chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose: past due; burning sensation on the left side of her chest and chest pain; rapid heart beat; dizziness; chest pain; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer reported (patient). A 45-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: unspecified), dose 1 via an unspecified route of administration, in the left arm, on 12Apr2021, as single for COVID-19 immunization in ambulance center. The patient's medical history and concomitant medications were not provided. The patient's family history included hypertension. No previous immunization with the Pfizer vaccine was given. The patient was not immunized in a long time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, immediately after receiving the vaccine, the patient experienced, burning sensation on the left side of her chest and chest pain, rapid heartbeat, dizziness and second dose was past due. No additional vaccines administered on same day. The patient did not visit to emergency room or physician Office. They told her to wait another 15 minutes. Caller received her first Pfizer Covid 19 Vaccine on 12April2021. Immediately after receiving the vaccine caller experienced a rapid heartbeat, dizziness, burning sensation on the left side of her chest and chest pain. Symptoms went away within 30-40 minutes. Caller questioned if she should receive the second Pfizer Covid 19 Vaccine. Got response. From the attached document no info under side effects/adverse reaction in reference to the chest pain & burning in the chest. Under who should not get the PFIZER-BIONTECH COVID-19 VACCINE and get response like you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of this vaccine had a severe allergic reaction to any ingredient of this vaccine. Caller stated she believed she got the vaccine on 12Apr2021, but she was not sure. She no longer has the vaccine card with her to verify the vaccine date at this time. Caller states she was past due, she had something come up and couldn't get the second dose. She was scheduled to get the second one coming Thursday, on 27May2021. She was due two or three weeks ago for the second one, so she was past due. It was in April that she got the first dose. She was supposed to get the second one the Friday before a holiday. Caller clarified her reaction to the Pfizer Covid-19 Vaccine as rapid heartbeat, some pain in chest and some burning. It was given in the left arm the burning stemmed from that side only. Also had a little dizziness. Her reactions started a couple minutes after receiving the vaccine and went away within thirty to forty minutes. No relevant tests were done. The outcome of the event second dose: past due was unknown and recovered for other events on 12Apr2021.  Information about batch/Lot number has been requested.
Papules with central pustrile   mainly on lateral aspect of trunk discreet 2 days after vaccination, lasted 6 days. No fever. Treatment 11-052009, Atarax 10mg, Saline nasal spray, amoxicillin-clavularate 600mg, triamanolone topical.
Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (cardiac arrest) and CAROTID ARTERY OCCLUSION (Block) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A,) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL PHOSPHATE and ROSUVASTATIN CALCIUM for an unknown indication.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion medically significant). On an unknown date, the patient experienced CAROTID ARTERY OCCLUSION (Block) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (cardiac arrest) had resolved and CAROTID ARTERY OCCLUSION (Block) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.
This spontaneous report as received from a registered  nurse refers to a 4 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 26-AUG-2014 the patient who was intended to received (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker (office manager), refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of VAQTA lot # L039659, expiry date 15-MAR-2017, (dose and frequency not reported), which were exposed to temperatures outside of the recommended range. No adverse effect has been reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of four reports received from the same reporter. Additional information has been requested.
Was informed by staff after administration that it was not marked with the correct expiration date.  Informed that Lot FL2757 expired on 9/30/22, but was marked as 10/10/2022
Arm pain, body aches, chills, fever of 101°F for 36 hours and temporary partial left eye blindness for 72 hours.
(2:00 AM 11/14/2021) - Feel Col/light shivering, no action taken (2:45 AM 11/14/2021) - Feel Cold/extreme shivering, no action taken (3:00 AM 11/14/2021) - Heart rate increases to 110 BPM with pounding/palpitations (3:40 AM 11/14/2021) - Heart rate increases to 115 BPM with pounding/palpitations, took 10mg of verapamil, 1 Extra Strength Tylenol (500mg) (3:40 AM 11/14/2021) - Heart rate still 115 with pounding/palpitations - Took 10mg of verapamil, 1 Extra Strength Tylenol (500mg) - Temperature 102.5F (4:30 AM 11/14/2021) - Heart still 115 BPM with pounding/palpitations, temperature 102.3F, took 1 more Extra Strength Tylenol (500mg), Blood Pressure 141/76 (5:00AM 11/14/2021) - Heart rate 105BPM, Temperature 101F (5:25AM 11/14/2021) - Heart rate 95BPM Temperature 99F (5:40AM 11/14/2021) - Heart rate 85BPM Temperature 99F Fell asleep
Headache, chills, body aches, nausea (Tylenol ~20 hours after vaccination & bed rest)
I had a sore arm at the injection site. It felt like I had the flu - body aches; joint aches. I was cold but I also I was running a fever (99 type of thing). I felt like I was a 99 year old. I felt like it was a really bad case of flu. These symptoms lasted for three or four days. Fluids and OTC pain medication for treatment. I went to hospital -  a walk-in - something to divert people away from urgent care - and no treatment from them that I remember. I had a really bad headache and that lasted for three or four days, as well.
This spontaneous report as received from a company representative via a registered nurse who was informed by the patient's mother refers to an 11 years old female patient. On 30-APR-2014 the patient was vaccinated with a first dose of GARDASIL (in the left arm, dose, route and strength not reported, lot# J014219, expiry 05-OCT-2015). Other suspect therapy included PNEUMOVAX 23 given in the right arm  (strength, dose, route, lot/batch number and indication not reported) given on 30-APR-2014 (on the same date). Concomitantly with GARDASIL and PNEUMOVAX 23 the VACCIN TH was administered on 30-APR-2014 (on the same date) in the right arm. On 30-APR-2014 (on teh same date) in the right arm. On 30-APR-2014 the patient experienced chills, nausea and high fever after receiving the first dose of GARDASIL. The patient did not take any medication for the treatment of the events. The patient sought medical attention on an unknown date in 2014 by calling the physician's office. The outcome of the events was unknown. The relatedness between the events and GARDSAIL and PNEUMOVAX 23 was not reported. Additional information has been requested.
Daughter-in-law called to report on 9/14/2013 stated pt had swollen, tender arm, difficulty breathing. 911 was called, pt brought to ER, was diagnosed with UTI with fever, administered nebulizers for asthma exacerbation, started on antibiotics and admitted for observation on evening of 9/13/2013.
The caller stated her arm always gets sore, even with the first dose of the vaccine and with flu shots.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took flu shots. On an unspecified date, the patient experienced that her arm always got sore, even with the first dose of the vaccine and with flu shots. The patient stated she received the second dose of the vaccine on Saturday and had absolutely no side effects. The patient wanted to know if it was normal to not have any side effects at all. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
12 hours after receiving the shot, he developed sudden onset of chills and fever; Tmax 101.5; + headache, body aches, fatigue and general myalgias; the arm did not get erythematous or warm but was tender; 24 hours later symptoms resolved; no residual symptoms today
Patient experienced chest pains & nausea bad enough she thought she would have to go to ER. She called her primary doctor & was told we should have waited 28 days from her RECLAST inj that dr gave at office.
Fever started 12-30-10 x 1 day. Rash started on abdomen on 1-1-11 and has no spread all over body with itching. Pt was treated with BENADRYL Elixir and sent to lab to have platelet count.
In 1996, the pt was enrolled in Lyme protocol 008 and was randomized to the placebo arm. The pt was, subsequently, enrolled in Lyme protocol 013 and received 3 injections of Lymerix on 4/10/97, 5/6/97 and 4/13/98. Per the study investigator, the pt informed the site that she was a bicyclist. During the study, 1 day post vax 2nd shot, she reported experiencing moderate fever and chills which resolved in 1 day. On 8/1/97, the pt reported having a permanent pacemaker inserted for a pre-existing cardiac arrhythmia. All events were noted not to be related to Lymerix. The pt's last study date of contact was 5/22/98 and there were no complaints reported on her follow-yp contacts. Per the pt, on 7/31/00, she experienced flu-like symptoms (consisting of achiness, chills, fatigue and sleepiness) within "hours" of each injection of Lyme vaccine during protocol 013. The symptoms were "milder" after the 3rd injection. All events after each injection resolved within "hours" without treatment or sequela. Toward the "end of 1997", vaccinee noticed stiffness as "arthritic pain" which required no treatment and physician was consulted. By the den of 1998, the pt had bilateral knee stiffness that was more intense and frequent. She was examined by an orhopedist in 2/00 who saw no swelling or warmth of joints. She received bilateral cortisone injections which were effective for a short time only. The events are currently ongoing.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered).    Concomitant medication was not provided. It was reported that they had more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date. The lot number for the monovalent vaccines with their corresponding BUD dates: 027C21A (BUD - 21May2021), 053C21A (BUD-01Jul2021), 939902 (BUD - 02Sep2021), 011F21A (BUD - 04Nov2021), 042J21A (BUD - 17Feb2022), 056M21A (BUD - 12May2022), 082B22A (BUD - 08Sep2022). The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A, (BUD - 17Nov2022), dates of administration: 18-28Nov2022, 023H22A, (BUD - 15Dec2022), dates of administration 16-20Dec2022. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received and added patient information and vaccination details updated. On 24-Jan-2023: Live follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
A report was received from a health care professional on 10/21/2003 concerning a vaccinee of unknown demography who was administered Fluvirin by an unlicensed route on 10/20 or 10/21/2003. On 10/20 or 10/21/2003, the vaccinee received one dose of fluvirin vaccine in the gluteal muscle instead of the deltoid muscle. At the time of the report the vaccinee had not experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Bloody stools that started the night of vaccines on 11/29/16. Still occurring on 11/22/16. I saw her at office, then sent her to ER. Ultrasound negative for intussusception.
Per , she has a new bruise on her right shoulder and varicose veins in a small series on her right leg. Patient claims that this bruise and the varicose veins were not there before. She noticed this around 1400 and reported it to me at 1433 over email. I then filled in this form with her over the phone.
I recieved the vaccination on Wednesday afternoon.  Thursday morning I woke up with a constant ringing in my left ear, which intensified when others spoke to me but diminished when there was silence.  I have never experienced anything of the sort and so I waited to see if it would regress.  It is now Saturday and it is still the same.  I don't know if I should see a doctor or if I should just wait to see if it goes away over the course of a month or two.  Please advise.
Approximately 1 week following immunization patient developed left knee pain, swelling and unable to extend knee fully. Symptoms worsened and she developed severe contractures requiring serial casting to strengthen leg. Currently not ambulating with pain/weakness of left knee. We ruled out neurologic, rheumatologic, ortho causes. She continue with casting and physical therapy. 3/30/06 Received partial medical records from provider which reveal normal labs & x-ray of leg revealed femoral shaft turned more outward.  Referred to ped ortho at another facility.   5/8/06 Received medical records from second facility which revealed patient developed hamstring contracture.  Eval by Rheumatologist, Orthopedics & neurologist as well as PT & serial casting.MRI & x-rays of left leg were WNL.  60 Day Follow-up Information 02-MAY-2006: Persistent knee pain/decreased range of motion. Not ambulating well. Improving minimally with Physical Therapy but unlikely to recover completely. Mild delayed gross motor milestones. Not jumping, but now walking and running appropiate for age.
rt arm swollen, red, hot arm in area of inj couldn't lift arm-swelling traveled down arm to elbow area by evening of 27OCT-lasted until 29OCT-no more pain but burning & itching on 30OCT
Felt a burning sensation during vaccine administration; Administered outside of the muscle, near to the shoulder joint,Patient concern that her / dose was given / into the skin rather than the muscle; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 2nd February 2022) for prophylaxis.   On 12th February 2021, the patient received Shingrix. On 12th February 2021, immediately after receiving Shingrix, the patient experienced burning sensation and intramuscular formulation administered by other route. On an unknown date, the outcome of the burning sensation and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details was reported as follows: The patient believed that vaccine was administered outside the muscle, into the skin near shoulder joint, which led to Intramuscular formulation administered by other route. The patient felt a burning sensation during vaccine administration but no other side effects. The reporter did not consented to follow up. No further was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021055000:same reporter
Chills, shivering, Fever of 103 degrees fahreinheit, unable to open jaw due to shivering/chills, alleviated somewhat with Tylenol administration, rash and soreness around the injection, pain upon site.
Patient is saying arm is itchy, warm to touch, and is bruised (much lower than injection site).
A report has been received from a physician concerning a three years old female patient. No medical history of the patient was reported. Concomitant medications included salbutamol, fluticasone propionate and montelukast for asthma. The patient was receiving nasal FLUMIST started on 16-Nov-2012. It was reported that the child was given FLUMIST by a nurse on 16-Nov-2012 and very shortly afterwards the child did not feel well, became very tired, weak for about 24 hours and then developed a fever followed later by a rash. For about 48 hours after she was given the FLUMIST, the child had flu like symptoms which started on 17-Nov-2012. She developed a cough, asthma conditions became worse and a runny nose with thick yellow mucous which started on 19-Nov-2012. On November 21st 2012, mother had taken her daughter to the ER of the Hospital because her asthma had flared up and she was concerned that it would not be controlled, they were seen and discharged within an hour. During the evening of November 21, the child developed a gastro type of flu and lasted until late evening November 22nd, 2012. The mother stated that she herself developed flu like symptoms on November 19th, and then had the flu though she did not receive the FLUMIST. Furthermore physician reported that gastroenteritis and cold could have been coincidental as the other children of daycare had a gastroenteritis and that the previous week was cold. FLUMIST was discontinued after one single administration on 16-Nov-2012. At the time of reporting, the child had recovered from all the reported events on an unspecified date. The reporting physician assessed all the events to be non-serious. The reporter assessed that the events of child had flu like symptoms, asthma conditions become worse/asthma flared up, developed a fever, developed a cough, daughter did not feel well, become very tired, weak for about 24 hours, later a rash and a runny nose with thick yellow mucous and developed a gastro type of flu to be causally related to the suspect drug of FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 29-Nov-2012 from the Physician: Added reporter causality for all the events. Added stop date of suspect vaccine FLUMIST. Updated event outcome. Update dosing regimen and action taken with FLUMIST. Case was medically confirmed. Narrative updated. Corrected report 11-Dec-2012: Added the vaccine details as purchased from and vaccinated at. Added concomitant medication. Added additional reporters.
stated vaccine leaked all over the medical assistant attempting to use the vaccine with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 28 years old female patient stated INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] vaccine leaked all over attempting to use the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Sep-2022 the vaccine leaked all over the medical assistant attempting to use the vaccine with no reported adverse event (occupational exposure to product). Operations manager stated that they received one broken Flublok quadrivalent prefilled syringe (lot UJ903AA, exp date: 30-Jun-2023). crack noted in the glass part in between the sticker and where the needle is attached. vaccine leaked all over the medical assistant due to the crack.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.
i was driving and my left eye stopped tracking with my right eye.  I had to pull over and let my daughter drive this lasted maybe 3 minutes .  I have never had this happen before.  I don't get sick or have issues  I have never taken a sick day in 20 plus years and I am fairly healthy