chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 19Nov2021 at 18:00 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin; Steroids, reaction(s): "Known allergies: Steriods", notes: Known allergies: Steriods. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Tested Positive for COVID on 30May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient immmediately held breath at onset injections. apneic approximately 1 min, then pale with gasping repisrations 90 seconds then tonic-clonic seizure X 3 min , given O2 via mask-subtle seizure X 5 more min, taken to the ER.
Pt. rec'd IM injection in rt arm on 11/11/09. Reports experiencing upper body itchiness, dizziness, loss of appetite, low bp 2 days later. No soreness at injection site. Rec'd seasonal vaccination 1 wk later in left arm. Consulted doctor by phone approximately 2 wks later, who recommended BENADRYL cream. Dizziness had diminished by April, 2010. Visited doctor June 1st for continued itching. Dr. prescribed CORTISONE cream. Itchiness on upper body w/ rashy welt areas continues.
Shoulder pain, tingling in hand, 'nerve' pain at site if injection. This has been to present time. Will have to see Doctor for further information.
Nausea, fever, chills, aches, HA less than 24 hr after pneumococcal pneumonia vaccine unable to eat, dry heaves, no diarrhea. Swelling, redness Lt upper arm.
severe fatigue; acute headache; malaise; nausea; inability to perform normal duties; Heavy eyelids which resulted in patient having to rest immediately; This is a spontaneous report from a non-contactable other hcp. An adult non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 22Feb2021 08:00 (Batch/Lot number was not reported)as dose number unknown, single for covid-19 immunisation. Medical history included asthma and allergies to medications, food, or other products to Shrimp, levaquin and tequin. The patient concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 10:00, after 2nd hour post vaccine, the patient experienced severe fatigue, acute headache, malaise, nausea, inability to perform normal duties and heavy eyelids which resulted in patient having to rest immediately. Therapeutic measures were taken as a result of the events (Tylenol, extra fluids). The clinical outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left Upper Brachium Pain, especially when lifting left arm or putting any pressure on it, Tender. So far only taken ADVIL.
Does not feel like eating; Duration between 2 doses more than 37 days; High Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Does not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Duration between 2 doses more than 37 days), PYREXIA (High Fever) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A2A4) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EATING DISORDER (Does not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Duration between 2 doses more than 37 days), PYREXIA (High Fever) and HEADACHE (Headache). At the time of the report, EATING DISORDER (Does not feel like eating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Duration between 2 doses more than 37 days), PYREXIA (High Fever) and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included paracetamol
Fatigue; Chills; Nausea; Vomiting; Headache; Muscle pain; Joint pain; Felt a little under the weather; A spontaneous report was received from a consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little under the weather/malaise, fatigue, headache, muscle pain/ myalgia, joint pain/ arthralgia, chills, nausea, vomiting. The patient's medical history was not provided. Concomitant medications reported were lisinopril, Vitamin D, Vitamin B for used for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) felt a little under the weather . On 16 Feb 2021, the patient experienced the event(s) fatigue. chills, nausea, vomiting, headache, muscle pain, joint pain.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s) headache was considered resolved on 17 Feb 2021.The outcome of event(s) muscle pain was considered resolved on 17 Feb 2021.The outcome of event(s) joint pain was considered resolved on 17 Feb 2021. The outcome of event(s), felt a little under the weather, fatigue,chills,nausea,vomiting was unknown.
Had 2 shots, one in each arm. Lt arm in morning, upper arm "grew big," red/purple, swollen, itching, skin very dark in color. Only local itching. From shoulder to elbow Mom describes swelling. Seen by MD given cephalexin supervision. Mom reports arm "smaller after medicine.
been sick since then; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 3 weeks after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: Age at vaccination was not reported. The patient got a flu shot 3 weeks ago and the patient was sick since then.  The patient never want to take flu shot.
pt recvd vax & had non stop screaming for 24 hrs per mom; unusual cry; did not sleep; local swelling & bruising; low grade t;
Received Flu shot in October, followed by Moderna booster in November, approximately four weeks apart.  Approximately 2 weeks after the booster shot, I started with symptoms of itchy palms & knuckles.  This progressed over the next few days to include my arms and torso.  I also had developed a "pins & needles" feeling in my hands.
This case was reported by a consumer and described the occurrence of shivering in a patient who received SHINGRIX for prophylaxis. The patient's past medical history included lung cancer. On 10th December 2018, the patient received the 1st dose of SHINGRIX. On 14th December 2018, 4 days after receiving SHINGRIX, the patient experienced shivering and tiredness. On an unknown date, the outcome of the shivering was unknown and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On 14th December 2018, list evening the patient woke up in the middle of night with uncontrollable shivering. The patient was not running a fever, but very tired which had continued till the day of reporting. Just curious if this could be a reaction 4 day after the fact. No other problems with the shot of possible note. The patient also had lung cancer. Diagnosed in 2013, 2 years of chemo then 1 year of Opdivo, finally last August 2017, 2 sessions of high dose radiation. No treatments since then and last PET (positron emission tomography) 1 month before the date of reporting showed no increase in size (6mm) of remaining tumors.
After about 10 minutes patient felt clammy,  blurred vision and nauseous.   She drank some water, sat on bench and tried to relax, was able to breathe but stated her vision was blurry and felt off.   We called 911 and the paramedics took her vitals which were all normal and she felt better after some time.   The paramedics did not take her to the hospital and believed she was very anxious after the shot.
No adverse event; Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.   Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and LOT ER8730) on 22-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Cancer and Immunocompromised.    On 13-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) 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 INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer dose 1 on 22-Aug-2021 and Moderna dose 2 on 13-Mar-2022) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    Patient past drug history included Shingles.  No concomitant medications were reported.  Patient was going through cancer treatment and unsure of type of cancer. HCP confirms that diagnosis was 1 year ago before receiving COVID-19 vaccines. Patient did not have any allergy.  No treatment information was provided.   This case was linked to MOD-2023-714594 (Patient Link).
Information has been received from a registered nurse concerning a 13 year old female with asthma and allergic eczema who on 10-NOV-2006 at 12:00PM, was vaccinated in the right arm intramuscularly with a first 0.5 ml dose of Gardasil (yeast) (lot#653978/0955F). Concomitant suspect vaccination included a dose of tetanus toxoidon 10-NOV-2004. Other concomitant therapy included albuterol and ZYRTEC. There was no illness at the time of vaccination. On 10-Nov-2006 the patient experienced bronchospasm 20 minutes after receiving Gardasil (yeast). It was also reported that the patient developed a cough but she did not vomit. The patient used her albuterol inhaler and then rested and was recovered on the same day, 10-NOV-2006. No vomiting and no other anaphylaxis type reaction was noted. Additional information is not expected.
pt recvd vax on 8AUG92 & on 9AUG92 seen in ER dx poss anaphylaxis; upon exam, anaphylaxis was r/o & pt condition was dx as pleurisy;
This spontaneous report as received from a pharmacist refers to a 76 year old male patient. Patient current condition includes alpha-galactosidase allergy from a tick bite and red meat intolerance. Patient historical drug includes alpha-galactosidase. On 16-MAR-2015 the patient was vaccinated with ZOSTAVAX (lot # K016326 and expiry date 24-DEC-2015), dose 0.65 ml via subcutaneous. Other co-suspects were not reported and concomitant therapies included metformin (manufacturer unknown). On 16-MAR-2015 within two to three hours after administration of the ZOSTAVAX, the patient developed swelling around the injection site. The patient came back into the pharmacy on 16-MAR-2015 and showed the swollen area to the pharmacist. The pharmacist described it as a large area from the shoulder to elbow. The swollen area was red, warm to the touch and was oblong in shape and localized to that arm the patient received the ZOSTAVAX. Reporter stated that the swollen area had decreased in size but the area was still sore. The patient sought medical attention and visited pharmacist. The patient received treatment, reported as pharmacist advised the patient to take TYLENOL as well as the BENADRYL as needed. Reporter stated that in the past on an unspecified dates, after administering ZOSTAVAX to unspecified patients, the patients complained of a quarter size swollen area at injection site on unspecified dates. Cancer and overdose was not reported. The outcome of the events was reported as recovering. Additional information has been requested.
Had Migraine HA's with menstrual cycle (never had migraine HA's before) , the migraine HA's caused 2-3X vomitting, sensitivity to light and noise.  and Irregularities in cycle - doubled the time of the cycle bleeding and heavier from 5 days normal to 10 days. These symptoms lasted for 6 months.
Injection site was sore for 3 days.  Body aches began 24hrs after injection, lasting another 36hrs.  Chills also began 24hrs after injection, but only lasted 8hrs. No fever. No respiratory or nasal symptoms. No superpowers. Treated with ibuprofen.
Patient was vaccinated on 8/3/07, he has been keeping his site covered.  He came in to the immunization clinic for a site check 2 weeks after his vaccination date.  Patient stated that he told the immunization tech. that the scab fell off but it wasn't healed yet.  The tech told the patient to just keep a regular bandage on it, but the tech did not check the site.  Patient noticed several pustules around the original vaccination site on 9/4/07, he has been keeping them covered.  Myself  and someone else examined the site and provided him with several bandages.  Patient is deploying on 9/9/07, advised him to follow up here if he has any problems before he leaves, otherwise to follow up at his deployed location in one week.
Day 1) after 5 mins: rapid heart rate sweatin,g lasted 5 mins.   at 45 mins: strong metallic taste and burning in mouth, both lips numb, loss of strength, lasted 1.5 hrs, slight nausea feeling rest of day Day 2) 99.8 fever, fatigue Day 3) 99.8 fever, fatigue, headache Day 4) better Day 5) bottom of both feet start burning, very noticeable at night, lasted 4 days Day 15) migraine headache, right side/top lasted 3 days
mild itchy sore throat; mild itchy sore throat; This is a spontaneous report from a contactable physician (patient) via medical information team. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that she was fine and experienced nothing but a mild itchy sore throat. She reported that most of her symptoms were resolved. The reporter wanted to know that if it will fine for her to receive the second dose and what are the chances that she will experience the same symptoms. No one was present. She was scheduled for second dose on 04Mar2021 at the mall. The outcome of the events was unknown.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FELT DIZZY, PHARMACIST KEPT PATIENT UNDER OBSERVATION INSIDE THE IMMUNIZATION ROOM. SHE RECOVERED QUICKLY, DRANK SOME WATER AND STAYED IN THE AREA FOR ABOUT 30 MINUTES WITH A FAMILY MEMBER.
Next day: Headache, eye pain, cough, fatigue, tinnitus, some congestion.  Current, as of 3/15/2021: Headache still persists almost daily, but seems to be lessening in severity. Eye pain, tinnitus occasionally, but improving. I did not receive the second injection on 2/26 because of these lingering side effects.
This spontaneous report was received from a medical assistant who was also the office manager and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 12-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent, lot#: M033585, expiration date: 21-APR-2019, was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered vaccine was stored in temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015680: US-009507513-1705USA015681: US-009507513-1705USA015683.
This spontaneous report as received from a physician refers to a 10 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
I would like to report an adverse reaction to the vaccine. I was vaccinated on 5/14/21 at the primary care facility. Time of vaccination was approximately 3:45pm. At that time there was no immediate reaction such as anaphylactic shock or other symptoms. The next day, 5/15/21, I experienced headaches throughout the day and a fever of approximately 102 degrees that began at approximately 5:30pm. There was also soreness at the injection site. The next morning, 5/16/21 I had a slightly low temperature of approximately  97.2 degrees. Sunday night the temperature was slightly elevated at 99.4. Headaches continued throughout Sunday. I took aspirin on 5/15/21 and 5/16/21 for generalized aches, headaches and fever. Temperature normal 5/17/21. Very slight headache continues as of 5/17/21.  Aspirin has been discontinued so as to not mask any potential problems. Relevant medical history from 5/14/21 is:(almost age 58), Blood pressure 132/82, pulse 71, temperature 98.3, Oxygen saturation 97%. Height is 5 foot 3 inches. Weight 248. No history of cardiovascular disease, stroke or prior Heparin use. Relevant medications include hormone replacement  therapy consisting of one 2.5 Mg tab Medroxyprogesterone Acetate and one .5 Mg Estradiol tab daily.
I was feeling fatigued with a sore throat. By December 26, 2022, I completely lost my voice. I also had a fever. I had a televisit on December 31, 2023, and the doctor recommended over the counter treatment. I went into the doctor on January 6, 2023, and the doctor gave me a steroid treatment for a week along with codeine, and my symptoms resolved after a week.
Case number PHEH2014US002081 is an initial spontaneous report received from a nurse on 27 Jan 2014 with a follow-up received on 25 Feb 2014. This report refers to a 3-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 13462P, expiry date: May 2014) intramuscularly into left thigh on 20 Jan 2014 at 16:55. Nurse reported that the patient under 4 years of age received FLUVIRIN. No adverse event was reported following medication error. Follow up received from health care professional on 25 Feb 2014: Site and time of vaccination updated. Reporter details updated.
10 days after the booster shot, SEVERE itching of scalp in the morning followed by random large red patches of skin on my body lasting anywhere from 1 to several hours.  Hives popping up randomly from my feet up to my face/head.  I took Claratin on the 2nd day of the same symptoms, which helped  A LITTLE.  It has now been 5 days and I am still getting red patches in various spots on my body that last for 1 to several hours, and then disappear.  I am also still getting raised, very itchy hives randomly on my body that last for hours.  Mostly, anywhere that gets friction from clothing , especially on my back, shoulders, panty line, wrists and ankles.
Initial unsolicited report received from a nurse on 31-Aug-2018. This case involves a four-years-old patient who was vaccinated with a dose of 0.5 ml of IMOVAX POLIO lot number: N1J451M via intramuscular route in unknown administration site on 17-Aug-2018 which had a temperature excursion. It was as actual medication error due to due to incorrect product storage. It was unknown that any adverse event was occurred or not. This suspected adverse holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.