chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after the SHINGRIX, 01/11/2019, I felt tired and soreness of the injection site, which was expected. It was 6 days after the injection, 01/16/2019, that I developed a headache above my right eye, reddness at the base of my right nostril followed by swelling and redness of my right upper lip with pain along the upper right gumline and teeth, radiating to my right ear. It is currently painful, swollen and tender to the touch in all the above mentioned areas. I saw my dentist to rule out a dental issue an she diagnosed me with a viral infection, likely Herpes. I have been using over the counter ABREVA Cream (docosanol 10%) and KANKA softbrush antiseptic/astringent. My Oncologist Dr. will see me on 01/22/2019 if I am still having problems or worse.
HISTORY OF PRESENT ILLNESS: Patient is a 49-year-old male with hypertension, obesity, splenectomy and end-stage renal disease with IgA nephropathy who failed previous right-sided renal transplant, now second left-sided renal transplant on 08/24/2016.  He presented to Hospital on 12/24 with new onset COVID-19 infection, creatinine of 3.6 with baseline of 2, fever, sore throat, cough, evidence of bilateral infiltrates.  Apparently, he was there for approximately two weeks.  He did receive remdesivir and 14 days of baricitinib.  He was discharged home about 48 hours ago. He developed hypoxemia and presented back to the hospital.  Because of no ICU beds, he is now transferred to another hosptial.  He was given broad-spectrum antibiotics there, started on steroids.  He did receive a full course of dexamethasone at another hospital.  He is currently on Vapotherm with sats in the 90s.  He was transferred on BiPAP.  Renal Transplant service at Upstate advised that we could continue holding his immunosuppressants.  He is currently not in any distress.
Child received expired varicella vaccine (expired 06/22/2011) on 06/30/2011.
Some erythema with some nodularity beneath it that was mildly tender to palpation.
No adverse event; Patient received 2 doses of Bivalent booster, 1 in each arm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7163B and AS7163B) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm).    No concomitant medications was reported. It was reported that patient scheduled to receive bivalent booster and flu shot but inadvertently received 2 doses of bivalent booster 1 in each arm. No treatment drug details was reported.
8-9-06 Mother called and reported that during the night the child had started crying uncontrollably and noted some muscle twitching in her legs, no fever.  Mom contacted the ER and was told to give tylenol and motrin alternating, some diarrhea started this am and mom was going to see her family doctor.
Pt recv vax on 10/9/98; on same day pt exp whelps all over
Severe redness, and swelling of the whole thigh/leg area.  Painful to touch and leg is fevering/hot to touch.
A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Practice manager reported that they accidentally gave FLUMIST to a patient on 26-Nov-2013. The patient had not reported any symptoms. The outcome of the event of ACCIDENTALLY GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Patient felt HR elevating, then c/o headache, tachycardia.  Monitored closly (see sheet for V.S. etc.) Benadryl 25 mg. by mouth.  7:42 Stable, discharged at 07:42 to self.
Paralysis.  12/21/09 Hospital records, discharge summary received. Service dates 12/05/09 to 12/12/09. Assessment: Guillain-Barre syndrome. Thrombocytopenia.  Patient c/o that he awoke and could not walk. Legs weak, esp proximally. Fell. Can ambulate with support. Feet tingling. Mild dysmetria left. Reflexes decreased. IVIG Administration. Acute renal insufficiency. Depression. Anxiety. Carotid atherosclerosis, neck aneurysm left internal carotid.   12/18/09 ED records received. Service date 12/5/09. Additional information abstracted. Assessment: (R) leg weakness, possible stroke. Patient complains that legs are weak, gave out, layed down on floor and could not get up. Cardiomegaly.
received a Daptacel vaccine from a expired vial today/ no side effects; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case involves a 4 months old female patient who was vaccinated with 0.5 ml single second dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5180BA and expiry date: 06-Apr-2019) via intramuscular route in the left thigh on 15-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No side effects noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Possible irregularities in vaccine storage and handling; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling). On 17-Mar-2021, PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
12/30/20 pressure in neck (like someone cupping it), mild   12/31/20 myofacial fatigue, jaw fatigue/weakness making chewing difficult 1/2/21 numbness and tingling in hands, worse left. Global mild analgesia 1/3/21 paresthesias in hands and feet.  Legs weak, left worse than right. Severe myofacial fatigue. Headache. Malaise.  Severe neck pain 8/10, general body pain 5/10 1/4/21: lymphadenopathy left deep cervical chain. Significant, visible through skin, easily palpable. Other symptoms improved 50% 1/8/21 (today) lymphadenopathy ongoing and unchanged, still severe. Assessed by PCP, felt to be adverse event.    Still some paresthesia in hands, malaise.
6 hours after vaccine was given, fever, fatigue, chills, weakness, body aches and headache began.  Tylenol and rest were used. Lasted for 24 hours. Patient is starting to feel better today.
Patients daughter called on 6/29/21 to inform pharmacy that patient had passed away. It is unclear what patient passed away from as patients family did not leave that information with the floater pharmacist who was working.
I was awakened during my sleep night of 1st dose Pfizer with racing heart and fever. I went to the bathroom with diarrhea and racing heart. The next morning it happened again but now with a migraine that lasted 3 days despite taking Tylenol. On and off fevers lasted 3 days as well as extreme weakness and fatigue.  7 days post vaccine I developed a sore throat . Urgent care diagnosed it as severe strep infection and highly swollen lymph nodes and gave me antibiotics.  A few hours after taking the antibiotics I had massive diarrhea, racing heart, and legs began to buckle . I went to my local ER where I was given an IV and kept for EKGs and bloodwork.  I was released with a different antibiotics. Several months post vaccine my dysautonomia as well as hashimotos have all flared up, impacting my health and quality of life. My migraines frequency has also gotten worse since vaccine.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUET. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Pt had flu vaccine on 11/6, reports "it burned and stung more than normal." That evening felt very sore, thought it was her normal. low grade temp of 99. Since then has had daily burning pain, "like it shocks me." goes from clavicle downward and pulses where she got the vaccine. Has noticed a knot there. No redness. Now feels more pulsing in her nexplanon. No numbness in her finger tips but  has felt tingling down her arm. No chest pain or SOB. No breast pain beyond her normal with her cycles.   Has tried icy hot, rest, heat/cold. Works as a phlebotomist, does notice it while working but worse when waking up and when going to bed. Has made it more difficult to sleep
Patient was given FLUVIRIN, which is indicated for 4 or over. Patient was only 3 yr 10 months. Patient's mother was ok with it on notification and did not want child revaccinated. There were no adverse events. Patient's physician was made aware as well and stated they were ok with not revaccinating as well.
Narrative: Patient was administered COVID-19 vaccine. After being administered patient had trouble breathing and tongue swelling. After patient was administered epi-pen and given famotidine 20mg once, they were taken by EMS to hospital were they were not admitted.
Tested Covid -19 Positive; Tested Covid -19 Positive on 02Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Sep2021 14:15 (Lot number: EW0196) at the age of 54 years as dose 2, single and intramuscular, administered in arm left, administration date 17Aug2021 14:00 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Dairy" (unspecified if ongoing), notes: known allergies: Dairy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Nov2021 07:00, outcome "recovering", described as "Tested Covid -19 Positive"; COVID-19 (medically significant) with onset 30Nov2021 07:00, outcome "recovering", described as "Tested Covid -19 Positive on 02Dec2021". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (30Nov2021) positive, notes: Nasal Swab; sars-cov-2 test: (26Nov2021) positive, notes: Tested Covid -19; (02Dec2021) positive, notes: Tested Covid -19. Therapeutic measures were not taken as a result of vaccination failure, covid-19. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine.  No follow-up attempts are needed. No further information is expected.
Pain and swelling at the site of the injection Heachaches, low grade fever, and muscle aches
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. On 07-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
screamed for 3 days p/DTP; t103-104, fever; APAP given; loss of appetite; scream was high pitched & pt was aggressive hitting @ mom; did not see MD;
I got really gassy and it kind of messed up my bowel movement a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0153) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure abnormal" (ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; CETIRIZINE.  The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "I got really gassy and it kind of messed up my bowel movement a little bit". Therapeutic measures were taken as a result of bowel movement irregularity.  Additional information: The patient reported that she did her first shot (Covid 19 vaccine) on April 07th and from that one the only side effect, she had that she had that she got really gassy and it kind of messed up bowel movement a little bit, and that happened for like 3 days and then it was back to normal. Consumer stated that the patient had my allergy medicines.   No follow-up attempts are possible. No further information is expected.
None reported at the time.   Father lied about daughter's real DOB so she could receive the vaccine which is currently out of her age range and could not wait the 1 month until she turned 5.
Information has been received from a registered nurse concerning a 32 year old female with asthma and type I diabetes mellitus who in 11/05 was vaccianted subcutaneously with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). It was reported that the patient had been vaccinated with the first dose of Pneumococcal 23v polysaccharide vaccine. The registered nurse reported that the next day the patient developed a local reaction involving pain and difficulty moving her arm, which was diagnosed as cellulitis that required hospitalization and treatment with antibiotics. The patient sought medical attention. At the time of the report the patient was recovering. Additional information has been requested.
the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"; the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the waiting period for getting the Pfizer COVID-19 Vaccine second booster after finishing treatment with Paxlovid "a week ago, tomorrow"". The patient underwent the following laboratory tests and procedures: COVID-19: positive.  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, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who received vaccine IMOVAX RABIES. The patients past medical history, concomitant medication and family history were not provided. On 12-Nov-2018, the patient received a first dose 0.5ml of suspect RABIES (HDC) VACCINE lot number, expiry date not reported via intramuscular route in the right deltoid. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that patient was one day late for dose 2 in the series of 3 of IMOVAX vaccine. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
This spontaneous case was reported by a physician and describes the occurrence of SKIN IRRITATION (Skin irritation) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia since 16-Nov-2018. Concomitant products included IBRUTINIB (IMBRUVICA) from 16-Nov-2018 to an unknown date for Chronic lymphocytic leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (Skin irritation). At the time of the report, SKIN IRRITATION (Skin irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Shoulder pain; Itchy at injection site; Rash -across chest to face and eyes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), VACCINATION SITE PRURITUS (Itchy at injection site) and RASH (Rash -across chest to face and eyes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Surgery (Surgery to right arm).    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced RASH (Rash -across chest to face and eyes). On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, ARTHRALGIA (Shoulder pain), VACCINATION SITE PRURITUS (Itchy at injection site) and RASH (Rash -across chest to face and eyes) outcome was unknown. Not Provided          Concomitant product use included singular.  Treatment details included benadryl.
Wife states patient has had a headache/migraine every afternoon since the 2nd vaccine. Describes it as a "lingering" ache that does not go away but that worsens each afternoon. His Provider recommended Excedrin but only "eases" the pain and doesn't "take it away."
I am on hormonal birth control and do not get my period on it. I have been on the same medication for over 9 months with no period or spotting.  Right after the vaccine, in a matter of a couple of days, I developed heavy, dark spotting and other symptoms like cramping that I regularly associate with my menstrual cycle. It seems to me that the vaccine interacted somehow with my hormonal processes to cause this menstrual abnormality.
Information has been received from a nurse concerning a 13 year old female patient who in the last week of September 2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast), lot #658556/1060U. She received diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) at the same visit. The nurse reported that the patient fainted when she turned to put her chart in the container. The patient had been out for about 3 seconds and was unaware that she had passed out. The patient fainted around 4 p.m. and noted that she had eaten an afternoon snack before coming to the office. She recovered and "was fine before leaving the office". Additional information has been requested.
Pt reports that she has a cough and body aches, also chills.  She has a headache.  Her symptoms started today. She did have her 3rd COVID shot yesterday.  She does have asthma and used her albuteorl this morning, it did not seem to help.  She does think she is breathing heavy.  She does not have chest pain, no palpitations.  No fever today.  She is not sure if she is congested or has had runny nose. No sore throat, no ear pain, no nausea.  No vomiting, no diarrhea. No loss of taste or smell.