chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Third dose/booster dose; lymph node swelling; swelling under her left arm pit; body aches/It hurts a lot/has a lot of body aches/pain; left arm pain (the arm she received the injection in); Fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 12:30 (Batch/Lot number: FJ8762) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing). Concomitant medication included: METOPROLOL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0162, Expiry Date: Unknown, Route, Anatomical Location: Not provided.), administration date: 08Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "Experienced left arm soreness and swelling", "Lymph node swelling", "Experienced left arm soreness and swelling/Left deltoid arm it is really sore", "Soreness at injection site/Left deltoid arm it is really sore", "swelling in the arm where she got vaccinated"; Bnt162b2 (Dose 2, Lot: ER8736, Expiry Date: Unknown), administration date: 29Apr2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 12:30, outcome "unknown", described as "Third dose/booster dose"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "lymph node swelling"; SWELLING (non-serious) with onset 07Dec2021, outcome "not recovered", described as "swelling under her left arm pit"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "body aches/It hurts a lot/has a lot of body aches/pain"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "left arm pain (the arm she received the injection in)"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Fever".  Additional information: The patient wanted to know if lymph node swelling can happen anywhere or only specific areas. The patient knows that fever and body aches were part of the side effects of the vaccine and knows it's just the vaccine working. It was stated that onset of all events were maybe 3 to 4 hours after being administered the booster dose; which would be around 15:30 to 16:30 approximate time of onset. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event did not caused Emergency Room or Physician Office visit and was not hospitalized. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior vaccinations was provided.  Follow-up attempts completed. No further information expected.
Blood pressure elevation of about 33 points, systolic (130 to 163) over a period of about 10 days
p/vax pt exp breakthrough case of 12-15 lesions around inj site & forehead;
About 10 minutes after receiving vaccine patient got hot/sweaty and vomitted.  Drank sips of water and sat for another half hour and was fine
Patient was supposed to receive Tdap, but was given Dtap; patient is not having adverse events
2JUL97 pt reports soreness, redness & swelling @ inj site approx 5 days p/vax;saw PMD who started IV ATB x 2 days;today reports has had 2nd course of IV ATB w/little response;states is to see MD for poss addtl ATB
This spontaneous report was received from a 88 year old female patient regarding herself. The patient's medical history included double pneumonia which occurred twice when she was a child at the age of 10 years and had a slight case of pneumonia, 2 years prior to receiving a pneumococcal vaccine. The patient had no drug reactions/allergies. The concomitant therapies included prednisone, CELEBREX, calcium and multivitamin. On 11-JAN-2019 (Also reported as Friday), the patient was vaccinated at a retail pharmacy, in the left arm with PNEUMOVAX 23 (Strength, lot # and expiry date were not reported) 1 injection to avoid pneumococcal disease. On the same day, minutes after receiving the injection, the patient began to experience pain and extreme weakness in her "joints hip", back and was unable to stand. The patient was offered a chair and sought medical attention. The paramedics were called to the pharmacy. The lab diagnostics/studies performed included unspecified checks by the paramedics. It was reported that after 30-40 minutes, the patient stated that her strength returned to her and the pain went away. The patient went home without receiving treatment. Approximately on an unknown date in January 2019, the patient felt tired for two days after receiving the PNEUMOVAX 23. There was no product quality complaint associated with this report. The outcome of the events of arthralgia, asthenia, back pain, dysstasia and fatigue was reported to be recovered (Also reported as fully recovered). The causal relationship between the events of arthralgia, asthenia, back pain, dysstasia, fatigue and the therapy with PNEUMOVAX 23 was considered to be related.
Symptom: Fever Start: 11/15/2004 End: 11/18/2004   Symptom: Fatigue, Malaise <60 Days Start: 11/15/2004 End: 11/18/2004   Symptom: Dyspnea (shortness of breath) Start: 11/15/2004 End: 11/17/2004   Diagnostic Tests: abnormal EKG (nonspec ST changes) normal 2D echo   Labs: normal troponins X 3
MOTHER REFERS PATIENT PRESENTED WITH FEVER, SKIN REDNESS, RASH THROUGHOUT THE BODY LASTING 6 DAYS.
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced with Advil Severe headache for 4 hours followed by mild headache for 3 days reduced with Advil Sore achy muscles in arms and legs - 2 days Sore joints, knees, elbows shoulders - 2 days Tired and lethargic for 2 days.
Developed typical fever, chills, body aches, headache for 24-48 hours but then developed diffuse ongoing paresthesias, tingling, muscle twitches and aches (similar to neuropathy that developed following 2009 H1N1 flu vaccine), in addition to status migrainosus x 4 weeks so far.
menveo reconstituted with sterile water instead of the CYW-135 liquid conjugate.; menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacy technician called on behalf of another clinic. The patient administered with Menveo vaccine that was reconstituted with sterile water instead of the CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have any patient details, date of administration, or vaccine lot number and expiration date. The reporter consented to follow up.
Swelling near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling near Injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Swelling of injection site, at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Swelling near Injection Site) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    Reporter did not allow further contact
Since 05Apr2021 her blood pressure has gone steadily up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Since 05Apr2021 her blood pressure has gone steadily up) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Hypertension (was under control). Concomitant products included METHOTREXATE for Rheumatoid arthritis, FISH OIL, METAXALONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), CLOPIDOGREL BISULFATE (PLAVIX), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), FOLIC ACID, LORATADINE, PREGABALIN (LYRICA), LISINOPRIL, SPIRONOLACTONE, VORTIOXETINE, PRAMIPEXOLE, CLONIDINE and METOPROLOL TARTRATE for an unknown indication, METOPROLOL TARTRATE (LOPRESSOR).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Since 05Apr2021 her blood pressure has gone steadily up). At the time of the report, BLOOD PRESSURE INCREASED (Since 05Apr2021 her blood pressure has gone steadily up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Clonidine. Patient informed that she does not have any events after second dose on 21-April- 2021   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: follow up received on 17-may-2021 contains information about medical history, concomitant medication and second dose details
was already opened and stored at 51.2F for 1 hour and 16 minutes with no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA237574 and 2019SA237575 (same reporter).  This case involves a female patient of unknown age who received vaccine IPV (VERO) [IPOL] and reported that vaccine was already opened and stored at 51.2f for 1 hour and 16 minutes with no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS A VACCINE (HEPATITIS A).  On 21-Aug-2019, the patient received 4th dose of suspect IPV (VERO) lot P1A242M and expiry date: 26-Apr-2020 via subcutaneous route in the right thigh.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report received from a certified medical assistant refers to an patient of unknown age and gender. On an unknown date in 2014 (also reported as since 24-JUN-2014) was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot # J013903) expiration date not reported), dose and route not reported which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to 1407USA009333, 1408USA013366 and 1408USA013368 as same reporter link. Additional information has been requested.
Pt. c/o itchy palms and red areas on extremities.  Cetirizine 10 mg po given and pt. observed for additional 40 mins.  Partial resolution of symptoms.  Pt. refused to stay longer.  DC'd with instructions to call 911 if needed.  Verbalized understanding.  Temp 37.3, HR 66, BP159/95, O2 sat 97%
Patient received the J&J vaccine on 8/24/21. Presented to ER on 1/31/22 and 2/13/22. Both times she was admitted. FOund to be COVID positive on 1/31/22. Presented to the emergency department secondary to decline in functional status and confusion.  Was found to be positive for COVID-19.  Seemed asymptomatic while in the emergency department did demonstrate mild hypoxia. Found to have a PE. Hgb low. Treated for that and infection in urine. Discharged on 2/11/22 and readmitted on 2/13, then discharged again on 2/25/22
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer, Case MOD22-013894. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on April 1 to April 8, 2022 from lot number 084J21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccine administered on April 9 to May 11, 2022 from lot number 084J21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. We are working on contacting the patient and recommending re-vaccination. No ill effect post vaccination has been reported to our practice.
Left mid upper arm (lateral aspect) red & swollen 4 inch diameter area occurred 2 days after injection and lasted 6 days. Rx Prednisone x 2 days.
pneumonia vax given pt went to work gave a perm & did a hair cut noticed arm swelling, red area, red streaks down arm; bothered pt all noc;
Deafness in the LEFT ear along with pain for three weeks following the vaccination (both first and second doses). Complete recovery.
seizure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: FJ1611) and on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, LOT: EW0150 , NDC/EXPIRY: Unknown, reading information from Vaccine Card, not on Vaccine Card for any of the doses.), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "booster hurt way more than any of the shots she had previously". The following information was reported: SEIZURE (hospitalization, medically significant), outcome "recovered with sequelae". The patient was hospitalized for seizure (start date: 30May2022, discharge date: 30Jun2022, hospitalization duration: 31 day(s)). The patient underwent the following laboratory tests and procedures: Testing: Unknown, notes: Had major testing done for seizure; SARS-CoV-2 test: Unknown results, notes: Checked for her COVID.  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years, minus 30 mcg/dose, Do not dilute. Reporter reported that 63-year-old female patient and states that she had a seizure after receiving the Pfizer COVID-19 booster vaccine. The patient was in hospital for Severe Seizure from 30May2022 to 30Jun2022. The patient had the booster on 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. The patient was so upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. The patient clarified she thought she had 4 doses total, but she only had three doses. Confirmed seizure was caused by second dose and third booster. Had major testing done for seizure. HCPs don't know what caused it. Checked her for COVID, relevant injuries, checked for a lot of things. Unknown test names or test results. Declined vaccine supplemental form.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient, different dose/events;
low platelet counts; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low platelet counts) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (low platelet counts). At the time of the report, PLATELET COUNT DECREASED (low platelet counts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) Low platelet counts.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant product use was reported.  No treatment information was provided.  Company comment.  This spontaneous case concerns a patient (unknown age and unknown gender) with no medical history reported, who experienced the unexpected, non  serious AESI of platelet count decreased. The patient received an unspecified dose number of mRNA-1273 vaccine, no information about previous vaccination schedule was provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and unknown gender) with no medical history reported, who experienced the unexpected, non  serious AESI of platelet count decreased. The patient received an unspecified dose number of mRNA-1273 vaccine, no information about previous vaccination schedule was provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I received my Covid-19 vaccine on 10/11/2022. On 11/28/2022 I woke up with a sore throat, minor congestion and feeling achy. Next day I took the Covid-19 home test was positive. Went to urgent care and retested. Doctor prescribed antiviral drug and symptoms lasted approx. a week then went away.
The day after the patient received the vaccines he fainted or passed out at his optometrist office. The office personnel called me to ask which vaccines he had received in case they were related to his fainting. I was told he was being transported to the hospital. I do not know what treatment he received or the outcome at this time. Per my company policy I submitted an incident report and the VAERS form to insure proper documentation.
A female child was vaccinated with Flumist, intra-nasally on 20 Jan 2006 for influenza.  After receiving Flumist the child complained to the school nurse about not feeling well.  The school nurse examined the child and sent the child back to class.  No specific symptoms were noted at that time.  On the evening of 20 Jan 2006, approximately 8 hours after vaccine administration, the parents took the child to the ER due to facial edema.  It was not reported whether or not treatment was received for the symptoms.  The child returned to school on 23 Jan 2006.
Patient left message on voicemail 01/09/2009 stating she had sore L jaw after receiving immunizations on day prior.  Call returned to client 01/12/2009 - at that time patient indicated that she felt sxs may have been r/t receipt of Tdap.  Reported sore L jaw and "swollen joint" that lasted approximately 2 days.  Sxs now improved.  No treatment reported.
History of Present Illness: Pt is a 67 Y F  with PMH  of hypertension, severe obesity, type 2 diabetes with CKD stage III and peripheral neuropathy, coming to the ED after she was found down at home by her sister.  Patient does not recall what happened before the fall or how she fell.  Patient reports that she recently was having multiple falls.  She lives by herself and ambulates with the help of a front wheeled walker.  Patient is able to give a history of medical conditions and the medications he uses at home but states that she cannot recall what happened before the fall or if she hit her head. Attempted to call patient's Sister who did not answer. Per ED note " Patient is a 67-year-old female with a history of type 2 diabetes, hypertension, severe obesity, uses wheelchair at home for mobility issues, is presenting today after being found down at her home.  I spoke to family who called EMS and they gave most of the details.   They report that the patient has some confusion at baseline, she has been living by herself but seems to not be able to take care of herself routinely especially over the last couple of months.  Apparently the patient has needed to call for the fire department for assistance for getting up frequently, and family is concerned that she is not taking care of herself, taking medications that she should consistently, etc.
Rash, Pain, swelling at injection site starting after 24 hrs. Seen by MD 4-12-07 dx'd allergic rxn. treated with Benadryl, Ice packs
After receiving COVID-19 Pfizer vaccine at noon, patient returned home and began mowing lawn. Shortly after, while mowing, felt lightheaded then passed out - was unconscious for < one minute. Had water that morning and food, but may not have had adequate water?   Has history of being nervous with vaccines but had never passed out before
Yucky feeling after first two doses; Sore arm after first two doses; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Parkinson's disease.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses). In 2021, FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses) had resolved.            No concomitant  and treatment medication were reported. The patient had a sore arm and yucky feeling. It didn't last very long.   This case was linked to MOD-2022-521969, MOD-2022-521546 (Patient Link).