chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to lift left arm above 90 degrees X 5 days.  Enlarged lymph node in axilla-left arm X 3 days Joint aches most severely in knees X 2 weeks
Information has been received from a licensed practical nurse (LPN) concerning a patient who on approximately 20-MAR-2008 ("in the last 2 weeks") was vaccinated with a 0.5 ml dose of MMRII (lot number and site not reported.  It was reported on an unspecified date, that these three patients were experiencing a fever, rash and injection site erythema after receiving MMRII.  The patients were reported as recovered on an unspecified date.  There was no product quality complaint.  Follow up information was received on 11-APR-2008 from a nurse who reported that she did not know the names of these patients and there was no hospitalization.  This is one of several reports from the same source.  Additional information has been requested.
SHIVERING; HEADACHE; FEVER; EYE PAIN; HOT EXTREMITIES; neck pain; everything aches; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced eye pain. On MAR-2021, the subject experienced hot extremities. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced everything aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 26-MAR-2021 03:00, the subject experienced shivering. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering, headache, eye pain, hot extremities, neck pain and everything aches was not reported. This report was non-serious.
Initial report received from a Health care professional on 13 April 2012. A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received a 2nd dose of IMOVAX on 09 April 2012. (Batch number: G1109-2, route and site of administration were not reported). It was reported that the patient received 1st dose on IMOVAX on 05 April 2012(lot number, route and site of administration were not reported). The caller stated that on 13 April 2012, the patient took IMOVAX vaccine from Pharmacy to get it administered from her own HCP as third dose for Post exposure Rabies. On an unknown date the patient complained of feeling awful, general malaise and reported that she feels like she's going to die. It was reported that the patient had not received third dose of IMOVAX vaccine. On an unspecified date outcome of the event was reported as not-recovered. Documents held by sender: none.
PHOTOPHOBIA; This spontaneous report received from a patient concerned multiple patients. 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced photophobia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of photophobia was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
went into hospital with heart issues then developed symptoms and was tested. symptoms were cough, congestion, diarrhea, headache and runny nose
This is a spontaneous report from a contactable consumer, the patient. A 66-year-old-non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) via the unspecified route of administration on 23Mar2021 at 16:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patients had no medical history reported. The patient was allergic to sulfonamides. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks of the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. On an unknown day in Mar2021, the patient experienced muscle aches and scratchy throat. The clinical outcome of the events muscle aches and scratchy throat was unknown at this time of the report.   Information about lot/batch number cannot be obtained. No further information expected.
Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended. No adverse effect.
5/10/07 - Right thigh red, sore, splotchy. 5/11/07 Fever - unknown - not red by mom. Right thigh swollen and red size of orange, very painful - looked like hives around area. Resolved by 5/13/07. Continue Claritin and Tylenol.
Muscle and joint pains; Muscle and joint pains; Hard time in opening and closing his hands/couldn't hardly carry a cup of coffee; Hurt so bad he couldn't even turn in bed; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267, Expiration date: unknown) administered in left arm on 25Feb2021 10:00 (age at time of vaccination: 65 years) as, single dose for covid-19 immunisation in a clinic. The patient medical history was not reported, and concomitant medications was none. Family medical history was none. The patient did not receive previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. On 07Mar2021, he suffers from side effects muscle, joint achiness and Hard time in opening and closing his hands/couldn't hardly carry a cup of coffee. Sunday night and Monday it was so bad, he couldn't hardly carry a cup of coffee. Since the muscle and joint achiness started it has improved, but now it has kind of stayed the same. It has levelled out. On Sunday and Monday, he hurt so bad he couldn't even turn in bed. He was not sure if he was going back for second one because of the achiness. The outcome of the events muscle and joint pains was not recovered and unknown for other events.   No follow-up attempts are possible. No further information is expected.
I did not have an adverse reaction to the vaccine. I developed symptoms of arthritis in January 2023. I went to my doctor in February 2023 and diagnosed with inflammatory arthritis.  As of today, I am working with my doctor to find a medication that will help with the inflammation.
Narrative:  PT STILL HAVING PAIN ISSUES 7 MONTHS POST INJECTION. NO COMPLICATIONS WERE NOTED WITH EITHER VACCINE ADMINISTRATION. PT COMPLAINS OF PAIN, NUMBNESS, AND TINGLING THAT RADIATES UP HIS NECK ORIGINATING FROM VACCINATION SITE.
SWELLING, PAIN AND REDNESS PER MOTHER NEXT DAY AFTER VACCINE GIVEN, RASH TO LEFT THIGH PER DR RX ORDERED HYDROCORTISONE 1% CREAM  APPLY THIN FILM TO AFFECTED AREA 2 - 4 TIMES DAILY AS NEEDED.  DR RECOMMENDATION TO GIVE NEXT DTAP WHEN SHE IS 4 Y/O SINGLE SHOT AND NOT COMBINED
First day a slight headache, second day (24 hours after vaccine) mild scratchy throat, fatigue
The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per CDC guidelines.
DVT, multiple PE, leukocytosis, tachycardia, elevated troponin
Severe SVT (racing heart beat, shortness of breath, light headedness) occurring several times a week to sometimes several times a day resulting in an urgent heart ablation.
Red spots all over the body (chest, neck, back); Legs are burning; itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation; was sick; headaches; severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)), BURNING SENSATION (Legs are burning) and ILLNESS (was sick) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (headaches). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (was sick). On 03-Sep-2021, the patient experienced PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation). On 13-Sep-2021, the patient experienced BURNING SENSATION (Legs are burning). On an unknown date, the patient experienced PETECHIAE (Red spots all over the body (chest, neck, back)). In August 2021, HEADACHE (headaches) had resolved. On 29-Aug-2021, ILLNESS (was sick) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)) and BURNING SENSATION (Legs are burning) outcome was unknown.            Concomitant medications included Cholesterol pills. No Treatment medications were reported.
Hives, rash, itchiness, muscle fatigue, and and instance if throat swelling starting 12 days after receiving third moderna COVID-19  vaccine.
Hep A vac given 2 youth at 0910. Youth c/o severe itching chest and back.  Began approx 1 hr after vaccine given. Nurse exam revealed red, raised, welts across chest, back, neck, upper arms.  No resp distress noted or repeated by youth. Benadryl given and Caladryl per protocol. F/U with rxn 7/19/04 4X3 7/20/04. Seen by MD 7/20/04. Rx'd Prednisone seen by MD 7/22/04.
nausea; chills; fever; shakes; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea). At the time of the report, CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea) 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 concomitant medications were provided.  No treatment medications were provided.
toes on right foot became itchy, red and swollen/Swelling went down in foot; toes on right foot became itchy, red and swollen; toes on right foot became itchy, red and swollen; rashes are lightening up a bit; diarrhea; woke up with swollen; I am having what I am believing is an allergic reaction to it; I had a red swelling itchy face and then spread up all over my body; I had a red swelling itchy face and then spread up all over my body/really red; I had a red swelling itchy face and then spread up all over my body/itching foot/the whole body is itching; Stomach pains/stomach pain; nauseous; dizzy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (age at vaccination: 39-years-old) as dose 1, single for COVID-19 immunization (Pharmacy or Drug Store). It was reported that patient did not receive other vaccine in four weeks. Patient not tested COVID post vaccination. Medical history included ventricular extrasystoles Verbatim: PVC in Heart. Concomitant medication included flecainide taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced stomach pains/stomach pain, nauseous and dizzy. On an unspecified date, patient toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit, diarrhea, woke up with swollen, i am having what i am believing is an allergic reaction to it, i had a red swelling itchy face and then spread up all over my body, i had a red swelling itchy face and then spread up all over my body/ really red and i had a red swelling itchy face and then spread up all over my body/ itching foot/the whole body is itching. On 23Mar2021, the patient underwent Blood test which showed everything was normal, there was nothing abnormal. On May2020 haematocrit was normal, there was nothing abnormal. On Jul2020, haematocrit was normal, there was nothing abnormal. Patient received methylprednisolone for the treatment of stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/swelling went down in foot, toes on right foot became itchy, red and swollen, toes on right foot became itchy, red and swollen, rashes are lightening up a bit. The outcome of the events Stomach pains/stomach pain, nauseous, dizzy, toes on right foot became itchy, red and swollen/Swelling went down in foot, toes on right foot became itchy, red and swollen, rashes are lightening up a bit was reported as not recovered and rest of the events outcome was unknown.  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Patient reported a small tender lump at the site of the injection and  she stated this is similar to what she experiences with other vaccines.  On December 30th, she reported that on 12/28 in the evening, she started feeling itchy at the site of the injection.   On 12/29/2020, the area looked red and warm and had grow to the size of a "clementine".  The patient took one dose of non-drowsy antihistamine and by the 30th the erythema improved. I spoke with the patient today, 1/4/2021, and all symptoms have resolved.
Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot.  It is now 14-1/2 hours after the shot and I am still dizzy.  I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.
Felt heart racing. Lasted for a few seconds. Racing again for few seconds during evening of 2/12/05 and morning of 2/14/05. This made me feel panicked. No trouble breathing, not dizzy. Back to normal after each episode. Note, sister has history of tachycardia and takes medication to treat condition.
Fever off and on; Chills; She was feeling very rough; Severe pain on the right side of her neck and then on the left side; Her legs and arms ached; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; She had the worst flu she had ever had, 10 times worse than a regular flu; She noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 68-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on 27Apr2021 10:00 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ Lot number was not reported), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified day the patient presented with fever off and on, chills, she was feeling very rough, a head (took ibuprofen), she had the worst flu she had ever had, 10 times worse than a regular flu, she presented severe pain on the right side of her neck and then on the left side, her legs and arms ached. The patient stated that when she looked into the mirror she noticed a bright red spot at the injection site, going from her left arm into the side of the size of a softball, she feels heat in it and started itching this afternoon. The patient stated that her doctor prescribed Benadryl. Therapeutic measures were taken as a result of fever off and on (pyrexia), chills (chills), she was feeling very rough (malaise). The events outcome was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Per pt's daughter, patient developed bruises on the day of receiving vaccines. However, patient does not feel any pain. Bruises were shown on (R) arm.
administering Pentacel today that was not reconstituted (only liquid was administered, not powder)v with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00672844) and transmitted to Sanofi on 07-Jul-2021 in United States.  This case involved a 6 month old male patient who administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL].  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  On 07-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: once) (lot U694DBA) via unknown route in the right thigh for prophylactic vaccination.   On 07-JUL-2021 the patient developed a non-serious when administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE.  This was an actual medication error case due to inappropriate reconstitution technique (latency was same day).  Additionally it was reported that the caller wanted to know how long they need to wait before starting the series over for this patient. The call became disconnected while the caller was holding and an outbound call was made and the MIA (manufacturing / importers authorisation) continued the call. The call was transferred from MIA. PENTACEL was administered incorrectly.  At the time of reporting, no adverse event 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.
Hematoma in left deltoid and warm to touch. Per MD's instructions, to apply warm compress and to give Benadryl every 6 hours.
Information has been received regarding a case in litigation. An X-ray technician reported that her colleague with no relevant medical history or allergies in October 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). In November 2007, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). In February 2008, also reported as soon after third dose, the patient had a positive PAP with abnormal cells. The patient sought unspecified medical attention. The patient's positive PAP with abnormal cells persisted. This is case 2 of 2. Additional information has been requested.
12/22/08 veteran called after hours with c/o fever, n/v/d since he received the flu shot on 12/18. He told the nurse he would go to a local hospital. I called and veteran was not home. Veteran's wife stated that he was feeling better that the arm where he got the flu shot was still red. Will notify PCP and team nurse of condition for any Fu indicated. 12/23/08 Presents to ACA for f/u on reaction  to PNEUMOCOCCAL Vaccine administered to the L. deltoid on 12-18-08. States symptoms have resolved but rash on L. arm remains. Conveys that site of care was contacted by pr and PCP instructed Pt to come in for f/u. Alert and oriented X4, steady cait, currently denies pain. 12/23/08 CHIEF COMPLAINT?PRESENT ILLNESS-patient is a 77 year old male in with c/o fever, and n/v/d/ after received the Flu shot on 12/18. He went to local clinic but did not require medication: TX other than TYLENOL. He is back in  stating; the he is feeling better but that the arm where he got his flu shot was still red. Symptoms Rash , diarrhea, nausea/vomiting, fever suspect drug #1 dosing; x1 treatment drug used. ACETAMINOPPHEN dose : Unit; Freq: Route
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/05/21pfizer,Lot#EL3246 2nd dose: 01/26/21,Pfizer,Lot# EL9262 Diagnosed covid positive:07/21/21 symptoms started: 07/19/21 Exposure:Community exposure Symptoms:sore throat,diarrhea,runny nose
Covid vaccine monitoring documentation. PT admission 1/18/22 ? 2/25/22. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 03/18/2021 lot EN6198. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 04/08/2021 lot EP7533. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) lot FC3180 10/08/2021.
Half of the dose leaked on her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Half of the dose leaked on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Half of the dose leaked on her arm). At the time of the report, UNDERDOSE (Half of the dose leaked on her arm) had 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.   No relevant concomitant medications were provided.  No treatment information was provided.