chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.
A physician reported that a 31 year old male received Flu Shield (2000-2001 formula) in November 2000. The patient subsequently developed hives and numbness in his right foot, right leg, right side of face and right arm. As of the date of this report these symptoms are continuing. He was seen by his primary HCP. A neurological exam was negative, with normal MRI and normal nerve conduction studies. The patient was referred to an allergist. No additional information was available as of the date of this report.
chills; redness; swelling; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling) and BURNING SENSATION (burning sensation) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M204 and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL, PRAVASTATIN, PARACETAMOL (TYLENOL) and PREDNISONE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling) and BURNING SENSATION (burning sensation). At the time of the report, CHILLS (chills), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling) and BURNING SENSATION (burning sensation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 80 years and gender corrected as being a male patient.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Patient details were updated.First dose and second dose details were updated.events were updated.
Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. The concomitant medications included vitamin d (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), l-thyroxine (MANUFACTURER UNKNOWN) and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN) for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 13:00 the patient experienced injection site soreness. The patient did not receive any treatment for reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
BLOOD CLOTS; STROKE; EXTREMELY SICK; DOES NOT FEEL WELL; This solicited report received from a patient via PPSCVM000808: Regulatory Authority-concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, oral, batch number: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had blood clots and had not been taking her rivaroxaban in four days. The patient had been out of her medication for a week but she was taking it last week while in hospital. The patient was not feeling well, she took the covid-19 vaccine and became extremely sick. The patient also had a stroke. The action taken with covid-19 vaccine ad26.cov2.s, and rivaroxaban was not applicable. The outcome of the blood clots, stroke, extremely sick and does not feel well was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots, stroke, and extremely sick was not related, and between covid-19 vaccine ad26.cov2.s, and does not feel well was related; and between rivaroxaban, and blood clots, stroke, and extremely sick was not related, and between rivaroxaban, and does not feel well was related.  This report was serious (Other Medically Important Condition). This case is a duplicate of 20210859193.  Additional information was received from patient on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Janssen covid-19 vaccine was captured as company suspect and additional events stroke, extremely sick and does not feel well were added. It was determined that Manufacturer Case Number 20210859193 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210843590.; Sender's Comments: V0- RIVAROXABAN-Thrombosis. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Was stopped at intersection, was disoriented and confused. Couldn't remember where she was ans was going After 5 minutes then nauseated, light headed, shaky, rapid breathing for 30 minutes. Went to store and home. Very tired. anted to sleep. Wore off.  Brought husband to drive today for Hep # 2.
Patient had chills, fever, night sweats, lower back pain, and frequent urination throughout the night.
Fully vaccinated with Covid vaccine x 3 (Moderna). Tested positive for Covid on 01/18/2022. Admitted to hospital on 01/18/2022. Expired on 01/25/2022 while still hospitalized.
Fever (101.5), chills, joint pain, headache, and fatigue all started at 4:30 AM on 1/23/21 the day after my vaccine. I took 600mg of ibuprofen and it helped with everything except my headache.  I alternated between 1000mg of extra strength acetaminophen and 600 mg of ibuprofen. My symptoms subsided in the late evening of 1/23/21. I felt back to normal on 1/24/21.   My sore arm started immediately after vaccination and is still a little sore but has significantly improved.
macular/papular rash on trunk & face;no visible oral lesions;mom reports pt has occu hoarse laugh;afeb
Information has been received from a physician concerning a 9 year old male who on 13-JAN-1999 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628246/1655H). The patient did not have any illness at the time of vaccination. On 07-APR-2007, the patient's mother reported that the patient had developed a pimple like rash on face and maxillary area. On 09-APR-2007, the mother reported that the patient developed "probably 24 lesions." There were no lab diagnostic studies performed. Additional information is not expected.
Skin felt extremely on fire,  body chills and sweats , bad headaches, fatigue. Took pain relievers and rested. Over just about 24 hrs after injection.
Information has been received from a mother concerning her 16 year old daughter who in February 2007, was vaccinated with Gardasil.  In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest.  On 30-APR-2007 the patient received her second dose of the vaccine and again experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing.  This is one of three reports received from the mother.  These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593.  No further details were provided.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a mother and a physician concerning her 16 year old daughter who in February 2007, was vaccinated with the first dose of GARDASIL. In February 2007, the patient experienced difficulty breathing, unbalanced feeling, "panic attack" and pressure on her chest. On 30-APR-2007 (also reported as 30-MAR-2007), the patient received her second dose of GARDASIL, (lot #656051/0244U), IM. Again the patient experienced unbalanced feeling, "panic attack", pressure on her chest and difficulty breathing. This is one of three reports received from the mother. These reactions occurred in less severe form than her sister which was reported in WAES #0705USA03593. No further details were provided. Additional information is not expected.
On day 1 (12/23/2020) after receiving her vaccine she states  her arm was sore.  On 12/31/2020 she developed Pruritus.  On 1/1/2021 a baseball size welt developed. She used ice and started taking Zyrtec.  She does not have any other symptoms.  On 1/2/2020 the baseball size welt decreased, but 2 more welts developed that were thumb print size..  Today she does feel like the redness and swelling are getting better.
fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer.  A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization.  On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.
Thurs 5/20 4pm 1st COVID vaccine given Friday: tingly all day; 6pm developed diffuse erethema, scc alp brigh tred Sat 5/22: redness, hives worse, facial swelling started. Seen at Danbury ED. Given all supplental anaphalsix stuff, then epi. Discharged home Sunday: 5/23: Facial swelling returns, mom gives IM Epi, returns to hospital. Found to have ST abnormalities on EKG, sent to hospital for prolonged allergic reaction and eval of possible pericarditis.  5/24: continues to have urticaria, now with new petechiae/purpuric breakouts in areas where hives were, but most prominently in bilateral ankles.
No additional AE; The second dose on 08-MAR-2010; First dose on 16-JUL-2007; This spontaneous report was received from a pharmacist and refers to a 11-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-JUL-2007, the patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate age at vaccine administration). On 08-MAR-2010, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate age at vaccine administration). Both doses were administered for prophylaxis. There was no additional adverse event.
Brain dead and she can't think straight; Headache; Felt tiredness; Nausea; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX support. A female patient of an unspecified age (age 45, unit not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient was scheduled for her 2nd dose 18 days later which was on 01May2021. After her first dose had a reaction. She had headache couldn't think straight, felt tiredness. She had side effects which were headache, nausea, tired, brain dead and she can't think straight in Apr2021. She would like to know if she could take the 2nd dose 18 days later instead of 21 days later. She shared her side effects after the first dose because if she got the 2nd dose on Saturday she would have help with childcare and would have no work. And she would have side effects after she got the 2nd one too. She would like to get the second dose on 04May2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Intense Chills/sweating, Low Grade Fever, Body Aches, Fatigue, Gastric Distress, Muscle Pain, "Brain fog", dizziness/vertigo. Far worse than 1st or 2nd shot. Basically felt like I had the flu.
itchy all over his body; hives on his arms and palms; low energy level; pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy all over his body), URTICARIA (hives on his arms and palms), ASTHENIA (low energy level) and PAIN (pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced ASTHENIA (low energy level) and PAIN (pain). On 20-May-2021, the patient experienced PRURITUS (itchy all over his body) and URTICARIA (hives on his arms and palms). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 25-Apr-2021, ASTHENIA (low energy level) and PAIN (pain) had resolved. At the time of the report, PRURITUS (itchy all over his body) and URTICARIA (hives on his arms and palms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.
2-3 hrs post vaccine had fever 103F, irritable increased sleeping and decreased appetite. Symptoms lasted 24-36 hrs told to go to ER, didn't go because symptoms improved.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Patient was given vaccine 7 days earlier than due. Firs vaccination was on 4-5-21. Second given 4-19-21
Two days after the heart rate went up to 135 and I went to the ER. It was better the next day. By day 13 I started to get intermittent headaches that are very sharp. I am still getting them after three weeks. I have tried muscle relaxants and anti-anxiety medicine but they did not help. At night I am able to sleep but, in the morning, when I get up, I get sharp pains that are like ice picks and last for 3-5 seconds. Some of the headaches are more electric and as the day goes on it gets worse. I have tried taking Magnesium and Vitamin B-Complex and the headaches have changed to where they are starting in the afternoon instead of the morning. The headaches are a seven on a scale of 1-10. Sometimes the headaches come with a low grade fever.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 12-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
84 y.o. male who presents with chills, weakness and low back pain that had onset approximately an hour and a half ago.  Upon presentation, the patient's temperature was noted to be 102°.  Patient's states that he had a similar set of symptoms several years ago was found to have sepsis of unknown origin.  He denies anorexia malaise generalized body aches headache cough dyspnea chest pain nausea vomiting abdominal pain diarrhea or urinary tract symptoms.  The patient has been covered vaccinated and reports no known exposures.  Of note, the patient has been on cephalexin for the past week due to a postoperative infection related to his recent carpal tunnel release.  Transferred to a different hospital for Severe Septic shock, on dopamine drip; remains inpatient as of 5/17/21
MANY PROBLEMS THAT WERE NEVER GOING AWAY; This spontaneous report received from a patient via a company representative concerned a female 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, expiry: unknown) 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 many problems that were never going away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from many problems that were never going away. This report was non-serious. This case, from the same reporter is linked to 20220243873.
pt recvd vax & 1 wk later began to experience joint stiffness in both shoulders which has persisted; ROM of arms has been severely limited; MD feels has developed a progressive bilateral brachial plexopathy;
Red circle area 15cm warm to touch, cool compresses to area and Tylenol PCN.
anxiety; fast heartbeat/ my heart beating faster; numbing of the big toe on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) 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: ANXIETY (non-serious) with onset Sep2021, outcome "unknown", described as "anxiety"; TACHYCARDIA (non-serious) with onset Sep2021, outcome "not recovered", described as "fast heartbeat/ my heart beating faster"; HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "numbing of the big toe on the right side".  Additional Information: It was reported that, after first dose of the vaccine, a couple days later he started feeling like heart beating faster like and he do not know like it might be due to anxiety but not sure if it could be something else. He stated that, it still continued to experience the fast heartbeat without thinking about the adverse event. But since then it was kind of beating a little bit faster than usual even when he do not think about the vaccine. Is report related to a study or programme: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.