chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Moderna Monovalent Booster instead of the bivalent Booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent Booster).    No concomitant information was reported. Reporter stated this happened because the monovalent vaccine with the purple border was labled "booster doses". No adverse effects noted No treatment information was reported.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-APR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Right off the Shingrix website. All began 2 hours after injection.  Pain at in injection area, enough I could not lift my arm. Muscle pain through the right shoulder about 8 inches diameter from injection site. Fever 100.2 within 5 hours of injection. Shivering, it was 80 degrees out and I was overcome with shivering, I ran and but sweat on and through 2 blankets on top.  This happened 2 times 3 hours after injection and another 4 hours Later. Hot shower seemed to prevent shivers. They were incredible, worse than the club dive I did on a New Year's Day
severe arm pain; Tiredness; no energy; fever; chills; body aches; joint aches (hip and neck); not sleeping at night; arm swelled up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), INSOMNIA (not sleeping at night), PYREXIA (fever), CHILLS (chills) and PAIN (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), LISINOPRIL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 14-Jan-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2012, the patient experienced HEADACHE (Headache). On 15-Jan-2021, the patient experienced INSOMNIA (not sleeping at night). In January 2021, the patient experienced SWELLING (arm swelled up). On 16-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (body aches), ARTHRALGIA (joint aches (hip and neck)) and ASTHENIA (no energy). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 15-Jan-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, INSOMNIA (not sleeping at night), PYREXIA (fever), CHILLS (chills), PAIN (body aches), ARTHRALGIA (joint aches (hip and neck)), SWELLING (arm swelled up), PAIN IN EXTREMITY (severe arm pain), ASTHENIA (no energy) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 100.3 (Inconclusive) 100.3F.     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.
Itchiness and swelling on face with hives on back, arms, legs, difficulty with breathing given 0.15ml SC of epinephrine 1:1000, Orapred 215mg/tsp : 2 tsp given: better after 15 minutes .Went home.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
A few  days after my covid vaccine while I was watching tv I felt my face was tingling , I went to the bathroom to look in the mirror and I can see my lip swelling and cracking and it started bleeding. Blisters inside my mouth, from one side of my mouth to the other side of my mouth and pink. My mouth and throat felt swollen. My chin was blistered and my neck. At the top of my chest I broke out with large whelps and they burn and itch. I haven't slept in 2 days. It really bothers me. My mouth hurts. My head felt hot but didn't take my temp. All lasting a week.  Treatment: None still have stuff on the top of my chest, like whelps and my mouth, bottom lip still broken and cracked.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of GARDASIL (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K010574, expiration date 08-APR-2017 and lot # K011562, expiration date 08-APR-2017 - 31F or colder (23F) for 80 hours, 32F to 35F for 63 hours, 47F to 77F for 7 hours. The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008728: US-009507513-1707USA008729: US-009507513-1707USA008730: US-009507513-1707USA008731.
Information has been received from an approximately 42 year old female with egg allergy, macrolides allergy, allergy to "almost all antibiotics" and no pertinent medical history who, on an unspecified date as a child, was vaccinated with a dose of MMR II (lot #, expire date and route not reported). Concomitant therapy included estrogen patch and Z-PAK. On an unspecified date, the patient had Measles, Mumps, Rubella-titers-negative. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. She also reported having anaphylactic reaction and flushing while received propathol, cefalezin, ZEMURON, ANECTINE and fentanyl during surgery. Initially it was suppose to be an outpatient procedure but she was hospitalized for 3 days because of reaction. She also reported that her Adam's apple was extremely sore while taking Z-PAK. No further information is available.
Got mine in August and in the hospital with pneumonia; flu; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer (under reference number: US-SA-SAC20211012000320).  This case involves a patient with an unknown demographics who experienced serious events got mine in August and in the hospital with pneumonia (pneumonia) and flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, in the month of August, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious events got mine in august and in the hospital with pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  An unknown corrective treatment was received for the events.  At time of reporting, the outcome of events was reported as unknown.  It was unknown if patient's physician provided consent to be contacted.; Sender's Comments: This case involves a patient with an unknown demographics who experienced serious events pneumonia and influenza (unknown latency) after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown with the role of the vaccine. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of suspect vaccine cannot be assessed.
Patient state that she didn't feel well after the shot. She wanted to sit in the chair at the pharmacy versus standing. She walked over to the chair, sat down, within 5 minutes her husband alerted us that she had fainted and if the pharmacy staff could help her. Staff then proceeded to lay her down on the ground where a cooler was placed under her feet to keep them elevated, a cushion was placed under her head for comfort, and she was given a bottle of water when she became alert. She then rested for a few more minutes before getting up in her chair again. She then got in the chair after 10 minutes, waited another 20 minutes and then felt safe enough to go home afterwards.
Cough, congestion, night sweats, sore throat, 101 temp, it was really bad. I was out of work for a few weeks. Cough and congestion was persistent and last 2-3 weeks. I received Plaxovid prescribed by the ER and the zpack. I'm still tired than normally and my voice is still not the same. I am back to work now.
8 year old patient inadvertently received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2LG35, expiry date 09-MAY-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old patient inadvertently received a dose of Boostrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: Receipt Date: 22-AUG-2023 The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
05/18/2021 evening patient devleoped headache and pain  05/20 patient developed nausea  05/23 patient developed sore throat
started feeling very itchy around the shot area; some rash; a little area of redness; some soreness of my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness of my arm), PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (some soreness of my arm). On 28-Mar-2021, the patient experienced PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness). The patient was treated with ALOE VERA (ALOE 99) at an unspecified dose and frequency. On 22-Mar-2021, PAIN IN EXTREMITY (some soreness of my arm) outcome was unknown. At the time of the report, PRURITUS (started feeling very itchy around the shot area), RASH (some rash) and ERYTHEMA (a little area of redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications includes OTC vitamins.
pt recvd vax 20MAY93 & 22MAY93 exp tenderness in the liver region in the absence of nausea or vomiting; exp soreness & pain in the rt upper quad just beneath the distal end of the rib cage;
On 12/8/2020 I experienced severe fatigue. By 8:00pm I had a severe headache, the worst I've ever had and a 100 degree fever. In the middle of the night I had severe body aches, even my ear hurt while laying on the pillow. My muscle felt very tight and achy.  My arm was sore and swollen at the injection site. This continued throughout the whole next day (12/9/20). I was so fatigued I could do nothing but lay on the couch. My thinking was muddled. I was sweating from the fever. I had no appetite.  I slept 11 hours that night and could have slept more but I had to get up for work (I work from home). When I woke up at 6:30am all of my symptoms were milder and by noon my fever and headache were gone. By the end of the end, the body aches ended but the fatigue continued (milder that the day before).  As of right now, my arm is still sore and slightly swollen and I am still tired.
I started to experience a chest and head cold. I had very mild symptoms. Three days later, I went to the hospital because I had to do a prescreening for a procedure. I was given a COVID test, and it came back positive. I did take Nyquil to help me sleep. Two days after that I lost my taste and smell about a week later, I had my taste and smell back. I took a home test on 12/14/2021 and it came back negative. Within 10 days from the onset of symptoms I was back to normal.
Information has been received from a physician concerning a 12 weeks old female with no known drug allergies and born with vocal cord paralysis, hypotonia, laryngomalacia lung disorder (requiring tracheostomy) and malaise after placental exposure to GARDASIL (WAES080USA01055) who on 10-Jun-2008 was vaccinated with the first dose of RECOMBIVAX HB and on 17-Aug-2008 was vaccinated with the second dose of RECOMBIVAX HB. Other vaccination included Polio, DTaP, PREVNAR and Hib conj vaccine (unspecified carrier). On 10-Sep-2008, the patient presented for a scheduled 3 month visit. The patient had severe laryngomalacia and a tracheostomy with a trach tube in place. The patient was on PREVACID twice a day and REGLAN three times a day. The patient's vocal cord paralysis was closely being followed by his ear, nose and throat (ENT) physician. The patient had feeding difficulties and mismanagement. The patient was currently on 24 Kcal carnation and was taking oral feeds well per his mother. A follow-up appointment was scheduled in October with the feeding clinic. The patient also had anemia and was on an iron supplement. On 15-Oct-2008, the patient presented for a scheduled 4 month visit. The patient had a gross motor delay. Respiratory pattern was unremarkable and had a trach in place. The patient had a significant head lag and slightly increased tone in his lower extremities. The patient's vocal cord paralysis was continued closely followed by his ENT physician. The physician advised the patient's mother to mismanagement. An early intervention plan (EIP) evaluation was scheduled on 21-Oct-2008 for gross motor delay. The patient continued to take SYNAGIS, PREVACID and REGLAN. The patient's symptoms persisted. Additional information has been requested. All available medical records will be provided upon request. All available medical records will be provided upon request.
COVID 19; COVID 19; 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 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol"; "blood pressure". Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).
First felt a hot electrical shock run down arm to finger tips approximately 2-5 minutes after the shot was completed, then arm became painful and by night numb and hard to lift. Later that night hives and itching at site, the next day started to be able to use arm again, day 3 painful arm and some redness/itching on upper arm.
Mom reported brief seizure with full recovery and normal exam in ER. Mom reports brief seizure s/p 4 mos immunization.
chest pain on left side; shortness of breath; left shoulder pain; showed a pulmonary embolism in my left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172), via an unspecified route of administration at the age of 30-year-old administered in arm left on 01Sep2021 13:00 at single dose for covid-19 immunisation. Medical history included crohn's disease. There was no covid prior vaccination and no known allergies. Concomitant medications included mesalazine (LIALDA); mercaptopurine in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) at the age of 30-year-old administered in arm left on 11Aug2021,01:00 PM for covid-19 immunisation. Woke up at 3am 08Sep2021 with chest pain on left side, shortness of breath and left shoulder pain. Went to (name) ER in (place name), a CT scan showed a pulmonary embolism in her left lung. She was admitted to hospital and put on blood thinners and pain meds. The events were resulted in Emergency room/department or urgent care and hospitalization. Days hospitalization was reported as one. The patient underwent lab tests included Nasal Swab: negative on 08Sep2021. The patient was treatment with Heparin, Morphine, Fetanol, Torodol. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Increased swelling and erythema of L thigh x 2 days DTaP given in that site 4 days ago. Given Keflex 250mg/5cc po bid x 10 days.
On march or April I had blood work done and everything was fine. I went to my regular trimonthly check up on 08/06/2021 and I had blood work done. I had an appointment on 08/17/2021 to discuss the results. My potassium was in range. My vitamin D was surprisingly low, which is weird since I take that daily. Everything is so out of range of how it used to be. My uric acid was very high, so he put me on a new medication. My A1C was the highest it has ever been and I have not done anything different besides the vaccine. I was diagnosed with arthritis 3-4 years ago and it bothers me only when the weather changes. Now I have joint pain very often. I only took Ibuprofen. Even with taking the extra vitamin D and multi vitamin I still have vitamin D deficiency.
Information has been received from a nurse practitioner concerning a 13 year old female who on an unknown dates was vaccinated with the three doses of GARDASIL. It was reported by the nurse that the patient developed reaction after each of the doses. On an unknown date, after the first dose the patient developed small rash at the injection site. On an unknown date, after the second dose, the patient developed a "bigger" reaction at the injection site. On an unknown date, after the third dose, the patient developed hives all over her body. The patient was given medication for the reaction. The patient was see by an allergist who determined that the reaction was due to the vaccine. On an unknown date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Initial event  7/6/2021   - Dizzy, nausea, couldn't catch breath, ssweaty, clammy, pale, increased heart rate Continued to have shortness of breath / easily winded.   PCP visit    7/29/2021   - had planned on discussing shortness of breath, while waiting to go into the appointment noticed along with a tightness in L leg- there was considerable swelling in calf.             PCP's reaction was immediate referral to ER.       With CT scan, ultrasound and thorough eval including bloodwork  was Dx  DVT w/ PE in both lungs.      Apixaban Prescribed and is currently still taking this.
Lump in thigh, temp 101 for 2 days. Follow up: left thigh uninvolved.  REaction reported weeks later.  No prescription.
red rash which covered face & neck then progressed to skin folds; rash was itchy; next day fever began & cont to inc; pt taken to hosp; t103.3 given DPH & Amoxicillin & sent home; next morning convuls; also devel blister-skin began to peel;
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Bloom consulted with the Dept and did not recommend repeating this dose in question. No ill effect post administration was reported.