chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; Itchy nose and ears; Diarrhea; Itchy ears; Dry eyes; Swollen eyes; Fever; back pain; pain continues unto lower back and ribs; numbness in both arms and wrist; Knee pain; Dry throat; Difficulty swallowing; Migraine headache; Muscle stiffness/ stiffness in the neck and shoulder; Joint stiffness; could not move her arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness/ stiffness in the neck and shoulder), JOINT STIFFNESS (Joint stiffness), EAR PRURITUS (Itchy ears), DRY THROAT (Dry throat) and DYSPHAGIA (Difficulty swallowing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness/ stiffness in the neck and shoulder), JOINT STIFFNESS (Joint stiffness) and HYPOKINESIA (could not move her arm). On 13-May-2021, the patient experienced DRY THROAT (Dry throat), DYSPHAGIA (Difficulty swallowing) and MIGRAINE (Migraine headache). On 15-May-2021, the patient experienced HYPOAESTHESIA (numbness in both arms and wrist) and ARTHRALGIA (Knee pain). On 16-May-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain continues unto lower back and ribs) and BACK PAIN (back pain). On 18-May-2021, the patient experienced DRY EYE (Dry eyes), EYE SWELLING (Swollen eyes) and PYREXIA (Fever). On 19-May-2021, the patient experienced EAR PRURITUS (Itchy ears), DIARRHOEA (Diarrhea) and PRURITUS (Itchy nose and ears). On an unknown date, the patient experienced FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness/ stiffness in the neck and shoulder), JOINT STIFFNESS (Joint stiffness), EAR PRURITUS (Itchy ears), DRY THROAT (Dry throat), DYSPHAGIA (Difficulty swallowing), MIGRAINE (Migraine headache), HYPOAESTHESIA (numbness in both arms and wrist), MUSCULOSKELETAL CHEST PAIN (pain continues unto lower back and ribs), DRY EYE (Dry eyes), EYE SWELLING (Swollen eyes), DIARRHOEA (Diarrhea), BACK PAIN (back pain), HYPOKINESIA (could not move her arm), PRURITUS (Itchy nose and ears), ARTHRALGIA (Knee pain) and PYREXIA (Fever) had resolved and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves Child of unknown gender patient and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
02/19/2021 after I left I was hot with this fatigue, like a overwhelming fatigue slept the rest of the day and the whole next day. That went on for a week, Finally I saw my Dr. and I was drawn lab work, My vitamin D came back low down to an 11 when it should've been between 30/100. I was given some vitamin D and I was referred to an allergist to see if the shot was the cause. I had my iron check and it was incredibly low. I had to get IV infusion for my iron. I have completed the IV and my vitamin D but in March I have to go back to get more iron infusion since my Iron is very low again. I never had this issue before the vaccine. This has been an ongoing issue since 02/2021.
Pt recvd vax 01AUG95 & 23AUG95 exp fever of 103 & a rash; in later 1995 pt exp cerebellar ataxia which subsequently dissipated; No further details were provided;
Body aches, chills, headache, fatigue.  Body aches and chills lasted about 24 hours.  Headache lasted about 48 hours Took Tylenol every 4 hours during day and rest.
Death Narrative: Patient died at home on 2/11/21, two days after receipt of the Pfizer COVID19 vaccine. Reviewed death certificate and cause of death is listed as chronic systolic heart failure and pulmonary hypertension. That is all the information that I have.
large red patch 3-4 inches below the injection site, red, slightly itchy;  first patch 2 days later is starting to fade but a 2nd patch formed 2 days later, smaller 1 inch below the first patch;  first patch is fading to very light pink;  both patches are both pink
Received T/C from mom at 18:07 on 1/15/03, stating that right child's right arm was very red and swollen, from his elbow up. Advised care and to call in AM if worse. Appt. made for 1/16/03 for above symptoms. On 1/16/03, seen by MD. Pt had erythema and swelling of right entire upper arm with induration. Likely a large local reaction vs. cellulitis. No fever, but did have itching. TX: included Augmentin and Orapred.
Patient received 2nd Pfizer Vaccine approximately 11:10 am. Patient reported burning sensation in chest and lightheadedness and feeling warm. Taken to medic room. Initial vitals: BP: 144/94, P: 83, O2: 98%.  Approximately 11:43 am: Patient reported left arm numbness and numbness in bilateral legs. Also reported blurry vision.   Patient with of CVA, MI, Pulmonary Emboli, Seizure disorder. He did stop Protonix 2 months ago per patient and Keppra discontinued by PCP 2 weeks ago.  On exam: grip bilaterally intact, sensation intact, oral mucosa intact, Heart regular rate and rhythm, Lungs CTAB. No rash noted. No oral swelling. Alert and oriented x3.    Recheck vitals: 145/97, HR: 80, O2 saturation 97%. Continued numbness on left side and lower extremities. Burning sensation/reflux in chest still ongoing.    EMS was called for further evaluation.
On 10/22/99, the pt developed right deltoid pain and right shoulder and arm weakness. The pt was unable to lift her arm above her head. She also developed a nodule at the injection site. On 11/10/99, the pt was seen by the nurse practitioner who prescribed ibuprofen, warm soaks and referred the pt to an occupational therapist.
Chest pain beginning 6/29/21, positive troponin, diagnosed with possible post-vaccine myopericarditis.
I am experiencing very unusual heavy mensural bleeding, first time in my life. I have very regular period and blood flow for years, but this time it alarms me for the amount of bleeding is tripled of the normal amount. Blood just gushes out from time to time.  (No change in my daily life and my pap smear is normal)
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was in the office now (on 09-AUG-2012) to receive the second dose of GARDASIL (dose, route and lot # not reported), which would be late. The first dose was administered a year ago (unspecified date). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
onset of hives noted p/nap approx 2 hrs p/vax; returned to clinic site; hives noted on body; t103.1; mom stated hives spread to entire body & t103; MD called;
Muscular ache across shoulders and next, lower back. Hypersensative skin on ribs. Lethargic. Still after 7 days.
Symptoms started in the night like before. Woke around 2:30 with chills. Had fever of 101. Achy and horrible headache. Continued to have symptoms with fever spiking to 101.6 until Monday morning. Treated like first injection with fluids Motrin and excedrine. Sore arm too.
Parent reported that patient woke from nap with swelling of right leg and puffiness of right arm and right face.  There were no problems with breathing or swallowing and no rash.
Ever since receiving my second vaccine dose my menstrual period has completely changed. The first two periods following my vaccine I experiences spotting and dried blood during urination, which I have never experience before. After a few days of spotting and dried blood it was followed by extremely heavy bleeding for only 2 days and then my period ended. On my third period following my vaccination it was extremely heavy (bleeding through clothing in the night heavy, also never experienced before) and lasted several days. My period has always consistently been heavy on day 1 and 2, lighted on day 3 and tapered off on day 4 or 5. However ever since my vaccine it has been concerningly different.
Pt. seen at 10:00 am. 11/10/99 & found to have URI and teething, on exam w/temp 99.7. Immunizations given and about 6 hrs. later, baby had apparent febrile seizure.
Narrative:  COVID infection following COVID vaccine series 01/18, Pfizer, dose #1 02/08, Pfizer, dose #2 06/11 COVID swab, result: NOT detected 09/20 pt cc: exposure: unknown 09/21 COVID swab, result: detected 10/25 COVID swab, result: detected 1026 SARS-COV-2 IGG Eval: 2.95 10/26 COVID swab, result: NOT detected 10/26 clinically resolved
Had covid exposure on 17Jan2021; This is a spontaneous report via Pfizer-sponsored program Pfizer from contactable consumer (patient herself). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported as patient was schedule for second dose of vaccine. Had covid exposure on 17Jan2021. Inquiring if she can get her second dose today. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Expired vaccine used; Time interval between 2 doses was less than a month; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between 2 doses was less than a month) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between 2 doses was less than a month). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between 2 doses was less than a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had no known allergies. Expired vaccine given to the patient with no adverse reactions reported. No treatment medications were reported
Mild pins and needles/Itching feeling intermittently throughout body since 1/28 continuing through today and hasn't gone yet.
Pt vaccinated with DTP lst immunization slep more that day, next morning seemed awake but not moving arms or legs, very quiet, weak cry, ate well when fed,over next 3 days gradually began to move more, office visit on 4JAN90 normal exam.
First dose: maybe a sore arm a little bit; a sinus issue and it led to mucus; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 4. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 20:10 (76-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. Patient vaccination because high risk of getting Covid, cannot wear mask due to breathing and lung issues. The patient's medical history included Breathing issues, Inoperable lung cancer, Diagnosed Nov2010. She took 2 different chemos for 3.5 years and had 6 weeks of strong radiation so that's whys she is at a risk of getting Covid, Lung issues (respiratory illness), Allergies like in spring and summer, compromised immune status, genetic / chromosomal abnormality, endocrine abnormalities (including diabetes), and obesity. The patient's concomitant medication included Xyzal every night for the allergies which does not always work and Amoxicillin 500mg 3 times daily for sinus issue. The patient previously took flu shot. On an unspecified date, the patient experienced first dose: maybe a sore arm a little bit and a sinus issue and it led to mucus. On An unspecified date Mar2021, the patient underwent lab tests and procedures which included blood test: unknown. On 12Apr2021, the patient was taking Amoxicillin, as Therapeutic measures as a result of a sinus issue and it led to mucus. The outcome of the events first dose: maybe a sore arm a little bit was recovered on an unspecified date and a sinus issue and it led to mucus was not recovered.  No follow-up attempts are needed. No further information is expected
Vertigo. Not just postural (ie, continuous when laying down or when sitting). Unrelieved by Epley and other maneuvers after 3 days.
pt recv vax & 6hr p/vax pt exp fever (unspecified), screaming inj site pain & site rash;
This spontaneous report as received from a registered nurse refers to a 53 year old female patient. The patient had no medical history or concurrent conditions. On 12-SEP-1990, the patient was vaccinated with one dose of M-M-R II albumin status HSA (human serum albumin) route default to subcutaneous (dose, lot# and expiration date were not provided). There was no concomitant medication. On 21-JAN-2015, the patient had performed studies for titers of measles - negative, mumps - negative, varicella - positive, rubella - positive. The patient has negative mumps and measles titers after receiving one dose of M-M-R II. The patient did not seek medical attention, and no specific treatment was given for reported events. Action taken with M-M-R II and the outcome of negative mumps and measles titers were not reported. The causality between M-M-R II and negative mumps and measles titers was not provided. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ oral (lot # K016314, expiration date 05-JUN-2015) dose was not reported. No adverse effects were reported. There was not a product quality complaint involved. Additional information has been requested.
A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee "in her 20's" who received FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were cased by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST. The reporter confirmed there were no late-occurring adverse events. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
After injection noted red, swollen L arm/shoulder.  Severe induration/erythema involves most of upper arm.
Day of vaccine: swelling, tenderness, enlarged lymph node. Next day redness, swelling, tenderness. 2nd node. 3rd day - swelling and redness - nodes larger and more painful. 4th day - swelling and redness decreasing. 5th day - redness and swelling resolved. 6th day- mildly tender delt. 2 nodes still lg. and tender.
2 days after receiving the vaccine, I got a sore throat for a couple of days and then I started to have a stuffy nose and I took a Covid test which came up negative. But I didn't like the symptoms and then I got a pain in my ear and was concerned about an ear infection. I wasn't able to get in to my PCP so I went to the local urgent care and they checked my symptoms and diagnosed a developing ear infection. She prescribed Augmentin and Flonase. Before I was able to pick up my prescriptions, I experienced nausea to the point of vomiting. I stayed out of work for a few more days while taking my antibiotic. I returned to work on a Friday as to not over exert myself. After that, things have gotten better and I'm approaching the recommended end of my prescriptions.
slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21.  Returned to work amidst continuing flu-like symptoms on Friday 2/26/21.  As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.
Incredibly excessive mucous discharge with nausea and vomiting, lasting until next morning. Chills, fatigue and blurry vision, improved but not gone 24 hours later.
felt lethargic Sat, but no s/s; Sunday had t102 oral, upper resp congestion & achiness; also c/o h/a sinus pain & sore throat; took APAP cold capsules; pt coughing up green mucus & nasal/sinus congestion;
Urticaria...started around site of vaccine, then spread to trunk and other areas of body...Started the following morning after vaccines.
Lips swollen, arm swollen, appear to be possible hive. Patient did start a new medication MACROBID, which could have led to possible adverse reaction.
Pt exhibited redness and swelling on left arm (slightly towards back of arm) measuring 3 1/8 inches by 1 1/2 inches. Area was warm to touch, slightly hard and raised. Pt had not applied ice to area, nor had she taken any OTC medication (ex Ibuprofen).
Patient received Yellow Fever and Typhoid vaccine at 1400 on 3/19/15. Developed SOB and chest tightness while playing basketball at 1630. Taken to hospital at 1740-given BENADRYL 50mg PO x1 and Albuterol Neb tx x1-given Rx for BENADRYL 50mg Q6h prn. Pt states had same reaction after eating eggs in past. F/U in clinic on 3/20/15-stated he felt fine.
0.3ml of dose given initially and error discovered in need for additional 0.2ml and 0.2ml dose Moderna  lot: 002C21A administered
Tachycardia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was reported.   Reporter did not allow further contact
Developed a very red (size of a half dollar), hard area at the injection site, feverish to the touch. Next day, taken back to the physician and he indicated she had an "adverse reaction" and recommended warm compresses. Within 2 days of the vaccination, the area turned to a bruise, which is still apparent 5 days later.
Patient is a 61y.o. female with T2DM, HTN, HLD who presents to the emergency department for shortness of breath and palpitations. Symptoms of SOB and dry cough for 2 weeks, presented to the ED for palpitations and dizziness. Found to be in atrial fibrillation with rapid ventricular response. No history of atrial fibrillation. No change in weight, fever/chills, diarrhea, chest pain, shortness of breath.
My dad died after he had symptoms of sweating without doing anything to increase his heart rate. He had stated his heart had been racing recently. He died suddenly and unexpectedly.
Patient sought out urgent medical treatment for a red rash and pain in the arm that received the injection. Patient was evaluated and diagnosed with cellulitis. Patient is undergoing an antibiotic therapy regimen.
102 degree temp, night sweats- changed clothing 2 times during night.  Throbbing headache. Pain in neck down to including both shoulders.
Exactly 13 hours after booster shot, I went to get water because I was extremely thirsty and had already drank 48 ounces of water between 10pm-1am. Shot at 12:07pm and black out at 1:07am. Once I filled up the water my knees started buckling, I grabbed the counter and blacked out completely. My boyfriend woke me up as I was laying  face down on the living room floor. I kept falling in and out of consciousness for a few minutes. Established I was sweating from head to toe. Got in a shallow cool bath to regulate body temperature.
Woke up at 3:00am after going to sleep at 11:00pm with a racing heartbeat. My heart rate was 140 bpm for 2 hours and then finally slowed to 100bpm. I did have a fever 99.6 during this time.  I took 800mg of Motrin at 4:30am which broke my fever.
Febrile seizure occurring x 3-5 minutes, treated at UC and then transferred to ED.  Given intranasal versed x1. Discharged home same day.
Left side of my whole body numbness, migraines, droopy left eye and no feeling in tow of fingers on the left side
pt stated that her left arm haa mild itching around the injection site.  It has now developed into a 2" raised bump that is red and warm to the touch.  Pt is waiting for her PCP to give her a CB for medical advice.