chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Contracted the COVID-19 virus after being fully vaccinated with all 3 doses. I received the antibiotic infusion.
Information has been received from a nurse concerning a female (age not reported) who on 23-OCT-2006 was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (lot 651374/0485F). Later the same day, the patient's arm in which the vaccine was administered swelled and became red and swollen from elbow to shoulder. She was seen in an urgent care clinic and was diagnosed with cellulitis and released. The next day, the patient was re-evaluated and diagnosed with bacterial cellulitis. At the time of this report, the outcome was unknown. The nurse reported that he was unaware if the patient missed work because of the reaction. The reporter requested a lot check to be performed on lot 651374/0485F. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Necrotizing pneumonia, Bacteremi - bl cult pos Pneumoncoccus. Treated with Resphin IV and Clndamyan Discharge summary states fever, shortness of breath, dehydration. msv
Got COVID; Got COVID; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 08:00 (Batch/Lot Number: EL9262) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 08:00 (Batch/Lot Number: EL9269) as single dose, both vaccinated at the age of 52 years old for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient got covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021.  patient visited Doctor or other healthcare professional office/clinic visit. Outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a two- months old female patient who was vaccinated with a 0.5 ml first dose of PENTACEL (lot number: PENTACEL- Dtap-IPV (Lot: C5426AA and expiry date: 04-Oct-2019); ACThib- Powder (Lot: UI907AA and expiry date: 26-Oct-2019) via intramuscular route in the left thigh on an 13 Dec 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), ROTATEQ and PREVNAR for immunisation. It was a case of actual medication error due to inappropriate reconstitution technique as dose of PENTACEL that was mixed with a component from ACTHIB.. No adverse symptoms were 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 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. List of documents held by sender: none.
Breakthrough covid case; Pt presented to ER with c/o abdominal pain,  nausea and vomiting. Hx of Pfizer vaccine x 3. Hospitalized at Hospital x 3 days. DX alcoholic gastritis, alcohol abuse and dependence, chronic pancreatitis, depression, DM, and covid 19. No other covid symptoms at this time. Patient hospitalized in May for pancreatitis then DC to rehab.
Patient fainted and was assisted to the floor by parent & Vaccine Administrator. Ammonia inhalent was used & she responded approxiamtely 1 minute later.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318), as dose 2, single (Lot number: EN6199) and as dose 3 (booster), single (Lot number: FF8841) at the age of 38 years 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) with onset 01Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jun2022, outcome "recovering" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: There was no COVID prior to vaccination, patient tested with COVID post vaccination, COVID test type of post vaccination was Nasal swab, on 01Jun2022 test result was positive.  No follow-up attempts are possible. No further information is expected.
Low grade fever & irritability approx 2 days; On 9th day noted total inability to abduct lt eye; Seen by MD who confirmed; CBC, SMA 19, Thyroid eval Anti Acetycholine antibody;
Wrong vaccine given. Pt came in wanting Pfizer but instead was given J&J. Pt was checking in at the window and a card stating Pfizer was placed on the table for another nurse to take and administer vaccine. Nurse brought pt back into vaccine room to administer vaccine. Nurse asked pt if he had any allergies which he stated tomatoes and stated he did not have trouble breathing. Nurse then stated you are getting your first J&J vaccine. Pt stated nothing.). J&J vaccine was administered into Rt delt. Nurse then gave pt his vaccine card and information sheet on the vaccine. Pt asked what he needed to do if he wasn't in the area on 12/27/21 and nurse stated I gave you) the J&J vaccine. Pt replied by stating that he wanted the Pfizer vaccine and that he would have a reaction to this vaccine. Nurse stated that she told him what he was getting prior to giving it and pt said nothing. Nurse then asked if) he wanted to speak with someone and he stated he did. Nurse stepped out of the room and notified CMA and Nursing Administrator, RN of what had occurred. They went into the room and spoke with Administrator, RN and Health Officer, notified of the incident.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 18-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Dizzy within 20 minutes of receiving the vaccine which lasted the duration of the day vaccine was administered. Headache and nausea for 24 hours after  vaccine given. Patient was able to treat with Aleve. Patient also reports an injection site reaction (red, raised bump) that started yesterday evening and is continuing through today.
Pt presented to clinic for Tdap vaccine after stepping on a nail the morning before. Pt received ADACEL 0.5 ml IM in (L) deltoid. Pt called clinic back after leaving and stated, "About 10 minutes after I left from my shot I had this metallic taste in my mouth and spit up a little saliva that was red. I rinsed my mouth out and it's been fine ever since." Referred pt to his primary MD. Will follow up with patient.
pt recv vax 6NOV95 & devel cervical neck pain, upper lt arm pain, numbness down into the lt hand;treated w/physical therapy & anti-inflammatory meds;sx have since dec in severity, but cont to persist
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K019560 with expiration date 02-JUN-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
I got extremely sick for 24-48 hours, but I noticed an elevated heart rate about a month after my 3rd dose. I was working out and I had a sharp pain in my chest and I noticed that my heart rate was over 160. I am still dealing with this at this time. I am unable to exercise and work out like I used to be able to. I can't hold my breath when I swim and I have a hard time walking up the stairs.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factor (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for cerebral infarction, Diabetes type 2, hyperlipidemia, tobacco use, COPD, kidney cyst, thyroid nodule. squamous cell carcinoma, right lung mass. Per note 4/19 "A PET scan showed a large, centrally necrotic right apical lung mass extending into the right hilum as well as invading the posterior right upper lobe proximal airways and right pleura. He underwent bronchoscopy with FNA of a lymph node on 3/30/21. The official pathology report on this is still pending the results of immunostains. He was also incidentally found to have evidence of a subacute CVA on MRI of the brain. He left AMA at that time. He returned to the ED on 4/13/21 to pursue additional workup of his lung mass and reported ongoing chest pain. He was then transferred to the hospital for ongoing care. The patient's chest pain, deemed to be pleuritic in the setting of lung tumor and post-obstructive pneumonia, has been controlled with Norco prn. He exhibited clinical signs of pneumonia, and was started on antibiotic therapy. He was initially on doxycycline and ceftriaxone, but he was switched to vancomycin/cefepime/Flagyl on 4/18/21 when his white count continued to rise" Patient deceased 4/25 but not notation of cause of death documented.
Information has been receive from the patient's mother concerning a female patient. On 04-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-OCT-2013 the patient was vaccinated with a second dose of GARDASIL (lot#,expiration date, dose and route not reported). Because the injection was unavailable at the physician's office, the patient received only two doses of a three dose series of GARDASIL. The patient did not experience any side effects. The patient did not seek medical attention and her present status was unknown. Additional information has been requested.
Two days after  2nd booster shot,  she started having pain and heaviness in both legs.  She has been taking Advil since then, however, the pain has not gone away.  She did not have this issue after 1st, 2nd and 1st booster shots.
Patient received Pfizer COVID vaccine on 4/7/21 (lot # ER8729), 5/5/21 (lot # EW0167), 11/5/21 (lot # FG3527), and 4/22/22 (lot # FK9893). On 6/17/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxemic respiratory failure due to COVID-19 pneumonia, possible bacterial pneumonia/bacteremia, COPD, and CLL. As of today (6/20/22), patient is still admitted in our med/surg unit.
Approxiamately 2 hrs post receiving the vaccine, I developed a raised, hard, itchy, warm, tender to the touch and red rash at the injection site which was about 2 inches in diameter. It persisted for 3-4 days.   On day 8, I awoke to a rash at the same site however, this time it is about 3 inches in diameter and very warm to the touch. I have yet to treat it with anything.
10/16 left thigh still erythematous, swollen from vaccine to (L) thigh on 10/4. No improvement. Area of swelling 3cm x 3cm. (L) thigh measures 32cm at site, (R) thigh 31.5cm. No warmth, no pain, no evidence of abscess or cellulitis. Instructed mother to perform gentle massage & notify if worsening.
Fever up to 103 deg F started about 48 hrs after shot given. (Flu shot). Swollen and achy neck body aches and chills. Lasted 3 days. Fever 103 deg. for on whole day. Then 101 deg for 2 days.
DEVELOPED PALPITATIONS AND POUNDING HEADACHE AFTER3RD PFIZER DOSE, WHICH HAS CONTINUED DAILY PAST T WEEKS. O/W NORMAL EXAM
mom described soreness & discomfort on 17AUG; on evening of 18AUG93 mom noticed redness & swelling of lt arm & blotchy appearance; seen in ER 1145PM; t99.4; redness persists down to elbow;
From initial information received on 09/03/2004 from a health care professional, regarding an adverse event occurring in the USA, it was reported that a two month old female patinet received her first dose of IPOL vaccine, lot number X1040 administered in the right leg, her first dose of  Daptacel vaccine, administered in the left leg, her first dose of Prevnar, manufacturer Lederle, administered in the right leg and her first dose of Comvax, manufacturer Merck, administered i/n the left leg on 09/02/2004. Reportedly after the fourth injection the patient became quiet and her leg stiffened, no other adverse events reported. The father of the patient picked her up and the patient was acting "normal" The patients recovery status is currently unknown. From additional information recevied on 11/01/2004 from the initial reporter it was reported that the patient received the vaccinations between ten and eleven on the morning of 09/02/2004. The patient was vaccinated at a private doctors office and the vaccine purchased with private funds.
I had previously had fluid drained from my knees and then shots into my knees to help them with pain and mobility issues. This had helped and I had not had a problem with them. Then I had my COVID-19 shot and then the pain came back in my knees. I have done nothing to trigger this like an injury. It is like I never had the shots with the pain and issues with being able move and walk. I do have a follow up to go back in and my provider did mention that I may have to drain the fluid again and get the shots again to get this cleared up.
received his first COVID booster shot (3rd total in series) on 22-Aug-2022.  He had headache and bodyaches from 23-24-Aug-2022 and severe arm pain and swelling.  On 26-Aug-2022, he fainted for the first time ever in his life.  We called his pediatrician's office and they told us to monitor him and keep him hydrated.  Over the next week, he had two more fainting spells and multiple instances where he felt like he was going to pass out.  I took him to urgent care on 05-Sep-2022 and he had labs and an ECG performed.  Everything came back normal and we were told to monitor him and that the fainting/dizziness would likely subside, but to call back if it didn't.  The fainting/dizziness subsided in mid-September, but personality/mood has changed ever since then.   He quit all activities he used to participate in (karate, swim) and became withdrawn.  In November, he started to hear voices.  We took him back to his pediatrician and they referred us to a psychiatrist and therapist.  No diagnosis of depression or anxiety was made, but the therapist picked up on a flat affect and "spaciness" and asked if he had a neurologic evaluation.  At that point, we began the process of having him seen by a pediatric neurologist.  He has had an MRI performed which came back normal and an EEG which picked up on epileptiform activity.  He has a 24-hour ambulatory EEG scheduled for 22-23 May 2023 at Hospital.  We don't have a formal diagnosis yet, but it seems that has developed a seizure disorder ever since he had the booster shot.  The withdrawal that we thought was depression is likely seizure events where he "spaces out" and feels "weird" but can't explain exactly what is happening to him and sometimes hears voices.  I have seen his eye roll in the back of his head a few times during these episodes.  My son's entire personality and quality of life has suffered ever since receiving the booster shot.  On almost a daily basis, he does not feel well, but can't explain exactly how he is feeling.  He has fallen down in school a few times.  We are still working to get a diagnosis and hopefully treatment, but as I've pieced the timeline together of all of these changes, it starts from the point he recieved his booster shot.
pt was inadvertantly given Tetramune instead of Influenza vax on 1OCT93; the following day exp pain @ the inject site, erythema, swelling, induration & warm to the touch; treated w/Advil & ice packs; pt recovered;
Menstrual cycle started on 12th day of cycle and lasted 7 days. Occurred three days after vaccine. Cycles are normally very regular.
Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.
This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 11:15 AM as a single dose for covid-19 immunization (at the age of 26-years-old). Medical history included fibromyalgia, myofascial pain syndrome, and endometriosis. Concomitant medications included VIIBRYD, HAILEY 1.5/30, CLARITIN-D, and PROBIOTIC 10 taken for an unspecified indication. The patient had known allergies of took opioids (narcotic/opioid pain medications) and pregabalin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had not taken any treatment for reported events. On 15Aug2021 at 12:15 PM, the patient experienced dizziness, confusion/difficulty focusing, fever, fatigue/tiredness, weakness/fainting, fast heartbeat, muscle aches, headache, injection site pain, and bruising and hot flashes/sweating. The outcome of all the events was recovering.
Vaccine given at 7:25am and at 8:15am patient reported throbbing pain to left arm. Pain goes down entire arm. Numbness and tingling to left arm comes and goes. Reports can't move arm.  Dx-Bursitis  possible injection to high  Dx Bursitis
Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 21-MAY-2013, at 62 years of age, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
This spontaneous report was received from a Registered Nurse (R.N) concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and allergies were not reported. It was reported that on 21-JUL-2014, the patient was administered his first dose of GARDASIL (Lot # H020901; expiration date 05-JUL-2015) (dose and route were not reported); on 07-NOV-2014, he received his second dose of GARDASIL (Lot # H020901; expiration date 05-JUL-2015) (dose and route were not reported); on 07-APR-2015, he was administered his third dose of GARDASIL (Lot # L001442; expiration date unknown) (dose and route were not reported). It was reported that on 28-FEB-2017, the patient was then administered a fourth dose of GARDASIL 9 (Lot # M041213; expiration date unknown) (dose and route were not reported). No adverse effect was reported. There was no PQC involved.
slight fever on and off; Chills; Slight headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Pfizer sponsored program. Follow up (20Apr2021) received from a contactable consumer or other non-healthcare professional was processed together with initial information.   A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included injured toe and patient was prescribed to take amoxicillin which he was waited 4 days after the vaccine to take the medication. The patient's concomitant medications were not reported. On an unspecified date, patient experienced a slight headache at the beginning of post authorization, has had a slight fever on and off lasting longer than 14 days post authorization and chills two weeks after receiving second dose of vaccine. Reporter mentioned that the patient took Tylenol for the fever and it will then go away. Reporter wanted to know that for how long patient can experience these side effects after receiving the vaccine. Reporter also wanted to know if there was any interaction with antivirals or amoxicillin. Outcome of the slight fever on and off was recovered while for the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.