chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Daptacel vaccine after it expired/ no adverse event; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to case 2019SA179271, same reporter.  This case involves a 20 months old patient with unknown gender who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided. Concomitant medication was not received.   On 29-May-2019, the patient received a fourth dose in series 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date 16-May-2019 via intramuscular route in right quad.  It was an actual medication error due to expired vaccine used.  It was reported that patient received Daptacel vaccine after it expired.  The patient did not experience any adverse reaction after the vaccination.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Info has been received from a health professional concerning a 10 year old black male, with no medical history and no allergies, who on 6/12/00, was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 4/15/05, the pt experienced chickenpox breakthrough, during a middle school outbreak. Described as a generalized mild rash with a fever of 99.8 for 3 days. There were no complications. It was noted that there were no lab test. It was reported that the pt recovered on 4/18/05 without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
feeling dizzy; tired; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Mar2021 in the morning (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. By late afternoon on 19Mar2021, the patient started feeling dizzy and very tired. She felt that way all day on Saturday. On Sunday, she was feeling "so much better". The outcome of events, feeling dizzy and very tired was recovering.  No follow-up attempts are possible; information about lot number cannot be obtained.
Patient came in two days after getting vaccine with a complaint of left leg swelling.  Patient sent for US Lower ext Venous Duplex Left  Results where Deep Venous Thrombosis
Arm became swollen, tender, and red circumferentially.  Generalized itching all over body, has lasted for 5 days and continues.
This spontaneous report as received from a healthcare worker refers to an unspecified patients with unknown demographics. Concurrent conditions and medical history were unknown. On an unknown date, the unspecified patients were vaccinated with 7 doses of improperly stored ZOSTAVAX (lot # L028279; expiry date: 28-OCT-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
son experienced arm soreness.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced arm soreness (pain in extremity) on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Read the order incorrectly and gave an extra Polio and was supposed to get a Pneumococcal.
ARRESTED; This spontaneous report received from a consumer via a company representative via social media (J and J) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced arrested (Cardiopulmonary arrest). It was reported as "sounds exactly like what happened to my brother but my brother arrested and they couldn't recuscitate so he died". On an unspecified date, the patient died from arrested. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221108956-Arrested. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: ARRESTED
3-4 days, post vax, every joint in body aches. Had eye surgery for glaucoma at the end of 4/99. Knees, elbows and wrists are worse in the mornings. On 5/3/99,  recommended to take anti-inflammatory X 5 days, then call if not improved. Pt cannot sleep or drive. Back of calves and back of knees are severely painful. The pain is worse when lies down. Does not hurt when she walks. On 5/28/99, dx'd with polymyalgia rheumatica. She also has OA of hands and both knees (R>L). I am a little bothered by the ptosis on the left which apparently began a few months ago. I will start her on 15mg prednisone a day and ask her to taper the Motrin as needed.
Redness, Tenderness, Swelling at site of injection times 3 days so far.  Icing and ibuprofen do help.
Description of Event or Problem: This medically confirmed spontaneous report (initial receipt 13-Oct-2011) concerns a female patient who had a history of fibromyalgia, COPD (Chronic pulmonary obstructive disease), high blood pressure, GERD (Gastroesophageal reflux disease), penicillin allergies and SULFA allergies. Concomitant medications included salbutamol and anti-hypertensives. Upon follow up it was reported that the patient had no other illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. On 20-Sep-2011 at 19:30 the patient received AFLURIA (batch number: N55105) injection intramuscularly into her left arm at a dose of 0.5 mL. On 13-Oct-2011 the patient called the pharmacist stating she has experienced arm pain, had difficulty/decreased range of motion of her left arm and had difficulty sleeping due to the pain after receiving AFLURIA. She also reported injection site reaction resulting in sore arm and shoulder. It hurt to move arm and raise above her head. The event outcome was recovered on 20-Oct-2011. The reporter considered events as non serious. Follow up (01-May-2012) : time of vaccination, lot number, additional AE terms, event outcome, medical history, reporter's causality assessment. Follow-up (17-Jul-2012) : further adverse events detail and recovery date.
Severe Arm pain; Body aches; Chills; Felt bit tired; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 57-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an intramuscular route of administration in the left arm on 01Nov2021 at 13:00 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an intramuscular route of administration in the left arm on 21Jan2021 at 16:45 (at the age of 56-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 10Feb2021 at 14:30 (at the age of 56-year-old), both as a single dose for COVID-19 immunisation. On 02Nov2021 at 11:45, the patient experienced severe arm pain, body aches, chills and felt bit tired. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe arm pain, body aches, chills and felt bit tired was resolved on an unknown date in Nov2021.
Patient went to ER 6/22/16 (R) arm swollen, red and vesicles noted ((R) upper arm). Diag. cellulitis and possible developing abscess. Given KEFLEX x 7 days, BENADRYL, hydrocortisone topical. F/U schedule July 6.
The patient fainted 10 minutes after his shot and fell from the chair he was sitting in. He had a brief seizure while on the ground and someone called for help. I ran over and yelled for someone to call 911. He stopped seizing and stood up when he came to. I supported him and asked him to have a seat. He sat down and I asked how he felt and if he would like food or water. He said he felt okay but accepted the food and water. At that time, firefighters that had been shopping in the store arrived and started interviewing the patient. They took his pulse and blood sugar levels. Medics arrived and he continued to be monitored. After several minutes, he refused the ambulance and said he was feeling good enough to leave.
Red circular itchy rash at site of injection that has lasted up to 10 days post vaccine
needle inserted into patient's arm and upon plunger depression vaccine leaked all down patients arm. It appeared patient did not receive any vaccine so new vaccine was readministered.
This spontaneous report as received from an approximately 73 years old male patient concerning himself. Pertinent medical history was susceptible to migraines. Patient had drug reactions/allergies to PENICILLIN and SULFER. On 30-Oct-2014 (also reported as yesterday around noon), the patient was vaccinated with ZOSTAVAX, under skin in left arm, (dose and frequency were not provided). Patient had taken unspecified concomitant medications. On 30-Oct-2014 9also reported as yesterday evening around 6-7 PM), the patient developed dizziness after being vaccinated with ZOSTAVAX. The patient said he sat down for a little and "while looking at the wall it seemed as if it were to be moving back and forth". After being seated for 5 minutes his vision cleared up. He still felt woozy and ate something and later felt fine. On 31-OCT-2014 (also reported as this morning), patient woke up and felt a little "off balance". When he walks he needs to hold on to something so he will not fall. He reported that he was not walking the way he normally walks. The patient was not experiencing any pain or swelling. No fever. No headache. The patient mentioned he get migraines once a week. He was not sure if this was stemming from a migraine that was soon to take place, but he had "never experienced this before". The patient stated that his symptoms are better than they were last night. Action taken with respect to ZOSTAVAX was not applicable. Treatment was not given for adverse events. Lab diagnostics studies performed were reported as none. Patient did not seek medical attention. The outcome of dizziness, off balance, while looking at the wall it seemed as if it were to be moving back and forth. After being seated for 5 minutes his vision cleared up and felt woozy was recovering (also reported as not resolved). Outcome of migraine was no recovered. Causality was not provided. No product quality complaint (PQC) was involved. No additional adverse event information was provided. Additional information has been requested.
cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Caller called and inquired about Pfizer Covid 19 vaccine booster shot. She wanted to get the new vaccine, the booster shot she only had was in Nov, but she kept on getting some cold. She was wondering for how long should she wait before getting the Pfizer booster bivalent shot. Caller was calling and inquiring about Pfizer Covid 19 vaccine booster shot. She wanted to get the new vaccine, the booster shot she only had was in Nov, but she kept on getting some cold. She was wondering for how long should she wait before getting the Pfizer booster bivalent shot. Created an AE form because caller mentioned that she kept getting a cold after the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Symptom of arm sore at injection site, lasted more than 60 hours. Symptom of chills lasted 3 hours. Symptom of sore joints lasted 3 hours.
Initial unsolicited report received from consumer on 22-Sep-2017. This case involves 39-year-old male patient who was vaccinated with 1 ml dose (5 doses) of Imovax and PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 15 Sep 2017. The patient's medical history and concomitant medications were not reported. On 16 Sep 2017, one day following the vaccination, the patient experienced headache stomach pain some pains in his joints and muscles he felt sick. Lab data and corrective treatment were not reported. On 17 Sep 2017 (reported as events lasted a day and feels better next day), the patient recovered from the events. Since then he has had 2 more injections without issue he has one more to go. It was reported taht, tthe patient was happy now. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-MAY-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 20-JUN-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Received tdap "BOOSTRIX" from my local pharmacy. A little over 24 hours later I kept experiencing vertigo and nausea and general unease. In the next 15 hours I developed increased pain at the injection site, severe chills for hours, major body aches, and a low grade/99.9 degree fever. I slept for 10 hours and began feeling better.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) with lot # M041510 and expiration date on 27-JUL-2017 (dose, route of administration and anatomical location were not provided), for prophylaxis; instead of VARIVAX. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
5 days of fever, malaise. Headache, nausea. Red, swollen injection site.
Developed Parkinsons like symptoms. Awaiting testing and evaluation from movement disorder team . Appointment is on (9/28/21
Patient administered expired pediatric dose of Hep B, expiration was 11/07 - no reaction.
19OCT93 woke up w/violent dizzy spell cont off & on x 2 wks; nausea, body aches arm & leg tingling both hands; redness-swelling lt arms; viral ear infect;
Patient reported neck swelling and arm- lateral rashes after/30 mins after her  1st covid Pfizer dose. She said it lasted about 2 days and cleared.
Pt exp chills, sweating, weakness, tingling & joint pain 6 to 8 hrs p/recvd 1st dose of Engerix-B;
Mom states child c/o nausea, headache, and febrile at 100.4 last evening. The nausea and headache have improved after 24 hrs and child feels as though she can eat. There is localized redness and swelling at the injection site. Mom to use TYLENOL and cool compress if s/s increase mom to follow up at office.
Information has been received from a 22 year old female consumer with a history of mild dysplasia and no drug allergies who on 30-MAY-2007, was vaccinated with a dose of Gardasil. There was no concomitant medication. On 12-JUN-2007, her menstrual cycle was about 11 days late. The consumer stated there was the possibility of being pregnant but it has not been confirmed. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
received a dose of Boostrix on 26Sep2023 that was exposed to a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C75N, expiry date 06-DEC-2025) for prophylaxis.   On 26-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: received a dose of Boostrix on 26Sep2023 that was exposed to a temperature excursion).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter reported that a patient received a dose of Boostrix that was exposed to a temperature excursion, which led to incorrect storage of vaccine.  No symptoms were reported. The reporter consented to follow up via email. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023133818:same reporter different pateint,different drug US-GSK-US2023133819:samereporter different pateint,different drug US-GSK-US2023133819:same reporter different patient
Patient received vaccine on Friday. By Saturday, she had one loose stool, felt tired and achy, and by Sunday, has a fist size rash around area. Also has a slight fever.
I started having symptoms I thought were hay fever on 7/18/2022-07/19/2022 (sore throat, sinus pressure, runny nose, nasal congestion). Then on 07/20/2022 along with the above symptoms,  my symptoms got worse with extreme fatigue, shortness of breath more than usual, nausea, 7-8 bowel movements a day, sweating, low grade fever, sharp bladder pain, unusual bilateral hip pain, all over body aches, headache, eye pain, eye burning, electrical weird feeling in my head & clogged left ear. So on 07/21/2022 I started to suspect I might have Covid-19. So on 07/22/2022 I took an at home rapid test by Abbott and I tested positive for Covid-19. I called my doctors office (Dr.) & I was advised to go to Urgent Care. So I went to this urgent care where they did a rapid test on me that also came back positive for Covid-19. Because of my comorbidities and meds I?m on I qualified for the monoclonal antibody infusion. The urgent care gave me the infusion 07/22/2022. Today 07/23/2022 I?m still experiencing shortness of breath (it?s hard to speak long sentences, walk or walk and talk without getting short of breath), and I?m still experiencing fatigue, sinus pressure, headache, some nasal drainage, eye burning, & eye pain. and some nasal drainage.
Got flu shot left arm on 01/02/2003. Reaction started right away. Swollen/ puffy measured 7 1/2 cm by 7 cm
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.