chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 4 decade old male of unspecified ethnicity. 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: unknown) dose,1 total, start therapy date was in either April or May for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced suspected covid-19 infection. The patient had experienced symptoms additional to testing positive and had contacted physician concerning the symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The type of test performed was unknown. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000185108.; Sender's Comments: 20210713582-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Client developed a severe headache 1 or 2 days after the yellow fever vaccine. The headache persisted for 5 weeks. She was taking 1 to 3 Vicodin per day. The headache finally went away after a course of Prednisone.
Information has been received from a physician concerning a 71 year old male who on 08-AUG-2007 was vaccinated with Zostavax (658085/0882U). On 17-AUG2007 the patient experienced a generalized pruritic rash. The patient's generalized pruritic rash persisted. Additional information has been requested.
one week after vaccine, developed itching at injection site; two large round red blotches appeared; one at the site and one a little higher on the arm; they were each about 1.5 in diameter; slowly faded over the next 3 days
Janssen 4/8 and 12/21. Positive on 12/24
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022 at 11:45 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medication was provided. On an unknown dates, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  Date vial was moved from freezer to refrigerator on 7-Sep-2022.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.  The vial had undergone temperature excursions. Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  It was reported that no adverse reactions were reported to their knowledge for any patients. Treatment medication was not provided by the reporter.
Patient should have received COVID19 PFIZER UPDATED BOOSTER 12+(BIVALENT) and received COVID19 (PFIZER AGE 12+) GRAY CAP.
Pt reported history of anaphylaxis to peanuts and bee stings.  Advised of risks of allergic reaction and requested 30 minute wait.  A few minutes after administration pt reported throat tightness and acid reflux similar to his peanut allergy.  Administered 25mg of diphenhydramine (10 mL of 12.5mg/5 mL solution).  After 5 minutes pt reported tongue thickening, chest tightness, and increased throat tightness.  Administered epinephrine 0.15mg auto-injector and called 911.  Continued to monitor pt.  He reported that his throat tightness subsided, his tongue felt better, and he no longer had chest tightness after epinephrine.  EMS arrived and transported patient.
she tested Home Ag positive 4/7; she tested Home Ag positive 4/7; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years 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 06Apr2022, outcome "recovering" and all described as "she tested Home Ag positive 4/7". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Family sick with COVID started 4/5 son daughter and husband. Then she got sx ST cough runny nose started on 4/6 and then she tested Home Ag positive 4/7. It was unknown if the patient received other vaccine in four weeks and covid prior vaccination. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events VACCINATION FAILURE, COVID-19 and suspect drug BNT162B2 cannot be excluded.
This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the right arm on 23Mar2021 at 14:15 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the right arm on 02Mar2021 at 16:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 02:30, the patient had experienced 101.8 fever, incapacitating headache, lethargy, aches, chills, nausea and sleeplessness. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events 101.8 fever, incapacitating headache, lethargy, aches, chills, nausea, sleeplessness was resolved with sequelae in Mar2021. No follow-up attempts are needed. No further information is expected.
Slight fever; Headache that started on top of head; A spontaneous report (United States) was received from a healthcare facility staff member, who was also a 66 year-old female patient, who received Moderna's COVID-19 Vaccine, and experienced slight fever and headache.    The patient's medical history was not provided. Concomitant product use was not provided.    On 23 Dec 2020, approximately 4 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. After four hours, the patient developed a slight fever. That evening, she developed a headache that started on top of her head.  On 24 Dec 2020, the fever subsided, and the headache lessened. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, slight fever and headache, was not reported.   The event, slight fever, was considered resolved on 24 Dec 2020. The outcome of the event, headache, was considered recovering.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the non-serious listed events of fever and headache.  Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
pt devel an inject site react consist. of swollen, red arm, felt feverish - temp not taken.
Initially, I had a fever and the normal symptoms that were to be expected. Towards the end, I was having dizziness and extreme ringing in my ears. I went to the doctor and had 2 physical therapy sessions. They readjusted my cochlear crystals in my ear. A few months later, I had floaters appear in my left eye. It was like a film with big black spots. I went to an ophthalmologist. I was checked for a retinal tear or burst blood vessels. I was told nothing was found to credit these floaters and to keep watching it. Since then, I've noticed my vision in the dark has gotten worse in that particular eye. The floaters have improved since then.
COVID+, but was + in Feb and has had vaccine since then, no COVID sx- do not suspect acute COVID infection now.
Patient developed a 3 x 7 cm area of erythema and swelling on left deltoid.
3 grand mal seizures/1st 12:00am/2nd 3:00am/3rd 5:30am
Crying, fussy, restlessness, spitting up, temp 101F, local rxn, 1 prior DTP; Recovered w/in 48 hrs;
8 days after the vaccination, a red rash appeared at the injection site.  The site became swollen, was itchy and covered the arm from elbow to armpit.    I texted my doctor and she prescribed Triamcinolone cream, which started to work after a day.  After 5 days of traetment, the rash disappeared.
The patient complained of dizziness, nausea and "not thinking clearly" within 24 hours of receiving the flu vaccination. The patient denies a fever, vomiting or loss of consciousness.
I got the flu shot once in my life years ago and got the flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.   This case involves an unknown age patient who got Influenza (I got the flu shot once in my life years ago and got the flu), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site.  On an unknown date, it was reported that the patient got the flu shot once in his/her life years ago and got the flu (Influenza) (Unknown latency).   It was reported that it did not give you the flu but the reporter mentioned that he/she was sorry that the vaccine made you susceptible to other strains. He/she got the flu shot once in his/her life years ago and got the flu. Never had the flu before that. It was 25 years ago. So he/she had not had one since then and been fine. Suggested to take vitamins which can Boost the immune system.  No laboratory data was reported. . It was not reported if the patient received any corrective treatment.  The event outcome was Unknown.  There will be no information available on the batch number for this case.
Chills; Tiredness; Headache; Coughing; Shortness of breath when I cough; Muscle pain; Nausea; Difficulty breathing; Sweating; Weakness; Feeling unwell; Fast heartbeat; Feeling sick; This is a spontaneous report from a contactable consumer or other non hcp.   A 67-years-old female patient received BNT162b2 (Pfizer BioNTech COVID-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunisation (Age at Vaccination was 67years). The patient medical history was not reported.The patient's concomitant medications were not reported.The patient experienced chills, tiredness, headache, coughing, shortness of breath when i cough, muscle pain, nausea, difficulty breathing on an unspecified date, sweating, weakness, feeling unwell, fast heartbeat, feeling sick on an unspecified date. Therapeutic measures were taken as a result of coughing.Other medications patient said she has taken some Delsym taking that for the cough, it's 10 mm (dosage unit not clarified further) every 12 hours. (Treatment of cough, hence not captured in other medications tab). Outcome of the events were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be requested.
Rolled onto my right side this morning and the room started spinning. Laid on my back for 30-45 minutes as it stopped. Tried to roll back onto my left side, spinning started again, returned to my back. After about 30 minutes I slowly sat up, little dizzy. Thought it was maybe my sinuses acting up, so went to use my nasal sprays, walking through the house like I was drunk. Nasal sprays relieved some pressure in sinuses. Contacted my business partner who replied "It's the covid vaccine. My mom and I both had this problem." At work now, a little dizzy on and off, and a little bit of brain fog.
Started to experience nasal regurgitation of fluids Friday evening 02/12. Progressively got worse the next day 02/13 and Sunday 02/14 with headache and sinus pain. Developed nausea with each swallow on Sunday 02/14. Inspected back of throat on 02/14 and tonsils look to be slightly swollen/enlarged. Just messaged primary care provider today 02/14 to request a doctors appointment.
WOKE UP FOLLOWING AM AFTER IMMUNIZATION AND C/O SORENESS TO TOUCH, REDNESS, ITCHING. SWOLLEN APPROX. 2 INCH DIAMETER. APPLIED ICE SAME DAY. 2 DAYS AFTER IMMUNIZATION NOT AS SWOLLEN, STILL SLIGHTLY TENDER TO TOUCH.
Severe swelling of both throat located lymph nodes; discomfort/pain extending to middle of chest; discomfort/pain extending to middle of chest; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 28Feb2021 08:15 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included hypertension, congestive heart failure and type 2 diabetes (in remission). Concomitant medications included clonidine; amlodipine; dipyridamole (METROPOLYN); potassium; furosemide, and potassium chloride (LASIKAL); all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Skelaxin, Ceclor and Lamisil, and experienced drug allergy. On 28Feb2021 14:15, the patient experienced severe swelling of both throat located lymph nodes, with discomfort, and pain extending to middle of chest. No treatment was provided for the reported events. The reported events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date after the patient was vaccinated with GARDASIL (dose, lot number and route were not reported) for vaccination, a small amount of GARDASIL trickled out of the patients arm following withdrawal of the needle used to administer the GARDASIL vaccine. Concomitant medications were not reported. No adverse event was reported. Additional information is not expected.
I HAD THE CHICKENPOX VACCINE ON MONDAY 03/28/2016 STARTED ON MONDAY NIGHT I FEEL SICK, I HAD FEVER OF 102 THE NEXT DAY  WHICH IS TUESDAY 03/29/16 IT WAS WORST AND WORST I WENT TO  WALKING CLINIC THE DOCTOR GIVING MEDICATION NOTHING WORK  AND I END UP ON EMERGENCY ROOM THE NEXT DAY AND THE DOCTOR GIVE ME MORE MED AND WANT ME TO STAY HOME FOR 5 DAYS.
Lump the size of a quarter.  Red mark about 5"x3".  Warm to the touch. Sore to the touch.  Still have it today 8/25/2016. Not getting better.
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown.  Information on lot/batch number for the product has been requested.
Information has been received from a physician concerning a 10 year old male (also reported as 8 year old at onset date) who on 13-NOV-2000 and on 13-NOV-2003 was vaccinated with a first dose and a second dose of MMR II (lot # not reported), respectively. On 11-JAN-2010 the patient experienced mumps (diagnosis date was reported as 13-JAN-2010). The patient experienced left parotitis and had fever of 102.7 F. On 13-JAN-2010, a blood work test showed IgM <1:10, IgG 10.16 and serum amylase 523. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Blood clot, inner right upper leg; Chills; stomach upset; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:30 (Batch/Lot Number: Er8735) as single dose for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced blood clot in inner right upper leg, chills, stomach upset, nausea, and headache on 01Apr2021 at 20:00. The events were not treated. The patient was not tested for covid post vaccination. The patient had the second dose on 22Apr2021 at 11:30 AM in the left arm (lot: Er8731). The outcome of the events was recovered with sequel.   No follow-up attempts are possible. No further information is expected.
Body aches Chills  Headache  Fever 103 Nausea  Weakness, severe misery
This spontaneous report as received from a physician refers to a 26 years old female patient. The patient was vaccinated with the second dose of GARDASIL. Lot # and route were no reported. In early September 2012, the patient developed Guillain Barre after receiving her second dose of GARDASIL. It was unspecified whether the patient received her second dose on time, and it was indicated that the patient would not be receiving a third dose. The patient was hospitalized in unspecified hospital. Unspecified treatment was given for the events. The outcome of Guillain Barre was reported as recovering/resolving. Additional information has been requested.
10/3/06-9AM-vaccine given (Tdap-Adacel). 10/4/06 and 10/5/06-Slight redness, swelling. Ice to site per pt. 10/6/06-c/o general weakness; injection site with induration, heat, swelling and noticed slight itchiness at site-continued to ice. 10/7/06-Increased weakness, fatigue; "choking" sensation and coughing with eating and drinking; no hives; noticed area of induration on same arm; the area of erythema was now about 70mm X 50mm at the injection site. A second wheal or indurated area appeared on 10/7/06 and a third on 10/9/06. The symptoms of "choking" continued until 10/10/06 when she reported to E Health. House physician assessed and treated her with Prednisone and Benadryl po. 10/11/06=Recheck in EH, no visible erythema, small dime-sized area of induration on palpation at injection site. Choking sensation is resolved. States she has received TD in the past without incident. Advised to notify PMD of event. Will need MD's advice regarding future doses of TD.
L hand started swelling up then became generalized. Rash especially on abdomen. Taken to ER.
Joint pain over entire body, chills, nausea, bad headaches, site redness and tenderness,.