chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (body swelling). At the time of the report, SWELLING (body swelling) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided Treatment information was not provided   Reporter did not allow further contact
After receiving my 2nd Moderna vaccine I have been receiving treatments in my left arm for severe pain.  After the shot I did have some redness, swelling and pain.  The redness and swelling went aware but the pain is still there and I am have severe pain in the muscle to the extent that I am going through PT and seeing an orthopedic.  I've been through 2 rounds of prednisone, Massage therapy, acupuncture and even an MRI which showed nothing is torn.  So far no relief.  I can still feel the knots in my muscle in my arm.  After seeing my PT therapist on Friday, 9/27/21 she asked if it could possibly be Moderna arm.  After doing research on this I've come to the conclusion that is probably what it is.  I'm going back to my orthopedic tomorrow, 9/30/21 to find out my next step.  This has been quite the mystery as nobody can figure out what is going on.  Has any one else had this problem.  I just want some answers and relief w/o surgery.
Information has been received from the Merck Pregnancy Registry via a medical assistant concerning a 17 Year old female with no pertinent past medical history who on 18-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #655619/1427F). On an unspecified date the patient was vaccinated intramuscularly with the second dose of Gardasil (657005/0188U). There were no concomitant therapies. It was reported by the medical assistant that the patient did not let the staff know she was pregnant and the first and second doses of Gardasil were administered respectively. The patient's last menstrual period was 26-SEP-2006. Estimated the patient's pregnancy to be at least 37 weeks gestation. Subsequently the patient's pregnancy ended in a fetal demise. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to approximately 5 year old patient (gender not reported). Pertinent medical history and concurrent condition were not reported. On 17-JUL-2014 the patient was vaccinated with expired dose of PROQUAD (lot # H020851, Expiry date: 26-MAY-2014) (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Received Paxlovid as treatment of COVID-19; Received Paxlovid as treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 at 09:30 as dose 1, single (Lot number: EK9231), in left arm, on 10Feb2021 at 09:15 as dose 2, single (Lot number: EM9809), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30135RA), in left arm and on 10Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing); "Allergis rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2000, stop date: 13Nov2022; LOSARTAN, start date: Jan2000, stop date: 26Nov2022; HYDROCHLOROTHIAZIDE, start date: Jan2000, stop date: 26Nov2022; LORATADINE, start date: Jan2000, stop date: 26Nov2022; FAMOTIDINE, start date: Jan2000, stop date: 26Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Received Paxlovid as treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: The patient has no known allergies. Patient received Paxlovid as treatment on 13Nov2022 to 17Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure,  covid-19 and suspect drug BNT162B2 cannot be excluded.
1st Dose - eyes became irritated, bloodshot, sore, and extremely dry.  Blurry vision, light sensitivity, and headache.  Left eye felt like something was stuck in the eye, and the entire eye socket was sore.  No itching or discharge.   Lasted for 36 hours. 2nd Dose - same experience, but not as bad due to increased use of eye drops.  Adverse effects could be due to Lasik surgery 17 years prior which left me with chronically dry eyes.
The patient stated that they had never gotten a COVID vaccine before, and was administered a dose of Pfizer today. Upon entering her vaccination into the database, it was noted that her profile listed a Moderna dose in July 2021. The patient was contacted and confirmed that they had received a Moderna dose in July 2021, making the Pfizer dose administered today the second dose in the Primary Series.
Redness at injection site after administration of ZOSTAVAX immunization.  Mostly outside of injection site and checked pt 20 minutes later and no change. Lot # K000995, exp 3/6/2015
12/20/21 pt had a positive COVID test. 12/24/21 pt to Medical Center via EMS with increasing SOB x 3 days; EMS found O2 sats to be between 60 - 70s on RA; 80% on NRB; admitted; also had a positive COVID test; placed on BiPAP; acute renal failure; IV fluids given; AHRF secondary to COVID pneumonia; steroids, ABX; worsening respiratory status; intubated; Baricitinib and Remdesivir given; pt's condition continued to decline; family decided to transition to comfort care; extubated and pt passed away in the hospital
Pt received HIB and PREVNAR vaccine on 8/13 then had a febrile seizure on 8/16. Hospital follow up mom reports that pt has a seizure yesterday they had called EMS because she looked like she was not breathing seizure lasted 6 minutes mom reports seizure occurred at 8:15 yesterday pm was in the ED until 2:00am pt has developed a fever since Sunday temp was 105 in ambulance yesterday
PFIZER VACCINE WAS PLACED IN FREEZER 05062021 AND DUE TO BE MOVED TO REFRIGERATOR 05192021.  VACCINE WAS LEFT IN FREEZER UNTIL 05212021 THEN MOVED TO REFRIGERATOR. IMMUNIZATION PROGRAM WAS NOTIFIED OF ISSUE ON 05252021 AND SENT EMAIL STATING  VACCINE AS SAFE TO USE .   05272021 TIP EMAILED  VACCINE WAS NOT SAFE TO USE AND TO DESTROY THE VACCINE.  THEN TIP EMAILED 05282021 THAT PFIZER PHARMACIST HAD DEEMED VACCINE STABLE AND IT WAS SAFE TO USE SO DOSES GIVEN 05252021 WERE GOOD.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up updated.
Could not lift arm more than a few inches for about 3 days due to soreness, but after that pain/soreness went away, several days later (8 days post vaccination), my arm got very itchy near the injection site. It also is raised and red. Day 9 and the circumference of the red area has increased around injection site. Other than being itchy, pain is minimal (only a little sensitive to the touch).
arm was sore; 17 years old at the time of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old at the time of vaccination) and PAIN IN EXTREMITY (arm was sore) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old at the time of vaccination). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). On 13-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old at the time of vaccination) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-JUN-2021. No new information was updated.
Pretty severe muscle soreness starting in right leg/hip area then down front of leg to knee.  Moved to left leg hip area down front to knee with a point of sharp pain where leg muscle attached.  The expanded to right shoulder then left side of back of neck then left shoulder.   Some right side rib cage soreness which is persistent. No treatment....acetamin barely touches the pain.  Oxycodone works for maybe 90 minutes.  Right leg pain mostly gone.  Left leg pain except for point mostly gone.  both shoulders and neck remain very sore and movement is restricted.  Pain started overnight in right leg is very slow to heal in every location.      No exercise or previous injuries. Could this be Guillen-Barre (sp)??  I am 73 and in good health otherwise.
Information has been received from a physician's assistant (PA) and a registered (RN) concerning a 35 month old male with reactive airway disease (RAD) who on 09-MAR-2004 was vaccinated in the right thigh with a dose of varicella virus vaccine live (Lot# 647519/1105N). Concomitant vaccinations administered on that same day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Other concomitant therapy included budesonide (PULMICORT). No post vaccination rash was reported within 42 days of vaccination. It was reported that on 10-MAR-2006, the patient developed shingles characterized by spotty right thigh dermatomal distribution from the top of his buttocks to his ankles. There was no fever, pain or itching reported. Neither recent nor past exposure to naturally occurring chickenpox was known. A specimen was collected for VZV evaluation. At the time of this report, the outcome was unknown and the patient was noted to be presently taking montelukast Na.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/12/2006.  Information has been received from a physician's assistant (PA) and a registered nurse (RN) concerning a 36-month-old white male with reactive airway disease (RAD) who on 04-MAR-2004 (also reported as 09-MAR-2006) was vaccinated SC in the right thigh with a dose of VARIVAX (Merck) (Lot # 647519/1105N).  Concomitant vaccinations administered on that same day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Other concomitant therapy included (PULMICORT) and (XOPENEX).  No post-vaccination rash was reported within 42 days of vaccination.  It was reported that on 10-MAR-2006, the patient developed shingles characterized by spotty right thigh dermatomal distribution ("dew-drop on rose petel") from his right lower back and the top of his buttocks to his ankles.  Mild pruritis was also noted.  There was no fever or pain reported.  Neither recent nor past exposure to naturally occurring chickenpox was known.  The patient was treated with ACYCLOVIR X 5 days.  A specimen was collected for VZV evaluation.  At that time, the patient was noted to be presently taking montelukast Na (MSD).  On 16-MAR-2006, the patient was noted to be recovered as per his mother.  Follow-up information from VZV testing revealed an inadequate specimen (vesicle), negative for B-globin and no strain I.D. VZV DNA was not amplified.  Additional information is not expected.
3x5 inch red swollen, tender and hot area on (R) arm, low deltoid
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Heart palpitations, shortness of breath, chest pain started a few days ago.. heart palpitations continue with some shortness of breath and some weird very mild pain
pt was seen for immun;pt was okay @ that time;2 days p/had poor feeding; found blue in crib;taken to hosp pt was found dead possible SIDS;
Received the flu 2 weeks after the shot then it turned pneumonia. 2/21/06 Received medical records which revealed patient experienced acute respiratory failure, pneumonia, CHF, hypernatremia, azotemia, HTN, MRSA pneumonia & MRSA UTI.  PMH: hypercholesterolemia, osteoporosis, compression fx, liver cyst, hypothyroidism & hyperlipidemia./ss
pt recv vax 25FEB97 & p/dose approx 5hr later pt exp a feeling of being overheated (feeling flushed) & had sweating;the exp lasted about 20min;pt reportedly recovered from this exp;
First injection of series was given 8/21/2018 with no signs of adverse events, and there was no pain initially when the second vaccine was given 11/26/2018. Later that day, patient reports she had injection site soreness and was unable to raise left arm above shoulder height. Soreness at the site completely resolved after approximately one week, but patient reports ongoing inability to raise arm above shoulder height. She states she was not sick anytime before or after the vaccine, and no reported injuries at this time either. She has not seen a medical provider for this event, nor does she have one scheduled, and no treatments have been done.
Information has been received from a consumer concerning her daughter who was vaccinated with a third dose of GARDASIL (lot # not reported) 5 weeks ago, on approximately 19-FEB-2009. It was reported that the patient still had pain off and on at the injection site. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with PROQUAD (lot # K023861 with expiration date of 25-MAY-2016, lot # K005644 with expiration date of 17-OCT-2015; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 4/29/99; 5 min post vax pt fainted, became rigid, body tingling, nausea, choking, dizzy
Pain in left arm . Swelling . Rash that is warm to the touch. Sore left shoulder .  Lasting over 2 weeks . Bruise that is still visible after 17 days . (Bleeding at the time of shot. )
On the way home the patient started to fill sick, and then felt like he was going  to pass out. He did pass out and wrecked his vehicle.
Fluvirin w/ Thimerosal given to OB pt. EDC = 11/08/2009. Pt does NOT have an OBGYN. Pt notified on 11/6/09. Denies any adverse effects. Pt NOT hospitalized after receiving H1N1 vaccine.11/10/2009 Patint received H1N1 on 10/26/2009. patient is pregnant, EDC 11/8/2009. Patient has reported no side effects.
burning during urination; aching in body; fever of 100 degrees; soreness around the injection site,; received first dose of Shingrix 2/11/20 (Inappropriate schedule of vaccine); This case was reported by a consumer via call center representative and described the occurrence of micturition burning in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chickenpox and Shingrix with an associated reaction of injection site erythema (1st dose received in 2nd November 2019, Please refer the case US2020AMR178503.).   On 2nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced micturition burning, general body pain, fever, injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the micturition burning and injection site pain were not recovered/not resolved and the outcome of the general body pain, fever and drug dose administration interval too long were recovered/resolved.   It was unknown if the reporter considered the micturition burning, general body pain, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix vaccine in the left arm intramuscularly. The patient reported after receiving the 2nd dose had soreness around the injection site, fever of 100 degrees, and aching in body. The patient reported the aching in body and fever have subsided but the soreness around the injection site is still ongoing currently. The patient reported burning during urination that began this morning and was still ongoing currently.  2nd November 2019, the patient received 1st dose and 2nd dose on 2nd September 2020, which led to lengthening of the vaccination schedule. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178503:same reporter
Fever; headache; fatigue; nausea; muscle aches; This is a spontaneous report from a contactable nurse reported for herself. This 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 09Jan2021 15:30 at single dose (vaccine location=left arm) for COVID-19 immunization.  Medical history included allergies: Iodine, shellfish. The patient had COVID prior vaccination. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient's concomitant medications were not reported. On 10Jan2021 07:00 AM, the patient experienced fever, headache, fatigue, nausea, muscle aches. No treatment received for events. Patient had not tested COVID post vaccination. The outcome of events was not recovered.    Information about lot/batch number has been requested.
The pt experienced an adverse reaction after receiving the tetanus and diphtheria adsorbed vaccine which included acute swelling, red blotches, internal bleeding and deep pain. It progressed to loss of feeling 90% in pt's arm.
Poor concentration; dropping things (like knife and scissors); Weak; Coughing; Hemorrhoid; No taste of food; Lack of sleep; Dry mouth; Congested; Trouble catching his breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food) and INSOMNIA (Lack of sleep) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), HYPOGEUSIA (No taste of food), INSOMNIA (Lack of sleep), DYSPNOEA (Trouble catching his breath) and NASAL CONGESTION (Congested). On 18-Mar-2021, the patient experienced COUGH (Coughing) and HAEMORRHOIDS (Hemorrhoid). On 19-Mar-2021, the patient experienced ASTHENIA (Weak) and MUSCULAR WEAKNESS (dropping things (like knife and scissors)). On 21-Mar-2021, the patient experienced DISTURBANCE IN ATTENTION (Poor concentration). On 19-Mar-2021, INSOMNIA (Lack of sleep) had resolved. At the time of the report, COUGH (Coughing), DRY MOUTH (Dry mouth), HAEMORRHOIDS (Hemorrhoid), HYPOGEUSIA (No taste of food), ASTHENIA (Weak), DISTURBANCE IN ATTENTION (Poor concentration), DYSPNOEA (Trouble catching his breath), MUSCULAR WEAKNESS (dropping things (like knife and scissors)) and NASAL CONGESTION (Congested) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-053010 (Patient Link).