chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild sore shoulder for me; The injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 20:00 (Lot number: EL9265) at the age of 67 years as dose 1, single and administered in arm left, administration date 22Mar2021 20:00 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: " Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; METFORMIN; EXFORGE. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "mild sore shoulder for me"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "The injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10)". Therapeutic measures were not taken as a result of arthralgia, vaccination site pain.  Additional information: The patient stated both me and my wife were vaccinated at same times and locations for all three doses. The patient stated the first two doses let to a mild sore shoulder for me but not for my wife. The patient stated booster injection for both of us were very painful, and our arms (right rear) continues to be very tender and painful 20 hours later. The patient stated we also received our senior dose Flu shot in the same right (front) arms. The patient stated this injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10). The adverse event start date reported as 05Nov2021 at 17:00. The patient received the third dose of BNT162B2, administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 68 years as dose 3 (booster), single. On the same day, the patient received Flu vaccine (Lot number: unknown) as dose 1 in arm right. Vaccine was administered at pharmacy or drug store. The patient was not received other vaccines within four weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination were Lantus, Metformin, generic ExForge. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
several pts recvd Engerix-B & exp back ache 1 to 10 days later;
headache; Very dizzy- I feel like room is spinning- disoriented; Very dizzy- I feel like room is spinning- disoriented; chest pain; numbness in left arm; fatigue; brain fog; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration on 15May2021 12:30 (at the age of 48-year-old) in left arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) in two weeks included fluoxetine hydrochloride (PROZAC); bupropion hydrochloride (WELLBUTRIN); ketorolac tromethamine (TORADOL); prednisone; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium citrate malate, colecalciferol (MALACAL) all taken for an unspecified indication, start and stop date were not reported. The Patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8734 and Expiry date was not reported), via an unspecified route of administration on 24Apr2021 12:30 (at the age of 48-year-old) right arm as dose 1, single for COVID-19 immunization. On 15May2021 20:00, the patient experienced headache, very dizzy- I feel like room is spinning- disoriented, chest pain, numbness in left arm, fatigue and brain fog. The patient did not receive treatment for the events. The outcome for the events was not recovered. Sender's Comments: Linked Report(s) : -PFIZER INC-2021516068 similar report from same reporter.
They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; They made a mistake giving my doses and they gave me more dose than I was supposed to get; not gave me the right dose; dull burning sensation in her chest and congestion.; sore injection arm; dull burning sensation in her chest and congestion.; I had headache yesterday after getting the vaccine and then I woke up to headache today; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0183), via an unspecified route of administration on 18Jun2021 at 09:00 (at the age of 33-years-old) as 2nd dose, single for covid-19 immunization. The patient medical history was none. The patient did not take any concomitant products. The patient did not receive any prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on unspecified date. On 18Jun2021, the patient experienced that patient reported that she received her second Pfizer Covid vaccine dose yesterday 18Jun2021 and was given more than the recommended dose. After her second dose on 18Jun2021 she also reported a sore injection arm that same night reported a dull burning sensation in her chest and congestion. She further stated that that they made a mistake and that was just giving my doses yesterday, they gave me way more than what I was supposed to get. They told her to monitor her symptom from the day because she never heard anyone stated have like burning sensation (in chest), she knew that was caused from not giving the right dose. The patient further added that first dose just a sore arm but after the dosage yesterday (second dose) she had a very sore arm than the first. She had headache yesterday after getting the vaccine and then she woke up to headache the next day. Upon follow up (19Jun2021) lot number added, and event headache was added. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown while outcome for headache was not recovered.  Follow-up(19Jun2021): This is a follow-up spontaneous report from a contactable consumer. Added new information regarding Other Products: No, Patient History: No, Investigation Assessment: No, when probed for second shot vaccine LOT#, consumer stated, "LOT#EW018 then may be 3." Any Prior Vaccination: No, added new event, I had headache yesterday after getting the vaccine and then I woke up to headache today." When probed for any treatment for the problems (events), consumer stated, "No."  Information on Lot/Batch number was available. Additional information has been requested.
Small rash at site of injection. Small red itchy bumps on upper arm starting day after vaccine was administered. No treatment.
Worst was swelling of gums in left side of mouth; plus slight temp; chills; aching over all body; This is a spontaneous report from a contactable consumer. This 87-year-old female consumer (patient) reported that:  A 87-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 11:00 (Batch/Lot Number: 59267-1000-2 FF8841) as DOSE 3 (BOOSTER), (at a age of 87-year-old) SINGLE for covid-19 immunisation. The patient previously took bnt162b2 for covid-19 immunisation. Medical history included hypothyroidism, anaemia, aortic aneurysm, allergies with morphine sulfa drugs, and lisinopril. Patient has no covid prior vaccination, and not tested covid post vaccination. On 06Oct2021 08:00, the patient experienced worst was swelling of gums in left side of mouth, plus slight temp, chills, aching over all body. No treatment  received for AE The patient underwent lab tests and procedures which included body temperature slight on 06Oct2021. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.
Screaming non stop for hours following shots, redness to legs - child wouldn't drink, be held or even touched for hours.  Mom gave tylenol.  Child screend and chart marked for allergy.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 39-year-old male subject who was vaccinated with ENGERIX B (Glaxosmithkline). On 12 September 2008, 10 October 2008 and 5 January 2009 the subject received 1st dose , 2nd dose and 3rd dose of ENGERIX B (20mcg/mL, left deltoid, right deltoid and left deltoid respectively).  On 05 January 2009, the subject experienced drug dose administration interval too short. On 20 March 2009, 74 days after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. On 20 March 2009, hepatitis B surface antibody was low at less than 1.0. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality statement: ENGERIX vaccine lot numbers AHBVB703AA, AHAVB584AA and AHBVB670AA met the requirements of Quality assurance's specifications and the batches were suitable for vaccination purposes.
Extreme fatigue and dizziness. Mental confusion.  Fever.  Extreme chills.  Within 10 hours of receiving shot.  Mild Right arm swelling noted down two fingers wrist pain on right arm because of swelling fingers stiff and painful to move.  Could not lift right arm elbow back or up more than 45°.  Could not use right arm to lift cup of water to mouth or move pillow.  20 hours after immunization extreme chills unable to get warm.  Arm swelling improved hand pain wrist pain improved still cannot lift arm.  Unable to go to work.  Day two still unable to go to work.  Chills improved but extreme muscle aches rash on chest and facial swelling.  Faigue.
Patient first noted edema and joint pain in the Fall of 2000. She developed eye pain in the winter of 2000. She developed Raynaud's Syndrome in January 2001. She has also developed back pain. Patient given second Lymerix vaccine on 8/25/00 and the third in December of 2000.
Associate stated about an hour and half after he had the flu vaccine administered; he developed a cough, 15 minutes later his face, head, neck and ears were flushed. During the next 15 minutes, his cough became worse and he felt his throat was constricted. He did not feel normal and there was a change in his voice. His co worker had him taken to the ER where he was evaluated and treated with medication (fexofenadine, famotidine), monitored and was released after his symptoms resolved and his blood pressure was normal. His throat was sore for a few days after.
12:30. Complained of headache.  VS: 170/74; p. 74 R 16. Sats 98% . Took Amilodopine 5mg (self med) 12:35.  Rested quietly. Immediate evaluation by onsite EMS and NP. Offered water. 13:02  VS: 150/73; hr 70; R 14. Sat. 96%  . DIscharged to home with improvement in headache at 1:05 pm.
Patient came in our office c/o left arm pain radiating up to her left side neck glands. The vaccine site was very red (large) and very hot to the touch she also had a red spot on her face the size of a quarter after getting this vaccine.
Not feeling well experiencing nausea; Not feeling well experiencing nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), NAUSEA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Not feeling well experiencing nausea".  Additional information: Patient had his 1st dose of COVID-19 Vaccine (08Apr2021) and 2nd dose will be today (29Apr2021) but he can't make it because the patient was not feeling well experiencing nausea and wanted to reschedule his 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Eye issues flashes; Floaters; blurred vision; low White Blood Counts; High PTT; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol. The patient did not have allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin calcium (LIPITOR), vitamin D NOS, and macrogol 3350 (MIRALAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient experienced eye issues flashes, floaters, blurred vision, and "IRH", new sudden onset. Follow up bloodwork revealed low white blood counts and high PTT. The patient stated treatment was received: cautious observation (as reported). The clinical outcome of eye issues flashes, floaters, blurred vision, low white blood counts, and high PTT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 69 years old female patient who was vaccinated with once 0.5 ml dose of TENIVAC (lot: U5541AA, expiry date: 12-Jan-2019) via intramuscular route in the left deltoid on 09-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference;
The patient came in for #2 Covid Vaccine.  The nurse diluted incorrectly with 0.3 ml saline instead of 1.3 ml.  Patient waited 15 minutes with no problems.  Phone call to mom states child is not having problems.  Phone call to doctor.  She stated to call mom and leave number in case child has a problem.  Mom was given number to call if needed over the weekend.  Mom verbalized understanding.
Developed a sore arm; chills; overall not feeling well.; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension. On an unspecified date, the patient experienced a sore arm, chills, soreness and just overall not feeling well. Patient wants to know if she can take tylenol for the side effects. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Right after the injection I did not notice any symptoms, I sat for 15 minutes and felt fine. A few days later I noticed some red bumps on my stomach and back area only. The bumps seem to be staying the same, they do not itch and are not in any kind of specific pattern. I do not have any other major symptoms. The rash is not painful, not hot, and i do not believe it was due to anything else.
LLE pain radiating down leg with tingling x 4 days; received J&J on 9Apr21; additional pain on LUA at injection site
DEMAND ISCHEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 3/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
According to an article I read it is being referred to as COVID arm? I have a baseballish size rash on my upper left arm. It is itchy, hard and warm. It is not keeping me from normal daily activities, but is noticeable. Icing it does help. So far I have had it about 36 hours. It showed up on March 18. My first shot was on March 10.
Pt recv vax on 10/6/98; 2 hr later pt exp shivering, quivering lips.  At 12:30 PM pt exp fever (102.5); tx=Tylenol/Motrin.
ON 5/7 SHE HAD SYMPTOMS INCLUDING  FEVER, MIGRAINE, CHILLS, FATIGUE AND BLURRY VISION.    ALL OF THE SYMPTOMS WENT AWAY QUICKLY EXCEPT THE BLURRY VISION.  HER VISION HAS BEEN BLURRY EVERY SINCE 5/7.  HER VISION IS CONTINUALLY BLURRY.  IT DOES NOT COME AND GO.  I CALLED THE PATIENT BACK SEVERAL TIMES TODAY TO SEE WHAT HER PCP DECIDED TO DO  BUT
Information has been received from a physician concerning a female with no pertinent medical history and no known drug allergies who on an unspecified date may have been vaccinated with a 0.5 ml dose of GARDASIL in her right buttock while at another physician's office. Lot number 0573X was reported, but the dose number was unknown. The total number of doses given was not reported. Concomitant therapy included YAZ. Subsequently the patient developed visible dimpling at the site. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
pt presented to ED one day after being seen at urgent care with a positive COVID test; SOB x1 wk with non-productive cough; HX of Cancer, diabetes - IDDM, HTN; diagnosed with acute respiratory distress, COVID pneumonia, chronic renal failure; pt's condition deteriorated and she died at the hospital
Bloody stools 24 hours after administration of ROTOVIRUS - continuous for 6 d
the vaccine was administered early - the 3 dose was given on 3/3/22 - dose 4 should have been administered at least 4 months after the 3 dose - no advers effects noted
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 66 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot no UI9958A and expiration date 01 Mar 2019) via intramuscular route in the left deltoid on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (FLUZONE HD was arrived warm and wasn't stable). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Patient states "hurting all over." Temperature went from 98 degrees to 99 degrees.  Her blood pressure was normal when checked twice.  Three hours later she started having a rash around neck.  Multiple times we asked her if her lips or throat was swelling.  She said no.  She went to urgent care-they sent her home with advice to take Benadryl or APAP.
It was reported that a female pt received a Fluzone UNSP vaccination, date not reported. Reportedly, sometime post vax, the pt developed a fever, tightness in chest, chills and general body aches. Pt is also coughing up yellow sputum. A chest X-ray and a throat culture have been done. Doctor's dx is bronchitis. From additional information received on 11/14/99, it was reported, "(Pt) called back to inform us that her chest X-ray and throat culture showed pneumonia. Her doctor put her own Levaquin. Doctor still refuses to give her information to file a VAERS report because he told her she did not have a reaction to the vaccine, she has pneumonia.
This spontaneous report was received from a 66 year old female patient reporting on herself. The patient's pertinent medical history were not provided. Concurrently, the patient was in an unspecified hormone replacement therapy, did not has any drug reactions/allergies and reported a sluggish thyroid (hypothyroidism). Her concomitant medications included: levothyroxine sodium (manufacturer unknown), estradiol (manufacturer unknown) and progesterone (manufacturer unknown). In July 2015, reported as two years ago in July, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, Lot # and expiration date were not reported) for prevention of shingles. On 26-JAN-2017, the patient began experiencing face numbness. Then, on an unspecified date, in 2017, her physician referred to her to neurologist who performed a Computerized Axial Tomography (CAT) scan of the brain, unspecified Magnetic Resonance Imaging (MRI) and a ultrasound of the patient's carotid artery. The neurologist advised the patient that the tests were negative. The patient was no hospitalized and did not receive any treatment for the adverse event. There was no product quality complaint involved. At the reporting time, the patient was not recovered of hypoaesthesia. The causality assessment between this event and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Three hours after the injection the site became red, swollen and painful.  20 hours later my arm from my shoulder to my elbow was swollen, extremely painful , red and hot to the touch. I went to the emergency room on 11/ 14/2019 at approximately 11:30 pm