chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot in lung from the operation; Blood clot in lung from the operation; This is a solicited report from a marketing program, FACILITATED COLLECT received from a contactable consumer (patient herself) based on information received by Pfizer from Facilitating Company, manufacturer control number: 21K-163-4117921-00. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  intramuscular on 18Mar2021 (Batch/Lot number was not reported) (at the age of 62-years-old) as DOSE 1, SINGLE, and the second dose of BNT162B2 intramuscular on 19Apr2021 (Batch/Lot number was not reported) (at the age of 63-years-old) as DOSE 2, SINGLE for COVID-19 immunisation; and upadacitinib (RINVOQ), oral on unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency  for moderate to severe rheumatoid arthritis.  The patient's medical history and concomitant medications were not reported. On unspecified date, the patient had left knee replaced and experienced blood clot in lung from the operation and non-serious Blood clot in lung from the operation with upadacitinib (RINVOQ).  PFIZER-BIONTECH COVID-19 VACCINE was also considered suspect.  The events were considered serious due to hospitalization prolonged and medically significant. The patient had her left knee replaced and was recovering. She got a blood clot in her lung form the operation. She was in hospital for five days. She was on blood thinner and was recovering. It was unknown if patient was enrolled in a COVID-19.  The action taken in response to the events for upadacitinib was unknown.  Therapeutic measures were taken as a result of blood clot in lung from the operation (pulmonary thrombosis). The outcome of blood clot in her lung from the operation (Pulmonary thrombosis) was recovering while Blood clot in lung from the operation (postoperative complication) was not recovered.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of Left knee replaced and Blood clot in lung from the operation unknown onset and Blood clot in lung from the operation unknown onset was not provided. Facilitating Company opinion is that there is no reasonable possibility that the events of IN lung from the operation unknown onset and Blood clot in lung from the operation unknown onset are related to RINVOQ(UPADACITINIB).  The reporter's assessment of the causal relationship of the events left knee replaced and Blood clot in lung from the operation and BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Information has been received from a medical assistant concerning a 2 year old male who on an unspecified date was vaccinated with a dose of varicella vaccine. On 10/09/2001, it was reported that the pt "now" has "shingles." He sought unspecified medical attention and was treated with acyclovir. The reporter declined VZV analysis. Follow-up info reported that the pt did not develop a rash. It was noted that the pt did not have a temp and did not experience any other systemic symptoms. The pt also did not have a history of chicken pox or exposure to chicken pox or herpes zoster. There was no specimen collected. It was reported that the pt recovered. No further info is expected.
has been almost 2 years since first Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. The reporter enquired if patient need 2 doses. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
High fever of 106.3,  chills, headache, aches, unable to stand,  weak, dizzy
June 27, 2021 abscess appears on right buttocks July 1, 2021: Dr visit, she drains it. given Percocet for pain, and Clindamycin HC1 300 MG 2 cps orally every 8 hrs of 7 days July 2, 2021: Dr visit, she finishes draining it July 7, 2021: Dr visit, she drains, washes and dresses it
Bad sinus infection that took three rounds of antibiotics to clear.  Swollen lymph nodes under both armpits.
Extreme pain and weakness in the right leg [mid thigh to lower calf].  Unable to walk or climb steps.  Unable to stand unsupported.  Right leg buckles and gives out.  Unable to travel, or see my doctor.  The onset of my issues were very sudden and immediate, no lead-up.  In a sitting or lying down position, I am able to freely articulate and rotate my right leg without pain.  In the nine days since the onset, I have treated myself with Aleive and a heating pad for my neck.  The issues have lessened by less than 25%.        Background:  due to spinal cord injury in 1996, I have permanent damage; sensory issues on my right side [mid chest to foot], and motor issues on my left side.
SWELLING  OF THE FACE AROUND BOTH EYES  WITH ITCHING AND LIPS SWOLLEN AROUND SUNDAY MORNING AT 2:00  AND BECAME WORSE  LATER  THAT MORNING.  EXTREME TIREDNESS.  TOOK BENADRYL TO RELIEVE THE ITCHING  AND SWELLING.
BLACKED OUT WHILE DRIVING THE DAY AFTER VACCINE ADMINISTERED - CAUSED CAR ACCIDENT
The pt received the vaccines at 9:00 am. at 9:40 the pt experienced an anaphylactic reaction. upper eye lid edema and facial hives, nasal congestion. Treated with epinephrine and chlortrimeton.
pt recv vax & devel migrating joint pain approx 3-4wk p/vax;the pain was reported to be greater in the lt shoulder than rt;testing for rheumatoid arthritis was positive but not conclusive;testing for lupus & other numerous blood test neg;
Chills, Malaise, Hot Flashes - All symptoms waxing and waning in severity, present from 0230 - 2230 on 01/14.
This spontaneous report as received from a other health professional refers to an approximately 22 month old patient. On an unknown date the patient was vaccinated with PROQUAD dose 1 for prophylaxis. Concomitant therapies included PREVNAR 13, hepatitis a vaccine, inactivated (manufacturer unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(manufacturer unknown). On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event was unknown. The reporter considered product use issue and no adverse event to be not related to PROQUAD.
Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors in his hands. Had a syncopal episode and chest pressure. Went to ER on 2/20/21
Information has been received from a physician concerning a 14 (also reported as 13) year old male who on 04-AUG-1997 was vaccinated with the first dose of MMR II (HSA) and on 27-JUN-2001 was vaccinated with the second dose of MMR II (HSA) (lot numbers not reported). Subsequently, the patient was febrile at 101F and had right parotitis. He had jaw pain and swelling. On 16-NOV-2009 the patient experienced mumps. On 03-DEC-2009, the patient was diagnoses with mumps. The patient's blood work revealed serum amylase of 480. At the rime of the report, the patient's status was unknown. Follow-up information was received which reported that the 14 (also reported as 11) year old patient on 10-JAN-2010 developed mumps. On 13-JAN-2010, the patient afebrile and was diagnosed. On the same date, laboratory data revealed that IgM <1:10, IgG 10.14 and serum amylase 592. The patient had left parotitis. At the time of the report, the patient's status was unknown.  No further information is available.
New onset Atrial Fibrillation w/in days of 2nd vaccine.  No patient/family history.  Absence of previous cardiac history. Signs/Symptoms during A-fib included heart palpitations, dizzy/lightheadedness, headache, shortness of breath, irregular heart rate, and energy depletion.  Required significant cardiac tests and complete work-up.  Treated with flecainide (Tambocor) and ASA daily.  Currently stable on medications; however, patient was an active runner  and involved in daily exercise regimen and exercise induces A-fib onset. Currently unable to be fully active.
Patient was to receive Pfizer Bivalent booster for ages 5-11 years (third in this patients series). Instead, patient received a dose of the Pfizer primary series for ages 5-11 years . State and PCP informed. Called and left a VM with the mother.
I was walking at a store and I didn't feel right, I looked at my watch  for my heart rate and it was at 108. My husband  brought  me to the ER and my blood pressure was at 170/105. They did all kinds of test and I worn a heart monitor for 5 days. I couldn't  work until I get my results  because my job is dangerous.
Prruitic rash on chest and legs for 6 days (20 lesions) afebrile.
This was my booster shot.   I had fever, cold chills, body aches, and diarrhea and puking.
When I awoke on 02.26.2021 a large knot had developed at the injection site and very sore.  Didn?t think much of it because I had read this could last up to a month. A few days later I started having trouble with the range of motion of my left shoulder and arm and progressively got worse so made an appointment with my GP who administered a steroid shot in my rear and prescribed Etodolac which did not produce any positive results.  Did physical therapy which also did not provide any relief.  Made an appointment with an orthopedic Dr but I didn?t feel he was looking out for my best interest so I am researching other doctors at this time.
It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week.; It was rashy, red, hard, itchy for about a week; Rash under the site; Little swollen; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021. The most recent information was received on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week) and VACCINATION SITE RASH (Rash under the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen). On an unknown date, the patient experienced ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.) and RASH (It was rashy, red, hard, itchy for about a week). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and CORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week), VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen) had resolved.            No concomitant medication was reported  Treatment Included application of Ice   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-Up received. Added Events, Updated event outcome and  treatment details
After dinner 14 days post first vaccine noted a raised red rash over L upper arm. No itching or burning. Applied Astringent spray. The next morning  the rash extended across the upper chest area Astringent spray  applied. By that evening the rash extended across the upper back and then faded away.
I have had a headache and respiratory problems ever since the second dose.  And it seems to be getting worse.  I have been given celebrex for the lungs and told to take tylenol for the headache.  As of this date I still have both problems.
Fever, chills, dizziness, joint pain. I also had swelling, redness that was itchy and sore at the injection site. I also have been feeling a little out of breath. I have asthma but I have noticed when I walk up a flight of stairs it is more difficult to recover.
pt recvd vax & became ill, c/o diarrhea 7x since last noc, c/o vertigo & nausea; color pale, resp somewhat labored poss due to pt's inc anxiety; observed coughing; influenza type complaints; h/a, weakness, malaise, abdo cramping; appetite;
Quivering of right upper and lower lips, numbness around lips, could not rinse correctly from a cup, right lower lid leaning towards left,  tearing of both eyes, reddened lower inside of lip, lips looked crooked started on November 6, and still remain Also extreme fatigue started next day after vaccination, slight nausea two hours after vaccination. Lip and eye situation remain the same as of November 13
This spontaneous report was received from a medical assistant regarding a 52 years old female patient. Pertinent medical history included history of asthma, diabetes and seasonal allergies. Drug reactions/allergies was reported as none. On 19-SEP-2016, the patient received PNEUMIOVAX 23 0.5 ml, one time, intramuscular in the right deltoid region of the upper arm for diabetes (Lot# M022521 with expiry date: 17-NOV-2017). Concomitant medications included multiple unspecified medications. On an unknown date in September 2016, the patient experienced swelling, redness and warmth to the injection site area of the right deltoid. On 21-SEP-2016, the patient sought medical attention for an unrelated matter of shortness of breath and upper respiratory issue, for which the physician prescribed antibiotics. During the same visit the physician also prescribed treatment for injection site reaction of ADVIL and cool compression application. Lab diagnostics studies were reported as none. Causality of the events swelling, redness and warmth to the injection site and injection site reaction was not reported. The reporter considered the events shortness of breath and upper respiratory issue as not related. Outcome of the events was reported as unknown. Product quality complaint (PQC) was not involved. Additional information has been requested.
Fever; my body hurt; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (my body hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PYREXIA (Fever) and MYALGIA (my body hurt). At the time of the report, PYREXIA (Fever) and MYALGIA (my body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Dizzyness - lasted all day 4/23 Shortness of breath - Lasted all day 4/23 Rash appeared on stomach and legs on 4/24, was gone by EOD 4/25. Took Benadryl to help
Immediately following vaccination go light headed turned blue and fainted out for approximately 60 seconds immediately followed by a migrain headache and nausea that lead us to the emergencey room 5 days later.3/6/09-records received for DOS 2/21/09-presented to ED with C/O ongoing headache, suddenly felt lightheaded and drowsy and slowly consciousness after recieving Gardasil vaccine 5 days prior. After regaining consciousness C/O severe frontal headache which waxes and wanes, worsened with bright lights and loud noises. Nauseated, emesis. Diagnosis-Headache.
NOT STABLE ON LEGS; FEELING LOOPY / FEELS OFF; NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-MAY-2021, the subject experienced not stable on legs. On 08-MAY-2021, the subject experienced feeling loopy / feels off. On 08-MAY-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling loopy / feels off, not feeling well, and not stable on legs. This report was non-serious.
injection is painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022. Reporter's Comment::This case was reported by a consumer via interactive digital media. The reporter stated that already vaccinated that injection was painful but it's worth it.  The follow up would not possible as no contact details were available.
patient was feeling anxious prior to administration, decision made to continue with vaccination, right after vaccine patient fainted and was unresponsive, tech immediately made rxm aware and rxm dialed 911, patient was breathing but unconscious, parents trying to wake up child, rxm continued to monitor breathing, ems came and brought patient out to ambulance and at that time patient regained consciousness, parent took child to pediatrician office
Urticaria developed immediately on both legs after shots given. Developed cellulitis following day and had to be admitted to the hospital for two days. Also diagnosed with urticaria of right thigh secondary to infection and allergic reaction to intramuscular polio vaccine.
Immediately at injection point tingling went up my left arm.  Numbness in fingertips. Numbness and tingling followed in right hand to midarm.  The neuropsymptoms have not lessened
Immunizations on 4/28/16. Tdap in left deltoid, MMR in right. The next day 4/29/16 developed swelling, redness and itching left deltoid. Seen 5/4/16 and swelling and redness to mid deltoid. Pain better. Scattered red spots on hands. No respiratory sx. Unable to take antihistamines so steroid cream given.
Extreme vertigo 14 days after 2nd dose of vaccine/ MD visit diagnosed her with benign paroxysmal positional vertigo; First dos of BNT162B2 on 28Dec2020, second dose on 11Jan2021; First dos of BNT162B2 on 28Dec2020, second dose on 11Jan2021; This is a spontaneous report from a non-contactable pharmacist. A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3246), via intramuscular on 11Jan2021 at single dose for COVID-19 immunisation at the age of 44-year-old. The patient medical history and concomitant medications were not reported. It was unknown if there were other vaccine in four weeks. The patient had no COVID prior vaccination. It was unknown if COVID tested post vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) for COVID-19 immunization on 28Dec2020 at the age of 44-year-old. On 25Jan2021, patient started experiencing extreme vertigo 14 days after 2nd dose of vaccine. There were no new onset diseases diagnosed or new medications started within this period. She went to emergency room (ER) and medical doctor (MD) visit for care. MD visit diagnosed her with benign paroxysmal positional vertigo. She was still having episodes that were treated with meclizine. The outcome of the event benign paroxysmal positional vertigo was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
The next morning I woke up with a fever of about 102. I developed an instant metallic taste in my mouth which stayed the entire day. My entire body ached, I was super tired and just felt really crummy. My arm at the injection site swollen and the lymph nodes in my collar bone swollen to where I could actually see the swelling under the skin all of which lasted for about 3 days and all symptoms resided on their own. But on 12/27 my ears begin itching, I began sneezing and my nose began to run. My voice changed and I developed a 103 fever. Was very lethargic and loss my sense of taste and smell. Diarrhea developed and my whole body just hurt and the symptoms progressively got worse so on 12/31 I took COVID test and it was positive. The texture of has food changed, drinking water taste like oil and feels super metallic. And I have since lost my appetite and the foods I can get down just taste awful. I get SOB easily and I am just tired all the time. My voice is still super scratchy, I still have the cough and I have a double ear infection they cant get to go away. Crackling was heard in my lungs so 1/17 a Chest x-ray was done but it was all clear.