chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On February 15, 2023, I woke up with body aches and fatigue.  I had a doctor visit already scheduled the next day.  I tested positive for COVID-19 while at the doctor.  I then began to feel like I had a heavy chest but not congested.  I had a mild sore throat.  I was prescribed Paxlovid and Prednisone.  I began to feel better within a couple of days.  But, as soon as I stopped taking medications, I began to have congestion and runny nose and was considered I had a rebound.
Started with headache at 5:30 PM, then cough at cough at 6:15PM, tongue swollen, eyes bloodshot beginning 6:45 PM, fever (100.3), chills, aches at 9:30PM.
Swelling of forehead, tongue, throat.  911 administered Benadryl by IV then took me to the Emergency Room.
Approximately 15 minutes after receiving the vaccine the patient reported difficulty exhaling and labored breathing. She stated her heart beat was a bit rapid as well. Paramedics were called to evaluate the patient and determined that she was stable. Her blood pressure was a bit high according to the paramedics, but the patient left on her own two feet.
Felt fine the day after vaccine. Woke up the second day after with a constant mild to medium headache, brain fog, and many dreams which affected sleep quality for 3 days. Headache subsided with aspirin. Brain fog lasted to some degree the fourth day. Also had tiredness for 6 to 7 days. Note, I had shingles in March to May of 2021.
Patient received third dose of COVID vaccine 1/26/2021. However, patient has experienced no side effects since vaccine was administered yesterday.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 03-OCT-2016, the patient was inadvertently administered improperly stored of ZOSTAVAX (lot number M028799 with expiration date 08-AUG-2017; strength, dose, frequency and route were unknown). The product was exposed to temperature 34.9 F for 65 hours. There was no data logger. The temperature was back in range. No adverse effect reported. Additional information has been requested.
I was literally down every, like three days after every shot; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I was literally down every, like three days after every shot".  Additional information: Patient age: 40-44 years. Experienced side effects after COVID vaccine. Stated I was like, I was literally down every, like three days after every shot. Action taken: Unknown, Outcome: Unknown. Causality: Not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of swelling in a 51-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included NEXIUM. On 20 October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). On 20 October 2008, within 24 hours after vaccination with FLUARIX, the subject experienced swelling and erythema. The subject received FLUARIX during a GSK employee health Flu Clinic. The subject reported that she developed redness and swelling within 24 hours after the vaccination. The subject received FLUARIX last year without any issue. On 3 November 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Follow-up information was received on 09 January 2009, via healthcare professional who reported the events resolved and were related to vaccination with FLUARIX.
L arm with warm red area. Approximately 7 x 6cm. Warm compress applied x 1 day. No fever.
This case was reported by a healthcare professional (the subject) and described the occurrence of flu-like symptoms in a 47-year-old female subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). No pertinent medical history. In November 2012, the subject received an unspecified dose of Influenza vaccine unspecified (intramuscular, right deltoid). Within 1 week after vaccination with Influenza vaccine unspecified, the subject experienced flu-like symptoms. After 2 weeks, the events were resolved. From January 2013, the subject developed severe right frozen shoulder that lasted until January 2014. In May 2013, she went to physical therapy and it made the pain worse, she couldn't support the therapy. In August 2013, she was treated with steroid but it was not effective. She continued the physical therapy until April 2014. Her shoulder was still not normal and it caused her great stress because she's right handed and had limited range of motion. She stated that her arm hurt so much that she could not move it and she couldn't even button her bra. The pain and tenderness was so severe that she could not sleep at night. Psychologically, the pain has been difficult and depressing. The healthcare professional considered the events were disabling. At the time of reporting, the events were unresolved. The subject considered the events were almost certainly related to vaccination with Influenza vaccine unspecified. As no additional information could be obtained, the case has been closed.
autoimmune diseases; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced autoimmune diseases after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed autoimmune diseases (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (autoimmune diseases).  At time of reporting, the outcome was Unknown for the event autoimmune diseases.; Sender's Comments: Sanofi Company Comment on 20-Jan-2022: This case involves Adult and unknown gender patient who experienced autoimmune diseases while receiving vaccine INFLUENZA VACCINE.. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
temp, not able to swallow, sugars went low, not feeling well, glands swollen, not eating well, weak, not active, sleeps a lot;
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 experienced not responding to therapy (please see case numbers A0962819-21A for the other 3 subject).
This spontaneous report as received from a registered nurse refers to an unspecified  number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, injection (lot # L017140, expiry date 13-NOV-2016; lot # L027634l, expiry date 21-JAN-2017; lot # L024497, expiry date 01-JAN-2017; exact dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter. Additional information has been requested.
Developed mild chest pains/tightness two days after 2nd Pfizer-BioNTech vaccine. Chest pain intensified 3 days after vaccination. Was advised by staff at Medical Center to report to the Emergency Room. Echocardiogram showed pericarditis. He was kept overnight for observation. Treatment is Colchicine for 90 days - 2 pills a day.
Patient reports at 16 days post injection, she is still having shooting pains that radiate up the neck. No swelling or redness but pain bad enough that she is having difficulty sleeping. She has contacted her physician, and is awaiting a call back.
Within 20 mins of vaccination she developed chest tightness which she thought might be her usual asthma symptoms and treated with symbicort and albuterol subsequently noticed that she had hives on wrists and swelling of her hands. Took benadryl for it. resolved. did not go to ER. felt dizzy and dehydrated despite having had plenty of fluids prior to the vaccination.   Other symptoms such as headache were present and continued for a few days
angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. 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.
Mother reported on 5/20/13 - 1 wk after vaccination her son would break out in a rash all over his body - trunk and extremities - itching - requiring BENADRYL. The rash would develop during PE, same time daily. After taking BENADRYL - 1 hour later itching would stop. 5/23/13 mother has not spoken to son today to see if itching occurring.
Sore throat, headache, chills, slight fever, fatigue, cough, and ear pain for seven days (since the night of the injection). Presents here to the clinic due to symptom duration and worsening = antibiotic due to ear infection.
50 year old female came in 10/11/07 for Tdap injection after cutting her finger while chopping wood about a week earlier.  Not ill at time of Tdap injection, allergic to several antibiotics.  No other IZs in previous 4 weeks.  Injection site (left deltoid) was sore for 2-3 days afterwards.  Itching and redness began 12/15/07.  Entire upper arm is now slightly swollen, reddened almost the whole way around her arm, feels hot and slightly hard or tight.  Small bruise at injection site.  Redness does not entirely encircle injection site.
pt recvd vax;7 days later exp weakness in lt leg followed by spasm of lt leg;pain from hip down in l4 distribution;numbness;spasms lasted 1 day;no tx;vax series discontinued
This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 18-year-old female patient who received BEXSERO (batch number 158701, expiry date 29th September 2017). On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, the patient received BEXSERO through subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccination. No further information was provided. Follow up information was received from a nurse on 24th August 2017: The patient's demographic details were updated. On an unknown date, unknown after BEXSERO, the patient undeveloped hard know to back of left arm where vaccine was administered. The outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to BEXSERO. The VAERS details were updated. This was medication error associated with adverse event.
Patient received a dose of flu vaccine instead of a PCV-20. There was no harm experienced by the patient. The correct PCV-20 vaccine was administered during the same encounter.
Following administration of Prevnar 13, child showed signs of malaise in the afternoon post-administration, did not eat or sleep well that night, and woke the next morning to a temperature of 101.9 and complaints of lower abdominal pain. Alternating doses of childrens' Tylenol and Motrin were administered throughout day two.  However, child continued to be febrile, with fever rising to 102.9, then 103, with continued and more frequent complaints of abdominal pain, lack of appetite, and disturbed sleep up to this time (approximately midnight on day two).
Positive Covid Home Test on 12/03/2022 Fever Cough Congestion
HORRIBLE pain in arm. Huge bruise/ red heat in arm. Hard lift arm. Hurts something awlful!! ??????
Systemic: Seizure-Mild, Additional Details: Patient experienced seizure within 20 minutes of administration that did not last for more than 5 minutes. Patient was able to sit back in chair to await ambulance.
Information has been received from a health care worker, via a company representative, concerning a 13 year old female, who on an unspecified date was vaccinated with the third dose of Gardasil (lot # not reported). Following the vaccination, the patient fainted. Subsequently, she recovered (duration not specified) and "was fine," with no medical action required.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
BLEEDING THAT CONTINUED DESPITE THE APPLICATION OF AN INJECT SAFE BARRIER AND A BAND AID FOR ABOUT 5 MINUTES AFTER THE ADMINISTRATION OF THE VACCINE AND WAS ACCOMPANIED BY A BLACK/RED BRUISE AT THE SITE OF INJECTION SITE AND SOME SWELLING. HOWEVER, PATIENT DID NOT REPORT ANY PAIN OR DISCOMFORT.
Pt's left deltoid is following immunization of PNEUMOVAX 23 next day was hot, red, inflamed about size of orange. Also developed fever of 100F for a day. Took TYLENOL, BENADRYL, and hydroxyzine for 5 days. Sore for 13 days and swollen for 1 week. For 3 days she was unable to move her arm. Symptoms started 9/26/18 fully recovered 10/13/18.
On June 20, 2021, I developed menstrual cramping and light spotting.  Have been menopausal for eight (8) years with no history or diagnosis of disease or gynecological issue. Did on-line research and found that post-menopausal bleeding is an identified side effect of COVID 19 vaccination. Symptoms have persisted for 24 hours as of the time of this submission.
I had a large red area on my arm (aprox. 3" x 2")  in between  my shoulder and my elbow, that was very itchy...it is now 10 days after my shot and the area is just almost gone...but it took 10 days for it to fade
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-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 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  First shipment was received it on 15-Mar-2021, and since they did not know it was refrozen, they used it beyond 14-Apr-2021. They had a sheet from the first shipment, that showed the transport conditions up to the time they had it. The earliest time on this sheet was 15-Mar-2021 at 6.45 AM, and the graph started at 0.4 degree C at 6.45AM, it had a 10-15 minutes time stamp, and stated that between 6:45 and 7AM it had -2 degree C. Once they received the shipment, they placed it at freezer temperature, at around -20 degree C. After that, they removed a vial from the freezer to use it that same day, whenever they needed a vial to administer the vaccine. The doses were viable up to 14-Apr-2021, the 30 days since it was thawed. The highest temperature could confirmed for the one shipment was 0.4 degrees Celsius, and the lowest was about -20 degrees Celsius.
No Adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medication details was not reported.  The patient received 0.5ml of the dark blue cap vaccine that was intended for use in 6-11 years old age patient, instead of the new bivalent vaccine.  Treatment details was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter)
DIZZINESS WHEN STANDING UP, HAVE TO HOLD ON WHEN GETTING UP
On 3/9/09 Pt received Td & Hep B on both L Delt.  Pt. states she has marble size knot under skin @ site.
Approximately 15 mins after injection, felt very hot, flushed, anxious. Symptoms resolved 15 mins after taking BENADRYL 25mg.
Reported rash on arm 1 week after vaccination from the innoculation site and extending to elbow. Redness and swelling followed.  At time of report (1 & 1/2 weeks after onset of rash) swelling and redness has begun to recede slowly. Pt went to private physician who has her taking antihistamine and applying cold compresses.
Patient telephoned clinic after leaving clinic (within an hour) stating he had developed 'little bumps all over' his body.  Patient was given the spelling of his vaccine and medication and advised to immediately go to the ED.
On Monday the 19th I was having a slight cough. That worsened and I had a lot of mucus the next day. I had been with my mom, and she was having a surgery and took a test for the procedure, and she tested positive. On the 21st I took a test, and it was positive. That day I had a fever 101 which it ranged from that to 103. It would come and go, I had a lot of mucus and I think I could have had a sinus infection at the same time, so I had the sinus pressure and headache. I reached out to a telehealth doctor through my insurance because I was having the fever and wanted PAXLOVID, but they did not end up helping or giving me anything to help. I did not have a fever after the 21st but the productive cough lasted another ten days or so. I am recovered but I had lost my voice due to coughing and that is not back fully so I would say I am recovered about 95%.