chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest area; Rash/ rashes in her neck and chest area; swollen lymph node in armpit area; soreness/pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: Mar2021), intramuscular in the left arm on 07Jan2021 at 0.3 mL, single dose for COVID-19 immunization. Medical history included testing positive for COVID in Apr2020. There were no concomitant medications. The patient previously took flu shot and experienced soreness. The patient did not receive any vaccination within 4 weeks prior to the COVID vaccine. The patient called in regards to Pfizer COVID Vaccine. She received her first vaccine last Thursday, 07Jan2021. She was not sure if she can report this as a side effect, but she had some rashes appear just today (11Jan2021), at midnight, in her neck and chest area. The rashes were going away, but she still has some itching. She also stated that she took some over-the-counter diphenhydramine (BENADRYL, UPC: 1254717031, lot number: PJF044, expiration date: Jun2021) tablets to relieve the symptoms. She explained that she started to experience soreness/ pain at the injection site a few hours after receiving the COVID-19 vaccine. The pain in her arm has already went away. She noticed a swollen lymph in her armpit area on Friday morning, 08Jan2021 and it's still a little bit swollen. She didn't expect on getting a rash since she read symptoms only appear around 2-3 days only. Therefore, she is not sure if she can report this as a side effect because its been like 3 days already. She noticed the rash just today, at midnight. She stated that she is still itchy. She stated that there is just a little bit of itchiness in her neck. She felt a little bit warm and itchy in her chest area, at midnight (unspecified date), and she kept scratching. She knows she shouldn't have done that but it was itchy. The patient would consider these events to be non-serious. She did have some soreness with a flu shot before so it's not too serious. She explained she is a healthcare worker. She works in a nursing home facility and they asked if she wanted to receive the Covid-19 vaccine and she filled out the form. She also explained that she doesn't have any allergies to any medications. So, with the rashes that came, she is not really sure what is the cause of it. The events did not require a visit to the emergency room or physician office. She stated she wanted to report this information but she also needs advice on whether she needs to continue taking Benadryl. Her rash is improving, but she is still a little bit itchy. She doesn't have any shortness of breath or anything. It's not a major reaction, just a little bit of a rash/itchiness in her chest and neck area. The outcome of the event vaccination site pain was recovered on 10Jan2021, for lymphadenopathy and rash was recovering, for pruritus was not recovered and for feeling hot was unknown.
2 Weeks after vaccination with varicella patient broke out with Chicken Pox.  On visit to doctor patient had no history of previous Chicken Pox Disease.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  In 2016, the patient was treated at a facility (considered a physician's office) for a persistent and severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age.  Medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with ZOSTAVAX subcutaneously to prevent shingles (lot # not reported).  On an unknown date, the patient experienced pain and swelling at the injection site for five days.  No treatment was given and the events recovered on their own.  The reporter did not rate causality. Additional information is not expected as the reporter did not provide consent to be contacted.
Initial report was received 26 July 2010 from a health care professional. A 55-year-old female patient had received an intramuscular right deltoid injection of ADACEL, lot number U3082AA on 06 July 2010 and four days later, she "blacked out" for two minutes, experienced a fever (temperature not recorded), and developed redness, swelling and blistering at the injection site. The events did not require medical intervention and the patient self medicated with unspecified pain killers. The patient was evaluated on 26 July 2010 (results not reported). The patient had last received a TD vaccination greater than 10 years ago and she had no illness at the time of vaccination. She had a past history of GERD (gastroesophageal reflux disease), low back pain, htn (hypertension), osteoporosis, "hyperlypidemia:, insomnia and anxiety and had been taking HCTZ, hydrocodone, Xanax, Lopressor, lisinopril, Boniva, Nystat, Prevacid, "symbastatin" and Ambien concomitantly. According to the reporter, the patient recovered. Documents held by sender: none.
No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD to a 26-year-old patient.; This spontaneous report has been received from a medical assistant and refers to a 26-year-old female patient. Her pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided. The patient's historical vaccines included measles vaccine live (Enders-Edmonston) (+) mumps vaccine live (Jeryl Lynn) (+) rubella vaccine live (Wistar RA 27/3) (M M R II) and varicella zoster vaccine live (Oka/Merck) (VARIVAX).  On 25-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection 0.5 milliliter as prophylaxis (route of administration, anatomical location of vaccination, lot number and expiration date were not provided) (product administered to patient of inappropriate age).  There were no additional adverse events.
pt recv vax 19OCT98 & devel an inj site rxn characterized by swelling & warmth;pt also felt flushed;
Patient states he got a cold sore on his lip about 12 hours after the vaccine. I came on faster and stronger then normal. Patient hadn't had a cold sore in 3 or 4 years prior. He did take a double dose of valacyclovir to clear up the cold sore but it still lasted 2 days. Patient was unsure if it was related but will watch for this after his 2nd dose that he received today (5-20).
This spontaneous report was received from a health care worker, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot # M011663, expiration date 08-SEP-2017; lot # M018637, expiration date: 11-OCT-2017) (dose and route were not provided). The temperature excursion was of 11F in a time frame of 30 minutes. Data logger was reported as Yes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
I do not have the lot number available at present, but it is on file at home.  First noticed a slight rash just below the injection site on day 8 after receiving the injection. Rash began about the size of a quarter and grew approximately 2 inches in diameter within 8h, pink, and noticably warm to the touch with mild, intermittent tingling sensation (not itchy, really). I had been continuing my standard daily OTC antihistamine (loratadine, 10mg) since receiving the injection. Upon noticing the reaction, I gave it about 8h to see if it would resolve on its own. After noticing it growing slightly larger, I took 1 benadryl tablet before bed. Rash is less warm to the touch in the morning and no tingling sensation is present. Currently, rash size is steady.
1243- Patient?s wife approaches RN stating her husband (patient) is feeling dizzy. RN approaches patient. NP and EMT are notified. Patient states this is his 3rd dose with Pfizer. (attestation letter was signed) 1244- NP, POD Lead, 4 nurses, EMT, and patient wife are at patient?s side. Patient is laid down on a sheet on the ground with his lower extremities elevated onto a chair. EMTs are attaching monitor to patient.  NP is assessing patient. He has a h/x of intermittent elevated BP, fibromyalgia, elevated cholesterol, and pre diabetes. Patient states his SBP baseline is in the 130?s. Pt takes Crestor and Cymbalta at home. Patient states he feels ?shaky? and states his last meal was at 0800 this morning. Patient?s hands are cold to touch.  Patient denies headache, chest pain, blurred vision, or SOB. NP requests BS reading.  1246- RN collects blood glucose sample.  BP: 151/86, P:67, O2: 99%, BS:111 Patient states he has a h/x of elevated BP. He verbalizes he is ?slightly shaky.? Patient is given cookies and Gatorade. 1250- patient states he is feeling better and he is assisted to a sitting position in the chair. He has cold hands. Denies numbness, diaphoresis is not present, denies dizziness, denies chest pain, denies SOB.  1300- denies lightheadedness, vision changes, patient is warm to touch.  1303- patient is still sitting in chair BP: 153/85, P:58, O2: 99.  1306- patient states he feels an intermittent heaviness after taking Cymbalta 30mg this morning and sitting in the same position for long periods of time triggers his fibromyalgia symptoms.  1310- Patient states he was taking metoprolol a couple months ago but his physician stopped the medication because his BP was too low. NP advises patient to follow up with primary care physician about elevated BP.  1314- Patient states he ?feels okay, ready to go home? Patient is advised to eat when he gets home. Patient is alert, and ambulates safely to car with wife and escorted by RN.
Patient watched for ~15 minutes after injection  called back shortly after leaving office that she  had a headache "tingling" sensation down back  and a rash on chest. Rechecked in office. Vitals stable Given small dose (12.5mg) of Benadryl- symptoms  resolved
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
This spontaneous consumer report (initial receipt 23-Oct-2013), concerns a 43-year-old female patient. The patient had medical history of allergies, asthma and drug reactions/allergies to sulfas. The patient also took unspecified concomitant medications. On 19-Oct-2013, the patient received AFLURIA (Batch: R56108). On the same day, the patient experienced that the whites of her eyes were bright red, she was spitting out green 'junk' and her asthma had worsened. The patient stated that she had looked into this and found out that she had developed oculorespiratory syndrome. The patient was self-medicated with erythromycin. Within 6 hours, the respiratory symptoms had recovered. It was reported that it took two days for her eyes to return to normal. Outcome was reported as recovered.
Patient received dose 1 of the COVID Moderna vaccine (lot 047B21A) at 1130. At 1200, patient reported to EMT that she felt nauseous, lightheaded, and pain radiating from the injection site in her right arm up to her shoulder. EMT alerted PHN who approached the patient to further assess. Vital signs: blood pressure 130/88, O2 96%, pulse 94, respirations 12. At 1207, patient reported the lightheaded had resolved and nausea was improving. Patient reported only eating a small breakfast. Allergies: epinephrine, Norco, Tramadol. Medical conditions include chronic migraines, status post gastric bypass surgery 2 weeks ago. Medications include: Effexor, Trazodone, Finasteride, Ubrelvy, ibuprofen, estradiol patch, diltiazem, progesterone, atorvastatin. At 1210, vital signs O2 95%, blood pressure 124/90, pulse 84, respirations 12. PHN offered Benadryl but patient declined. PHN encouraged patient to notify provider and when to contact 911. At 1217, vital signs: O2 93%, pulse 80, blood pressure 110/76, and respirations 14. Patient stood up, reported feeling dizzy with a headache. Patient sat back down and drank some water. AT 1220, patient stood up again reporting all her symptoms had resolved. Vital signs: blood pressure 138/74, O2 95%, respirations 14, pulse 82. PHN encouraged patient to stay until 1230 but patient insisted on leaving. Patient left walking with steady gait at 1221.
After the vaccine I experienced brain fog. It lasted for about three days. Also, sore arm and fatigue.
Burning sensation both arms, chest, face; itching upper torso; "moderma arm"; outbreak of shingles in week 2 after receiving first dose.
Critical thrombocythemia, causing anemia due to nose bleeding, GI bleeding and metrorrhagia. Elevated WBC. Acute kidney failure. Pancreatitis. Admitted with Dx of Tumor lysis syndrome required blood and platelets transfusion
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; Vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired by 1 day) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Type of test : STPH).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired by 1 day) had resolved.            No relevant concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-207778 (Patient Link).
Patient has history of vasovagal reaction to blood draw and vaccines, BP dropped to 90/60 HR80, then 10 minutes later 94/64. Discharged in stable condition
his wife got her first dose of SHINGRIX in 2018 and has not yet received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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: his wife got her first dose of SHINGRIX in 2018 and has not yet received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-JUN-2023 This case was reported by patient's husband.  The patient had not yet received her second dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient received vaccine on 7/5/18, reported about ADER on 7/6/18 am- he reported that he had severe chills on night and in morning he had sweating, high temperature, weakness and ultimately syncope. He felt dizziness and disoriented whole time. Also he has injection site redness and swelling.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient also indicates shortness of breath, and bruising of arms and hips since recieving injection of third dose.  She reported all these details back to pharmacy in person on 1/15/22, 5 days after injection.
pt recv vax 7AUG95 & 10OCT95 pt varicella zoster titer was neg;
Severe pain in injection arm, profuse sweating on second day.  A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.
Mild symptoms night of receiving vaccine injection. Followed by 3 days in bed due to EXTREME muscle pain and shivering. Also suffered frequent nausea and headaches. No registered fever.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 15-SEP-2015, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Headache, nausea, fatigue ,sore arm, fever- 102.3.  Lasted 2 days.  Then 2 days after first reaction, started with Covid arm.  A dark red rash on Left (injection) arm.  Very itchy, and lasted 4 days.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9, Lot number reported as M026306, expiration date: 30-APR-2018 (strength, dose, frequency and route of administration were not reported), for prophylaxis with a temperature excursion of >0 but < 2 degrees Celsius for 49 hours and 5 minutes. Additionally, this excursion was detected due to a digital data logger and there was no previous temperature excursion reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006813: US-009507513-1701USA006818.
Extreme weakness in all muscles & pain. Unable to walk 1st 2 days. Leg muscles still not right 7 days later. Pain slowly subsiding. (Had regular pneumonia vaccine Nov, 2013).
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 01-NOV-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. On 20-FEB-2014 the patient was vaccinated inadvertently with ZOSTAVAX vial (strength, dose number, dose unit unknown) with lot # J000492, subcutaneously that has expired on 19-JAN-2014 for vaccination. No adverse effect was reported. The outcome of she inadvertently administered ZOSTAVAX which expired on 19-JAN-2014 to a patient and no adverse effect was unknown. No further information provided. Additional information has been requested.
Severe headaches,   A little nausea,   Upset stomach,   Heart racing, and I think it made my diazepam and the stuff I take for my restless legs stop working. As my tremors from the withdrawals I have from Valium I?ve gotten worse, and my doctor switched me to another medication for restless legs. Cold all the time.
First, at about 3:30 p.m. on 3/23 I had my blood pressure taken and it was 130/77. This is the highest blood pressure reading that I have ever had in my entire life. I have never had a systolic number this high and rarely a diastolic that high. By about 5:00 p.m. I could bare lift my left arm. By 9:00 p.m. I began to feel sick to my stomach and had he chills - simultaneously feeling freezing cold and burning hot. I had to be covered in blankets even though the room was 71 Fahrenheit and I was too sick to move or get up from the couch. This continued until about 3:00 a.m. when I moved from the couch to the bed, feeling very weak and like I would throw up. I had severe gas during the night. By about 7:00 a.m. I could move again, and I had diarrhea. Today I feel dehydrated and have muscle soreness, lower back pain, a woozy stomach, and a headache.