chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient had a stroke after the booster. Company Comment: This is a spontaneous case concerning an adult patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Cerebrovascular accident which occurred on an unknown date after a booster dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine (unknown COVID-19 vaccination schedule). It was reported that patient had a stroke after the booster. No further clinical or diagnostic information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
pt recvd vax for prophylaxis;w/in 1 mo of 2nd dose devel "ear problems" then exp Bell's palsy (rt side paralysis of face)seen by MD;tx for 1 mo;event resolved p/ 1 mo;
Received possible counterfeit vaccine; A spontaneous report was received from a consumer, concerning a 65-year-old, female who received possible counterfeit vaccine.    The patient's medical history was not provided. Concomitant product was not provided.   On 29 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.  The outcome of the event, possible counterfeit vaccine were considered resolved.  Company Comments: The reported event possible counterfeit vaccine administered was not applicable to mRNA-1273.; Reporter's Comments: This report refers to a case of counterfeit product for mRNA-1273, batch number - not provided,  with no associated AEs. Causality is not applicable.
Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm), MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Feb-2021, the patient experienced NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm), MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 4 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at a dose of 4 dosage form. At the time of the report, NECK PAIN (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) and ARTHRALGIA (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) had not resolved and MUSCULOSKELETAL STIFFNESS (Patient is experiencing pain across all shoulder, back of neck is sore and stiffness on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event also included pain relieving cream.
Wrong dose of Moderna Bivalent was given to patient. Patient was supposed to receive 0.5ml of Moderna Bivaslent and patient only received 0.25ml of Moderna Bivalent
Heart rate 186, shortness of breath, profuse sweating.  Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration.
gen rash, throat cult, rapid strep, rash occurred 5 days;no fever;
extremely tired; site of the injection was a bit sore/lift my arm up there is a heaviness/tightness in the area of the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TART CHERRY; OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE]. Past drug history included: Demerol, reaction(s): "known allergies:Demerol"; Erythromycin for Known allergies: Erythromycin. Vaccination history included: BNT162b2 (DOSE: 1, SINGLE; Lot No: EP7533; Anatomical location: Arm Left), administration date: 13Apr2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, SINGLE; Lot No: ER8733; Anatomical location: Arm Right; Vaccine Administration Time: 02:15 PM), administration date: 06Jul2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Feb2022, outcome "not recovered", described as "extremely tired"; VACCINATION SITE DISCOMFORT (non-serious) with onset 24Feb2022, outcome "not recovered", described as "site of the injection was a bit sore/lift my arm up there is a heaviness/tightness in the area of the injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, vaccination site discomfort.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 65 years old patient who was vaccinated with expired dose FLUZONE HIGH DOSE (lot: UI977AC, expiry date: 09-Mar-2019) in the right deltoid, on 15-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. 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 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. List of documents held by sender: none.
Information has been received from a dermatologist concerning a 20 month old male who on approximately 10-APR-2008 was vaccinated with a 0.5 ml first dose of  VARIVAX (Oka/Merck). Three weeks within receiving the vaccination, the patient developed 12 lesions on his trunk, arms, legs and groin. The patient was afebrile. The patient also had otitis ear infection and respiratory infection since receiving  VARIVAX (Oka/Merck). It was unspecified if the patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Rotateq on 6/25. 6/27 vomited by 2 in am. Diarrhea - water, explosive, x 10 on 6-27. Appetite decrease 6/28 - diarrhea x 3, appetite nl.
Missed miscarriage. Expected due date 01/20/22. Fourth pregnancy. One termination, One live birth, two miscarriages. This is a second missed miscarriage in a row first one being in January 2021.
On 9/18/09, patient came in for well visit (annual P.E.) and received MENACTRA, BOOSTRIX, and Hep B vaccines.  Later that evening, he started to experience left facial palsy.  Seen in office on 9/21/09 L facial palsy still present.  Concern of Lyme, DOXYCYCLINE prescribed for 1 month.  Blood work obtained.  As of 9/24/09, mother reports by phone that facial palsy still present, but better. 10/15/2009 received records from PCP for visit date 9/21/2009. Patient presents with sx of left facial palsy 3 days post vaccination. PE notes lt facial assymetry, unable to close lt eye fully, + eye tearing. Tx: Doxcycline, eye patch at night and Artificial tears.
Developed granuloma annulare and worsening of psoriasis approximately one month after receiving the fourth dose of Pfizer COVID vaccine. Granuloma annulare first appeared as flesh colored bumps under the skin of arms and forearms and spread to torso and back. After approximately 6 months the outbreak became increasingly inflamed, red, and itchy. Psoriasis lesions on arms, elbows, forearms, and scalp became larger with more scales and skin flaking.
First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washcloth on forehead) Chills Muscle ache in hips (hot rice pillow, Advil) Pain at injection site  2nd day: Lower fever (99.7, Advil, no damp wash cloth, seemed too cold) Chills Muscle ache in hips and hands (hot rice pillow, Advil) Fluttering under right breast (about 2 seconds long, happened 6 times) Start of migraine (Aleve, took edge off but not completely gone) Pain at injection site  Day 3: Migraine (Aleve) Muscle aches in hands (Advil) Late in day, around 2pm, migraine turns into headache in left eye socket by around 7pm pain feels more like congestion in same area. (Aleve, doesn't seem to help much, neither does Advil)  Day 4 (Morning): Headache/congested feeling in left eye socket continues (Aleve or Advil, neither help so far)
Continuing complete loss of vision in left eye beginning 4/14/19. Treatment thus far has consisted of Brimonidine 0.2% Ophth Soln.
Information has been received from a medical assistant concerning a 19 year old female with no medical history and no known drug reactions or allergies who on 22-MAY-2007 was vaccinated with the first dose of Gardasil. On 23-July-2007 the patient was vaccinated with the second dose of Gardasil. And on 21-Nov-2007 the patient was vaccinated with the third dose of Gardasil (Lot # 0530U). Concomitant therapy included LOESTRIN. On 21-NOV-2007 the patient developed a white spot at injection site. At the time of reporting the patient had not recovered. No laboratory diagnostic tests were performed. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Case number PHEH2014US025094, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 10 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Loss of lactation in breastfeeding mom. Took the vaccine on Friday at 10:30 am.  Had fever, chills, night sweats beginning at 11:00 pm, lasting through the night. Breast fed baby around 4 am per routine. Attempted to breastfeed baby per routine at 6 am. Less  milk was available during this feed as indicated by short feed time and upset baby. Breastfeeding routine was kept through the weekend which includes feedings at 4 am, 6 am, 5 pm, and bed time (approximately 9pm). This has been routine for 10 months. Less milk was available through the weekend and today as indicated by frustrated baby and short feed times with no active feeding observed. Monday there is only a drop of milk available with manual stimulation. Breasts feel lighter and "empty", nursing bra is now baggy and does not fit (too large).
After vax, pt devel hives, itching at inject site. Treated with Benadryl and applied ice. Reporter indicates that of 100, 15 devel this rxn. Additional reports to be generated.
Symptoms began with  intermittent nausea, vomiting for 5 days. She has had intermittent food and liquid particle emesis. Associated symptoms included some shortness of breath, dry nonproductive cough; increased lower extremity edema, weakness, fatigue; admitted to hospital with acute diastolic heart failure with pulmonary edema, pleural effusions.  Patient had an ECHO showing a decrease in EF from 50-51% to 20-25%  Hospital course:  Patient was admitted and monitored on telemetry. She was started on Lasix and losartan was changed to Entresto. She showed steady progressive improvement and was able to come off oxygen fairly quickly. No chest pain or shortness of breath. She had a urinary tract infection on admission, which was treated with 3 days of Rocephin. Kidney function  remained stable. Cardiology was consulted and evaluated the patient.  Cardiology and care management team coordinated for patient to discharge with LifeVest given her significantly reduced EF, which is new.
Patient received MMR and Varivax boosters.  10 minutes later he vomited 3-4 times, had a bowel movement (on the toilet), and had a near syncopal episode.  He became flushed and somnolescent.  Oxygen saturation below 95%.  Normal respiratory rate and pulse.  No wheezing or respiratory distress or hives or facia/limb swelling.  Given supplemental oxygen.  No improvement after 30 minutes.  Still somnolescent but responsive.  911 called.  IV inserted by EMS after pt. became ruddy.  Given dose of IV Benadryl and brought to ED.  In ED, given IV steroids and pepcid, IVF.  Clinically improved.  To be discharged from ED 4 hours after steroid administration and follow up with me tomorrow.
Patient, (staff member at this facility) complained of severe arm pain (Rt. Arm - Booster dose given)shortly after receiving both vaccinations. Within a short amount of time she got the point where she couldn?t move it without crying. She then began feeling faint. She sat in the employee breakroom for a while. She spiked a fever of 102, got very weak to the point that she could not stand, and at one point couldn?t talk. A relative took her to the ER.
Lt arm swelling from shoulder down past elbow, itching, "blotchy redness". Benadryl 1 1/2-2 tsp every 6 hours to give PO.
On July 19, 2021 about 05:30PM I was driving home and I had severe chest pain, on the right side of my heart. Once I got home I felt awful even after the pain stopped, I was diaphoretic. I went to work the next day and called a nurse. She suggested I go to the ER since I had chest pain. At the ER, they started an IV, did EKG, did a portable chest x-ray and gave me aspirin. I was sent home from the ER that day.
Left arm swollen and red after shot, seen when undressing for bed, went to urgent care, entire bicep swollen and red, completely resolved by 11/20/2001.
Patient complained of itching at injection site. 12 min after injection. No SOB, chest tightness or rash. Resolved with treatment.
Woke up Monday morning at 2AM with severe abdominal pain. Had a strong headache over the weekend as well.
Dizziness, neuropathy, tachycardia... Provider believes pt. has long covid sx of Pots and small fiber neuropathy, postural orthostatic tachycardia syndrome.
YF-VAX was potentially reconstituted with a diluent other than the supplied YF-VAX diluent, with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient who reported yellow fever vaccine - [YF-VAX] was potentially reconstituted with a diluent other than the supplied yf-vax diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect yellow fever vaccine (dose, strength, lot number, route, administration site: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event as representative stated that she called on behalf of her client and that there was a possibility that YF-VAX was reconstituted with an alternative diluent other than the supplied diluent that was supplied with the vaccine (product preparation error) (unknown latency). Representative stated she was not completely sure if an event actually occurred and wanted to be proactive and report it just in case.   Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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.
Information has been received from a health care professional concerning a child patient who was vaccinated with a dose of MMR (second generation). It was reported that the patient has autism and the parents feel that it was due to the vaccine. Unspecified medical attention was sought. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Flu vaccine given (Lt) upper arm , noted pain and burning sensation down arm and joint pain wrist, (Lt) thumb and elbow. Tender to touch unable to exercise. Also noted tenderness (Lt) side of body to mid back
Pain in arm, pain in back, headaches, pain in kidney, pain in lung, minor spotting on wrist.
Local induration redness, swelling to size of baseball, Zyrtec, Ice.
patient did not advise physician that she had already received Moderna bivalent booster on 10/2/22 when Pfizer bivalent booster was offered to her. patient received pfizer bivalent booster as well on 12/27/22, and has now received 2 bivalent boosters.
w/in 5min of vax pt devel hives @ the site of MMR vax;also on face, neck, arms;child remained alert & there was no sign of resp distress;DPH given;f/u phone call on 8/12/99;no hives & doing well;
Localized swelling, pain (sensitive to touch and movement), and erythematous rash at site of injection lasting for 5 days (ongoing). Minor fatigue in first 24 hours post vaccination.
I just felt unwell and I though I may be coming down with the flu, I also felt lethargic and did not have energy.  I also contracted COVID-19 in February of 2023.  I had a runny nose and severe sore throat. I thought it was strep throat an Urgent Care clinic test was negative for Strep they asked if they may test for COVID-19 and I agreed and I was positive for COVID-19. I was prescribed Paxlovid.
It was reported that a 15 year old female pt received a TD Adult vaccination on 3/4/00. Reportedly, on 3/13/00, the pt complained of forearm swelling, numbness, tingling and weakness in fingers with flexion. The pt also developed a red, flat lesion 4-5mm on flexor surface of forearm. From correspondence received on 3/30/00, additional physician and vaccine information was provided.
Information has been received from a nurse practitioner concerning a 22 year old female with a history of vasovagal responses, but not as a reaction to medications or vaccines who on 16-JUN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscularly. The patient had a vasovagal response after getting GARDASIL and she passed out cold. No laboratories studies performed. The patient sought unspecified medical attention. The patient recovered on 15-JUN-2009 after stopping therapy. Additional information has been requested.
scleroderma; lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs; feel unwell; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I was forced to be vaccinated with 1 dose of Pfizer coronavirus vaccination. I didn't feel any negative reactions.), administration date: 13Sep2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RASH MACULAR (non-serious) with onset 18Oct2021, outcome "unknown", described as "lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "feel unwell"; DIZZINESS (non-serious) with onset 18Oct2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "weakness". The events "scleroderma", "lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs", "feel unwell", "dizziness" and "weakness" were evaluated at the physician office visit. Addition information: It was reported that: I went to the doctors and was diagnosed with Scleroderma. I am sure that the immediate development of this dangerous disease was provoked by the Pfizer Covid19 vaccine. I am ready to undergo an examination to clarify the disease caused by the Pfizer Covid19 vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Approx 2 min after getting vaccine I felt lightheaded.  I noticed my heart was pounding and racing. I got help and Sat in office with nurse.  My pulse was 140's ,I felt sweaty and shaky.  Whole episode lasted approx 10 minutes
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot#L012838, expiration date: 10-MAR-2018, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Acute respiratory failure with hypoxia and acute encephalopathy 2/2 COVID-19 pneumonia requiring hospitalization