chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in left arm; Very tired, fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm) and FATIGUE (Very tired, fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Soreness in left arm) and FATIGUE (Very tired, fatigued). On 28-Jul-2021, VACCINATION SITE PAIN (Soreness in left arm) had resolved. At the time of the report, FATIGUE (Very tired, fatigued) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported by reporter.  Treatment information were not reported by reporter.   This case was linked to MOD-2021-297855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received contains Non significant information.
provider ordered DTAP-IPV but DTAP-IPV-Hib-HepB(Vaxelis) was given; Vaccine administered to a 5year old child; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2443227-1. The original narrative from the sender is the following:  Provider ordered DTAP-IPV, but  DTAP-IPV-Hib-HepB (Vaxelis)was given.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Wrong product administered".  No further information is expected.
Parent and Patient came to the clinic for a 2nd COVID vaccine Pfizer, when we did not have an appointment for her  the patient and mom then went over to the pharmacy to get the 2nd pfizer vaccine. Mom provided the wrong birthday so pharmacist came to the NP at clinic and we looked up the patient and saw the patient was given the pfizer vaccine on 9/4. We asked mom to confirm her birthday and mom reports  I lied about her birthday so she could get the vaccine. Both myself (NP) and the pharmacist would not give her the second does due to false information. MOM gave a birthday of (private) and actual Birthday is (private)
This case was reported by a healthcare professional and described the occurrence of shoulder pain in a 66-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. Concurrent medications included Aspirin, ZOCOR, Trazadone, KLONOPIN, ESTRATEST and  CLARINEX. On 18 September 2009, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). On 18 September 2009, less than one day after vaccination with FLUARIX, the subject experienced shoulder pain, left trapezius pain, fatigue, malaise and neck pain. A GSK employee reported that a subject received a FLUARIX injection and experienced left should pain, trapezius pain, neck pain, fatigue and malaise. The subject was given the injection in the morning and symptoms began later in the afternoon. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with FLUARIX. Follow-up information received on 02 October 2009 indicated that the events remained unresolved. The events were considered to be possibly related to treatment with FLUARIX. Bursitis was reported as a past condition resulting from flu vaccine (manufacturer not specified).
Information has been received from a consumer concerning her son with no pertinent medical history, no drug reaction/allergies, who on unspecified dates was vaccinated with two doses of GADRASIL. There was no concomitant medication. The reporter stated that her son was prescribed by physician to get GARDASIL and that her son never completed the GARDASIL series. No further information is available.
Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noticed to be lethargic and just didn't feel right.  Upon checking vitals it was determined that the patient's blood pressure was a little high, but all other vitals were fine.  Patient still said that he didn't feel right so EMS was called and the patient was transported to Hospital for further evaluation.
No apparent adverse outcome yet;  patient presented to pharmacy for second Moderna Booster dose with card, dose was input to system as 0.5ml "second initial" dose.  Before administration patient was asked to confirm if this was "second shot", patient said yes, but patient believed pharmacist meant second booster and not second overall.  Patient recieved 0.5ml dose instead of 0.25 ml dose.  No AE reported so far but keeping in contact.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: 0Patient's mother did not indicate on form that patient experiences fainting spells after immunizations.
Patient received the vaccine 12/28/20. She developed a localized reaction of redness, warmth, and swelling on 1/5/21. She went to ER due to chills later in the day and was diagnosed with COVID. She was given antibiotics for arm, but reaction was gone the next day so she never filled Rx.
A few hours after getting the shot I began having pain in the shoulder which got a lot worse as the day went on.  By 10PM I was having multiple symptoms: severe pain and limited motion of my left arm where the shot was given.  I have also been throwing up, running low grade fever, no appetite, very unsteady gait.  Husband had to help me get to the BR, change clothes, etc.  Had to sleep in recliner as could not get up and down on the bed.  Considered ER visit due to extreme pain and other symptoms. Did not know what was happening.  I called the phone number for after hours for the doctor's office and was told to put heating pad on and take Tylenol.  9/12/19 ? Called to let doctor?s office that I?m having severe pain and limited motion of my left are where the shot was given.  I also have been throwing up, running low grade fever, no appetite, very unsteady gait.  Husband was having to help me get to the BR, change clothes, etc. They said if I?m not better by Monday (5 days from now) to call them back.   9/13/2019 ? I woke up with congested head and some coughing so went to urgent care. Still having symptoms as above. .  He said he thinks I caught some ?bug? at the doctor?s office.  Said nothing abnormal involving shot. Prescribed Prednisone for 7 days.  9/14/2019 ?.  Arm still painful to move but doing a little PT to try and get it back in shape.   Feeling better.  Tolerating food.
After the shot I started to feel dizzy and a hot feeling on my neck. My legs felt weak. The next day I had the normal vaccine side effects. 6 days later I developed numbness and tingling on my left side. My whole left side felt cold. I went to the ER. They did a CT and CTA of my neck and head. Everything was negative. I still have those symptoms on and off. I also went to my PCP and had x-rays done on my back, lumbar and cervical, which did not show anything wrong. Something I found weird is that the nurse that gave me the shot started to rub it very vigorously and she said it was to get it into the muscle faster, which I have never seen before.
Headache Narrative:  fatigue, restlessness, warmth, soreness. Lasted 2.5 days
Initially after the vaccinations, she was dizzy.  About 30 minutes after the vaccine she vomited once.  Then she fell asleep and Mom had difficulty waking her.  Upon wakening, patient was "out-of-it."  Patient does not remember her conversation with her mom.  Now when she sits up she feels nauseous.
cannot feel anything; Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (cannot feel anything) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and INSULIN for Diabetes.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Oct-2021, the patient experienced VACCINATION COMPLICATION (cannot feel anything) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). On 18-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) had resolved. At the time of the report, VACCINATION COMPLICATION (cannot feel anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   It was reported that the patients wants to see how the symptoms are until 29-Nov-2021, and may not receive the 2nd dose if the symptoms get worse so considered as potential dosing interval more than 35 days.  This spontaneous concerns a 29-year-old female patient with a relevant medical history of Diabetes mellitus undergoing treatment with metformin and insulin, who experienced Maternal exposure during pregnancy and the unexpected non serious event of Vaccination complication after mRNA- 1273 Moderna vaccine. The patient received the first dose of the vaccine at an unknown period of gestation. The event occurred immediately after the first dose of mRNA- 1273 Moderna vaccine. The event was reported as "cannot feel anything", without further information. The rechallenge is not applicable since only information about the first dose was disclosed. Diabetes mellitus remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.; Sender's Comments: This spontaneous concerns a 29-year-old female patient with a relevant medical history of Diabetes mellitus undergoing treatment with metformin and insulin, who experienced Maternal exposure during pregnancy and the unexpected non serious event of Vaccination complication after mRNA- 1273 Moderna vaccine. The patient received the first dose of the vaccine at an unknown period of gestation. The event occurred immediately after the first dose of mRNA- 1273 Moderna vaccine. The event was reported as "cannot feel anything", without further information. The rechallenge is not applicable since only information about the first dose was disclosed. Diabetes mellitus remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.
Urticaria started 2 days after vaccination. Started on abdomen and spread to face. Worsened x 2 days. Provided antihistamine treatments.
60 seconds to one minute after IM administration, the patient experienced very sudden onset dizziness, flushing, and a strange taste in his mouth. A few minutes later he reported a large headache. We asked if he was having any trouble breathing and he stated no. We checked on him numerous times over the next few minutes until he notified us all but the headache had disappeared. We are notifying the patients physician.
Right shoulder pain and muscle swelling with difficulty lifting arm beginning 11am on day of injection and lasting until 10PM on the 16th Ice and massage
Severe headache, nausea, severe muscle aches/cramps, dizziness, chills, sweating
Myalgia, Diarrhea, stomach pains Narrative: Per nursing report: "received the Covid vaccine Tuesday morning [5/25]. She called in due to being sick [5/26]. C/o body aches and 1 episode of diarrhea and stomach pains."
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was administered from 10Dec2021-13Dec2021 No concomitant and treatment information were reported by the reporter.
fever; chills; sore arm; fatigue; nausea; lightheadedness; vertigo; vomiting; diarrhea; hot flashes; This is a spontaneous report received from a contactable consumer, the patient. A 27 years-old patient of female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route on 12Mar2021 18:30, at an age of 27 years old and on right arm site as a single dose, for COVID-19 immunisation. Medical history included Spina Bifida, hydrocephalus, chiari malformation, fibromyalgia, lumbar radiculopathy and migraines from an unknown date. The patient was allergic to sulfur drugs, latex, penicillin and fentanyl. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received LAMICTAL, STRATERRA and NUEDEXTA from unknown date and unknown if its ongoing within two weeks of vaccination. On 13Mar2021, the patient experienced a fever, chills, fatigue, and sore arm for about 12 hours after vaccination, then felt fine for 3 days but at the time of reporting experienced all these events along with nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes for six days. Patient had been waiting to hear from doctor for recommendation as patient was very concerned about receiving second dose. The patient did not receive treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events fever, chills, fatigue, sore arm, nausea, light headedness, vertigo, vomiting, diarrhoea, and hot flashes were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a contactable Other HCP reporting for self. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 18Jan2021 09:30 at single dose for COVID-19 immunization. Patient received first dose of bnt162b2 on 31Dec2020. Medical history included Fatty liver and vertigo.  The patient's concomitant medications were not reported.  Patient had allergies medications. The patient experienced Injection site pain, headaches, muscle pain, chills, fever on 18Jan2021 16:00. Outcome of events was recovering.
Extremely heavy menstrual cycles.  My periods used to last approximately 5 days and bleeding was relatively even throughout.  Starting in May (2nd dose of my vaccine was administered on April 28th), the duration of my period has shortened to around 3 days with the 2nd day being extremely heavy bleeding - as if all of the bleeding is occurring on that 2nd day.   I?ve also experienced some spotting in May but that is no longer occurring.  The extremely short and heavy cycles are still occurring, however.
Two days later she experienced increased pain at the injection site, pain in the armpit on the left and multiple swollen lymph nodes on the left side of the neck. She denies any fever, cough, sore throat. She also denies abdominal pain, vomiting. She did report a headache associated with nausea and photophobia on 11/2108, but states that she gets these symptoms with her migraines. She denies any difficulty breathing.
Continued severe sharp pain in left arm when extended out from the body at a perpendicular angle, or when raised and also positioned away from the body.
This spontaneous prospective pregnancy reprot as received from a female patient of unknown age, refers to herself. On an unknown date, the patient was vaccinated with a dose of GARDASIL dose, route, lot# and expiration date were not reported. Later, on an unknown date, she found out that she was pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not known. The pregnancy outcome was outcome pending. Additional information has been requested.
Patient had a flu shot in the left arm at approx 1:30 friday the 13th and then that night started having pain to the left deltoid and this got worse and went down to the mid forearm on same side until she saw us Tuesday 9/17/13.
This spontaneous report was received from a Pharmacist via a company representative referring to a female patient of unknown age. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 05-AUG-2016 (referred as "on Friday"), the patient was vaccinated with a first dose of ZOSTAVAX, subcutaneously, strength, lot# and expiration date were not reported). On 08-AUG-2016 (reference as "on Monday"), the patient experienced erythema and rash popular (reported as "redness and raised bumps"). The reporter also stated that the physician that administered the vaccine advised her to use a heating pad. There was no product quality complaint (PQC) involved. The patient's outcome regarding the events of erythema and rash popular was unknown. The reporter did not assessed causality between the events and the use of ZOSTAVAX. Additional information has been requested.
Patient presented with a syncopal event at home, nauseous, woke up on the floor, reports cough and sore throat 2 days prior to admission. Tested positive for Covid-19. Patient received Decadron. Patient was able to wean down from 3L to room air and passed walk study. Patient was discharged home.
The pt experienced arthritis of both knees ultimately resulting in bilateral total knee replacement on 8/31/00. The pt was diagnosed with osteoarthritis.
On October 13, 2022, I began having diarrhea and this happened in the morning.  On the 16th, I was picking up a cooler and I noticed my chest felt tight and when I put my hand over my heart, I had a rapid heart rate.  I also had pain in my back near my ribs close to my spine.  I hike a lot and I was having the same symptoms when I walked up hill or climbing the ropes.  It was same tightness in my chest.  I had a cough that would originate from my sternum area, and it was only one cough.  I noticed I was also having shortness of breath beginning yesterday.  It is only when I am exercising.  This is not normal for me as I work in the field and have not experienced this before.  I went to the doctor on Monday October the 24th.  At the doctor my blood pressure was 145/90 and it normally runs at 114/77.  Heart rate was 101bpm and the last time I was at the doctor it was 67 bpm.  I was referred to a cardiologist and I will have that appointment scheduled soon.  I also have an appointment with my doctor to follow up on the blood tests results.
FLUMIST administered at 20:15 on 9/25/14, at office visit for allergic rhinitis. Difficulty breathing reported by parents to have started the evening of 9/28/14. She was seen at Urgent Care at 2230. Received albuterol nebulizer and ORAPRED. Pulse ox at 93% RA post treatment. Sent to ED by car upon arrival sx were resolved.
PATIENT CAME IN TODAY 12/03/2021  FOR A FIRST TIME COVID VACCINATION . PATIENT REQUESTED JANSSEN COVID VACCINE AND MISTAKENLY RECEIVED HALF DOSE (0.25ML) OF MODERNA VACCINE . PATIENT HAD NO REACTION BUT REFUSED TO GET THE OTHER HALF OF THE DOSE  TO MAKE IT A FULL DOSE (RECOMMENDATION  PER CDC AND MODERNA UPON CALLING FOR GUIDANCE ) . PATIENT HAD NO REACTION DURING THE TIME FOLLOWING THE INTERACTION  ABOUT 30 TO 45 MINUTES.
Large bruise blue (ish) at site a couple days later. At time of injection "dollar bill" size long developed after 1-2 minutes.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in October 2015, the patient was vaccinated with a first dose of ZOSTAVAX (dosage and route of administration were not reported) lot # M033335, expiration date 11-OCT-2017, for prophylaxis. On 15-FEB-2017, the patient was vaccinated with a second dose of ZOSTAVAX, which was considered as extra vaccination. No information regarding concomitant therapies was provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Went to bed with head ache on 09/12/2022 and on 0913/2022  woke up with lips swollen and throat feeling swollen.  Pain at injection site. Mom took patient to ER.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient unable to be contacted to inform of adverse event.
Woke up around 4 AM in pain with 102 F fever, shakes, frozen finger tips, then needle feeling like after mild frostbite, complete body aches,  neck and pain in the back of skull.    Took Tylenol x2 extra strength at 6 AM, fever went down to 99.8 (normal is 98).  Fever returned to 101.5 by 5 PM.  Took 2 extra strength Tylenol at 6 PM and fever went to 99.4.  The next morning temperature was 98.5 and only mild head pain.
PT FELT UNDER THE WEATHER FROM BOTH IMZS GIVEN- MODERNA SPIKEVAX AND FLUBLOK
swelling of eyes, nose, face;severe sore throat;breathing difficulties 7PM 27MAR96 through 31MAR96;1APR96 present redness of face;28MAR96 immed care MD;
Initial and follow up information has been received from a registered nurse and a pharmacist concerning the nurse, a 79 year old female patient blood pressure high, gastrooesophageal reflux disease, gout, allergy to chocolate, sulfer and carbonic anhydrase inhibitor who on 16-OCT-2009 was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 in left arm (lot #662841/0626Y). Concomitant therapy included digoxin, thyroid, enalapril maleate (MSD), PREVACID, allopurinol and "thiopyridine". On the same day 30 minutes after the vaccination the patient developed body aches. She experienced pain in the left shoulder. Heat and pain started a few hours later followed by pain in the arm, joint pain all over and malaise. She continued with arm and shoulder pain. The patient was treated with TYLENOL and ADVIL. It was also reported the patient 8 years ago approximately in October 2001, was vaccinated with PNEUMOVAX 23 and with no adverse symptoms. No laboratory tests were performed. Unspecified medical attention had been sought. At the time of reporting the patient was recovering. Additional information has been requested.