chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (mild reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1 (Mild reaction)), JANSSEN COVID-19 VACCINE (First booster (Mild reaction)) and JANSSEN COVID-19 VACCINE (Dose 2 (Mild reaction)). Past adverse reactions to the above products included Vaccination adverse reaction with JANSSEN COVID-19 VACCINE, JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (mild reaction). At the time of the report, IMMUNISATION REACTION (mild reaction) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that patient received fifth vaccine from Pfizer COVID-19 Vaccine Bivalent as booster with batch number as CJ2524. It was reported that patient had two regular Johnson and Johnson, one booster Johnson and Johnson, one booster Moderna and then 6 months later or post to 6 months later he had  yesterday the Pfizer booster.   Patient had very little reaction to the other four, hardly any but was having a very much stronger reaction with Pfizer. Patient was having a hard time standing up, pale, weak, feeling dizzy and was all sweaty as back was all sweaty.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-646090 (Patient Link).
pt reports  he walked a long way from his vehicle and felt dizzy. he reported shortness of breath and dizziness. Pt felt dizzy just after receiving 1st dose of modenera (within 2 mins) said he thought it was exertion. Pt felt dizzy with no relief after rest. ASA 324mg and 3LPM P2 v12 lead EKG showed Afib and paced rhythm. hospital transport to  hospital. Pt care and report given.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on 16-JAN-2014 for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately January 2014 [reported as shortly after receiving ZOSTAVAX], the patient developed irritation, inflammation, and pain in his left eye. Thereafter, the patient presented to an optometrist and was diagnosed with herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea. As a direct and proximate result of these malfunctions, 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. The outcome of the events is unknown. Upon internal review, herpes epithelial keratitis in his left eye along with keratitis of his left eye cornea was determined to be medically significant. Additional information has been requested.
Pt complete ATB for ear infect 4FEB92; mom didn't feel pt was ill day of vax; On 6FEB92 pt began throwing up; crabby, irritable; mom could not satisfy pt; MD hospitalized pt because of dehydration; MD did not feel illness caused by vax;
Patient with progressive swelling, redness and pain at injection site which required 3 ED visits. Diagnosed initially with localized reaction and given Tylenol/Motrin. On secondary trip to ED, patient diagnosed with cellulitis and placed on topical antibiotics and clindamycin. Last visit to ED, patient received Benadryl for swelling. No respiratory distress or swelling. F/U with PCM symptoms improving.
Vomiting three times; very bad headache; very bad joint pain; tail bone pain; both ankles pain; fever( 99.3 F); sleepiness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) in the left arm on 09Apr2021 at 10:15 (at the age of 29-year-old) as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) in the right arm on 19Mar2021 at 13:00 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 22:30, the patient had experienced vomiting three times, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness. The patient underwent lab tests and procedures which included SARS-CoV-2 test via Nasal Swab and the result was negative. On 09Apr2021, the patient also underwent body temperature test and the result was 99.3 degree fahrenheit. Therapeutic measures were taken as the result of adverse event which included two tylenol. The 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 vomiting, very bad headache, very bad joint pain, especially tail bone pain and both ankles pain, fever (99.3 F) sleepiness and weakness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (10Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information: Lab data information and narrative were updated.
Pt exp lt thigh inject site red & swollen, pt fussy; leg w/minimal local inflammation, mom concerned about red swelling area to lt leg; poor appetite, creis a lot; swelling to lt thigh beginning to turn eccymotic;
I had vaccination on 09/08/2022. I took a trip overseas and started to experience COVID like symptoms on 09/10/2022 to include runny nose scratchy eyes teary eyes. I took a COVID-19 test on 09/27/2022 and it was COVID-19 Positive. I was prescribed quarantined for five days and I tested COVID-19 Negative.
Employee states that after one hr she felt her heart pounding and took her pulse and it was 158 and no other symptoms. Denies chest pain. Staff took her R BP  and it was151/113 on a machine.  Recheck 10 minutes later BP 151/112,  P 126. Patient was brought to the Occupational Medicine Dept.  Recheck  at 20 min BP 125/68 and an apical pulse of 88. HR regular, rate and rhythm.  Employee states she feels fatigued currently, denies shortness of breath, chest pain, itching, swelling of oral cavity.
Chronic Hives started ~2 weeks after getting this booster. They are still occurring today.  I have never had hives in my life before this.
Mom called T-103 no other sx. Advised TYLENOL. Call if symptoms worse.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. This report is regarding a 19-24 year old female patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (ORAL) batch: 34600018, on 11-Jan-2012. On the same day, the patient experienced ANAPHYLAXIS. The patient was treated at an outpatient visit with medication. The event resolved the same day. Treatment medications administered on 11-Jan-2012 included: ranitidine HCL 150mg QID, PO, stopped on 21-Jan-2012, diphenhydramine 25mg TID, PO stopped on 10-Feb-2012, cetrizine HCL 10mg daily, PO stopped on 11-Apr-2012, epinephrine 0.5mg daily, IM, stopped on 11-Jan-2012, BENADRYL 50mg daily, IV, stopped on 11-Jan-2012, SOLUMEDROL 125mg daily, IV stopped on 11-Jan-2012, oxygen 6 L/min daily nasal cannula, stopped on 11-Jan-2012. The patient's concomitant medication included INFLUENZA VACCINE (on 05-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE (on 05-Jan-2012); IPV (on 05-Jan-2012); DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (on 11-Jan-2012); HEPATITIS A VACCINE (on 11-Jan-2012). The maximum severity of the event was not assessed. Lab/diagnostic tests: 04-Jan-2012: HCG beta subunit less than 0.1 MIV/ml; hepatitis B virus surface AB: positive; hepatitis A virus surface AB: negative; varicella zoster virus AB: immune; rubella virus AB IgG: immune; rubeola virus AB IgG: immune; G6 PD 14.1 u/g hgb. 11-Jan-2012 HCG: inconclusive; urinalysis normal. The outcome of the AEs were: anaphylaxis: recovered/resolved. The patient's concomitant medication included INFLUENZA VACCINE (on 05-Jan-2012); MENINGOCOCCAL POLYSACCHARIDE; (on 05-Jan-2012); IPV; DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (since 11-Jan-2012); HEPATITIS A VACCINE (since 11-Jan-2012). Action taken with suspect drug: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's past medications were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Per medical monitor: "Meds given for anaphylaxis same day as vaccines given." The medical monitor has assessed the event as possibly related to Adenovirus vaccine.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 11:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ehlers danlos syndrome" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "seafood allergy" (unspecified if ongoing); "yellow dye" (unspecified if ongoing), notes: Yellow dye number 5. Concomitant medication(s) included: LEXAPRO; LITHIUM; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BACLOFEN. Vaccination history included: BNT162b2 (Dose Number: 3 booster, Batch/Lot No: FN2590, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22Oct2021, when the patient was 50-year-old, for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown.), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) all with onset 17Jul2022 at 02:00, outcome "not recovered" and all described as "migraine headaches bilateral". The event "migraine headaches bilateral" required physician office visit. Therapeutic measures were taken as a result of headache, migraine. Additional information: Dose number 1 (Lot FN2590) given at left arm on  22Oct2021 and dose number 2 (Lot FN2908) given at Left arm on 15Jul2022. The patient did not get these side effects with first pfizer booster. Prescriptions for ubrelvy and Imitrex as treatment of adverse events.
On 11/02/1999, approximately one month subsequent to receiving the second dose of Engerix B, the pt was seen by physician complaining of a very sore throat, swollen gland in the neck, low grade fever and fatigue. A Mono test was negative. A routine evaluation revealed elevated liver enzymes. Symptoms lasted for approximately one month. Blood work in 01/2000 was normal. The pt was instructed by physician to have the third dose of Engerix B. The pt received the third dose of Engerix B in 03/2000. In 04/2000 the pt had an extremely swollen neck (her jaw was hard to open), low grade fever, diaphoresis at night, and her SGPT was 85 U/L. She was being treated with Augmentin 875 mg and Tylenol. A doctor visit was required. The most recent information received reports the condition of the pt is ongoing.
Chills; Felt hot through the night; fever; weakness; felt tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included oral thrush. The patient had a history of allergy to oysters, Vicodin, penicillin and had seasonal allergies. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and DIFLUCAN for unknown indication received within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Mar2021 at 14:00, about 30 min after the vaccination, the patient felt tired. Within 1 hour at 14:30, the patient had a fever, weakness and had to lay down. This was only the first dose. On the same day at 16:00, the patient had chills which were continued and had felt hot through the night. It was reported that the patient had to take Tylenol. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events felt tired, fever, weakness, chills and felt hot through the night was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother states pt experienced a seizure at 10:30pm 5/21/03. He is presently on Lamictal for a seizure disorder. Was taken to hospital ER. She does not remember physician's name. Observed x 3-4 hrs. OK this am.
Red patch developed  around injection site 8 days after receiving first dose of vaccine. Patch is swollen,  itchy and  painful.
Pt has MS and has his primary pain in his r arm, shoulder and leg which he had. He also had pain in his l arm, thigh and chest
can i get the second vaccine now; COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now). The patient was treated with MONOCLONAL ANTIBODIES (intravenous) ongoing from 13-Mar-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID) and PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.   Reporter did not allow further contact
pt recvd vax & devel painful swelling of the lymph nodes; pt also had inject site swelling & redness; The react resolved w/in 3 to 4 days;
He felt like a bus hit him; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: He felt like a bus hit him). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR095588   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter was a patient. The reporter commented on the Shingrix page about his ordeal with the Shingrix vaccine. The reporter reported that after receiving Shingrix vaccine he felt like a bus hit him. No other information was provided. The reporter did consent to follow up.
Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and crackers.
Upper lip and left side of face felt puffy for a couple of hours. Took Benadryl. Puffy feeling went down a few hours later.
DTAP administered 5/8/06, by 5/11, had significant swelling, redness and pain in L arm. 5/15/06, symptoms persist. Was seen to have erythematous flush, red to purple area of induration 3 1/2 X 4 1/2cm. Redness approx. 9 X 13cm surrounding. Dx: Cellulitis.
sore throat; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported.
A report was received from a health care professional on 12/9/03 concerning a 13 or 14 year old male vaccinee who inadvertently received 1.0ml of Fluvirin on the same day. On 12/9/03, the vaccinee inadvertently received 1.0ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Information has been received from a nurse practitioner concerning a 57 year old female patient with asthma and no allergies or drug reactions who on "10-NOV-2011", was vaccinated with a dose of PNEUMOVAX 23 0.5 mL, intramuscularly (also reported as subcutaneously) (lot number not reported). Concomitant therapy included Tdap administered on the same day (also reported as no concomitant medications). On 08-NOV-2011 (conflicted information according with the date of vaccination), the patient experienced "ascerbated asthma" with flu like symptoms, a fever of 102 degree, hives, malaise and injection site soreness. The patient received as treatment for the event prednisone, and was instructed to use inhaler more frequently. There was no laboratories performed. At the time of the report the patient was recovering and working with her healthcare provider to address the situation. "Ascerbated asthma" with flu like symptoms, a fever of 102 degree, hives, malaise and injection site soreness were considered to be an other important medical event by the nurse practitioner. Additional information has been requested.
Itching at injection site and sporadic itching in multiple areas of body. Itching, very dry skin centralized on face starting Friday, February 19 around 5 PM. It continues. Benadryl 25 mg taken by mouth.
MODERNA COVID19 VACCINE EUA  Fever, headache, pain in joints for 5 hours
I am in my 22 weeks pregnancy.  The estimated date of delivery is Oct 1, 2021. My whole belly is constantly bloated, hard and tight a few hours after taking the second dose of Pfizer on May 27. I went to the hospital on May 30 and the doctor said the baby is fine and the symptom is probably something related to gastrointestinal problem. Neither the doctor or I are sure about this symptom is caused by the vaccine. But the weird symptom do happens after the 2nd dose of Pfizer vaccine.
Lacunar stroke of the right hypothalamic region initially with loss of balance, facial droop, tongue deviation, and slurred speech now resolved with only minor residual speech deficits. Signs first observed on 10/14 at 0400 by patient and patient's spouse.
One week after getting my first shot I had pain in both breasts, both underarms and my collarbone area. I still have a lump under the arm I got the vaccine in and both underarm pain still exists 2.5 months after getting the fist shot. I have not got the second shot yet.
Patient stated she developed large area of bruising. Estimates 3-inch diameter ecchymosis right wrist and dorsal aspect of right hand, immediately after vaccination.
pt received Prevnar 20 and approximately one hour later pt started to have redness and itching below the injection site. pt in office 2 days later to have it evaluated and was determined to have hypersensitivity to the vaccine. antihistamine given to pt for syptoms.
Drowsiness, driving collision, feeling "like no body is home", didn't feel like herself, felt like a "zombie"
experienced chest pain after taking the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "experienced chest pain after taking the vaccine".  Additional information: It was reported that, he experienced chest pain after taking the vaccine. He wanted to know if it's normal to experience chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low-grade temperature 99.9 with headache.  The next morning, headache, temperature of 100 with nausea and fatigue.  That night, temp of 100.2 with fatigue and a random cough, nausea.  Now, it's 11/3 at 2:30 am and she awoken with temp of 102.2, vomitted, wheezing cough.  I called Pediatrician and he thinks she has H1N1.  The last day any of my 3 children were in school was Wed. 10/28/09 because we wanted patient vaccinated for 10 days before they went back to school to insure patient had full immunity to H1N1.  We also have avoided the public. We did not trick or treat, nor did we give out candy.  When we've had to go into public, we've worn face masks.  I really think this injectible vaccine gave her H1N1. 12/08/09  PCP records received for DOS 11/03/09. Pt. presented with h/o of fever, headache, cough, fatigue, nausea X 2 days. Treated with Tamiflu. Impression: Influenza A