chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients' who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, second patient in 2010-04836, third patient in 2010-04837 and fourth patient in 2010-04838. Initial report received from a health care professional on 07 September 2010. A 46-year-old female patient received on 04 August 2010 an injection (route and site not provided) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed severe fever of 103+ (fever lasted for 3 days), chills, arm at injection site bruised and a red, painful, swollen and sore arm. The arm soreness and swelling lasted for 10 days. The outcome was reported as recovered. Documents held by sender: None.
1st 36 hrs slept only @ 1/2 hrs intervals; Saturday PM began high pitched screaming lasting 1 hr; 1215PM taken to ER began vomiting; around MN would clench fists & stiffened; t102 R;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 4:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 4:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported as (Privacy). Concomitant medications were not provided. Patient received booster dose and vaccination time was given as 16:05:58. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment medications were not reported.
I've had COVID-19 three other times. This variant hits hard and fast. I had a really bad sore throat and pharyngitis for 2 days, severe body aches for 2 days, sneezing, a lot of drainage, within 24 hours I had shortness of breadthening and tightness in my bronchial tubes and fever. That night I couldn't breathe and I called my Dr. The next day I had a video call with my Dr. and got on PAXLOVID from Nov 1st for the full course. I got better every day, had the fever and aches for a few days. After completing it I was great. On the 8th day after PAXLOVID I had rebound and got really really sick. Sore throat worse than original and was testing positive. I had terrible drainage, worst sneezing and blowing my nose, lung congestion. I'm feeling better today, each day getting better. Now it's morphed into sinus. And I'm still coughing up infection.
She woke up in the middle of the night, and she was so sick; fever of 102; Headache; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) on an unspecified date for COVID-19 immunisation. The patient woke up in the middle of the night and she was so sick; she had fever of 102 (unit not reported); headache; chills; sweats; on 09Feb2021. The patient took Tylenol for the fever. The outcome of even fever was not recovered; while outcome for events she was so sick, headache, chills, and sweats was unknown. The patient was asking if she was contagious. She lived with her son who was immunosuppressed.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/1/2021 and 3/5/2021. Patient presented to ED on 8/26/2021 with shortness of breath, after a diagnosis of COVID-19 the day prior.  Patient also has had nausea, diarhhea, diffuse muscle aches and fever as high as 101. UTI noted and patient was discharged from ED with Bactrim. Patient returned to ED on 8/31/2021 with complaints of fever, back pain, and O2 sats of 88% subsequently admitted with diagnosis of COVID-19, E. coli UTI, Severe sepsis with organ dysfunction. Patient started on ceftriaxone, remdesivir, and steroids. Blood cultures positive for staph epi 2/2 sets and started on vancomycin. Cultures cleared with patient placed on Vancomycin. Patient ultimately required high O2 requirement on HFNC. She showed some improvements but declined and 9/10 repeat CT chest showed: persistent infiltrates, worsened fibrotic changes and traction bronchiectasis compared to 1.5 weeks ago. She also was noted to have a positive fungitell. She eventually progressed to BiPAP. Pallitiave care was consulted and patient's MPOA, transitioned to DNR/AND on 9/15. Comfort care initiated with the assistance of palliative care physician.
pain between legs; pain between legs, hip; back pain lower left side.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history included old injuries. Concomitant medications were not reported. The patient experienced pain between legs, hip and back pain lower left side. Patient was still experiencing it after 1 week. It was asked if it was known that old injuries could make symptoms worse. The patient had not recovered from the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt c/o swollen face and hands  later the same day followed by a red, bumpy, itchy rash on arms, legs, and trunk.
Onset: within 24 hours - very large bruise. Bruises, discolored, achy, hot, with a hard lump under the skin. Bruise is slowly resolving w/o treatment. Arm swollen: bruise 3" in diameter day 1 then 5" by day 2.
Since receiving the first COVID-19 vaccine I experienced occasional ringing in my ears.  (Tinnitus)  After the second vaccine it has become louder and almost constant.
pt stated that she started having a headache a few days after the imz, and it has continued. she did not take anything for it. it could be due to her ongoing allergies/ sinus/ ear issues. i suggested she try ibuprofen and a 1 a day antihistamine to see if it would help.
Redness, swelling, pain over 2/3 Lt upper arm, some blistering small area.
Nausea; Chills; Blurry brain; When the needle got in, she felt warmth in her body; Felt pressure in her head; Left side of the face got numb; Felt lightheadedness/dizziness; Her nervous system started tingling; Redness at the hand; Headaches; severe allergic reactions, including anaphylaxis; Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included diabetes type 2. Concomitant medications were not reported. It was reported that, "severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials." She received the first dose of the vaccine on 19Apr2021. She was due for the second dose on 10May2021. She says she had a severe allergic reaction after the first dose on an unspecified date in 2021. When the needle got in, she felt warmth in her body on 19Apr2021. After the shot, she felt pressure in her head, her left side of the face got numb, she felt lightheadedness/dizziness, her nervous system started tingling on 19Apr2021. She stayed at the vaccination site 1 hour until they told her it was ok to go. She added that she had redness at the hand on 19Apr2021. The next day (20Apr2021), she had nausea, chills, blurry brain. She says she's still getting headaches/dizziness on an unspecified date in 2021. Enquired what was the efficacy after one dose. Referred to her healthcare professional. Enquired how many severe allergic reactions were reported. Response: No specific numbers found. Enquired should she get the second dose or not. The outcome of the events headache, dizziness was not recovered and unknown for the other events.  Information on the lot/batch number has been requested.
slight headache; A spontaneous report was received from a non-health professional concerning a male consumer who received Moderna's COVID-19 vaccine and developed a slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:  unknown) for prophylaxis of COVID-19 infection.     The patient received the vaccine and developed a slight headache for the remainder of the day. He reported no further adverse reactions and felt fine overall. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, a slight headache, was not provided.; Reporter's Comments: This case concerns a male of unknown age who experienced NS expected event of headache.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome known. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
second dose one month apart from first; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 9-year-old male patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 28th August 2021, the patient received the 2nd dose of Havrix. On 28th August 2021, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Nurse Practitioner reported that the patient had received a Havrix second dose one month apart from first dose, which led to shortening of the vaccine schedule. The reporter consented to follow up via email.
General soreness at the injection site for 48 hours.  4 days later left arm (injection) swelling of armpit lymph node.  And later entire arm.  Very painful, tender, sore and with restricted movement.  Home medical visit Sat and Monday with Doctor.  Ice/heat, liquids, Ibuprofen compression sleeve and elevation
Left hip fracture -post left hip gamma nail, discharged from hospital and then ED visit 12 days later for left leg swelling. Patient has evidence of extensive thrombosis extending from the left common iliac vein to peroneal veins of mid calf. Order for interventional radiology thrombectomy of the left leg, Order for interventional radiology thrombectomy of the left leg. Hospital admission and ED visit were both within 6 weeks of receiving the COVID vaccine.
Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid) 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 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 COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest COVID-19, after receiving the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined as the date of vaccination and the date of the event were not provided. The outcome of the event was unknown at the time of the report and no details regarding the symptoms of COVID-19 infection, as well as regarding the clinical course of the events was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest COVID-19, after receiving the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined as the date of vaccination and the date of the event were not provided. The outcome of the event was unknown at the time of the report and no details regarding the symptoms of COVID-19 infection, as well as regarding the clinical course of the events was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a health worker referred to unspecified number of patients of unknown ages and genders. The healthcare worker stated an unspecified number of patients were vaccinated with GARDASIL (lot# 672232/1495AA, exp date 22-AUG-2014), injection, (dose, frequency, route and indication unspecified) between April 2013 and December 2013 with doses that reached 29F for 7 days. Healthcare worker stated no patient records or details available. No adverse effects reported. Additional information has been requested.
Chills, Migraine, aches, Feels like I have a fever, but don't.
Funny taste in mouth; Dizziness; Eyes hurt; Knee gave out; Cant stand up; Blood pressure was high at175/high blood pressure of 175; Chest pain; Shortness of breath; Shaking; Blurry vison; Fatigue; Pain in left shoulder/knee is sore; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out) and DYSSTASIA (Cant stand up) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, PROPRANOLOL, LORATADINE (CLARITIN [LORATADINE]) and COLCHICINE for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Red raised rash developed beneath injection site.  Swelling, warm to touch and very itchy.   First appeared 8 days after injection. Had video visit on 1/27 because rash & swelling getting worse. She said that this reaction has been reported and rash should resolve in several days.  OK to apply a little hydrocortisone cream to help with itching and discomfort.
Seen at urgent care on 10/9./15. Fever (99.2 with TYLENOL) aches, no cough, congestion or respiratory problems. Advised to continue with TYLENOL for fever and aches. Drink plenty of fluids and cool baths to control temp. Stated fever up to 103.7 at home.
Fever of 102.5 orally. Rash started on trunks to lower legs. Mother pointed to the Measles poster and indicated that type of rash. No URI symptoms and no nausea and vomiting. Fever was treated for 2 days with Advil. After wards the rash is almost gone but has a few areas in back of legs and trunk.
Site: Swelling at Injection Site-Mild, Systemic: Other- induration around injection site
Mom noticed adverse events on 3/16/06 at approximately 8 am. Left arm was warm to touch, red and swollen from shoulder to elbow. Mom called pediatrician and per pediatrician, Mom gave son Tylenol and an ice pack to put on his arm. At noon on 3/16/06 redness and swelling have decreased. Arm still warm to touch.
On second day after the injection an itchy rash without heat appeared and flared up the next day (the third day), and the fourth day it started to subside and resolve.
On January 2nd I woke up with a fever, chills, bad cough, body aches, night sweats, diarrhea, and vomiting. On January 7th I got a X RAY and they confirmed that I had pneumonia and they provided a z pack(antibiotics). After two to three days later I started to fell better and back to my normal self.
Initial case received from a healthcare professional on 13 February 2012. A 28-year-old female patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number not reported, on 19 January 2012. The patient had no medical history and had no illnesses at the time of vaccination. Adverse event following prior vaccination in patient was unknown. The patient took concomitant medications: TREXIMET and XANAX. One week after vaccination, the patient was seen in the office for symptoms of ear pressure, fatigue and intermittent dizziness. The patient had an Magnetic Resonance Imaging (MRI), which was reported as negative. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 15 March 2012. The sanofi pasteur Ltd. lot number of ADACEL was C4063 (sanofi pasteur Inc. lot number U4308BA). No treatment was prescribed. No other additional information was available at the time of the report. The patient's outcome remained not recovered. Documents held by sender: None.
Approximately 12 hours after injection, Pt spiked a high fever, chills and vomiting. By 9:00am he collapsed and had two seizures. He was administered Tylenol and Ibuprofen
Received flu shot Sanofi Pasteur FLUZONE vaccine Lot # U3784AA on 11-22-10 (L) Delt called our office 11-26-10 with complaint increased ringing in ears, vertigo, and nausea - stated vertigo resolved - but ringing in ears and pressure remain.
My son had his shots and then had a fever.  I was giving him alternating tylenol and ibuprofen.  Then his fever went up to 104 degrees under the arm the next day.  Then I called his pediatrician and she said to just keep giving him medicine.  So, it was time to give him ibuprofen, but this time he threw it up.  I put him on the floor so he could rest.  Then his eyes rolled all the way to the side of his face.  And he was breathing very shallowly.  I called 911.  His arms were jerking.  It lasted about five minutes.  Then the paramedics arrived and gave him an iv and took him to the hospital.  He was diagnosed with a high fever and a febrile seizure and the doctor said he would have to have a follow up visit but he was ok and released him.
COULD NOT WALK; COULD NOT STAND UP; CAUGHT A FLU OR A COLD; BAD REACTION/REACTION TO VACCINATION; EXTREME PAIN IN SPINE/BURNING SENSATION IN SPINE; LUNG HURTS/ BURNING SENSATION IN LUNG; COULD NOT DO ANYTHING FOR HER SELF; MESSED UP; EXTREME PAIN IN HIP AND JOINTS/BURNING SENSATION IN HIP; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stronger reaction to common cold, and stronger reaction to other illness, and concurrent conditions included: nerve damage in hips, chronic nerve pain, chronic illness, food intolerances, disabled, castor oil allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage, never had a reaction or anything like this in the past with a vaccine. He was very very comfortable getting a vaccine. The patient experienced drug allergy when treated with amoxicillin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.