chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen region on her neck and jaw line; swollen region on her neck and jaw line; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen region on her neck and jaw line) and SWELLING FACE (swollen region on her neck and jaw line) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SWELLING (swollen region on her neck and jaw line) and SWELLING FACE (swollen region on her neck and jaw line). At the time of the report, SWELLING (swollen region on her neck and jaw line) and SWELLING FACE (swollen region on her neck and jaw line) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-089306 (Patient Link).
This case was reported by a physician via call center representative and described the occurrence of chronic graft versus host disease in a 70-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster ophthalmic. Concurrent medical conditions included sight disability (shingles destroyed sight in one eye). On 22nd February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced chronic graft versus host disease (serious criteria GSK medically significant), fatigue, dry mouth and muscle cramp. On an unknown date, the outcome of the chronic graft versus host disease, fatigue, dry mouth and muscle cramp were recovered/resolved. The reporter considered the chronic graft versus host disease, fatigue, dry mouth and muscle cramp to be related to SHINGRIX. Additional details were reported as follows: The case reported by the patient who was a retired physician. The patient mentioned that the reason that he retired prematurely was because he got shingles in his left retina in his eye and  it destroyed his sight. About a week after the vaccination, the patient got reforming of three symptoms of chronic graft versus host disease (GVHD). The specific symptoms that, the patient had as intense fatigue, dryness and muscle cramping. The symptoms were lasted for about 3 weeks. The reporter did not consent to follow-up. This case has been linked with the case US2019064000, reported by same reporter.
sore arm at injection site, body aches and pain all over her body, extreme fatigue, feverish, upset stomach (3 days after receiving injection)
24FEB99 pt exp severe h/a w/lt sided numbness both upper & lower extremity;pt exp throat pain & tight chest pain x 2mo;slurred speech & foggy vision noted; cont to exp numbness w/fine & gross motor tremors to lt side w/constant cont h/a,  Annual follow-up received on 9/12/00 provided no additional data.
Several hours after the vaccination, my son started complaining about his leg hurting. I looked at the vaccine location, and his entire upper leg was swollen, red, and warm to the touch. He became lethargic. The pain and lethargy lasted about a day, and the redness and swelling lasted about three days.
Left hand erythema/Lines in his hands seemed to be exaggerated; Left hand erythema/Lines in his hands seemed to be exaggerated; Upset stomach; Some diarrhea; Soreness in arm; His GI complaints started about maybe 2 to 3 hours after the vaccine.; Tingling in his scalp on the left side/Tingling on lateral aspect of abdominal wall; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:30 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included he has put on a few pounds from lockdown. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Historical vaccine reported as He has gotten flu shots.  Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Relevant Tests reported as none. On 19Apr2021 the patient experienced left hand erythema/lines in his hands seemed to be exaggerated, tingling in his scalp on the left side/tingling on lateral aspect of abdominal wall, upset stomach, some diarrhea, soreness in arm, his gi complaints started about maybe 2 to 3 hours after the vaccine. It reported that about 4 to 6 hours later on the same side of his body that he had the shot he started having some symptoms. On his left hand he had some erythema, and the lines in his hands seemed to be exaggerated where the lines were deeper. He had tingling in his scalp on the left side. Also on the lateral aspect of his abdominal wall he had the same type of sensation. He didn't see anything on his abdominal wall and he didn't shave to see his scalp. It was reported that like his symptoms would appear and disappear over the course of a day. It was reported that 2 to 3 hours after he got the shot he had an upset stomach and some diarrhea. The patient stated that when his hand thing showed up his wife said it looked like it would be itchy. It was not itchy but he could tell it was not normal.It was not burning or itching but there was something wrong with his hand how he described. He is wondering if it is still safe to get the second shot. It was reported that the erythema was coming and going. It is weird how things were transient, and it was kind of rotating between 3 different spots. Other than the soreness everything has recovered completely. Patient not received treatment for the events. Outcome of the event soreness in arm was not recovered and other events was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected
At 11:12am pt c/o increase heart rate due to anxiety and tingling numbness in last 2 fingers of left arm. Vital taken at 11:12am - BP: 159/116. HR: 75. SpO2: 100% Vital taken at 11:30am - BP: 160/112. HR 75. SpO2: 100% Nurse practitioner on site did the assessment on pt and did not call EMS. Advise pt to see PCP for high blood pressure.  Pt left site in stable condition.
The pt experienced complete upper arm left deltoid redness, a hard lump and warmth to the touch. No change in activity level.
I experienced small itchy bumps all over my body. This lasted 2 weeks total. I also experienced perhaps 30 angiomas that appeared suddenly.
Clinic immunized TWO patients with expired vaccines with no adverse event reported; Initial information received on 01-Nov-2021 regarding an unsolicited valid  non-serious case received from via other health professional under reference number: US-SA-SAC20211108000274.  This case involves Adult and unknown gender patient who was administered an expired dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   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 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.
Starting when I woke up at 0600 AM on 1/26/2021, I felt light-headed and had a headache and full body ache all day. It finally subsided at approximately midnight on the morning of 1/27/2021.
Information has been received from a pharmacist referring to a newborn. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 8AUG97 & same day pt devel 4.5 x 3cm raised, reddened, pruritic area @ the inj site;the reporter felt this event was not r/t vax;
Information has been received from a licensed practical nurse concerning a 31 month old male who on 3/20/99 was vaccinated with a varicella virus vaccine live (lot 626132/1548H, invalid) (lot number corresponds to MMR). There was no concomitant medication. The LPN reported that on 10/18/00, the pt presented with greater than 50 lesions, 100F fever and itching. Follow-up information from the LPN indicated that the pt was not vaccinated with varicella virus vaccine, but was vaccinated with MMRII. Additional information is not expected.
Patient reported black vision around the edges about 10 minutes after vaccine administration.  Symptoms subsided about 1 hour after onset.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Fatigue, lethargy., pain at injection site during same day. Next day, all the same symptoms plus headache and nauseous. Nauseous lasted all day and is still present, headache corrected with medicine.
pt recv vax 20AUG96 general hives devel 21AUGG96 & taken to ER & treated w/DPH & steroids;cont have some hives 23AUG96;saw MD on 22AUG96 who requested give next vax in office p/mom give DPH a/vax;
This case was reported by a pharmacist via call center representative and described the occurrence of heaviness in limbs in a patient who received BOOSTRIX. On 18th October 2017, the patient received BOOSTRIX. On 22nd October 2017, 4 days after receiving BOOSTRIX, the patient experienced heaviness in limbs and injection site tenderness. On an unknown date, the outcome of the heaviness in limbs and injection site tenderness were not recovered/not resolved. The reporter considered the heaviness in limbs to be unrelated to BOOSTRIX. It was unknown if the reporter considered the injection site tenderness to be related to BOOSTRIX. Additional details were provided as follow: The age at vaccination was not reported. The healthcare professional stated that, the patient did not have any adverse effects until 4 days.
Severe legs muscular stiffness; This is a spontaneous report from a contactable consumer (patient). This 63-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 07Mar2021 11:00 (Batch/Lot Number: EN 6207) as dose 1, single for covid-19 immunisation.  Medical history included Inflamation carpal tunnel 2020 and ongoing (Physiotherapy). Concomitant medication(s) included diltiazem hydrochloride (ANGIOTROFIN) taken for high blood pressure from Jan2020 and ongoing; tamsulosin hydrochloride (SECOTEX OCAS) taken as prostrate treat from Feb2021 to Apr2021. The patient experienced severe legs muscular stiffness on 10Mar2021. Relevant tests: blood test on10May2021: glucose prostatic antigen units: 104, 7.75 (Norm low: 55, <4, Norm high: 99), Comments: before 8,66; blood test on 17Jun2021: glucose prostatic antigen units: 97 (Norm low: 55, Norm high: 99), Comments: After treatment on treatment. patient received treatment for the event. The outcome of event was not recovered. Event considered serious due to disability/incapacity.   No follow-up attempts are needed. No further information is expected.
was expecting sore arm. At 4pm on Tuesday 3/16(day of my 2nd covid vaccination)started getting the soreness at site. at 4:30, head to toe body aches, hands especially hurt. II began taking ibuprofen q 4hrs. The ibuprofen did not relieve it. Next day(Wednesday 3/17) in afternoon, all the symptoms came back, head to toe body aches, chills and thirst as well. Went to bed that night at 8pm, very thirsty nd chills. This morning Thursday 3/17, so far I amk feeling much improved. arm still sore but that is it.
Following day reported low blood pressure, dizziness, light-headedness, "hot flash", sweating
slight fatigue/ little bit of fatigue; More than 35 days in between doses of the primary; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (slight fatigue/ little bit of fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02M20A, 012M20A and AS7146B) for COVID-19 prophylaxis.     Patient reported no chronic medical conditions. The patient reported that she does not take any medications. The patient has never had Covid-19 and the patient was not diagnosed with Myocarditis or Pericarditis.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary). On an unknown date, the patient experienced FATIGUE (slight fatigue/ little bit of fatigue). At the time of the report, FATIGUE (slight fatigue/ little bit of fatigue) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. After first dose, patient reported ADR of slight fatigue lasting about 24 hours. Patient did not have any ADRs after second dose. After the first booster dose, patient reported ADR of a little bit of fatigue for a couple of hours. No treatment medications were reported.   This case was linked to MOD-2023-713038 (Patient Link).
noticed hair might be thinning; Muscle soreness,achiness; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (noticed hair might be thinning) and MYALGIA (Muscle soreness,achiness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included TOCOPHERYL ACETATE (VITAMIN E-400), VITAMIN C [ASCORBIC ACID], VITAMIN D3, VITAMIN K2 [MENAQUINONE], VITAMIN B COMPLEX, NIACIN, FISH OIL, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (Muscle soreness,achiness). On 08-Feb-2021, the patient experienced ALOPECIA (noticed hair might be thinning). At the time of the report, ALOPECIA (noticed hair might be thinning) and MYALGIA (Muscle soreness,achiness) 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 information was not provided   This case was linked to MOD-2021-248944 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up received. New reporter, allergy medication and concomitant medications was updated
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
On 3/3/2021, experienced severe headache, body aches, fever, and generalized feeling of inflammation throughout body. Headache & fever resolved by 3/4/2021. Body aches, fatigue & inflammation resolved after a week or so. However, felt dull pain and sense of inflammation on left side of chest, tingling sensation in left arm. By 3/21/2021, I became so concerned about symptoms that I went to the ER.
I had a flu like illness in March. I was tested and found out that it Adeno Virus. I had sore throat, cough and other flu like symptoms. I took TYLENOL and naproxen to treat the systems. It a full week for all symptoms to dissolve. I have since completely recovered.
Headache; like he/she got a hangover; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; HANGOVER (non-serious), outcome "unknown", described as "like he/she got a hangover". Additional information: The patient gets a headache every day. The patient stated that he/she has been drinking like he/she got a hangover.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness; Muscle aches; Chills; Headache; Metallic taste; Severe dizziness/lightheaded; Numbness; Weird; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and PAIN (Soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Soreness), MYALGIA (Muscle aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Faulty syringe/needle combo - came apart when vaccine was being administered. Dose had to be re-administered per CDC info line guidance.
pt's rt upper arm became reddened, swollen, & tender 9 days p/DT inject; adm to hosp dx cellulitis, ?myositis/fascitis;
NORMAL REACTIONS AFTER BEING VACCINATED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced normal reactions after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal reactions after being vaccinated was not reported. This report was non-serious.
Fatigue, headache, nausea and vomiting (2) and severe body/muscle aches.
Initial medication error received on 02 December 2013 from nurse. An under 3 year patient whose gender, medical history and concomitant mediations were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unknown date. Patient received 0.5 ml to who was under age 3. Patient did not have any adverse events. List of documents held by sender: none.
This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient previously had nuts and experienced allergy to nuts and patient had sesame and experienced food allergy. The patient previously had sulfa and experienced sulfonamide allergy. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included cefalexin (CEPHALEXIN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced swollen lymphnodes / pain in underarm on side of injection. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events swollen lymphnodes / pain in underarm on side of injection was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
Woke up Friday morning with lots of red bumps, almost like bug bites all over legs, arms , and hands. They are very itchy.  Looks like it could be a rash.