chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer, reporting for herself. This 81 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified day in Feb2016 at the age of 80 years for pneumococcal immunisation.  The patient medical history and concomitant medications were not reported.  The patient had a bad case of pneumonia on 22Aug2016. She stated that she was not hospitalized and she has not reported it to her doctor. Outcome was unknown.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Shingrix for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in unknown arm. In 2018, the patient experienced pain in her injection arm which was resolved after a couple of nights. This case is linked with the case US2018146936 (case reported for 2nd dose).
This spontaneous report was received from a pharmacist, referring to a 71 year old female patient. The patient's concurrent conditions, pertinent medical history and  concomitant medications were not provided. The patient did not have any known drug allergies or reactions. On 05-SEP-2017 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular in the right arm lot # N012840 with expiration date on 20-JAN-2019) for prophylaxis. On the same date (reported as "that evening"), the patient experienced soreness at the injection site (injection site pain). The next day, on 06-SEP-2017, the patient developed swelling at the injection site (size of a grapefruit), injection site tenderness and injection site warmth. It was also reported that the patient thought she developed a kidney infection on an unspecified date after vaccination. No treatment was given for the adverse events and no laboratory tests were performed. On 07-SEP-2017, the patient sought medical attention by calling and spoking with the pharmacist regarding the events. The outcome of kidney infection, injection site warmth, injection site swelling and injection site pain was reported as not recovered. Upon internal review, kidney infection was considered medically significant.      The causal relationship between vaccination with PNEUMOVAX 23 and the events was not provided.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients in her facility received doses of ROTATEQ (strength, dose, route and lot number were not provided), that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses that were administered. This case is linked to cases 1309USA005768 and 1311USA012345 via same reporter link. Additional information has been requested.
Patient's daughter called pharmacy on behalf of her mother. Patient has been experiencing a red, raised, itchy rash that developed on the back of her neck and has spread across body including her hands. She recently ended up going to the emergency room where they prescribed steroids and she is also is taking Benadryl. She has been taking the medication for 2 days. She states that she started getting itchy about 3 weeks ago and thinks that it may be correlated to her 2nd dose of the Covid vaccine which was administered on 6/22/21.  Counseled on potential covid vaccine ADRs, timing, etc. They request that we report this to VAERS. Advised patient to follow up with physician.
Pt states, immediately after injection, her arm felt funny. Within 1 hour her arm was very sore and started swelling from shoulder to fingers. Also sore up to neck. She could not use her arm for 3 days; could not hold anything or carry a laundry basket. She still has a knot in the arm at site of injection. Did not consult doctor or seek medical attention elsewhere. Swelling is gone. Can use arm now.
Information has been received from a registered nurse (R.N.) concerning a 15 week old patient who on an unspecified date was vaccinated with a first dose of ROTATEQ (lot # not reported).  The patient sought an unspecified medical attention.  No adverse effects noted.  Additional information has been requested.
Patient presents to ER from EMS for SOB and confusion. Of note, patient's husband passed this morning. Troponins elevated. Chest xray shows edema and likely left lower infiltrate. Patient admitted and started on IV antibiotics, Lasix, aspirin, nitroglycerin, and albuterol nebulizers. Patient is currently still admitted.
01/07/2005 got immunizations, 1/05 felt warm, child won't let mom take her temp, 01/11/05 seen in office T98 pharyngitis.
Severe all over body pain/ache. Went to Emergency Room. Given fluids and pain med. IV. Went to PCP next day. Did blood work. SED rate very high. On prednisone for 3 weeks add'l blood showed elevated white blood count.
Stated her arm was purple; Stated her arm was red; Stated her arm was red, purple, swollen; Her entire body looked like road rash; This spontaneous case was reported by a consumer and describes the occurrence of PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Pain, Relapsing-remitting multiple sclerosis (Relapsing remitting multiple sclerosis), Gastroparesis, Depression and Anxiety. Concomitant products included OCRELIZUMAB (OCREVUS), BUPROPION HYDROCHLORIDE (WELLBUTRIN), BACLOFEN, DOCUSATE SODIUM (COLACE), LUBIPROSTONE (AMITIZA), OXYCODONE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), GABAPENTIN, SPIRONOLACTONE, DULOXETINE, ALPRAZOLAM (XANAX), BUPRENORPHINE HYDROCHLORIDE (BELBUCA), VITAMIN D NOS and ASCORBIC ACID, BIOTIN, TOCOPHERYL ACETATE (BIOTIN GUMMY) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash). At the time of the report, PIGMENTATION DISORDER (Stated her arm was purple), ERYTHEMA (Stated her arm was red), PERIPHERAL SWELLING (Stated her arm was red, purple, swollen) and RASH (Her entire body looked like road rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's concomitant medication included hair, skin and nails gummies with biotin.  Treatment information was not provided.
The Medical Assistant made an error. Instead of administering PCV13, she gave PPSV 23,  No adverse event or side effect occurred. The parent was notified. CDC was consulted.
Exactly one week after shot was given I woke up freezing, trembling and aching. Had high fever (almost reaching 104) on and off for a week. Extreme headache for a week. Severe body aches and pains. Very very sick.
Information has been received on 14-NOV-2016 from a registered nurse referring to multiple unspecified patients (ages and gender unknown). The patient's concurrent conditions, medical history and concomitant medications were not reported. The registered nurse reported that on unspecified dates, multiple unspecified patients may have received improperly stored doses of the following vaccines: GARDASIL 9 Lot # L040164 expiration 20-FEB-2018, L043214 expiration 30-AUG-2017, M016193 expiration 24-APR-2018, L036301 expiration 20-DEC-2017, M018810 28-MAY-2018, M031557 expiration 07-APR-2019, M030380 01-FEB-2019, L024993 17-OCT-2017, L048237 08-MAY-2017 and M018840 01-FEB-2018; GARDASIL also reported as HPV4, lot # K008931 expiration 14-MAR-2017; PNEUMOVAX 23 lot number M029680 expiration 17-JAN-2018, M022085 expiration 09-OCT-2017, L048265 expiration 10-JUN-2017, M006141 expiration 28-MAY-2017, and L027732 expiration 23-FEB-2017; RECOMBIVAX HB lot number M000442 expiration 31-MAR-2018, L048849 expiration 04-FEB-2018, and L039660 expiration 04-FEB-2018: ROTATEQ lot number M007307 30-NOV-2017, M019706 expiration 24-OCT-2017, M014318 expiration 30-SEP-2017, L048854 expiration 31-AUG-2017, L013193 expiration 20-JAN-2017 and M017574 expiration 07-NOV-2017. The vaccines were reported by a data logger at 32.4 degrees F for 2 hours with no previous excursions. No adverse effects were reported. Additional information was received on 15-NOV-2016 from a registered nurse. The nurse reported that the vaccines: GARDASIL 9, GARDASIL, PNEUMOVAX 23, RECOMBIVAX HB, and ROTATEQ were exposed to 32.4 degrees F for 4 hours (previously reported as 2 hours). No adverse effects reported. No further information was reported. Lot number M017574 is an invalid lot number for ROTATEQ. Additional information has been requested.
got the new double shot this year, I have shingles; shingles; burning feeling; nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (the patient had shingles shot several years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot several years ago. Then got the new double shot this year. 8 months later the patient had shingles on the side of foot.  The patient went to doctor after about 2 weeks as he/ she thought it was poison ivy until the burning feeling started. Turns out the burning feeling was nerve pain along the nerve running down the side of his/her foot to where the shingles was on the side of foot near toes.  The physician confirmed it was shingles and said thankfully the patient got the shot or patient most likely would have had a severe case.  The patient was shocked with his diagnosis as shingles was the last thing that would have ever crossed His/her mind because the patient had both the old vaccine and the 2 dose new vaccine. The patient stated that vaccines aren't 100% but offer much greater protection This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Patiet received expired rotorix today, and was called back immediatly and received non-expired dosage. This was discussed with mother
Received vaccination on 10/5/04. Mom called 10/7/04 stating that child's arm contained redness and swelling the size of an apple. His arm was also very tender and hot to touch. He came for a visit, was prescribed a 10 day Tx of antibiotics.
She got her vaccine, initially she had a sore arm.  The vaccine itself was much thicker than others so could feel it going in.  At 5:00 AM she woke up with shaking chills, and had to get extra blankets to put on her.  She tried to get up out of bed, and could not and actually urinated in her bed due to the weakness.  Then she spiked a fever of 103.2 and lives with a pharmacist who told her to take Tylenol, which she did and able to keep it down.  Her fever came down fairly quickly but stayed in bed the rest of the day due to being worn out.  The chills passed, and this reaction lasted for 24 hours.  She then did not have any other symptoms.  She has had 2 COVID shots for which she had the same reactions.
Fever, chills, headache, general malaise. Symptoms started on the evening of receiving the vaccine and have continued so far for 72hrs.
Pt received Covid 19 Pfizer vaccine and about 5 minutes after sitting pt stated was feeling very dizzy and was going to faint.  Pt was sweating and starting to black out, could answer my questions but did not see his wife who was standing infront of him and talking to him.  Pt was given a sip of water.  Paramedics were called and arrived within 5 minutes.  At  that time of their arrival pt started to feel better, his blood pressure was 110/70 mmHg.  He was able to walk out with paramedics.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot and throbbing spot at injection site) and VACCINATION SITE ERYTHEMA (red spot at injection site). On an unknown date, the patient experienced RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot and throbbing spot at injection site), RASH PAPULAR (red spots get bigger and bigger, like 5 inches by 3 inches now) and VACCINATION SITE ERYTHEMA (red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
I got the booster along with the flu shot and shingles booster and have been experiencing chest pressure .
L sided facial tingling after 2 days followed by L facial numbness for 2 days followed by L facial drooping at time of visit
This spontaneous case was initially received on 15-Oct-2015. The case report was received from a Health Professional and concerns a male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, the patient received expired AFLURIA vaccine from multidose vial (non serious, outcome: Unknown). Action taken: not provided. Event treatment: not provided. Rechallenge/Dechallenge information: not provided. For relevant test results see appropriate report section. Reporter's assessment: not provided.
Large raised red rash in deltoid area. Covering area 2.5 inches in width and 4 inches in length, Region is warm to touch and itches
Erythema, tenderness, "knot" to left deltoid. Worsening erythema spread to entire anterior of left upper arm.
Fever, chills, aches and nausea on first day unable to continue daily activities. Injection site swollen painful. Second day symptoms much improved.
On April 12, 2021 I had aches, chills, headache.  On April 13, 2021 I experienced a "tinny" sound in my left ear.  On April 15, 2021 I had a ringing "echo" sound in left ear.  On April 21, 2021 my hearing in my left ear was completely gone
No adverse event; Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient 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 07-Apr-2023, 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 07-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023) 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 WRONG PRODUCT ADMINISTERED (Patient received Bivalent booster as 1st dose instead of monovalent primary series on 04-07-2023).    Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
A week after vaccination, got swollen lymph nodes in left armpit, but eventually went away. 10 days after vaccination I broke out in a rash on the right side of my face and was diagnosed with Cellulitis. Was given Mupirocin Ointment and Hydrocortisone Cream. Had still started worsening over time. On March 1, 2023 was Bactrim and told to continue with Mupirocin Ointment and Hydrocortisone Cream as well. On March 2, 2023 started to get extreme swelling in my face and went to Urgent Care. Was advised to give the medications one more day, and if it didn't get better to go to the ER. The next morning everything worsened so went to the ER and was diagnosed with Shingles. Prescribed Clindamycin, Prednisone, and Valacyclovir. Because of the location on my Shingles, Doctor was concerned Ramsay Hunt Syndrome. Was also given a test for Shingles of the eye and it was negative. Initial rash is starting to improve, but it has spread to my scalp. Following up with my Primary Care Doctor because it hasn't completely gone away.
Muscle pain that continues even today, one month post injection. Unable to lay on my left arm and painful to raise left arm.
Hospitalized (9.27.21);  COVID-19 positive (9.24.21);  fully vaccinated  Admission Date: 9/27/2021 Discharge Date: 09/30/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Elevated INR [R79.1] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 70-year-old male with a history of severe pulmonary hypertension, chronic thromboembolic disease, chronic respiratory failure on 4-5 L NC at baseline, diastolic CHF, OSA on CPAP, atrial fibrillation and mitral valve replacement on Coumadin, and hypothyroidism who presented with worsening shortness of breath.  Approximately 1 week prior, he developed significant diarrhea, followed by a cough and shortness of breath.  He tested positive for COVID on 9/24.  He did receive his Moderna COVID vaccination in March 2021. Secondary to progressive weakness and shortness of breath, he presented to the emergency department.  He was hypotensive upon presentation, which improved with IV fluids.  Labs notable for acute kidney injury with creatinine 2.3 and elevated INR of 7.7. CT angio thorax showing significant interval worsening of diffuse scattered ground-glass and consolidative opacities.  Significant worsening of mediastinal and bilateral hilar lymphadenopathy, suspicious for neoplastic process given degree of enlargement, but possibly reactive. He was admitted for further care and placed on Decadron.  Home antihypertensives and diuretics held.  He was given a small amount of IV fluids with improvement in renal function to baseline CKD stage 3.  He was seen by pulmonology and started on remdesivir after renal function improved. Pulmonology to arrange close outpatient follow up for lymphadenopathy and infiltrates. INR did up-trend to >8 and coumadin was held. No bleeding reported and hemoglobin remained stable. Supplemental oyxgen weaned to 4L and patient was feeling back to baseline, vastly improved. Home torsemide, aldactone, sildenafil, and metoprolol resumed. PT/OT evaluated and recommended discharge home with HHC. Patient was instructed to quarantine until 10/3, 10 days from positive test given unclear exact start date of symptoms. Given severe underlying lung disease, will complete 10 day total course of decadron. He should have BMP checked within 1 week to monitor renal function while on diuretics. Flu shot to be provided prior to discharge.
Pain at injection site, muscular and joint pain and stiffness all over the same day. shivers, nausea, weakness, hot and cold sweats the next day, headache
expected post vaccine symptoms - fever, chills and aches and pain at injection site, all symptoms resolved x24hrs except arm pain  1/28 s/p Vax +4d, left arm felt tight, hot and very painful, was also swollen and red, full range of motion and pulses + but very painful and hot, throughout the day the redness was spreading down the upper arm to the lower portion
33 year old female was administered second dose of MMR II 1 day prior to the recommended scheduled time; This spontaneous report as received from an unspecified reporter refers to a 33 year old female patient, who was a student. The patient's concurrent conditions, medical history and concomitant medications were not reported.      On 23-SEP-2020, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S013683, expiry date 05-MAY-2021, therapy type rHA, (dose and route of administration unspecified). The dose was administered 1 day prior to the recommended scheduled time according to the vaccine label.
PATIENT'S REPRESENTATIVE REPORTS NAUSEA, VOMITTING, FATIGUE THAT BEGAN WITHIN 24 HOURS OF RECEIVING VACCINE DOSE.
Person was vaccinated for COVID in January 2021. Tested positive for COVID 5/21/21
Information has been received from a licensed practical nurse concerning a 20 month old female with no medical history or drug allergy who on 02-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 662201/1544X), SQ, 0.5ml. There was no concomitant medication. On 16-MAR-2009 the patient developed erythema and duration at the injection site of the left upper arm. The patient was examined in the office on 19-MAR-2009 and no treatment was prescribed. The patient did not have any lab diagnostics study performed. At time of the report the patient was recovering. Follow-up information has been received from the licensed practical nurse concerning the patient was vaccinated in the left arm. On 17-MAR-2009 morning (previous reported as 16-MAR-2009) the patient's skin at vaccine site developed 0.5cm induration, erythema and 2 papules. No further information is available. This is one of several reports received from the same source.
Severe headache, muscle pain, fatigue, high fever (over 101), stomach pain, nausea, diarreah, tingling sensation in tongue.