chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient was given a third injection of Menactra, no AE; a patient was given a third injection of Menactra instead of a MMR vaccination, no AE; Initial information received on 10-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 22 year old patient who was given a 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AB and Exp. Date 04-Apr-2021) via an unknown route in the left deltoid for prophylactic vaccination instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (extra dose administered and wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to extra dose administered and wrong vaccine administered.  At the time of report, 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
PERIPHERAL NEURITIS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a neurologic complication diagnosed as peripheral neuritis concerned by primary care physician. She had arm pain, weakness with tingling and weakness in her legs. Her doctor told her to give it time and she was reporting improvement in strength but still had tingling mainly in her legs. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from peripheral neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211036875-covid-19 vaccine -Peripheral neuritis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Hives-4 hours after vaccine. BENADRYL as needed. Last breakout 13 days later.
pt recv vax 3JUN96 & exp excessive sleepiness, lack of appetite, inactivity, diarrhea, vomiting for 3 1/2 days;high pitched screaming evening of vax lasting 3 1/2 hr;3wk later mucus in stools;pt not seen by MD;MD concerned about dehydration
6 by 3 cm area of mild erythema and warmth right bicep area when Daptacel was given.
became sick after second dose; could not get out of bed; Little sore arm; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure, Hypertension, COPD, Kidney failure and Overweight.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed). At the time of the report, ILLNESS (became sick after second dose), BEDRIDDEN (could not get out of bed), VACCINATION SITE PAIN (Little sore arm) and FATIGUE (could not get out of bed) outcome was unknown.            No Treatment information was provided. The patient's passed medical history was not provided. Concomitant medications was not provided.   This case was linked to MOD21-074459 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-04-2021:Added events like became sick after second dose, could not get out of bed.; Sender's Comments:  MOD21-074459:
Thursday after walking down 2 flights of stairs and getting into car numbness occurred in the left neck and lower side of my face. I took advil and it has came and went for the last several days along with numbness and tingling in my left arm and hand.  Yesterday and today the numbness in my face is along my mandible and throughout sometimes I feel strange sensations in my left ear.  This morning I woke with additional numbness and tingling in my left foot and leg. As I have been awake this morning, my left leg feels heavier, tingly and my lower right leg is having some issues.  I am also having an extreme cold sensation in my feet and the thermostat reads 70 and I am dressed with socks and shoes on. My feet are white with no discoloration.
DIZZY; CHILLS; TIRED; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included genetic blood clot history, supraventricular tachycardia, and covid-19 infection, and concurrent conditions included penicillin allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced dizzy, chills, tired, nausea, injection site pain. Patient took Tylenol for chills and Pepcid for nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021, was recovering from tired, dizzy, and nausea, and had not recovered from injection site pain. This report was non-serious.
Consistent migraine; Headache; Sore throat; Upset stomach; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 17:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. 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 10Apr2021, the patient experienced consistent migraine, headache, sore throat, upset stomach and diarrhoea. Therapeutic measures were not taken as a result of adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events consistent migraine, headache, sore throat, upset stomach and diarrhoea was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother called to report that patient had fever, headache, shakiness, and lethargy shortly after receiving vaccine at office visit on 9/7/18. Patient was roomed for office visit with PCP at 3:57PM and mom called to report patient symptoms at 6:40PM. Mother advised by on call nurse to give MOTRIN and monitor if symptoms not resolved to return call to office. Status checked patient on 9/8/18 and patient symptoms had resolved.
Felt dizzy the night of, pressure on chest, shaking, blood pressure elevated more than usual, blood glucose levels elevated more than normal, increased SOB, flushing of face. When walking very short distance about 5 feet would feel dizzy, winded (SOB), face would turn red and hot, and blood pressure would elevate.  Treatments: 2/24/2021: EKG, Rapid & PCR COVID test, both negative. BW ordered for CBC w/autodiff, CMP, TSH  2/26/2021: Gabapentin D/C  3/04/2021: RX for Hydralazine 25mg, was too strong and D/Cd on 3/19  3/19/2021: UC visit for decreased urinary output, dizziness and elevated blood pressure.  on 3/24/2021: follow up OV, patient is now feeling back to normal, but experiencing SOB with exertion  4/20/2021: follow up OV, patient is feeling normal, but experiencing SOB with exertion.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), diarrhea and muscle spasms (cramps) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included diverticulitis and irritable bowel syndrome. On Feb 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 8, 2021, patient experienced pain in extremity (sore arm). On an unknown date, patient experienced diarrhea and muscle spasms (cramps). At the time of the report,  pain in extremity (sore arm), diarrhea and muscle spasms (cramps) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
UNABLE TO URINATE; LOWER BACK PAIN; STOMACH PAIN; This spontaneous report was received from a parent (mother) concerning her daughter, a 34 year old female. The patient's height, and weight were not reported. No past medical history and concurrent conditions were reported. On 08-APR-2021, the patient received initial Janssen COVID 19 vaccine shot for prophylactic vaccination (Janssen series 1). After initial shot, she had kidney problems started in MAY-2021. She felt really sick one day with headache, stomach ache, back ache, and throwing up. The patient went to the emergency room which revealed a 5 mm kidney stone that was taken out the next day. The patient had a headache for about a week after initial shot. The patient had not urinated on own after getting kidney stone out. In OCT-2021, she started urinating a little on her own.  The patient received Covid-19 vaccine ad26.cov2.s (Janssen series 2 Booster dose) (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: 09-APR-2022) dose was not reported, 1 total, administered on right arm on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-NOV-2021, the patient had not urinated since receiving her booster vaccination (unable to urinate) and she sought advice from doctors but they found nothing wrong. The patient had also been experiencing lower back pain and stomach pain since 11-NOV-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to urinate, lower back pain, and stomach pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211145488.; Sender's Comments: V0-20211144980-Covid-19 vaccine ad26.cov2.s- Unable to urinate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 15-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 13th patient out of 30 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patinet 1)
positive Covid-19 test; positive Covid-19 test; She has sniffles; Nose congestion/Stuffy nose; Stuffy nose and I think she might have little scratchy throat type of; This is a spontaneous report from a contactable consumer (Patient's Parent). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 13Apr2021, as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 23Mar2021 (age at vaccination was 17 years), as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were not taken other products. The patient stated that she had sniffles on Sep2021 and tested and day before reporting, she received a positive Covid-19 test on 11Sep2021 and there were just sniffles, just like nose congestion on Sep2021 if anything else she would call back. No that was it at the moment she had no other symptom besides that actually like stuffy nose and she thought she might had little scratchy throat type on Sep2021. She did not receive treatment for adverse events. The outcome of event covid-19 was unknown and outcome of other events was not recovered.  No follow-up attempts were possible. No further information was expected.
Went to work the next day. Felt fatigued by noon, headache all day.  Nasaua was mild but prevalent all day. By 3 or 4 pm,  24 hours later, chills had started. Took Advil twice for headache. Got home, went straight to bed. Chills much worse, headache is splitting. Skipped dinner due to nausea, fever started around 8 pm.  By 11 pm, fever reached 101.4, average temperature is 97.9. Fever broke early morning, by 10 it was normal. Went to work.
On 8/20/21, around 6:00 am, the morning after the vaccine, I had left arm numbness/tingling which resolved after about a minute. The following morning on 8/21/21, the same thing happened.  On 8/23/21, at approximately 3:00 pm while sitting on the couch, my left foot started tingling. This tingling is continuous and has not stopped. On 9/9/21, my right foot started tingling but only temporarily. This happens only once in a while. On 9/13/21, I started to feel severely fatigued and this has continued.  Since around 9/21/21, I have had decreased strength in my legs and am not able to walk as far as I used to.
Patient stated that on March 25th she was unable to move left arm, she had reported this to our facility on 4/15 but refused to be evaluated by Provider.  On July 27th she calls and says arm movement has improved but continues to be weak.  Again, encouraged to be evaluated by a Provider, but refused.
myalgia, flu-like sx, stomachache in 24hr p/vax;
headache, rating 7/10, pt reports feeling flushed and funny feeling in chest. Pt describes quality of headache as a pounding sensation.  o Action(s) taken: Other - Tylenol 650 mg PO, v/s, water, rest  Outcome: Pt sent home in good condition
13 days post vaccine, woke with small area of erythema around injection site, spread throughout day and now indurated, tender and warm to touch.  No fever.
4.5 hours after administration ( high deltoid) pain began in the upper arm that quickly escalated from a 2 on the pain scale up to an 6 within 20 minutes. Within one hour, unable to lift arm and pain was radiating around the left scapula and down the arm. After warm compresses and two ibuprophen, it escalated to a 10 with no way to get any relief in any position. A sling was applied as it felt as if the socket was not going to hold up the arm.  Pain described as unrelenting, constant with a throbbing component . Pain was in all portions of the arm but not the hand or fingers. Unable to move without excruciating pain.
Headache, muscle ache, joint pain, low grade fever, nausea, fatigue. Symptoms lasted only few hours.
Hospitalized (11.22.21);  COVID-19 positive (11.22.21);  fully vaccinated  ED 11.22.21:  CC - Shortness of breath - diagnosis COVID-19 - transferred to hospital for admission Admission Date: 11/22/2021 Discharge Date: Nov 24, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE:  71 y.o. male with PMHxof CLL not currently on treatment, RUE DVT, HTN, HLD who presents with shortness of breath. He states his symptoms started about 1.5 to 2 weeks PTA. He has been having gradually worsening shortness of breath, associated with cough, poor appetite, weakness, fatigue. He says at baseline he goes on lengthy walks with his dog but now gets very short of breath when just ambulating across the room.   He went to the ED vitals significant for tachypnea and hypoxia with SpO2 82 percent. He improved with 6 liters NC. Labs with normal WBC count. CMP with bicarb 18, BUN 32, creatinine 1.44, AST 106, ALT 100, normal NT-proBNP and troponin 25 then 22 with negative delta. EKG with NSR, T-wave inversions. He was COVID positive. CTA thorax with no evidence of acute PE, but showed extensive ground glass airspace opacities and new bronchiectasis in right middle and b/l lower lobes. He was given IV dexamethasone and admitted for further evaluation, patient remain stable on 6 liters and symptoms start improving , his Oxygen weaned to 4 liters and CPR was trending down , he was evaluated by Pulmonary rehab and will need 2 liters at rest and 4 liters with activity, patient was discharged on stable condition
a large, tender welt appeared at the injection site of my vaccine the day of receiving it. all of my other side effects have subsided but this one. it?s been two days and there?s still a large, red bump that is sensitive to the touch.
Syncopal episode approximately 10-15 minutes after the vaccine. Patient starting to fall. Mom grabbed her and together we had her lie down on the exam table. I elevated her legs and began taking her vitals.
Red Rash on chest and upper stomach; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm right on 02Mar2021 13:15 (at the age of 85-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included stenosis, neuropathy and lupus. Concomitant medications included simvastatin; tamsulosin hydrochloride; acetylsalicylic acid (ASP); all were taken for an unspecified indication, start and stop date were not reported. The patient experienced red rash on chest and upper stomach on 04Mar2021. No treatment was received for the reported event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
throat swelled up still c/o of soreness & swelling on 11/3/99;
Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Felt faint & had nauseated with vomiting. Gave GARDASIL last. Prior to GARDASIL C/O "a little weakness", but threw up immediately after GARDASIL.