chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; Fever (Temperature 101.4); Chills; Injection site tenderness; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (Injection site tenderness), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Tremor and Depression. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Tremor.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site tenderness). On 03-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills). On 03-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) had resolved. On 04-Mar-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101.4 (High) 101.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include an antidepressant, blood pressure medicine, and a statin for cholesterol. Reported that the patient didn't take any medications for the symptoms.   This case was linked to MOD21-045920 (Patient Link).
pt was given the Janssen vaccine at 12:05pm and pt had little bit of anxiety and was also having menstrual cycle. pt felt light headed 3 minutes after the shot and continued to have it for 20 minutes. Pharmacist offered to call 911 and pt denied it as pt have had panic attacks before. Pt was given ammonia inhalant once to breath in as she felt like fainting. Pt also developed chills. Pt was back to normal except menstrual cramping and had a friend come pick her up. Pt was adviced to go to talk to her doctor and get medically checked out and go to ER/call 911 if any of the symptoms comes back.
Headache HA, extreme pain, lymphadenopathy, chills, fatigue Narrative:  Took OTC ibuprofen for above sx
Very sore arm, moderately severe (6/10) headache, Low grade fever of 101F, chills, nausea, fatigue.  I?ve never had any significant reaction to other vaccines including 1st Shingrix dose, pneumovax, COVID-19, TDAP, and influenza. Treatment was acetaminophen and ibuprofen with moderate improvement.
Extremely itcy rash at injection site; Extremely itcy rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itcy rash at injection site) and VACCINATION SITE RASH (Extremely itcy rash at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medication history was provided.  Concomitant products included IPRATROPIUM BROMIDE (IPRATROPIUM [IPRATROPIUM BROMIDE]) for Allergy, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM, BIOTIN, CHOLESTYRAMINE, ESCITALOPRAM OXALATE (LEXAPRO), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LEVOSALBUTAMOL TARTRATE (XOPENEX HFA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itcy rash at injection site) and VACCINATION SITE RASH (Extremely itcy rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pruritus and Vaccination site rash, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Extremely itcy rash at injection site) and VACCINATION SITE RASH (Extremely itcy rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include hydrocortisone cream  for Vaccination site pruritus and rash.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: email address updated. On 14-Jun-2021: Dose 2 events have been reported.
This spontaneous report as received from a nurse refers to a 15 year old female, non pregnant patient. The patient had none pertinent medical history and developed none drug reactions or allergies. On 12-JUN-2014 the patient was vaccinated with PROQUAD (Merck) 0.5ml (lot # K004418, expiration date: 25-SEP-2015) (route of administration was not reported) due to the patients titer being negative rubeola and negative varicella. Concomitant therapy included unspecified asthma medications. The patient did not seek medical attention. This case is linked with MARRS # 1407USA001571 and 1407USA001009 (same reporter links). Additional information had been requested.
Sudden high temperature of 104F, uncontrolled shaking and muscle stiffness.
Dizziness, heart rate up and down between 62-118 while doing nothing physical. Had to sit down numerous times because I almost passed out. Heart rate would rave then drop and I'd break out in cold clammy sweat. Did not seek treatment tried to rest and had friends and kids keep an eye on me. Day 2 better but still times heart would race.
These symptoms seem typical; however, the length of time for which they have lasted does not seem normal: Exhaustion - severe Body Aches Migraine  Sore arm - but unlike any other arm soreness, even the second dose was not like this
Pt recv vax on 11/12/98; on same day pt exp painful LA w/ red, warmth, tenderness; tx=compress &Benadryl
My arm got sore and I got this large lump and its red with a rash, and it itches.
Case number PHEH2014US012837 is an initial spontaneous report received from a nurse on 24 Jun 2014 and with a follow up information received from a nurse on 20 Aug 2014. This report refers to a 14 year old female patient. Her past medical history and concomitant medications were not reported. She received only Men CWY liquid conjugate component of MENVEO (batch number: X14021) without reconstitution with Men A lyophilized component intramuscularly in the left deltoid on 23 Jun 2014 at 17:20 PM. No adverse events were reported following this medication error (inappropriate preparation of medication). Follow up information received from the nurse on 20 Aug 2014: Updated patient demographics (height and weight), site of vaccination and time of vaccination.
sore throat, headache, nonproductive cough, runny nose, body aches, chills, sinus congestion, nasal congestion, post nasal drainage. starting on 1/23/22
feeling extremely dry eye symptoms; feeling extremely fatigued; This is a spontaneous report received from contactable Consumer or other non HCP. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER 8729) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; ATORVASTATIN. Past drug history included: Asprin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER2613, Anatomical site: Right arm), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "feeling extremely fatigued"; DRY EYE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "feeling extremely dry eye symptoms". The events "feeling extremely fatigued" and "feeling extremely dry eye symptoms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dry eye as  Eye drops issued but ineffective.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Two weeks after my second dosage of the Pfizer COVID 19 vaccination, I've started feeling extremely dry eye symptoms. This has never occurred prior to the shot series. I'm also feeling extremely fatigued, which occurred the next day after the second shot. The patient received Refresh eye drops within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
The evening of the day the vaccine was given, the patient experienced pain in the area the vaccine was administered. Since that time, the patient has experienced pain in her upper left arm and stiffness in her neck. She stated she is unable to lift her left arm all the way up and has difficulty moving her head down towards her chest. Patient followed up with her primary care provider on 1/7/19. Her provider referred her to physical therapy. Patient stated that she will begin physical therapy on 1/11/19.
The patient reported to me that approximately 8-10 hours after receiving the vaccine, she experienced what she described as "whole body weakness", brain fog, and having an unstable gait. This lasted for approximately 24 hours, and she began to feel better thereafter.
Feel poorly; Flush; Pain; Fever; fluish; This case was reported by a consumer via interactive digital media and described the occurrence of feels poorly in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced feels poorly, flushing, pain, fever and influenza like illness. On an unknown date, the outcome of the feels poorly, flushing, pain, fever and influenza like illness were unknown.   It was unknown if the reporter considered the feels poorly, flushing, pain, fever and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 2nd dose a day before reporting and the patient felt poorly, flush and fluish. The patient asked if it was ok to take Advil. The patient did not wanted to repress the action of the vaccine. The patient was referring to medication as pain reliever such as ibuprofen. The patient just asked if it was ok to take fever or pain reducing medication post vaccine. The patient did not wanted to repress the mode of action of the vaccine. The patient could handle it but wished to take Tylenol or Motrin. The reporter denied to provide further information
no additional information provided/no additional AE; improperly stored temperature excursion; This spontaneous report has been received from an office manager (also reported as administrator) referring to a 4-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 03-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, and route were not reported; lot # T030760 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). Lot number T030760 is a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA), expiration date reported as 05-MAR-2022, but upon internal validation established as 08-MAR-2022). The vaccine was improperly stored at 5.3 degree Celsius for 45 minutes (product storage error). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional information or adverse event was provided.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA000596: US-009507513-2105USA000739:
Roughly 10 hours after receiving shot, began to feel chills. Fever started. Fever throughout the night and to the next morning. Fever reached 102.7 and was steady at that temperature for over 12 hours. Muscle aches and pains, then joint pain for a few hours. Headache and was unable to eat or drink. Pain and fever made it difficult to sleep
lymphadenopathy of left axilla started one month after injection, persisting for 4 months and ongoing
Summary: Huge flare up of Eosinphilic Esophagitus. May be a coincidence, but I was called by the Vsafe CDC survey people and requested to submit a report here. Hopefully this is unrelated, but in case you guys get an influx of "I can't swallow food anymore" reports, you can add mine to the pile.  After Shot 2, I had a lot of Side Effects that were non-dangerous and I was only out of work for a couple of days.I was curled up in agony/only able to crawl around for a night, but all of the side effects were already known/listed. I submitted reports on these inconvenient but known side effects and lamented I was a bit unlucky with them, but I was otherwise fine. I stopped submitting reports after the obvious and known side effects had passed.  However, by the end of May, I was having to eat food more and more slowly. I was used to having random but easily manageable rough patches with food, thought, so I paid it no mind.  At this point I was still able to (slowly) eat things like chicken, beef jerky, etc. I did not report these events as I did not know what my condition was, how severe it was going to get, etc.   However, by June 19th I started really struggling to eat, more than usual. I stopped being able to eat tough foods like beef jerky and most meats, but I could stilll (slowly and very carefully, by thoroughly chewing) eat most foods as long as they could be turned into mush.   At the end of June it rapidly went downhill. I could only eat half of a hamburger after much effort. Eating a small bowl of salad was workable. I remember, at one point, trying to eat a plate of french fries and crying over the fact I was unable to despite being super hungry.  I did not seek urgent medical treatment as I was moving out of my apartment at that time, and I kept telling myself that I just needed to "hang in there" for a few extra days. I did, however, get a referral to a specialist during this time.I was living off of just one baked potato (with cheese) and salad + ensures at this time.  July 3rd, I stopped being able to eat anything, basically. So in the span of 2 weeks I went from baked potato + salad to unable to swallow basic non-chunky soup puree and ensures. Yikes.  I went into the ER, had a surgery performed by another specialist (not the one I was referred to this man is Dr. who has since transferred me to Dr., and a biopsy taken. My esophagus tore, and I spent 5 more days in another hospital waiting for that to heal (luckily no additional surgery was needed).  Because my esophagus is so narrow and has a nasty chance of tearing again, they haven't been able to do much improvement. I am getting multiple surgeries over the course of months, and I am unable to function much let alone work.
The patient received a flu shot on 09/19/22 and 12/10/22
Pt given both flu and Pneumovax in same arm by persons at CVS pharmacy. Site reaction, body aches, temp. Pt seen in our office 2 days later.
This spontaneous report as received from a nurse via company representative refers to a 11 year old female patient. No demographic information was provided for the nurse. The patient's had received three doses of GARDASIL on an unspecified dates. No concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (lot number, dose, frequency and route of administration not reported). No concomitant medications were reported. In 2015 (dates unspecified), the patient experienced vomiting about four times. On 29-JUL-2015, the patient experienced rash, pain, redness and swelling at the GARDASIL 9 injection site. The outcome of rash, vomiting, pain, redness and swelling was unknown. No further details were provided. No product quality complaint (PQC) was filed. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 15-NOV-2013 the patient was vaccinated with ZOSTAVAX lot# J006831 expiry date 14-SEP-2013, 0.65 ml, subcutaneously. After vaccination, on 16-NOV-2013, the patient experienced at the injection site redness, pain, some swelling, itching, warm to the touch and the size of the affected area was 2x3 inches in diameter. The outcome of the events was reported as not resolved. Additional information has been requested.
It has been itching all day; Silver dollar red area where I was given the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It has been itching all day) and VACCINATION SITE ERYTHEMA (Silver dollar red area where I was given the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (It has been itching all day) and VACCINATION SITE ERYTHEMA (Silver dollar red area where I was given the shot). At the time of the report, VACCINATION SITE PRURITUS (It has been itching all day) and VACCINATION SITE ERYTHEMA (Silver dollar red area where I was given the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 001B21A and 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised, Hashimoto's disease and Inflammatory arthritis (Rare type that is autoimmune). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided. No treatment medications were provided.
1st injection was wonderful, even helped my ra.  2nd injection - immediate flush of face and neck, dizzy and numb on left face and arm, this only lasted 10 minutes. Now high fever >103, then chills, cold and hot sweats, lethargy, malaise, headache, body ache, feeling of dread like I could die,  site injection redness, heat, and 2.5" lump.  Fever not affected by medication.  It feels just like covid - except no shortness of breath/ cough.
New minor tingling in digits 1-3 and surrounding area of left foot starting 04-23-2021 approximately 09:00 AM,  subsided approximately at 10:30 AM. Minor tingling returned in same area 04-24-2021 approximately 09:00 AM, subsided approximately 10:30 AM. Minor tingling returned in same area 04-25-2021 approximately 09:00 AM, minor tingling remains in sole of foot by 1st metatarsal as of this report (04-26-2021 at 10:00 PM).
This spontaneous report was received from a physician assistant and refers to a 38 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 12-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1320 hours (55 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Extreme increase in pre menstrual cramps, which changed from mild/unnoticeable to debilitating/stabbing lower abdominal pain, accompanied by nausea, sweating, weakness, trembling the night before/1st day of period. Due to being on hormonal birth control, PMS and menstrual cramps had previously been negligible or nonexistent. ??   Menstrual flow is mildly increased in intensity, but the biggest change really has been the cramps. They happened again this morning and I almost couldn't stand up from bed/almost fainted while walking downstairs to get Tylenol/water. ??  Thankfully they do mostly pass after 1 day but I've heard from other people who menstruate that they've also experienced an increase in PMS/menstrual symptoms after getting their vaccine.  I'm still glad to be vaccinated I just wanted to report this change in my life since I got my vaccine in case the data is helpful. I've heard this will pass and certainly hope it does.
Received my first Moderna shot on 7/13/2021 in my right arm. On 7/21/2021 I felt a lump in my right armpit and panicked. Called my doctor to schedule an immediate mammogram. Doctor told me there was a good chance the lump is a side effect of the shot and scheduled me for a mammogram just to be safe.
Patient experienced fever, joint pain, gastrointestinal upset, headache (migraine), irritation and swelling of left arm from elbow to shoulder.  She did not specify if she took any medications to help.  After about 2 or 3 days the symptoms started to resolve.
Estimated due date: 09/04/2021  I felt fine that afternoon after the vaccine and just felt a little more tired than usual when I arrived home at night. Around 12:30AM I felt feverish, and body aches, severe headache and chills that woke me up. Took Tylenol. Felt like I had the flu. Next day kept treating with Tylenol as needed and the fatigue, body aches and low energy persisted along with headache but by night time I was feeling somewhat  better. Next day I was much better that I could work from home. Still felt a little fatigued other symptoms subsided.