chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe migraines for weeks; Fatigue; Nausea; Rash on both sides of my neck; strange dreams; Night sweats; Extreme sore arm; Burning in the back of my head; Muscles soar in the back and lower rib cage; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 09:45 (Lot Number: ER8734, Expiration date was not reported) (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient received other medications in 2 weeks (details were not reported). The patient had known allergies (details were not reported). The patient had covid prior to vaccination and was tested for covid post vaccination (blood test and nasal swab). Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 09:30 (Lot Number and Expiration date was not reported) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid vaccine. On 10Apr2021 19:00, the patient experienced patient experienced severe migraines for weeks, fatigue, nausea, rash on both sides of my neck, strange dreams, night sweats, extreme sore arm, burning in the back of my head and muscles soar in the back and lower rib cage. Laboratory tests on an unspecified date included sars-cov-2 test (blood test) unknown result and sars-cov-2 test (nasal swab) unknown result. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Shot of Zofran and tramadol, Benadryl & Cortizone. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
COVID 19; COVID 19; dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'; dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 at 16:30 as dose 2, single (Lot number: FF2587) at the age of 44 years, in left arm for covid-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Aug2021 at 19:15 as dose 1, single (Lot number: 939893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood clotting disorder factor 5" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "scleroderma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE]; ELIQUIS; MAXALT taken for migraine; MINOCYCLINE. Past drug history included: Known allergies : reglan, reaction(s): "Allergy"; Known allergies : topamax, reaction(s): "Allergy". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Sep2021, outcome "unknown" and all described as "dose 1 'Moderna' , dose 2 'Pfizer / BioNTech'"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 08Aug2022 to 13Aug2022.
Fever 102.3 and diarrhea onset 7/7/11.  Vomiting onset 7/8/11 R arm with edema, erythema, increase color, 15 cm area and area of clear secretion.  L arm no edema but erythema 5cm.  Pt. usually vomits with fever.
Erythema, swelling, itching of upper arm surrounding administration site. Tingling to fingers of administration arm.
Cold/clammy to touch, dizziness, fatigue, difficulty breathing, temporary vision loss. Treatment: Epipen done to right thigh w/in 2 minutes of patient symptoms.
This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 19 year old female with Human papilloma virus infection (16,18,31,33,35,39,45,51,52,56,58,59,68) and no allergies, who, on an unspecified date, was vaccinated with a second dose of GARDASIL.  There was no illnesses at the time of vaccination. Subsequently, the patient developed a delayed injection site reaction. It was reported that the vaccine was administered on a Friday and Saturday the patient developed redness at the injection site. On Sunday the patient developed a hard lump on the arm and pain that lasted for 2 to 3 days.  It was noted that the patient had tested positive for human papilloma virus at a prior Pap smear. The patient sought unspecified medical attention. It was reported that the patient was not seen by medical personnel because she was away. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Developed severe injection site pain about 3 hours after the injection, which has persisted until now (18 hour later). Developed subjective fever overnight, did not take temperature but slept with ice pack on head and was still hot. The next morning had 2 presyncopal episodes in the shower, then had dry heaving that would have been vomiting if there was food in stomach. Did not take any antipyretics.
At 10:00 pm 11/19 mother noticed left upper arm reddened, swollen, hard and hot to touch. Took child to ER was told it was a vaccine reaction given Rx for Benadryl and prednisone. Told to use ice pack as well then discharged from ER.
Pfizer-BioNTech COVID-19 vaccine EUA on 12/15/2020--12/19/2020 @ 0300 I woke up with joint pain in all joints including hands, feet, fingers & toes, also muscle aches. I had an occasional cough, nasal congestion, nausea and headache. The joint and muscle pain lasted approximately 48 hours and was relieved with Tylenol and ibuprofen  every 4-6 hours. The HA lasted until 12/22/20. As of today 12/23/20 I still have some nasal congestion but no other symptoms. I never ran a fever.
Left arm swelling and some bruising. bruising resolved after few days. also some cervical lymphadenopathy and rash x few days, now resolved. patient with residual arm swelling 2 weeks post vaccination.
That night I had lower abdominal pain. I had blood clots when I went to the bathroom too pee. I notice a lot of blood and   in the morning I went to urgent care. They took urine samples and I had Urinary tract infection after they prescribed me antibiotics. After 5 days I felt much better.
This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertensive, Hyperlipidemia, Diabetes and Hyperthyroidism. Concomitant products included: Amlodipine; Atorvastatin; Metformin; Olmesartan; Methimazole for an unknown indication. On 02-Mar-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no allergies to medications, food and other products. The patient had not tested positive for COVID-19. The patient did not have any adverse event. No treatment medications were reported. This case was linked to MOD-2022-503824 (Patient Link).
Onset of acute (L) sided Bells Palsy on 3/21/2021
Mild nausea, on and off for first 36 hours after shot, no need for any medication to mitigate, resolved on its own
About 5 to 8 minutes after receiving Janssen Covid-19 vaccine. Patient passed out. Patient lost consciousness for a few seconds. Patient was laid down on the floor & feet elevated. Patient then started vomiting. He vomited several times. We were able to use cold compresses & cold rags to help cool patient down. Vital signs were taken. O2-99%, Pulse:69, B/P- 120/82. Patient was given a coke to help with nausea. Patient did state that he had not ever passed out before. But did state that he had not really eaten today. Also stated that after receiving the vaccine it was painful for him. Patient had significant other with him today. We did recommend calling family provider & letting them know what happened today. Also if not any better take to ER. Patient did not have shortness of breath and no chest pain. Patient was able to walk out with significant other and nurse without any issues.
Patient is 12 and received pediatric dose of covid 19 pfizer vaccine. Patient parents notified and patient to receive correct dosage at his second dose appt.
Covid-19; Loss of taste; General congestion; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), SINUS CONGESTION (General congestion) and COVID-19 (Covid-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced SINUS CONGESTION (General congestion). On 25-Jan-2021, the patient experienced AGEUSIA (Loss of taste). On 27-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, AGEUSIA (Loss of taste), SINUS CONGESTION (General congestion) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided
pt states that the day after getting the flu vax she developed muscle and body aches, had difficulty breathing, she could not breath through her nose and has slept more than average since. Pt is still weak and sleeping, She can breath through her nose and mouth at this time.
My smart watch showed irregular heart rhythm. I thought it was impossible. I went to see my cardiologist and I was given a monitor to wear for 30 days. And sure, enough it showed I had AFIB. I was prescribed a blood thinner Eliquis. That was about it at that point. My smart watch is showing AFIB. I came to another state and saw a cardiologist here and my heart rate was over 100. And this doctor put me on two other drugs to help Flecainide and Diltiazem. I was on those for one month to bring the heart rate down. It did not, so then he scheduled a Cardioversion. The next step I had to have a Cardiac Ablation it has worked so far; this is because I'm young and it seems my heart will wear out in 20 years. As of today, I feel good. It is possible I will need another; it does happen to people.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil. Subsequently, the patient developed a "rash all over her body". It was reported that the "rash had subsided within 24 hours". The nurse reported that the contact dermatitis was not related to the vaccination with GARDASIL.  The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Vial 1 of 2 AS01B Adjuvant Suspension Component was only given to the patient. The nurse had grabbed both vials, drew up the liquid component first, got distracted by another staff member in the med room, never mixed it with the powder vial, gave the immunization and realized that it was not mixed properly until she was documenting.
Pt. began feeling dizzy and was instructed to sit down. She then turned pale yellow color and "blacked out". The patient was not treated with anything. She awakened about 10-15 seconds later.
developed hives on left leg and developed a different type of rash that actually looked like bruises on both the left and right arm, rash on leg went away in a couple days, rash on arms was there longer probably about 1-2 weeks and rash at injection site was still there at 21 days post shot.
Information has been received from a registered pharmacist concerning a 69 year old male with hypertension, high cholesterol, thyroid disorder, enlarged prostate, skin condition (type not specified) and penicillin allergy who on 28-MAY-2008 was vaccinated subcutaneously in the right upper arm with ZOSTAVAX (Merck) (Lot # 659760/0159x). Concomitant therapy included metoprolol, DIOVAN, SYNTHROID, AVODART, RETIN-A, baby aspirin and multiple vitamins. On 28-MAY-2008 the patient developed a knot on the arm a few centimeters from the injection site. There was no complaint of warmth, pain or color change at the site. The patient was recovering. The patient sought medical attention at pharmacy. Additional information has been requested.
Woke up in AM with sore/red spot at injection site, throughout the day pain escalated, along with headache. Took Ibuprofen. Following morning (11/16/2012) whole upper arm was very painful and sore, redness had spread to whole upper arm. Also experienced low grade fever, and nausea, and headache.  Visit to Doctor to rule out infection. Redness continued to spread down arm for a few days, as pain diminished.
12/07/21 presents to ED for "DOE" "labored breathing w/ wheezing". PMHx of "non-ischemic cardiomyopathy, CAD s/p CABG, asthma, TIA (2014)"
Phlegm in her throat; Nose was runny; Like a cold; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold). The patient was treated with AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported that all adverse events that were previously reported had resolved and she was "doing good".    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR was added. Provided event outcome.
bruising at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 31st December 2020) for prophylaxis.   On 23rd January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovering/resolving.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and on the day of reporting the patient came back to the pharmacy complaining about bruising all around the site of injection.  The pharmacist said that it looks like someone punched her all around the site of injection.
A physician reported that an 8 month old female received her 3rd doses of Prevnar, Hib-Titer, IPV and Infanrix vaccines on 1/19/01. On 5/26/01, at 12 months of age, the infant died of "presumed SIDS-like syndrome". An autopsy report is pending. The reporter did note that the infant had a history of seizures; however, she has been "seizure-free while on meds". The reporter also indicated that the infant's death is under investigation for "possible Munchausen's by proxy via mother" or a "possible interaction between Lamictal (lamotrigine) and phenobarbital." Both the investigator and the medical monitor agree that the event is not related to vaccine administration. This report of a serious, labeled event is being submitted as requested. COD as per autopsy report -- undetermined. Follow-up info received on 03/15/2002 indicated that on 05/26/2001, the child became fussy, then lethargic and "appeared to be breathing heavily." That same evening, the mother found the child unresponsive and not breathing. Emergency services were called. CPR attempted and the child was transported to an ER. On arrival, she was in full arrest. Resuscitation efforts continued and cardiac medications were given; however, the child was pronounced dead. A full body x-ray revealed no abnormalities. An sutopsy was performed; however, the cause of death could not be determined. The original assessments of relatedness remained the same. Per F/U 3/27/02 COD: Cardiopulmonary arrest; subdural hemorrhage and neomembrane, indeterminate age, very limited area, right fontoparietal parasagittal region, probably incidental finding. This decedent had only a partial right middle lobe (minor congenital anomaly). A fatal seizure is not ruled out, but, in view of the history of 2 recent overdoses inflicted by the mother, imposed suffocation is also considered a possible cause of death but no cause of death was determined on autopsy.
Patient states that after she got the shingles vaccine her arm became swollen & red. Patient went to doctor on Monday 8/23/10 and received Antibiotics.
Pt felt faint, nauseous and pale after injection, with rest, fluids, food she perked up and went home well.
Back pain; Feel like I'm catching a cold; My stomach is bubbling.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: EP7533) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Back pain"; FEELING COLD (non-serious), outcome "unknown", described as "Feel like I'm catching a cold"; GASTROINTESTINAL SOUNDS ABNORMAL (non-serious), outcome "unknown", described as "My stomach is bubbling.".  Additional info: Patient stated I had took the first shot 07Apr2021, I was supposed to go back the 30Apr2021 for the second one. It totally slipped my mind. I didn't had any reaction after the first one, I missed the second one. I was experiencing some back pain on Saturday, and feel like I am catching a cold. I missed the second dose, wondering if this reaction could be because I missed the second one. My stomach is bubbling.  No follow-up attempts are possible. No further information is expected.
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myocardial infarction (MI) on 16-Dec-2016, Fusion lumbar spine (L5S1OR) in 1985 and Fusion lumbar spine (L4-S1 fusion twice) in 1999. Concurrent medical conditions included Allergy to antibiotic (Allergic to bactrim), Drug allergy (Allergic to toradol), Chronic back pain since 1972, Nerve pain (post fusion), BPH and Clot blood (CV anti clot). Concomitant products included ALFUZOSIN from April 2010 to an unknown date for BPH, ASPIRIN [ACETYLSALICYLIC ACID] from 2010 to an unknown date for Clot blood, LAMOTRIGINE from 2001 to an unknown date for Nerve pain, TIZANIDINE from 2001 to an unknown date, AMITRIPTYLINE from 2001 to an unknown date, RANOLAZINE (RANEXA), ROSUVASTATIN, CARVEDILOL and LOSARTAN POTASSIUM for an unknown indication.    On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 antibody test: 2070 (Positive) SARS-CoV-2 semi-quant total Ab was reported as 2070 U/mL.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Patient did not notice any ill effects from or attributable to her medications.   This case was linked to MOD-2021-300198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Live followup document contains no new information.
Patient had a syncopal reaction to her immunizations, Tdap and Varivax, that she received at 12:15 pm on 06/09/2010 in the clinic. The patient fell on the floor and hit her head.  This was witnessed by the patient's mother and this writer, both were in the room with the patient when it happened. Her vital signs were checked and blood pressure was found to be low.  Heart rate was normal.  She was transferred upstairs for intravenous fluids and observation.  She received one liter of normal saline.  She had an episode of emesis after she ate some food.  She was observed until about 4:00 pm.  The patient felt better and was ready to be discharged home.  She will follow-up with family physician as needed.  Patient was advised to eat food next time before she comes for immunizations and also to lay down while she is getting the immunizations to avoid a vasovagal reaction.
Vaccine was given beyond use date, incorrect BUD was listed on the vaccine. BUD: 2/27/2023. Patient did not present with any adverse reactions.