chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable 39-year-old male healthcare professional reported to have received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, after the first dose of vaccine, the patient felt sick at some point, so he took a rapid test which came back positive. He stated that the test if testing the antigens (as reported). Antibody testing was not currently recommended to assess for immunity to COVID-19 following Pfizer-BioNTech COVID-19 vaccination. Events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
The pt reported a rectangle patch 8 cm x 4 cm that was red, hot to touch, edematous and recovered within 2 days.
Nurse stated the vaccine leaked back out of the left arm after the ID dose administered; full dose not administered.  The same nurse repeated another ID dose in the same arm (left arm); administration successful. No patient complications.
On Friday, April 4, 2021 client  (DOB 5/3/1996) received his first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 12:56pm. Per EMT report: at 1:06pm, client fell out of chair, landed on his left knee and regained consciousness immediately. Upon assessment, client stated his left knee pain was a 3 out of 10 scale. At 1:07pm, client was sat in the zero-gravity chair in supine position and given a bottle of water. Client stated he "felt pressure in ears-mainly right ear." EMT  & 2nd EMT coached client to breathe normally. At 1:09pm vitals were taken: BP: 120/70, HR: 52, RR: 10, O2 sat: 95%, skin: pale, moist, cool, eyes: PERRLA, LOC: A&O x4. Lead RN was notified and advised vitals be taken every 5 minutes for an additional 30 minutes. At 1:13pm vitals were retaken: BP: 120/70, HR: 69, RR: 12, O2 sat: 94%, eyes: PERRLA, skin, pale, moist, cool, LOC: A&O x4. On assessment, client stated he has no history of fainting, no allergies, and not taking any medication. Client stated he had a small amount of food and water intake and was not currently experiencing nausea. At 1:20pm, client stated the pressure in his ear subsided and was experiencing no headache, light-headedness or dizziness. At 1:25pm vitals were retaken: BP: 120/70, HR: 69, O2: 98%, skin: warm, pink, dry, LOC: A&Ox4. At 1:35pm, vitals: BP: 120/78, HR: 72, RR: 12, O2: 96%. Client was lowered to sitting position in gravity chair. No changes in vital signs were assessed by EMTs. At 1:40pm one final set of vitals were taken: BP: 120/76, HR: 66, RR: 13, O2 sat: 97%, eyes: PERRLA, A&O x4, skin: pink, warm & dry. At 2:15pm, client was able to safely stand up. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up. Client left vaccination site at approximately 2:15pm with a steady gait. A family member was able to pick him up and drive him home.
Case number PHHY2013US020537 is an initial spontaneous report from the nurse received on 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 61-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) at a dose of 0.5 ml at a dose of 0.5 ml via intramuscular route into her deltoid on 27 Sep 2013. It was reported that the vaccine which was given to the patient was stored at temperature during shipment for 72 hours. No adverse event reported following this medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination updated.
Information has been received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced "neurological problems", (specific problems unspecified). No product quality complaint (PQC) involved. The outcome of the event was unknown. The causal relationship between GARDASIL and the event was unknown. Additional information has been requested.
injection site itchy; injection site rashy; injection site raised; she had a red circle about size of half dollar at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (she had a red circle about size of half dollar at the injection site), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE RASH (injection site rashy) and INJECTION SITE SWELLING (injection site raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pain in left arm at injection site pain in left underarm for a few day; pain in left arm at injection site pain in left underarm for a few day; sluggishness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Mar2021 (Lot number: OEN6206) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: EM9809,, lot unknown: False,, dose number: 1), administration date: 19Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Mar2021, outcome "recovered" (2021) and all described as "pain in left arm at injection site pain in left underarm for a few day"; SLUGGISHNESS (non-serious) with onset 14Mar2021, outcome "recovered" (2021), described as "sluggishness". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, sluggishness.  Additional information: Patient had pain in left arm at injection site pain in left underarm for a few days sluggishness the day after second dose.  No follow-up attempts are possible. No further information is expected.
11 x 9 cm area of erythema and warmth and induration at site of injection L deltoid. No fever
High fever, entire body sore in all joints, extreme nausea, diarrhea, dry heaving, vomiting. I took no medication in efforts to prevent change in effectiveness to vaccine. Severe symptoms were between 11PM and 4AM. Afterward continued to have a fever and slight soreness until later in the night.
After both the first and second doses I did not feel well.  What I mean about that is that I was not as energetic as usual.  I was reluctant to get either dose because I had no health issues and I was afraid it would hurt my natural immunity.  I asked if they could test for that first.  I noticed after the second dose, problems walking up hill.  I normally walk a few miles per day but I was watching it to see if I had to stop on my way up the mountain behind my house.  Until 11/20/21 I did not.  On 11/21/21, I woke up and my entire right leg was swollen.  I had experienced intermittent swelling and discoloration prior to this time.  I could not do even yoga and I only wanted to lie down.  I went to the Emergency Room where I was diagnosed with DVT.  I have no pre-existing heart conditions, am 5'8" - 147 lbs. so not obese, never smoked, etc.  I knew not to get the vaccine and I am very upset that I may now have damage!!!
HPV #1 given to R Deltoid 3:09 PM R Deltoid 1 min after vaccine given, felt cold and clammy. Pt was actively talking c/o feeling weak, nausea and lower abdominal cramping. Patient was able to speak w/full conscience. B/P 64/42 dropped. Monitored for extended time.
Daily Headaches (no change in sleep, exercise, or other routine; no change in diet, medications, etc in that time)
Patient expressed anxiety and hesitations about receiving the moderna vaccine. Prior to administration she discussed benefits and possible side effects with pharmacist and was asked 3 separate times whether she wanted to receive it and she stated yes. After administration she went to the restroom and came back at 5:36pm. Approximately 11 minutes after administration patient stated she felt like her throat was closing up and asked the pharmacist to call 911. 911 was immediately called (approximately 5:36pm). Patient reported she did not feel dizzy or like she was going to faint and did not have any noticeable swelling or rash appearing. She was alert, sitting or standing, and able to speak during the entire visit in the pharmacy. She had minimal coughing and did not appear to be in respiratory distress. Store manager arrived in pharmacy at 5:43pm and asked patient if she was ok. Patient stated she was coughing and proceeded to explain that she had asthma. Pharmacist stayed on the phone with 911 dispatcher until ems arrived. Ems arrived at 5:46pm and transported patient to the hospital for further evaluation and treatment
Was given 1st Shingrix shot on Wed, 7/6/22 @15:40 in right arm just below shoulder joint. Woke up on Saturday,  7/9/22 at 02:00 with great itchiness in creases behind both knees, but more behind right knee. Covered itchy area with Calahist. Itching continued throughout Saturday. Kept applying Calahist as needed and took two Benadryl's prior to going to bed. Sunday, 7/10/22, itchy "bite" spots began to blister and my wife being a nurse said they were Chicken Pox. This was confirmed by the PA she works with. Started antiviral, Daltrex, 1 g, 3x per day on Sunday, 7/10/22 @ 16:00.
approx 2hr p/vax pt had fever (unk degree) devel apneic episode, poss sz;pt taken to ER resuscitated successfully  & put on apnea monitor;MD recommended ped DT for further immun;
covid vaccine breakthrough case  dose 1 1/5/21 EL0140 dose 2 1/26/21 EL3249
09/04/2021  The patient presents with 1 week hx of of worsening shortness of breath. Per EMS, pt was evaluated at his PCP at onset due to viral symptoms. Pt was diagnosed with an URI and prescribed with antibiotics, ceased administration of at home medication. Pt was evaluated today by nurse at Assisted Living and was noticed to be experiencing increased shortness of breath. At arrival, EMS found pt on 82% room air. At ED bedside, pt has been experiencing shortness of breath with cough, nausea, and abdominal pain. Pt denies vomiting, fevers, chills, chest pain, diarrhea, and all other symptoms. Pt has recieved the COVID vax
MMR admin without difficulty, no c/o by patient. Stated she forgot about shot and bandaid after showering 4/25/06am she removed the bandaid and noted a 6cm circular bruise on her left upper posterior arm. Upon removing the bandaid the adhesive left an imprint on the arm where placed. Pt reported this to campus health nurse 4/27/06 after being referred by her instructor. On 4/27/06 an oblong 4cm x 6cm area of ecchymotic skin was noted in the area the MMR was administered. No erythema or streaking, no warmth to touch. Pt has full range of motion of left arm and can do all daily activities. No other side effects noted. Evaluation of bruise on 4/28/06 measures 3 1/2 x 5cm. Evaluation 5/1/06 bruise measures 3x4cm. No other c/o. On 5/2/06 bruises on left arm measures 2 1/2 cm x 4cm. Follow up telephone call on 5/12/06 pt states bruise is resolved. No others complaints.
Had a fall fractured L-2 vertebrae, fine now; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), dose 2 intramuscular, administered in Left upper arm on 26Mar2021 11:00 as dose 2, single (69-years-old) for covid-19 immunisation. Medical history included , ongoing osteoporosis (drug name: vitamin d, reason for use: osteoporosis ongoing: yes), ongoing allergies (drug name: Claritin, reason for use: allergies ongoing: yes), ongoing acid reflux (drug name: pantoprazole sodium, reason for use: acid reflux ongoing: yes). Concomitant medication(s) included colecalciferol (VITAMIN D) taken for osteoporosis from 2018 and ongoing; loratadine (CLARITIN) taken for allergies from 2017 and ongoing; pantoprazole sodium taken for acid reflux from 2016 and ongoing. Patient previous took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810; Expiration Date: Jun2021), dose 1 intramuscular, administered in Left upper arm on 05Feb2021 11:00 as dose 1, single (69-years-old) for covid-19 immunisation. On 05May2021, patient had a fall fractured l-2 vertebrae and fine at the time of reporting. The patient underwent lab tests and procedures which included computerised tomogram: stomach ok on 03Mar2021 Had stomach pain, x-ray: compression fracture on 05May2021 Had a fall-fractured L-2 vertebrae, fine now. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
I started having a scratchy throat on March 2, 2023, the next day I started feeling worse by March 4, 2023, I had a fever of 101F, so I used a home COVID-19 test that came back positive. I called my doctor's office and had a telehealth visit with a nurse practitioner. We discussed my symptoms, prescribed PAXLOVID and a new inhaler in case I needed it. The rest of the week I had severe brain for the next week although I was starting to feel better. I have a lingering cough and some lower back pain but for the most part I feel that I am recovered.
Patient came into pharmacy on 9/30/18 with an injection site reaction on her right arm. The injection site was red and warm to touch. She said it swelled up, had a small lump at injection site, and was warm to touch the day after receiving vaccine. Also stated that she had an upset stomach for a day after vaccines were given (may or may not be related). She stated that the swelling had decreased since two days ago.
patient received vaccine. was asked to wait 15 minutes. patient fainted then came to. patient fainted again then came to, fainted a third time came to. we called 911.  Paramedics came and found no health concerns. ran EKG it was normal. they checked blood pressure. found to be normal. they said there was no reason for patient to to hospital. patinet sat alittle longer and went home with her mother
Patient was observed post Covid-19 immunization for 15 minutes and during that 15 minutes at 0915a reported to RN that he was feeling dizzy/lightheaded at 0915a. Bp was 134/81, RR 18, p 75, t 96 oral and 02 sat 96 on RA. Patient states he is tired as well and has history of COPD, sometimes wearing mask can increase SOB. Patient given water and offered crackers, which declined. Removed coat and hat and continued to monitor with wife at side. T 0934 BP was 135/64, O2 sat 95 on RA, RR 20, t 96.5 continue to monitor for another 10 minutes. At 0934a, pt states still feeling lightheaded but slightly better. Had patient stand and stated he was dizzy, EMS at side and assessing at 0934. EMS continued to monitor patient and at 1000a, pt stated he was "much better" and EMS released. Walked short distance without any dizziness or lightheadness. Encouraged wife and patient to notify PCP of events and if symptoms return
Hives on torso, legs, arms started 37 days after 2nd shot.
No treatment-related AEs occurred. I am reporting  a "breakthrough" infection: First symptoms occurred 6/28-29, 5-weeks post 2nd booster vaccine (original vaccines Pfizer; both boosters were Moderna). Symptoms included deep cough, congestion, diarrhea, body aches, but no fever >100F. I received Paxlovid and took the entire course of therapy (6/30-7/4). Symptoms resolved by 7/2.  Mild symptoms returned on 7/8 and worsened significantly on 7/9 and 7/10.  Slight improvement on 7/11 (today).
Fever as high as 103 over 36 hours, chills, tiredness, sore arm, cold sores on the lips (the cold sores are a relapse of lifelong condition and began 48 to 60 hours after the vaccination)
We didn't connect to the first vaccine shot, but patient started having spasms/seizures for several days. His neurologist had increased Bacolfen and we had scheduled a follow-up for May. He went to the ER, but was not in life threatening danger and additional tests were completed. He has been tired for a month. Then, he had his second shot, and he has begun having muscle spasms/seizures again.
Pulse Ox was bet 87-90% then dipped to 85%; Felt soreness and fatigue; Felt soreness and fatigue; Low grade fever of 102; Warm and clammy; Warm and clammy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%) and PYREXIA (Low grade fever of 102) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, ALLOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, COLECALCIFEROL (CALCIUM PLUS VITAMIN D), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MAGNESIUM OXIDE, MELATONIN, METOPROLOL TARTRATE, MULTIVITAMIN [VITAMINS NOS], TRIAMCINOLONE ACETONIDE (NASACORT), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), CLOPIDOGREL BISULFATE (PLAVIX), VITAMIN D NOS and DOXAZOSIN MESILATE (CARDURA) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy) and PYREXIA (Low grade fever of 102). On 30-Jan-2021, the patient experienced PAIN (Felt soreness and fatigue) and FATIGUE (Felt soreness and fatigue). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%), PYREXIA (Low grade fever of 102) and FATIGUE (Felt soreness and fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) and was hospitalized.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Red rash area approx 1" x 5" across deltoid, below inj site.  Non itch, area is tender and firm to touch.
I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.
06/07/01, this infant had a reaction, she was asleep gurgling, went limp, and not breathing, was aroused by the baby sitter (one time episode) on Thursday at 2 PM once on Sunday at 7 PM, 06/10/00.
severe fever; aches / soreness; severe nausea; dizziness; received the 1st dose of Shingrix on 29Aug2018 / the 2nd one on 25Sep2018; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 37KL2, expiry date 12th February 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th September 2018, the patient received the 2nd dose of Shingrix. On 25th September 2018, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced fever, general body pain, nausea and dizziness. On an unknown date, the outcome of the fever, general body pain, nausea, dizziness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fever, general body pain, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, the patient experienced fever, aches, soreness, nausea, dizziness and said it was the worst thing she had ever experienced in the world. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up. The case was considered as medication error with harm. This case has been linked with US2020223963, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223963:same reporter
excruciating arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced excruciating arm pain that lasted for 8 days and resolved. The reporter did not consent to follow up. The reporter declined to provide any contact information. There is a discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered/resolved with sequel).