chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anemia; inflammation; administration date=23Jan2021, dose 1, administration date=03Feb2021, dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2021 (Lot number: en5318) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cardiac issues" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: en3248, Location of injection: Arm Right), administration date: 23Jan2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: ANAEMIA (non-serious) with onset 18Aug2021, outcome "not recovered", described as "anemia"; INFLAMMATION (non-serious) with onset 18Aug2021, outcome "not recovered", described as "inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2021, outcome "unknown", described as "administration date=23Jan2021, dose 1, administration date=03Feb2021, dose 2". The events "anemia" and "inflammation" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anaemia, inflammation.  Additional information: Patient had mysteriously developed anaemia and significant inflammation as confirmed in multiple batteries of blood tests without any identifiable cause as of yet especially at the time of the booster being received. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. COVID test post vaccination COVID test type post vaccination: nasal Swab, COVID test name post vaccination was unknown. Other medications in two weeks: Yes. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Redness, tender, itchy, swollen, warm to touch. Symptoms improved by 11/16/2012 (after 3 days). No treatment was given.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 12 years old, female patient with no pertinent medical history reported. On 20-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 24-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
First swollen lymph mode in armpit of left arm. Week later swollen lymph node near elbow and tingling. The tingling spread down my arm, then to my lower legs and other arm.   Sore muscles for no reason, particularly leg muscles. Generalized weakness and fatigue with some intermittent headaches that are atypical. Left arm is also very sore and painful. I had no real side effects in the first week.  Although symptoms arose 3 weeks after, i cant think of any other cause and havent changed anything else.
Tdap given between 4-7 PM at clinic, RA - Woke up with headache, soreness right arm.  Temp 99 degrees at school - per parent ok - acetaminophen given at 7:55 AM back to school nurse at 12:05 P.M.  Headache temp 103 degrees.  No reaction at injection site.  Advised MD follow up.
Started with itching and rash from injection site around my left arm.  Then moved to both legs and back. Symptoms come and go but are persistent on my left arm.  Getting worse since 1-11-2021. Making an appointment with doctor.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date roughly 20 unspecified were vaccinated with (Oka/Merck) VARIVAX injection (strength, dose, frequency, route of administration and indication were not provided that reached 18/5F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert, however, in house stability data can support those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. NO adverse effects reported. NO product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available.   Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning (Oka/Merck) VARIVAX temperature excursion and the patient (patient ID# 168840) of unspecified age  and gender who were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J008652: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
Father of patient came to store pharmacy to inform us of his son's passing. He stated patient died 5 days after receiving his Moderna vaccine on 6/13/2021 due to blood in the lungs. He stated the autopsy has not been done yet to confirm his death, however he was curious of the possibility. I contacted Moderna on July 8th at 4:30pm and spoke to a pharmaceutical representative of Moderna regarding possible side effects of the vaccine.
Received vaccines on 01/08/07 at 5:30pm approx. Called 01/10/07 today stating site where SW vaccine given (Polio and yellow fever) local reaction and tightness inc chest and light headed and flushed face. L arm non affected.
states she went to the ER, they said she had a heart attack, treated her with a heparin drip; heart palpitations; tingling in both hands; hands blue & purple in color; circular rash on right breast; she just feels funny and has not been right; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot number EW0181) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 49 years old) via an unspecified route of administration in the left arm on 28Jun2021 (Batch/Lot number EW0181) for covid-19 immunization. Two weeks after the second vaccine (Aug2021), she experienced tingling in both hands, hands are blue and purple in color, and heart palpitations. She was seen and treated in the ER, heart attack was ruled out (as reported). She feels funny and symptoms feel worst. The patient was asking if the symptoms may be related to the vaccine. The patient stated that she is starting to feel some symptoms from having the shot. Starting about 2 weeks after the second dose of the vaccine, she has had a lot of tingling in her right hand and her heart has been palpating, symptoms of heart attack (both were reported as worsened). She went to the ER and they said she had a heart attack, treated her with a heparin drip. She waited in the ER for a bed for 24 hours, got a bed to be admitted at 5 o'clock the next day but she left the hospital on her own accord. The insurance company said it was not a heart attack, she stated that her right hand is also a blue or purple color, and that she has circular rash on her right breast, looks like ring worm but it is not. The patient also stated that she just feels funny and has not been right since the vaccinations. The patient thinks the heart attack was maybe on 10Aug2021. The patient stated, "the insurance company said that the chemical came out of the heart with a heart attack, the chemical that starts with a T, states it went from a 9 to a 2. States it explains that in a heart attack that level would not go down like that". The patient wanted to know what other symptoms could be connected with this shot. The outcome of the events "hands blue & purple in color", "circular rash on right breast" and "she just feels funny and has not been right" was unknown while the other events were not recovered.
little chilly; little fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8727, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left upper arm (left shoulder) on 16Apr2021 as dose 1, single (at the age of 76-years-old) for COVID-19 immunization. The patient's medical history included bad back (has been having problems 15 years or longer), high blood pressure (has had for 20-something years), gastro stomach problems (has had for 15 years, probably 10 to 15 years), COVID-19 from Jan2021 and unknown if ongoing, clot in her lung from unknown date to unknown date, chills since starting her blood thinner from Jan2021 to unknown date, anxiety, pain and allergies from unknown date to unknown if ongoing. Patient had no family medical history relevant to adverse event. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had that antibody, she had antibodies before she realized she had COVID-19. Concomitant medication included cetirizine taken for allergies, apixaban (Eliquis) as blood thinners, lisinopril taken for blood pressure high, famotidine for the stomach, amlodipine besilate taken for blood pressure high, vitamin D and vitamin C for an unspecified indication. Patient also had anxiety and pain medications, but she did not take them prior to the vaccines. Patient also has acetaminophen-hydrocodone but did not use in the two weeks prior to the vaccines. On 16Apr2021, after the first shot patient was okay, but at night, patient was just little chilly but not had a cold and had a little fever, but, like she said, she does not feel bad.  Patient does not feel weak or tired or anything.  She does take blood thinners, too. Patient stated that fever and chills did not stick around. On an unspecified date of 2021 (last week from 06May2021), patient did have some lab work results were unknown. The only thing the doctor did was give her a chest, nuclear. Patient confirmed that as chest, nuclear. The doctor said the clot was gone. The doctor did not see it, that was why they did a nuclear test and they injected nuclear fluid into her arm so it could go to her lungs to let them know if anything was still there, patient developed the blood clot when she got COVID. Patient had no physician office and emergency room visit for the events. The outcome of both the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Influenza. A non-serious spontaneous report of influenza has been received from a MedImmune representative concerning a child, female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 26-Sep-2009. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced the event of flu-like symptoms on 29-Sep-2009 and influenza on 30-Sep-2009. On 30-Sep-2009, the patient had a fever of 101, sore throat, and positive rapid flu test. The outcome of the event of influenza was not reported. All follow-up attempts have been completed per company SOP.  No further information is available.  19-Feb-2010.
Joint pain, fatigue, slight fever.  The joint pain has kept off work, unable to stand/walk for more than a few minutes.  Hand pain making it hard to type. Prednisone prescribed.
Shot did not hurt at all, but the soreness the following morning was shocking. I?m a tough girl, but it felt like I had a Cramp horse in my shoulder and still extremely sore today.  It?s not a huge issue, as I am able to use my arm, but I was definitely caught off guard and feel it should be noted. I?m sure many are experiencing the same thing if not all. My friend experienced the same thing.
Patient received vaccine on Saturday and on Sunday she said that she developed itching all over and the left side of her face swelled slightly.
This is a 78-year-old female with a history of altered mental status, Parkinson's, fibromyalgia, chronic pain, dementia, GERD, and hypertension who recently was admitted to a skilled nursing facility.  Today they found the patient to be hypotensive with a blood pressure of 88/55.  She also recently tested positive for COVID.  She was brought into the ER for further evaluation.  Consider her blood pressure decreased to 50 over 30s.  She was sepsis alerted in the ER and received 3 L of normal saline which improved her pressure to the low 100 systolic, however her blood pressure then again trending down into the 80s.  She was unable to keep her map of 65 was started on Levop. This is a 78-year-old female with a history of altered mental status, Parkinson's, fibromyalgia, chronic pain, dementia, GERD, and hypertension who recently was admitted to a skilled nursing facility.  Today they found the patient to be hypotensive with a blood pressure of 88/55.  She also recently tested positive for COVID.  She was brought into the ER for further evaluation.  Consider her blood pressure decreased to 50 over 30s.  She was sepsis alerted in the ER and received 3 L of normal saline which improved her pressure to the low 100 systolic, however her blood pressure then again trending down into the 80s.  She was unable to keep her map of 65 was started on Levophed drip.  She has is she is lethargic difficult to arouse and only mumbles incomprehensible sounds.  Unaware of her baseline as she does have a history of dementia.  She is also noted to have AKI.  Patient was admitted to ICU for blood pressure support, drip management, and COVID pneumonia.  8/4/2021tested positive 8/10/2021 discharged
FAINTED AFTER VACCINE, HER DAD CAUGHT HER, REGAINED CONCIOUSNESS SHORTLY AFTER, REFUSED PARAMEDIC MEDICAL ATTENTION
Information was received from a certified nurse assistance regarding a 13 year old female patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in left deltoid on 30JUN2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.
2/11, Pt. c/o of "doesn't feel good" decr energy, decr in BP, incr in blood sugar, does not have DM, concern w/dehydration, assisted living facility sent to hospital, given IV fluids. Case has infected tooth.
Severe (not normal Flu Vaccine sore) pain in Left (injection) arm lasting 24+ hours.  Caused no sleep from discomfort. Body aches general. Prior body aches aggravated more than normal (i.e. lower spine, opposite shoulder previously separated decades ago) extra discomfort. Mild headache Fatigue 24-36 hours
AGGRAVATING AN OLD ROTATOR CUFF INJURY; INSANE PAIN; SHOT WAS SLIGHTLY OFF AND WENT DIRECTLY INTO A TENDON; BIG RED BUMP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included rotator cuff injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 subject experienced aggravating an old rotator cuff injury, insane pain, shot was slightly off and went directly into a tendon, and big red bump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the big red bump, insane pain, shot was slightly off and went directly into a tendon and aggravating an old rotator cuff injury was not reported. This report was non-serious.
Tinnitus and roaring of bilateral ears that has continued with no improvement onset 2 days post vaccination. Had a provider from my facility evaluate the inner ear to rule out fluid/ infection but was told normal assessment.
Less than 5 min. after vaccine admin., pt c/o throat/chest pain, a small amt. of water was given, then emesis occurred. Pallor, dizziness, near-syncope ensued. Pt was escorted to an exam room. Pt stated her arms felt heavy, numb, difficult to move. Pt was able to sit up w/assistance. After 30 min pt was not improving. Paramedics were called.
Chills; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 23-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 CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test positive: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment given
Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 Vaccine EUA
Austen was very anxious when given his immunizations at 11:30am.  Immediately after he became pale and c/o nausea.  Less than 5 minutes after vaccination, at about 11:35am, he became unresponsive, lost consciousness and convulsed.  The convulsion lasted less than 5 seconds after which he regained consciousness and appeared visibly upset by crying.  His respirations increased and he began to hyperventilate.  He was able to follow commands to breath into a paper bag slowly.  His pulse remained normal throughout the episode.  He experienced no allergic response or fall.  He stayed in the office for 30 minutes and was able to walk to his mother's car at 12noon.  She took him to his family doctor where he was examined.  Mother reported exam was normal.  When I spoke with her around 2pm, he was sleeping comfortably at home.
STROKES; This spontaneous report received from a consumer via social media concerned multiple patients (3 patients) with unspecified age, gender, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that on an unspecified date, the patients experienced strokes. It was stated by the reporter that "I am aware of some horrible jab statistics. In my immediate circle of friends, 2 heart attacks (1 died 5 days after her jab) 3 strokes". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220208979, 20220208988 and 20220208980.; Sender's Comments: V0: 20220208918-COVID-19 VACCINE AD26.COV2.S-strokes. 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).
16 yo previously healthy male who presented with dad for his second vaccination today, after a couple of minutes later the patient without any prior hx of fainting, experienced a syncopal episode, patient had loss of consciousness for about 30 seconds, patient was held by the dad, never hit the floor, patient denies any prior episode, denies any use of ETOH, neither drugs, states that was hydrating over the last couple of days prior with gatorade for prevention of dehydration, denies any prior symptoms such as headaches.   The patient was seen by EMS and Dr , he was assisted in the medical tent , vitals signs were consistent with HR; 56 BP: 112/48 O2 sats of 98% , patient was placed on a strecher and legs we were elevated to 90 degrees with a chair, No head trauma, Patient was stable, AAOx3 , PERRLA, EOMI, Lungs CTA B/L and regular pulse was noted. hydration with water 16 oz was provided, father at side, patient was observed for 30 mins and another set of vitals was taken which revealed BP: 119/72 HR: 75 O2 sats: 99%. Patient was dispose to home, father was advised to take son for his regular check up, also to make any further medical provider that he had an episode of syncope after second dose of Pfizer vaccine.
This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated exposed to temperatures outside of the recommended range ROTATEQ (dose, route of administration were not reported, lot number: K013868, expiry date: 27-MAY-2016, lot number: K023535, expiry date: 22-MAY-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
This patient had swelling of the right knee, noted one day after immunization, she denies injury although she did have surgery on her right knee 6 years ago. She does kick boxing.