chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Tdap (BOOSTRIX) in OB clinic during 3rd trimester of pregnancy on 10/24/18. On 10/29/18 patient notified clinic that she was still experiencing pain at the injection site. The pain was rated as 5 out of 10 and was interfering with movement, sleep, and ADLs. Pain worsens on movement, but does not hurt when pressure is applied to the injection site. Patient feels that the injection was placed too high on the shoulder and that the pain is associated with the joint, not the muscle. The injection site is "2 fingers down from the bone". Patient reports no redness, swelling, or warmth to touch. Patient called again on 11/1/18 reporting that pain had not resolved, and in fact had worsened to 7/10. Patient was completely unable to move arm on 11/1/18. Patient self-treated symptomatically with ice and acetaminophen, but symptoms continued to worsen. Patient followed-up with a provider outside of our organization, so I do not have details of treatment or symptoms between 11/1 and 11/14, but by 11/14/18 symptoms had all resolved.
Nausea, vomiting, fever, dizziness, headache, body ache, fainting
From initial information recieved on 10/01/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 20 month old male patient received a dose of Daptacel, lot number C1663AA, administered in the left leg on 09/21/2004 at 9:30 am. Route of administration was not reported. The following day, the patient develoeped a lumb under skin at hte site of injection measuring approximately five to six millimeters in diameter with secondary inflammatory reaction. The patient was seen by a physician on 09/30/2004 and was also noted to have a cold. Physical examination revealed a small firm pen dot, most likely non-tender just distal to the spot representing the site of injection. Physicians impression was that of an upper respiratory infection with a lump likely due to the shot with secondary inflammatory reaction. Pediacare was predscribed for upper respiatoratory infection and cough as needed. No treatment was provided for the lump. Reportedly, the patinet recovered from these events. From additional information received on 11/29/2004 from a health care professional, it was reported , "Reviewed, no additional information at this time" No further information is anticipated, this case is considered closed.
NASAL CONGESTION, CHEST CONGESTION, COUGH, BODY ACHES, DIARRHEA
This spontaneous report as received from a physician refers to a 17 year old female patient. On 01-JUL-2013, reported as 6 weeks ago, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 02-JUL-2013, reported as 1 day post vaccination, the patient experienced trouble breathing and asthma and 4 days post vaccination, on 05-JUL-2013 the patient experienced urticaria. The patient went to the local emergency room but was not hospitalized and received an unspecified treatment. The outcome of trouble breathing, asthma and urticaria was reported as recovered and healthy. Additional information has been requested.
Fever up to 101.4, shakes, chills, and feeling poorly.  He also have 2 very loose watery stools.
6/19/09 MMR given Left arm. 2nd in series #/MMR 5/14/09. 6/20/09 Noticed bruising, swelling, tender. 6 inch oblong area of redness and warm to touch. 6/22/09 2 inch circle of bruised, tender, swollen and red area around injection. Warm to to touch. Advised to use cool compress, antipyretics and monitor. If worsens contact care provider.
Female patient (44 years old)  came to COVID-19 Clinic on 04-08-2021. Patient reported she does not have severe reactions to food, pet environmental, oral medications. Patient marked "No" on all questions on the COVID consent form. Based on patient's report, patient was instructed to sit down for observation for 15 minutes, instead for 30 minutes. After 15 minutes, patient started to have adverse reactions such as severe diaphoresis and fatigue. The pharmacy team instructed the patient to lay down on the floor with legs elevated. After 10 minutes, patient reported in better condition. The pharmacy team  reconfirmed if the patient has other allergic reactions to other medications., patient now mentioned the allergies list. such as contract dye (rapid heart beat), erythromycin, bactrim, keflex (severe dehydration. nausea, vomiting)  However, the vaccine coordinator contacted 911 while the pharmacy assisting the patient. Fire department and EMS arrived shortly and cleared the patient at the spot. Patient's husband accompanied her home shortly after.
Sore arm; This is a spontaneous report from a contactable physician (Patient). A 28-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 18:06 (Age at vaccination: 28-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included Anxiety, Birth control both from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN) taken for contraception from Jan2015 to an unspecified stop date, sertraline (SERTRALINE) taken for anxiety from 01Oct2020 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:53 (Age at vaccination: 28-years-old) single dose for covid-19 immunization. It was reported that patient experienced sore arm after administration of second dose. The outcome for the events was reported as unknown at the time of this report.   Information on the lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years 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) and as dose 3 (booster ), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: 01Jan2020; LISINOPRIL, start date: 01Oct2018. 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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Lower arm sore after 12 hours,  fever severe convulsions,  high fever,   nausea, vomiting, shortness of breath,  body aches after 15 hours that lasted about 2 hours in severity. Today is 4 days post incident and still have weakness,  body aches and fever are subsiding.
Patient called and said at night she had pain and couldn?t move her hand even for 10 degrees, she searched online and believes she has frozen shoulder. Advised her to contact her doctor or emergency room ASAP to be evaluated and treated and completed the report.
Each time the lymph node under her armpit swelled up like a kiwi; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (Tetracycline).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi). At the time of the report, LYMPHADENOPATHY (Each time the lymph node under her armpit swelled up like a kiwi) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, SARS-CoV-2 test: (Negative) Nasal Swab.         No concomitant medications were reported. The patient had received 3 COVID shots 2 Pfizer and 1 Moderna. Each time the lymph node under her armpit swelled up like a kiwi. The patient got her flu shot on 16-Oct-2022 in her left arm with no problem. On 21-Oct-2022 at 03:30 PM, the patient had received the most recent Pfizer Bivalent COVID-19 vaccine, dose 4, with lot GJ2524 in the right arm. She felt fine, not even a sore arm until 12 pm of 22-Oct-2022. All of a sudden, she felt sore all over, chills and checked her temperature which was 103.7. She took a shower and went to bed. She slept for 4 hours. When she woke up the lymph nodes under her arm, right breast and neck were all swollen and painful. Her husband called out doctor. She took Tylenol and Motrin and tandem  for the next 48 hours. This was the most extreme reaction she was yet to have in getting any of the COVID shots or boosters. The swelling in the lymph nodes still persisted but was improving. She no longer had a fever. She had never tested positive for COVID since she received this recent fourth dose of Covid vaccine. No treatment information was provided.   Reporter did not allow further contact
little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in the arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in the arm). At the time of the report, PAIN IN EXTREMITY (little soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Red and swollen knot and fever at the sight of injection of DTAP. Apply ? cream BID to area with cool compresses.
Covid test result: Positive; Covid test result: Positive; dizziness; fatigue; runny nose; Patient was exposed to covid 29Dec2021; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 31 year-old patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 31 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Covid test result: Positive"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 29Dec2021, outcome "unknown", described as "Patient was exposed to covid 29Dec2021"; DIZZINESS (non-serious) with onset 31Dec2021, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "fatigue"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab; (02Jan2022) positive, notes: Unknown; (02Jan2022) unknown results/ pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, dizziness, fatigue, rhinorrhoea. Patient was exposed to covid 29Dec then symptoms of dizziness fatigue and runny nose on 31Dec.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Family called EMS after finding patient on the ground and unresponsive; dc'd day before from another hospital with diagnosis for COVID-19 pneumonia; EMS found patient with O2 SATS 83% on RA, hypotensive and bradycardic; treated with Decadron, remdesivir, and O2 supplementation; code blue was called at one point and after several rounds of CPR, patient returned with ROSC; transferred to local hospital where she coded again; patient was intubated; condition worsened; had rapidly rising vasopressor needs; multi-organ failure; shock; hyperkalemia; respiratory failure; developed PEA despite doses of vasopressors and died in the hospital.
the same day I received my vaccination, and the following day, I road my bicycle long distance, each day a multi-hour workout. By mid-week my left knee felt like it was accumulating fluid (limited range of motion).  I assumed that I'd injured the knee. The next day I experience the same symptom with my right knee. A few days later my left knee is feeling better (greater range of movement), while my right knee continues to have a limited range of movment.
Started with cough/mild chest congestion, followed shortly after by scratchy/watery eyes.  By 2:00PM fever, scratchy throat, nausea.  By 4:00 PM extreme headache and muscle aches.  All lasting through 2/3/10 and starting to subside by 2/4/10 mid-afternoon.  2/5/10 all symptoms gone.
Information has been received from a physician concerning a 2 year old female, with no medical history, drug reactions or allergies, who on 08-MAR-2007 was vaccinated subcutaneously with 0.5 ml of MMR (LOT # 654983/1168F). There was no concomitant medication. One week post vaccination, approximately 15-MAR-2007, the patient developed conjunctivitis, otitis media and runny nose, which were all treated with antibiotics. Thirteen days post vaccination, on approximately 21-MAR-2007, the patient developed a head to toe morbilliform rash, that included her scalp and the palms of her hands. The symptoms have since largely resolved except for some lesions that are continuing to heal on her face. Unspecified medical attention was sought. There was no product quality complaint. The patient was considered recovering at the time of this report. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
A few hours after first capsule of oral typhoid vaccine client describes nausea and stomach pain. After second dose client has Nausea, Vomiting and Diarrhea, stomach cramps.
Started with chills, then extreme muscle weakness, lost consciousness for an hour, awoke with massive sweating and nausea and weakness, then onset of full  rigors.  Whole event lasted about 6 hours.
dizzy, lightheaded, sweaty and warm laid flat and elevated legs BP 140/78 P 76 no SOB vasovagal episode, no allergic response left after 40 min
Body aches and fever, 3x3 red raised hot area on arm. Headaches and dizziness. Saw doctor who diagnosed cellulitis. Began oral antibiotics and injection of antibiotics. Told to return a few days later if not feeling better.
About a week after my vaccine I began feeling some swelling at the intersection of my left armpit. Next day was some more so but didn't hurt, just swollen feeling. I figured it was from the shot since I'd recently had a mammogram and it was clear. A few days later I figured I should put it on my vsafe checking, but apparently it had expired. Today I  read an article that said some women had felt a lump under their arm after getting the COVID-19 shot and gone to the doctor, gotten a mammogram, and swelling showed on the picture.  Final statement of the article said it is most likely a reaction of the lymph node (mine was same side as shot[left] except one day only on right side) to the injection. Not to be concerned unless it lasted over a month, then see your doctor. I thought it might be helpful for both of us if I reported this. I'll keep track and see Dr. Last if it lasts more than a month.
body aches; chills; subsequent sweats; my left arm and upper back felt numb; aches in my middle back; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 17:30 (Lot number: FJ8757) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Allergies: aspirin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 17Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "my left arm and upper back felt numb"; BACK PAIN (non-serious) with onset 03Dec2021 20:30, outcome "unknown", described as "aches in my middle back"; PAIN (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Dec2021 02:30, outcome "unknown", described as "subsequent sweats"; IMMUNISATION (non-serious) with onset 03Dec2021 17:30, outcome "unknown", described as "Dose number 3". Therapeutic measures were taken as a result of hypoaesthesia, back pain, pain, chills, hyperhidrosis.  Additional information: The patient didn't receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to the vaccination. The patient was not tested with Covid-19 since vaccination. Immediately after shot was administered, the patient left arm ad upper back felt numb. Over the course of about three hours, the patient began to develop aches in her middle back. Approximately 10 hours after the shot, the patient woke with body aches and chills. The patient took Advil and was able to fall back to sleep but the chills and subsequent sweats continued all night.  No follow-up attempts were possible. No further information was expected.
It has been more than a year since initial dose; This case was reported by a pharmacist via out of hour services and described the occurrence of drug dose administration interval too long in a male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy (splenectomy done in May 2014). Previously administered products included Bexsero (1st dose received in May 2018).   In December 2019, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received 1st dose of Bexsero in May 2018 and 2nd dose was received in December 2019 which led to drug dose administration interval too long. This case was considered as medication error without harm.
DIZZINESS; NAUSEA; FEVERISH FEELING (TEMP NOT MEASURED); MINOR DIARRHEA; ONSET OF MIGRAINE HEADACHE, MINOR VISION DISTURBANCES.
Per pt. and older sister, she got her first covid vaccine (pfizer) on last Wednesday the 29th, Friday night the 31st she started having sore throat, then rash and swelling with itching, rash to face, lips swollen, puffy face and little rash to left hand and right arm, all itchy. No Benadryl has been given and her epi-pen has expired. No wheezing, No headache, No N/V/D. No fever. No contact with allergens, new foods, new products or new environment.
Brachial Neuritis. Intense pain in left arm, numbness and tingling of thumb, index and middle finger on left hand constantly. Temporary paralysis of left hand/wrist typically after waking up lasting for an hour.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PEDVAXHIB (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received the Pfizer covid19 dose 1 on 1/21,2021, subsequently developed at DVT diagnoses by Dr. on 2/4/21, left lower extremity, Dr. authorized the second shot and patient received this on 2/11/21
Patient states that she has had a menstrual cycle every 2 weeks since receiving the vaccine.
pt recvd vax 20JAN93 & the next day devel weird blisters on toes & one spot on stomach; @ the time of report sx was resolving; No further details were provided;
Patient recieved pneumococcal 23-valent vaccine at an outpatient clinic. He returned to the clinic the next day complaining of pain and erythematous area around where the vaccination was given without fever. It was described as cellulitis and the patient was admitted to the hospital for intravenous antibiotic administration.
Complained of dizziness after the shot. No lightheadedness or difficulty breathing. Patient stated that he was anxious before receiving shot. Hx of lightheadedness after flu shot. VSS. Patient remained seated x 30 minutes. Offered water and patient drank. Started feeling better after sat down and drank. Dizziness resolved. Feeling better, observed steady gait when leaving.
24FEB98 n/v, fatigue, sore throat, h/a;strep screen negative;7MAR98 CBC WNL, EBC <1:10, tSH WNL;10MAR98 saw MD-suspected low grade hepatitis infect;mom states LFT's to be repeated in 6wk;30MAR98 cont w/h/a, tires easily;
Fatigue, 102 temp., swelling around the injections site, red skin around the injection site, pain in the arm of the injection site, hives, headaches, body aches, skin painful to the touch, hot and could chill and flashes, ear sharp pain, appetite suppressed,   All events lasted for 24 to 48 hours.