chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the booster shot on Saturday morning, the 29th of January. I didn?t feel many effects until the following day, when I experienced typical flu symptoms and chills in the afternoon. When the evening came on Sunday the 30th around 8pm, I started to experience chest pains. I have never experienced chest pains like this in my entire life. It was a tight constricting and sharp pain that was so bad, I laid in bed for hours and couldn?t fall asleep. I sat there and around 6am i called my father and had him take me to Hospital, because my pain had not gone away and the sharp feeling in my chest lasted all through the night and only got worse. After I got out of the hospital a few hours later, I took pain medication to be able to sleep and live without being in constant pain, and that lasted for the next two days. I?m mostly feeling better now, but I still feel a slight pain in my chest when I raise my voice or engage in strenuous physical activity.
This case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced numbness in leg. On an unknown date, the outcome of the numbness in leg was recovered/resolved. It was unknown if the reporter considered the numbness in leg to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got her dose of SHINGRIX in her left deltoid and the next morning about 5 am, she was awoke and her left leg was numb. The patient stated that she slept on her back and the numbness did resolve, but she was concerned if she would get the 2nd dose of SHINGRIX, could she have numbness again or worse, or loose the function of her leg all together. The patient had denied permission to contact their physician. The patient disconnected the call abruptly and was asked for name but declined. The patient noted she would be calling back to see if any other reports in 2 months. The patient disconnected before she could be told, GSK would not be able to provide that information. The patient was referred to her physician for discussion about 2nd dose. This case was linked with US2018131399, reported by same reporter for the patient's husband.
Fever, stomach pain, headache and arm where vaccines was given still hurting after 2 days.
Patient received vaccine, waited 30 minutes and left.  He reports he was fine until about 7 pm when he began to have significant chills and diaphoresis.  This resolved overnight, he felt a little "weak" the next day.  Was able to come to work.  Was afebrile.  Reports he is back to normal.
Started at 8am the next morning. Tired- barely get out of bed, slept most of day and all night. Took temp at night and it was 101.5. Took Tylenol and fever went away. Lasted till about noon the next day. 26 hours.  Injection site was sore and could feel pain when lifted arm but not unbearable. Felt like a train hit me.
Presented to the ED after developing chest tightness, cough, lightheadedness, and throat closing sensation. She received the Moderna COVID-19 vaccine on the morning of presentation. Within 15 minutes of receiving the vaccine she developed pain and numbness, starting at the injection site traveling down the ulnar aspect of her arm, and nausea. Over the next several hours she continued to develop worsening nausea, chest tightness, cough, lightheadedness, and the sensation that her throat closing. She took PO Benadryl 25mg; however, her symptoms were not alleviated. She was subsequently evaluated in the ED.   Received PO Benadryl 25mg, IV Benadryl 25mg, Epinephrine 0.3mg x 2, IV Famotidine 20mg, IV Solumedrol 125mg & 60mg, DuoNebs x 3, Racepinephrine x 1.
Approximately 24 hours after vaccinations pt. began shaking & writhing.  Hx of decreased appetite/fluid intake x24 hours & fever 103 degrees.  CBC WNL, urinalysis indicated dehydration.  Family hx of seizures - maternal aunt & paternal uncle.  EEG ordered & referred to neurologist.  9/30/08 Reviewed hospital medical records of 7/10-7/11/2008. FINAL DX: no d/c summary available Records reveal patient experienced shaking, writhing x approx 30 min.  Had oral intake reduced, fever x 1 day.  Admitted overnight for observation.  11/14/08 Reviewed neuro consult medical recods of 8/5-8/28/2008 FINAL DX: seizure-like events Records reveal patient experienced a series of spells 7/08 w/fever, sweating, restless, shaking of extremities, head jerking, unresponsive followed by balance difficulty, pallor, weakness, fatigue, irritability w/each spell lasting 5-30 min & identical in presentation.
This spontaneous report as received from a physician via field representative (learning of the AE within 24 hours) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dosage and route unknown) in the left arm. Concomitant therapies included oral typhus vaccine given at the same time with GARDASIL. The patient was diagnosed with subclavian deep vein thrombosis, approximately 2-3 weeks after receiving GARDASIL. The patient was treated with Tissue plasminogen activator (t-PA) and had surgery involving the removal of her first rib and 2 unspecified muscles. The patient was in hospital on the reporting time. The outcome of the event was not reported. Upon internal review, subclavian deep vein thrombosis which needs surgery, removal of first rib and 2 unspecified muscles was determined to be medically significant. Additional information has been requested.
Localized rash, itchy pain - treated with BENADRYL and clindamycin - resolved after 4 days.
Pain at injection site, significant bruising, red and swollen area beneath injection site, weakness in left arm, severe neck and back ache, headache, extreme fatigue - immediate onset lasting 5 days so far.
itching / still has itching on her arms; received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps; she has joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA426189.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "lost 50 pounds" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers.; "skin ulcers" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "itching / still has itching on her arms"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps"; ARTHRALGIA (non-serious), outcome "unknown", described as "she has joint pain". Therapeutic measures were taken as a result of pruritus.  Additional information: Treatment included was she was adding over the counter cream (unspecified) for she stated that she still had itching on her arms and not reported for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache, pain behind the eyes, slight fever, local pain at site of injection, mild diarrhea next morning.  Better by next morning but still not 100%  Treatment:  2 Advil
Pt felt rush of warmth throughout body immediately after vaccine administered.  About  30 minutes later, he felt itchiness at the back of his throat.  Pt was accompanied to ER , where he received solumederol 125 mg, pepcid 20 mg and benadryl 50 mg IV.  Pt symptoms resolved post medication.
upper muscle pain; joint pain; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (upper muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (soreness at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced MYALGIA (upper muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, MYALGIA (upper muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are reported.  The treatment information was  not provided.
Patient developed symptoms of MISC on 1/9/22; fevers began on 1/10/22 with a Tmax of 40.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, shock, sinus tachycardia, hypotension, cough, abdominal pain, rash, mucocutaneous lesions, headache, neck pain, and cervical lymphadenopathy. Abnormal labs included elevated transaminases, thrombocytopenia, elevated NT-ProBNP, elevated CRP, elevated ferritin, and elevated D-dimer. ECHO studies showed trivial mitral regurgitation. Patient was admitted to the hospital on 1/12/22 and treated with IVIG, infliximab, norepinephrine, and high flow nasal cannula. She was admitted to the ICU from 1/12/22 to 1/14/22. She was discharged on 1/16/22.
This spontaneous report as received from a registered nurse refers to his 64 year old wife. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date after receiving the ZOSTAVAX, the patient experienced injection site pain, pain above the injection site, joint pain, coughing and flu-like symptoms. The patient did not seek any medical attention. At the time of the report, the outcome of injection site pain, pain above the injection site, joint pain, coughing and flu-like symptoms was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old female patient who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot #, expire date and route not reported) and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse reported that on 17-AUG-2010 (also reported as "soon after" receiving the first dose of GARDASIL, the patient experienced pain, soreness and swelling ("the size of a baseball") that lasted 1-2 months before resolving. Registered nurse mentioned that on 18-OCT-2010 after receiving the second dose of GARDASIL , the pain, soreness and swelling ("the size of a baseball") returned, lasting 1-2 months. No symptoms were seen at the time of the third dose of GARDASIL. No treatment was given to the patient. It was unknown if the patient sought medical attention. In 2010, the patient had recovered. Follow-up information was received from the registered nurse concerning female student with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid. On 18-OCT-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # 665547/1318Y, expire date not reported), intramuscularly in the left deltoid and on 17-FEB-2011, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). Registered nurse stated that patient's mother reported that on 17-FEB-2011 with the third dose of GARDASIL, the patient had a local reaction that lasted 1-2 months and was the size of a tennis ball/baseball. Registered nurse stated the lesion size was only 1/2 dollar indurated but not near as a ball. There were no laboratory diagnostics studies performed. That patient did not seek medical attention. Registered nurse mentioned that the patient experienced the same events on first and second dose of GARDASIL. At the time of the report, the patient recovered. Additional information is not expected.
vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2011, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in Urgent Care, for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Two weeks after first dose I lost the shine in my hair. Second dose given 02/05/2012 in the right arm. Two weeks later I started losing my hair. I have a short thick head of hair and it is normal for me to shed some. This hair loss is three to four times greater than normal. The Moderna shots are the only thing that corresponds with this problem.
No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were provided. No adverse events were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662377, US-MODERNATX, INC.-MOD-2022-662382, US-MODERNATX, INC.-MOD-2022-662383, US-MODERNATX, INC.-MOD-2022-662384, US-MODERNATX, INC.-MOD-2022-662385, US-MODERNATX, INC.-MOD-2022-662387, US-MODERNATX, INC.-MOD-2022-662389, US-MODERNATX, INC.-MOD-2022-662390 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662377:same reporter US-MODERNATX, INC.-MOD-2022-662382:same reporter US-MODERNATX, INC.-MOD-2022-662383:same reporter US-MODERNATX, INC.-MOD-2022-662384:same reporter US-MODERNATX, INC.-MOD-2022-662385:same reporter US-MODERNATX, INC.-MOD-2022-662387:same reporter US-MODERNATX, INC.-MOD-2022-662389:same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter
DTaP was given 7/22/02 into left deltoid. Child woke up with swollen left upper arm and shoulder and scapula. Area was hard and hot. No redness or fever noted (per parent) was given Tylenol at home 2 times. Yesterday, no discomfort moving some.
pt states felt fine a/vax;later chills, fever, swelling of lt deltoid, couldn't move arm;feeling of being unwell-burped up egg taste;reported sx to hlth dept 5NOV97;states knows this was a rxn to flu shot;
Initial unsolicited report received from a medical assistant on 17-May-2018. This case involves child patient who was vaccinated with only the PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to inappropriate reconstitution technique. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
PATIENT GIVEN REPUNCTURED  VACCINE VIALS REFRIGERATED FOR  OVER 6 HOURS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced subject given repunctured vaccine vials refrigerated for over 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given repunctured vaccine vials refrigerated for over 6 hours was not reported. This report was non-serious.  Additional information was received on 29/Mar/2021. No new information received.
Vomiting and diarrhea approx 12 hours after vaccine administration. Hives and rash on stomach, chest and under arms.
Shortly after receiving the vaccine, the patient's spouse reported redness and swelling to the patient's face.  The patient denied sensing any new symptoms.  Vital signs within normal limits.  He felt fine and declined urgent care.
BLOOD CLOT; MULTIPLE RED SPOTS ON NECK/RASH; This spontaneous report received from a patient concerned a 19 year old Asian and not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAY-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms of blood clot  and multiple red spots on neck. Patient reported that the red spots on neck might be a rash. The patient's father wanted to know about treatment of rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple red spots on neck/rash and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524274- Covid-19 vaccine ad26.cov2.s- A 19- year old Asian and  not Hispanic or Latino female presents with Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Hives on left arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on left arm) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Hives on left arm). At the time of the report, URTICARIA (Hives on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Bright red large area around injection site, itchy and warm. Spread more after approximately 3 days.
After getting the covid vaccine tenatis, and each month its been going down a bit, but after I took my 2nd the same thing happened. Ive had headaches, eye twitching, muscle spams, my sinuses are off, my sense of balance is off. I have insomnia. I had extreme fatigue. I had trouble swallowing, and some problems with nightmares. My temperature would go from hot to cold and back and forth. My cuts take a while to heal. Things smelled off, my appetite was up and down. I have some swelling in my face. My memory has had some lapses, and I have now some blood in my urine. I developed dry eye in my right eye that was way worse then it was before the vaccines.  I went to multiple doctors because of all the things occurring with me.  I now have bladder cancer. And now I have vaginal atrophy, and have no sensation down below anymore, which was not a problem before the vaccines.