chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely fatigue for 4 days; Heavy sweats; Loss of appetite; Headache; Dizzy; Continuing vertigo for longtime today is 5th day; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01May2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 07:00, the patient experienced extremely fatigue for 4 days, heavy sweats, loss of appetite, headache, dizzy and continuing vertigo for long time, today was 5th day (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely fatigue for 4 days was resolved on 06May2021 at 07:00. The clinical outcome of the events heavy sweats, loss of appetite, headache, dizzy and continuing vertigo for long time today was 5th day was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
How high a fever could someone expect after vaccination / Side effect fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient experienced side effect of shingrix a fever. The patient wanted to that how high a fever could someone expect after the Shingrix vaccination.
Patient is fully vaccinated and boosted.  COVID positive on 4/12/2022 at ED visit. 77-year-old female who presents complaining of cough, congestion, and wheezing.  Patient was sent from urgent care because they said that she had a pulse ox at 88%.  She denies any chest pain or shortness of breath with exertion.  She denies any nausea, vomiting, diarrhea, abdominal pain, back pain or leg pain.  She denies any leg swelling.  States that she does take Lasix occasionally.  She is on blood thinners.  States she missed her dose for today but that she will take it tonight.  She states that she is chronically in A. fib. Remained 97% in the ER.  Chest x-ray negative for acute process.  Labs reviewed, no significant abnormalities.She was also given steroids, magnesium, and Tessalon Perles in the ER with improvement.  She received an IV fluid bolus.  She was given a prescription for steroids and Tessalon Perles for home.  Discharged home.
Patient was given his Covid Bivalent this am (12/02/22) at 8.35am.    The Covid Bivalent 5-11 is supposed to have a diluent of 1.3ml added before the vaccine is given.   The diluent was not added to the vaccine before it was given to patient.    another staff member and myself were in the med room this morning, while this staff member was pulling out the Covid vaccines for the day, I asked if she would be able to draw me up a 5-11 Covid bivalent. While talking she grabbed the diluent to draw 1.3 ml, however this was not added to the Bivalent before drawing the initial vaccine to give to patient. this was not caught until another staff member went to draw up this vaccine to give to another patient.   A provider was informed of this and updated a parent of patient about the incident and what reactions if any were to happen
pt to hospital with GI bleed (on Coumadin) on 8/14/22; received 2 U of PRBC transfusion; DNR;  pt had a positive COVID test on 8/22/2022 at a local healthcare center; was asymptomatic and required no therapies for COVID; suffered V-Tach cardiac arrest and passed away in the hospital
Pt recvd MMR vax & 24 hrs later devel nausea, aches, pain, & flu-like sx; no further details were provided;
Pain and redness to thigh (left) warm to the touch. 9cm erythematous.
One week after the shot I had a small red patch at the injection site. Over six days the red patch grew in size and was painful. After a week it began to fade and was less itchy and painful. The same thing happend with the second dose but was less severe
Information has been received from a registered nurse concerning a 67 year old male patient with hypertension, polycythaemia vera, peripheral neuropathy, gastrooesophageal reflux disease, hyperuricaemia, erectile dysfunction, sinusitis, no known drug allergies and a history of kidney stones who in 2005 was vaccinated with a dose of PNEUMOVAX 23 "without problem". On 13-JAN-2010 the patient was vaccinated with a 0.5 ml IM dose of PNEUMOVAX 23 (Lot # 664864/1365Y) in his left arm. No other vaccines were given. That same day the patient was prescribed AUGMENTIN for his sinusitis. Concomitant therapy included VERELAN, ECOTRIN, folic acid and ALLOPURINOL. On 18-JAN-2010 the patient reported to the nurse that four hours after receiving PNEUMOVAX 23, on 13-JAN-2010, he became shaky and developed redness and swelling at the injection site; by 18-JAN-2010, shaking and redness were gone, but his left arm was still slightly swollen (recovering). It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. On unknown dates the patients received GARDASIL (lot#, expiration date, dose and route not reported), after being improperly stored for one month. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started bleeding and blood clotting and hemorrhaging blood really bad. I have fibroids and anemia. That 2nd shot made my condition really horrible. I was managing my condition before that shot. I have to get a surgical procedure done. I wasn't asked if I had a blood disorder during both of my shots and I was not aware that I should have not gotten the shot when I have a blood disorder. I just found out about this today.
Sore throat, coughing, runny nose, tired, headache, joint pain, no rash
2 shot series in 2019, diagnosed with shingles; Shingles bumps on head heading to his eye.; tingle of a cold sore; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (20 years ago had a very mild case of shingles bumps on the side of his head) and laser therapy (had an elective surgery on his right eye called Selective Laser Treatment (SLT)).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles and cold sores were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and cold sores to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient reported case for himself. The age at vaccination was not reported. He received Shingrix 2 shot series in 2019. He did not know the exact dates or lot numbers of the Shingrix he received but he did provide his pharmacy's contact information where he received the shots. The pharmacy should have that information on file. He said he confirmed with the pharmacy that it was the 2 dose Shingrix series, not  the 1 dose Zostavax shot. He did not remember which arm the Shingrix shots were given in. He could not confirm if the shots were given intramuscularly or other.  He stated that a week ago he had an elective surgery on his right eye called Selective Laser Treatment (SLT). The next day he had the tingle of a cold sore and took some Valtrex (which he had). On Saturday night 21st August 2021 a line on the top of his head was noticed that was heading toward his eye. He thought it might be shingles and he was worried that it would spread into his eye so he went to urgent care. He was diagnosed with shingles bumps and the doctor prescribed Valtrex 1000 mg three times a day for 7 days (which is a higher dose than he was taking for cold sores).  The patient wanted GSK to know that he feels that the SLT triggered the shingles outbreak. He said he read online of 2 case reports of patients who developed shingles after SLT surgery.  He stated he would not going to get the left eye done. The reporter wanted GSK to know that he did not think he was under any stress as he had read that stress could bring about shingles outbreaks. The reporter feels that there was a relationship between herpes and shingles, that they were cousins. The physician did not probe more into his history of cold sores (herpes) but it seemed to be a pre-existing condition otherwise he would not have had the Valtrex on hand. The reporter did not consent to follow up.
According to school nurse, patient experienced paralysis and blindness. Unknown if attributed to possible viral illness patient had.
Developed sever psoriasis about 1-2 months later on palms of hands and bottoms of feet and genitals and now shins.
Single seizure with generalized shaking. Fever 101 on prior. Increased WBC count and atelectasis shown on chest Xray. Dx=pneumonia. Rocephin antibiotic given via IV. Seizure, Single: Number of seizures; The type of seizure was generalized shaking; Time since the seizure: about 25 minutes; Event witnesses: friend; During the seizure the patient did not suffer any trauma; Before the seizure there was no head trauma; The patient has no known history of seizures; The patient has not had any known vomiting; Other History: Patient received shots yesterday (DPT, Hepatitis, and another shot). Last night, noticed a fever (101) gave Motrin. This morning patient got Tylenol at 1000 hrs; The child has apparently been normally active and playful.  9/29/08 Case closed w/medical records that accompanied report. FINAL DX: leukocytosis, pneumonia, seizure Records reveal patient exprienced fever 104.6 & had multiple generalized seizures.  Tx w/IVF, antibiotics, O2, bronchodilators.  Improved & d/c to home.
This case was reported by a consumer via call center representative and described the occurrence of cold in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cold and incomplete course of vaccination. On an unknown date, the outcome of the cold and incomplete course of vaccination were unknown. It was unknown if the reporter considered the cold to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient mentioned briefly that she developed a cold after getting the SHINGRIX vaccine. She stated that it had been more than 9 months since she received her first dose of the SHINGRIX vaccine, till the reporting time she did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. She wanted to know if she should receive the second dose of the vaccine at the reporting time. No further details were provided.
some dizziness within a few minutes.  19 hours later,severe nausea promptly turning to cramps in the stomach and intestine area so severe I laid on the floor only able to focus on the Intense pain.  It went on for about 40 minutes, heavy breathing, itching palms of my hands.  I describe it as a siege or attack on my body.  I have given birth to 10 children and I can only say the pain of this reaction was so terrible my husband said if it doesn't go away soon I'm taking you to emergency.  I was left exhausted and with a continual stomach ache for hours.  I was unable to eat anything until about 2p.m.   Costco's pharmacy scheduled six different dates for people to come and administer flu shots.  I don't know the name of the group.
We are reporting the fact that this 9 month old recieved 3 injections of .25 cc of H1N1 over a period of 2.5 months, was given at two different locations. At this time he has not had any adverse reactions but this is a FYI in case something does develope.
bad stomach; Fall asleep during the day; Had nausea after sleeping/nauseous; Very tired/tiredness; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 20Jan2021 10:15 as unknown single dose (at the age of 65-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included acid reflux and IBS along with allergies to medications, food, or other products that included raw fruits and veg tree nuts. The concomitant medications included Omeprazole, Famotidine and Cranberry supplement and Cult. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID- 19 since the vaccination. Patient stated that she received her Pfizer covid vaccine on the 20Jan2021 and from 21Jan2021 14:00 she has been having tiredness and nausea while sleeping in the day also. Patient wanted to know about the symptoms and how long they lasts. Patient says she has a bad stomach anyway, but not like this normally. The patient was not treated for the adverse events nausea while sleeping in the day also. The outcome of the event feeling tired and bad stomach was unknown while for others was not recovered.   Upon follow-up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that: Patient says that she filled out the reporting form online while she was on hold. She clarifies this was on the website. Patient reported about the adverse event she experienced as updated in the initial narrative and is tells this happened everyday and asks whether any else complained about being very tired and having nausea after sleeping which constitutes the medical information request.  NDC and Expiration Date were not provided on her handwritten vaccine card. Patient says that lot number is either E13247, or El3247 as it is handwritten and she cannot tell.  Upon follow-up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported that included relevant medical history, age and pregnancy status at the time of vaccination, drug start date and time and anatomical location, event description with onset date and outcome, batch number updated as unknown from previously reported as E13247, concomitant medication details, treatment details as updated in the initial narrative.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Slight fever of 99.  Redness at the injection site.  Some itching at the injection site.
No adverse event from the vaccination on 1/31/2022.  Break through COVID infection from exposure on 14- 15 May 2022 while traveling over 24 hours in various airports returning from Hawaii after the mask mandate was cancelled.  I wore my mask at all times except while eating.  COVID symptoms appeared on May 18th. At home COVID tests showed positive on May 19th.  Symptoms:  severe sore throat, slight fever (~100) for a few hours controlled with Tylenol, sinus congestion, light headedness, head aches.  PA  wouldn't prescribe Paxlovid.  She insisted Ivermectin was best with a complete line of BS about using  medicine as a guinea pig.  Another PA in her practice had to prescribe Paxlovid.   Completed 5 day course of Paxlovid.
Day 3 of hospitalization.  FIrst dose given 3/22/2021.   89 y/o F  presents from her pulmonologist's office for evaluation of cough and shortness of breath. Patient reports her symptoms began about 3 weeks ago with a dry nagging cough and have gradually worsened since that time. She endorses loss of appetite, generalized aches, malaise, SOB and cough that has become productive and "rattling" although she is having trouble expectorating. She uses 3L of oxygen by nasal cannula at baseline due to her history of COPD. She had been using nebulizer treatments at home without much relief of symptoms.
Fever, extreme weakness, body aches, headache, nausea the following morning of the shot. Difficulty standing and urniating. Stomach cramps. These symptoms ended by 8/8.  Shingles showing rash on 8/8/2021 at 8:00am. Still currently spreading.  Heart Flutters
Patient called pharmacy via telephone to discuss that she thought she was having an allergic reaction to the moderna vaccine that she received on thursday (2 days ago). She described that it started as tingling roughly 10-20 minutes after the vaccine resulting in swelling around her lips characterized by an odd tingling, dry, itchy area with tiny hard to see bumps - I discussed with patient the possibility of cold sore - pt states they have had cold sores before but it has never felt like this before - she stated this started after receiving the moderna vaccine on thursday - I advised follow up w MD to evaluate need for exam / diagnosis of possible allergy to vaccine vs symptoms being unrelated to the vaccine, and to do this sooner rather than later and definitely before she receives the next dose of moderna vaccine just to be sure. I advised discussing with the MD the need for epi-pen prescription or discuss risk vs benefit of getting the second vaccine, before she gets the next dose of vaccine, due to facial swelling and possible allergy - advised if facial swelling continued to get worse or began to compromise breathing to seek medical care, although it seems unlikely this would occur due to the shot being administered days ago and symptoms do not appear to be progressing. I advised using an antihistamine (claritin or zyrtec during the day and benadryl at night) to see if this helps with swelling/reaction - advised that if this helps that it may indicate higher likelihood of this being an allergic reaction to the shot and to report this to the MD as well. patient confirmed that she will be following up with MD to discuss.
Pfizer-BioNTech COVID 19 Vaccine EUA Dizziness, feeling like I would faint, chills/sweats/fever for 48 hours, soft ball size swelling, redness and heat at injection site, diarrhea, rash on arm at site of injection, aching all over. Feeling unwell lasted three days, swelling and injection site related symptoms are still present but fading.
12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022; Vaccine were stored in refrigerator after beyond use date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022), PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19SEP2022 until 09NOV2022) and PRODUCT STORAGE ERROR (Vaccine were stored in refrigerator after beyond use date).    No concomitant medications was reported.  Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-JUL-2022 and Beyond use date was 05-AUG-2022. 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19-SEP-2022 until 09-NOV-2022. 9 Boosters 3rd dose and 3 second doses. No previous excursion. The vaccine was administered to 6 Patients on 19-SEP-2022, 2 Patients 04-OCT-2022, 1 Patients 06-OCT-2022, 1 Patient on 09-NOV-2022.  No treatment medications was reported.  This case contains information about Patient 9th out of 12 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
My arm was sore and a little itchy after. I did not experience any fever or anything like that. It wasn?t that bad. On 9/22, I had a fever of about 101, moderate to severe fatigue and my right leg was unable to support me. I was told to go to the ER where they gave me saline solution via IV, they took blood, they did a Cat scan, covid test and a lung xray. They did say it was some kind of viral issue and suggested Tylenol. The Tylenol did help along with fluids. I use the cane or walker but I am able to walk again.