chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of expired dose of FluMist administered was received from a physician concerning a three-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FluMist. No medical history nor concomitant medications were reported. The patient received FluMist vaccine on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. A follow-up call to the reporter four weeks later on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving the expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This is in follow-up to report(s) previously submitted on 02/05/08. A non-serious spontaneous report of expired dose of FLUMIST administered was received from a physician concerning a 40-month-old female. No medical history was reported. There was no adverse event associated with this medication error; therefore, treatment and reported/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 21-Nov-2008: No adverse event occurred as a result of the medication error.
chest tightness; This is a spontaneous report from a contactable physician reported for herself. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on left deltoid on 17Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma well controlled.  There were no concomitant medications. The patient experienced chest tightness on 17Jan2021 with outcome of recovered on 17Jan2021.  Event reported as serious with medically significant. It is reported that the patient wanted to report a side effect she had when she and her husband got their first Covid vaccine from Pfizer on 17Jan2021. She had chest tightness 15 minutes later. She asked for her husband's albuterol inhaler and was back within baseline within minutes. Stated that she used her husband's albuterol inhaler once and recovered completely. Clarified the name as Albuterol HFA 90mcg Inhaler (90mcg; one box has 200 puffs). Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Palpitations  Menopause   9-1-2021 Hospitalized for Cardiomyopathy and Heart Failure
Had a rash red, raised and itchy rash. Went to Urgent Care. Applied 2% Hydrocortisone cream.
rash; facial swelling; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a male patient (Father) that. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history, concomitant medications were not reported. Therapeutic measures were taken as a result of rash (rash), facial swelling (swelling face).Treated with Benadryl. On an unspecified date The patient experienced rash, facial swelling. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient came. On 5/5/2021 to get 2nd dose of PfiZER. Specfic stadium not giving Pfizer that day and pt. had vaccine card with pfizer sticker. Pt. vaccinated with Moderna and given 2nd Card.  Patient 1st shot pfizer lot #EW 0158 given on 4/10/21. Pt. Came back today 5/20/21 to get his "2nd Pfizer dose." Error explained.Patient counseled. Recorded by RN.
Raised, painful red bump on Lt thigh. Back into office 9 days after immunization given.  Follow-up states raised red wheal on left outer thigh at site of DTaP vaccine.
not receive dose two of Twinrix series/first dose was on 04/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAB (Twinrix) and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Twinrix on 28th April 2021. The pharmacist reported that, the patient did not receive dose two of Twinrix series.  After first dose the patient had not received 1 month dose, which led to incomplete course of vaccination. The reporter consented to follow up.   The VAERS details reported for 1st dose.
Hematoma spreading from shoulder site down past elbow over last six days. Little discoloration. No pain. On Tuesday or Wednesday hematoma shown to  pharmacist who did not perform the injection. .
I was having some circulation nerve tingling feeling in my arms, so I checked my blood pressure and it was high so I saw my doctor who first recommended that I up my dosage of my current medication and also added another blood pressure and so far it has been controlled.
itchy; warm to touch; redness; A spontaneous report was received from a consumer concerning female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy, warm to the touch and red.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient stated that it was still warm, itchy and red, but there is minimal discomfort.  No treatment information was provided. She inquired if she should get the next shot and wanted to know the delayed reaction had been seen before.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itchy, warm to the touch and red, were unknown.; 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.
Information has been received from a medical assistant referring to several unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with supported vaccine products post excursion, VARIVAX lot# K007781, expiration date 28-MAY-2016 (dose and route were not reported). No adverse effects reported. There was no concomitant medication provided. This is one several reports received from the same source. Additional information has been requested.
Pt received Hep A, MMR & PCV-13 vaccines on 11 May 2011. Fever that night and 1-2 days after. No temp recorded. She also developed a rash 2-3 days after receiving vaccines. (Diffuse papular rash to trunk, lesser on extremities per Dr.). No treatments were done. All symptoms resolved by day 3. Pt was seen at the pediatric clinic 17 May 11.
2 vaccine  doses given back to back.  Total dose administered estimated at 0.45 mL. Watched for 30 minutes without  any reaction noted. Called on 3/13/2021 as still no signs of reaction.
14 yr old male given 4 vaccines syncopal episode after administration. Assisted to prone position. B/P 138/70 pulse 56 then B/P 80/60. Hydrated, ate crackers, leaving with mom, felt dizzy weak, monitored in prone position c/o blurry peripheral vision, weak grips bilaterally. 911 called at 1725 VS WNL, BS 72, EKG normal. Mother states she would bring to ER but she did not. RN called to check on client next day and he was fine.
Periodic sharp pain and aching on vaccine site; persistent and near-constant fatigue since second dose
vax administered 4PM, fever (102) started around 730PM; by 10PM temp was 103.4; parent called ER instructed to give APAP every 3 hrs; also shallow rapid breathing & lethargy, whimpering, appeared disoriented & unsure of surroundings;
Patient developed fine erythematous papular rash on cheeks after receiving the vaccine.  The rash was pruritic.  She also developed itching of her eyes and body aches.  She says it is at night.  She was already taking OTC antihistamines- Tavist, Claritin and Benadryl.  I treated with Atarax 25mg.
Constant fever between 98?101.5 over the past five days; stomach hypersensitive to salty or oily foods. Increased bronchial congestion.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Rash on chest area only, red dots; Rash on chest area only, red dots; Ongoing headache; Body aches/ body sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots), HEADACHE (Ongoing headache) and MYALGIA (Body aches/ body sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ18) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots), HEADACHE (Ongoing headache) and MYALGIA (Body aches/ body sore). On 13-Mar-2021, MYALGIA (Body aches/ body sore) had resolved. At the time of the report, RASH MACULAR (Rash on chest area only, red dots), RASH (Rash on chest area only, red dots) and HEADACHE (Ongoing headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
T 99.9, Chills, aching, no breathing pblms. I/2 dollar size red hot to touch, pain @ insertion site the same day & night. T down to to 98.6, no further chills,  no aching today. Site is still painful & painful & hot to touch. Dr notified. Took Benadryl  when obtained vaccine per drs recommendation.u
Pt had swelling of the eyes, throat closed, difficulty eating, migraine, swelling at injection site, pain in neck, shoulder and arm.
23NOV93 pt started vomiting, running a fever, mom didn't have a therometer;
Woke with spots on face and hands, looking similar to chicken pox or measles. Rash spread to arms and legs later in the day. As of 12/10/12, AM, has not completely cleared up.
Patient received 1st Moderna dose of sequence, and lost conciousness for a few seconds a few minutes after receiving the vacciene.
Created severe migraine headaches. Pt began having a prolonged, severe headache starting on day 7 after Sp vaccination and lasting several days. Lp WNL. Pt has hx of migraines, but none lasting this long. Migraines have been controlled with prophylatic meds
11:30 pm: chills, body aches, headache 3:00 am: chills subsided, then fever of 101 along with all-over aches 5:00 am: took ibuprofen, called in sick to work! 8:00 am: fever and body aches subsided, nausea began 11:00 am: nausea finally subsided after bout of emesis, headache subsided as well. Exhaustion, lightheadedness, and occasional anxiety continued for next 48 hours
Starting at 11 hours post injection: severe headache, nausea/dry heaves, fever, chills, heart palpitations for 18 hours; lingering headache for 8 more hours
Began with achy joints, fever, chills but sweating at 3 am 10/16. By noon, fever of 101.4, entire body hurt and head, eyes foggy. Could not think, focus, stand and was alternating between hot and freezing cold. This lasted until 10/17 around 2:00 pm. When fever broke, muscle and joints ached and  had no energy. Threw up all food and drink for the next 24 hours. Was able to begin eating slowing on the evening e 10/18. Joints still swollen and achy and still having trouble with no energy and my eyes focusing on 10/25.
contracted covid after getting the vaccine; contracted covid after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported similar events for 4 patients. This is 3rd of 4 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient contracted COVID after getting the vaccine. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003873 same reporter/drug/event, different patient
pt recv vax 4MAR97 & 6MAR97 pt devel five lesions that look like chickenpox;
Error in administration, a second dose was administered that did not correspond to the patient it was 37 days after the first dose. He only had one dose. First Dose 10/13-2022 Second Dose that was not correspondent because it was monovalent 11-21-2022. Monovalent 11-21-2022.
he had a sore arm but only for a couple of hours; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 06Feb2021, for COVID-19 immunization, reaction(s): "before he has asthma but after taking the second dose he is virtually asthma-free."; Bnt162b2 (Dose: 2), administration date: 27Feb2021, for COVID-19 immunization, reaction(s): "before he has asthma but after taking the second dose he is virtually asthma-free.". The following information was reported: IMMUNISATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "he had a sore arm but only for a couple of hours".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Approximately 5 minutes after receiving vaccination in his right arm, he reported itching of his right lateral thigh. He appeared pale. He denied respiratory complaints, chest pain or difficulty speaking or swallowing. Over the next 2-5 minutes while sitting on gurney, he reported progressive itching of his upper back and neck and then his buttocks.  He was administered one dose of adult Epipen at 16:25 in his right lateral thigh. His vital signs were BP=130/84, PR= 80 and RR=18. His itching symptoms improved but he still had thigh and neck/upper back itching. At 16:33 he was administered 25 mg diphenhydramine IM in his left deltoid. Over the next 15 minutes he had continued improvement of his symptoms.
This spontaneous report was received from a physician and refers to 2 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with first dose of GARDASIL 9 (lot #, expiry date, dose, strength, vaccination site, route unspecified). On an unknown date, the patients experienced intractable seizure disorder after vaccination. The reporter stated that, the patients never had seizures until they received GARDASIL 9. The outcome of the event was unknown. Causality assessment was not provided. No further information was provided. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Approximately 20-30 minutes after immunizations were given patient slumped to the ground, it appeared that she blacked out for approximately 5 seconds.  Doctor carried her to a room and asked her questions which she responded to correctly.  Observed her in office for 30 minutes and discharged her.  Patient alert, oriented with no complaints.
pt recv vax 23SEP96 & 30SEP96 pt devel a sl raised, very itchy rash consisting of more than fifty skin eruptions/lesions scattered on limbs & trunk that were red on the outside & scabby inside;
Patient hospitalized since 10/16/2021 with multiple issues. Screened for COVID-19 on 10/28/2021 and tested positive.
This spontaneous report as received from a licensed practical nurse refers to an approximately 68 years old female patient with lupus and merkel cell carcinoma. About 3 months ago (reported on 12-DEC-2012)(September 2012) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number and route were not reported) at an unspecified pharmacy in an unspecified location. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was given the vaccine even though he had both lupus and merkel cell carcinoma. The nurse reported that after the vaccination, over the following 2 months, the cancer progressed more aggressively (death, medically significant, life threatening and hospitalization). On an unknown date the patient sought medical attention. The patient was admitted to the hospital (date not provided) and died while in the hospital. The patient died about a month ago. (November 2012) and the cause of death was reported as cancer. The patient's doctor at the hospital told the patient's family that he believed that the cancer's progression was caused by ZOSTAVAX. Discrepant information reported in Source Document: patient is referred to as 'female' in the patient section of the report, but referred to as 'he' in Narrative. Additional information has been requested.
I felt a little dizzy, I would see flashes of lights when I raise my arms, I had fatigue but I haven't gotten any treatment.
Rash occurred 8 days after the shot on right arm. Still have the rash 7 days after it was first noticed. Was hot to the touch. Now just itchy
Patient stated that she hurt all over from her fingers to her toes. It lasted about 24 hours, starting at 7:00 p.m. the evening of the vaccine and continuing until 7:00 p.m. the next evening. After that, she was fine.
Fever 102 degree red bumps stomach, back , face, neck, arms and legs.  Gave him TYLENOL but made it worse.  Change it MOTRIN and gave him 7-up with jello.  He also has diarrhea and couldn't eat.  He still has diarrhea till now
Looks like keloids; Rash on fingers and knuckles; Blisters on fingers and knuckles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. In December 2022, 1 week after receiving Shingrix, the patient experienced rash and blister. In January 2023, the patient experienced keloid. On an unknown date, the outcome of the rash and blister were unknown and the outcome of the keloid was not recovered/not resolved.   It was unknown if the reporter considered the rash, blister and keloid to be related to Shingrix.     Additional Information: GSK receipt date: 06-JAN-2023 Reporters comment:  This case was reported by a patient via interactive digital media. The patient developed a rash and blisters on fingers and knuckles a week after Shingrix. At the time of reporting had what looks like keloids in those areas. The reporter asked should get a 2nd dose.
This case was reported by a medical assistant and described the occurrence of cellulitis in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. On 1/15/04 the patient received the fifth dose of Infanrix (lot DTPA610A2) in his left arm. On the same day, at an unspecified amount of time following administration of Infanrix, the patient experienced swelling of the left arm from elbow to shoulder. The reporter also stated that the injection site and swollen arm were red and hot to touch. The patient was diagnosed with cellulitis that was 10 to 15 cm in diameter and was hospitalized. Diagnostic examination revealed elevated C-reactive protien vlue. Peripheral blood culture was negative for bacteria/yeast after six days. He was treated with IV antibiotics. The events were unresolved.Follow up: The events resolved on 23January 2004. In the reporter's opinion, the events were related to vaccination with Infanrix.
Significant menstrual bleeding exactly 1 week after vaccine; subchorionic hematoma diagnosed; has now resolved; due Aug 2021; never had any bleeding during my previous 4 pregnancies; had significant fever/chills after 1st vaccine as well; no AEs after 2nd vaccine; pregnancy healthy otherwise
I have experienced vertigo and dizziness. I am still experiencing it but it has calmed a bit. Some days are better than others.
Hospitalization 9/5-9/11 for COVID. Treated with dexamethasone 6 mg IV daily and Remdesivir