chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed nose bleeding/waking up at night with his bed full of blood/The patient is saying it took a very very very long time to stop the bleeding this morning, like 30 minutes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), 0.3 ml single (Lot number: FM9992) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2;  unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 Immunization. The following information was reported: EPISTAXIS (medically significant) with onset 11May2022, outcome "unknown", described as "developed nose bleeding/waking up at night with his bed full of blood/The patient is saying it took a very very very long time to stop the bleeding this morning, like 30 minutes". Therapeutic measures were taken as a result of epistaxis. Clinical course: The report was not related to a study or programme. NDC number of COVID-19 vaccine: 59267102504. Caller is a pharmacist reporting an adverse event on behalf of a patient who received their second booster dose of the Pfizer Covid vaccine on 11May2022. That evening after receiving the vaccine, the patient developed nose bleeding. The patient reported waking up at night with his bed full of blood and it took a long time to stop the bleeding. This happened again the following night (12May2022). Patient told that it was related, patient has never had a nose bleed before in his life. Patient was thinking of going to the urgent care for the nose bleeding event. The patient said that it took a very long time to stop the bleeding that morning, like 30 minutes. Patient said the bleeding had stopped already yesterday, and caller instructed the patient to not take patient's baby Aspirin, but then the nose bleeding happened again last night, 12May2022. Caller was going to tell patient to get some of the bleed stop product, but patient was very angry and upset. Patient picked up the baby Aspirin over the counter, patient told the caller over the phone that he takes baby Aspirin. NDC number, lot number, expiration date: Unknown. Manufacturer date: Oct2021. Beyond use date: 31Jan2023.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  epistaxis    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.
Day 1 (4/7/2021) - Vaccine Day 2 & 3 -extreme fatigue. Day 4 - diarrhea. Day 5 - all clear Day 6 - 8 - High BP symptoms began (didn't realize that is what it was) Day 9 (4/15/20201) - Doctors visit due to symptoms, BP 200/110, Diagnosis Stage 2 Hypertension with no history of BP issues. Possible family history.
pt recvd vax;rash/welts,inner arms & neck; persistent dry cough;chest tightness;felt light sensitivity,blurring vision, sleepy;no appetite;to PMD 30nov;states had flu-like sxs,but feels alright now;
I fell when I went to get the mail and tripped. I was unable to get up. I did not suffer a stroke. The ambulance came to my home and I was shortness of breath and decided I should go to the ER. I was in the ER for 10 days, I was not injured, suffering symptoms that they felt they needed to address.  I also had water retention and they put me on diuretics and monitored for ten days.  I have recovered from my symptoms.
Information was received from a health professional regarding a patient, demographics unknown, who on an unspecified date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, that had been improperly stored. The outcome of the vaccination was not provided. This is a corrected report. On 23-SEP-2013 information had been received from the registered nurse, who stated that the doses of VARIVAX (Merck), Lot # J003221, expiration date on 15-MAR-2015 were exposed to unknown temperatures for 5 hours during interoffice transport. All vaccines were unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Pt recvd DTP/OPV/HIB 1APR92; Afternoon of 2APR92, pt screamed for 3 hrs; consecutively on exam on 2APR92 by MD no other sx;
redness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (soreness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (soreness at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE PAIN (soreness at the injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD-2021-061192, MOD-2021-061192 (Patient Link).
Itching near site of Injection.  Itching then spread down the arm to the elbow area. Itching on neck and side of face. Itching also on back and legs. Itching persistent for 30+ minutes
Thrombosis in right axilla at superficial tributary. No Pulmonary embolism. Axilla pain developed within 48 hours of vaccine. 1 week later she noted a lump at axilla. Presented to clinic for evaluation on 2/8/21
Low grade fever Chills Body aches  Neck pain  Muscle tension  Fatigue  General flu-like symptoms
This report was received from the investigator trial on 23 April 2010. A 33 year-old male subject with a history of chest pain received the following vaccines on 24 June 2009: ACAM2000, lot number not reported); Typhim Vi (lot number not reported); and Anthrax vaccine (other manufacturer and lot number not reported). Fifteen days after vaccination, the subject was diagnosed with an acute myocardial infarction of the inferolateral wall. The subject's record also included ICD-9 code 410.9: acute myocardial infarction, unspecified site with the same diagnosis date. Nine days after vaccination the subject had an abnormal electrocardiogram. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
The patient experienced severe and sudden fatigue, aching all over - especially severe from right earlobe to right elbow beginning at 7:00 PM. Continued with very hot, painful injection site, shivering, nausea, chest cavity aching throughout the night. Temperature was 99.2 when taken later in the evening. The patient put an ice pack on the injection site and took Ibuprofen 400 mg both of which seemed to help. She repeated the Ibuprofen dose later as well. The reaction ended around 7:00 AM the next day. As of 10:00 AM, she was doing much better.
Right arm swelling and tenderness. Patient given Benadryl and Tylenol.
Reportedly, sometime after the vaccination, the pt experienced tingling sensation of right facial area. The pt also experienced discomfort of right clavicle and sternum (injection given in right deltoid), the discomfort moved to scalp and right ear. Reportedly, the pt was seen by physician, all signs and symptoms subsided now but lasted 1 week.
It was found that a box of 10 MENVEO were not reconstituted correctly so the patient only received half of the dose. Once discovered HCA was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Patient brought into clinic on 2/7/08 with red, swollen, hot to touch LA. LA approx. 12cm x 8cm. 2/7/08
0n 4-23-21 I was going to sleep when my arms started burning then my legs, my face and upper chest. I had a rash, swelling and redness    that started in my arms to finally my head. It burned like I was on fire and my heart was racing more than usual. I put wet towels on my arms, legs and face. Took benadryl and after 4 hours took zyrtec.  It took 4 hours for swelling to go away and the rest of the night for the redness to go away. I have taken either Benadryl or Zyrtec each day as I can feel the urge for the hot itchy stuff wanting to return. On the 27th of April I had another reaction just as described with swollen face. This time I woke up with it. Took additional benadryl with zyrtec.  May 2nd had another full body rash with redness and swelling, this one went away quicker once I took benadryl.  I elimanated anything new from my diet/supplements when this first happened but quickly there was not anything but my usual every day food and medication that was left to eliminate.
Face swelling. Elevated BP 160/100 pulse 110 Constant Palpitations. Couldn?t catch breath Nauseous. Metal taste in Mouth At Medical facility 8:50 am till 7:00 PM Palpitations continued for 10 days  I wear a loop record and constantly recorded incidents
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Aug2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 68 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Negative; (27Sep2023) Negative; (29Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Sep2023 to 25Sep2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Patient presented 11/13/20 stating that she had a rxn in her left arm where she had both psv23 and fluzone hd on 11/11/20 (her request) . Her arm, above her elbow and down to her wrist was red and swollen, which pt said occurred on 11/12/20. Pt stated it was painful. She had no issues with itching or breathing or any other anaphylactic type rxn. She went to her family NP today where she received cephalexin 500 and prednisone 20.
Redness of left arm, mild swelling, full arm from shoulder to hand, pain. Happened same day of vaccine, followed up 2 days after.
Exactly one week posit vax, the pt experienced hives covering the entire body lasting 2-3 days.
10/05/17: 1900 muscle weakness in left arm and general tiredness; 2100 whole body weakness and general tiredness; 2200 whole body fatigue and aches, tiredness, and fever; 2300 whole body aches, fever, chills, diaphoresis, GI discomfort. 10/06/17: 0100 drank fluids and decaffeinated tea, took 400 mg Ibuprofen. 10/07/17: 0900 previous symptoms became more mild and tolerable; fever broke during sleep. 10/21/17: 0800 pain similar to a bursitis in left shoulder. 10/21/17: 0830 applied heating pad with little relief; 400 mg Ibuprofen provided more relief, but discomfort persisted. This bursitis-like pain (discomfort and pain while lifting left arm above level of abdomen) has persisted since 10/21/17. It is more bearable on 11/09/17 at 1500, but it is still uncomfortable. I have done nothing (i.e. physical sports, injuries, activities) to believe that this shoulder pain was a result of physical motion.
Only a sore arm, but about a week after the first dose I had sensitivity in my front teeth that progressively got more sensitive. I took some Aleve to help with the sensitivity.
At about 1AM on 04/14/04, I woke up with 7 welts on right shoulder, all within a 3 inch of each other.  No temp.  Heart rate fine.  Welts were about half inch long, 1/4 inch wide and about 1/4 tall.  Hard to touch, no indication of insect bite.  At 5AM the welts were gone.
tested Positive for COVID; tested Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "tested Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive; (02Jun2022) Negative; (07Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient tested positive for COVID on 25May2022. The patient received treatment with Paxlovid on 26May2022 to 30May2022. The patient tested negative on 02Jun2022. The symptoms recurred on 06Jun2022 and on 07Jun2022, the patient tested positive for COVID. No drug or alcohol abuse. The patient had no family history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events Drug ineffective and COVID-19 cannot be excluded.
This spontaneous report was received from an office manager via a social media regarding to a 97 years old female patient with warts. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, strength, anatomical location or route of administration were not provided) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and product use in unapproved indication. Furthermore, the patient had been free and clear of the warts.
I have continuing scalp issues. In the beginning, I was just using a shampoo. After I got the shots it did not work. I tried shampoos with zinc in them. I was told it was making it worse. My doctor said it could be an autoimmune disease.  Never had any COVID symptoms.
Sight of injection was red, hot and itchy.  Continued to spread down the arm toward elbow.
I began with headache, won?t go away, body aches, sore arm and 100.6 fever  Slept 14 hours and woke up fever broke but headache stil there, very weak and no energy
Pt. received Varivax #2 (RSQ), HPV #1 (RD) & Tdap #1 (LD) 7/17/07. Developed nausea and dizziness within 24 hours, lasting >48 hr after imm. Also developed erythema and induration at Varivax site 48 hours after injection (3 1/2 x 4 cm diam.)
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 66 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna,Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GH3275) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 at 14:00 as dose 1, single (Lot number: 025J20-2A), in left arm, on 16Feb2021 at 16:00 as dose 2, single (Lot number: 041L20A), in left arm, on 24Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 050c21A), in left arm and on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022 at 18:00, outcome "unknown", described as "Vaccine brand other=Moderna,Vaccine dose number=4 / Vaccine brand=Pfizer / BioNTech, Vaccine dose number=5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
pt recvd vax; exp cellulitis p/ vax;tx w/ atbs
Severe body aches, chills and intense shaking, full body pain including fingers and toes. Felt like having the flue X 10.
Vaccine administered 11/02/15, redness at injection site same day, hives began 11/03/15.
Patient reported a vasovagal syncope episode that appeared to be psychogenic nonepileptic involuntary movements by bystanders, however the patient retained consciousness throughout the experience.  It lasted roughly two minutes.
1st injection felt warm all over and sore.  Arm became inflamed from top of shoulder to elbow.  Weak for several days. 2nd injection my face and lips swelled up beyond recognition.  My I phone would not recognize me by face recognition.  Used anihistamines for swell and was close to going to ER for Allergic reaction.   My body hurt to take a step due to all over soreness.  Weak for several days. I have photos.
LIGHTHEADED; NOT FEELING RIGHT; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced lightheaded. On MAY-2021, the subject experienced not feeling right. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, lightheaded and not feeling right was not reported. This report was non-serious.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored ROTATEQ (unknown lot #s and expiration dates). The vaccine was stored under 1.3 degree Celsius for 35 hours. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.