chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post menopausal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) outcome was unknown.            The concomitant medication was not reported. The treatment medication was not reported. The reporter stated she knew about 3 other women who had post menopausal bleeding after Covid-19 booster doses from unknown manufacturers.  Company comment: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected event of postmenopausal hemorrhage. The event occurred on an unknown date after the third (booster) dose of mRNA-1273. No further information was provided regarding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected event of postmenopausal hemorrhage. The event occurred on an unknown date after the third (booster) dose of mRNA-1273. No further information was provided regarding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
1. Patient calm at time of vaccine administration (patient was sitting on exam table) 2. About 5 seconds after administration patient fell backward, hit head on sheet rock wall. Patient lay flat on exam table, hitting her head on side wall adjacent to the exam table 3 Doctor examined patient with a minute: patient's feet were elevated: Blood pressure elevated, patient expressed dizziness, blackout, sore throat, and severe pain on arm of vaccine site blood pressure readings follow 148/88; 134/72 at 10 min intervals and 30 minutes later BP taken again 108/68 4. Head contusion, no physical abnormality of scalp 5. Patient scheduled for follow up in 2 days 6. Mother instructed to take patient to ER if worsen 7. Patient left office accompanied by moth walking and stable
Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient received the 6 month to 5 year old formulation of the Moderna Covid-19 vaccine).    No Concomitant medications were provided.  It was reported that patient wanted to receive the Moderna Bivalent vaccine but the patient received the 6 month to 5 year old dosage. No adverse reaction were observed for patient.  Reporter also reported that patient received the Moderna Covid-19 vaccine for primary series and booster doses however, does not have any information on these vaccinations.  No adverse reactions are known of from these vaccinations  No treatment medications were provided.
Headache Confusion/Lethargy Dysarthria and Ataxia Subsequent presentation to ER and Admission to medical ICU (see below)
PATIENTS EXPERIENCED VERTIGO AND DIZZINESS. AFTER SITTING DOWN FOR A WHILE HE INSISTED HE WAS OK AND WAS ABLE TO LEAVE. HE REFUSED ANY ATTEPMT TO CALL EMERGENCY SERVICES
lt upper leg swollen no redness, no hardened area;area painful to touch;T99.5;mom instructed to cont warm wet cloths & given APAP;
Patient presents to Medical Center one week after receiving his first dose of Pfizer vaccine with  headache and left side weakness
At 11:40 patient comes in the vaccination area. Initial screening is done as routine for patients receiving the COVID-19 vaccine. The patient states he feels well and is not allergic to anything. In his intake we see he stated the same as he told the staff. The second dose of the COVI-19 vaccine was given at 11:45am, in his left deltoid. Patient reports he feels well and no complications at the time of vaccination. He is asked to wait in the 15min area. After 11 minutes, the patient refers he has a rash in his abdominal area, which he states due to two Panadol tablets he had prior to vaccination. Physical exam revealed two red areas on his abdomen that are also itchy. When interviewed for a second time he admits he had the rash before the vaccine, but he did not mentioned it to the nursing staff. Patient is moved to the are where the paramedic staff was.
RECEIVED FLU SHOT 11/2/03 AROUND 1430. AFTER AROUND AN HOUR C/O FEELING STUFFY HEAD, DIZZY, SHAKEY FEELING,AND BODY WEAKNESS.BENEDRYL 25MG PO. DOCTOR ORDERED 24MG MEDROL PO GIVEN @ 1634. WENT TO ER @ 1640. 1900 IV NS 1000CC BOLUS, BENEDRYL 25MG IVP, ZANTAC 50MG IVP. 1915 ORTHOSTATIC BPS 139/94 HR 92 LYING, BP 144/90 HR 84 SITTING, STANDING 112/65 HR 96. 1915 C/O CHEST TIGHTNESS EKG DONE. ADMITTED 23HOUR OBSERVATION @ 2248. D/C'D FROM HOSPITAL 11/3/03 @ 1230. The medical records received on 1/12/04 states achey, body pain, headache and SOB.
This spontaneous report as received from a healthcare worker refers to an approximately 55 year old female patient with penicillin allergy. Approximately in 2003 (reported as "about 10 years ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported). Approximately in 2003, the patient developed lymphadenopathy one hour after receiving PNEUMOVAX 23 about 10 years ago. The patient sought medical attention via seeing a physician. The patient received the unspecified treatment for the event. There were no lab diagnostics studies performed. Subsequently, the patient recovered from lymphadenopathy. The outcome of lymphadenopathy was reported as recovered/resolved. The patient also had the same reaction lymphadenopathy after receiving streptomysin sulfate (manufacturer unknown) (Case# 1304USA016347). Additional information has been requested.
pt recvd vax & devel severe local rxn w/ pruritus at needle site & area of erythema & edema over the upper arm;
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with VARIVAX, injection, subcutaneously (lot#, expiration date and dose were not reported) with diluent (lot# and expiration date were not reported) which was kept in frozen temperature conditions, less than - 15 degrees Celsius. No known side effects were reported. No previous temperature excursions were reported.  Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013577: US-009507513-1701USA005859:
I had mild nerve pain in my right knee from a previous virus, but it was under good control. Within three hours of the jab, I had excruciating pain in the whole upper right thigh, and this pain went on for four months. It got better, but still has not gone back to where it was pre jab. I hav e had to be on extra gabapentin and hydrocodone. My neuropathy in my feet got twice as bad, and that also took about four months to show improvement. I still have days now seven months out where the neuropathy is very bad.
red rash in the roof of the mouth; Fever; chills; body ache; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 07Mar2021 at 14:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included G6PD deficiency, COVID-19 and sulfonamide allergy. Concomitant medication included levothyroxine sodium (SYNTHYROID) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  On 08Mar2021, next day, the patient experienced fever, chill, body ache and after 6 days on 13Mar2021, the patient experienced red rash in the roof of the mouth that lasted 5 days and was very uncomfortable, never had it before. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever, chills, body ache was recovered on an unspecified date in Mar2021 and of the event red rash in the roof of the mouth was recovered on 18Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient is a 76-year-old female with history of COPD on 2 L nasal cannula at home presenting to the emergency department for increased shortness of breath with Covid infection.  Patient is vaccinated against Covid.  She came to the hospital today to receive a BAM infusion, however her oxygen was low, so she was evaluated in the ER.  Patient noticed her oxygen to be low at home, so she increased her oxygen to 4 L prior to coming to the ER.  She admits to feeling short of breath, she denies chest pain aside from when she is coughing.  Denies nausea, vomiting or diarrhea.
Pt received the Covid 19 vaccine at 11:40 am and developed a rash to lt ear and throat irritation at approx 11:59.
40 hrs later, Emily had abnormally high pitched cry lasting 10-15min no fever, acting normally, resolved spontaneously; Fine several hrs later;
This is a spontaneous report from a contactable consumer via Pfizer sales Representative. (patient, reported for self). A 74-year-old male 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 on an unspecified date) as dose 2, single for COVID-19 Immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced chills, Headache on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
administered an expired dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received HBV (Engerix B) (batch number 3JD32, expiry date 6th April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 3rd May 2021, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was administered already expired vaccine, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # M007762, expiration date 07-DEC-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. There were no previous temperature excursions reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Shingles on face; This is a spontaneous report received from a contactable consumer, for patient. A 79-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on left arm on16Feb2021 at 15:30 (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient took several prescriptions but did not had the list as concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on left arm on 26Jan2021 at 13:30 as a single dose for COVID-19 immunisation. It was unknown whether the patient had any allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021 at 22:00 the patient experienced shingles on face unsure if at all connected to vaccination. The patient did received treatment for the reported events and the medication was unknown. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event shingles on face was resolving at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
July of 2021 I took the first shot of the Moderna vaccine. About 1 hour after taking the shot I fell ill and was in bed for 3 days with flu like symptoms. About 2 weeks after taking the first shot I started noticing redness in my groin area. Over the next 4 weeks the red area was expanding out to about 4" out on my thy on both legs. August 18th, 2021, I got the second shot of Moderna. In early October, 2021 I noticed 3 red spots appearing on my right arm, small at first but grew larger over time and they started growing scales in layers and in patches the size of a 50 cent piece. I visited a Dermatologist and I was diagnosed with Plaque Psoriasis. By November it had spread to my legs and feet (top and bottom). The area around my groin (privates included) had spread to my posterior covering 80%. During this period I always felt as if I had a slight case of the Flu 24/7 with headaches, muscle aches, runny nose, drained energy and chills to the bone with muscle spasms and contractions that exists to this day, and every Day. In mid August 2022 (like an anniversary gift) the Flu like symptoms worsened and lasted for about 3 days and during this time I had developed what appeared to be a rash, however this rash was solid and blood red and covered my entire back from my waist up to the top of my shoulders and it worked it's way around to my front torso and covered my entire chest. The palms of my right and left hands turned blood red up to my fingertips, my face turned spotted with red patches and my scalp was completely covered red and started producing skin cells. My scalp has to be basically stripped of these scales once a week and is taking most of my hair with it.  Once the Flu symptoms eased off and the rash started to recede; what it left behind was a million (well I didn't count them all, but it was a lot) of tiny bumps all over my chest and back, so now I am completely covered from the top of my head to the bottom of my feet and inside of every crevice. The tiny bumps are expanding and joining together to make large areas. skin gets so dry it splits open and bleeds. My hands have become almost useless as I am loosing fingernails (3 so far) and I cannot make a fist due to the Psoriasis in my joints, it is getting into my joints of my hips and knees and making moving around very painful. My feet swale to x2 their size and my toe nails are next to be lost. It grows in my ear canal until it makes a plug and I have to go to the ear Doctor to have them cleaned. . I cannot run the air conditioner at home as anything under 80 degrees causes me to have the chills and uncontrollable shakes. I can only take cold showers because warm or hot showers burn like fire, even a cold shower leaves my skin burning and stinging like crazy so I keep my showers short. As of November 2022 I still am covered over 80% of my body. I am undergoing UV light treatment 3 times a week.
Information has been received from a registered nurse concerning a 6 year old child with no known allergies, no illness at the time of vaccination and no past medical history who on 08/04/1997 was vaccinated with varicella vaccine. On an unspecified date, "recently," the child was exposed to chicken pox at school. On 06/04/2001, the child's mother reported that he developed a rash. On 06/05/2001, the child presented to the physician's office with a itchy, small scattered vesicles with crusts on his face, trunk, chest and buttocks. He had no fever, but did have a runny nose. On 06/06/2001, the child recovered. Additional info is not expected.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-MAR-2019, the patient was vaccinated with a dose of VARIVAX (lot # R027993 with expiry date 01-OCT-2020) and a dose of PROQUAD (lot # R027988 with expiry date 30-MAR-2020) for prophylaxis (dose, strength, dose number, route unspecified) during the same office visit. A sterile diluent of lot # R033667, expiry date 14-JUN-2021 was used to reconstitute VARIVAX and PROQUAD. No adverse effect was reported. No product quality complaint (PQC) was involved.
First symptom, shortly after, into next day, inconsolable, fussy, uncomfortable  2nd, left side arm and leg went limp a week later-for a minimum of 6 days
11Apr90 pt vax; 14Apr90 exp rash on neck.  2 days later rash progressed over body & devel fever 100F to 101F. Fever resolved, rash persisted. Pt also devel rash after recv dose of MMR at one year. (WAES90050076)
Severe diarrhea, universal tremors, body aches, fatigue.  No treatments, except aspirin and ibuprofen.
Arm began getting stiff 8 hours after injection. 11/5/21 began feeling flu like symptoms. Body ache, low grade fever, nausea, vomiting, sore injection site. Haven?t gone to the dr.
5 days after finishing paxlovid, started feeling symptomatic again and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination.    Concurrent medical conditions included Anxiety, Depression, Asthma, Peanut allergy, Allergy to nuts (Tree nut), Sesame allergy and Fruit allergy (Stone fruit). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive). At the time of the report, COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test negative (Negative) Tested negative after 5 day course of paxlovid.. On 15-May-2022, SARS-CoV-2 test: positive (Positive) positive and.          Treatment was not received. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine.  Tested negative after 5 day course of paxlovid. 5 days after finishing paxlovid, started feeling symptomatic again and tested positive. Device Date :16May2022. COMPANY COMMENT: This is an spontaneous case concerning a  27-years-old female patient with  medical history of Anxiety, Depression, Asthma,several allergies, Concomitant products included ESCITALOPRAM for an unknown indication, NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination who experienced the unexpected AESI event   of COVID-19, 197 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  27-years-old female patient with  medical history of Anxiety, Depression, Asthma,several allergies, Concomitant products included ESCITALOPRAM for an unknown indication, NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination who experienced the unexpected AESI event   of COVID-19, 197 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Severe headaches and nausea. Hospitalized for 2 days with eventual resolution of symptoms.  Discharge diagnosis: viral meningitis.  Patient currently with no notable residual symptoms.
Patient's reaction(s) noted during COVID vaccine observation period:  Received 2nd dose vaccine @1745 began with tremors and tingling. 1755: B/P 121/76. 1800: c/o tingling/burning and twitching in legs and tingling/burning in arms. 1805: B/P 113/69, HR 72, O2 sat 98%, temp 98.3.   Pt does have history of COVID diagnosis July 2020 required hospitalization for decreased O2 sats, dx: pneumonia.  1815: B/P 112/69, HR 86, O2 Sat 99%. Also began to have sharp pain high in shoulders and increased muscle soreness. 1830: B/P 129/76, HR 90, O2 Sat 98%.  Actions Taken: Reassurance, monitoring Disposition: Taken to ED via W/C accompanied by clinic staff at 1835 In the ED, pt received diphenhydramine IV, IV fluids, ondansetron IV , famotidine IV, methylprednisolone IV and ibuprofen PO.  Discharged from ED at 2308
Severe Chills, fever 102.2 degrees, muscle pain, headache, extreme thirst and fatigue for first 24 hours. Next day fever down to 100.1 degrees, fatigue, some muscle pain, dry cough and scratchy throat , lasted 24 hours. Was feeling fine by next morning.