chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Thrombocytopenia remission; Vaccination site pain; A spontaneous report  was received from?a consumer, concerning a 77-year-old, Male patient, who received Moderna's COVID-19 vaccine and experienced pain at injection site (left) arm (Vaccination site pain) and thrombocytopenia remission (Thrombocytopenia).  The patient's medical history included autoimmune disorder and thrombocytopenia remission. No relevant concomitant medications were reported.  On 11-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11-Mar-2021, the patient experienced thrombocytopenia remission (Thrombocytopenia) considered medically significant and pain at injection site (left) arm (Vaccination site pain).   No treatment information provided.  Action taken with mRNA-1273 in response to the events?was?not?reported.??   At the time of the report, the outcome of?the events, thrombocytopenia remission and pain at injection site (left) arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  However, patient's underlying autoimmune disorder and thrombocytopenia may have been contributory to thrombocytopenia remission.
Developed urticarial rash with itching approximately 24 - 36 hours after recieving vaccine. No other symptoms. Went to urgent care on 03/13/2021 and was treated with  IM steriods, 6-day taper pack and hydroxyzine. Symptoms abated and at the time of this report, only vague evidence of rash remains without itching.
Within 1 hour post vax, pt developed a generalized erythema of skin (except legs and patchy distribution on face) and urticaria on trunk with no edema. Treated with Solumedrol, epinephrine and Benadryl. Resolution of hives and decrease in erythema by 5 minutes.
Patient presented 8 hours after vaccination with erythema and swelling around injection site on right arm despite premedication prior to vaccination and at home. Redness and swelling appears to be approximately the size of a baseball. Patient treated with Acetaminophen 500 mg and BENADRYL 50 mg and instructed to continue with cold compress recommended. Patient presented 20 hours after vaccination with feverish, erythema, and swelling around injection site on right arm that had not subsided with prior treatment course and reported chills and pain during the night. Redness and swelling still appeared to be approximately the size of a baseball, with slight increase in size. Primary Care Physician's office notified by phone of AE. Patient given Acetaminophen 1000 mg and BENADRYL 50 mg in pharmacy and cold compress applied for approximately 20 minutes for observation. No change in reaction, but patient did not have any pain or chills. Patient was instructed to continue Acetaminophen Q4hours and alternate with NSAID Q6hours, continue cold compress PRN, and BENADRYL 50 mg Q4-6hours PRN. She was instructed to come back in for reassessment if the reaction continued throughout the day.
Information has been received from a health professional concerning an 8 year old Indian male with no allergies or medical history who on 08 Oct 1998 was vaccinated with Varivax. On 16 Mar 2006 the patient's mother noticed several flat fed small red spots. Some had a dark red center. There were about 12 spots total that were pruritic on the face, neck, chest, back and upper arm. There was no fever, no cold symptoms and no vesicles were visible. The patient was not acting ill. He was seen in the office on 21 Mar 2006. The spots were scabbed and there was no distress and no itching. The impression was ameliorated varicella. It was noted that the patient was exposed to varicella 2 weeks prior. No lab tests were done. The patient was considered recovered on 21 Mar 2006. No additional information was expected.
Allergic reaction immediately after vaccine administration. Pt. observed a macular rash and blisters at injection site. ((R) deltoid). Came in to see MD 2 days later.
Narrative:  Pt reported clinic nurse that he got anaphylaxis from second COVID-19 vaccine that he got from another clinic.  No detail of event has documented in note.
Three months after 4th dose of Moderna, started feeling sick with fever and cough in the evening of 7/3/2022. Took a home test and it came back positive. Called Dr. and he prescribed PAXLOVID.
Adverse effect of vaccine, initial encounter The left elbow skin lesion which appeared immediately after her vaccination has suspicious timing, and we discussed with her that we will report this to the vaccine reporting system.  The lesion almost appears to resemble psoriasis.  In any case it is improving, and she can use the over-the-counter ointment that she has had on an as-needed basis.  No further treatment needed.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (five years ago) and shingles (five years ago). Concurrent medical conditions included eye pain. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of the SHINGRIX in late November 2018 at around 2:00 pm, on a Sunday. Approximately 10 to 12 hours after receiving the vaccine, the patient began to experience flu like symptoms which included, body aches, fever, fatigue, he could not bend down. The injection site was red and sore. Around 2:00 pm on Monday, the patient started to feel significantly better, with lingering soreness and redness at the injection site, and body aches, and everything started to resolve by Thursday or Friday. The reporter did not give consent to follow up. This case has been linked to the US2019GSK031818, reported for the dose 1 of the same patient.
started with a fever of 104 without medication, today is day 4 and I still have a fever of 101 while alternating Motrin and Tylenol.
pain in the groin area, and was not able to walk with right leg. severe soreness.  patient went to urgent care, and was given toradol shot.  monday evening symptoms subsided.
Evening of 11/08 area around injection site swelled, red, and hot, painful. Day of 11/09 further swelling, erythema, heat and discomfort entire upper arm. Advised in Pm to take Benadryl, apply ice for 15-20 mins Q3-4H, Tylenol for Discomfort. 11/10 am advised to continue the same, increase fluids 5pm symptoms decreased.
Hypersensitivity reaction: swollen, erythematous injection site reaction; approximately 2cm diameter and growing
Pt became pale, somnolent after DTaP/Hib/IPV administration. Had pulse of 99%, HR 120, R 36-40. Received epinephrine and Dexameshone.
Ongoing palpitations with dyspnea for 2months. Started 5 days post vaccines. Wasn't ill at time. Had stress echo, tte, ziopatch all negative.
vaccinated 17 year old at facility based mass immunization clinics  in group 1A
In January 2023, I began to have a runny nose. I tested positive on January 14, 2023. I took PAXLOVID beginning that day. I did not have many symptoms, maybe a bit of a cough. I had my first negative test on the 189h of January. I tested positive again on January 23, 2023. My symptoms with the rebound were worse. I had cough and fever and really tired. It felt like the flu and my cough was mostly at night. My oxygen levels got a little low into the 80s. I didn't test negative again until January 30, 2023.
Dose of 0.2ml administered to patient who was only 4 years old at the time the dose was administered.
Developed a large pustule on an erythematous base on rt dorsal proximal 5th digit approx 2 wks post spv. Did not wear gloves while changing dsg. Symptom: Lesions, Pustule Start: 04/01/2008 Comment: Rt 5th digit
About 2 hours post-injection I started to feel very strange. I felt some psychological effects like derealization and I felt like I might lose control and start screaming (that feeling lasted only a few moments). Heart racing, heart is beating "heavily" like there's some abnormality, shortness of breath, increased blood pressure, dizziness, disoriented, panic, anxiety, diarrhea, nausea, body feeling extremely hot but no fever, chills, trembling, fullness in chest, thumping in chest
suspected vaccination failure; I still had them; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. The patient was treated with dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient's doctor gave cream to put on them and it helped a lot.  It dried up the blisters. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt was seen in office 11/8/02 with a possible mild case of chicken pox.
Large raised Hive at injection site 1 week from injection, spread down upper arm for a few days. Discomfort, itching and heat.  greatly reduced one week later but still present, no treatment sought. used Ice packs and topical cream to reduce itching.
04/02/02-Pt broke out today in red, raised rash on side of face , both sides of neck and wrist, fever also. Doesn't itch, No indication of per mother child also hoarse 4/3/02 increase breakout of rash, continued fever to doctor. Per Mom, doctor felt not RI shots, but a virus that would run its course.
patient was administered Fluzone High Dose on 09SEP2020 and 17OCT2020 with No AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist via Agency (Reference number-00322320) and transmitted on 19-Oct-2020.  It was reported that a 81-year old female patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT twice (extra dose administration), the first dose received on 09-Sep-2020 (lot number: UJ546AA, expiry date: 30-Jun-2021, Route: Intramscular at an unknown administration site) and 17-Oct-2020 (lot number: unknown, expiry date: unknown, Route: intramuscular in the left arm). It was reported that the patient did not know they received 2 doses.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to extra dose administration (latency same day).  At the time of reporting, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error..
Presented from nrsg. home for confusion and hypoxia, recent covid+ infection, progressively worsening in resp. status. Tx for acute respiratory failure with hypoxia secondary to acute pneumonia due to COVID-19 virus infection w/ O2, steroids
Tech mixed an undiluted adult vial with an undiluted pediatric vial and injected patient with 0.2ml dose. Both vials were undiluted.
pt recv vax;evening of shot, became fussy;mom reports T 104; irritable; also had pain in legs, next day would not walk normally;resolved w/ in 48 hr; no tx;
Patient received the Covid-19 vaccine. She reports symptoms of Vasovagal with dizziness and dark spots in visual field. She stated 10 minutes after the vaccine she noticed symptoms. . Pt stated she had the same reaction with her first dose and felt fine an hour later.  Pt was assisted to lay down flat on bed at 1225.  She stated she felt warm at 1230.  At 1235 she reports the dizziness has stopped. Treatment/intervention Pt was given crackers and water at 1210 and again at 1230. Patient was monitored and was vitals were taken every ten minutes. Staff reintroduced her to sitting up and raising HOB in intervals of 15 degrees. All interventions were tolerated well.  Pt stated at 1255 she felt better sitting upright in the chair.  At 1300 she was accompanied by staff to her vehicle were a driver was waiting for her. She stated at that time all symptoms had resolved and she would contact her PCP to notify them of her reactions to the vaccine. See vitals in documentation. Patient received the Covid-19 vaccine. She reports symptoms of Vasovagal with dizziness and dark spots in visual field. She stated 10 minutes after the vaccine she noticed symptoms. . Pt stated she had the same reaction with her first dose and felt fine an hour later.  Pt was assisted to lay down flat on bed at 1225.  She stated she felt warm at 1230.  At 1235 she reports the dizziness has stopped. Treatment/intervention Pt was given crackers and water at 1210 and again at 1230. Patient was monitored and was vitals were taken every ten minutes. Staff reintroduced her to sitting up and raising HOB in intervals of 15 degrees. All interventions were tolerated well.  Pt stated at 1255 she felt better sitting upright in the chair.  At 1300 she was accompanied by staff to her vehicle were a driver was waiting for her. She stated at that time all symptoms had resolved and she would contact her PCP to notify them of her reactions to the vaccine. See vitals in documentation.  - Documented by MA in electronic medical record
Patient was administered a covid vaccine on 3/18/23 that was dated to expired on 03/14/2023. Pfizer and CDC was contacted and per Pfizer the vaccine stability data supports the storage between 2 to 8 . C for up to 75 days. No adverse event was reported from the patient.
Patient's right upper arm developed swelling and redness the evening of 3/2/11. By 3/4/11 patient had developed a 12cm x 6cm area of erythema with a 6cm x 4 cm area of darker red in the center. The injection site was within the center. Area was warm to touch and itched.  Patient was seen at Walk In Clinic by PA-C. Patient was told to use oral Benadryl for itching.
Red and sore arm around injection site, inflammation, ? cellulitis. Ice packs, antibiotics.
on and off chest pains, shortness of breath with little exertion,headaches, lightheaded, back pain (mid area)
6" round reddened area on L anterior thigh noted since 8/20/08 vaccines given 8/19/08. Advised by Dr to give Benadryl OTC and watch.
11/18/15, 7:00am woke up w/ a horrible headache, runny nose, sneezing, sore throat, all day felt extreme tiredness.  During the night of 11/18/15, her heart started racing and had shallow breathing, "I thought it was the end," didn't have chills, but couldn't stop trembling, horrible headache throughout the night.  11/19/15, cough, runny nose, bad headache, extreme tiredness.
Vaccine was given to patient in left thigh; vaccine had expired on 9/30/2023; once this was recognized the provider was informed as well as the operations manager; manufacturer was called and case was opened.  Manufacturer stated that case would have to be escalated to vaccine department with a f/u timeframe of 10 days
Patient was given a booster dose (2.5ml) instead of 2nd dose (0.5ml).  Incident immediately recognized and resolved by giving the remaining 2.5ml dose to equal 5ml in additional IM injection in opposite arm
Major anxiety attack (only 1 x in past history 2001 when given procardia after birth)   Anxiety attack lasted 4 hours.  Headache all day , sore arm (hot swollen ).
Approximately 10 minutes after vaccination c/o feeling shaky, she then stated her neck itched and she exhibited generalized urticaria.  Was given .5ml Epinephrine IM at 1000.  Stated she was having thickened feeling in her throat, had high blood pressure on 191/126 and was nauseated.  Was given 1ml of Benadryl IM.  Ambulance called at 0958 and transported to hospital at 1008.
Pt developed a rapid heart beat and fever after receiving an influenza virus and pneumococcal vaccines on the same day.
Chills, pain at injection site, temperature of 100.3, dizziness. Lasted 8 hours. Redness still continuing at injection site on 07/17/2010 with itching. Redness 3" diameter.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium
No adverse out events.  Event Vaccine was 5 days past approved stability date.   Had been in refrigerator 75 days.
Red dots on both arms and legs.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737), via an unspecified route of administration in the right arm on 30Mar2021 at 17:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 09Mar2021 at 14:00 (at the age of 31-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 had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 (After 12 hours), the patient developed red dots on both arms and legs. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the red dots on both arms and legs. The clinical outcome of the event red dots on both arms and legs was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), in arm, on Mar 21, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity/her arm started to feel a little bit sore, onset Mar 21, 2021, with outcome of unknown. Additional information: The patient received her 1st dose of vaccine yesterday afternoon Mar 21, 2021. The night after getting the 1st dose, her arm started to feel a little bit sore. She would like to confirm if this is normal and how long will she feel the sore. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
tired/fatigue; This is a spontaneous report from a contactable consumer.   A 81-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration on 19Feb2021 (at the age of 81 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient had no concomitant medications. The patient previously received BNT162B2 on 29Jan2021 (Lot number: EL9265) as dose 1, single (at the age of 81 years old) for COVID-19 immunisation. On an unspecified date, the patient experienced tired/fatigue with outcome of unknown. No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to her currently 69 year old boyfriend with diabetes, hypertension, blind in one unspecified eye, deaf in one unspecified ear, with no drug reactions or allergies and pertinent medical history of traumatic brain injury who on unknown date in 2012 was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route were not reported). Concomitant therapies included insulin, lisinopril (manufacturer unknown), baby aspirin and unspecified vitamins. Since he received ZOSTAVAX had developed shingles "about 6 times per year". So he was seen by unspecified physician in August 2013 and was treated with acyclovir (manufacturer unknown) for unspecified amount of time. The nurse stated that her boyfriend's last episode of shingles was in February 2015 which resolved on unknown date in 2015. No laboratory diagnostic tests were performed. This is one of several reports from the same source. Additional information has been requested.
PT'S SITE OF INJECTION BECAME RED, SWOLLEN, ITCHY, AND HOT TO TOUCH. SITE MEASURED ABOUT 60MM.
Vaccine given 1145am ; Patient noted at 12:25pm generalized urticaria, pruritis; no lip, throat, mucous membrane or respiratory involvement.  Benadryl 25 PO given immediately; MD consulted due to lack of Respiratory involvement which was recommended decadron 10mg IM. Patient recovered and returned to work which is on site. Staff, including Providers were made aware of patient's response. Patient did then have a rebound response at about 2:20pm and sought Provider assistance were Adult Epi pen was administered and EMS called. Patient was transported to hospital for continued care. Patient recovered
severe sternal pain, short of breath, thyroid lab level went in opposite direction, joint pain, irregular cycle,  inflamation, leg swelling, weight loss and fast heart beat
Patient received his vaccination too early. His due date was 05/10/21 for his second shot.
When I had the first dosage (1/29/2019) I had severe muscular pain throughout my body.  It went  away in about a week.  The second dosage was similar but also included a stiff neck and headache (maybe due to anxiety).  Again, everything went away in about a week except for the stiff neck.  This has lessened, but remains in a annoying form.  Will it eventually go away?
Weakness in my back and both arms. Ache/sore lower back and both ribs areas. I had a shingles vaccine on 1-7-13. I started having these symptoms about 1 month after 1-7-13. I've had several dr. appts with different drs. I'm currently taking gabapentin and tram-dol and nortriptyline.