chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site was hot; tchy; Injection site was hard; redness around the injection site; injection site looked significantly worse and larger in size; Fatigue; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore). On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE PRURITUS (tchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included prednisone 20mg for 4 days, Patient started taking it on 13 Apr 2021, use ice pack on the injection site and take diphenhydramine.  Patient reported that after starting the Prednisone the injection site got a little better. Patient reported that the injection site is still itchy, red, and sore.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
The patient had three dosis of the vaccine before the administration. The patient classify for the 2nd Booster beacause of his age. The dosis that should be administrated was a Booster of Moderna (0.25mL) after four months of the last vaccine administrated (12/29/2021). The new dosis was administrated below the four months especify by the manufacturer.
1 ml of vaccine administered; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 1 ml of vaccine was administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient received a 1 ml dose of the Moderna COVID-19 vaccine, instead of 0.5 ml, during their first dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, 1 ml of vaccine was administered, was considered resolved on unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.
Slight cough; Chills; body aches; fatigue; migraine; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in left arm on 01Feb2021 at 12:30 as 1st dose, single for COVID-19 immunization. Medical history included recurring sinusitis, recurring migraines, hypothyroid, anxiety. Patient had allergies with Codiene, Dillauded. Concomitant medications included thyroid (ARMOUR THYROID), guaifenesin, pseudoephedrine hydrochloride (MUCINEX D), levocetirizine dihydrochloride (XYZAL), ibuprofen, ergocalciferol (VIT D). Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not pregnant. On 06Feb2021 at 04:30 PM, patient experienced slight cough, chills, body aches, fatigue, migraine, sore throat. No treatment was received for the adverse events. Patient had not been tested covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Started off with high fever (102.5F) and erythematous pharyngitis originally diagnosed as strep throat (positive throat culture) but when returned to doctor today and he was diagnosed with measles (generalized rash, bilateral ear infection, high fever, lethargy)
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 06 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the event as non-serious.
blood pressure started rising her pressure was very high/However, reached 172 over 56; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (lot Number: EL9261) as single for COVID-19 immunisation. The patient Historical vaccine included first dose of BNT162B2 for Covid-19 immunisation.  Concomitant medications were not reported. As reported, two days after the patient second injection on 30Mar2021 (01Apr2021), her blood pressure started rising her pressure was very high for her as it usually is normal. However, reached 172 over 56. The patient's lab data included Blood pressure 172 over 56 on 01Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
01/05/22 presents to EC ED for "panic attack, cough". PMHx of "anxiety".
I started having  shortness of breath within one week of taking the first of two vaccines of the Moderna vaccine.  The shortness of breath became worse and a dry cough developed.   I have not had COVID19 prior to or after taking the vaccine.  I do not have any personal history or family history of respiratory illness.  I now have an ongoing dry cough that occurs early morning and late evening.  I also have fluctuating O2 saturation percentages that range from high of 100% to a low of 79%.  My O2 saturation rate can drop from high 90's to low 80 percentage ranges in 3-5 mins of moderate paced walking or if trying to talk and do an activity or work related task at the same time.    Some mornings my O2 saturation rate is in low 80's which makes it very difficult to get ready for work due to SOB and coughing.  This has affected my general endurance drastically.
Severe migraine/sinus headache, left sinus tenderness & congestion, body aches
Sore shoulder right after the shot.  Soreness increased  making it painful to sleep on that side. Next day: headache, fatigue, body aches, swollen around the injection site, and some redness and rash around the injection site. 2 days after shot: swollen area has subsided for the most past gone; soreness persists, although lessened. Redness and rash persists.
Started with coughing, then throat constricted, so difficulty breathing and swallowing, continued up the head w/nasal and sinus congestion, red, swollen, bloodshot eyes.
pt recv vax 4SEP96 & 5SEP96 pt devel a chickenpox-like rash on trunk & face;6SEP96 pt devel hives all over body;to MD;dx erythema multiforme;
This spontaneous report was received from a registered nurse, referring a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 24-JUL-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # J008534, expiration date on 12-JUL-2015 (strength, dose, anatomical location and route of administration were not provided). There was not a product quality complain involved. No adverse effects were reported. Additional information has been requested.
The vaccinee worked with cleaning products (NOS) as a housekeeper. On 1/23/02, the vaccinee received her 1st dose of Engerix-B. She received 2 injections of the 10mcg pediatric formulation, to provide the adult dose of 20mcg. On 1/24/02, the vaccinee was seen at the ER for treatment of burning back pain, chills and sweats around her left upper back. At the ER, the vaccinee was told that her bra was too tight or she "was having a reaction to a chemical". The vaccinee was given Keflex by the ER physician. The vaccinee returned and showed the NP her back. The NP described the area as a linear burn on the left lower portion of her back near the bra strap. The area extended to the left underarm. The NP described the burn as resembling skin that had been peeled off and underneath was deep red. The NP was unsure if there were any blisters. The vaccine site looked "fine". The vaccinee had not had any complaints about her left arm. The vaccinee was seen by 3 physicians. They were reportedly were in agreement, that her dx was contact dermatitis and that there was "no connection to the vaccine". The NP did not think that the event was due to the Engerix-B administration. However, the cause of the event was unknown. As of 3/6/02, the outcome of the events were unknown.
Shingles/Shingle site located on septum of nose; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in Arm Right on 13Apr2021 17:30 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history reported as none. Concomitant medication within two weeks included atorvastatin (ATORVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA), levothyroxine sodium (LEVOTHYROXIN), all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration, administered in Arm Right on 23Mar2021 17:30 (at the age of 47 years old) as single for COVID-19 immunisation. Patient did not received other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced shingles/shingle site located on septum of nose on 19Apr2021 08:00. Event reported as, Shingles diagnosed by PhD medical professional. Shingle site located on septum of nose. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment included anti-viral prescribed and ophthalmolog appointment. Patient did not tested for COVID post vaccination. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Day after vaccine right hand was cramping, felt stiff, but thought it was a normal symptom then Saturday the 10th was in the shower when my right I had distorted vision, looked like pixels was rushed to the ER and blood pressure was 240/130 they called a stoke alert and had multiple tests
Initial misuse report received from a healthcare professional on 25 September 2013. The cases were received on 21 March 2014. A 74-year-old patient received FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient described feeling light headed, nauseated, dizzy. She developed hypertension and HA over time frame of 5 minutes after vaccine to 1 hour and 30 minutes after vaccine up to a BP of 201/115. Range of BP was 163/94 up to 201/115 with HR 76-89, Patient was alert, oriented, able to move all extremities, transfer to chair and respond appropriately. Major complaint was feeling dizzy and nauseated with feeling of HA emerging.
Myalgia, Arthralgia, NauseaVomiting, Chills, dizziness, redness/swelling@injection site Narrative:
No adverse affects; first dose of VAQTA was given to patient on 4/18/2019 and a second dose was given on 5/24/19; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy details were not reported. On 18-APR-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength and dose were not reported) intramuscularly for prophylaxis. Second dose was given on 24-MAY-2019 (inappropriate schedule of product administration). No adverse event was reported. No product quality complaint (PQC) was involved.
Patient starting feeling very anxious, heart rate increased, very sick to stomach, nausea, diarrhea symptoms continued for approximately 24 hours then subsided.  No fever.  8/3/2010 patient broke out in a rash, non-itchy, prickly pinpoint red bumps all over body, palms of hands and feet.  Not on face or neck.  Doesn't feel sick.  No cold or cough.  Patient took Benadryl, but has not sought medical care.
hives on lower legs, lower back w/swelling @ site & itchy;fussy;resolved w/in 24hrs;
Headache LEFT ARM SWEELING AND PAIN Narrative:  MISSED WORK DUE TO SYMPTOMS
fever 4 days after vaccine; This is a spontaneous report received from a contactable 56-year-old female physician (patient) who reported in response to HCP letter, received pneumococcal 13-val conj vac (dipht crm197 protein (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), Unknown formulation, Batch/Lot number was not reported), via an unspecified route of administration on 01Nov2015 at an unspecified dosage for an unspecified indication. The patient's medical history included chronic sinusitis from 01Jan1980 and ongoing Sinus surgery 09Feb2019, migraine from 01Jan1980 and ongoing, hypertension from 01Jan1994 and ongoing, sinus operation from 09Feb2019 to an unknown date. The concomitant medications included hydrochlorothiazide, losartan potassium started from 2005 and ongoing for hypertension at most recent dose of 50mg/12.5mg and esomeprazole sodium (NEXIUM MUPS) started from 2010 and ongoing for prevention of gastritis at most recent dose of PRN prior to Asprin or NSAID product. The patient took PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) Vaccine on 01Nov2015, and on 05Nov2015, four days after the vaccination, the patient developed fever, with no source of infection. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
several pt @ this facility devel fever & inj site pain p/vax;the subject vial was cultured & reportedly micrococcus was isolated;
Lymphadenopathy, left clavicle for 9 days. Joint pain right shoulder and left side of body for 7 days.
Information has been received from a physician concerning a 14 year old female who on 12-MAR-2008 was vaccinated with the second dose of GARDASIL (lot# not reported).  On approximately 19-MAR-2008 the patient experienced very dark, almost black blood for the first three days of her period.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from very dark, almost black bleeding.  No further information was provided.  Additional information has been requested.
Received flu vac received 10/28/08 1912 L deltoid T max 38.5 red, warm to touch, rash that came to expand x 24 hours. PO keflex d\c, then Vancomycin x 2 doses then Bactrim DS.
Information has been received from a physician concerning a nine year old Asian Filipino, male pt who on 26Jul95 was vaccinated with varicella virus vaccine live (lot 60858/0414B). On 17Feb99 the pt experienced breakthrough varicella. Additional information has been requested.
Sore arm at injection site started day of injection and lasted 2 days, itching at injection site 7 days after injection, swelling in lymph node under arm on same side as injection 5 days after injection
Symptoms: Hot harden swollen bump the size of note pad 3IN X 3IN. Tingley and Itchy the entire left arm to include left hand and fingers. Treatment: Cold pack applied on arm and took 2 Advil for the pain as of approx. 11pm, 4am, 9am as arm continued to hurt until January 21, 2021
pericarditis; Chest pain; This is a spontaneous report from a non-contactable physician. A 20-year-old female patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included generalised anxiety from an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 10Mar2021 for COVID-19 immunization. On 01Apr2021, the patient experienced pericarditis and chest pain. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab and PCR: both negative on an unknown date. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of pericarditis and chest pain which included High Dose NSAIDs. The outcome of the events was unknown. The events were assessed as serious which caused hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The events pericarditis and chest pain are most likely intercurrent conditions and unrelated to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Platelets dropped from 468 K/micro L to 10 K/microL. The discharge summary received on 2/9/04 states itching/ puritis rash, decreased appetite, weight loss, and purpura. The medical record received on 2/10/04 states abd tender, and fatigue.
Facial spasms left side of forehead starting 72 hours; Heart palpitations around 80 hours after second dose; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 17Apr2021 at 15:00 (at the age of 47-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received sulfa; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021 at 03:15 PM (at the age of 46-year-old) at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations around 80 hours after second dose on 20Apr2021. Lasted only 20 minutes. Facial spasms left side of forehead starting 72 hours after second dose on 20Apr2021 at 15:00 and lasted 5 days. Since the vaccination, patient had not been tested for COVID-19. The outcome of the event facial spasms was recovered in Apr2021 for 5 days, outcome of event palpitation was recovered on 20Apr2021 for 20 minutes.  No follow-up attempts are possible. No further information is expected.
Urinating blood multiple times.  This has occurred over the course of 2 days now and is ongoing, but getting a bit better.  Symptoms came 1 day after receiving 2nd dose of Pfizer COVID 19 vaccination.    At the advice of the doctor, we went to the Emergency Room as it was Friday night at 9 p.m.  A urine test confirmed blood in the urine and the diagnosis was "gross hematuria" and "adverse effect of vaccine, initial encounter"
Flulaval to be stored at temperature below what is recommended; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable to this report. The reporter stated that the Flulaval was stored at temperature below what was recommended, which led to incorrect storage of drug. The pharmacist did administer the suspect Flulaval to patients. The reporter did not consent to follow-up.  No additional information was provided.
Developed Bells Palsy on 02/21/2021. Presented to hospital 02/22/2021. Treated with Prednisone and Valacyclovir  Is improved