chrisvoncsefalvay/vaers-outcomes huggingface dataset:
egg sized raised bump; hot to the touch; mild rash; redness; itchiness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness) and VACCINATION SITE MASS (egg sized raised bump) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 21-Jan-2021, the patient experienced RASH (mild rash), ERYTHEMA (redness) and PRURITUS (itchiness). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch). At the time of the report, INJECTION SITE PAIN (injection site pain), RASH (mild rash), ERYTHEMA (redness), PRURITUS (itchiness), VACCINATION SITE MASS (egg sized raised bump) and INJECTION SITE WARMTH (hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information included Corticoid cream.
My eyes were feeling dry and irritated and I was going to bed to close my eye. In September felt like something was in my eye. The white of the eyes looked red and called the doctor and was diagnosed with Episcleritis. Steroid drops were prescribed. Normally people with lupus , cron;s disease and rheumatoid arthritis  which I don't have. This Sat, I was outside watching a game outside, the sun in my eye bothered me felt irritated, eyelid didn't feel right like difficulty focusing.
Developed redness and swelling at and distal to injection site on L upper arm - started within one day of injection.  He had a hx of delayed reaction one month ago that occurred 6 days after the injection.
Had severe chills that began about 8 pm on 1/5/2021. Had chills all night, and muscle aches began around midnight. When I woke to get a shower around 5:30 am on 1/6/2021, I was extremely lightheaded and laid down on the bathroom floor to keep from passing out and falling. The lightheadedness did not improve and my husband was able to help me back to bed. I was unable to overcome the chills and lightheadedness even with lying down, until about 10 am. I am able to sit up but still some what lightheaded and chills are beginning to fade. I do not feel I would be able to walk more than a few feet or drive at this time due to ongoing symptoms.
A physician reported that a 59 year old pt received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 10/3/00. The next day, the pt developed left parotid gland swelling.
Day 1: pain/swelling at injection site with redness, muscle aches, joint pain Day 2: pain/swelling at injection site with redness, muscle aches, joint pain, headache; worked but with considerable discomfort/strain Day 3: pain at injection site, muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia; unable to work Day 4: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work; attempted to see doctor but was refused care due to "CoVid-like symptoms" Day 5: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, diarrhea; unable to work Day 6: extreme muscle aches, joint pain, headache, chills, fatigue, feeling unwell, insomnia, fever, sweating, sore throat, nausea; unable to work; attempted to see care at Urgent Care but was turned away for having "CoVid-like symptoms;" went to hospital per the recommendation of MD and urgent care Day 7: mild muscle aches, fatigue, feeling unwell, insomnia, sweating, sore throat; unable to work Day 8: sore throat, mild fatigue, sweating; unable to work
TOOK A THIRD PFIZER AND A SHOT OF JANSSEN COVID-19 VACCINE; CHEST PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced took a third pfizer and a shot of janssen covid-19 vaccine, and chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of took a third pfizer and a shot of janssen covid-19 vaccine was not reported. This report was non-serious.
In addition to severe pain in my left arm at and around the injection site, my left lower back - which had been being treated by a doctor for a couple of years and was not hurting anymore - is now ON FIRE! Like hot knives stabbing me constantly in the same spot that was initially problematic resulting in MRIs, physical therapy, and taking Meloxicam (which I had stopped taking). My arm and back have both gotten progressively worse throughout the day.
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning current 18 year old male patient with no known medical history and no known drug reactions/allergies who on 15-JUN-1995 was vaccinated with a dose of VARIVAX (Merck) (Lot # 608235/0396B). There was no concomitant medication. The patient was diagnosed with shingles at an unspecified date after receiving VARIVAX (Merck). This occurred at some time in the past, and the patient no longer has shingles. The patient went to an office visit. Additional information has been requested.
We gave her the shot in her right deltoid and after a couple minutes sitting in the waiting room she felt itchiness in her face. I administered 1ml of diphenhydramine (50mg/ml) into her left arm and monitored her (including BP which was slightly elevated at 155/94). After a few minutes she reported feeling less itchy and starting to improve. We continued to monitor her for 30 min. She stated that she felt better at that time. We checked her BP and breathing one last time and then let her go.
dry mouth; discomfort in the mouth; swollen/red gums; tooth aches; tongue is tingling/burning; tongue is tingling/burning; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches) and PARAESTHESIA ORAL (tongue is tingling/burning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (VASTATIN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of 1 dosage form and ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included rinsing with salt water.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up appended: Pregnancy status updated and contact information updated.
The patient did not receive his/her 4 month or 6 month dose of VAXELIS.; This non-serious spontaneous safety report with reference number 02126618 was received by a partner on 11-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event 'The patient did not receive his/her 4 month or 6 month dose of VAXELIS' was assessed as not applicable due to the nature of the event.  No further information is expected.
Initial and follow-up information has been received from a physician concerning a 26 year old female with no known medical history and allergies to penicillin, amoxicillin and Biaxin who on 27-DEC-2006 was vaccinated intramuscularly with a second 0.5 mL dose of Gardasil (Lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient developed a quarter size area of redness at the injection site. No laboratory diagnostic tests were performed. Approximately one month after the injection was given, the patient recovered. It was also noted that on 30-Apr-2007, the patient was vaccinated with a dose of GARDASIL (Lot # 657622/0386U). On an unspecified date, the patient developed redness, swelling. On an unknown date, the patient recovered.No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information is not expected.
Initially just had pain at the injection site down my bicep which resolved after 72 hours.  On 1/10/2021 I noticed a very red/warm/swollen area  near my injection site.
In addition to expected side effects (chills, myalgia, arthralgia, fatigue, night sweats and pain at the injection site) I also had a sensation of perineal burning for several hours the day following vaccination.
10:15 am -vaccines given, early afternoon tongue swelling. Advice nurse said give BENADRYL and come in if gets worse, 6pm went to ER as BENADRYL didn't help and swelling was worse, Dr gave steroid and said continue BENADRYL for 24 hrs, 2am swelling returned, back to ER they watched him and sent us home at 6am.
6 x 4.5 cm tender, red, warm induration on (L) upper arm.
Feeling sick 2 days; Problem sleeping; Hands were trembling / Arm were trembling; Panic attack; Anxiety; Did not receive schedule 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 37-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.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Adverse event, at a dose of 1 dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I came down with COVID-19 around January 9th, 2022. I started to feel like a cold was coming on. It wasn't very bad, had the sniffles, I had slight congestion. My primary care prescribed Zinc, Vitamin C, Vitamin D, Melatonin. My symptoms lasted for about a week. I have some fatigue that is lingering still.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 99-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles after several years later receiving the shot and it was bad. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR178214, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178214:same reporter
I am following up regarding your message to document my vaccine reaction after vaccination for Covid on 04Jan22. The lot administered was J&J lot 21ID21A. As you noted, I had drooping of the left eye with pain and inflammation that was also associated with headache, brain fog, and an extreme fever of 103 and chills for 2 3 days un responsive to anti pyretics. I started getting strength back on 08Jan22 and feel  pretty normal finally today 10Jan22.
She reports pain and then a red rash around injection site. It had resolved to just a slight red rash by the date she came in 04/12/18.
Initial unsolicited report received from a pharmacist on 10-Oct-2017. This case is linked to case 2017SA199735 (same reporter). This case involves a patient (onset age and gender not reported) who was vaccinated with a 0.5 ml single intramuscular dose of TENIVAC (batch number, expiry date and site of administration were not reported) on 27-Sep-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following the vaccination, the patient developed extreme muscle weakness and pain in the arm of vaccination. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Difficulty breathing, wheezing, fast heart beat, fever, cough, aches. Had flu shot around 8:30 am (9/15/2011) by 11: AM I had a fever and my whole body ached other symptoms followed shortly after. I took TYLENOL, went to bed (netter by the next day).
Patient was given the 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a physician in the. This case involves a male patient (age reported as 15 and 16, units not reported) who received his second dose of 0.5 ml MENACTRA dose at age 15 and the the third dose of the same vaccine at 16. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was actual medication error due to extra dose administered. It was reported that the HCP was not sure that the second MENACTRA dose was valid. No AE reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Swelling, erythema, and tenderness (R) upper arm (Bi upper bicep/tricep area increased 2-3 cmarea (L) arm diameter) - developed approx 1 day s/p getting TDaP, MENACTRA in that arm. Seen on exam 2 days s/p vaccine.
(02/16/2015) Back and leg pain especially on the left side. Foot pain when walking.  Lower left side back pain. (02/19/2015) Hard to walk and stand upright. PCP prescribed oral steroids. Unable to go to work. (02/25/2015) Pain progressed to inability to walk without assistance and total inability to use legs. Went to ER and was admitted.
Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; This is a spontaneous report from a non-contactable consumer (patient) via sales representative. An 8-decade-old (mid 70's) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6208) via an unspecified route of administration on 03Apr2021 as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6198) via an unspecified route of administration on 13Mar2021 as a Dose 1, single for COVID-19 immunization. The reporter stated that, he "just had his second COVID shot and had bad side effects with fever, nausea, and vertigo." The outcome of the events was unknown.  No follow up attempts are possible. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 07May2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "CVID" (unspecified if ongoing), notes: other medical history: CVID; "Known Allergies: penicillin" (unspecified if ongoing), notes: Known Allergies: penicillin. There were no concomitant medications and also reported as no other medications in two weeks. Past drug history included: Neomicyn, reaction(s): "Known Allergies: Neomicyn", notes: Known Allergies: Neomicyn; Prednisone, reaction(s): "Known Allergies: Prednisone", notes: Known Allergies: Prednisone. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 included Paxlovid (Batch/lot number: GA1529) started on 25May2022 and stopped on 29May2022. Clinical course was reported as, For Paxlovid Extreme dry mouth, bad fatigue, dizziness, hotflashes, nightmares on 27May2022. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dry rough facial skin, itching and slight facial puffiness. Red papules on arms and legs. Began about 6 hrs after vaccines.
patient was administered (8-May-2023) an expired (8-April-2023) dose of the pediarix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 08-MAY-2023, the patient received the 1st dose of Pediarix (left thigh). On 08-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was administered (8-May-2023) an expired (8-April-2023) dose of the pediarix vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received an expired dose of Pediarix, which led to expired vaccine used.
Approx. 5 days post Shingrix injection I developed an intensely itchy rash (Hives) on decollate, right side, followed by back top left shoulder, back right shoulder, mid back, thighs, addomen, scalp, nape of neck. Rash continued to spread. Saw Derm NP on 3/11/20, who Rx'd Tramcinolone 0.1% cream. Did not abate itch or spread. Saw MD, derm w/ interest in autoimmune skin disorders who took a biopsy. She diagnosed HIVES/dermal hypersensitivity due to either a spider bit or drug reaction. Vaccine is highly suspect as Hives initiated so shortly after vaccination. I've never had HIVES before. Zyrtec 40mg/day did not help. Elect not to use immunosuppressive therapy recommended by Dr. Hives continue.
This spontaneous report as received from a Licensed Practical nurse refers to a 4 months old child (gender unspecified). On 27-NOV-2012. The patient was inadvertently administered with a dose of PNEUMOVAX23 (lot number, expiry date and dose were not reported) intramuscularly. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. Additional information has been requested.