chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got her period and her period is not supposed to start for another 18 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset May2022, outcome "not recovered", described as "got her period and her period is not supposed to start for another 18 days".  Additional Information: Patient received the Pfizer COVID-19 vaccine Wednesday night and got her period and her period is not supposed to start for another 18 days. Her period is irregular or right on time. She is supposed to get it for 18 days. Is this normal to get her period after getting the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myalgia 1) Arm stiffness, 2) Muscle soreness 3) Localized swelling 4) Small warm spot at injection site Narrative:
The day after I got the shot I got a migraine, that I did not think was related at first.  After having the migraine for 10 days I went to see Dr., because I also had a rash on my head.  Turns out I had Shingles and the migraine, which lasted 14 days was the Shingles pain.  At first we assumed I was already coming down with the Shingles and just did not get the shot in time, HOWEVER, after receiving the 2nd Shingles shot in February at Pharmacy, I also came down with Shingles 2 days later, in the exact same spot, although a much milder case
patient described symptoms of swelling and itching in her tips of fingers on hands, bottom of feet, and face that started about 1 hour after getting vaccine for which she took benadryl for and then it resolved
Pt recv vax on 10/9/97; on 10/14/97 pt exp erythema, induration & itching below vax site-LA
Client reports getting an enlarged lymph node that is very tender on the right side of neck 24 hours after receiving ADACEL in the right arm.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: right arm and right leg, observered for 30 minutes with husband and went home, we called twice and symptoms went away
Pt was vaccinated by RN @ 12:01 pm.  At 12:06pm, the pt stated she was feeling unwell.  While sitting in the observation area, the patient experienced restlessness, slowed speech, and weakness.  EMT intervened right away for support.  A set of vitals were taken.   BP - 80/52, 02 @ 98%, HR 70.  Mom denied PMH and no current medications.  Mom reported patient being seen by a Cardiologist 2 weeks prior d/t a history of and abnormal EKG:  slight prolonged QT interval.  Pt transported to South Shore Hospital by EMS for further evaluation.  Follow up call to Mom on 12/29/2021:  Mom stated that no intervention needed.  The patient was feeling much better after an hour and was released to home.
Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111698:Same reporter US-GSK-US2022AMR111700:Same reporter
8 days later- itching at injection site, red and swollen 6" across. Hot to touch.
STAYED EXTRA 15 MIN TINGLING MIDDLE OF TONGUE WHICH RESOLVED.
left leg is hurting more and burning more, very good burning sensation, probably where the clots are; now both legs are cramping and aching; now both legs are cramping and aching; left leg is hurting more and burning more, very good burning sensation, probably where the clots are; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 60 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, NDC number, lot number, expiration date: ER6213, Dose and route: Unknown), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller's legs have been cramping"; BNT162b2 (Dose: 2, NDC number, lot number, expiration date: EW0153, Dose and route: Unknown), administration date: 08Apr2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "2 blood clots in 1 leg", "Caller's legs have been cramping". The following information was reported: THROMBOSIS (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "left leg is hurting more and burning more, very good burning sensation, probably where the clots are"; MUSCLE SPASMS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "now both legs are cramping and aching". The events "left leg is hurting more and burning more, very good burning sensation, probably where the clots are" required physician office visit. Therapeutic measures were taken as a result of thrombosis, muscle spasms, pain, burning sensation.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history ws not reported. On 29-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
acute renal failure; This is a spontaneous report from a contactable physician. This report was received via a sales representative. Reporter is sister of patient and a physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 301558A), via an unspecified route of administration on 29Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included zoledronic acid (RECLAST) taken for an unspecified indication from 14Oct2021.I first heard of the patient(s) condition on 24th but did not understand that COVID-19 vaccine was implicated until 25th (understood that reclast was implicated prior). The patient experienced acute renal failure on an unspecified date. Patient developed acute renal failure requiring ICU admission. Still admitted as of 25Oct2021.The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Acute kidney injury and the suspect drug BNT162B2 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.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was the day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow up received. No new information updated.
2 days after Fluzone HD, pt woke with mild redness 5-6 inches in diameter around injection spot.  It is slightly itch, but not sore or warm to touch.  He has no fever. He took a Zyrtec that morning and applied hydrocortisone cream.
Vomiting, Patient comforted. Provider with patient with parent. Vital Signs performed. PO Hydration tolerated.. Discharged to home on  June 11, 2018. Follow up on 06/12/2018, spoke with parent. No complaints offered.
Contracted COVID-19 after I have been vaccinated with both the first and second dose; Contracted COVID-19 after I have been vaccinated with both the first and second dose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248; Expiration Date: Apr2021), dose 1 via an unspecified route of administration, administered in right arm on 03Mar2021 (at the age of 34-years-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 34-years-old) (Batch/Lot number was not reported; Expiration Date: 30Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included lupus. The patient's family medical history included she thought type 2 diabetes run in her family on her father's side. The patient had no prior vaccination (within 4 weeks) other than COVID-19. The patient stated, she was calling because the adverse event reporting site was not working and she need to report an adverse event with the COVID-19 Vaccine. she specified that, in Mar2021, she contracted COVID-19 after she has been vaccinated with both the first and second dose. The consumer stated, any lab test like for COVID, she thought she had a blood test probably. She don't remember the date but the results were positive like it was for monitoring her lupus condition and there was nothing negative about her results. Basically her treatment was going all good. There was nothing. It was normal. The only thing she took was over the counter medication in the form of 'dichlo' and 'diclo' (Further clarification was unknown) and Tylenol PM. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No additional adverse events reported; an expired dose of VAQTA was administered today; This spontaneous report was received from a temp stability agent (medical assistant) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 19-MAY-2021 (reported as today), an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T014590 and expiration date 15-APR-2021; strength and route were unknown) was administered for prophylaxis (expired product administered). The reporter reported that product was properly stored up through administration. The reporter did not report any signs/symptoms. No further information provided. No additional adverse events reported. No product quality complaint. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Pt. reports fever, muscle and joint pain. Started PM after AM injection. Arm and joint pain lasted 4 days.
Information has been received from a a registered pharmacist concerning a 21 year old female who with no pertinent medical history who "7-8 days ago" on approximately 21-MAR-2008 was vaccinated with a dose of GARDASIL (lot number, route and site of administration not specified). There was no concomitant medications. On an unspecified date the patient presented with bacterial meningitis and the only medication she was given was GARDASIL before this occurred. The patient was hospitalized on an unspecified date for an unspecified amount of time. At the time of reporting the patient was recovering. The reporter felt that bacterial meningitis was life threatening. Additional information has been requested. 4/24/08-records received for DOS 3/25-3/31/08-DC DX: meningitis, resolved. Presented with frontal headache. Progressive headache and at ER lethargic and obtunded. ICU- One episode ventricular tachycardia. Temperature 100.4.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old female patient who received PEDIARIX (batch number 33E9E, expiry date unknown). On 23rd September 2016, the patient received the 1st dose of PEDIARIX (intramuscular) 0.5 ml. On 26th September, 3 days after receiving PEDIARIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to PEDIARIX. Additional details were provided as follows: The nurse reported that the injection site reaction was from left upper arm up to elbow.
Redness, swelling @ site spreading to axilla & lt breast area & then down inside of lt inner arm to elbow. Pt self administered oral Benadryl & used Benadryl ointment on site & reaction.
Pt experienced red face, hives on face, shortness of breath and feeling of throat closing up.
pt recv vax 29SEP95 & 2APR97 pt devel full blown chickenpox;pt recovered from sx;
fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 3rd of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The events were considered serious as caused patient's hospitalization, because the reaction was so severe.  The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020096703 Same reporter/ drug/ event, different patient
Tingling in palms of hands and bottoms of feet. Tingling and numbness, weakness progressed eventually up to both knees and past elbows. Had 15 infusions of GAMMAGARD from Oct. 15, 2015 to Nov. 2016.
Influenza vaccination administered at 09:45 am on 10/16/07.  Patient presented to health unit at 11:00am with syptoms of generalized body warmth, redness and "tight" feeling in throat.  VS 124/80-72-20  Pt. was alert & oriented x 3. No respiratory distress noted.  Generalized rednesss & hives noted to face, neck, torso & upper extremities.  Pt. given 0.3cc SQ of epinephrine and 911 called.  VS recheck 138/80-84-20. Pt. given benadryl en route and evaluated at local ED. Pt given prednisone at the ED and sent home with a prednisone pack.  Pt returned to work on 10-17-07 with no c/o.
Redness swelling itching warm to touch firmness in whole upper left arm day after injection I?m on day 2 and it seems to have worsened
About 20 minutes after the injection, the arm i received the injection in became very cold, changed color like I was not perfusion to the limb. This was gone in about two hours. Woke up eye lid continually twitching.
Information has been received from a registered nurse, via a company representative, concerning a female patient (age with allergies to sulfonamide and penicillin, who on 15-MAR-2007 was vaccinated with a dose, 0.5 ml, IM, of Gardasil. There was no concomitant medication. On approximately 18-MAR-2007 ("three days" later) the patient developed a fever of 104F, and visited the emergency room. Diagnostic labs were as follows: complete metabolic panel (CMP), urinalysis, "mono, strep and influenza" screenings, all with negative results. Subsequently, the patient recovered from the fever. Additional information is not expected.
Patient has Parkinson's and I spoke w/patient's husband. Redness, soreness and pain at site of inj. Slightly red "blemished" today - 10 days later.
HCP, injected Moderna vaccine to patient using the 1mL Haiou 23G syringe. She gave a little extra push to activate the self retracting needle. The needle/hub separated from the syringe, and with a popping sound, this caused a tiny amount of vaccine to splash onto her face, hitting her forehead. Needle remained in patient's arm, and HCP had to pull it out and dispose of it. She reports no side effects.
This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB via unreported route (batch# L040458, exp. 03-FEB-2018; L048236, exp. 31-MAR-2018). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree Centigrade for a time frame of 11 hours 35 minutes (Incorrect product storage) on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
Patient admitted to Hospital on 10/13/2021 for a principle and pre-operative diagnosis of Seizure (HCC)  (primary encounter diagnosis), S/P total knee arthroplasty, right, Contusion of rib on right side, initial encounter, Hypotension due to drugs.   The patient tolerated the surgical procedure without complications and was hospitalized for a total of 5 nights following the surgical procedure. The hospitalization was necessary for pain control, therapy, medical care and discharge placement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
swelling and soreness in lymph nodes under left arm.  today (October 4 is the 2nd day of swelling and soreness)  I had the same results when I received my 2nd shot on February 19, 2021.  That was results of the 2nd Pfizer vaccine.  the swelling and soreness went complete away after the 3rd day.
Nasal congestion; hemorrhage from her nose; This spontaneous report was received from a 63 year old female patient who was reporting on herself. The patient's medical history included sinus infections. The patient's concomitant therapies included unspecified thyroid medicine and metformin hydrochloride(GLUCOPHAGE XR). the patient had drug reactions/allergies to scopolamine and prednisone.  On 06-JUL-2016 (also reported as "about 5 years ago") the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided). On the same date (also reported as "in the days following the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine"), the patient had nasal congestion for about two years followed by a hemorrhage from her nose (epistaxis). The patient did not seek medical attention and no lab diagnostics/studies were performed. The outcome of nasal congestion was resolved on approximately 06-JUL-2018 and epistaxis was reported as resolved on an unknown date. The causality assessment was not provided.
I have pain in the lower right part of my head in the back. MRI scheduled for 06/27/2022 in the PM. I have taken TYLENOL if the pain gets to bad.
Chills, sweating, shivering, headache, eye pain, severe aching of shoulders/neck/hips/spine/knees, nausea, weakness.
pt recv vax 1OCT96 & devel fever up to101.4 & restless sleep (awakened every 10 min);addtl info recv 21NOV96;pt was dx w/URI/bronchitis on 29OCT96 dx w/sinusitis on 2NOV96;pt recovered;