chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; Inbound call from HCP who stated a pregnant patient came in for their second dose of VARIVAX where it was determined she was pregnant and did not receive her second dose. Patient had stated she had an injection site reaction after her first dose whic; This spontaneous prospective pregnancy report was received from a nurse, and refers to a 24-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 13-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5ml, lot  U016064, expiration date 20-MAY-2023 (route of administration was not reported) as prophylaxis, which was diluted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown).  The patient stated that on 13-JAN-2023, after the first dose, she experienced an injection site reaction after her first dose which was red, warm, and itchy but spontaneously resolved on an unspecified date in 2023 (reported as "a few days after she received the injection"). The patient had an ultrasound on an unspecified date in 2023 (reported as "since the first dose") which determined "everything was fine".  On an unspecified date in 2023, the patient came in for their second dose of varicella virus vaccine live (oka/merck)(VARIVAX) where it was determined she was pregnant and did not receive her second dose. The patient became pregnant with last menstrual period of 15-AUG-2022. Estimated date of delivery was 22-MAY-2023. Initial exposure to varicella virus vaccine live (oka/merck)(VARIVAX) was at 21 weeks. The pregnancy outcome was outcome pending.   Causality assessment was not provided.
Shots given 8-12-08, Gardasil, Menactra, Varicella.
Pt called reporting fever and persistent shaking chills at 11:30pm. Earlier that day had tetanus shot w/ subsequent site pain and slight redness/swelling. Sent to ED-no treatment given.
Pain in her arm; Tingling; Weird feeling going through body; stuffy nose, itchy nose; stuffy nose, itchy nose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm), PARAESTHESIA (Tingling), FEELING ABNORMAL (Weird feeling going through body), NASAL CONGESTION (Stuffy nose) and NASAL PRURITUS (Itchy nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Trigeminal neuralgia. Concomitant products included PREGABALIN for Trigeminal neuralgia, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm), PARAESTHESIA (Tingling), FEELING ABNORMAL (Weird feeling going through body), NASAL CONGESTION (Stuffy nose) and NASAL PRURITUS (Itchy nose). At the time of the report, PAIN IN EXTREMITY (Pain in her arm), PARAESTHESIA (Tingling), FEELING ABNORMAL (Weird feeling going through body), NASAL CONGESTION (Stuffy nose) and NASAL PRURITUS (Itchy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included Octravis for Multiple sclerosis.  No treatment information was provided.
Patient states, went out to eat a few hours after receiving shot, getting into SUV and fell back and hit her head via her pony tail. Does not have a headache or bump. She did not feel dizzy. States she does not feel its related to shot. She has health conditions that cause her to fall (possible thyroid tumor, other issues). Gets sharp shooting pain in bones when about to fall, felt them the pains like normal and fell. She is supposed to use a walker and did not today. She just wanted to let us know she fell. Reporting just in case related to vaccine.
Had slight headache and nausea in between doses which resolved. Had 2nd dose on 1/20/21 and have been nauseated ever since. On approx 03/27 started having severe headache and continue to have.
Chills, nausea, fever, headache, dizziness, exhaustion, loss of appetite, malaise, lethargy
severe arm pain and shoulder for over a week; severe arm pain and shoulder for over a week; sleeping for 7 days; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 25Feb2021 (Batch/Lot number was not reported) (at the age of 70 years old) as dose 1, single for COVID-19 immunisation in a public health clinic/ veterans administration facility. Medical history included asthma. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aminophylline on an unspecified date and experienced allergies. On 25Feb2021 at 01:00 PM, the patient experienced severe arm pain and shoulder for over a week and was sleeping for 7 days. The patient did not receive any treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt presented to ED with worsening shortness of breath with cough and fatigue, pt discharged with dexamethasone.
about 30 minutes after the shot my throat began to feel strange and then I started coughing. I realized that my throat was swelling some. I coughed and was nervous for about an hour and then my throat start to let up. I felt very disoriented for several days and was unable to drive a vehicle...felt very dizzy. I felt tightness in my chest/lungs and it hurt to breath and finally after a week of this, I went and saw my PCP. I discussed what has happened and he said that he did not recommend that I get the second covid shot but if I did that I should wait the full 6 weeks. I was put on a steroid and a nebulizer.
This is a spontaneous report from a non-contactable consumer (the patient) via Pfizer sales representative. A 18-year-old patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration on unknown date (on 15Jun, year not reported) at 0.5 ml single. Relevant medical history and concomitant medications were not reported. On unknown date, 24 hours after the vaccination, the patient experienced goose bumps on fingers right hand and arm was a little stiff on unknown date. The outcome of the events was unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
After receiving the vaccine, I had a sore arm for two or three days and fatigue for one day. I started to not feel well on  11/27/2022 with a cough, fever and congestion. On 11/28/2022, I tested positive for COVID-19, and I started taking PAXLOVID. I was sick for about eight days.
itching; rash is red; rash on the back of her legs / rash is now on her arms and both wrists; small pustules within the rash area; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (historical cancer 2018 unspecified).   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2020, 20 days after receiving Shingrix, the patient experienced itchy rash, red rash, rash and pustular rash. On an unknown date, the outcome of the itchy rash, red rash, rash and pustular rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash, rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient developed rash on the back of her legs approximately 20 days after Shingrix vaccine. The patient reports that the rash was red and there are small pustules within the rash area.  The rash and symptoms are intermittent. The rash came, then went away, only to return.  The patient reports that the rash was now on her arms and both wrists, which began before reporting date. The follow up consent was not granted.
RECURRENCE OF VTE BILATERALLY IN UPPER EXTREMITIES WITHIN A SHORT TIME PERIOD OF STARTING ELIQUIS; This case was received via {BP} Pfizer Inc (Reference number: PV202300024518) on 07-Feb-2023. Information was received from a Health Professional concerning a patient, who received Suspect product APIXABAN for product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for COVID 19, lot number: Unknown. On an unknown date, the patient had deep vein thrombosis (recurrence of vte bilaterally in upper extremities within a short time period of starting eliquis), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the deep vein thrombosis was unknown. Patient with bilateral upper extremity DVTs. Patient was on Eliquis and had recurrence of VTE bilaterally in upper extremities within a short time period of starting Eliquis and had been vaccinated with Covid vaccine. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included deep venous thrombosis arm. Concomitant medications were not reported. The reporter did not provide a causality assessment for event deep vein thrombosis to APIXABAN. The reporter considered event deep vein thrombosis related to COVID-19 VACCINE. Consent to contact health professional for follow-up information was denied. Tracking of Changes: 07-Feb-2023: Initial information was received.  Eliquis is under agreement the agency.; Sender's Comments: BMS Comment: This patient had recurrent deep vein thrombosis after receiving apixaban therapy along with COVID- 19 vaccine. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspects, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban/ COVID- 19 vaccine could have contributed to the event deep vein thrombosis. Pfizer comment: Based on temporal association, a contributory role of COVID-19 VACCINE  to the event deep vein thrombosis cannot be excluded. 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.
2 to 3 patients received 2nd dose outside of the recommended 4 week window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 to 3 patients received 2nd dose outside of the recommended 4 week window) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 to 3 patients received 2nd dose outside of the recommended 4 week window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 to 3 patients received 2nd dose outside of the recommended 4 week window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Started with lump at injection site then increased redness, swelling, heat, soreness involving most of upper arm over 3 days starting about 24 hours after shot. Treated with Prednisone per mouth and antibiotic if needed.
Patient received the vaccination in deltoid of left arm, after removing needle, patient was bleeding from the injection site more than expected from not being on any type of blood thinning medicine. Patient remained in same chair for a few minutes. He then walked to the checkout counter after getting some Tylenol. He stood at the self checkout for a minute and then fell back on to floor. He was sweating and was flush in the face. No reported shortness of breath or any other symptoms. The patient was returned to the pharmacy self ambulating. He was seating in a chair and given a bottle of water. He reported having worked a 12 hour shift and been awake for longer than 24 hours. This course of time from vaccination to time of returning to pharmacy would have been approximately 5-8 minutes. Patient remained seated for over and hour and drank 16 fl oz of water.
Receiving a dose from a vial after more than 24hours of first puncturing; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing). On 26-Jan-2022 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from a vial after more than 24hours of first puncturing) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Significant information received on 26-JAN-2022 Included : Suspect drug Start date, Batch number updated, Dose number updated, Event Outcome updated
a few hours after vaccine complained of shortness of breath and dizziness, lasted 2 days.
Arm is swollen, hot, and red four days later.  Looks like Popeyes muscles.
VARIVAX given 5/23/08.  5/24/08 2" red itchy, swelling around injection site.  5/25/08 well circumscribed blotchy red warm tender swelling 6x8cm.
Pfizer bivalent Booster (6m-4y) was given when doses 1 and 2 were Moderna.
constant tinnitus; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Right arm on an unspecified date at the age of 19-years-old as dose number unknown, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included crisaborole (EUCRISA) taken for an unspecified indication, start and stop date were not reported and unspecified topical steroids taken for an unspecified indication from an unspecified date received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Device Date : 19May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced constant tinnitus that started within 24 hours of vaccination. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Doctors were unable to find a solution. The patient did not receive treatment for adverse event. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test): negative on an unspecified date. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of event was not recovered.  Information on the lot/batch number has been requested  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Experiencing body aches; Severe tiredness; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills) 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 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills). At the time of the report, MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Pt reported that the left upper arm was swollen, warm and red on 10/26/00 and all symptoms resolved within 1 week. No remaining adverse reaction.
After getting the shot, the administer said "now it's up there a little higher, so be sure to take some tylenol or ibuprofen to help with the inflammation"  Stiffness and pain in the muscle started a few hours after administration that only increased in severity throughout the day. Woke up with very low range of motion, about 30 percent, and was then unable to work my full 11 hour shift as a hairdresser due to the paralysis in movements.
Low Grade Fever; Soreness at Injection site; Scratchy Throat; A spontaneous report was received from customer concerning a 58-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pyrexia, injection site pain and oropharyngeal discomfort.  The patient's medical history is not provided . Concomitant medications reported included High Blood Pressure Medication, Anti-Anxiety medication and Aspirin.   On 17 JAN 2020 , the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced low grade fever, Soreness at injection site and Scratchy throat. Expiry date of vaccine is 07/08/2021  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is Unknown.
50mm x 48mm red, erythemic spot on left upper arm where vaccine was given. Very difficult contacting as reported by mother of child-parents and onset reported as 24-48 hours-red raised bumps, rash. No open lesions, no blisters. Resolved without medical intervention.
5 minutes post vaccinations, patient fainted. Pt had fevers and vomiting. Pt left w/ EMT and went to the hospital.
Sharp pain under breast; swelling just below neck area; Redness and itching just below injection site; Redness and itching just below injection site; Sharp pain under left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 13:00 (age at vaccination: 67 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient did not receive any other vaccines in 4 weeks. Patient did not receive other medications in 2 weeks. The patient experienced sharp pain under breast, swelling just below neck area, redness and itching just below injection site, sharp pain under left arm on 20Feb2021. swelling just below neck area (still there after 10 days) Redness and itching just below injection site, appearing after a week. Sharp pain under left arm and breast. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Treatment received was unknown. The outcome of the swelling just below neck area was not recovered. The outcome of the rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Severe arm pain, fever, fatigue, leading to dehydration, acute renal failure.
R upper leg swollen and red and warm started 2 hrs after immunizations using ice and Motrin for leg. R leg swollen twice the size of normal.
no adverse effect; inadvertently administered a dose of Pneumovax 23 instead of second dose of Prevnar 13; This spontaneous report was received from a pharmacist referred to a 5-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 23-NOV-2019, the patient was inadvertently vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (route, lot # and expiry date were not reported) instead of administering the second dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (co-suspect product) (dose, route, lot # and expiry date were not reported) (wrong product administered). There were no adverse effects reported.
After vaccine was administered by CMA at 1637 and during observation period, I reviewed pt's documents and noticed that previous COVID-19 vaccine was administered 15 days ago (1st dose on 4/19). Supervising MD, Dr. and clinic manager were both immediately notified when this was realized (before pt ended his 15 minutes observation period). Dr.  advised that pt be informed that minimum window for the 2 Pfizer vaccines is 17 days. He will contact Dr.  for further clarification if patient needs to return for another dosage or any other recs. Pt was stable at end of 15 minutes observation period (1652) and was informed of supervising MD's recs. He was also informed to notify clinic with any side effects. I will call and check on patient status tomorrow. He voiced understanding. - PA-C 5/4/2021 1700
Terrible sore throat 2 days - resolved    nasal congestion and running nose 7 days - resolved  coughing 14 days - resolved ear pain  2days - escalated to an ear infection 7 days varying pain  Tiredness 10days - resolved
Redness at injection site. 37 mg Benadryl-1805, rash gone 1850.