chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN9581) via an unspecified route of administration on 01Feb2021 at 15:00 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history and concomitant medications were both reported as none. The patient did not receive any vaccinations within 4 weeks of the COVID-19 vaccine. The patient did not receive any additional vaccines on the same date as the COVID-19 vaccine. Family medical history was not provided. It was reported that the patient received his first vaccine dose on 01Feb2021 and was diagnosed with COVID-19 on 07Feb2021. The event required a visit to an urgent care center. The clinical course was reported as follows: "The patient received his first Pfizer COVID-19 vaccine shot on Monday, 01Feb2021. On Saturday, 06Feb2021, he started feeling bad. He said he had chills, then clarified that he stayed cold feeling from Saturday evening into Saturday night. His joints hurt so bad on Saturday (06Feb2021) that he did not sleep well on Saturday night. He woke up on Sunday (07Feb2021) and continued to not feel well, he also had a cough. He felt so bad that he did not go to church on Sunday. He decided to go to an urgent care center because he thought maybe he had the COVID-19 virus. The urgent care did a flu and COVID-19 virus "quick" test. He tested negative for the flu, but positive for the COVID-19 virus on 07Feb2021." The patient reported that he read through the COVID-19 vaccine paperwork that listed the COVID-19 vaccine shot side effects, and he said he had the COVID-19 vaccine side effects listed. The patient reported that he was told by the doctor at the urgent care center to take Tylenol and to take it easy and stay hydrated. He said that he took 2 Equate brand Extra Strength Tylenol 500mg on Sunday evening (07Feb2021). He continued to take 2 Equate brand Extra Strength Tylenol 500mg (Lot Number: 4JRD267 or 4JR0267; Expiration Date: Jun2017) about every 6 hours, for 24 hours. The patient reported that he needed a magnifying glass to read the Equate brand Extra Strength Tylenol 500mg product label. He said he normally wore glasses and that he found the Equate brand Extra Strength Tylenol 500mg product label information to be small. He was unable to clearly read the product Lot Number. The patient reported that he felt good yesterday (09Feb2021), but today (10Feb2021) he was not feeling well again. He said he had no chills today. The patient reported that his next COVID-19 vaccine shot was on 24Feb2021. He asked if he would be able to receive the second COVID-19 vaccine dose since he was now positive for the COVID-19 virus. He wanted to know if and when he should get his second COVID-19 vaccine dose after having tested positive for COVID-19 following administration of his first dose. The clinical outcome of the event "positive COVID-19 test with symptoms" was unknown.
shortness of breath and light headedness within one hour of injection.  Nausea and headache within a few hours of injection.  Extreme headache and extreme nausea 10 hours after injection.  Extreme skin/nerve pain and sensitivity, body aches, soreness at injection site, large red rash from shoulder to elbow on left arm (injection site.)  Fever of up to 101.5 for 4 days.  Headache lasted 13 days.  Mental confusion for two weeks.  Extreme fatigue and body pain, neck stiffness for two weeks.  Unable to drive or perform simple tasks for two weeks.  This was after the first dose.  Have not taken the second dose yet.
Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) had not resolved.            No Concomitant medications were reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning  an  elderly female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness. The event occurred on an unknown  day after the second dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. No treatment information was provided. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an  elderly female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness. The event occurred on an unknown  day after the second dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. No treatment information was provided. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Patient complained of redness, pain, itching, swelling to site of injection site warm to touch. On examination 10 cm diameter excessively warm, indurated localized erythematous eruption, not tender to palpation.  No open wound.  No extending lymphangitis.  Neurovascular intact . Injection was given with a 1 inch needle
Erythematous, lacy rash noted on trunk (chest primarily) immediately after receipt of vaccines. Child alert and not in respiratory distress though tearful and anxious.
Tingling from left deltoid to distal portion of phalanges. Localized to left arm.
Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade fever, which ramped up quickly. Fever-topped out at 101.4 by 3:00am, body aches, repeated vomiting, repeated massive diarrhea, severe headache -crushing, squeezing vise  (in the top 10 worst of my life -including migraines!), bright pink/red fingers and toes, racing uneven heartbeat. Couldn't sleep. In tears from headache pain. In desperation took an 800mg Ibuprofen pill at 4:00am. Finally got to sleep. Woke up 5 hours later. Fever mostly gone. Other symptoms receding, except headache. Took 2 aspirin at noon. Still have minor headache. Yuck!
Patient called the office on 10/9/19 to report left arm pain since receiving the flu vaccine
Adverse reaction started the day the vaccine was administered. The vaccine was given in the left arm and the bicep was red with a profound rash that covered the front of the arm. There was a shooting pain that went from the shoulder to the elbow. Patient called her doctor and the doctor recommended BENADRYL. The patient took one BENADRYL per day for 3 days then presented to the pharmacy to discuss what to do further for the rash. The pain had subsided and the rash improved by the end of day 3.
2JAn93 pt was taken to hosp because illness had grandmal sz w/temp 100.5; had had 2 seizures prior;
Each time the lymph node under my armpit swelled up like a kiwi; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Each time the lymph node under my armpit swelled up like a kiwi". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Each time the lymph node under my armpit swelled up like a kiwi". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got flu shot 16Oct2022 in left arm no problem. Patient received 3 COVID shots 2 Pfizer 1 moderna. Each time the lymph node under armpit swelled up like a kiwi. On 21Oct2022, patient got the new COVID vaccine. Patient had never improving and never tested positive for COVID. The patient had never tested positive for COVID. Patient didn't received any vaccines within four weeks and tested positive post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
THE PATIENT WAS GIVEN A PFIZER AS A 2ND DOSE WHEN 1ST DOSE WAS MODERNA.  SHE WAS OBSERVED FOR 15 MINUTES AND THERE WERE NO ADVERSE EVENTS NOTED.  THE MISTAKE WAS NOTICED WHEN THE PATIENT WAS CHECKING OUT.
Pt received vax on 11/17/1999.  Pt returned to the office on 11/22/1999 after developing aching in every joint, weakness in the knees, generalized muscle stiffness which is more noticeable in the neck, malaise and an injection site reaction characterized by redness and swelling.  Blood work was done, however, results were pending as of the date of this report.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: The patient's blood pressure was monitored and was normal. The heart rate was 67. 911 was called out extreme caution on the request of the patient and the medics evaluted her blood pressure and sugar and found all her vitals as normal. She left the store along with her escort without any further issues.
Red rash on arm, it is red, hot, and swollen; Red rash on arm, it is red, hot, and swollen; Red rash on arm, it is red, hot, and swollen; This spontaneous case was received on 15-Sep-2021 from non-health professional (consumer) via Med Communications (reference number: SEQW21-02335) and concerned an 18-year-old female patient.  The patient's concurrent conditions included celiac disease, eosinophilic esophagitis (EoE), and allergy to wheat, flour and chicken. The patient was not taking any concomitant medications.   On 12-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 308451 and expiry date 30-Jun-2022.   On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. The patient did not receive any treatment for the events.   At the time of initial reporting on 15-Sep-2021, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  Company comment: An 18-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: An 18-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced red rash on her arm and it was red, hot and swollen. Causal role of the suspect vaccine is assessed as possibly related.
Information has been received from a physician concerning a female patient who on unspecified date was vaccinated IM with 0.5ml of GARDASIL. The patient got terrible pain in upper quadrant above the gall bladder after receiving GARDASIL (Number of doses unspecified). Her mother took her to several gastroenterologists (names and locations unspecified). Quite a few lab diagnostics tests were performed, the results were not reported. "The patient was hospitalized and finally got her gall bladder removed."It was stated "there was a problem with her gall bladder". After the surgery, she was getting better. The adverse event was considered to be disabling and other important medical event by the reporter. Additional information has been requested.
Guillain-Barre Syndrome with  and rehabilitation; loss of use of feet legs arms and hands; loss of sensation plus pain and lack of coordination in hands and legs; loss of ability to walk and carry out basic functions of living; treatment remains ongoing, with recovery proceeding slowly.
IM given in left arm 3rd dose. (Booster).  Moderna Covid-19 Vaccine Lot 045C21 given was removed from freezer on 10/6/2021 @ 11:45am, Given on 11/5/2021, out of time range.  Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday  letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them.  Called patient today 11/17/21 and let him know that Moderan let us know the vaccine was viable, no additional booster vaccine is required.
Per client statement:  Local warmth and readness approx 2 inches starting 8/7/08 and lasting 2-3 days.  On 9/9/08 noticed a number of red bumps on legs and ankles with a few on thighs, hip, and hands assumed mosiqito bites.  9/10/08 bumps began to blister.  States multiple on ankles and legs with fewer on thighs and hip, and a couple on hands and arms. Red, itchy blisters, individual no clustering.
Pt vaccinated with Pneumovax on 3AUG90 on 8AUG90 seen for febrile illness w/headaches, myalgias & malaise. Had tender maxillary sinuses & was given Amoxicillin. 10AUG90 seen again rash. Had erythematous rash w/papules w/small pustules.
Late on 12/28/22, I was kind of stuffy, I wasn't running a fever. My daughter called to let my husband and I know that four out the five in her house were positive for COVID-19. I took a home COVID-19 test on 12/29/22, it came back positive. I called my doctor, to let them know I had tested positive. I had a telehealth visit and was prescribed PAXLOVID. I was on day three of the PAXLOVID, I noticed I was getting a rash all over my body that was itchy. I called the doctor and was instructed to stop the medication just in case it was the PAXLOVID. I was starting to feel better with the PAXLOVID, but then it felt like the COVID19 came back with a vengeance. It took two weeks for me to start feeling better.
WEAKNESS; MUSCLE ACHES; SWELLING; ITCHING; RASH ON EXTREMITIES AND BACK ON THE LEFT SIDE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's concurrent conditions included diabetes mellitus 2, alcohol user, non smoker, gout, stomach ulcers, cholesterol, and blood pressure, and other pre-existing medical conditions included patient does not have known allergies. patient does not have drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prevention of covid-19. Concomitant medications included lisinopril for blood pressure, atorvastatin for cholesterol, glimepiride for diabetes mellitus 2, metformin for diabetes mellitus 2, metformin hydrochloride/sitagliptin phosphate monohydrate for diabetes mellitus 2, febuxostat for gout, and pantoprazole for stomach ulcers. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash on extremities and back on the left side. On 29-APR-2021, the subject experienced swelling. On 06-MAY-2021, the subject experienced weakness. On 06-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Non-reactive for Lyme, and Skin biopsy (NR: not provided) Insect related. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on 09-JUN-2021, was recovering from weakness, and muscle aches, had not recovered from rash on extremities and back on the left side, and the outcome of itching was not reported. This report was non-serious.
This spontaneous case reported by a consumer, describes the occurrence of macular rash (red blotchy rash) and erythematous rash (red blotchy rash) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced macular rash (red blotchy rash) and erythematous rash (red blotchy rash). At the time of the report, macular rash (red blotchy rash) and erythematous rash (red blotchy rash) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was known to patient. The age at vaccination was not reported. The reporter stated that, he/she know someone(patient) who got the Shingle shot and now had shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
One week after vaccine was administered. Patient came into office with mother. There is a raised rash at injection site. It is raised, sore, not warm. Pt c/o that it is also itched.
Pain and swelling in left armpit that developed the day after vaccination and persisted after pain at the injection site subsided
PRESSURE IN FRONT OF MY HEAD, MAINLY ON L SIDE, HEADACHES, LIGHT HEADEDNESS, NAUSEA AT TIMES, FATIGUE, ANXIETY, RINGING IN LEFT EAR. MUST REALLY FOCUS TO READ BY BLINKING MY EYES A FEW TIMES OR ELSE IT IS BLURRY MANY TIMES DURING FEB, MAR, & APRIL I COULD NOT DRIVE BECAUSE OF THE PRESSURE IN MY HEAD GO TO #18 ON PAGE 2 I WAS THEN SENT TO A ENT DOCTOR FOR A COMPLETE CHECK UP & A HEARING TEST TO RULE OUT A SINUS INFECTION THEY PUT ME ON A SINUS SPRAY CLEANER & PUT ME ON MONTELLUKAST 10MG @ BEDTIME. I HAD TO GET OFF THIS BECAUSE IT WAS MAKING MY HEADACHES WORST. I HAD ANOTHER APPT ON 6/30/21. EVERYTHING WAS OK. THEY SAID IF I DON'T IMPROVE, I SHOULD MAKE AN APPOINTMENT WITH A NEUROLOGIST FOR THE HEADACHES. I WAS AT THE ENT OFFICE ON 5/17/21 AND WAS TREATED BY A PA-C. * MY PRESENT CONDITION AS OF 6/30/21 IS: EAR RINGING IN L EAR, COMES & GOES. IT IS ABOUT THE SAME AS IT WAS BEFORE THE MODERNA COV19 SHOT ON 2/3/21 THE HEADACHES NEVER WENT AWAY. I WAKE UP EVERY MORNING WITH EITHER A SMALL OR MEDIUM HEADACHE THE HEADACHES STARTED ON 2/3/21 & I STILL HAVE THEM ON 6/29/21. BEFORE THE MODERNA SHOT, I CAN'T REMEMBER HAVING A HEADACHE IN THE LAST 10 OR 20 YEARS.  THE MODERNA SHOT IS DEFINITELY THE CAUSE OF THESE HEADACHES. THERE IS NO DOUBT IN MY MIND. ** A REPLY WOULD BE APPRECIATED
Left upper arm/shoulder pain when lifting arm to dress etc that hasn't improved, have not yet sought treatment but plan to.
Rapid onset dizziness, tachycardia (150+ pulse), high BP (200+/140+); symptoms persisted for about 4 hours, gradually returning to normal pulse and BP: 75-80 pulse, BP 115/77
Patient experienced pain down arm to fingers, stiffness, limited movement and strong pain. She also experienced chills, weakness and was very fatigued. She experienced these symptoms soon after shot and for several days.
hives; welts; This is a spontaneous report from a a contactable pharmacist. This report received from a 48 year old male patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) from batch/lot number EN6208 via an unspecified route of administration on 24Feb2021 17:00 for COVID-19 immunisation on left arm.The other concomitant drug used was omeprazole and drug used to treat adverse drug reaction was hydroxyzine. No patient medical history included. The patient experienced hives and welt on 13Mar2021 and events were not recovered. The action taken was not applicable. The clinical outcome of the events was not recovered. No Allergies to medications food, or other products were reported. Ethnicity information was available. Race information was available. No follow-up attempts are needed. No further information is expected.
Rash on (R) arm that came up the day after she got shingrix #1 vaccination in that arm. Rash started distal to (R) axilla + was painful + itchy. Used Cortisone + it didn't help. Rash spread to ears, neck, chest, back, legs, feet bilaterally
Site L deltoid area, soreness, then developed red area, pain with ROM of arm. 3/6/12, induration 4.5cm,  3/9/12 red warm area 10cm x 14 cm.  Rash on left side of neck.
Rash (R) upper extremity upper arm & anterior forearm-papule, dull red, small crops.
Patient given booster 24 days after dose #2 because year on patient's vaccine card was incorrect (01/11/2021 instead of 01/11/2022).
Shot was administered rather high on arm which he noticed when he went to remove bandaid - arm hurt that day and has not gotten any better-the first week he could not raise his arm - he can raise it now but it really hurts - he describes it as feeling like something is out of joint.  Has not taken any NSAIDS as of yet
Travelling to country next week after starting Vivotif; Took unrefrigerated dose of Vivotif; Spontaneous report received on 13DEC2019.  A female consumer reported that she "took unrefrigerated dose of Vivotif" (PT: Product storage error) and was "travelling to country next week after starting Vivotif" (PT: Inappropriate schedule of product administration). She was scheduled on Vivotif for immunization. On 10DEC2019, the consumer took the first dose of Vivotif and then left it out of refrigerator until she took the second dose on 12DEC2019. It was reported that she was going to country next week. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took an unrefrigerated dose of Vivotif (Incorrect product storage) and was also travelling to country a week after starting Vivotif (Inappropriate schedule of product administration). Vivotif course should be completed at least one week before travelling. Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.; Sender's Comments: A consumer took an unrefrigerated dose of Vivotif (Incorrect product storage) and was also travelling to country a a week after starting Vivotif (Inappropriate schedule of product administration). Vivotif course should be completed at least one week before travelling. Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.