chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling in arms and face/ Nerve tingling; blurry vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in arms and face/ Nerve tingling) and VISION BLURRED (blurry vision) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis since 2016, Blood pressure high since 2000, Diabetes since 2019 and Spinal canal stenosis (Narrowing spine canal) since 2016. Concomitant products included LOSARTAN for Blood pressure high, INSULIN DETEMIR (LEVEMIR) and METFORMIN for Diabetes, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Nerve pain, ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA (tingling in arms and face/ Nerve tingling) and VISION BLURRED (blurry vision). On 24-Feb-2021, PARAESTHESIA (tingling in arms and face/ Nerve tingling) and VISION BLURRED (blurry vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient presented to his doctor's office at 17:30 however his symptoms were receding at the time and he was told to monitor his symptoms, which resolved the same day.  No treatment was reported for the events.   This case was linked to MOD-2021-252561 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up information was received and Rechallenge updated. On 09-Jul-2021: Updated reporter address. Updated patient demographics[Race], medical history.  Added Concomitant medicines.Updated Vaccination center details. Updated outcome of events from Unknown to Recovered.
Severe back pain and left foot swelling  Took Motrin and got x-rays but resolved in 24 hours
On 05/05/2021 Pt received the Pfizer vaccine.  The next day she got chills, headache, muscle aches.  These symptoms lasted until 05/08/2021.  "I was feeling much better and started working in my garden, suddenly I felt on my right calf, and I noticed a "big knot".  Daughter of the patient took her to the ER on 05/08/2020, where she was scheduled to a diagnostic test on 05/12/2021.  On May 12, pt also received the phone call of her PCP, who diagnosed her over the phone: "blood clot" and prescribed her with Xarelto (Rivaroxaban), a blood thinner. A doppler test was performed to the patient that day and a blood clot was found.  On May 21 Pt had an appt with her PCP, and PCP advised to report this to the CHD.  Pt currently walks with a cane.  her next appt is with an Hematologist to find out for how long she will be taking blood thinners.
pt recv vax 1993 & MAR98 devel pain in the rt upper quadrant which was treated w/advil, APAP & bufferin;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicllin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nontender, erythematous, indurated swelling left arm on lateral aspect around vaccine site.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: On the first shot, pt has constant sholder/neck pain from shot and still continued after 3 weeks when recieving the 2nd shot (on opposite arm). She says the left arm pain is getting better, but it still has pain. On the second shot, the pain subsided after 3 days.
Tachycardia within 15 minutes of injection. One week after vaccination pain in left ankle. 1.5 weeks after vaccination numbness in arms and hands as well as night sweats.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Tetanus NVS (Tetanus vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the insomnia, chills, muscle pain and joint pain were not recovered/not resolved and the outcome of the pressure in limbs was unknown. It was unknown if the reporter considered the injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received tetanus shot as concomitant vaccine a week and a half before the SHINGRIX shot. 5 weeks ago from the date of reporting, the patient received SHINGRIX. The patient experienced pain at injection site when injected. Two to three days following the injection, the patient experienced what she described as muscle joint pain in legs from the waist down. Less than a week after receiving SHINGRIX, the patient also had chills every now and then. The patient experienced muscle pain which felt like pressure in her lower legs and she had not slept well because of it. The patient declined the request by the reporter to provide additional information as she had to get to work.
Large red spot, with bruising and a knot, bump last for 10 days, red spot decreasing daily but still visible 1 month later.
soreness at injection site, body aches, fever starting  about 8 hours after injection and resolved the following evening, about 30 hours after injection
Patient presented to the hospital with respiratory distress and was diagnosed with covid. He was given supplemental oxygen.
I woke up at 2:00 am 4/3 with extreme physical discomfort.  At 11:00 am the fatigue was incredible and I was running a fever.  By 14:00 my fever was 101.9  I was suffering incredible body aches and chills. (reminded me of day 4 of covid last March)  The itching on the back of my neck was noticeable by 7:00 am 4/4, but the fever was gone.  The body aches were improving.  at 17:00 4/4 I felt human again and was able to eat.  The itching has continued and I have a rash on my chest; lower back; back of neck; and the groin area.  It reminds me of roseola and may just be a reaction to the sudden intense high fever?  However at 3:00 4/6 my arms , thighs and face are starting to itch as well.  Monitoring, if swelling starts I will see doctor.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified number of patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were administered improperly stored doses of ROTATEQ (dose and frequency were not reported). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. Additional information has been requested.
Subjective fevers, chills, arthralgias, malaise, headaches and flu like sx's for 3 weeks.
shortness of breath; low blood pressure; tachycardia; edema of feet and ankles; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and FUROSEMIDE for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles). At the time of the report, DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Echocardiogram: inconclusive (Inconclusive) Test showed Low ejection fraction.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-222316 (Patient Link).
I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.
CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
FOLLOWING DAY CHILLS & FEVER (DID NOT TAKE TEMPERATURE) FATIGUE SWELLING REDNESS INCREASED PAIN HOT AND SWOLLEN SLIGHTLY ALONG UPPER ARM . FIRST APPEARED AS RED BLOTCHES THEN BECAME A SOLID BAND APPROX 4 INCHES ACROSS ARM
Pain in left leg, pit in left leg, swollen left calf. Received care at Patient First. Platelets and white blood cell counts were normal. Received ultrasound of left leg from Progressive Radiology. Results were normal, no sign of clots.
About 5 minutes after patient received HPV and meningococcal B vaccines, patient fainted. After a few minutes later patient was ok and left the clinic in good condition.
Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no drug reactions/allergies who on 19-OCT-1995 was vaccinated with a 0.5 ml first dose of  VARIVAX (Oka/Merck) and on 10-Jul-2007 was vaccinated with a 0.5 ml subcutaneous second dose of  VARIVAX (Oka/Merck) (LOT# 657791/0720U). There was no concomitant medication. Subsequently, the patient failed to seroconvert after receiving 2 doses of  VARIVAX. The patient received the first dose from another office so lot number was not available. Titer test was performed and no result was provided. The patient was seen by physician and there was not product quality complaint. Additional information has been requested.
Pt was seen in ED for a rash on his body that occurred about 15 days after he received the smallpox vaccine while abroad.  Pt's case was discussed with multiple public health entities who determined after looking at photos I sent to them that this was likely a folliculitis post smallpox vaccine (benign condition).
AT ONSET PATIENT HAD A BLANK STARE AND WAS NON-COMMUNICATIVE. PATIENT HAD BOUTS OF LETHARGY AND HYPERACTIVENESS AFTER HOSPITAL ADMISSION/DISCHARGE
Per MD office, I received a FLUCELVAX QUAD 2018-2019 0.5.
Initial was received 05 October 2010 from a health care professional. A cluster of two unidentified patients had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) and an unspecified amount of time later, the patients developed red swollen eyes and throat tightness. Outcome was not reported and no additional information was provided at the time of the report. Documents held by sender: None.
Started with itchy eyes and persistent cough with phlegm production. Eyes became very red and puffy. Cheeks flushed; eyes and face puffy. Lips became swollen, chest red, warm and itching. later c/o headache, fever, chills and bodyaches. Took one generic Ibuprofen in evening. Treated swelling with ice chips. No reaction at injection sites reported. Did not seek medical treatment. RN encouraged MD follow up. Patient made appointment with MD 11/06/2008 per RN instructions
Nausea, low grade fever, severe shoulder pain up into my lower part of my neck, right sided chest pain.
Approx 10 to 15 mins post vaccination mother returned with infant saying she was having a hard time to "catch her breath" and had spit. RRNL@ 38 heart rate nl at 138, no color change.  Infant belched in office and was almost immediately better. telephone call to mother later=infant acting NL nursing well doubt vaccine reaction.
DOES NOT FEEL VERY WELL; NAUSEA; CHILLS; HEADACHE; LOW FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included coronary artery disease, non-alcohol user, non-smoker, sulfa allergy, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced low fever. On 28-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced does not feel very well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and low fever on 28-MAR-2021, and had not recovered from headache, nausea, and does not feel very well. This report was non-serious.
BROKE OUT WITH COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced broke out with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000221663. The suspected product quality complaint has been confirmed to be this report indicates medical adverse event for the patient "my son" ("broke out with covid"). there is no product quality issue described. while the reporter states they were vaccinated, there is no report of symptoms, tests performed or statement indicating the vaccine did not work. therefore, this case is being sent for void approval. based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220327336 and 20220327382.; Sender's Comments: : Medical assessment comments not required as per standard procedure as the case is considered non serious
The day after my booster I experienced notable heart palpitations ? my heart would skip a beat, and the following beat would be more forceful.  I experienced similar symptoms a few weeks after my second dose, but these have come even sooner and with much greater frequency. They occur most frequently when I am at rest,  but still do occur when I am active.
I?ve been having palpitations, headaches, tremors, no longer can drink coffee, or any other stimulant, cannot do any sort of physical exercise except for walking a short distance. As soon as I carry anything I immediately start having palpitations. This has been happening for more than a month now.
feels better after she takes a nap; Vaccination site discoloration; felt sleepy; Tiredness; Vaccination site erythema; Vaccination site pain; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (feels better after she takes a nap), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration), SOMNOLENCE (felt sleepy), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 042B21-21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (The patient have allergy towards azithromycin and sulfa drugs. Azithromycin makes the patient vomit.).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced FEELING OF RELAXATION (feels better after she takes a nap), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration), SOMNOLENCE (felt sleepy), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, FEELING OF RELAXATION (feels better after she takes a nap), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration), SOMNOLENCE (felt sleepy), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given. No laboratory details was given. No treatment information was given. Patient had same adverse events like swelling, sleeping , tiredness after 2nd dose of vaccination but along with that she had itching too.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24 May 2021 contain significant information of history and second dose information
DISCOMFORT RIGHT AWAY AT THE INJECTION SITE; INJECTION SITE PAIN; HIS ARM STARTED SWOLLEN; HIS ARM STARTED TO HURT AGAIN AND TENDER ARM PAIN THAT CAME BACK/HURT TO THE TOUCH, HURTS TO SLEEP ON IT; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced his arm started swollen. On DEC-2021, the patient experienced his arm started to hurt again and tender arm pain that came back/hurt to the touch, hurts to sleep on it. Laboratory data included: COVID-19 virus test (NR: not provided) NOT REPORTED. On 02-DEC-2021, the patient experienced discomfort right away at the injection site. On 02-DEC-2021, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, discomfort right away at the injection site, his arm started to hurt again and tender arm pain that came back/hurt to the touch, hurts to sleep on it, and his arm started swollen. This report was non-serious.
Fever 102 .0 for multiple hours. Injection site became  red swollen with induration on entire upper right arm.
A 9 Y male who presents with COVID vaccine 1 week ago. Since then his has had a lump. His arm hurts a lot. Tylenol given for pain today the lump seems to be improving and the redness seems to be dissipating per father.  It is painful but less so.  He is afebrile.  He did not have any reactions for the initial series of COVID shots. SKIN:  normal skin exam, no jaundice, left upper arm hard to evaluate any erythema.  Some pain to palpation over injection area.  No pustule seen or obvious induration. Presumed more local inflammatory reaction.  Encouraged ice and ibuprofen.