chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lower lip as though it's about to form a cold sore and has not gone down at all; Swollen lower lip as though it's about to form a cold sore and has not gone down at all; A rash behind left knee; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient broke out in Hives several hours after she Left the office. Patient took Benadryl and the symptoms went Away.
Not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2017).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-AUG-2023 The reporter is a friend of the patient who stated that her friend received first dose of Shingrix in 2017, and never got the second dose. According to reporter patient had intention of receiving second dose soon.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to a 11-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 11-JAN-2016, the patient was vaccinated with an improperly stored second dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). No concomitant therapies were reported. The administered dose was exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Developed severe inflammation and conjunctivitis in left eye within 24 hours of getting updated booster
1:30 pm- Patient walked into the office with a swollen right side of his face. That morning he had come into the office and received his 2nd Covid-19 vaccine. Patient had no reaction during his 15 minute waiting period after receiving the vaccine; denied any SOB, wheezing, throat closing. The patient was given 50mg/10mL of Benadryl and 40mg of Prednisone while in the office, which he took. He waited 30 minutes after receiving both medications and his swelling improved. No worsened symptoms. Patient given Vsafe information and advised per provider to go to the ER if symptoms worsen. Prescriptions for Prednisone sent to pharmacy and instructed patient to start taking it tomorrow. Patient was also advised to take Pepcid and Benadryl as instructed that evening if symptoms not improved.
On 07/24/2022 I had a sore throat for few days since I work in a health care place I tested negative then on 07/28/2022 I tested positive. I had a cough along with a sore throat. I had random headaches went on for a month. I went to the urgent care on 07/29/2022 I was asking for PAXLOVID but they won't give it to me since I wasn't a candidate for it. The doctor recommended to do a nasal wash, vitamin C and vitamin D. Everything resolved slowly. I also had no energy at all. I was extremely tired. I had a lack of appetite. After 1 month my headaches are. I forget things which I never had before after COVID-19 I have to write stuff in order for me to remember.
Chills, Nausea, Diarrhea, Low Temperature (96) Symptoms lasted for 8 hours
muscle pain, weakness, tiredness, chills and I just feel like I have Covid all over again.  I had it in Aug/Sept 2020
Pain from shoulder to elbow, fever, chills, loose bowels, SOB, restless, decreased sleep, increase BP, fatigue. TX Aleve PRN pain, Avelox 400mg #5 x 5 days. Clarinex 5mg QD.
June 13, 2021. Went to hospital for shortness of breath and chest tightness. Temp 99.2. DX: )Acute non-ST segment elevation myocardial infarction, Acute coronary syndrome ; Pulmonary edema Transferred to  Medical Center  Negative Covid test on June 13, 2021. Positive Covid test June 16, 2021 at Medical Center
SKIN RASH ON LEGS AND ARMS; SUSPECTED COVID-19; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nirmatrelvir/ritonavir (batch number: GJ7115 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose and frequency were not reported from 13-AUG-2023 to 15-AUG-2023 for covid-19 treatment. Concomitant medications included aciclovir for drug used for unknown indication. On 2023, the patient experienced suspected covid-19. On 14-AUG-2023, the patient experienced skin rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from skin rash on legs and arms, and the outcome of suspected covid-19 was not reported. This report was non-serious.
Received first dose of Moderna vaccine on April 8th at 12:40, on Sunday April 11th shortly after 9pm I developed rapid heart rate, tightness with pressure in chest, feeling like breathing was inhibited and by Thursday April 15th pain in rib/back started. All all these systems are still affecting me as of April 17th.
a few circular, shiny, raised patches of skin on the injected arm; whole body itching and My fingertips itching; a few circular, shiny, raised patches of skin on the injected arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included year round environmental allergy and asthma. The patient received unspecified medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, after the third day of the second dose, the patient developed a few circular, shiny, raised patches of skin on the injected arm and whole body itching and fingertips were itching. 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 the reported events which included treatment with benadryl. The clinical outcome of the event few circular, shiny, raised patches of skin on the injected arm and whole body itching and fingertips were itching was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Vaccination given was expired as of Feb. 2023. The prefilled syringe in question was placed in a box of NON expired vaccines.  The other syringes in the box were going to expire in 2025. Unsure of how expired vaccine ended up in this box. No adverse reactions noted on patient.
arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 031A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm is really sore). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 08-Nov-2021 for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm is really sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient arm was really sore today (09-nov-2021) and took a Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received: No new information added.
Initial and follow-up information has been received from Merck Pregnancy Registry for GARDASIL from a Nurse Practitioner concerning a 25 year old female patient with a history of 3 full term delivery pregnancies who on 03-DEC-2008 was vaccinated with a first dose of GARDASIL (lot # 661703/0651X) 0.5ml, intramuscularly. On 04-FEB-2009 she received second dose of GARDASIL (lot # 661954/1496X) 0.5ml, intramuscularly. There was no concomitant medication. The patient was pregnant. Pregnancy was discovered on test performed at the office before administering the third dose of GARDASIL when the patient reported missing a period. The patient had last menstrual period on 16-APR-2009. Estimate date of delivery is on 21-JAN-2010, but is subject to change with ultrasound schedule for the near future. On 16-JUL-2009, ultrasound was performed resulting 11 weeks and estimate date of delivery was changed to 04-FEB-2010. Follow up information has been received from a health care professional concerning a female patient with no concurrent medical conditions and no infections or illness during pregnancy who on12-SEP-2009 experienced a complication during pregnancy of fetal demise at 15 weeks. On an unspecified date serum alpha-fetoprotein test (AFP) was performed and showed increased risks of Down's. On 12-SEP-2009 (15 weeks from last menstrual period) the patient had spontaneous abortion (< 20 weeks) due to fetal demise. The patient did not have complication during labor/delivery. The products of conception were examined and were normal. The fetus was normal. Additional information is not expected.
About 4 hours after the 2nd vaccine, I started to feel like I was getting a serious head cold and buzzy like I had taken original strength Sudafed. Over the course of the afternoon, I started to feel more lightheaded.  After work, I went to bed immediately. The next day I felt worse: worse versions of the previous day?s reactions plus a  fever ~99.0, chills, body aches and just general discomfort. Fearing these symptoms would get worse, I messaged my doctor?s office at noon (~28 hours after the vaccine) and her partner on duty that day immediately got back to me and assured me I could take tylenol to relieve those flu - like symptoms. I took 1000mg of extra strength tylenol. I felt more comfortable. The body aches stopped after a few days.  I felt out of it and fatigued for about a week. I don?t know if this is related, but 2 months (April 22, 2021) later I had a severe migraine. It was much worse than the first migraine I had 5 years before. I went to urgent care and was referred to a neurologist, who diagnosed the severe migraine a week later. Since the severe migraine in April, I have had 1 more with similar symptoms (numbness in arms and hands, etc)  in October.
Lymph note near clavicle visibly enlarged/swollen starting the day after the vaccine (same side as the arm that received vaccine). Continues to be enlarged a month later. Developed visibly swollen glands under jaw and in upper arms last week (approximately Monday).
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
experienced arm pain at the injection site; discomfort at the injection site/discomfort she thinks at the site; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 89-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: diagnosed many years ago; "Hypertension" (ongoing), notes: diagnosed many years ago. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/ lot number: EN6203), administration date: 07Mar2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site"; bnt162b2 (DOSE 2, SINGLE, Batch/ lot number: EL926), administration date: 28Mar2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ lot number: 30145BA), administration date: 30Sep2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "discomfort at the injection site/discomfort she thinks at the site "; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "experienced arm pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: This report was for the reporter's mother. The reporter's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The reporter had the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the reporter's mother and she both had the same shot on same day but the reporter's mother was ok except for arm and body discomfort at the injection site and the reporter was not concerned about that. For the injection site pain, reporter stated it was unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Due to the reporter stated the patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines, the patient's first dose was populated into the formal suspect product field. The patient had been covid negative and had been fine except for that discomfort she thinks at the site and they had been pretty lucky.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347227 same reporter, vaccine, different patient and event;US-PFIZER INC-202300347233 same reporter, vaccine, different patient and event;
got the shot around 11 am on 12/26 and my mouth became immediately  parched. My arm was super sore as the day went on and around 4:30 am I woke up shivering with chills and aches and a mild temp of 99.  Passed out and BP was extremely low. Parents  called  an ambulance  and I went to Emergency room.
pt recv vax 5NOV96 & exposure to varicella x 3wk from sibling 30-50 papules & vesicles over body;
Mother reports 14 days post vaccine, pt had bruising. Pt was seen 2/20 by physician. Physician noted purpura, bruising 2nd petechia,. PH 39,000 (INR PT/PTT normal) 2/26 PH 26,000. No treatment currently. Report to follow.
Information has been received from a health professional concerning a 5 year old Hispanic male with no known medical history or allergies who on 12/26/01 at 14:00 was vaccinated SC in the left arm with a second dose of MMR II (lot 640234/1091L). Concomitant vaccination the same day included a fifth dose of diphtheria toxoid+pertussis vaccine+tetanus toxoid (Infanrix lot 525A2) given IM in the left arm. There was no illness at the time of the vaccination. On 12/28/01 at 9:43, the pt was "swollen" and developed "cellulitis." The pt was seen by a physician. Additional info has been requested.
Information regarding Prevnar was received from a pediatrician regarding a 4 month old female patient who experienced a febrile seizure, two brief seizures without fever and aspiration pneumonia. At 4 months of age, the patient received a dose on 10/1/04. The patient also received a dose of Pediarix vaccine and a dose of Act-HIB vaccine on 10/1/04. Relevant medical history was not provided. Family history is significant for febrile seizures; the patient's sibling has had febrile seizures. Indication for Prevnar was immunization. Product was administered on 10/1/04. Dose regimen was 1 dose. Concomitant medications were not reported. On 10/9/04, eight days post-immunization, a 4 month old female patient experienced a febrile seizure. The patient's mother reported that her child spiked a fever and experienced a seizure. She was transported to the emergency department and evaluated 45 minutes after her arrival. The patient was afebrile upon examination; she was admitted to the hospital. On 10/10/04, the patient experienced two brief seizures without fever. On the same day, she was diagnosed with aspiration pneumonia. The patient was seen by a neurologist and treated with Phenobarbital. The patient has recovered. No additional information was available at the time of this report.
Severe hives, fatigue, itch  Symptoms are still present but relieved by a daily Zyrtec
Eight days after the vaccine the site began itching in the morning. By late afternoon it was swollen and red. That lasted for approximately 4 days. I used OTC cortisone cream for the itching. Then fourteen days after the injection when the itching and most of the swelling and redness had gone a new band of about 1 inch formed around the initial redness. The swelling and itching are worse. I have used ice to treat it today. It has helped with the inflammation and itching. Although I am still using the anti-itch cream on it.
This case was reported by a consumer via out of hour services and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In May 2018, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The same day of vaccination, in the afternoon and through the next day she had fly like symptoms. The patient also experienced soreness at the injection site which lasted for 3 days.
16JUL95 fever, sl cranky t102R; no other sx; temp dec w/APAP, sponging; fine by evening;
Client received dose of vaccine at approx 1225.  Was sitting in parking lot for monitoring.  Summoned attendance d/t report of heart racing, slight SOB, "weird feeling in chest".  RN and NP were called.   By their arrival, pt reported s/sx beginning to resolve.  At 1240 BP 100/78, HR 72.  At 1250: BP 100/78, HR 80.  At 1300:  BP 108/70, HR 72, R 18.  Pt was instructed to go home and rest.  Was allowed to leave site.  RN called pt at 1435.  Pt reported all symptoms had resolved.  Was doing fine.  RN
PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old not Hispanic/Latino white male. The patient's height, and weight were not reported. The patient's concurrent conditions included pancreatic cyst, and alcohol use. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On approximately 09-APR-2021, at the night of Thursday/Friday (overnight), suddenly the patient experienced pancreatitis. It was reported that, on day of vaccination the patient was fine and drank 1/2 glass of wine in the evening after receiving vaccine and before he experienced pancreatitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pancreatitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Pancreatitis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.