chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day of vaccine, patient slept approximately 2+ hours after vaccine, then awakened unconsolable. Mother was unable to console infant, and unable to get infant to take breast. Unconsolable between 2 and three hours. Later that afternoon, infant examined by MD--consolable but fussy and not herself for 4-5 days after vaccine.
developed symptoms and tested positive for Covid on Saturday; developed symptoms and tested positive for Covid on Saturday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (COMIRNATY), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), on 04Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2023, outcome "recovering" and all described as "developed symptoms and tested positive for Covid on Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient reported that she got vaccinated with Pfizer COVID-19 vaccines on 14Mar2021, on 04Apr2021, and on 15Apr2022 as "Pfizer gray cap", and the most recent one was on 19Sep2022 as "Pfizer bivalent, lot GH9702".  She developed symptoms and tested positive for Covid on Saturday, 17Jun2023. She took Paxlovid and it helped. She also reported that her husband was also vaccinated with Pfizer COVID-19 vaccines (dates not provided), and he also got COVID and is recovering with treatment including Paxlovid. She mentioned that she and her husband were just getting over it.  The reporter further asked, "How long do we have to wait after COVID infection until we can get another booster, either the new booster that just came out or another Pfizer Covid 19 bivalent booster?".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228787 Same reporter, product, events; different patient;
He had sounds in his left ear, like birds chirping, like tinnitus.; Hearing was muffled, after third dose/trouble hearing/issues with hearing; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101317606 (Pfizer).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for covid-19 immunization; Bnt162b2 (Second dose), for covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Booster"; HYPOACUSIS (non-serious) with onset 29Sep2021, outcome "unknown", described as "Hearing was muffled, after third dose/trouble hearing/issues with hearing"; TINNITUS (non-serious) with onset 30Sep2021, outcome "not recovered", described as "He had sounds in his left ear, like birds chirping, like tinnitus.". The events "hearing was muffled, after third dose/trouble hearing/issues with hearing" and "he had sounds in his left ear, like birds chirping, like tinnitus." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoacusis, tinnitus.  Additional information: Caller states he was fine, after his first two vaccines. Caller states he went to the ENT doctor, and reclarified, he is scheduled for a CT Scan. Caller states his doctor prescribed him Prednisone but does not specify if he has started taking the Prednisone yet.  Follow-up (24Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/22/2021 ATHEROSCLEROSIS OF AORTA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/22/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
exaggerated cellulitis; painful arm; really swollen arm; Initial information received on 12-Nov-2021 regarding an unsolicited valid serious case received from an other health professional.   This case involves adult and unknown gender patient who experienced exaggerated cellulitis (Cellulitis), painful arm (Pain in extremity) and really swollen arm (Peripheral swelling) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On 08-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number : C5882AA and expiry date not reported] via an intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious exaggerated cellulitis (cellulitis) 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious painful arm (pain in extremity) and really swollen arm (peripheral swelling) 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported pharmacy intern reports 4 patients who received an Adacel vaccine between 08-Nov-2021 and 11-Nov-2021. She states that four vaccines from this box had been administered, and all four patients developed this classic exaggerated cellulitis.   It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  Information on the batch number was requested.; Sender's Comments: This case involves adult and unknown gender patient who experienced cellulitis, peripheral swelling, and pain in extremity after vaccination with ADACEL. The time to onset is compatible. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
pt recv vax 2MAY96 & 3MAY96 awoke in AM w/t103 ax APAP given & temp to 100 ax;onset of rash was noted on 6MAY96;dx of german measles;
When I woke up on 2/6/21, my arm ached. Upon looking at it, I noticed a red circle at the injection site. It burns, is itchy, and warm.
Case number PHEH2013US017178 is an initial spontaneous report received from a pharmacist on 12 AUG 2013. This report refers to an adult female patient. She was given only the CYW135 liquid component of MENVEO (batch number: M12026) intramuscularly without being reconstituted with MenA component on 10 AUG 2013. No adverse event was reported following this administration error.
Patient reported chills.  Per H&P from Hospital pt started with fever on 4/14/21 at 1400 with loose watery stools, nausea & dry heaves, bloated abdomen and dry cough
pc fr PMD 14JUL95 to report mom called PM of 12JUL95 w/ c/o fever, vomiting, diarrhea;MD contact 13JUL95 w/mom reporting fever 100-104 all day;MD eval 14JUL95 w/ T98.6, sore throat;neg strep culture;WBC 12.2;D/T fever MD reported adverse rx
24 hours after injection in my left arm, my right arm began to itch with entire arm covered with little bumps. this itchie condition & bumps lasted 24 hours. the itchieness abated but the bumps are still barley visible under the skin
About 30 minutes after the vaccine she developed a headache, that evening she had body aches, a sore throat and a fever of 100.3 which lasted into the next day.
severe headache; complete loss of taste and smell; complete loss of taste and smell; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581), via an unspecified route of administration, in the left arm on 10Feb2021 at 4:15 PM (at the age of 75-years) as a single dose for COVID-19 immunization. Medical history included asthma, mite allergy, allergy to animal (cats, guinea pigs), Vasovagal Syncope. The patient had known allergies to sulfa and Iodopropynyl Butylcarbamate. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications taken within two weeks of vaccination included pravastatin, ciclosporin (RESTASIS), calcium, and senior multivitamin. On 11Feb2021 about 9 hours after vaccine, at 01:00, the patient experienced severe headache and complete loss of taste and smell. No treatment was given for the events. The clinical outcome of severe headache, complete loss of taste and smell  was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Moderna COVID-19 Vaccine EUA- dose was given 16 days after BUD for refrigeration
Full body rash  with intense itching. Covered in poxes (very similar to chicken pox)  Treatment included large does of Benadryl, Zyrtex, hydroxyzine, Steroid cream and mmoatmeal baths to control the itching.  Reaction lasted 9 days  I am now covered in scabs including scalp  note age atvaccination was 65 the form only takes one digit as input
DRUG INDUCED POLYNEUROPATHY 6/19/2022,  11/8/2022,  11/30/2022 -- RECURRENCE OF SAME SYMPTOMS
Syncope - patient became pale, sweating, she felt dizzy, and weak; her hands were cold but she did not lose consciousness.
Information has been received from a health professional concerning a 6 year old female who on 01/07/2002 was vaccinated with varicella vaccine. On 01/08/02, the pt experienced varicella-like rash. Unspecified medical attention was sought. The child was afebrile and experienced no further symptoms. It was noted that the child had been exposed to chicken pox at school. Additional info has been requested.
Every part of his body was complaining; Super high temperature up 104 F; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Every part of his body was complaining), PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Carotid artery stent insertion (he had a stent placed in his right carotid many years ago).   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DISCOMFORT (Every part of his body was complaining), PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills). On 23-Feb-2021, PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills) had resolved. At the time of the report, DISCOMFORT (Every part of his body was complaining) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Pyrexia: 104 (High) Super high temperature up 104 F.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
A non-serious spontaneous report of arm swollen, hives, very ill, rash, fever and cough has been received from a consumer/mother concerning a 36-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient has history of seasonal allergies. The patient received FLUMIST first time this season; received injections before. The patient received pneumococcal vaccine on same day of his first dose of FLUMIST. On 11-Nov-2010, the patient received his first dose of FLUMIST and on 28-Dec-2010, the patient received his second dose of FLUMIST. The patient's arm was very swollen after the pneumococcal injection. It was treated with warm compress. On 18-Nov-2010, one week after the first dose, the patient had fever of 101-102 degrees F on every other day with a rash on his neck and face and cough for about two weeks. On 31-Dec-2010, three days after his second dose, the patient had hives all over his body. He was taken to the physician and physician did not think that the symptoms were related to FLUMIST. On 01-Jan-2011, the patient was seen by a nurse practitioner at pediatrician's office. The patient was currently prescribed loratadine 1tsp daily for his history of seasonal allergies. The nurse recommended that the dose be increased to 2 tsp for the treatment of current symptoms. The patient was also received diphenhydramine and was bathed in oatmeal baths to reduced itching. The outcome of the events arm swollen, hives, very ill, rash, fever and cough was resolved. Additional information was received on 10-Jan-2011 and incorporated into the narrative: received updates on adverse events, patient history, concomitant medication, treatment medication and outcome of the events.
fatigue/exhaustion; headaches; she couldn't lift her arms, she couldn't do anything; short of breath; a little tired and has a rash on her arm; a little tired and has a rash on her arm; This is a spontaneous report from a contactable nurse. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 11Feb2021 as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue/exhaustion, headaches on 16Feb2021, she couldn't lift her arms, she couldn't do anything, short of breath, a little tired and has a rash on her arm on an unspecified date in Feb2021. It was reported that, patient received the second dose on Thursday, 11Feb2021. She stated her mother "felt fine" that Thursday and she had: "fatigue , exhaustion and headaches", on the following Friday. She added patient "felt better" on the next day, Saturday and on the Sunday, she got up and had an "episode", which she described as: "she couldn't lift her arms, she couldn't do anything, she rested in bed all day, and she thought she felt short of breath". This morning, Monday, caller explained patient still felt "short of breath, a little tired and has a rash on her arm". Reporter enquired if the shortness of breath was reported as a side effect of the COVID-19 vaccine and what was suggested to do for the shortness of breath. The outcome of the events she couldn't lift her arms, she couldn't do anything, short of breath, a little tired and has a rash on her arm was unknown and fatigue/exhaustion, headaches was recovered on an unspecified date in Feb2021.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
During registration at , , informed  that she might be pregnant and was not sure whether it was safe to get the Pfizer vaccine.  explained to  that she could still get the vaccine even if she was pregnant. But if she had any questions or concerns regarding the vaccine and her pregnancy, she should speak to her healthcare provider first.  also told staff that was allergic to Penicillin and nuts. Staff explained to her that she could still get the vaccine, but she would have to sit for 30 minutes in the observation area so that staff could make sure she did not have any adverse reactions.  decided to go forward with getting the vaccine.  After getting the vaccine from ,  was directed to sit in the observation area for 30 minutes. During this time, , would periodically check on her to see how she was feeling, and each time  said she felt fine. After her 30 minutes were over,  told  that she felt dizzy.   asked  if she could stay longer in the observation area as it was unsafe for her to stand up and walk.  agreed. Staff offered her some candy and water to drink.  After eating some candy,  said she felt better. About 6 minutes later,  said she was having trouble breathing and that it was getting worse.  checked her oxygen level and it was 98. Staff explained to  that her blood oxygen level was normal, but said she still couldn't breathe.  tried to do some breathing exercises with her.  called EMS at 1:50 p.m. and then went outside and waited for them to arrive.  then told staff that she was having chest pain and that it hurt. Staff continued to monitor  until EMS arrived at 2:07 p.m. They assessed  and then transported her to Hospital at 2:20 p.m. to have her further
shortness of breath/lungs not filling with air; low energy; chest aches; headache; sore arm/ achy; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/lungs not filling with air), ASTHENIA (low energy), CHEST PAIN (chest aches), HEADACHE (headache) and MYALGIA (sore arm/ achy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/lungs not filling with air), ASTHENIA (low energy), CHEST PAIN (chest aches), HEADACHE (headache), MYALGIA (sore arm/ achy) and COVID-19 (tested positive for covid-19). At the time of the report, DYSPNOEA (shortness of breath/lungs not filling with air), ASTHENIA (low energy), CHEST PAIN (chest aches), HEADACHE (headache), MYALGIA (sore arm/ achy) and COVID-19 (tested positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She was treated with an infusion since she is older and high risk on 12Aug2021.  No Treatment information  were reported
Swelling. Redness (L) arm from shoulder to elbow. Tenderness. Fever to 102 degrees.
Woke up about 4 AM on 12/24/18 from very sore, painful muscles in my back (don't have back problems). Took an ALEVE but then about 5 minutes later started vomiting for about 10 minutes. Was able to go back to sleep within a half hour. Thought I had contracted the flu but this was the only event. Then I read all the side effects of the vaccination which prompted this report.
Difficulty breathing; Dizziness; Weakness; Chills; Fever; Nausea; headache/sharp pain in the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure and Cholesterol. Concomitant products included LISINOPRIL for Blood pressure, METFORMIN for Diabetes.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (headache/sharp pain in the back of the head). The patient was treated with PARACETAMOL (TYLENOL EXTRA-STRENGTH) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 29-Jul-2021, DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (headache/sharp pain in the back of the head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included a medication for cholesterol.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow up document received contains no new information. On 08-Nov-2021: Follow-up document received, contains no new information.
High temp (above 103), extremely fussy (looked like in pain), legs felt feverish with "carpet burn" like areas above injection site, diarrhea.
Fever; chills; body ache; stomach ache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 25Jan2021 10:45 at single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had unknown allergies to medications, food, or other products. Concomitant medication included hydrocodone. On 26Jan2021 01:30, the patient experienced fever, chills, body ache and stomach ache. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Clinical outcome of the events was unknown.  Information on the batch/lot number has been requested.
Patient complains of facial swelling and numb feeling in the face the evening after receiving the vaccine. The patient did not have any difficulty breathing and took over the counter allergy medication. Patient was instructed to switch to Benadryl and if it continues to worsen or affects breathing to seek immediate medical attention.
The day after vaccine he developed fever 100.3, fatigue, severe headache, myalgias. He returned to office the next day (7/31/11), still ill. No local reaction noted. He was sent to ER for labs, possible meningitis evaluation. Labs-WBC 12.3, otherwise CBC normal. Felt to have viral syndrome vs febrile vaccine reaction. As of 8/5/11 patient now feels better, recovered.