chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6203) via an unspecified route of administration, administered in left arm, on 12Mar2021 at 11:30 (at the age of 49 years old) as 2nd dose, single dose, for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of report. The patient has no known allergies. Concomitant medications included amlodipine, olmesartan and etonogestrel (NEXPLANON), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Feb2021 at 10:30 A.M, for COVID-19 immunization. The patient has no other vaccine in four weeks; she had no COVID prior vaccination and was not tested with COVID post vaccination. On 13Mar2021 at 03:00 A.M on Saturday morning, it was reported that the patient experienced chills and body aches. She took tylenol at 4 A.M which helped, and she also had a fever and body aches all day Saturday and into Sunday. Tylenol helped with symptoms. The outcome of the events were recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Swollen, erythematous rash at injection site approximately 24 hours after admin. Treated with BENADRYL with no reduction in symptoms.
Diarrhea. Administered Immodium.  Controlled by 12 PM
12 hr after vaccine, pt had temp of 40 C. Myalgia, dizziness, and generalized weakness. F/up call in morning - fever cleared.
Nausea immediately following injection and burning in throat. Next day, extreme joint pain throughout entire body.
Wisdom tooth extraction; fever; hypersensitivity; strange feelings in his spine and his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EP7533) at the age of 17 years as dose 1, single and administered in arm right, administration date 21Apr2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TOOTH EXTRACTION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Wisdom tooth extraction"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "hypersensitivity"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "strange feelings in his spine and his back". Therapeutic measures were taken as a result of tooth extraction.  Additional information: The reporter states that her son has already the first and second dose of the Pfizer Biontech COVID-19 vaccine. He just got his wisdom teeth extracted and is on methylpredniso-lone. The reporter didn't mention the date. Last week her son underwent wisdom tooth extraction and now her son is requiring Methylprednisolone. The reporter questions is if her son should wait to get the booster dose after this procedure. The reporter is reporting this because the extraction happened after the COVID vaccine. The reporter clarified that her son had the last vaccine back in Apr and he had his wisdom teeth taken out last week. The caller wants her son to get the booster and is wondering if the medication he's on will lessen the effects of the booster. The reporter stated that her son has a hypersensitivity to vaccines. He has strong reactions to them but not anything that makes him go to the doctor. He is just hypersensitive which is really weird. He is not looking forward to the booster because it will put him in bed for at least 24 hours. just with the COVID vaccine and he just had the same reaction to both. He's the kind of person that when he's going to have a fever he feels it coming on. That's what the caller meant by hypersensitivity. He had strange feelings in his spine and his back; just weird reactions to it.  The vaccination facility type: It was a place called in withheld. It was a technical college where withheld had a full service vaccination thing going on.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.
Tinnitus began approximately 3 weeks after first vaccine. I received my second vaccine on 3/14/2021. I am still experiencing tinnitus. I have seen two ENT doctors regarding my condition.
Initial unsolicited report received from a consumer (patient herself) on 26-Apr-2018. This case involves a 69-year-old female patient (age was not reported), who was vaccinated with 0.5 ml single dose of YF-VAX (Batch number, expiration date and dose in series were not reported) via subcutaneous route in left deltoid on 04-Apr-2018. The patient had a medical history of glaucoma, high cholesterol and no known drug allergy. It was reported that the patient had cortisone shots previously and did not experience such discomfort. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced hip was very painful and having trouble moving the joint (On a scale from 1 to 10 her pain level is an 8), not any redness or swelling to the area and having a headache. Lab data was not reported. Patient received CORTISONE SHOTS on 19-Apr-2018 as a corrective treatment. The patient was not yet recovered/resolved from all the events. List of documents held by sender: none; Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruing out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
p/vax pt exp local rxn of 4x6cm area of swelling & redness;
where they gave the shot was red; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9263, Expiry date: Unknown) via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021, the patient reported that where they gave the shot was red. Therapeutic measures were taken as a result of where they gave the shot was red. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201075 Same reporter, different patients/ events.
This non-serious initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 38-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 18703 (as reported), expiry date: Apr-2018, route of administration and anatomical location: not reported). The patient received the vaccine under 65 years of age, which was considered as inappropriate age at vaccine administration. It was reported that, no reactions were occurred after administration of vaccine. The reporter assessed the report as non-serious. Significant case correction received on 27-Sep-2017: The event was changed from no reactions to no AE (adverse event). The narrative was amended accordingly.
adverse effect of the Moderna booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine). At the time of the report, VACCINATION COMPLICATION (adverse effect of the Moderna booster vaccine) outcome was unknown.            Patient reported an adverse effect of the Moderna booster vaccine. No concomitant medication were provided. No treatment information were given.
On 9-20-2012/0940 pr received one year old vaccines per dr orders. Pt s/s of allergic reax approx two to three minutes after vaccine given noted. Hives on pt face, neck area per dr order pt given 2.5 mL cetirizine. Pt tolerated well. Pt status check at 1000 pt ok.
Muscle and joint aches, low-grade fever, soreness at injection site noticeable about 8 hours after injection continuing to the next day. Symptoms are still present and controllable with ibuprofen.
faint; I start to see blurry; I start to sweat; nauseous; blood pressure was dropping; headache; fever; chills; joint pain; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 56 years) for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]); fish oil (OMEGA 3 [FISH OIL]); zinc (ZINC); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient received the first dose of COMIRNATY on 30Mar2021, 11:00 in the left arm at the age of 56-years for covid-19 immunization. On 21Apr2021 at 19:00, when the patient stood up for 10 minutes she started to see blurry,  start to sweat, felt nauseous and felt like going to faint, she had to sit or lie down immediately so she don't fall. Patient sweat cold as if her blood pressure was dropping, this was happening to her on the second day after the second dose, also headache, a little fever, chills and a little nausea, on the third day (at the time of the report) she got up and stood up for 10 minutes again the same thing happened to me, although I no longer have fever or joint pain only a slight headache. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on data given and temporal association, the event syncope is assessed as possibly related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Hives; A spontaneous report was received from a physician concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273 ) and experienced hives.  The patient's medical history was not provided.  No relevant concomitant medications were provided.   On 30 Dec 2020, approximately half an hour prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced hives half an hour later after the injection. Treatment for the event included Benadryl and physician was not sure if patient took steroid as well.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event hives was not reported.; Reporter'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.
This child came with his parents to COVID vaccine clinic to receive dose 1 of the Moderna under age 6 product. After vaccination, it was discovered that patient had received the Pediatric Pfizer (ages 5y-11y) vaccine 12/29/2021 and 01/31/2022. For those doses the parents listed the DOB as 06/29/2016 instead of 06/29/2018. The appointments in Acuity, all of the demographics including email address and home address match. The DOB is only off by the year. We pulled the paper consent from December. Both were filled out electronically and appeared identical in style and printing. The Father?s signature also appears identical. The Nurse confronted the parents and they denied this. They only wanted to prove that his DOB today is correct. The Father said ?the signatures are similar but not exactly the same?.  We have canceled their dose #2 appt.
pt c/o severe flu sx 2 days p/vax;t101, body aches, severe sore throat, nasal congestion, cough & fatigue;
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23. During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured. Additional AE filed in 02190216, 02190130, 02190106, 02190106, 021; This spontaneous report has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) lot number U022819 with expiration date on 14-JAN-2023 for prophylaxis (dose, route of administration, strength and anatomical location not reported). The pneumococcal vaccine, polyvalent (23-valent) was stored at a temperature of 1.4 degrees Celsius (°C) for the time frame of 24 hours. No additional adverse effects reported. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA007068: US-009507513-2206USA007098:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 02-NOV-2012, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of shingles or severe herpes zoster. On or about 22-JUL-2014, the patient was treated at a medical facility for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt in SNF; found to be positive for COVID; DNR/comfort measures; pt passed away in the SNF
Lips began to tingle and then went numb.  Face became warm and itchy.  Throat scratchy. First signs began about 40 minutes after vaccination and patient went to ER.  Was given Slumedrol, Benedryl, & Famotidine in the ER and observed.  Symptoms diminished and patient was released the same night.
Fever, Swollen shoulder /arm Itchy across back and shoulder blade it lasted for 10days
Vomiting, fussiness X 24 hrs, vomiting, resolved after 24 hours.
Patient started complaining of dizziness within few minutes of vaccination.  Also complaints of difficulty in breathing.  After resting on exam table, no improvement.  Although vitals remained normal.  BP: 120/80, pulse 118/min, RR: 24/min.  Patient was sent to ER from ER she was sent home in 2 hours.
Patient reported arm swelling at injection site.  She also stated that she left the band aid on for close to a week before removing which resulted in blistering at the site.
BELLS PALSY GAVE STEROIDS FOR 1 WEEK AND STARTED TAKING VALTREX  ON 01/23/2020
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
After receiving the vaccination, I experienced slight soreness at the site of the injection and a mild headache every day until Friday 12/25. Starting Friday  evening 12/25 I started to experience tingling around my jaw  after flossing my teeth. It continued when I woke up the next day and spread to my chin and around my lips. I now feel the sensation on my forehead as well. In addition to this I have been having chills, runny nose, pressure in my face, head, and ears, had diarrhea X1 and have been nauseous . I tested COVID negative on 12/28 and had my electrolytes checked along with CBC which all came back normal. Today 12/29 I took 2 Benadryl in the event it could help an allergic reaction.
I had vaccination 10/06/2022. On 03/24/2023 I had a runny nose frequent cough and tachycardia. I did not have a fever. I had a telehealth appointment and was prescribed Paxlovid. I feel I have completely recovered as of 04/26/2023.
20MAY sore rt leg over weekend; definite bruising to inside of rt thigh; no fever; 24MAY seen by MD appears to be local react, red area, warm, hurts to touch; looks like bruise; 31MAY over weekend fever, red rash to abdo, chest, eye matting
21FEB99 inc fever, nasal drainage, cough-sudafed, APAP, flu dx;
Pt LMP 7/29/09.  Vaccinated first trimester.  Early-onset IUGR noted (by 22nd week gestation) in fetus after serial first trimester ultrasounds had shown appropriate interval growth.
FEVER ,DIZZINESS, BILATERAL DEAFNESS, TINITUS  TREATMENT -  PREDNISONE,  EAR DROPS, IBUPROFEN STRICT BED REST.
w/in 15mins p/vax pt had the feeling of tightness in the throat & chest; pt also c/o chest pain; pt devel wheezing; this responded to inhalation of albuterol; pt had an absolutely neg hx for asthma or other resp problems
Headache; chills; aches; itching. I also had pain and severe itching of the left shoulder. I was later treated for shingles one week after the shot. I know the Pfizer triggered this. I had these symptoms of pain and itching within 2 1/2 hours of taking the vaccine.
Twenty minutes after injection patient reported tingling to left arm and back.  Faint pale pink macular rash to left forearm.  VSS.  No reported distress.  Within 20 min patient reported decreased tingling.  Faint rash remained.  D/C'd home.
Critical lower leg ischemia. Pt had thrombolysis of left lower extremity on 2/23 followed by angiogram. He had complete resolution of the thrombosis. Discharged home with follow up with vascular clinic as well as addition of Plavix. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 25 days later.
Extreme burning pain throughout my spine within 2 hours after vaccine, then bottom of feet and hands were also extremely painful , still having issues with that since vaccine on and off and then today 5/13/2021 I went in the sun for only 5 minutes and my shoulders are Burning and developed a rash on both shoulders within minutes however I had clothes covering the shoulders and you cant even touch the shoulders as they were burning hot ( but just the shoulders ) .. This has never EVER happened to me in my life.. My body has been so off since this vaccine I am miserable.
Patient is experiencing double vision since the injection.  It was originally constant and now random.  Patient also had kidney stones, sepsis, emergency stent placement and kidney stone removal within 10 days of shot.  Did not have previous vision problems and has not seen an md yet for the vision issues
Pt's arm swelled up, red- this lasted until Saturday morning.  Yesterday, she states her entire arm was sore, pain in the axilla. It was very sore to touch still.   No fever, no rash, no shortness of breath
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route of administration were not provided), lot # reported as L020157, expiration date 12-MAR-2018. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions
Noticed a lump and soreness near the injection 9 days after my first dose. The following morning it had turned into a rash about 5-6 inches in diameter. A bit itchy but otherwise no discomfort. Just concerned about taking the second dose.