chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding, wetness at the injection site drainage lighter than blood color; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 93-year-old female patient who experienced bleeding, wetness at the injection site drainage lighter than blood color (vaccination site haemorrhage), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Medical history, past medical treatment, vaccinations and family history were not provided.  Concomitant medications included WARFARIN SODIUM (COUMADIN) used as blood thinner.  On 28-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ461AA, expiry date 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 28-Aug-2020, the patient had bleeding, wetness at the injection site drainage lighter than blood color (vaccination site haemorrhage) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   Other laboratory data not reported.  It was not reported if the patient received any corrective treatment or not.  On an unknown date, the patient recovered from vaccination site haemorrhage.
First episode of wheezing with severe respiratory distress 20-24 hrs after MMR vaccine. Treated with albuterol & oral steroids. Responded well. Very mild runny nose at time of vaccine administration but no other signs of illness.
Patient received the children's 5-11 pfizer vaccine instead of the adult 12+ pfizer vaccine as their first dose
High blood pressure dizziness vertigo headaches tingling in my feet and hands. Headache has been here since the second vaccination. It appeared one week after second dose
Information has been received from a nurse practitioner concerning a "normal, healthy" 20 year old black male hospital employee with no significant medical history including no immunosuppression and no known recent exposure to varicella or other viruses, who on 12NOV2003 was vaccinated with a second dose of varicella virus vaccine live as part of his employment. Concomitant vaccination on the same day included a dose of hepatitis B virus vaccine. There was no other concomitant medication. On 01OCT2003 the pt was vaccinated with a first dose of variccella virus vaccine live. On 16NOV2003 the pt reported that he began to develop a rash. The pt was seen in employee health the following day. At that time, the nurse practitioner reported that the pt had approximately five lesions on his back, five on the trunk, and 10 in the "folds of his arm" (side unspecified). The lesions were described as macular/papular, but not vesicular. The reporter indicated that if there were any vesicles, they were extremely small/minimal, and she was not really able to discern if there was fluid in any of the lesions. The patient also reported that the lesions were itchy, but had no other complaints at the time. Diphenhydramine hydrochloride, benadryl, was prescribed. He was ordered to stay home from work until the lesions resolved/ crusted over if applicable. The pt had been ordered not to work in the hospital since his rash began on 16NOV2003. The pt was scheduled to be seen again on 24NOV2003. The nurse practitioner indicated that she would like to submit a specimen to the varicella zoster virus identification program if possible but ws not sure if she would have any viable specimens on 24NOV2003. On 24NOV2003 the nurse practitioner saw the patient in the office and indicated that his rash was macular/papular and she could not obtain any specimens. the reporter stated that the initial rash started just four days after the second vacciation. It was noted that the rash was resolving, however, a new macular/papular rash was developing on the patients thighs. The reporter planned to consult dermatology since she was not sure this was a post vaccination rash or something else. The nurse practitioner also planned to question the pt further regarding concomitant medication or concurrent conditions. The reporter did not feel the pt could return to work with a pediatric population at this point. She indicated that notification would be provided if a specimen should become available. A product quality complaint was not involved. Additional information has been requested. Additional information has been requested.
Inadvertently administered Pfizer bivalent vaccine (6mo-4y) as second dose in series instead of monovalent dose.
sore throat; runny nose; phlegm; sore arm for 3 hours post first dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and VACCINATION SITE PAIN (sore arm for 3 hours post first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 3 hours post first dose). On 08-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm). At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), PRODUCTIVE COUGH (phlegm) and VACCINATION SITE PAIN (sore arm for 3 hours post first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported.
Person was vaccinated for the 2nd dose 14 days after her first shot. She came into the mass clinic and did not catch that she was early.
Nausea and extreme abdominal discomfort lasted 2-3 days. This caused eating to be quite painful and sleeping was also difficult.
pt recv vax 3FEB98;@ next visit on 3MAR98 mom reported took pt to ER on 3FEB d/t constant crying x 3hr;ER said pt had a rxn to DTAP;
infections on my tooth; Toothache; This is a spontaneous report was received from a contactable consumer (patient). A 54-years-old male patient of weight 92.99 kilograms and height 175 centimetres received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 31Jan2021 at 09:00 (at the age of 54-years-old) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that he had his first dose of the Pfizer vaccine on Sunday 31Jan2021. He said on 02Feb2021, he had a toothache and was going to the dentist, he was expecting to be started on an antibiotic. The patient wanted to know if he could take an antibiotic and Aleve (as reported) since he had taken the vaccine. He would also like to know if he can drink alcohol after receiving the vaccine. On 02Feb2021, the patient had a tooth infection and was prescribed Amoxicillin. He was asking if it was okay to take antibiotics after the first dose and wanted to know whether it would affect. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I got a flu shot and still got the flu it was worst then the covid; Initial information received on 25-Dec-2022 regarding an unsolicited valid non-serious case received from a Consumer/Non-HCP (non-healthcare professional) via Social Media.  This case involves a patient of an unknown age and gender who reported i got a flu shot and still got the flu it was worst then the covid after receiving Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed events of i got a flu shot and still got the flu it was worst then the covid (influenza) (latency: unknown) following the administration of Influenza Vaccine.  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved
Narrative: Pt was a 60 YO male with PMH of schizophrenia, DM, HTN, CAD, and drug dependence who was found deceased in his apartment by police conducting a welfare check.
Information has been received from a pharmacist concerning a 61 year old female patient with no known drug allergies. The patient had no concomitant medication or pertinent medical. On 17-NOV-2015 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L017165 and expiration date 13-AUG-2016), subcutaneously. The patient came to the pharmacy on 26-APR-2016 reporting that, 48 hours after being administered the ZOSTAVAX (approximately on 19-NOV-2015), she experienced a feeling of burning up, profusely sweating, vomiting and losing consciousness for a bit. The patient called her physician to report what she experienced, but was not seen by the physician. No lab diagnostics studies were performed. No treatment was given for the events. The patient reported that after what she experienced she was completely fine and without further symptoms on 19-NOV-2015. The causal relationship between the events and ZOSTAVAX were not provided. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 71-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX(intramuscular). On 6th April 2019, 1 days after receiving SHINGRIX, the patient experienced itchy rash and skin warm. On an unknown date, the outcome of the itchy rash and skin warm were unknown. It was unknown if the reporter considered the itchy rash and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that the patient received SHINGRIX and about one day later experienced an itchy rash on the torso that felt hot like a sunburn.
After patient had received his two vaccines this morning, within 2 minutes he expressed feeling light headedness and dizzy. His facial skin color and lip color became very pale and his skin became very cold and calmly. Concerned he may be hypoglycemic, I questioned whether he had eaten breakfast this morning which he had acknowledge he did not. He further explained that he was actually fasting for the past 12 hours now in preparation for his blood lab draw with his PCP that he was planning on heading over to after he was done here. I rushed to get him a cup of cold water and a Relion glucose liquid drink in hopes it would help raise his glucose should his blood sugars may be bottoming out. He accepted the water but declined the glucose liquid saying that he felt these symptoms would pass. Within a minute of him saying this his eyes slowly began rolling back and then he passed out. During this time he was seated and leaning against a wall so he never fell to ground nor did he hit his head. Immediately I began calling his name out loudly while firmly rubbing his sternum. Patient was none responsive to these stimuli. I checked pulse and felt he had one but it was very weak. After 30 seconds of being passed out, the patient began vomiting up the water he had just sipped on. I gently leaned his head to one side to avoid him from aspirating. Around that time he regained consciousness and was disorientated. I explained what had just happened and asked that he take deep breaths. While all this was happening, a pharmacy customer of ours was witnessing this all unfold and immediately called 911. Within 5 minutes of him regaining conscious, parademics arrived and further assisted the patient. BP was around 105/53. Glucose was 170. EKG was showing PVC, which warranted he be taken to the hospital for further assessment
falling; couldn't walk; broke leg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 14Apr2021 14:15 (at the age of 71-year-old) (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced couldn't walk after falling, broke leg (all hospitalization from 04May2021 to 06May2021, medically significant, resulted in emergency room) on 04May2021. The patient received her first dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on 05May2021. On 04May2021 the patient broke leg and ended up going to the hospital and rehab. The patient received the second dose Pfizer Covid Vaccine in the rehab center on 17May2021. The patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17May2021 4:15 or 5:00 (at the age of 71-year-old) (Lot Number: GW0168, not sure if it is the letter o or the number 0 in the lot number) as single dose for covid-19 immunisation. The patient went to the emergency room because she couldn't walk after falling on the night of the 04May2021. The patient was hospitalized for two days. On 04May2021, the patient was going down the stairs to feed the cat. The patient was going down the stairs and missed the last step. The patient remembers holding onto the rail and telling herself not to hit head or hips. The patient rolled onto the floor and felt something awkward in the leg like an electricity shock and The patient made out a yell. The patient laid down in the floor and got up and fed the car and went back upstairs to her room for one hour. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning a "previously healthy" 4 month old male who was vaccinated with the first dose of ROTATEQ. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, PREVNAR, Hib conj vaccine (unspecified carrier (manufacturer unknown), and poliovirus vaccine. At the end of January or early February 2008, the patient was observed for 23 hours in the hospital for intussusception after receiving his first dose of ROTATEQ. No lot number was provided. Subsequently, the patient recovered from intussusception on an unspecified date. Therapy with ROTATEQ was not reintroduced. There was no product quality complaint. Additional information has been requested.
Parent noticed on 1/15/19 at approximately 12:00 PM that the patients arm was hot to the touch and red. Patient complained of stiffness, swelling and pain. Patient was taken to the Emergency Room.
Pain and soreness in right breast, enlarged breast, In 2017 I had breast cancer. Stage 0 and a Lumpectomy operation was performed.
Patient reported 2 inch diameter rash and soreness around injection site as well as fever and general aches
Flushing/sweating and dizziness. After pt rested an extra 15 minutes while being hydrated, pt voiced feeling better and no more dizzines. Stable and released.
PT DEVELOOPED FEVER OF 103 AND DEVELOPED HERPERTIC RASH ON FOREHEAD AND CORNER OF LIPS AND MOUTH
Patient notified me he thought he might be having an adverse reaction to the vaccine. He complained of chest pain/back pain, and was coughing. 911 was called, and patient was sat down and his blood pressure was taken twice about 5 minutes apart (both high results). Paramedics arrived and took the patient to the hospital.
was given the COVID-19 vaccine at 1130am on 7/9/21, within 10 minutes after giving the vaccine she began to feel dizzy, nauseated, had a lump in her throat, was complaining of chest pain and a "weird" feeling in her left arm. Her initial vital signs were concerning for pulse oximetry on 88% on room air with a normal blood pressure 130/93. Given her nausea, throat tightness, and decreased SpO2 she was given IM epinephrine 0.3mg at 1144am. Her blood glucose was 96. Her vital signs were cycled every 5minutes and blood pressure remained normal., and SpO2 improved to 100%. EMS was called and arrived at 12pm, EKG was normal, and she was transported to the emergency department for further treatment.
Full body rash at exactly one week after my vaccination. Bumps that are red and irritated.  On arms, legs, stomach, chest, back and chin. Doctor prescribed an antihistamine to help with itching sensations
finger laceration of the administrator; Syringes that had the finger flange break after administration; finger flange break after administration; the removable flange safety guard not present; This spontaneous report was received from a health care professional via a company representative referring to a female patient of unknown age. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   The reporter stated that multiple hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes had a finger flange break and the removable flange safety guard was not present (MARRS # 2102USA004230).   The reporter advised that one of these episodes resulted in a finger laceration to the administrator of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S028738; expiration date 03-APR-2022) on 08-FEB-2021.   The reporter said that when the employee attempted to push the plunger down to give the injection, the flange broke and the employee's right thumb was cut by a sharp edge of the broken flange. The administrator received assistance by the healthcare provider there and the right thumb was repaired using "skin glue and then sterile strips and a dressing".  At the time of the report, the patient had recovered from the event. There was no damage noted to the syringe or the flange area prior to the administration of the vaccine. It was reported that the syringe was not cracked ant the syringe was broken into 2 or more pieces at syringe finger flange.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2102USA004230:
Information has been received form the healthcare worker who reported that on 16-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 D for 4 hours) reported as 0,5 (units not provided) of M-M-R II (HSA) (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter.  Additional information has been requested.
The patient was given BOTH varicella and ProQuad (MMR+Varicella).  Parent has not noted any adverse effects as of 1/10/2020
right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; dose_number=3; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 68-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: fc3182 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 07Oct2021 at 01:30 PM, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at Pharmacy or Drug Store (Age at vaccination: 68Years). The patient was not pregnant at the time of vaccination. The patient medical history included COPD and tendinitis. Concomitant medications included influenza vaccine (FLU), naproxen (NAPROXEN), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), salicylic acid (SALICYLIC ACID), albuterol (SALBUTAMOL), ipratropium (IPRATROPIUM). The patient received other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Previously patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: en6201 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 17Feb2021 at 10:30 AM, as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: en6205 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 09Mar2021 at 10:30 AM, as DOSE 2, SINGLE for covid-19 immunisation. On 07Oct2021 at 01:30 PM, the patient received third dose of BNT162B2 (Booster) and on 08Oct2021 experienced right upper arm swollen to half again its size, hot to tough and red 7 days after vaccination. The AE did not result in emergency room or physician office visit. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
periorbital swelling; somnolence; flaccidity; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to soy).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling). At the time of the report, PERIORBITAL SWELLING (periorbital swelling), SOMNOLENCE (somnolence), HYPOTONIA (flaccidity) and SWELLING (swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 146/91 at 9:50am high, 139/97 at 9:51 am got down from high with the treatment. and 135/88 at 10:03am. On 13-Jan-2021, Heart rate: 115, 128 and 116. On 13-Jan-2021, Oxygen saturation: 100%, 100% and 100%. On 13-Jan-2021, Respiratory rate: 16, 16 and 16.     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.   No treatment medications were reported.