chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left thumb got hard; left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm; swelling; tiny bruises on left lower arm; nod in stomach; This spontaneous case was reported by a consumer and describes the occurrence of SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     Patient did not have any allergies, never had COVID positive test or diagnosis and not had both acute and chronic illnesses at the time of vaccination. Did not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 16-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach). At the time of the report, SKIN INDURATION (left thumb got hard), SKIN DISCOLOURATION (left thumb turned purple/ the color is all around finger nail/ the purple color is travelling down her palm/ugly purple color on thumb and palm), SWELLING (swelling), CONTUSION (tiny bruises on left lower arm) and ABDOMINAL DISCOMFORT (nod in stomach) had not resolved.      She was not on any concomitant medication. The caller just provided the information for the last dose that she received since she did not experience any side effects with the other doses. All the vaccines received were from Moderna. She was very worried and scared because it did not stop moving down. Patient primary physician and the pharmacist who administered the vaccine told her it was because of the Booster dose. She saw her primary doctor and the pharmacist who administered the vaccine. She said she would have to go to the urgent care to take a look at it. No treatment was given.
COVID-19 vaccination; COVID-19 vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 vaccination".  Clinical course: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior and post to the vaccination the patient was diagnosed with COVID-19. If Other vaccine in four weeks: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
arched back while sitting-less than 5 seconds-appeared alert-VS 90/60, 64, 20;
No adverse event; patient pregnant. 12/01/09 Medical records received for DOS range 9/25-11/26.   22 week IUP.  G3 P2 .  LMP 6/16/09. EDD 3/24/10.  Currently treated for depression and PTSD w/psychotherapy and Risperdal.  HSV suppression. SAB precautions.
patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 042H22A, 032M20A, 036B21A1, 065F21A, 011B22A and 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient received a dose of the Moderna COVID-19 bivalent vaccine today, 16DEC2022, already received a dose 2NOV2022).    No concomitant medication information was reported. No treatment medication information was reported.
I had an occasional irregular heart rhythm, but now have atrial flutter several times per day, per hour, even per minute during an episode. Worsened after covid vaccine,  may be purely cooincidental.
Apprx 12 hours later, I had severe chest pains in which I thought I was having a heart attack. Another 12 hours later, I developed a fever of 102. This lasted for 2 days. Followed up with pcp on 48 hours later. It was recommended I get a Covid-19 test in which I did and it came back negative. Followed up with the provider 9 days later. A blood panel was administered in which both my alt and ast results have increased substantially. I'm awaiting  feedback from PCP. Please note, I have never been a smoker or consume any alcohol. I was tested for Hepatitis C in which was negative and I am vaccinated for both Hepatitis A and B. I exercise daily, teach yoga, and eat healthy.
I have been feeling dizzy, like dizzy spells; it comes in a way, like I get dizzy and then I have to like hold my head down and it goes away; my heart goes a little bit faster; burning'' in the back of my throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 18Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "I have been feeling dizzy, like dizzy spells; it comes in a way, like I get dizzy and then I have to like hold my head down and it goes away"; HEART RATE INCREASED (non-serious) with onset 18Dec2021, outcome "unknown", described as "my heart goes a little bit faster"; THROAT IRRITATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "burning'' in the back of my throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got the COVID-19 Vaccine day before around 03:45 and about 30 minutes, patient want to say almost 30 minutes later, patient started feeling dizzy and patient had been feeling dizzy, like dizzy spells as the following day. Reporter meant patient thought maybe yesterday because had it yesterday but it lasted for 3 hours and in the evening got better and then at that time, patient had been up holding for an hour and then it started all over again. And then patient do get like, feels like not too fast but yes while patient lie down, patient's heart, when patient was having the dizzy spells, patient felt like, heart goes a little bit faster but it was nothing, not much or anything. Patient did experience like some 'burning' in the back of patient's throat. Patient didn't know what that was, if that was even related. Patient's concern was should patient be worried about the dizzy spells. Was this something that was going to go away. Was it something patient cant take, so patient could see somebody, like patient didn't know what to do. Patient read the paperwork and patient didn't know, didn't know what patient should do but it was the following day and I am still dizzy." Consumer was requested to visit nearest ER or call # if the situation is critical. Consumer stated, "I really needed someone to tell me what to do because don't want to unnecessarily go to a hospital, you know. Is their nobody, I mean I just (Incomplete sentence)." Consumer stated, "Yeah, wow. That doesn't help. That doesn't help if they are not open today because the only think on dizziness is under allergic reaction (Further clarifications unknown) and I don't know if, waiting another day like this, you know what I mean".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Itching, redness, heat, tender, firm area 5" horiz and 3" vert just below site of injection in (L) upper arm....2 days after injection - (started itching 1 day after shot). T 98.8.
Got Covid; Got Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive again several days following finishing my course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Patient received other medication in 2 weeks. COVID 19 Treatment included paxlovid from 29Nov2022 to 04Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receipt of vaccine and hit his face on the ground resulting into bruising. He immediate regained consciousness. EMS was called and pt taken to ER for monitoring.
PT has HX of allergies and needs observing in EMS room for 30 min.
Patient had erythema & swelling at vaccine site which improved after 15 min and after administration of 25 mg BENADRYL.
Pt broke out in a red rash and itchiness almost immediately after the injection. The rash was on her chest and neck and cheeks. We immediately gave 10mls of Diphenhydramine liquid (equivalent to 1 capsule). Pt did not feel dizzy and had no swelling in throat, mouth, or tongue. Pt left the pharmacy area about 10 minutes later. Rash was beginning to subside as was the itchiness.
Diagnosed with diffuse large B-cell lymphoma on 12/17/21.  Now on hospice.
A really bad head cold; Runny nose; UTI; Severe aches and pains; Cough; slight headache; Arm is sore; the chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains) and COUGH (Cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the chills). At the time of the report, NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the chills) outcome was unknown.        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.   No concomitant medications were provided No treatment information provided
Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain; Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain; Arm pain, a throbbing arm pain at the injection site, it was preventing her from sleeping; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in arm on an unspecified date (reported as 3-4 days ago at 15:30 in the afternoon) as a Dose number Unknown Single for COVID-19 immunization. The patient's medical history included The patient previously took shingles shot and flu shot and stated she has reacted like that with the shingles shot and sometimes with the flu shot just slightly. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced arm pain, a throbbing arm pain at the injection site/arm started throbbing and hurting/pretty extreme arm pain and arm pain, a throbbing arm pain at the injection site, it was preventing her from sleeping. The consumer reported that "she received the first dose of the vaccine about 3-4 days ago. She stated she was fine, she just had some pretty extreme arm pain for a day or two. She stated it didn't come right away. She had the shot at 3:30 in the afternoon and during the night (also reported as 13 hours after vaccination) the arm got pretty sore. She took ibuprofen and wondered if that was okay. She took a small dose, the over the counter simple dose and two of the 200 mg only once. The patient took this to relieve the arm pain, a throbbing arm pain at the injection site. It was preventing her from sleeping. The next night she put cool packs on it. She stated it was gone now. She stated she heard it can be more severe with the second shot. She heard something about maybe she shouldn't have taken the ibuprofen and asked, is it okay that i took the Ibuprofen?" The patient received treatment for the event Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain with ibuprofen. The outcome of event Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain was resolved whereas the outcome of other event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient received a dose that had already expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 04-May-2022 Reporter's Comments:  The pharma intern reported on May 4th 2022 that on May 3rd 2022 patient received a dose of Twinrix that had already expired on February 28th 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information:  The patient received an expired dose of Twinrix vaccine, which led to expired vaccine used.
t103.4;screaming x 30min;bulging fontanel hosp x 3 days;
Seen on 7/27/06 for follow up s/p Smallpox vaccination reaction per ER notes. Facial rash present as well as persistent vomiting per report. History of Liver enzymes being elevated as well. No lab report available for those test results. Repeat LFTS and CBC done in ER see below. Smallpox vaccination site with 2 1/2 cm necrotic area that was gently debrided in the ER and new antibiotic ointment was applied. Ordered to advance diet as tolerated and follow up the next day. Medical notes also indicate possible heat injury during this time. It is unclear if initial visit to ER was heat related or smallpox vaccine adverse event. The initial ER report was not available for review.
swelling at injection site; Numbness; Tingling; episodic palpitations; Chest pain; Throat Swelling; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling. On an unknown date, the outcome of the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling were unknown.   It was unknown if the reporter considered the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient received the Shingrix series in February and April and experienced chest pain, palpitations, throat swelling swelling at injection site, tingling, numbness and episodic palpitations. The reporter wanted to know if it was associated with the vaccine. Follow-up would not possible as no contact details were available.
More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Saturday, 1/09/2021-Foggy, nasuea and tired. took 1-2 hoiur nap and symptoms went away.  Thursday, 1/14/2021-Slight rash on right deltoid, around injection site. Applied topical bebdryl and rash went away by Monday, 1/18/2021. Thursday, 1/14/2021-Swelling in right armpit region medial to right pectoral muscle. no fever pain/tenderness around area affected. On Monday, 1/18/2021 swelling remains.
pt recv vax 24OCT95 & 12-24hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: pt complainesd that she had a pain in her arm since then, she mentioned that her tendon was imflammed because of that and she had to get a surgery done to remove inflammed tendon. pt is recovering now
Within five minutes of the injection eyes began itching,  s within 10 minutes of the injection nose mouth lips tongue itching and full /pressure sensation in face. Hives on upper chest,  itching throughout entire body including legs toes fingers. Given 50 ML via I am injection in left thigh. Taken to hospital for further monitoring. Given 20 mg of Pepcid at hospital. No other meds given.
11-23 about 9:30 pm, my body was working very hard similar to flu.  In the early morning my legs would not hold me up., very frightening, but had heard of that reaction from an acquiantance.  By 1:30 11-24 I was strong enough to get up and dressed..
The pt developed a full blown case of chicken pox that was severe. The pt was sent to an eye doctor because of the pox around the eyes.
Patient received the COVID-19 shot (Moderna) on 03/23/21 and has been having a severe arm pain from the site of injection. She was checked by her Dr and was told that she is having a nerve pain as a result of the vaccination. She just called the pharmacy today on 04/16/2021 to report the adverse events as advised by her Doctor. According to the patient she is taking the Gabapentin 300 mg  prescribed by her Dr and it is helping her with the pain.