chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/9/21 the patient reported to Fire Department headquarters for the COVID-19 booster that was being offered to public safety members of the city. The patient is a firefighter-paramedic, and had his first two doses of the Moderna vaccine on 1/8/21 and 2/18/21 respectively, with mild to moderate reactions of aches, fatigue, and low-grade fever. Patient received the Moderna booster by a clinician contracted via the city on the left arm. A slight soreness and fatigue/aches were reported hours after the injection, but quickly resolved by the next day. No other symptoms or adverse reactions were reported.  On 12/19/2021, patient was at work performing normal duties while wearing full protective PPE on all medical and fire-related calls. At 0130 AM, patient stated he had a sudden onset of itchiness and widespread urticaria around the hips, groin, anterior chest, and posterior neck. He did not report any new detergents, foods, medications, creams, and had not been in any new environments that could cause the reaction. The urticaria was mitigated with lotion and antihistamines, but would return 12 hours later in different locations of the body. Symptoms continued when he returned home, and increased in frequency and itchiness over the next 24 hours. On 12/20/2021, patient sought medical care by contacting his EMS coordinator, to be seen by a physician. He was prescribed oral Medrol pack to be taken for the next 6 days.
very sick; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case received from digital media in via a consumer.  This case involves an unknown age patient who was very sick (Illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient very sick (Illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  The outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 07-SEP-2016. Patients' identifiers and dates of vaccination were unavailable at the time of the call. The nurse reported that there was no patient who had reported issues following GARDASIL 9 administration. This report refers to a patient of unknown age and gender who on 27-JUN-2016 was incorrectly stored dose of Hepatitis B Vaccine (Recombinant) Lot#M006708 or M006708, maximum temperature excursion 22.7C for 3 h 48min, minimum temperature excursion 0.2C for 7 h 36 min. Additional information has been requested.
ACHY; FEELING WEAK; CHILLS; HEADACHE; FEVER; NAUSEA; RAPID HEARTBEAT OF 120; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported and has been requested) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced rapid heart rate. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 92. On 13-MAR-2021, the subject experienced achy. On 13-MAR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate, chills, headache, fever, and nausea on 13-MAR-2021, and achy, and feeling weak on MAR-2021. This report was non-serious.
his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 09:41 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (51-years-old at the time of vaccination). The patient medical history was not reported. Concomitant medication included ubidecarenone (COQ-10) taken for an unspecified indication. Patient had no prior vaccination. No family history of itchy hands and legs. The patient previously took first dose of BNT162B2 on 15May2021 (Age-51-year-old) (Batch/Lot Number: ER8733) for covid-19 immunisation with no reaction (No events reported). Consumer stated, he had second shot Pfizer Covid vaccine on 05Jun2021 and when he woke up that morning his hands and feet and legs were just itching and burning all day almost in jun2021 (About two days, 14Jun2021 (not clarified)).Consumer was informed about Pfizer Medical Information department. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Swelling, redness and warmth to touch that started 'a few hours after the injection'. Patient came in to the clinic 2 days later due to symptoms not better. DepoMedrol 80mg and Decadron 6mg given IM.
The barrel seperated from the hub and needle when the shot was administered. This resulted in an unknown amount getting into patient and liquid squirting onto her leg and arm.  I have talked to the administer of the shot, and Health Department. Since an undetermined amount was administered we followed CDC guidelines and got another shot in her opposite arm.  I was told this was equipment error and I feel it needs to be reported and investigated if this type of syringe that comes in two pieces needs to  be modified or stopped if there is equipment error.
Tingling in mouth, itchiness all over. Next several days, itchiness, hives over full body, pinpoint red dots on skin all over, tingling in mouth. Arm pain, headaches, body aches, swollen lymph nodes in right armpit, fatigue. Heavier periods since first Covid 19 vaccine dose in April.
Knee and foot pain; Knee and foot pain; Noticeable stiffness; Loss of balance; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 19Mar2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, Chronic Obstructive Pulmonary Disease (COPD) and prostate cancer. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), febuxostat (ULORIC), montelukast (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 26Feb2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021, the patient experienced knee and foot pain, noticeable stiffness, loss of balance and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events knee and foot pain, noticeable stiffness, loss of balance and dizziness were not resolved at the time of this report.
I administered the vaccine to Jake and he sat down. About two minutes later, he slumped in his chair. My manager rushed to catch him from falling and I assisted in steadying him. He was breathing erratically, excessively diaphoretic, and his muscles were twitching frequently. His eyes were dilated and he became unresponsive. Fearing a seizure, we lowered him to the floor and turned him on his side. He became responsive and coherent again approximately one minute later and was speaking to us normally. Paramedics arrived several minutes later and took over care. He was taken to the hospital due to abnormal vital signs.
No additional adverse event reported; Healthcare provider is reporting a 2 week old female patient was administered ROTATEQ on 20FEB2023. Caller is inquiring on the possible adverse events associated with off label use of product. No further information provided.  No additional AE report; This spontaneous report was received from a Medical Assistant referred to a 2 week old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 20-FEB-2023, the patient was vaccinated with her first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1879875 expiration date 19-NOV-2023, once, oral, (strength was not provided), for prophylaxis (Off label use in unapproved age group). The reporter was inquiring on the possible adverse events associated with off label use, however it was reported that no additional adverse event reported, at the time of reporting.
5 minutes after receiving vaccine patient "zoned out" and felt like he could not move.  Looked like he was on the verge of fainting or blacking out but never lost consciousness.  Patient was sweating after as if he fainted or had a panic attack.  This event only lasted 1 minute and patient denied an ambulance.
fever; chills; ACHY; lethargic 6-36 hours after injection; This case was reported by a consumer via sales rep and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced fever, chills, pain and lethargy. On an unknown date, the outcome of the fever, chills, pain and lethargy were recovered/resolved.   The reporter considered the fever, chills, pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 2nd dose of Shingrix. The patient had chills, achy and lethargic 6-36 hours after vaccination. The patient also developed fever at approximately 18 hours post vaccination. All symptoms were resolved within 48 hours. The patient did not felt the need to follow-up with physician. The reporter felt that symptoms were definitely related to the injection. The reporter consent to follow up.
Bruising; This is a spontaneous report from a contactable other health care professional (patient).  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EU0168 and expiration date: not reported), via intramuscular, in Left Deltoid, on 10Aug2021 (at the age of 36-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  The patient experienced bruising on 10Aug2021. No treatment was received for the adverse event. The outcome of event was not recovered at time of report.; Sender's Comments: The event of bruising is assessed as possibly related to the suspect vaccine Comirnaty based on strong temporal association "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Patient received vaccine PREVNAR 13 on 04-19-10.  Within 24 hours patient developed mild swelling and erythema over left thigh below injection site.  Mild tenderness.
Patient is a 4  y.o. 11  m.o. male who presents with left thigh redness and swelling after getting the DTAP/Polio vaccine on 8/21/14. The area is warm to touch. He is not complaining of pain. Mom noticed the swelling on 8/22/14. She has given him ibuprofen once. She has been putting ice on it around the clock. No fever. Bactroban given.
he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered.   Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received SHINGRIX. Concurrent medical conditions included fibromyalgia (past 30 years) and systemic lupus erythematous. On 22nd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was recently been diagnosed with Systemic lupus erythematosus (SLE). The patient's arm at the injection site was very swollen, hot and red. It was spreading down and around the area. The patient had very sore and tight muscles. The patient was asking how long do these side effects typically last. She asked her booster shot (the 2nd one) going to be the same for her. The patient wanted to know anything she could do to make it not so bad. Besides, taking ibuprofen a couple of hours before she goes on appointment day.
Extreme pain in middle right of back located near Liver, Kidney, and Gall Bladder during any movement. Only discomfort when still.
p/vax pt devel an inj site rxn characterized by erythema, swelling, tenderness & warmth extending to the elbow;pt recovered;
The first night I had itching down my left arm and palm of my hands, my wrist. Then my hands swelled up quite large. It lasted about 3-4 hours and then completely went away. The following day, the same thing happened but this time it was both hands around midday. I had some pain, but it was not severe. This lasted 3-4 hours again and went away. The next day, both my armpits swelled up profusely and itched. I had light itching on both arms and swelling again. On my back, the pain shot down my back and in my left hip. The pain was not extreme, it was just uncomfortable. This lasted a few hours and went away as usual. About 24 hours and nothing happened. Then my left hand and palm started itching lightly. My tongue and mouth began itching and swelling profusely to a point where i couldn't eat anything. The next day, my heels started itching on both feet and my toes swelled up. I saw my doctor who provided me steroids. They lasted 5 days and I had no symptoms while on the steroids. When the steroids ended, my throat started to swell and my mouth as well. It got a little difficult to breathe but by the time I got ready to go to the ER it had subsided. This was accompanied by lite swelling and itching in my left hand. The same symptoms keep occurring. I went to an allergist/immunization specialist. I am now on my 3rd run of steroids. As soon I am off the steroids, my symptoms return. I have also been on antihistamines which seemed to help a little in conjunction with the steroids. Without the steroids, they do not help.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-396216, MOD-2021-396194 (Patient Link).
Expired Hiberix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received Hib (Hiberix) (batch number 42EM3, expiry date 7th January 2023) for prophylaxis.   On 10th January 2023, the patient received the 2nd dose of Hiberix. On 10th January 2023, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 10-JAN-2023 Reporter's comment: At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was administered an expired Hiberix dose, which led to expired vaccine used.
sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore muscles). At the time of the report, MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consumer took a Tylenol before getting her first dose of the vaccine, because she is old and gets sore muscles. Treatment information was not provided.      As per client, MI error in DOB capture
Pt presented with pink tinge cough/ chest congestion, hypoxic; CT with Covid PNA pattern, Covid test neg; but treated as Covid based on CT result and symptoms; Did not require COVID specific therapy as he did not require supplemental O2; Did receive supportive care and p.r.n. meds ; rec'd decadron, rocephin, Vit C, and zinc
Information has been received from a physician concerning a 12 month old male with no medical history or no drug allergies who was vaccinated with a dose of VARIVAX (Merck) (lot # 660084/0333X). Five days after vaccination, the patient developed vaccine related chicken pox. The patient had no fever but had a lot of vesicles. The patient was seen in the office and had a lot of vesicles. The patient was seen in office and physician suggested to treat the patient with over the counter BENADRYL. On an unspecified date, the patient recovered from vaccine related chicken pox. No product quality complaint was involved. The reporter felt that chicken pox was related to therapy with VARIVAX (Merck). Additional information has been requested.
HA, Itching all over, Rash (shingles like around neck), Itching ears, Swollen legs, Shortness of Breath
Since shot, I had respiratory symptoms that were management, aches. On 10/23/2013, I began to vomit. My eyes started to swell--and were completely swollen shut, oozing out liquid. My nose also swelled three times it's size and I could not breathe. I slept until 10/25/2013 when I was taken by ambulance to the ER and administered by IV saline, prednisone and Benadryl. I have had 16 flu shots annually. First time one that I've had the facial and eye swelling. It was very frightening to me and my family.
lymph node swelling under arm of side that had received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node swelling under arm of side that had received the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node swelling under arm of side that had received the vaccine). At the time of the report, LYMPHADENOPATHY (lymph node swelling under arm of side that had received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.