chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 5Jan2021 at single dose for COVID-19 immunisation. The patient received the Dose 1 of the Pfizer-BioNTech COVID-19 Vaccine last 05Jan2021, and Dose 2 on 25Jan2021. She mentioned that she was not sure if the second dose was administered properly. She "isn't sure" she received her second dose correctly. She was worried because, she stated, "I have lower efficacy because I'm on Budesonide." She was calling to ask if it is possible to get a third dose and if so, how long would it be before she could get it. She states she had a sore arm after the second dose. The event was assessed non-serious. Information about lot/batch has been requested.
Pt given routine checks at 4 y/o physical. The following day (L) arm red, hot, swollen. Swelling extended to elbow. Had assoc fever. Taken to ED. Seen for f/u 2d later.
Reddened area 4 x 2 1/2 in area warm to touch, tenderness at Dtap site.
Pt. given varicella vaccine on 9-7-17. She reported developing a mild rash on arm of injection, and lip swelling 24 hours after vaccine given. Swelling lasted 2 days with pt. taking BENADRYL for symptoms.
Pt had rash develop on arm that was vaccinated. Pt also c/o tingling lips.
Ringing in both ears; This is a spontaneous report from a contactable pharmacist, Pfizer employee.   A 61-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 17Feb2021 (at the age of 61-years-old) as DOSE 2, SIN-GLE for covid-19 immunization. Medical history included drug hypersensitivity (known allergies: sulfa) from an unknown date and unknown if ongoing. Concomitant medications were not report-ed. The patient previously received historic vaccine as a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 27Jan2021 (at the age of 61-years-old) as DOSE 1, SIN-GLE for covid-19 immunization. Other vaccine in four weeks; covid prior vaccination included none. The patient experienced ringing in both ears started 2 weeks after vaccine 2, on an unspecified date in 2021. Event resulted in Doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included ENT visit, but nothing they could do. It was reported that ENT MD saw nothing that would cause this. Covid was tested on an unspecified date, post vaccination which included sars-cov-2 test (nasal swab) result was negative. Outcome of the event was reported as not resolved.  Information on the lot/batch number had been requested.
Linear, raised rash down right forearm from elbow to wrist. 1 hour following vaccine administration. Patient stated it lasted for approximately 1 hour. No anaphylaxis.
Narrative:  Death from COVID-19 breakthrough infection. Local health department requested report be filed with VAERS. Patient was 83 y/o with pmhx sig for Parkinson's, dementia, Afib. Vaccinated with Pfizer product 01-18-21 and 02-08-21. First presented to ED 7-20-21 with covid sx (cough, h/a, runny nose) and exposure (wife dx'd 3 days prior) -- patient tested positive for COVID-19. Patient then began declining -- stopped eating/drinking and had several falls. Returned to ED 6 days later and was admitted for 2 days and then discharged home per family request. Patient then had several more falls and continued to worsen so was brought back for another admission a few days later. Per medicine note on day before death "Pt with Parkinsons disease, advanced dementia, COVID PNA and multiple comorbidities likely to succumb to these acute and chronic illnesses within hours to days currently on hospice comfort care." Patient's date of death was 8/13/21 at 0700
Pt got the Menactra at 11 year no reaction gave the Menquadfi for 2 dose at 16 years and had allergic reaction with swelling, red and burning on the left arm  On the right arm trumenba had the same reaction not as bad as the menquadfi. We informed them that the menquadfi doesnt need another dose so we dont have to worry about that on but the trumenba needs a booster so we asked them to keep an eye on that arm to see if it gets bigger if it gets to big we might not be able to give the booster asked them to take pictures.  Told them to take cetirizine and called in a steroid cream.
pt transferred to SNF after a hospitalization for diverticulitis, pneumonia, compression fx L-1, and being positive for COVID; DNR; comfort measures; pt's condition worsened and he passed away in the facility
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-MAY-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, 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 herpes zoster. On or about 27-JUN-2016, the patient was treated at a medical office facility by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Twinrix dose that had already expired on 22/Sep/2023 was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 23-SEP-2023, the patient received Twinrix. On 23-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix dose that had already expired on 22/Sep/2023 was administered to a patient.).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2023 It was reported that a Twinrix dose that had already expired was administered to a patient which led to expired vaccine used. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
pt recv vax & devel an inj site rxn characterized by apin,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax
States did not react to pneumonia vaccine and verbalizes it does not itch. Was monitored thirty minutes post administration; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date as an unspecified dose for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, it was reported that did not react to pneumonia vaccine and verbalizes it does not itch. was monitored thirty minutes post administration. The outcome of the event was unknown.
8/26/02 4pm, 8/27/02 9:30 red area L upper arm around injection site. 8/30/02 red area gone no fever no other symptoms. Zithromax 35mg q d x 5 days.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA272311 (same reporter). This case involves 87 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiration date and dose was not reported) via unknown route in the right arm  on an unspecified date. The patients past vaccination(s) included INFLUENZA VACCINE  n NOV-2017 with Pain in extremity as it was heavy dose. The patients past medical history, medical treatment(s) and family history were not provided. On 26-SEP-2018, the patient developed a non-serious pain in right arm (pain in extremity) following the administration of INFLUENZA VACCINE. No information about a corrective treatment reported for pain in arm. The patient outcome was unknown for pain in right arm. List of documents held by sender: none.
4 y/o M presents with chest pain starting last night around 2300. No fever, no cough, no vomiting, no diarrhea, no sore throat. Pt denies any trouble breathing or SOB. Pt denies any palpations. Pt reports his current chest pain is 1-2/10 but at its worse it is 8/10. Pt describes the pain as localized and burning. Pt reports that his chest pain is constant and is exacerbated with movement. Pt has not taken any medication for pain. Pt denies any dizziness or syncope. Mom reports pt received 2nd COVID-19 Pfizer vaccine in R arm yesterday at 0930. No sick contacts. No known COVID-19 exposures. No hx of asthma, no past surgery. No hx of asthma or sudden death in family. Mom has a hx of SVT and heart murmur. Differential Diagnosis: Chest pain tachycardia, arrhythmia, myocarditis, post vaccine reaction. Pt feeling much better, is now afebrile, currently has no chest pain, no signs of myocarditis, pt likely with post vaccine reaction. Will d/c home with close f/u with Primary. Return precautions discussed.
Delayed reactivity to vaccine. 1/22/2021 - noticed red circle around injection site approximately the size of a dime. 1/24/2021 - the red mark had reduced in color but increased in size to approximately that of a silver dollar. Red outline with purplish red color (light color) in center. Some heaviness/fatigue feeling in arm. Mark still present as of 1/25/2021. Redness did not appear until over one week after initial injection of vaccine. Tenderness at injection site is mild. No treatment taken at this time.  No hospital visit.
left shoulder/upper arm red hot swollen and painful to move that started 1 day after vaccination
On 1/9 had cold sore outbreak on right lower lip (not new).  On 1/11 at 0730 started having changes in hearing mostly in right ear (never happened before) Also started having headache and red/swollen area below right eye. Uncertain of all related to cold sore or possible vaccine side effect?? Never had other symptoms with cold sore outbreak
He experienced severe itchy, flaky, dry skin on both arms that started the day after receiving the immunizations and has persisted since.  He has applied moisturizers without much benefit.
got sleepy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received single dose of BNT162B2 on an unknown date for Covid-19 immunization (Lot number: Unknown).On an unknown date the patient stated she got sleepy. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Child received Varicella vaccine that was stored at 8 deg > 24 deg. Child will have titers drawn or get revaccinated.
Event occurred after 2nd dose. Patient was diagnosed of COVID Aspirin, Tylenol Discharged home
Vaccine dose #2 on Mar 17/21.   Admitted to hosptial on 3/21/20 with chest pain, rapid heart rate, and increased dyspnea.  HR at rest 100 - 120, BP 194/96.  NO history of hypertension. Physically active,  Normal HR after 2 miles in 10 min on stationary bike = 120  Initial evaluation in Clinical Decision Unit. Admitted for Cardiac Cath.
He developed severe eczema. Two days after the DTaP vaccine, his face was completely raw and weeping. He was officially diagnosed with atopic dermatitis one week after the vaccine. He had completely normal smooth skin before the shot. Immediately following the vaccine, he developed allergies to everything he came in contact with. Prior to the vaccine he never had one reaction or symptom to anything (for example, soap, cream, food, clothing).
Delayed Itching Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Delayed Itching Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 630L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Delayed Itching Injection Site). At the time of the report, INJECTION SITE PRURITUS (Delayed Itching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: This case concerns a 69-year-old female who experienced a NS unexpected event of Injection site pruritus.  Event onset occurred 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Large swelling of approx 3 in at 2 sites - site of HPV and Varicella. Treated at home with Ibuprofen and diphenhydramine. Self resolved.
Severe headache for four days after vaccine, trouble keeping temperature below 100, extreme fatigue, shortness of breath, chills, nausea, loss of appetite, body aches, chest pain.
10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW MINUTES, STATES JUST FEELS LIKE MILD ALLERGY TICKLE/IRRITATION IS ALL THAT REMAINS. INSTRUCTED ON BENADRYL IF NEEDED AT HOME AND TO MONITOR AND SEEK FURTHER EVAL IF WORSENS. ESCORTED TO EXIT TO MEET SPOUSE WITHOUT ISSUES AT 1545. 1530 INITIAL BP 172/97 HR 98 RR 20 SATS 98% ON RA (REPORTS SITUATIONAL ANXIETY) 1540 BP 131/88 HR 73 RR 18 SATS 100% ON RA
didn't receive second shot because of pandemic; This case was reported by a consumer via  interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient did not get the second shot because of the pandemic, which led to social problem. The reporter enquired if he/ she could just sign up to get the second shot now or if the patient had to start over.
Expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  The vial was punctured on 28 DEC 2021, and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
Day after vax, L/arm was sore. Following day, has a red spot. 3rd day, blistered. 10 x 10 cm area of erythema observed on 2/15/00. (blistering with satelite lesion). Area of reaction was below & medial to where injection was given.
Pt developed heavy chest and SOB sensation with pain behind her left ear.  All self resolved after approx 10 mins.
Within 1/2 hr swelling, warm to touch, just tender and hot to touch felt and looked swollen.
Fever, chills, right hip pain. Started immediately after; so severe almost went to ER. Lasted approximately 24 hours. Rest and ibuprofen.
8 days after shot my arm swelled up and was red around injection site in about a 3 inch diameter. The left side of my mouth also swelled up
A non-serious spontaneous report of woke up with flashing light in eyes has been received from a physician concerning a 20-year-old female, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications was reported for this patient. In Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient woke up with flashing light in her eyes. The outcome of the event was unknown.
Vaccines were given on 2/9/16. Patient seen on 2/12/16 for localized reaction on left deltoid area. Reddened area is 5 inch by 4 inch, reddened slightly edematous, non painful, skin is only slightly warm.
Redness and swelling at the injection site and then large red area below it, extending from below the vax site to just above her elbow. Her granddaughter says she has fever as well, but that she is not uncomfortable.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2021-418891 (Patient Link).
But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose bnt162b2 (BNT162B2 reported as Pfizer- Biontech COVID-19 Vaccine; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration right arm on 19Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included diabetes and high blood pressure, although both are mostly kept at bay with diet and exercise. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHET SALTS XR), trazodone, metformin and lisinopril. There was no other vaccine in the last four weeks. The patient received her vaccine in a school or health clinic. The patient reported that on about 30 minutes (19Jan2021 03:00 PM) later, he got home. He felt a little tired and maybe just out of it. It's now 2.5 hours later and he is very spaced out. He mentioned that she's feeling disconnected a bit but mostly just out of it. She was not dizzy but like a bit drunk. No treatment received for the adverse events. The patient did not have Covid tested post vaccination. The outcome of the events was not recovered.
Tachypnea, CoughWheeze, LUmp in throat, chest tightness Narrative: Onset SOB,,cough, lump in throat, chest tightness w/in 2 hrs of 2nd vaccine. ED evaluation is pending. After 1st Covid vaccine, had rhinorrhea and cough.
Per FOC-patient developed L arm numbness to include fingers. Redness and swelling at site of injection. FOC called PCP.
Patient been feeling ver sick, with high ever, muscle ache and abdominal pain lasting over a week after the administration
Pain and swelling at the injection site, rash that is itching, warm to the touch and swollen. Began the day after injection and is still itching, swollen, and warm to the touch today 4/15
Patient had a syncopal episode. He fell out of his chair and hit his head and right wrist.
Severe swelling and redness at injection site, cellulitis.  The day after injection given.
10/28/09 sore throat, sleepy. 10/29/09 belly hurt, temperature 4:30 PM 102 degrees, eyes red, MOTRIN took away fever. 10/30/09 12 AM fever 103.5 degrees; sleepy, achy. 10/30/09 home today, achy stomach.
Red welt around injection site; Rash around injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red welt around injection site) and VACCINATION SITE RASH (Rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Information has been received from a physician concerning a male who was vaccinated with a dose of MMR II and was diagnosed with autism.  The physician was unsure if the diagnosis of autism has anything to do with getting vaccinated with MMR II.  The patient sought medical attention by visiting the physician's office.  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested.
patient's upper arm starting swelling from shoulder to elbow, no other symptoms reported.  advised patient to apply ice pack, take benadryl and ibuprofen, and monitor for improvement in the next 30-60 minutes.  patient called back 30-60 minutes later stating swelling was worsening.  advised patient to seek medical attention.
HAD PHIZER VACCINE:  HEADACHES,  CHILLS,  HOT FLASHES,  NAUSEA, SLIGHT TEMPERATURE.  STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE