PRILOSEC [OMEPRAZOLE]; VITAMIN D [ERGOCALCIFEROL], vitamin B. Past drug history included: Lovonox, reaction(s): "Allergy"; Heparin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient received Paxlovid from 31May2022 to 05Jun2022 for the treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6201 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of the complaint history for the reported lot. The final scope included the reported finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Swelling, pain, heat and redness at sight. Fever, headaches, body aches, joint pain. Feeling extremely tired and awful
I had normal symptoms (headache, aches, muscle and joint pain, fatigue) shortly after the injection. Around 5pm, I began feeling worse. I woke up at 1am and started feeling a chest pain: both sharp pains and a dull throb. It continued when I woke up and has throughout the day.
pt recv vax 7NOV96;about 5 to 7 days later pt reportedly devel an encephalopathy;
I had extreme fatigue for approximately 3 weeks. After 3 weeks the fatigue lasted into August;  the fatigue kept me from working to my full potential and completing all the daily tasks. My menstrual cycle in April - present has been affected by the vaccine as well. I have a very regular menstrual cycle and since April it has swayed between being very light and shorter days to extremely heavy flow for up to 3 weeks and with apple sized blood clots. I am still experiencing these symptoms and never know what to expect month to month. I have also experienced an increase of ringing in the ears after the vaccine. I would get ringing 1-2 times year normally, but after the vaccine it was constant and daily. This picked up after the 2nd shot.
No reaction to the vaccine.  I started getting sick on Nove 21 with a sore throat; on the 22nd, I had a sinus headache and felt fatigued.  On the 23rd, I had a lot of sinus drainage and felt like a cold or sinus infection.  On the 24th, I woke up early with a sore throat that felt like a strep infection.  I hadn't had a sore throat of that intensity since a child.  I took a Covid test, and it was negative.  I felt mild flu symptoms, strep throat, and sinus infection all day.  I took another test that night-negative.  I took another test on the 25th around 11 AM.  It was positive.  My doctor's office was closed because of late Nov. holiday so I called the Urgent Clinic and was able to get a 5 PM appointment.  This is where I got an RX for Paxlovid.  Picked that up and took the night dose around 9 PM.  I woke up several hours after taking the medicine and felt 90% better.  I took the Paxlovid over the next 5 days as instructed.  I felt some fatigue, had a cough and had sinus drainage for the next 2 weeks.  My cough lasted the longest time about 4 weeks.  It usually only came on several times a day and before bed, occasionally waking me at night with a coughing fit.   I still, as of today, 1/10/2023, only have some days of feeling very fatigued, usually, if I have done a workout for over an hour.   I normally work out 5-6 days a week for a minimum of 2-3 hours, so this is new.  I have no other symptoms I had when, cough, sinus drainage, headaches, or sore throat.
Started a low grade fever not over 102. Red and swollen at the injection. Took Benadryl  and put ice on it because the redness kept getting larger. The redness went away but then came back. Took Benadryl and iced it and the redness went away.
- Severe local pain, swelling, local rash, and not able to walk - fever (102.4), chills, no appetite
Information has been received from a registered nurse concerning a 51 year old male who on 04-APR-2007 was vaccinated with a dose of Pneumovax 23 (lot 655500/1005F). On 04-APR-2007, 5 hours post vaccination, the patient experienced severe pain and a 14cm by 10cm area of redness involving the injection site arm. The patient sought medical attention and was treated with ice and ibuprofen. The patient was also having great difficulty raising his arm. The patient's creatine kinase level was being checked. At the time of this report, the patient was recovering. The nurse felt that the patient's severe pain, area of redness involving the injection site arm, and difficulty raising his arm were considered to be disabling. The nurse requested a lot check on lot 655500/1005F. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
This spontaneous report as received from an approximately 71 year old male patient regarding on himself. The patient concurrent condition included high blood pressure. No drug reaction/allergies were reported. In 2012 the patient was vaccinated with a dose of ZOSTAVAX (dose not reported) for shingles prevention. In approximately March 2013 (reported as "4 months ago exact date unspecified) the patient experienced itching and burning sensation all over his body after receiving ZOSTAVAX. The patient went to physician's office. The patient was treated with Cetaphil (dosage unspecified). No lab diagnostic studies were performed. At the time of the report the patient had not recovered from itching and burning sensation all over his body. All attempts of his dermatologist to alleviate the itching and burning had been unsuccessful. Additional information has been requested.
Episodic whole body tremors developed within days of immunizations. Saw pediatric neurologist on 8/28/01.
Fever, post-nasal drip, sore throat, nasal congestion, some coughing and sneezing
HER ARM HAS A LARGE, HOT, RED RASH AND THERE IS A HARD LUMP AT THE INJECTION SITE.  IT IS NOT ITCHING OR BURNING.
"dizziness after first dose"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS ("dizziness after first dose") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 DIZZINESS ("dizziness after first dose"). At the time of the report, DIZZINESS ("dizziness after first dose") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided by reporter. No treatment medications are provided by reporter.   This case was linked to MOD-2021-278429 (Patient Link).
patient received the booster instead of second dose by contract immunizer. patient doesnt have any side effect at the time. try to contact her the next day, cant get in touch with her
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 13-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received HPV vaccine for prophylaxis. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to HPV vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter was concerned about how terrible the vaccine was. It was on the top of the list with so many adverse reactions and side effects. The patient received vaccine and left bad enough reactions. This case was linked with the case US2018GSK214692, reported by the same reporter (son's case).
lightheadedness, weakness, Pain Narrative: A 63yo male with history of tobacco use, Cocaine dependence in remission, PTSD, Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he received Covid-19 vaccine on January 11, 2021, per protocol, without complications and was advised to stay on site for 15 minutes. Instructions about side effects and ADR reporting were also provided. He called hospital advice line on January 12, 2021 to report ADR symptoms of having LT arm pain that radiates to his back and chest which started on his way home after he received the vaccine. Also reported he felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the call documenting nurse, to go the hospital ED, for evaluation. Per telephone note - Physician A/P documentation included that symptoms were discussed with the patient on January 12, 2021 @13:01 PM, patient was assured what he experienced was an expected reaction from the vaccine and it'd be safe to get his second scheduled shot On January 14 the patient called back to report feeling a little light headed, having muscle/ body ache and feeling weaker after the Covid-19 vaccine. Recommendation was made to go to the ER by the call taker Patient called on January 15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17, 2021 the patient presented to the ED with chief complaint of Chest pain, was hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained in MICU and passed away on February 4, 2021
Shingles after 1st dose of SHingrix; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date unknown) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On 22nd December 2019, the patient went to urgent care and was diagnosed with shingles. The reporter did not had have lot or expiration date of shingrix. The reporter consented to follow up.
pt recv vax & exp a negative titer by latex agglutination;MD reported 9 patients;
Red, raised, mark that is sensitive to the touch at injection sight about 2 inches across.
Vomiting, nausea, fever, chills, fatigue, joint pain. All resolved within 24 hours.
Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered chronic inflammatory demyelinating polyneuropathy.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In or around 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).  On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered chronic inflammatory demyelinating polyneuropathy.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). Chronic inflammatory demyelinating polyneuropathy as disabling event, due to the pt's permanent and incurable injuries. Upon internal review, chronic inflammatory demyelinating polyneuropathy was determined to be a medically significant event.
card also says NDC#80777-0273-99  Extreme redness traveling down my arm from injection site to elbow.  Was given the injection in the middle of top half of arm instead or near the top.  Burning and itching.
This spontaneous prospective pregnancy report has been received from a physician refers to a 35 years old female patient with cervical dysplasia and amoxicillin allergy. The history of previous pregnancies and live births of the patient was not known. The patient was vaccinated SC with a 0.5 ml dose of M-M-R II on 23-JUL-2012. No other co-suspects were reported. Concomitant medications included diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and metronidazole. Physician stated patient called the office on 30-JUL-2012 stating she was pregnant. Patient was seen in the office and urine pregnancy tet taken and result was positive. Gestation 4 weeks and 3 days. Estimated due date was 17-APR-2012. Physician stated patient was not experiencing any adverse effects. Follow up information was received. The lot number 1119AA for M-M-R II  was verified as a valid lot number. Additional information has been requested.
Patient had tongue numbness/tingling 1 min after vaccine.  VS: 169/119, HR 91, SaO2 98%.  Given 25 mg PO Benadryl x 1.  Repeat VS 144/108, HR 82, SaO2 98%.  Pt monitored for additional 30 min.  Repeat BP was 136/86.  Pt released to care of husband.  Encourage her to take another Benadryl when she gets home.
Information has been received from a health professional concerning a patient who in 1998, 6 years ago, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Now, on approximately 04/29/2004, the patient experienced chickenpox.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information was provided.  Additional information is not expected.
Patient presents to clinic after receiving flu shot at health dept. on 10/04/2022. Patient states that after flu shot she has had pain and limited range of motion in left arm that has not improved. Patient states that she believes the flu shot was given too high on arm. Nurse assess patient's left Deltoid. No visible redness, edema, or bruising present. Nurse unable to visualize precise injection location as the site has healed and no visible point of injection present at this time. Patient reports limited range of motion and pain of arm and shoulder. Patient informed that nurse will complete a CDC VAERS report. Nurse recommends patient be seen by PCP to be evaluated and treated. Patient denies further questions.
This spontaneous report as received from a licensed practical nurse refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-SEP-2014, the patient was vaccinated with an unspecified live intranasal flu vaccine. On 14-OCT-2014 the patient was vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified) and M-M-R II (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. The outcome of the events as unknown. Additional information has been requested.
Narrative: Received 1st Pfizer COVID vaccine on 01/16/21, 2nd dose of Pfizer on 2/16/21. No boosters noted. Pt admitted to ICU with COVID-19 infection on 7/1/22. This is a 73-year-old male who has been admitted via emergency room with diagnosis of bilateral Covid pneumonia and acute hypoxic respiratory failure..Patient required 2 to 2.5 L of FiO2 by nasal cannula and SPO2 and ranging between 94 to 96%. No fever or chills are noted. Has scanty dry cough.. Tmax noted since admission is 101.3 degrees.
Fever, headache, body aches. Site of injection very red and hot and swollen as large as a baseball
Initial unsolicited report received from a non-health care professional via other company (Pfizer, reference number 2016066192) on 09-Feb-2016. This case involves a 72-year-old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date and site of administration were not reported) in left arm on an unspecified date. Medical history was not reported. Concomitant medications were Diltiazem, atorvastatin for the indication high cholesterol 40 mg tablet. Other conditions reported as hypertension, high cholesterol, osteopenia and fall with cracked ribs. On an unspecified date of Sep-2015, following the vaccination patient experienced big red rash the size of her hand, itching and really hot arm. Laboratory investigation and corrective treatment were not reported. On an unspecified date of Sep-2015, the outcome of event was recovered. List of documents held by sender: none.
RN notified of patient having reaction and being taken by ambulance. Per EMT report, pt. began having chest pain radiating down her arm, chest heaviness, right arm numbness, and some shortness of breath. Vitals BP:146/78, O2 94% on room air. Patient also pale and diaphoretic. Taken by ambulance to emergency room.  Patient has extensive cardia history per EMT report: has pacemaker, had stress test and scheduled for a cardiac procedure.  3/29/21 Phoned patients daughter to follow up with patient's status. Patient does not have cell phone and speaks Bosnian. During hospital stay, she reports her O2 sats were low, had a heart cath. procedure,
Severe chills, body aches, sweats. Spine feels icy cold. Symptoms were originally almost constant and have gradually become a bit less frequent but are still, as of this date, debilitating. Loss of weight and appetite have continued. Headaches.
Patient fully vaccinated with Moderna 1/21/21 and 2/27/21. Patient admitted 1/19/22 with COVID19 after having symptoms of worsening shortness of breath and hypoxia over 4-5 days. Patient is still admitted
The patient was administrated with an expired Act-hib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via  consumer/non-healthcare professional via Global Medical Information (Reference number- 00726333) and transmitted to Sanofi on 16-Aug-2020.  This case involves a 3-year-old female patient who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB, expiry: 28-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "stated that an expired ACT-HIB was given and wants to know what the recommendations would be on the vaccine. stated that she does not have that information"  No adverse event was reported.  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.
Localized redness/swelling reaction for 3 days and hasn't yet resolved. Fever that lasted around 1 day.
Left thigh with redness and swelling down to knee. Not bearing weight on left leg. He was given Benadryl 12.5mg X 1 with resolve.
Awoke during noc w/diaphoresis, chills, syncope, passed out x 3, maculopapular lesion of approx 3" diameter on rt leg; Ringer's lactate IV, oral dicloxacillin prescribed;
Four days after injection both the right and left  hand started turning red and feeling like I was sunburned, a little on my forehead as well. By Monday, morning the redness started turning purple and now almost 4 weeks after the first shot the spots have turned brown (slightly fading but not by much).
The diluent used for the Yellow Fever Vaccine expired 6/21.  Patient was contacted and advised to return after 28 days for a valid dose of Yellow Fever Vaccine.  Patient was asymptomatic.