chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient immediately slumped over and collapsed onto the table. His eyes closed and his arms became rigid and one of them smacked into the wall. The nurse lifted his feet onto the examination table and after several long seconds he opened his eyes and asked what happened.
Pain and stiffness around injection site that lasted about 5 days; Pain and stiffness around injection site that lasted about 5 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. On 02Nov2021 at 10:00, the patient experienced pain and stiffness around injection site that lasted about 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and stiffness around injection site that lasted about 5 days were resolved on 07Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No further AE details; HCP reported that a single dose of VARIVAX: Lot X006979 Exp: 3/7/2025 was given to one patient; This spontaneous report was received from a registered nurse referring to a patient of 15-month child. The patient's medical history, Concomitant therapy included sterile diluent (lot #: W039703, expiry date: 15-AUG-2025), drug reactions, and allergies were not reported.  On 28-JUL-2023, the patient received a single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5mL/once (lot #: X006979, and expiry date: 07-MAR-2025, and anatomical location were not provided) for prophylaxis. On that day, the temperature excursion was 18.3 F for 35 minutes (product storage error). No further adverse event (AE) details.
Administered 0.5 cc Moderna Bivalent Covid booster to patient, age 9 on 2/10/23. Spoke w/mom @ 900 AM Sat. 2/11/23. Advised of dosage. Mom reported no side effects at that time. Gave instructions to observe, increase H2O, ice to arm, Tylenol, Motrin, and offered Pharmacist consult if desired. Mom declined.
Lip swelling; Blistering of lips; Dry/ chapped; Dry/ chapped; This is a spontaneous report from a contactable consumer or other non hcp. consumer reporting similar events under the same suspect product(s) for 2 patients. This consumer reported for male patient (reporters brother). A 57-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Jan2021 11:00 (Batch/Lot Number: EK9231) as dose 2, single for covid-19 immunisation. Medical history included hypothy. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 2008 and ongoing. The patient received first dose of bnt162b2 on 29Dec2020 at 11:00 (Anatomical site if injection: Arm, Intramuscular, Batch/Lot number: EL1284) for covid-19 immunisation. The patient did not receive any Prior vaccinations. On an unknown date the patient experienced lip swelling, blistering of lips and dry/ chapped. It was reported that Horrible swelling and blistering of lips lasted 3 months. Now no longer swollen but constantly dry/ chapped. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985958
Within 24 hours, I began to have headaches and feel excessively sleepy, requiring up to 18 hours of sleep a day. Symptoms peaked at 5 days after the vaccine administration. Did not leave bed that day. Also mild photophobia. No fever. No URI or other symptoms of infection. Husband and son who got vaccines were well with no other illness and no side effects except local soreness around injection site. The excessive sleepiness and headache gradually resolved by the seventh day after the vaccination.  I get influenza vaccine every year, I have never had a reaction like that.
Patient died @ home per death certificate due to Progressive Hypoxemia and COVID-19 pneumonia; positive for COVID-19 on 8/30/21 per (reporting group); no medical records pertaining to her death per phone call from Doctor's medical records department (this doctor signed the death certificate).
At the site of the shot it's red; At the site of the shot it's  itchy; At the site of shot it's swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 013A21A and 020A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen). At the time of the report, VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Patient took Moderna booster  yesterday 08-Nov-2021. At the site of the shot, it's red, itchy, and swollen. She thinks that when she took the other two shots, she took Benadryl. She doesn't want to take anything she can't take, so she was calling to see if Benadryl was ok for her.
rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown.  No follow-up attempts are possible. No further information is expected.
No adverse events at this time.  One day clinic for all their employees on 5/20/2021. Patient is Spanish speaking.  Patient indicated that she needed her second vaccine and that she did not have her card with her.  We explained to her that we were given the Pfizer vaccine only and she indicated that its the one she had. We vaccinated 104 total people and she was very assertive of the information provided.  We administered the Pfizer vaccine but once in Immtrac2 we discovered that she had indeed had the Moderna vaccine on 3/28/2021.  We left her several message since yesterday and we will be speaking to her.  The entire staff has been trained and we will bring a internet device when off site to verify what the general public is affirming to through Immtrac so that these miscommunications won't happen again.  We apologize for any inconveniences this may have caused and please note that we are taking extra measures to be sure that we are not put in this situation again.  Please let us know if we need to do anything further.  Thank you for your time.
The pt experienced a single urticarial lesion approximately 1 cm below the injection site. No other symptoms or adverse events.
Patien is an 85 y.o. female who presented to the local Hospital ED from an independent living facility  on 2/4/2023 with increasing shortness of breath and worsening cough following recent SARS-CoV-2/COVID-19 diagnosis.  Patient was found to be in acute hypoxic respiratory failure and required heated high flow O2.  Pulmonology/critical care evaluated and assisted with management.  Despite aggressive medical management, patient's hypoxia and shortness of breath persisted while on heated high flow.  On 2/10 morning, patient discussed with family that she did not want to continue aggressive treatment.  At that time, patient was sound of body and mind.  Family agreed to withdraw care and proceed with comfort care.  Patient expired 2/10/2023.  Family was at bedside.  Acute hypoxemic respiratory failure -Secondary to COVID-19 pneumonia and superimposed bacterial pneumonia with pre-existing interstitial lung disease -Despite aggressive treatment while on heated high flow oxygen, patient did not improve -Family agreed to comfort care.   COVID-19 Presumed bacterial pneumonia -Presented with cough and shortness of breath - Symptom onset: 1/27/2023 - Positive COVID-19: 1/28/23 at a HCF facility - Vaccination status: Vaccinated + boosters - CTPE on admission showed ground glass mid-upper lung changes, and dependent lower lobe consolidation.  No PE. - Oxygen status: Heated high flow -Status: Not improving - Decadron: Patient was treated with Decadron during hospitalization - Remdesivir: No.  Completed antiviral therapy with nirmatrelvir/ritonavir -Tocilizumab: No.  Patient did not qualify.  Acute encephalopathy -Secondary to sleep deprivation, sundowning, and respiratory issues   Hyponatremia -Most likely related to decreased oral in setting of acute illness +/- mild SIADH in setting of active pulmonary process  -Resolved    Elevated troponin -Likely related to hypoxemia and demand ischemia.   Hypokalemia -Resolved   Primary myelofibrosis -Follows with Dr. at a HCF, treated with Jakafi, with reduced dosing (50% reduction) for recent nirmatrelvir/ritonavir use -Jakafi was on hold during hospitalization since patient was on steroids  Interstitial lung disease Suspected, initial diagnosis in fall of 2022 after hospitalization at RMH, possibly drug-induced (macrobid). -Follows with pulmonology (Dr.).   Essential hypertension   Pulmonary hypertension With echo in fall of 2022 revealing RVSP of 55 mg Hg.  Possibly related to chronic lung disease
had whelps & rash over entire body;seen in ER for fever 102-103;was found to have otitis @ time of ER visit;
Strongly itching/burning rash developed in four or five places on body, one at a time, beginning 21 days after vaccine: left forearm, left side of jaw, right side of body above hip, side of right calf, and top of left hamstring. Rash started off red, then appeared to leak fluid and crusted over. Except for the unusual combinations of locations, it appeared much like shingles. So far it's been ten days and the initial rash on left forearm is healing but still visible; all the other sites are still actively red.
This spontaneous report was received from a physician referring to a currently 85 year old female patient. The patient had allergies to seafood, iodinated contrast media-intravenous dye, penicillin's, sulfanilamide, theophylline, odine, albumin human, tetracycline, sulfamethoxazole, metoclopramide, egg, REGLAN, PLAVIX, acetaminophen, LORTAB, FLUZONE, FLUVIRIN, erythromycin base, CIPRO, ZELNORM, XIFAXAN, THEO-DUR, VIOXX and hydrocodone. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported). On an unknown date, the patient experienced allergy to PNEUMOVAX 23 with a symptom of asthma. At the time of reporting, the outcome of the events was unknown. This is one of several reports concerning the same patient. Additional information has been requested.
I had a sore arm and couldn't swim for 2 days. It gradually wiped me out within an hour. I felt like I was in a haze, my body felt stressed. I couldn't think clearly. I had vomitting and  had no apetite. The room was spinning.
Pt recvd 3 doses of Engerix-B 19FEB91, 19MAR91 & 5SEP91 & it was determined that pt did not convert p/vax series;
Body Aches, Nausea, Chills, Headache, Injection site pain
This spontaneous report as received from a licensed practical nurse refers to an 17 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 05-MAY-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # N020353, expiry date: 28-APR-2020) (anatomical location, route of administration, dose and frequency were not reported) for prophylaxis. No product quality complaint was involved. The GARDASIL 9 was exposed to a temperature below 0 degree Celsius (°C) (-2.10°C) for 20 minutes. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects have been reported to date. The patients' guardians were notified that the patient needed to be re-vaccinated. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA004276.
A few minutes ( 5 -10 minutes) after the vaccine was given, the patient was in the waiting area getting her coat on.  Her grandfather was assisting her when she felt dizzy and her vision turned black.  She then fell to the ground, but did not lose consciousness.  The patient was pale and was seated in a chair.  She waited another 30 minutes in our waiting room and then felt good enough to go home.
were out of range for an estimate of 72 hours and reached 35.38F(1.9C); Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced were out of range for an estimate of 72 hours and reached 35.38f(1.9c) while receiving vaccine YELLOW FEVER VACCINE [YF-VAX] and while treated with DUPILUMAB [DUPIXENT] via prefilled pen.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) via prefilled pen (lot - OF024A) (with an unknown dose, strength, form, route, frequency, indication and expiration date). On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE lot number not reported.  On an unknown date the patient developed a non-serious event were out of range for an estimate of 72 hours and reached 35.38f(1.9c) (product storage error) (unknown latency) following the first dose intake of DUPILUMAB. On an unknown date the patient developed a non-serious event were out of range for an estimate of 72 hours and reached 35.38f(1.9c) (product storage error) (unknown latency) following the administration of YELLOW FEVER VACCINE.  It was reported temperature excursion involving punctured and unopened YF-VAX, punctured and unopened sodium chloride diluent for YF- VAX and DUPIXENT. Cause of excursion is unknown. Products were out of range for an estimate of 72 hours and reached 35.38F(1.9C). Caller requesting stability information. DUPIXENT- Lot: OF024A This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error. Caller requesting excursion information for Dupixent prefilled pen due to unknown reasons. Temperature was 35.38F for 72 hours over the weekend. Caller states excursion information is for administering Dupixent. Caller is not sure of the strength of the Dupixent. Additional Description of event Adverse events :Caller requesting excursion information for Dupixent prefilled pen due to unknown reasons.  Action taken with DUPILUMAB (DUPIXENT) and YELLOW FEVER VACCINE (YF-VAX) was not applicable.  Corrective treatment not reported.  At time of reporting, the outcome was Unknown for the event were out of range for an estimate of 72 hours and reached 35.38f(1.9c).  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 guidelines. 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.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 18-MAR-2015 the patent was vaccinated with an improperly stored of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On September 16, 2015 pt received the first GARDASIL vaccination. After some research we did not continue with the series. About 2 months later pt had bruising on between knee and ankles on both legs. We first noticed this at the end of October 2015. This turned into extreme bruising by the end of November 2015. In December 2015 took pt to Dr., blood test revealed ITP. Received IVIG in December. We did labs for 1 yr. He was cleared in January of 2017.
A rash and bumps begin to break out on forehead and scalp on 5-18-2008. It continued to move to my right eyebrow, nose and eyelid with no loss of vision. It was spreading and very painful. On 5-25-2008 I went to Urgent Care. I was seen by a P.A.. His diagnosis was Herpes Zoster/Shingles. I received prescriptions for Valtrex, Neurontin and Vicoprofen. I am to take the Valtrex for 10 days. The Neurontin/1 per day for one week then increase to 2 pills per day. The Vicoprofen every 6 hours for pain.
pneumonia; flu; Initial information was received on 28-Nov-2020 regarding an unsolicited valid serious social media case from the patient.  This case involved an unknown demographic patient who experienced pneumonia and flu (influenza), after the patient received vaccine INFLUENZA VACCINE.  The patient had received influenza vaccine in the past (reported as the patient always get flu shot).  The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On an unknown date (about 3 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed serious pneumonia and non serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, people may not get it from the shot but still can get it.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly document social media case concerns an unknown demographic patient who had pneumonia and influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information role of the vaccine cannot be assessed.
redness at injection site >3inch diameter. injection in middle of redness. patient reports itchiness >3 weeks post vaccination
Injections triggered mild pain crisis; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included sickle cell trait. The patient 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 vaccination. Concomitant medications included over the counter (OTC) and severe flu medicine. On an unknown date in 2021, the patient had sickle trait (SC) and injections triggered mild pain crisis. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included hydration with pedialyte after the first one and it went away. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injections triggered mild pain crisis was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.