chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given with COVID 19 Treatment; given with COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FK9223) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: which was not triggered during COVID infection; "Certain shellfish allergy" (unspecified if ongoing); "allergy with anything with aluminum" (unspecified if ongoing); "Sulfa drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "given with COVID 19 Treatment". Therapeutic measures, Paxlovid from 22Jul2022 to 27Jul2022, were taken as a result of drug ineffective, covid-19.
Was given PEDIARIX on 09/29/08 and was seen for seizure that evening.
pt devel red, swollen arm from armpit to forearm; pt had been placed on ATB; no long term sequelae, pt had not received pneumococcal vax;
Patient received Hep A, MENACTRA, and flu vaccine in our office on 12-19-16. On 12-20-16 patient woke with swelling and skin tenderness of face and neck. Mom contacted physician and gave BENADRYL. No trouble breathing. Problem resolved.
SEVERE BAD ALLERGIC REACTION; FELT PUNCHED IN THE FACE; DIZZY; REALLY BAD HIVES AROUND NECK; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin, and allergic to ibuprofen, and other pre-existing medical conditions included the patient had 10-11 reactions during her lifetime.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested No concomitant medications were reported. On 05-MAR-2021, the subject experienced severe bad allergic reaction. On 05-MAR-2021, the subject experienced felt punched in the face. On 05-MAR-2021, the subject experienced dizzy. On 05-MAR-2021, the subject experienced really bad hives around neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe bad allergic reaction on 08-MAR-2021, felt punched in the face, and dizzy on 07-MAR-2021, and was recovering from really bad hives around neck. This report was non-serious.
This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced posterior reversible encephalopathy syndrome (serious criteria hospitalization and GSK medically significant), hallucination (serious criteria hospitalization), weakness (serious criteria hospitalization), cortical blindness (serious criteria hospitalization and GSK medically significant), metamorphopsia (serious criteria hospitalization) and loss of vision (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the posterior reversible encephalopathy syndrome, hallucination, weakness and metamorphopsia were unknown and the outcome of the cortical blindness and loss of vision were recovering/resolving. The reporter considered the posterior reversible encephalopathy syndrome, hallucination, weakness, cortical blindness, metamorphopsia and loss of vision to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome (PRES) in female patient of unspecified age who was vaccinated with unspecified influenza vaccine (manufacturer unknown). No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient initially developed ascending weakness. Subsequently, the patient was treated for suspected acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Over the course of her hospitalisation, the patient had a progressive loss of vision which led to cortical blindness. The patient had typical magnetic resonance imaging (MRI) findings suggestive of PRES, including scattered areas of cortical and subcortical T2 and T2 Flair hyperintensities within the occipital and parietal lobes. Her vision had improved, but during this time, the patient noted an increase in what she had described as hallucinations, including people changing appearances, as well as objects around the room changing in size. This case has been considered serious due to hospitalisation. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between PRES and unspecified influenza vaccine.
sister had the shingles vaccine and ended up in intensive care with GBS; just starting to walk with a walker after 2 months; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome in a female 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 guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and gait disturbance. On an unknown date, the outcome of the guillain barre syndrome and gait disturbance were unknown.   It was unknown if the reporter considered the guillain barre syndrome and gait disturbance to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported The reporter stated that, his or her sister had the shingles vaccine and ended up in intensive care with guillain barre syndrome. The patient was just started to walk with a walker after 2 months.
Right toe began hurting on May 8. 3 out of 10 pain. No redness or warmth.  Fever (103 F), body aches, and fatigue on May 8.  Took Tylenol 500 mg  TID that day. No fever, body aches on May 9 but fatigue remained.  Fatigue remains mild to moderate.  Right toe continues with discomfort.
Shaking chills. Achy body. Fever 100.5. Slight headache and nausea. Exhaustion. Sore arm. I received the vaccine at 3:40 p.m. Sore arm within 2 hours.  I began to feel effects (tiredness) around 9:00 p.m. Fever, chills, body aches became intense about midnight April 3 and lasted until 8:00 a.m. April 3 As of submission I am no longer achy nor do I have chills, but am tired and a little brain fog. Also, slightly congested in nasal passages.
Swelling in breaststroke and under left arm; Swelling in breaststroke and under left arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was receiving unspecified concomitant medications. The patient previously received penicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) on unknown dates and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 31Mar2021, the patient experienced swelling in breaststroke and under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event swelling in breaststroke and under left arm. The clinical outcome of the event swelling in breaststroke and under left arm was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
INTENSE VERTIGO, NAUSEA, DIZZINESS, EYE PAIN, CONSTIPATION, LOSS OF APPETITE, LOSS OF BALANCE, MIGRAINE, SENSITIVITY TO LIGHT, LEFT ARM PAIN WHERE SHOT INJECTED. SOUGHT MEDICAL ATTENTION TWICE AT ER.
Still having symptoms a month after the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Still having symptoms a month after the first shot) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Still having symptoms a month after the first shot). At the time of the report, VACCINATION COMPLICATION (Still having symptoms a month after the first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information provided.
10/8/2020 - Injection site knotted, burned, sore, entire arm hurt for around 5 hours, I felt tired, achy, there was heat at and around the injection site.  10/9/2020 - From the injection site the redness began to run down my arm with heat at the redness sites.  Still felt tired and achy. 10/10/2020 - Redness continued to run almost to elbow and now itches.  The redness that ran down my arm, is whelped. 10/11/2020 - Arm not as sore, redness still there, itches badly.
Body aches and headache. brain fog, fatigue.  Headaches continued for 8  weeks after vaccination
Lost consciousness; possibly had a seizure; tingling in his hands; unable to speak; felt dizzy; was tired afterwards; felt sick; This is a spontaneous report from a contactable physician.  A 27-year-old male patient started to received dose 2 bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received BNT162B2 first dose on unspecified date with unspecified lot and expiration date.   The patient reported at 4:30 after second dose of vaccine lost consciousness for 15 seconds on an unspecified date, possibly had a seizure on an unspecified date, tingling in his hands on an unspecified date at 9:00 in the evening, unable to speak on an unspecified date for 15 seconds, felt dizzy on an unspecified date, was tired afterwards for about 2 hours on an unspecified date, and felt sick on an unspecified date.  Outcome of event Lost consciousness was recovered, possibly had a seizure was unknown, tingling in his hands recovered, unable to speak was recovered, felt dizzy was unknown, was tired afterwards recovered, and felt sick was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure, LOC and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, serum toxicology screen, chemistry panel and EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
In march, I had a prescription to take Macrobid as a preventative for a UTI. I had taken it in the past with no problems. I took it on Saturday evening and in the morning I had a really bad cough, shortness of breath, body aches, fever. I had to call in sick to work, The next day on Monday,  I felt completely better, I felt like I hadn't been sick at all. I took Macrobid again on the 16th of  march and the same thing happened, I woke up the next morning on the 17th with shortness of breath and body aches this time was worse than the first. By the 18th I felt mostly back to normal. I was tested for Covid which came back negative on the 18th. My doctors said over the phone could have  been an acute reaction to the Macrobid.
Induration, swelling and redness over the lateral left arm up to before the left elbow.
patient sat down and was very out of it and swaying.  pale and clammy very sweaty, passed out put him on the floor and put cold bottle on face his pulse remained steady.  finally was coherent did call emergency number the ambulance came and he vomited before he left the building  very non coherent at first
This spontaneous report was received from a pharmacist refers to a patient of unknown demography. On 03-MAR-2014, the patient was vaccinated with expired dose of M-M-R II lot # 0232AE (Expiry: 26-JAN-2014) (dose, route and frequency were not reported). No adverse event reported. No other information to report. Additional information is not expected.
Dry cough (occasional); Fatigue; Swelling of the arm; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough (occasional)) and FATIGUE (Fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling of the arm) and OROPHARYNGEAL PAIN (Sore throat). On 28-May-2021, the patient experienced COUGH (Dry cough (occasional)) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), OROPHARYNGEAL PAIN (Sore throat), COUGH (Dry cough (occasional)) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Hospital told / her kidneys were shutting down; Hospital told her creatine level was at 8; Hospital told / her blood pressure was dropping; Diarrhea / took her to the hospital because she was still out of it; Vomiting / could not keep anything down / took her to the hospital because she was still out of it.; This case was reported by a consumer via call center representative and described the occurrence of kidney dysfunction in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th July 2021, several hours after receiving Shingrix, the patient experienced vomiting. On 20th July 2021, the patient experienced diarrhea. On 22nd July 2021, the patient experienced kidney dysfunction (serious criteria hospitalization and GSK medically significant), creatine increased (serious criteria hospitalization) and low blood pressure (serious criteria hospitalization). On 21st July 2021, the outcome of the vomiting and diarrhea were recovered/resolved. On 25th July 2021, the outcome of the kidney dysfunction, creatine increased and low blood pressure were recovered/resolved.   It was unknown if the reporter considered the kidney dysfunction, creatine increased, low blood pressure, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The patient received Shingrix in right arm at about 10 am and a few hours later she began vomiting and could not keep anything down. Next day on 20th July 2021, she was still vomiting along with diarrhea. On 22nd July 2021, the patient husband took her to the hospital because she was still out of it. The reporter reports the hospital told her creatine level was at 8 and her kidneys were shutting down, as well as her blood pressure was dropping. The health care professional  were able to save her and got her creatine back to 1 and her kidneys functioning, and her blood pressure stabilized by sunday 25th July 2021 when she was released from the hospital. The patient has had no problems since then. The reporter did not consented to follow up
T.C. from client.  States "Igot a flu shot thursday and my neck and shoulder got really sore friday"  Woke up Friday AM with neck being so sore that she was unable to move it denies left arm being sore.  C/O left side to buttocks region being sore.  Taking ibuprofen every 4 hours.  Client intends to call physician.  Denies doing thing unusual thursday.  11-25-03 2:30 pm follow-up with patient - possible adverse reaction to flu vaccine - phone call placed to patient.  She stated she had seen the doctor Monday 11-24-03 and he said it was highly unlikely that the flu shot had anything to do with her sore neck and shoulder and left side of buttocks region.  Doctor ordered cyclobenate (muscle relaxer) and bestra (anti-inflamatory) Patient states she is felling better.
Patient admitted 4/12/21 with fatigue and abdominal pain.  Found to have UTI but no definite sepsis, and acute renal failure.  Treated with iv antibiotics and iv fluids.  Over next 48 hours developed worsening encephalopathy and thrombocytopenia.  MRI/MRA/MRV showed no acute findings.  Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis.  Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy.  Renal function worsened.  Patient became obtunded and was intubated 4/16/19.  Platelet nadir of 31k.  Dialysis started.  Left common femoral DVT developed.  Patient had DIC type picture.  Respiratory failure worsened, hypotension developed, patient passed away 4/20/21.  No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.
Patient stated prior to vaccination that he had a fear of needles.  Once vaccinated patient seemed anxious so pharmacist continued to directly monitor the patient.  He proceeded to feel nauseous and lightheaded.  At this point, patient was laid on the floor on his side to prevent falls and 911 was called.  Patient lightheadedness continued along w/ perspiration, and cold extremities.  Cold compress was applied to patient's neck and face area.  We maintained conversation until EMS appeared in which he disclosed he had been fasting.  EMS proceeded to conduct patient well check and released patient --patient disclosed that this always happens when he receives shots or has blood drawn.
Student first received 3 vaccines in right arm with no reaction. Student was then given MCV4 in LUD with no observed reaction, and then given HPV in LLD. Student was fine initially and then less than a minute after his eyes were closed and started fluttering. He started to tip over forward. Exam bed was reclined back and student responded to name and stated he felt like the room was spinning and he was hot. Was provided with water and cold cloths applied to forehead as he started sweating. Sister was present at time and Mom was called. VS were BP 114/79, HR 64, Temp 97.5 orally. Student was able to sit up after five minutes and talk noting he did have breakfast and lunch that day. Mom arrived and explained situation to her and she took the student home around 2:05 pm with instructions to monitor through the night and keep hydrated with water.
RESTLESS LEGS; SPINE PAIN; BACK PAIN; HIP AND KNEE PAIN; FEVER; BODY ACHES; HEADACHE; CHILLS; FLUSHING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced flushing. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced restless legs. On 21-MAY-2021, the subject experienced spine pain. On 21-MAY-2021, the subject experienced back pain. On 21-MAY-2021, the subject experienced hip and knee pain. On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless legs on 21-MAY-2021, and chills on 14-MAY-2021, and had not recovered from body aches, hip and knee pain, headache, flushing, spine pain, back pain, and fever. This report was non-serious.
July 3 started aggressive behavior, would not sleep for 2 days straight, keep talking non sense, turning on all the lights, slam doors, bang on walls, obsessed with the trash cans, clean the floors in the middle of the night, anxiety, screams a lot, does not want to shower or brush his teeth, looses control, does not listen.  Our son never acted this way until the second dose of the Pfizer vaccine. This has been going on for 2 months. We talked to all the doctors back and forth and no help until we spoke   with our neurologist that our son is being treated for PANS.