chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal bleeding 2 days after shot , very dark red, and had just finished period 5 days prior. Swollen lymph nodes under left arm pit
Family says that child developed a high fever (104) after the vaccines.  Family stated that child was speaking prior to vaccines and not speaking after vaccines.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Last flu shot that received made sick; Initial information received with live follow-up on 05-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case was linked to case 2020SA350855.  This case involves a male patient of an unknown age who got sicker than ever (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) Last flu shot that received made sick. That was a few years back. Will not take something that causes reactions.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
an 11 year old female, NN, received a dose of Adacel on 20AUG2019, had had a Tdap on 20AUG2018; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that an 11 year old female, received a dose of Adacel on 20 Aug 2019, had had a TDAP on 20aug2018 (Inappropriate schedule of product administration (10081572).  The patient's past vaccination(s) included Tdap on 20-AUG-2018.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 20-Aug-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA and expiry date: 04-Apr-2021 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate schedule of vaccine administered.  It was not reported if any adverse event occurred or not.  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.  List of documents held by sender: none.
Day 1: Chills, fever, sleepiness, low mood, muscle pain From Day 2: dizziness, headache, tinnitus, mood swings, crying, anxiety, depression  It was the same after the first shot. Tinnitus and dizzines almost lasted 3 weeks after the first shot.
Inflammation, itching, swollen down to elbow. Patient iced area and took BENADRYL, swelling went down.
Breakthrough case admission after 4 vaccines Moderna 3/17/21 Lot# 002B21A;  Moderna 4/14/21 Lot# 040B21A;  Moderna 11/15/21 Lot# 004F21A;  Moderna 10/10/22 Lot# AS7162B
Rash, itchy, swollen, red, hot at injection site 7 days after 1st dose.
Arrhythmia was noticed by cardiologist approximately 2 weeks after first booster, at the time no association was made between the two.  Second Booster was on 5/18/2022 noticeable signs of Arrhythmia noticed after 2-3 days.  Normal heatbeat 60-65, went to 130-133, with blood pressure 115/(90-100).
Day 1 bruise at injection site. Day 7 WHOLE left arm swollen and tender and stiff , red raised rash below injection site, hot to touch, burning sensation around injection site,  shooting tingling throbbing pain down to pinky and ring finger, swelling continued up shoulder into and around neck,  two red lines appeared for a day and faded away.  Presently on Day 14 swelling has somewhat subside but remains in upper arm, rash faded away,  burning sensation at site remains, arm and shoulder aches and mild shots of pain still continue. Delayed reaction has lasted 7 + days.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna/Vaccine administration date: 01Apr2022/Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 22Jun2021 at 14:00 as dose 3 (booster), single (Lot number: OGIE21A), in right arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: 027L2iA), in right arm for covid-19 immunisation. The patient's relevant medical history included: "2 small aneurysm's" (unspecified if ongoing), notes: 2 small aneurysm's,1 in left carotid artery 1 in Aorta. Both are small and under medical observation. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "known allergies: Pseudoephedrine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022 at 14:00, outcome "unknown", described as "Vaccine brand other: Moderna/Vaccine administration date: 01Apr2022/Vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was Unknown. The patient previously receive a COVID-19 vaccine. Patient received Paxlovid for COVID 19 treatment from 20Jan2023 to 24Jan2023.
I had my second dose of Moderna on 2/10/2021. Experienced fever, Temp up to 101 F, for 48 hrs immediately after the shot. And had my period on 2/12/2021, which is one week earlier than normal. Moderna makes my circle 1 week shorter than usual.
Patient reported to the pharmacy today 09/19/22 that she had a red patch about 3 inches in diameter at the injection site, a bit swollen, hot, sore and painful to touch
Patient experienced warmth at injection site as well as pain in left and right shoulder. Pain in hand of vaccinated arm as well as a "saucer sized" welt at injection site. Symptoms have persisted for over a week...Other symptoms reported were body aches and pains, but no reported fever.
pt recv vax 6MAY97 presented to ER 17MAY97 (11 days p/vax) w/red, raised fine rash, t100.3, c/o itching, & c/o h/a;lab hemogram (CBC) & chem profile done-result unk;
January 20 @ 10pm -  Itchy back.  January 21 @ 4am -  burning, itchy palms. January 21 @ 8am -  Itchy and burning hives begin to appear on palms, hands, arms, back, torso, chest, and neck. January 22 - primary physician prescribes 6 day steroid pills.  January 22 - 24 - hives do not reduce and become worse. January 25 - primary physician gives steroid shot. Conducts fiber and allergy blood tests. January 25 - 26 - hives do not reduce and stay the same. January 27 - visit dermatologist and confirms side effect of vaccine. Receive steroid creams.
administered DAPTACEL to a patient on 25JAN2022 that expired in May 2021 (with no reported adverse event); Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from a consumer/non-hcp via sales rep.  This case involves a 1 year old female patient who was administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] on 25-Jan-2022 that expired in May 2021 (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for prophylactic vaccination; influenza vaccine (Fluzone) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine for Prophylactic vaccination.  On 25-Jan-2022, the patient received a 0.5 ml, total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: May-2021) via unknown route in unknown administration site as Immunization (expired product administered, latency: same day). There will be no information available on the batch number for this case.  It was reported "Sales representative was calling on behalf of a client at a facility that administered DAPTACEL to a patient on 25-JAN-2022 that expired in May-2021. Sales representative states that the head nurse would like to know if the DAPTACEL needs to be re-administered."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered DAPTACEL to a patient on 25-JAN-2022 that expired in May-2021 (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event administered daptacel to a patient on 25-Jan-2022 that expired in May-2021 (with no reported adverse event).  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 the 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.
Systemic: Lymph Node Swelling-Mild, Additional Details: above right clavicle, doesn't hurt but noticed bump, visually difficult to see
After the shot i had the normal headache and sore arms. The kidney stones came about 2-3 weeks ago. I went to the ER and they sent me to the urologist. i have a urologist appointment this monday.
This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling bad. On 4th June 2018, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved. The reporter considered the influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient woke up on Saturday morning feeling bad.
Massive outbreak full body hives neck to feet. Hundreds of thousands of hives. Extreme immune response. Extreme diarrhea for over 6 months post-vaccination. Extreme stomach upset and full body issues resulting in panic attacks and 7 hospitalizations.  Body was put into fight or flight mode due to neurotransmitter alterations due to vaccine. Affected GABA, dopaminergic system, acetylcholine, norepinephrine.
Per mother pt. experienced hallucinations, diaphoresis and vomiting late afternoon on date of receiving Tdap immunization.
w/in 30min of vaccine, pt devel coryza, conjunctival edema, wheezing, anaphylaxis, treated w/SC epi & solumedrol;hosp
A few hours after the vaccine I began to have nausea which continued feel unwell for over 24 hours. Fatigue as well.  My right arm felt like it was broken it hurt so bad that I could not life my arm and I took Tylenol and Advil.
Later that night was not able to sleep all night rest less and site of injection was very painful.   Next day 5/13/14 ran a fever school nurse took temp and it was at 102.00 in addition headache, nausea with stomach ache, very tired/weak and dizzy.
All over body aches that put me in bed for rest of day. Following day worse..in bed all day. Day 3, pain ended in me extremities, but worsened in lower back to point of barely able to walk or bend. Took 800 mg ibuprofen for minimal relief.
This spontaneous report was received from a male patient of unknown age who was reporting on himself. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9, for prophylaxis (lot#, expiration date and route of administration were not reported). On an unknown date, the patient returned to the office for his second dose of GARDASIL 9 but he have might received one dose of GARDASIL, for prophylaxis (lot#, expiration date and route of administration were not reported) because his chart was marked with GARDASIL instead GARDASIL 9. No adverse reaction was reported.
Left arm red, hot, swollen, painful, decreased range of motion. Diagnosed with cellulitis. Given Bactrim on 3/16/19.
Pt became pale and diaphoretic about 5 mins after injection given. Pt passed out and became unresponsive but was breathing for 5 mins-after given cool cloth and cool water and placed on exam bed Pt became responsive - color improved and was released with Mom in 10 mins.
Patient had a rash on his head that started prior to the vaccine.  The day following the vaccine rash got worse, patient went to doctors office and was diagnosed with shingles.
Aches and pains. I attibuted it to getting both the flu and pneumonia vaccine the day before and normal side effects.  I got progressively worse over the following week and a half. I had chills, aches, pains and then finally chest pain. I returned to the MD office and was treated with Medrol dose pack for suspected pleurisy. I still did not improve. I returned again around 10/27. A Chest Xray was done at that time and I got a call a couple of days later stating that I did indeed have Pneumonia.  I do believe that I got it from the vaccine as I was FINE when I got the vaccine and very next day started feeling poorly.
some of the vaccine may have escaped during injection; felt a cold sensation at the injection site; gauze was covered with blood; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection), VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for an unknown indication.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection), VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood). On 04-Mar-2021, INCORRECT DOSE ADMINISTERED (some of the vaccine may have escaped during injection) had resolved. At the time of the report, VACCINATION SITE COLDNESS (felt a cold sensation at the injection site) and VACCINATION SITE HAEMORRHAGE (gauze was covered with blood) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Action taken with the mRNA-1273 in response to the events was not applicable.
Left arm redness 10 days after administration.   Swelling and numbness to the arm
Became very sick; Blood pressure went up; Eyes were blood shot; Face was beet red; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became very sick), HYPERTENSION (Blood pressure went up), OCULAR HYPERAEMIA (Eyes were blood shot) and ERYTHEMA (Face was beet red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Contrast media allergy (contrast dye) and Drug allergy (Allergic to Advair).    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced ILLNESS (Became very sick) (seriousness criterion medically significant), HYPERTENSION (Blood pressure went up) (seriousness criterion medically significant), OCULAR HYPERAEMIA (Eyes were blood shot) (seriousness criterion medically significant) and ERYTHEMA (Face was beet red) (seriousness criterion medically significant). At the time of the report, ILLNESS (Became very sick), HYPERTENSION (Blood pressure went up), OCULAR HYPERAEMIA (Eyes were blood shot) and ERYTHEMA (Face was beet red) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Blood pressure measurement: high (High) Blood pressure went up.         Reported that Patient not had both Acute and Chronic illnesses at the time of vaccination. Patient had not tested Covid positive. Also reported that Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant product use was not provided by the reporter.  Treatment information was not provided. Patient had not experienced similar event in the past.Outcome of events was reported as gotten better. Symptoms and status was improved. Patient went to Emergency and said it was a reaction from the vaccine.  Company comment: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Illness, Hypertension, Occular  Peraema, and Erythema. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.     Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up includes no new information.; Sender's Comments: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Illness, Hypertension, Occular  Peraema, and Erythema. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Patient came in 5 days later to pharmacy and reported an all over body rash started a few hours after vaccination. Patient took 50mg of benadryl and rash went away shortly after. No other symptoms experienced. Advised patient to inform doctor.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), administered at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician at a medical facility/office for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Itching and swelling in left arm. Round rash appeared on my arm at the injection site the size of a dollar bill one week after shot.  Was severely itchy for a day and slowly got better. Red rash lasted several days.
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not reported) which was exposed to 11.5C for 82.5 hours an excursion that was not supported by in-house stability data. No adverse effect. This is one of several reports received from same source. Lot number H022281 is an invalid lot number for PNEUMOVAX23.  Additional information is not expected.