chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have not had a period since my second vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EN8733) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6205, Vaccine location: Left arm), administration date: 06Mar2021, when the patient was 32 years old, for COVID-19 immunization, reaction(s): "Fatigue", "My period came a week early", "was lighter/didn't last as long", "Headache". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I have not had a period since my second vaccine". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: No other vaccine in four weeks. No Known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, patient's period came a week early and was not on birth control and have had a regular period for her lifetime. After first vaccine, patient's period started one week earlier than expected (22Mar2021) and was lighter/didn't last as long. Pregnancy test negative (taken 07Apr2021). She also had a headache and fatigue two hours after getting first vaccine. After the second dose (31Mar2021), patient no symptoms. she have not had a period since second vaccine to know if menses has been affected again (usually the last weekend of the month). Patient stated she reported this because, she have spoken to other (#) healthcare professionals like her that have gotten the pfizer vaccine have changes in their menses as well. Mainly a heavier/longer menses however.   No follow-up attempts are possible. No further information is expected.
This is a pleasant 72-year-old man with recent bioprosthetic aortic valve replacement May 2021, diastolic CHF, cardiac amyloidosis, CKD stage 3, diabetes, OSA and narcolepsy, paroxysmal atrial fibrillation.  He presents today with increasing shortness of breath found to be COVID positive and diastolic heart failure exacerbation.   He reports feeling well, recovered after his aortic valve replacement, had history of hypotension was added on midodrine and Adderall.  Over the course of the last 10 days, has been feeling ill with cough, nasal congestion, shortness of breath, increasing lower extremity edema bilaterally.  He presents emergency department, was found to be hypoxic requiring non-rebreather, blood pressure 139/78, 95 beats per minute, afebrile 37.3.  WBC is 10.5, hemoglobin 11.5.  Lactic acid normal.  Creatinine at baseline 1.8.  Chest x-ray showed bilateral infiltrates.  BNP is elevated to 7000 up from 4000 earlier this month.  He denies any chest pain or chest pressure at this time, no pain in his legs but he does have significantly increased bilateral pedal edema.  He is agreeable to treatment with steroids and remdesivir.  He is previously vaccinated for COVID and got his booster about 1 month ago.   Review of Systems Constitutional:  Positive for activity change, appetite change, diaphoresis and fatigue. Negative for chills and fever.  HENT: Negative for trouble swallowing.  Eyes: Negative for visual disturbance.  Respiratory:  Positive for cough, shortness of breath and sputum production. Negative for wheezing and chest tightness.   Cardiovascular:  Negative for chest pain.  Gastrointestinal:  Negative for nausea and trouble swallowing.  Genitourinary:  Negative for dysuria.  Musculoskeletal:  Negative for joint swelling.  Neurological:  Negative for dizziness.  Skin:  Negative for rash.
Had surgery in February so was unable to received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had surgery in February so was unable to received second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20X1) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had surgery in February so was unable to received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had surgery in February so was unable to received second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of product dose omission issue for mRNA-1273, lot # 042L20X1  with no associated AEs.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273, lot # 042L20X1  with no associated AEs.
Patient had a syncopal event (passed out) on the way out of the clinic.  Was quickly revived and alert, but then was nauseated and threw up.
This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of M-M-R II (albumin status: recombinant human albumin, rHA) (involved lot numbers: L007577 with expiration date at 05-MAR-2017 and M016233 with expiration date at 31-MAR-2018; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA000822.
VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021
Ach all through my body, headache, cold, could not get warm,fatigue, weak  Lasted about one and one half however still very weak.  Felt like extreme flu
2-3 Days after first shot I developed ringing in my left ear. I tried many things and have been doctors but nothing has helped. I'm reporting as I'm positive its a vaccine side effect and hoping that CDC can help here.
The night of the vaccine, 08/22/2021 @ 1:00 AM I woke up with chills, flu like symptoms fever, sore muscles, sore joints.  A couple of days later  I was better. Then on 09/03/2021, I took methotrexate 2 - of 2 1/2 mg  as I was supposed to about 40 minutes later,  I noticed my throat was getting scratchy, and I broke out in a little bit of hives. On 09/04/2021,  I took my 2nd dose. and within 40 minutes I broke out completely in hives, on my back, neck. legs, chest, face.. On 09/05/2021 I went to, Clinic, I was seen by a provider. The healthcare provide at the clinic suggested taking an antihistamine, Clairton. They said  it could have been from the methotrexate after having the booster or it having an allergic reaction to the methotrexate . Those were the only 2 different things that were different . If I waited a whole week, and skipped that dose and waited till after the vaccine as recommended by the CDC. I saw my rheumatologist , on 09/08/2021, she put me on Prednisone for a week in addition to the Clairton. On 09/10/2021, some of my hives came back and now they are gone, but I am also still taking antihistamines.. I just finished my prednisone on 09/15/2021. I'm still taking Clairton, until my rheumatologist on 09/20/2021. I see my immunologist on 10/19/2021.
Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In 2017, the pharmacist gave a Shingrix vaccination to a local physician, and the local physician gave him a Shingrix vaccination.  The pharmacist did not have any problems, but he said a few days later the physician had flu like symptoms for a couple of days. No further information is available at time of initial report. The reporter did not gave permission to follow up.
Joint discomfort, lethargy, dizziness when standing up, mild fever, scratchy throat.
Patient was inadvertently given two  0.25mL booster doses of Moderna 10 days apart (5/25/22 and 6/3/22).   We often provide vaccinations for the facility the patient resides in. On 5/24, we made arrangements with that facility to come out on 6/3 and verified everyone who needed a vaccine.   On 5/25, the patient's family brought him to our store location for his booster and we did not mark him off of our list to do on 6/3.   I do not believe the facility was made aware of the fact that he had been vaccinated while out that day.   Therefore - the patient received a 0.25mL dose of Moderna vaccine on both 5/25/22 and 6/3/22. No adverse event has occurred.
Presented to ED on 1/23/22 minimally responsive, hypoxemic, and initially hypertensive but then became hypotensive. Treated for septic shock and rocephin, doxy, IVFs. CXR showed bilateral lower lobe PNA. Pt was in renal failure, hypoxemic respiratory failure, septic shock, and confused. Consulted with palliative care and pt expired on 1/24/22.
Dx COVID-19 with syncope, hypotension;Patient's aspirin dose adjusted to 325 mg daily.   Patient started on steroid and inhalers and also cough medicine as needed.   Patient's blood pressure is stable at the time of discharge.  Pt discharged home.
Patient was advised to stay at observation area for 30 minutes after the first dose of COVID19 shot. Previously she had anaphylactic reaction to oral medication that required Epi-pen. She was knowledgeable regarding the allergy reaction and what she was allergic to. She was released by her doctor to get the shot even though she was on isatuximab and carfizomib. About 15 minutes after the injection, her tongue felt funny. I gave her 10ml of diphenhydramine 12.5mg/5ml orally. She was advised to stay for another 20 minutes. She felt ok after the medicine so I released her back home.
This spontaneous report as received from a registerd nurse concerning to a 26 year old female patient, who is also a nurse. The patient's medical history, concurrent conditions, and concomitant therapies, drug reactions and/ or allergieswere not provided. On an unknown date, the patient was vaccinated with unspecified series of hepatitis B vaccine (recombinant) (manufacturer unknown) (the lot #, expiration date, route, frequency, and strength were not reported). On an unspecified date, the patient had a failed serconversion response as show by negative lab titers (hepatitis B surface antibody negative). It was reported that on an unspecified date, the patient had received an inadvertent needle stick injury of an unspecified product (captured in MARRS# 1703USA012511). Reportedly, following the needle stick injury, the patient was given the RECOMVIBAX lot# M044032, expiration date 03-JUL-2019 (route, frequency, and strength were not reported), but the dosage used was actually a pediatric dose of 5 microgram  rather than the adult dose of 10 microgram. The outcome of the event of hepatitis B surface antibody negative was unknown.   The causal relationship between the event and the vaccine was not provided. Additional information is not expected because there was no consent to contact physician.; Sender's Comments: US-009507513-1703USA012511:
This is a spontaneous report received from a contactable other HCP. An adult male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient stated "I have seen two women and one man over 65 years old who got redness and swelling in their arm from shoulder to elbow a few days after getting the Pfizer booster shot." The patient experienced erythema/redness, peripheral swelling/swelling in their arm from shoulder to elbow, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
broke out with shingles; it won't work again; This spontaneous report was received from a patient of unknown age and gender, referring to themselves via Glaxosmithkline. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 18-SEP-2015, the patient was vaccinated with zoster vaccine live (manufacture unknown) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On an unknown date in 2016, the patient was vaccinated with varicella zoster vaccine rge (SHINGRIX) (dose, strength, route, indication, lot# and expiration date were not provided).   On an unknown date in 2020, the patient broke out with shingles. They were surprised because they did not think they would have to worry about it. It was very painful just like the commercials say. So should they get another vaccine? They could not afford to pay for it again if there's a chance it won't work again (vaccination failure). The outcome of shingles and vaccination failure was unknown.   The reporter considered vaccination failure to be related to suspect vaccines. The causality assessment between the event of shingles and suspect vaccines was not provided.
Informatoion has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L019126, expiry date: 27-MAY-2017; lot # L015047, expiry date: 29-APR-2017; lot # L011083, expiry date: 01-APR-2017) (dosage, strength and route were not reported). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient states that she suffers from arthritis, and she typically has some moderate joint pain. On February 12, 2022, patient states that she was barely able to move from her bed to her bathroom and back because every joint in her body ached so badly. Patient states that she is currently experiencing increased joint pain in her body versus her baseline status before the third dose of the Covid vaccine.
Headache, Myalgia, Fever, CHILLS, SORE NECK Narrative:  Other Relevant History:
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is first of two reports. A patient of an unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018401777 same reporter, suspect drug and event, different patients.
pt recv vax NOV95 & 5 days later devel a fever accompanied by severe muscle pain & mental confusion;adm to hosp for w/u;WBC count was nl,but BUN was elevated;because of history of prostatitis underwent prostatoscopy;dx prostatitis;
Information has been received from a registered nurse concerning a patient with milk allergy and egg allergy who at age 15-18 months of age was vaccinated with a dose of MMR II. Subsequently the patient showed symptoms of autism. It was unknown if the patient sought any medical attention. At the time of this report the patient was now 8 years old and was not recovered. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021 at 4:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 4:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.45. Concomitant products were not provided. On 08-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 29 and 35, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.  This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a medical assistant referring to a 16 year old female patient. The pertinent medical history and concomitant therapy were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as M009773, expiration date: 17-MAY-2017 (dose and route unspecified), instead of VARIVAX (lot #, expiration date unspecified). No adverse effects reported. The patient's vaccination history included first dose of VARIVAX (lot information not provided) om 01-JUN-2001, second dose of VARIVAX (lot information not provided) on 23-JUL-2007 and M-M-R II (lot information not provided) on 12-AUG-2016.  Additional information has been requested.
had DTP/OPV/MMR @ 10AM on 27AUG92 by 3PM had fever of 100, pt began screaming; no seizures but tremors; seen by MD; c/o sore arms w/erythema around inject site c/o h/a & stomach hurting, dysuria; dx w/UTI & treated;
Friday (13th), patient asked my opinion on bumps (hive like) on ankles and legs. Sat, (14th) She came back in and the hives were more widespread and closer together. Advised her to seek medical treatment.
I began to have a sore throat around 6pm.  Later in the evening my lips had some swelling, then I noticed my eyes were red.  About 10pm I checked my blood pressure which was 200/100.
Positive COVID test result Narrative:  Employee tested positive for COVID. Her symptoms included "not feeling well." Specifically, she reported sore throat, congestion, malaise, fatigue, sleepiness, diarrhea, dizziness, and HA. All symptoms were mild. Her husband, who also tested positive, required hospitalization. Positive test on 3/27/2021. Vaccinated, as above, with Moderna on 12/30/2020 and 1/27/2021.
Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Slight soreness). At the time of the report, PAIN (Slight soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown. The patient was scheduled for a mammogram.
A few hours after receiving vaccine became dizzy and felt hot/cold/sweaty with temp 100.6. Positive myalgias, arthralgias, dental pain, fatigue; sx's lasted 4 days.
Information has been received from a registered nurse concerning her friend's 7 year old grandson who was vaccinated with a dose of varicella virus vaccine live. Three years later, the patient developed shingles. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved Additional information has been requested.
We were offering a Covid vaccine clinic off site from our pharmacy at the patient's company, for all employees. Following vaccination, the patient did not want to wait around and started to return to her work station. She begin to feel light headed, hot and sweaty so she returned to our vaccine station about 15 minutes post administration. At this point the patient had hives on both wrists and said her entire body felt itchy and like it was on fire. She had no chest tightness, trouble breathing, airway or mouth swelling. I administered 50mg of diphenhydramine but the patient did not want epinephrine at that time. We kept it close by in case her symptoms worsened. We then observed her for the next 60-90 minutes and she began to feel slightly better, but because the benadryl was making her sleepy decided to go home instead of returning to work. I warned her of the potential for worsening of symptoms and to contact her doctor to let him know what was going on, as well as to call 911 if she had any worsening of symptoms