chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; Redness; Itching at the injection site; Rash in arm at the injection site; Big circle around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL and CALCIUM for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from the patient's husband and as well as the 75 year old female patient regarding herself. Patient's medical history was none, drug reactions/allergies were none. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX Refrigerated VIAL 19400 PFU (Lot number, expiry date, route and dose were not reported). Concomitant therapies included Cymbalta, lisinopril (manufacturer unknown), metoprolol, hydrochlorothiazide (manufacturer unknown) and alendronate sodium (manufacturer unknown). Around 30-SEP-2013, the patient experienced wooziness, muscle ache, joint ache, nausea and headache. The patient sought medical attention and has called the doctor and the doctor has prescribed Methylprednisolone, 4 mg oral tablets, taken as a "dose pack" over the course of 5 days. The patient's husband was refusing to administer this medication to himself and his wife due to the adverse events that were reported in the PI (package insert) of this specific medication. Lab Diagnostics Studies Performed was none. No treatment was taken. The patient had recovered from most of the symptoms but the joint and muscle pain was still present, although it seemed to be getting better with time. Approximately on an unknown date in 2013, the events wooziness, headache and nausea were recovered/resolved. The outcome of joint ache and muscle ache was reported as recovering/resolving. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # J014655 with expiration date 16-APR-2016, lot # K006682 with expiration date 17-DEC-2016, lot # K018180 with expiration date 17-SEP-2016, lot # K009505 with expiration date 07-FEB-2016 (adult); dose and route of administration were not reported). No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
have had the shingles several times and the shot hasn't helped me / suspected vaccination failure; have had the shingles several times and the shot hasn't helped me; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient was 17 years age when he/she 1st experienced this). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that there were side effects to shingles shots and they were not good. The patient had shingles several times and the shot did not help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B VAX.  TREATMENT:  PT COUNSELING.  DOSE #2 22Jan90 PT EXP PAIN AT SOI SIMILARLY.
Started with tingling and burning sensation in left arm and left leg, racing  heart rate, shortness of breath. Then got dizzy and felt like weight on chest. Finally felt like my throat was swelling up. Was given 2 benadryl right away and then 2 Prednisone about 5 minutes later.  Blood pressure was 178/91, heartrate was 83. My throat felt better by the time EMS arrived. At the ER I still felt very dizzy and very confused.  Blood pressure got down to 155/84.  Hospital took NO tests - gave me water then an IV fluids and sent me home.  Continued to have weight on chest through out the night.  Next day just slight heaviness but still short of breath.
Patient had had HA, Nausea, Muscle Ache. The vaccine was exspired, and wasn't realized until after it was administered.
right hand began to twitch and a couple days later, his left hand started twitching; a reddened area around the injection site; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who experienced right hand began to twitch and a couple days later, his left hand started twitching and a reddened area around the injection site, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  On 14-Dec-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6656KA) via unknown route in the right deltoid.  On 14-Dec-2019, the patient developed a non-serious a reddened area around the injection site (injection site erythema) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 23-Dec-2019, the patient developed a non-serious right hand began to twitch and a couple of days later, his left hand started twitching (muscle twitching) nine days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not reported.  Final diagnosis was a reddened area around the injection site and right hand began to twitch and a couple days later, his left hand started twitching.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for both the events.
This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 13 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R018143, expiry date: 25-JUN-2020) (dose and frequency were not reported) subcutaneously for prophylaxis. The VARIVAX was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1811USA002375:Original Case : 1811USA002232; US-009507513-1811USA002232:Original Case : 1811USA002232; US-009507513-1811USA002374:Original Case : 1811USA002232; US-009507513-1811USA002371:Original Case : 1811USA002232; US-009507513-1811USA002372:Original Case : 1811USA002232; US-009507513-1811USA005285:
Fatigue, increased urination, vomiting, thirsty. All symptoms presented 2 days after varicella vaccine administered. Diagnosed with Type 1 diabetes 3 days later. Med Rec rec'd 10/21/2005, additioanl symptoms were flatulence and ketouria. Discharge summary sttes ketoacidosis. msv
This spontaneous report as received from a healthcare worker - Certified Medical Assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored PNEUMOVAX 23, MMR II (Reference MARRS # 1510USA006844), RECOMBIVAX HB (reported by CMA as RECOMBIVAX) (Reference MARRS # 1510USA011361), and GARDASIL (reported by CMA as GARDASIL (HPV-4)) (Reference MARRS # 1510USA009473 (Lot #, expiration date were provided for this case). Lot numbers and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. on 15OCT2015, the healthcare worker - Certified medical assistant (CMA) called back to provide data as follows on administered dose: Patient (gender not reported, patient initials provided) received a dose of improperly stored PNEMOVAX 23 (Lot number 1005563 (as reported), expiration date 03NOV2016) on 12OCT2015. [Lot number 1005563 is an invalid lot number of PNEUMOVAX 23.] The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from the same source.
The Moderna COVID-19 vaccine was administered into the patient's left arm at 11:00 am on 03/04/21. Approximately 12 minutes after receiving the vaccine, the patient reported a "taste of medicine similar to cough syrup." The patient reported no other symptoms and was able to leave the pharmacy with no problems.
COVID toes - First injection was on 12/28/20. After the first injection the 2nd toe on her R foot was affected. My toes were tingling and slightly red at about the two week point post injection. She stated that she never actually had fluid filled blisters but it felt as if there were blisters there. The skin actually peeled off the toe after the first injection. I received the 2nd injection on 1/26/21 and again at the two week mark the toes again were more red than usual and more sensitive than usual and felt as if there were blisters there. The toes most affected after the second injection were left foot 4th and 5th toe and right foot 2nd & 4th toe. After a week, the discoloration & sensitivity resolved.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: Ew0196), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: Fk9893) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Breast cancer recovery in year 4" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: IRBESARTAN; LEVOTHYROXIN; LEVOFLOXACIN; METFORMIN; ACICLOVIR; ZYDUS received in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive, notes: Also COVID test was much more immediate in giving positive very dark lines. The 2 previous COVID test were very light lines; (15Aug2022) Positive, notes: Experienced rebound 4 days final paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for COVID 19 treatment included Paxlovid, Treatment start date 06Aug2022, Treatment stop date 11Aug2022, Lot number 00069-1085-30.
DRY COUGH; CHEST TIGHTNESS; PAIN AT INJECTION SITE; HEADACHE; BODY ACHES; SWEATS; FEVER; CHILLS; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included stopped birth control pill 30 days ago, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered, on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced sweats. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced dry cough. On 03-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 04-APR-2021, sweats, and chills, fatigue, and pain at injection site on 03-APR-2021, and had not recovered from dry cough, chest tightness, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
August 15th, I had post-nasal drip that worsened over the days. I got tested on 08/17/2021 and had body aches, developed a productive cough, and lost my taste and smell. I got my results back the same day for positive for COVID-19 as my symptoms worsened. I had a telehealth appointment with my physician and followed up with pulmonologist after testing negative to check in my condition and health. I was prescribed an Breo inhaler to still use as of today due to the productive cough I still have since my exposure to COVID-19.
Patient, 4 years old, was inadvertently given a 5-11yo Bivalent as the 3rd dose in the 6mo-4yo series.  He should have been given a 6mo-4yo bivalent.  The lot number was 1 digit off.  Patient without any complications and adverse reactions.  Physician spoke with family and notified of the error and discussed side effects to watch for.  Dose was given yesterday late afternoon.
About 7 min. after vaccine was given child states seeing black spots in vision and feeling lightheaded.  We had child lay down and rest w/feet up.
Patient expired approximately 24 hours after receiving Tdap vaccine. Patient experienced seizure like activity and cardiopulmonary arrest while on sports field.
Left forearm: Contact Dermatitis; Left Forearm: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of contact dermatitis in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix. On 2nd July 2019, 104 days after receiving Shingrix, the patient experienced contact dermatitis and vesicular rash. On an unknown date, the outcome of the contact dermatitis and vesicular rash were unknown.   It was unknown if the reporter considered the contact dermatitis and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The reporter gathered the patient information. The healthcare professional stated the patient received Shingrix on 20th March 2019, but report 2nd July rash that appears like contact dermatitis or Shingles.
My 16 year old daughter was given GARDASIL injection #1 on 9/24/08 along with MENACTRA and TdaP.  Immediately she was nauseated. One week later she developed a headache that would not go away for seven weeks. We went to a doctor after hours and received a shot of TORADOL which did not stop the pain, they began orders for MRI of the head. Two days later she almost passed out in the shower and was so weak she could not walk up the stairs at home. I took her to the ER where they did blood tests ruling out diabetes, mono, infection, virus etc. 11/5/08. They did a head CT which showed nothing. They gave IMITREX which made the headache worse. We were referred to a neurologist and would need an MRI which we could not get done because of insurance problems, but ultimately the neurologist eluded to problems with the HPV virus and that this should go away and did not need to get MRI. She spent seven weeks straight with a headache and weakness that is unparalleled. She missed a minimum of six days of school due to exhaustion and headache. During those seven weeks she had constant headache, weakness, severe lethargy, nausea and vomiting. She almost missed making her basketball team that she had been working out for every day of the months because she could not even function on the lowest level.  12/2/08 Reviewed ER medical records of 11/05/2008. FINAL DX: chronic HA & fatigue. Records reveal patient experienced HA x 6 weeks & had developed chills, nasal drainage, nausea, decreased appetite.  Had completed antibiotic course recently for sinusitis.  Had been seen in urgent care & referred to ER for MRI of brain.  Phone consult w/neuro who recommended CT scan instead & outpatient f/u.  12/5/08 Reviewed PCP & neuro medical records. FINAL DX: protracted HA related to immunizations or URI.   Records reveal patient experienced usual state of good health on day of vaccination.  Neuro consult done 11/18/08 for protracted HA.  Had HA, fatigue, intermittent weakness & nausea day starting day after vaccination.  Also experienced URI & rhinorrhea.  Neuro exam was WNL.
After administration of MENACTRO and BEXSERO, the patient had a pale complexion, felt dizzy and slid out of the chair she was sitting in. This author caught the patient before she fell on the floor and was able to put her back into a sitting position. The patient then lost vision in both eyes, but was breathing and able to answer commands. This author held the patient for about 5 minutes, until she was able to sit up by herself. A medical assistant did retrieve some water for the patient and provider was notified. The Provider came in and patient was able to answer her commands, however then experienced nausea and vomiting. Ice pack was applied to back of neck and patient put her head between her legs for an additional 5 minutes. Medical staff then moved her to the exam table where she was able to tell this author she could see again and could recall some events that had just transpired. Patient did stay on exam table for an additional 15 minutes, was examiner by provider and was able to ambulate out of office without difficulty, with her mother accompanying her.
Information has been received from a nurse practitioner concerning a male patient with acute lymphocyctic leukaemia who in 1996 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  Shortly after administration of the vaccine, the patient experienced achiness, a slight fever and a cough.  Subsequently, the patient recovered.  In 2001 the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine and had achiness again but more severe involving the entire side of the body where the vaccine was administered and petechiae on the injection arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.
Severe UTI - Was tired and nauseous starting May 18th.  Saw a doctor on May 21 when I had blood in the urine.  Gave me Levofloxacin and it seemed to clear it up.  June  24 I got a high fever of 101.5.  Went to Immediate Care and another UTI.  Due to the fact I started itching at the end of the last treatment, decided to try Myobic.  Had a fever for 4 more days and it finally it cleared up.
This case was reported by a consumer (subject) and described the occurrence of arm swelling (injection site) in a female subject aged between 50 and 59 years old who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included arthritis, high blood pressure and seasonal allergy. Concurrent medications included arthritis medication, DIOVAN and allergy medication. On an unspecified date the subject received unspecified dose of influenza vaccine (unknown details). The subject described this as "last year's vaccination." At an unspecified time after vaccination, the subject experienced flu-like symptoms. The subject described these symptoms as "slight flu symptoms" "after last year's [influenza] vaccination." On 2 December 2013 at 08:30 the subject received a dose of influenza vaccine (unknown, left arm). On 2 December 2013, less than a day after vaccination with influenza vaccine, the subject experienced arm swelling (injection site), body pain, hardness injection site, flu like symptoms, fever (described as "slight fever") and feeling tired. The subject reported that her "left arm is hard and puffy, and her left arm is swelling." The subject felt that her events were disabling. The subject did not know the manufacturer of the flu vaccine. At the time of reporting, the outcome of the event of flu-like symptoms following "last year's flu vaccine" was unknown. At the time of reporting the events were improved in 4 December 2013. The subject also reported that the symptoms were worse in 3 December 2013 "but have declined in severity today (4 December 2013)."
SYNCOPAL EPISODE, MOVED TO FLOOR, EYES OPEN, PALLOR, RESPONDED VERBALLY, COLD CLOTH TO FOREHEAD, BP 140/70, MAINTAINED SUPINE POSITION WITH LEGS ELEVATED APPROXIMATELY 10 MINUTES, COLOR IMPROVED, MOVED TO SITTING, DRANK JUICE, TALKING, LAUGHING WITH PARENT, MOVED TO SITTING IN CHAIR, MONITORED APPROXIMATELY 25-30 MINUTES, NO FURTHER ISSUES, WALKED TO CAR BY NURSE AND MOTHER