chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My father experienced an acute stroke,  1month +7days after receiving his 2nd shot. We are reporting this because when we mentioned the stroke to members of our church, there were at least 2 others who knew of someone in my fathers age group who also had a stroke 1 month after their 2nd covid vaccine shot. My father is currently at hospital, and is being moved to Rehab Center today. (April 28, 2021)     On Saturday, April 24th, he woke up with wobbly legs around 3am, accompanied with an odd sensation in one of his arms, and legs. He went on about his day, but felt off. He fell around 2:20pm, I was called by mom. My husband and I arrived about 10 minutes later. He was up, and walking at that point, but his speech was very slurred. We checked his blood levels (159), and went through the stroke symptoms, and drove him to Hospital, where they immediately took him in under stroke protocols. It was determined he had an acute stroke.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2017, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 02MAY90; 5JUN90 & 09NOV90 & it was determined that pt did not respond; A 4th dose of Engerix-B was administered 17DEC90; p/this still did not respond; pt treated w/Prephenzine & Impramine; dx is unk/unconfirmed
Injection site itchy; injection site redness/outside of arm, just above elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Hypertension and Leg edema. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN, FUROSEMIDE and SPIRONOLACTONE for an unknown indication.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (injection site redness/outside of arm, just above elbow) outcome was unknown.            Patient used an ice pack and took Tylenol before she went to bed. Action taken with mRNA-1273 in response to events was not applicable.
Patient complained of nausea after receiving vaccine .  symptoms resolved and no further issues at this time.
Intensive itching rash; Rash travelled all over body to every part/Rash was also in ankles, and bottom of the feet; Worst itching in torso and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Intensive itching rash), RASH (Rash travelled all over body to every part/Rash was also in ankles, and bottom of the feet) and PRURITUS (Worst itching in torso and back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced RASH PRURITIC (Intensive itching rash), RASH (Rash travelled all over body to every part/Rash was also in ankles, and bottom of the feet) and PRURITUS (Worst itching in torso and back). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itchy, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. In December 2021, RASH PRURITIC (Intensive itching rash), RASH (Rash travelled all over body to every part/Rash was also in ankles, and bottom of the feet) and PRURITUS (Worst itching in torso and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Since patient did not change anything in daily life, thinks that the vaccine might have caused it. About the events Patient said that it has been 2 weeks but 3 days ago it started to subside and now patient is okay. No concomitant medications were mentioned.   This case was linked to MOD-2021-419372 (Patient Link).
Initial unsolicited report valid received from administration on 18 Jun 2018. In this case the patient had received an expired dose of Act-HIB (Batch number, expiration date, dose, route and site of administration was not reported) was administered on an unspecified date. It was an actual medication error due to expired vaccine used. 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 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. List of documents held by sender: none.
Narrative:  Patient was hospitalized in timely manner with Pfizer mrna vaccine on 2-19-21 and 3-15-21 respectively at a non-facility site. Pt presented to ED 11-9-21 with polyuria, weakness and poor appetite. He tested positive for COVID at a non facility provider 11-1.  Patient had a positive biofire on 11-9. He remained hospitalized due to weakness--patient never required O2 support or any COVID treatments. He was later transferred for rehabilitation due to deconditioning related to COVID weakness and later discharged home.  Patient has history of DLBCL but has been in remission since 2018--not likely related to COVID
pain in lt upper arm ( @ inj site) cont 3mo post vax, limiting ROM;
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-MAR-2015, one dose of improperly stored ZOSTAVAX (0.65 ml, subcutaneous (SQ), lot# and expiration date not reported) was administered to the patient. No adverse effects were reported. Additional information has been requested.
Whew big red egg on arm; Whew big red egg on arm; feel punk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Whew big red egg on arm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel punk". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
pt recvd vax 10OCT95 & that day pt devel an inj site rxn which was characterized as warm & approx the circumference on an orange;rxn was treated w/ice & persisting as of the date of the report;
Parent called on 12/28 to report rash on leg, top of arm, across chest to other arm. Began about 24 hrs after imm. seen by Dr on 12/28 & Dxd with urticaria.
I got my flu shot n still got the flu, 3rd year on a row n bad; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who received INFLUENZA VACCINE. and  still got the flu, 3rd year on a row and bad.  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 Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient received INFLUENZA VACCINE. and  still got the flu, 3rd year on a rowand bad (influenza) (unknown latency).  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Cough     Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches, cough. Had 2nd covid shot 4/29/21. ? Diarrhea ? Fatigue     Patient is a 81 y.o. female    HPI   Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 10 days ago. Sinus pain and pressure No Fever/ chills Yes Headache Yes Body aches No Cough Yes Sob No Sore throat No Nausea/ vomiting/ diarrhea. Yes Loss of taste or smell Yes Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. yes   Patient felt sick before receiving her second COVID 19 vaccine on 4/29. She states her and her husband were also exposed to someone at church who tested positive x 5 days ago and they were not wearing masks.    She does use her rescue inhaler as needed for her cough.  ED to Hosp-Admission Discharged  5/5/2021 - 5/17/2021 (12 days)  Hospital   MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine           Discharge Summary   Hospitalist Medicine        Patient:  Date: 5/17/2021 DOB: Admission Date: 5/5/2021 PCP: DO Length of Stay: 10 Days Discharging provider:  MD Discharge Date: 5/17/2021     Admission Diagnosis     Medical Problems     Hospital Problems        POA   * (Principal) Pneumonia due to COVID-19 virus Yes       Asthma without status asthmaticus Yes       Systemic lupus erythematosus (CMS/HCC) Yes   Overview Signed 12/1/2020  7:46 AM by  LPN      Note: Document: 08/22/19 - Consults Rheumatology -           Paroxysmal atrial fibrillation  Yes       Atrial fibrillation with RVR  Yes       Esophageal stricture Yes
Patient last night started to have a fever, headache, swollen/red/warm area at injection site, and experienced a swollen lymph node in her armpit. Patient called the hospital and the doctor told her to take motrin, to take a steroid pill she has on hand for another condition and to put ice on it. Patient still has not been feeling well today.
Runny Nose, Lose of Taste and Smell, Headache, Congestion and Cough
No additional adverse events reported; Caller reports that an expired dose of MMR II was administered to a patient today; This spontaneous report was received from a medical assistant concerning to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.      On 22-SEP-2021 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029457 and expiration date since it make match with the autopopulated expiration date: 19-SEP-2021 (dose, frequency, route of administration and indication were not provided).
This child was seen  at the Dept. of Health's Vaccine clinic for administration of TDaP and MCV-4 vaccines.  During the visit his mother, stated she lied about her child's age to receive the covid vaccines in June and August 2021.  He was 11 years old and received the 12 year and older doses of Pfizer (0.3ml) at a local Pharmacy.  There were no adverse effects as per mom.
Felt achy all over; All joints hurt; Left node underneath chin was puffed out - like swelling of left lymph node; Couldn't lift her arm up; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Couldn't lift her arm up), PAIN (Felt achy all over), ARTHRALGIA (All joints hurt) and LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DYSKINESIA (Couldn't lift her arm up). On 22-Feb-2021, the patient experienced LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node). On an unknown date, the patient experienced PAIN (Felt achy all over) and ARTHRALGIA (All joints hurt). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 25-Feb-2021, LYMPHADENOPATHY (Left node underneath chin was puffed out - like swelling of left lymph node) had resolved. At the time of the report, DYSKINESIA (Couldn't lift her arm up), PAIN (Felt achy all over) and ARTHRALGIA (All joints hurt) was resolving.            The patient administered Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information included updated patient demographics.
patient requested the new shingles shot (she said it was the second dose); but dr's office called and said she received two doses already and we gave her the third one.
sore throat 3 days, 24 hours a day and it is still as last time; my calves are in pain 24 hours a day and they have not changed; 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) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat 3 days, 24 hours a day and it is still as last time"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my calves are in pain 24 hours a day and they have not changed".  Additional information: The booster it caused me to have a sore throat 3 days, 24 hours a day and it is still as last time. Also the, gives me, my calves are in pain 24 hours a day and they have not changed. I am not a history of Charley horses, I am not a history of sore throats but this is since the time I took your shot and it doesn't get any better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from two healthcare workers referring to an unspecified number patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored VAQTA (lot#, dose, route not reported). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
tested positive on january 15th; sore throat; runny nose; body aches; felt like winded; A spontaneous report was received from a  Consumer concerning a 50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch:037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 15 Jan 2021, The patient tested positive with covid 19,the symptoms were sore throat and a runny nose but a week before testing positive the caller reported that felt like winded, it wasn't bad. The sore throat and also body aches appeared when the patient took the test   Treatment details are not provided.  The second dose of the Moderna COVID 19 Vaccine on January 22nd.Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event(s) tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache, was unknown.
2 days p/vax pt beginning w/leg twitching & spasms, arm tightness & heaviness;14NOV96 dry mouth, muscle tightness in hands & arms & arms feel heavy;legs feel tight & tingling;went to MD
About a minute after getting a shot, he started feeling lightheaded. He also felt some anxiousness with tingling in his left arm. He says that his symptoms lasted about 20 minutes or so.
feeling achey; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling achey.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown, Exp unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced feeling achey. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  Outcome for the event, feeling achey was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
12/30/21: Got the shot at about 5:45pm. Some redness at injection site but not much. Arm was sore. 12/31/21: Still some redness and hot to the touch. Arm was sore. 1/1/22: Severe migraine and some redness around injection site 1/2: Red around injection site (about golf ball size) 1/3/22: decrease in redness 1/4/22: started getting itchy 1/5/22-1/6/22: Redness around injection site about baseball size. Swollen and hot to the touch.  1/7/22-1/9/22: Gradual decrease in redness, swelling and heat 1/10/22: started getting itchy again with some redness and swelling 1/11/22: Redness around injection site started to spread 1/12/22-1/13/22: Redness around injection site the size of my hand, itchy swollen and hot to the touch
On my first vaccine shot done in 03/26/2021, only minor fever was experienced (expected, no complaint on this one).  On my second vaccine shot done in 04/23/2021, I experienced: 1). slight fever (temp "normal" around 96-F) on the first and second day after the shot was given at 1:10pm (I took 800mg Ibuprofen  before sleep  at first night around 3am, and took 400mg Ibuprofen at the second night around 2am), AND 2). rather heavy diarrhea on 04/24/2021 twice (at around  4pm), and heavier diarrhea on  04/25/2021 twice (at around 6pm); in both days, I took Imodium to treat my stomach upsets.
12 year patient was today by mistake given a Menactra dose and one year apart, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 year old female patient who received two doses MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] one year apart [extra dose administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On an unknown date (today), the patient received a0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6455CA and expiry date: 15-Nov-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (same day latency).  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 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.; Sender's Comments:  US-SA-2020SA250172:same patient
1-2 minutes after the shot.  She fainted and fell at the examining table. 20-30 seconds was unconscious, then she was ok. She felt dizzy, emergency medical services examined, blood sugar 113, blood pressure 86/68, pulse 78, took her to emergency room, observed 2 hours  then discharges.
Day 1: Chills, fever starting in evening.. Left arm was very sore. Took ibuprofen before going to sleep. Day 2: Fever all day, rash started on arm in large area below vaccine location. Swollen and sore arm. Took ibuprofen before going to sleep. Day 3: No fever. Arm less sore than day two but rash still there and grown larger.