chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 03/27/21 this patient came to COVID Vaccine clinic at that time the person may have received a dose of Pfizer vaccine dlluted with Sterile Water rather than the saline solution dlluent from the manufacturer. Our office was shipped 26 vials of the vaccine 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under direction the DOH sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 to 72 others who may have had a dose of this mix
5days after my son received his 2month vaccines he was taken to the ER for having a seizures. Where he then presented to have several more for the next 12ish hours. There is no family history of seizures and he has been completely healthy leading up to this. No cold of flu symptoms ever and wasn't ill the day he received his shots. He got a slight fever as results of vaccines which was treated with the recommended Tylenol dose.
Spots all over face noticed next morning (vaccine was give 6pm Thursday.  Effects noticed Friday morning). Left eye swelled up. Gave him Benadryl next day after calling doctor.  Spots diminished and are slowly disappearing.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox described as vesicles on the trunk, face, and extremities.
This spontaneous report as received from a pharmacist via Poison ad Drug Center refers to a 22 year old female patient. The patient's medical history and concurrent conditions were not reported. On 28-MAY-2017, the patient received an expired dose of GARDASIL (lot # M014929, expiry date: 27-MAY-2017), (route: intramuscular). No additional adverse effects were reported. As of 28-MAY-2017 it is unknown if the patient continued to receive another GARDASIL and the outcome of receiving an expired dose is unknown. Additional information has been requested.
Initial soreness in arm/fatigue. Tuesday through Thursday intense night sweats. Wednesday night a rash appeared on my left side. Thursday morning the rash became more prominent and started to hurt. Friday to now (1/20/21) pain from shingles rash and extreme headache/fatigue. Occasional nausea. Shingles was diagnosed Monday night at an Urgent care facility. I have been taking Valtrex since Monday (1/18/21).
Severe headaches, back tightness and pain, tingling, pneumonia, tired, swollen glands, double vision, paralysis, mono. 11/19/01 flu shot. 12/17/01 collapsed. 12/18/01-12/12/24/01 critical care. 12/25/01-1/3/02 intermediate care. 1/4/02-1/17/02 rehab. hospital out patient. 1/18/02-3/18/02 rehab. Thorocic nerve continues to heal.
Patient received DTaP/IPV/MMR vaccines on 1/6/05 PM and within 1hour showed symptoms of nose swelling with redness and complained of small "hive" on left lateral cheek along with flushing of palms and soles.  no wheezing, no resp distress.  Subcutaneous epinephrine given at time of presentation 1:1000 .2mg single dose.  Quick resolution of all symptoms.  Advised continued Benadryl at home 2tsp po q6hrs for 3days.
Patient administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva468a, expiry date 31st March 2022) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The medical assistance reported that a patient was administrated with an expired dose of Menveo. The vaccine expired on March 2022. No adverse event was reported . The reporter consented to follow up. Additional Supportive Information: The patient was administrated with an expired dose of Menveo which led to expired vaccine used.
Patient seen for a well check 08/26/2022. His mom requested the COVID-19 vaccine (Moderna). I got the vaccine ready and put in the information for the 6 years to 11 years old. I thought the patient was 6, but I failed to double check the age. The patient was actually 5. Instead of giving the 0.25mL dose, he got 0.5mL instead.
Headache; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 08Mar2021(at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 11Mar2021 at 05:00, the patient experienced headache and sore throat. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache and sore throat were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reported extreme pain in vaccinated arm and in corresponding side of chest over the weekend following vaccination (Saturday July 31st and Sunday August 1st). Patient also reported waking up in the middle of the night in between previously stated days during the weekend with extremely high heart rate.  Patient took one of his blood pressure medications to lower heart rate. He only takes these medications on an 'as needed' basis otherwise. Heart rate returned to normal after taking blood pressure medication. Patient reported normal blood pressure readings during event. Advised patient's wife to consult physician to determine appropriateness of receving a second dose.
Tues 9/7/04 had MMR and TD vaccines. At 2AM on 9/8 awoke with fever and vomiting. Later same day still fever 103.5 and hives to right side of face in clusters. Took to MD. Sibling also has flu sx with vomiting. Also sore throat. MD Dx hives r/T fever. Rx Benadryl and Motrin. Cultured for Strep. Hives resolved by Sat 9/11 after travelling down right arm.
3 weeks after injection, developed pain and induration at injection site. No erythema or infection.
Pt stated she had received the vaccine and about 1 hour later started developing a rash around her arms. Pt took benadryl and took a hot shower. the next morning it was not better and pt stated that the rash was now burning. pt was advised to continue taking benadryl and contact dr
DEVELOPED SMALL BLISTERS ON RIGHT AND LEFT LEGS ABOVE THE KNEE.  APPX 7 BLISTERS TOTAL AS OF 9/11/2014 BLISTERS WERE DRYING UP (PER MOTHER REPORT).
Pediatric patient presented to Covid vaccination clinic for scheduled first dose of Pfizer.  Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine. Patient had headache and tiredness in the days following vaccination was fine on 6/23.
This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 14-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) that was exposed to 20F for 264 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001216, 1302USA001214, 1302USA001215). Additional information has been requested.
Headache, Myalgia, Fever Lymph node swelling to left armpit. Narrative:
My arm started to slightly swell and become painful about 7 hours after I got the shot. It?s warm to the touch and moving it is painful. I?m having congestion and fatigue that started the same time as the arm pain.
MOTHER STATES HE HAD A HARD LUMP AND A 3" BRIGHT RED CIRCLE AT THE INJECTION SITE, ALONG WITH MUSCLE TIGHTNESS IN THE AREA.
Had symptoms of right arm parsonnage turner syndrome also known as right arm brachial neuritis. Symptoms were pain in shoulder followed by weakness in parts of the right arm that started during the first week of October 2018.
Few hours after receiving the Tdap, she woke up with pain, swelling and hyperpigmented became and crops of vesicles, burn like lesion as reaction to Tdap.
12 patients received fluzone hd qiv that was expired at the time of administration with no reported adverse event; Initial information received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-Dose Quadrivalent] that was expired at the time of administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired 0.7 ml dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot UT7715BA, Expiry date: 30-Jun-2023 with unknown strength and form) via unknown route in unknown administration site as Immunization with no reported adverse event (expired product administered) (latency: same day).  It was reported 'caller stated that 12 patients received Fluzone HD QIV that was expired at the time of administration. What are the next steps? Should we give the high dose again, or a non-high dose? What is non-live? How long should we wait before repeating the dose?"   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 the 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.
No adverse event; which was not 5 months out to be able to count as a booster dose; third and forth dose of Moderna were 0.5 mL doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose), ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COMIRNATY (Dose 1) on 19-Jan-2021 and COMIRNATY (Dose 2) on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY and COMIRNATY.   On 19-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose) and ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose), ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose) and ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses).    No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624659 (Patient Link).
Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022.  No adverse events were reported.  The vial did not undergo any temperature excursions.   No treatment medications were provided.
Moderna 3/10/21, 4/7/21, 10/31/21. Positive on 7/29/22
I thought I was having a heart attack; chest pain; shortness of breath; pounding; rapid heart rate; high BP; headache; malaise; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Arm Right on 20Aug2021 (at the age of 48-year-old) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia, cystitis, palpitations (heart palpitations that I take medicine for), Known allergy: sulfa (sulfa). Patient took concomitant medications (other medications the patient received within 2 weeks of vaccination). Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 30Jul2021 (at the age of 48-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Aug2021 03:00, the patient experienced i thought i was having a heart attack, chest pain, shortness of breath, pounding, rapid heart rate, high bp, headache, malaise, fatigue. The patient underwent lab tests and procedures which included blood pressure measurement: high on 23Aug2021, heart rate: rapid on 23Aug2021, sars-cov-2 test: negative on 23Aug2021 (Post vaccination). Clinical course: Within 48 hours of my second vaccine patient woke up at about 3:00 am with chest pain, shortness of breath, pounding and rapid  heart rate, high BP, headache, malaise, fatigue. Patient husband took her to the ER. Patient thought she was having a heart attack. Therapeutic measures taken as a result of events included steroids. The events resulted in emergency room and physician office visit. The events were reported as non serious. The outcome of the events was unknown.
On October 2, 2013 I received a mandatory flu vaccination. I started to have bouts of jabbing pain in my right eye on October 7th, by October 12th the jabbing pain was more severe and had a burning sensation. This pain became more intense and started to happen more frequently. I saw the dr on October 28th, a retina specialist. He advised me to see my family doctor. I saw dr on October 30th and he diagnosed me with trigeminal neuralgia, he put me on carbamazepine twice a day. The medication did not help the pain. I had an MRI on November 11th and a CT scan on November 14th. Both of these tests came back normal. Dr increased my medication on November 25th to three pills a day. The medication still was not helping the pain so I sought other options. I saw dr who is a DC on December 11 and January 6th, 2014. On January 7th 2014 dr prescribed four pills a day because the three pills were not sufficiently stopping the debilitating pain in my right eye. On February 28 I dr who is a neurologist and he confirmed the diagnosis of trigeminal neuralgia, he suggested I have a gamma knife procedure because six months is a very long time to have trigeminal neuralgia consistently. I wanted another opinion so I went to dr on March 13th, she confirmed trigeminal neuralgia and it was caused by the flu vaccination. Here are all the symptoms: Stabbing and burning in right eye, constant headache, memory loss, confusion, sad, weak bladder, fatigue, anxiety.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.
09/16/00 at 1700, small hard bump at site, quarter size, warm to touch. Bump raised slightly. 09/17, redness tennis ball size with quarter bump harder. Temperature increased to 99.6. Very painful. 09/18, the same. 09/19, same. 09/20, same redness, bump is the same, swelling and redness decreased. 09/21, bump is size of nickel, redness not as dark, still tennis ball sized, warm to touch, less painful. 09/28, continues to resolve, only has bump which is nickel size. Completely resolved on 10/06/00.
Severe aches and pins, shivering, low grade fever starting within 24 hours. i nearly went to urgent care it was so bad, much worse than the first two shots. then after i felt better several days later, i found that i could not smell or taste anything. this lasted for 6 or 7 weeks. now my ability to smell/taste is intermittent.
Patient came to pharmacy complaining he has swollen lymph node in left armpit started on 08/24/2021 evening, with minor pain
Initially no pain, then moderate-severe pain at injection site that radiated down towards my fingertips. This started approximately an hour after receiving the vaccine. Tingling in both hands and forearms, which began shortly after midnight.  Today (12/24) I have mild swelling, as well as the same pain and tingling.
The 3rd vaccine caused her heart rate to go to "99" with a little fever; The 3rd vaccine caused her heart rate to go to "99" with a little fever; she had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single unknown manufacture), for COVID-19 IMMUNISATION; Covid-19 vaccine (dose 2, single unknown manufacture), for COVID-19 IMMUNISATION. The following information was reported: HEART RATE INCREASED (non-serious), PYREXIA (non-serious), outcome "recovered" and all described as "The 3rd vaccine caused her heart rate to go to "99" with a little fever"; HEADACHE (non-serious), outcome "unknown", described as "she had a headache". Relevant laboratory tests and procedures are available in the appropriate section. Additional information The patient received the 3rd dose of the Pfizer COVID Vaccine on Friday night, 24Sep2021. She is calling today to know if she can use Valtrex, another antiviral after receiving the antiviral vaccine on Friday or would it impede the vaccine in any way. she does not think it will interact, but before she took it, she wanted to make sure there was no caution she should take before taking another antiviral. She wanted to know if it is okay to take anti-viral medications after getting the third dose of the COVID vaccine. she did not file an Adverse Event but notes that she was fine after dose 1 and 2 and states they didn't bother me. She did not have anything side effect wise after the first two COVID vaccines. She had side effects after getting the COVID booster. The 3rd vaccine caused her heart rate to go to 99 with a little fever, all of which have resolved by now she says. She just got the booster Friday night 24Sep2021.Saturday she was warm, and she had a headache. Then Saturday evening to Sunday, her heart rate was 99. Her temperature was 99. something. Her fever came down. Her pulse is back to 62. She states I guess everyone has a different reaction, nothing major. She just wanted to question if she could use Valtrex or would it have an impact on the vaccine. She really just wants to find out if she can take the medication. She was a pharmaceutical rep for 15 years which was almost 20 years ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, CoughWheeze, anosmia/ ageusia Narrative:  Employee has a fever of 102, chills, loss of taste, smell, body aches, sore throat, H.A.
High pitched screaming for 8 hours, staring spells, rash on trunk, more than normal drooling and coughing, post vax. Also, vomiting and stiff in all extremities. Pale. Was admitted 2 times to the hospital. Treated with injected antibiotic.
Large 10 cm circular rash at MMRV injection site in right thigh. Itchy, low grade fever to 100.5 F ax. Responded to oral steroids x 3 days.
7 hours after injection given noticed pain, redness and swelling. 8 inches x 3 inches inner aspect of left upper arm. Warm to touch. Placed on KEFLEX 500mg 1 capsule every 6 hrs x 7 days.
A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving intramuscular FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT(intranasal) started on 27-Oct-2014. The patient experienced fever of 100.5F which started on 27-Oct-2014. The outcome of the event of fever of 100.5F is unknown. The report was considered to non-serious.
Per the patient, she tested positive for "coxiella burnetii" on 09/24/2019 and believes it is a result of having had lhe PNEUMOVAX 23 vaccine.; This spontaneous report was received from a 38 years old female patient referring to herself. The patient had asthma. Concomitant medications included beclomethasone dipropionate (QVAR) inhaler. The patient had no other pertinent medical history or drug reaction/allergy.       In approximately September 2018 (reported as fall of 2018), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis. On 24-SEP-2019, the patient had a blood work with result of positive for coxiella burnetii. On 08-NOV-2019, the patient was also vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis.  The patient did not sought medical attention. The outcome of the event was reported as not recovered.   The reporter believed the event was as the result of having had the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
MMR and FLUMIST given.  10 minutes after leaving clinic patient returned with MD sensorium, Injection of eyes, erythema, neck, chest, hives trunk, blister with approximately 2 cm at MMR site.  2 dose 0.2 ml Epi + O2 5L; Benadryl 25 mg x 1: 911 transport ER.
Fainted / Vasovagal Syncope. 1st time I?ve ever fainted outside of a blood test. Woke up in the morning after my shot and within 30 seconds I had passed out. My girlfriend found me on the floor.