chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine   Received vaccine at 1330CST, general soreness around injection site.  Around bed time (2200) chills and sore hips, continued soreness in arm.  Next morning, woke up at 0700 with significant body ache, fever of 100.2.  Significant fatigue.  Fever resolved by 1200, took 600mg ibuprofen.  Body ache persists throughout the day.   I?ve had COVID, side effects of vaccine more drastic than Covid was for me.
Patient was 15 years today and was given a booster. The age group has not been approved for boosters. Patient did not have any adverse reactions to the vaccination. Child's parent was notified of the mistake.
got my first shot on 2019, and get the second one now, is this ok; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient got first shot of Shingrix in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient's doctor said that, go ahead and took second dose of Shingrix now. The reporter wanted to know if this was okay. The patient stated that, how often did you have Shingrix shots. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
I experienced pain in my right arm, and I experienced swollen painful/burning lymph nodes under my arm, which lasted for 4 or 5 days.
Headache; Sore arm; pain below the crown of head; Shingles; Swelling behind ear/swelling by mastoid gland; Pain right side of neck/turns her neck to the right, it hurts; bumps on right side of scalp; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pain in arm (barely had a sore arm from the vaccine).   On 27-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 29-APR-2023, 2 days after receiving Shingrix, the patient experienced ear swelling (Verbatim: Swelling behind ear/swelling by mastoid gland), neck pain (Verbatim: Pain right side of neck/turns her neck to the right, it hurts) and scalp swelling (Verbatim: bumps on right side of scalp). On 02-MAY-2023, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced headache (Verbatim: Headache), pain in arm (Verbatim: Sore arm) and pain (Verbatim: pain below the crown of head). The patient was treated with cefalexin (Keflex). The outcome of the shingles, ear swelling, neck pain, scalp swelling, headache and pain were not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   It was unknown if the company considered the shingles, ear swelling, neck pain, scalp swelling, headache, pain in arm and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023 The reporter was the patient.  The patient received the Shingrix on Thursday. On Saturday afternoon, the patient began experiencing swelling by her mastoid gland, swelling behind her ear, pain on the right side of her neck and bumps on the right side of her scalp.  She was experiencing sharp headaches and sharp pain below the crown of her head.  When she turned her neck to the right, it hurt.  The day before reporting, the patient saw a dermatologist who believed that she might have shingles.  The dermatologist might do a biopsy.  The patient saw an ENT (Ear, Nose, Throat) doctor at the time of reporting, who prescribed Keflex every 8 hours for 7 days.  She might need to get a MRI (Magnetic resonance imaging).  The patient reported that she barely had a sore arm from the vaccine.  The reporter consented to follow up.
Patient had a positive COVID test on 1/26/22 and 2/25/2022.
Headache, Sedation, Myalgia, CHILLS AND PAIN Narrative:
As walked out of the office had near syncopal event with drop in BP and HR (was 104/64 and 72 at beginning of visit, afer episode dropped to 80/40 and 50).  Given rest, water and candy and BP and HR returned to baseline within 10 minutes.
1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: severe chills, worsening headache and neck pain, temperature started to rise, muscle and joint aches began 0500 - chills and aches continued, temperature max of 102.2 0800 - severe muscle aches, fever remained around 102, pulse 130's, SO2 99% 0900-2100 - rested the entire day, unable to move much because my body aches were so severe, when I did get up to go to the bathroom, I could barely walk because my hips and knees hurt so much, headache so severe that I began getting nauseous and dry heaving, I took 650mg acetaminophen and 25mg Benadryl around noon and used ice packs on my neck and the back of my head, ate very little, no appetite, drank water and ginger ale, temperature fluctuated between 101 and 102 all day, came down to 99.6 after acetaminophen, but came right back up to 101 as it wore off 2200 - took 975mg Tylenol and 25mg Benadryl and went to sleep, temperature 100.9 1/9/21 - 0900 - woke up after sleeping all night, temperature 98.2, body aches and headache gone, feel normal
Initially, after the injection, the place where the injection was done had a red circle around it and a hard knot under it. This went away after 3 days.  on day 11, the injection spot started itching quite a bit.  On day 14, a large red circle the size of a half-dollar showed up.
Patient who received the vaccine beyond the use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received the vaccine beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Itchy rash with coarse skin on top of spots, mostly on trunk and upper legs.  2 rounds prednisone, still having issues after going off prednisone. Skin is red/blotchy.  Scars where first spots showed in March.
13OCT pt recvd vax; 15OCT91 had severe back went to ER & was admitted to Hosp & dx viral kidney infect; MD stated it was related to flu vax also exp nausea, vomiting, diarrhea;
pt devel bell's palsy 5 wk p/vax;pt was treated w/pred
Weakness in leg, joint pains, numbness in arms, chest and legs, vision disorder. MS type symptoms. Diagnosis of MS supported by MRI.60 day follow-up dated 7/10/00 provided additional text.
Pt presents to office 24 hours, post vax, with 25mm erythema, hardness and warm to touch. Pt tired and achy.
Face completely swelled( eyes almost shut) and red. Hives and redness on body worse on thigh, neck and face
Vaccinated 1/11/2021 at 11:30 AM, at approx. 10 PM experienced moderate pain scale diffuse body aches. This lasted a few hours, improved with advil. After body aches subsided at around 2 AM  1/12/2021  experienced mild allergic reaction of hives and lip swelling. This allergic reaction subsided by morning 1/12 with benadryl.   I have never had any side effects or allergic reaction to a vaccine.   I did experience similar mild allergic reaction with antibiotic bactrim, a sulfa based medication.
pt recv vax 24FEB98 & 25FEB98 had fever & diffuse erythematous rash typical to erythema mult;no prev rxn;
Patient waited her 15 minutes post vaccination and then left to go home with her husband.  As she was riding in the car on the way home, she noticed numbness in the lip on the side the vaccination was given. Her arm was sore, and felt tingly.  She had no rash.   She felt a headache starting to come on.  She took diphenhydramine upon arriving home (25 minute drive) and felt much better after.
Caller reports that she is running a fever today in which the fever was 100 degrees Fahrenheit; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she received the first dose of the Pfizer Covid-19 vaccine yesterday and she is running a fever today in which the fever was 100 degrees Fahrenheit earlier today and is now 100.9 degrees Fahrenheit. Outcome of event was unknown.  Information about lot/batch number has been requested.
Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
Within 12 hours of receiving vaccine, pt had episode of staring without movement, followed by emesis.  Awake and breathing but unresponsive.
Site: Pain at Injection Site-Medium, Additional Details: pt reported immediate tingling in arm & pain for full 24 hours. took tylenol as advised by brother physician. felt better days later
RECEIVED PNEUMOVAX 3/31/05 @ APPROX 0830.  PATIENT CALLED 4/2/05 @ 0359 had developed five hives 3 inches below injection site, left deltoid, and one hive near left axilla.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a 79 years old patient (gender unknown) received a dose of suspect FLUZONE HD, lot number not reported via unknown route in unknown administration site on 01 Oct 2018 and on 06-Nov-2018 (date of report) patient again received 0.5 ml single dose of the same vaccine lot UJ051AA, expiry date 01 June 2018 via unknown route in the left deltoid by mistake. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was taken. It was a case of actual medication error due to extra dose administered. No adverse reaction occurred. 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.
pt had body aches, chills and headaches for 4 days, and has hence resolved. did not need medical intervention
temperature excursion of negative 0.1 degrees C for 5 hours and 51 minutes then, negative 2.6 degrees C for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute/ no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional. (Reference number- 00307411) and transmitted to Sanofi on 08-Oct-2020.   This case is linked to cases 2020SA283022, 2020SA283023 and 2020SA283024 (same reporter).  This case involves female patient (of an unknown age) who dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ516AB, expiry date: 30-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 08-Oct-2020, which had temperature excursion of negative 0.1 degrees Celsius (C) for 5 hours and 51 minute s then, negative 2.6 degrees C for 10 hours and 54 minutes and then positive 1.1 degrees C for 2 hours and 1 minute (product storage error).  Medical history, concomitant medications, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  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.
Post vaccination patient felt fatigued, on day 4 post vaccination developed swelling of both lips with tingling  and swelling hands especially on palm side, fingers very pruritic.  Patient took Benadryl, it helped somewhat with swelling of hands and lips so that it was not getting worse, but also was not resolving.  Patient continued having tingling and hands pruritus.  On day 8 post vaccination patient developed blisters on both lips and hands which cracked open and patient was hospitalized for bleeding lips and blisters on both hands from August 22?August 24.  Patient responded to treatment with corticosteroids.
Warm (ring) on skin; Swelling; Bump (L) arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form, bid and IBUPROFEN at a dose of UNK dosage form, bid. On 14-Feb-2021, FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Right deltoid of 5cm X 5cm area of redness, swelling, warmth. Left deltoid of 3cm X 3cm area of redness and swelling and less warmth.
Pt report she got Influenza injection aprox. 10:30am on 10/30/08.  at aprox 3:45pm she noticed throat closing up, eyes got red and swollen and throat felt "burning hot"  Went to ER at 4:00pm was seen at 1618 in Emergency Room and was treated with Benadryl, prednisone, and pepcid.  Pt also reports she has been on Penicillian for 2 weeks and took a dose at aprox 3:00pm
I am breastfeeding and it caused my supply to drop drastically; I am breastfeeding; I am breastfeeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 08:00 (Batch/Lot number: unknown) at the age of 24 years as dose 1, single and administered in arm right, administration date 07Sep2021 12:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL [FOLIC ACID;IRON]; BIOTIN. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Aug2021 08:00, outcome "not recovered" and all described as "I am breastfeeding"; SUPPRESSED LACTATION (non-serious) with onset 21Aug2021 08:00, outcome "not recovered", described as "I am breastfeeding and it caused my supply to drop drastically". Therapeutic measures were not taken as a result of suppressed lactation.  Additional Information: Patient received other medications in two weeks prenatals and biotin. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not receive other vaccine in four weeks of vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182557 mother/baby
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-NOV-2016 at local pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016 (conflicting dates), the patient was treated by physician for an ongoing painful rash which was diagnosed as shingles with a cellulitis infection. Although shingles is a incurable viral condition the patient was prescribed gabapentin and VALTREX for management of his symptoms and outbreaks. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
5 patients who got the Moderna booster after the vial was already punctured 20 times; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939930) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times). On 21-Dec-2021, PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP provides identifiers (see attachments) but has no information on concomitant medication for the patients.  No concomitant products were reported.  No treatment drugs were reported
Under eye swollen, large itchy patch at injection site which has increased in size on day 3, long ulcer on inside cheek, itchy eyes
Arm which the shot was given, patient felt a tingle within seconds after receiving shot. Patient said her arm started swelling minutes after the shot. No other side effects were experience. Patient did not have any pain, redness, warmth in the arm. Patient was given 25mg of liquid benadryl. She was monitored for almost 30 minutes after given benadryl. Patient said the tingling went away and the swelling was getting better.
My right inner-ear muscle(s) will not stop twitching. It is annoying but it?s also becoming exhausting and also very difficult to concentrate. Sleep seems ok so far.
p/vax pt could hardly move arm & had T101, ached all over like had flu x 48hr;8/20/99 feels better;flu like sx gone arm still painful, swollen deltoid region, pea-sized reddened area @ inj site;also has erythematous area lt shoulder region;
The evening of the flu shot and the following day, I experienced malaise and flu-like symptoms of fatigue and headache. Left arm was sore. Fatigue and mild non-continuous headaches have continued to present. 1-18-11 I came down with a urinary tract inflection, followed by symptoms of lowered immune response in form of skin infections and outbreak of oral herpes, fingernails breaking (not usual for me) and extreme need of extra sleep. Also for two weeks after the shot, when showering (light water flow), the injection site would itch when water hit it. Came down with flu on 2-16-11. Something is wrong!
Light headache; 100 fever; Some light fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue). At the time of the report, HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-354688, MOD-2021-354702 (Patient Link).
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/10/2021 HX OF CEREBELLAR STROKE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/10/2021 ENCEPHALOPATHY
Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching". Additional information: Patient stated she wanted to know and speak to someone about the side effect of Pfizer. When probed what side effects was she facing, Patient stated "She was talking about Itching." Product details (Lot#, expiration date, NDC#, UPC#), purchase details could not be probed over the call as patient hung up the call abruptly. Hence limited information available over the call.   Follow-up attempts have been completed and no further information is expected.