chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 04-JAN-2018, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX, the patient suffered severe, intractable back pain, itchy skin, and skin rash.  On 07-APR-2018, the patient presented to a hospital (considered an Emergency Room (ER) visit until follow-up is received) and was diagnosed with varicella zoster. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. Causality assessment was related. Varicella zoster was considered to be disabling. Additional information has been requested.
pt reports onset of sore lt deltoid & sl sore throat; no inflammation in lt deltoid area beginning 21OCT92; 22OCT92 onset of nasal congestion & nasal drainage & sore throat; 23OCT92 onset of productive cough, sputum whitish mucous; flushing
The patient fainted ~20 minutes post-vaccine while talking to his colleague. I immediately assessed the patient for s/sx of anaphylactic or severe reaction. He woke up within ~30 seconds of fainting. He was breathing and speaking fine. He told me he was anxious and also did not have anything to eat or drink all day and believes this is the cause of why he fainted. I had him take a few deep breaths. Injection site looked normal and no issues with breathing. Called EMS to assess him: glucose, blood pressure, & vital signs were all normal. While being assessed he passed out in chair so EMS took him to the hospital. He was discharged from the ER the same day per RN, at the facility. They did not find anything wrong with him and also believe it was due to nerves/lack of eating. No significant medical history per form patient filled out or that he verbally stated.
About 24 hours after patient got his second dose of the Pfizer Covid-19 vaccine, he started to get muscle twitches throughout the entire body. This lasted for 24 hours, and then reduced to legs only. He now has leg twitches, chills and flu-ish symptoms that have continued to today, Monday April 19, 5 days after the second dose.
bodyache,fever,chills. PT states getting J/J vaccine this am with fever, chills, and body ache starting afterwards. HISTORY OF PRESENT ILLNESS: 21 yo M p/w fatigue, body aches, subjective fever, nausea after receiving J&J COVAX earlier today. Acute onset of symptoms, constant, mild muscle aches. Nausea without vomiting. Denies recent illness, headache, vision changes, chest pain, dyspnea, weakness/numbness. MDM: 21 yo M presents with vaccine reaction.  Stable on arrival, afebrile with reassuring vitals.  Patient well-appearing on exam with no respiratory difficulty or other exam abnormalities.  Given tylenol/toradol/zofran/IV fluids with improvement of symptoms. Plan for discharge with tylenol/motrin/zofran, and primary care follow-up in 7-10 days.  Discussed findings with patient/caregiver. Plan for discharge as above. Patient/caregiver verbalized understanding and agreement with plan. All questions were answered to satisfaction of patient/caregiver. Written and verbal discharge instructions were given to the patient, including strict ER return precautions. Patient was discharged in stable condition
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter informed that in the facility where she worked there had been temperature excursions with her freezer. It happened for weeks since April 2022. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials were now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure. No treatment information was reported.
she did cut her finger on the syringe; syringe that was broken "around the top where plunger is"; This spontaneous report was received from a nurse, who is also the female patient of unknown age referring to herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 17-JAN-2020, reported as 2 weeks ago, the nurse was trying to attach the needle to the pre-filled syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)  lot # S008151 expiration date on 20-NOV-2021, when she noticed that the syringe was broken "around the top where plunger was". As result, the nurse did cut her finger (wound) on the syringe. Subsequently, she put a "Band Aid on the wound and kept on working". There were no symptoms reported. It was reported that the patient did not seek medical attention and no treatment was given for the event.  The outcome of wound was reported resolved on an unknown date in January 2020. The causality between the event and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was unknown.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 01-JUN-2023) dose was not reported, 1 total administered on 28-MAY-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  The patient reported, she did three antibody tests that all came back negative. The first test was done on 13-OCT-2021, Laboratory data included: Immunoglobulin G (NR: not provided) Non reactive. The second test was done on 02-NOV-2021 and it was a spike test (possible Immunoglobulin A) that came back negative. On 16-NOV-2021, had the T detect test which was negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000203678.; Sender's Comments: V0; 20211152159-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Inflammation of optical, nerves + muscles weight loss, excessive urinating and thirst, tiredness, rash, blurry vision. See attached letter!
Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt itchy and then immediately afterward a very painful and swollen further inside. That was Friday night. for the remainder of the weekend I had terribly painful urination. I called my OB/GYN and scheduled an appointment for January 19. I prescribed Valtrex for possible herpes and Ciprofloxacin for possible bladder infection. The results came back as Oral herpes that were in my vagina.  I would like to add that I did have a strong immune response to the second covid vaccine and had muscle aches, chills and malaise.
Mom called 9/7/04. States Friday 9/3/01. Left deltoid area red and swollen the size of her palm. Sat 9/4/04: swelling expanded  to arm pit (left). Called MD 9/5/04 Family Care walk-in . 9/10/04: Telephone call with mom continues to be red and swollen. No pain and or illness. Note from our doctor. States no treatment.
described via telephone from pt's mom nausea/vomiting, abd cramping, aches & pains-chest pains, fever, h/a, sore throat
Left lateral thigh SC with 3 inch in diameter indurated, erythematous, warm circular reaction site.
administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021) 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.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. Pharmacist reports that they received the shipment of the Moderna Covid-19 vaccine on 08Nov2021 and placed them in the refrigerator with the proper storage and lighting conditions. The health department found out that they misinterpreted the stability date of the vaccine. Pharmacist reported vials have been sitting in the refrigerator for more than 30 days and the administered 4 booster doses, two doses were on 22Dec2021 and 23Dec2021. Lot number/Expiration date - 013F21A.
stiff arm; a very sore throat; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiff arm"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a very sore throat"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states after the vaccine was given, she developed symptoms of irritation at the site. States it was red/hardened yesterday 12/7/17. Today, 12/8/17 pt states she continues to have redness and that there is warmth to the site now. Localized swelling noted as well. Pt took 2 Benadryl last night.
Ct. to receive PPD 0.1cc ID, Ct. received Td 0.5cc ID in left forearm, became inflamed, red with increase in discomfort over next several hours. On 8/17/04 area by client report red and approx size of 50 cent piece.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-NOV-2012 16:14, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Initial near syncopal episode at time of vaccination on 7/30/09.  Approximatley 8/11/09, she began to have intermittent problems with easy bruising, tingling,  9/25/09 Received PCP medical records which reveal patient in good general health on day of vaccination & had brief vasovagal syncope after shot.  RTC 8/28 after symptoms began 8/11/09 of malaise, tiredness, easy bruising & near fainting episodes while driving.  Exam revealed shotty cervical lymph nodes, erythematous throat, macular bruising on arms & nodule on right shin.  9/11 labs revealed + strep & had recent tick bite.  Tx w/oral antibiotics.
Pneumonia due to COVID-19; dyspnea on exertion; acute respiratory failure due with hypoxia; elevated troponin; acute on chronic combined systolic and diastolic heart failure; general weakness; type 2 diabetes mellitus with microalbuminuria, without long-term current use of insulin; chest pain
Inj arm itches as well as stomach BENADRYL 2mg & ZANTAC take 1 pm & one in am.
Information has been received from an office manager within the office concerning a male who was vaccinated SQ with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced, injection site reaction. The patient also experienced swelling at the injection site which formed a hard ball. The patient sought unspecified medical attention. The patient's outcome is unknown. Additional information is not expected.
Patient stated he have not received a second dose of moderna. Staff checked with employee and employee called the state and the state sent a note to pharmacy.  Staff was ok?d to give dose by the state. After we have given the patient his dose the leader of the facility informed us that the patient already had his second dose. The leader of the facility is the individual that took the patient to get his second dose. At pharmacy.Patient denied again that he haventh had the vaccine. Therefore, patient have had 3 doses of the moderna vaccine.
3 hours after patient was given vaccine (after which she engaged in strenuous exercise via a dance class), she began to feel disoriented and faint. Her friends brought her to the ER where her temp was measured at 103 degrees F and her HR at 120 bpm.
Does this vaccine affect anyone from having a pregnancy or from becoming a parent; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent). At the time of the report, EXPOSURE DURING PREGNANCY (Does this vaccine affect anyone from having a pregnancy or from becoming a parent) had resolved.            Concomitant medications were not reported. No treatment medication details was reported.
Pt vaccinated with DTP/OPV found to have funny breathing early AM later mother found her not breathing.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 29-DEC-2016, the patient was vaccinated with M-M-R II lot # K010318 (strength, dosage and route unspecified) for prophylaxis, which was with the expiration date of 22-JUL-2016. No adverse effects reported. No product quality complaint was involved. No additional information provided. Additional information has been requested.
About three weeks after receiving the COVID-19 vaccine I received my flu vaccine, and I started experiencing mild to moderate fatigue. On the 18th of November I went to see a doctor about being congestion, facial pain, fatigue, not breathing well. I was diagnosed with a sinus infection and given a round of doxycycline. On Nov 29th, I went to see an ENT, he told me to come back the next time I had a sinus infection. On Feb 2, 23, when I had another sinus infection and was prescribed a fourteen-day dose of doxycycline. I feel that I have some congestion, but I feel that it has more to do with allergies.
I went deaf for half an hour. Strange substance came out of ear. I have regained some hearing but it is muffled with a great deal of pressure.
Narrative:  Patient received Pfizer vaccine outside of the agency system. Experienced swelling of throat during second vaccine dose, was given epinephrine and prednisone to help with reaction.
Chest pain.  Right leg swelling. Cough. Bronchitis. Pneumonia. Back and chest pain. Very rapid heart rate.
Moderna 1/18/2021, 2/12/2021 and 12/22/2021. Positive on 7/28/2022.
This case was reported by a other health professional and described the occurrence of influenza in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to FLUARIX QUADRIVALENT. Additional information: three patients vaccinated with FLUARIX QIV that got the flu later in the season. MD did not have any further information at this time.
Headache, nausea, chills at start; chills transitioned to fever/hot sweat in middle of night then improved. Next day very weak and lethargic with headache, loose stool (not classified as diarrhea but looser and more frequent than normal), lots of indigestion (burping, gas). Day after than felt tired and weak with minimal stomach indigestion, and the day after that fully back to normal, with some fatigue
swelling around injection site Narrative: Circular 2-3cm diameter area of swelling developed around injection site about 10 hours after vaccination. Resolved approximately 24 hours later.  Associated with tenderness at injection site. Denied warmth, pruritus, erythema, induration or other adverse effects. No therapies tried or applied.
Could walk on right leg for week felt like I pulled a muscle and can't hear out of right ear.
some solution leaked out of the syringe; the patient may not have received the recommended .5ml; A spontaneous report was received from a pharmacist concerning a 31-year old, male patient who was scheduled to receive Moderna's COVID-19 vaccine but during the administration the patient may have received an invalid first dose as some solution leaked out of the syringe (syringe leak and underdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient presented to the clinic for their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  The pharmacist stated that, during attempted administration, the consumer may have received an invalid first dose as some solution leaked out of the syringe and the patient may not have received the recommended 0.5ml.    No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events, syringe leak and underdose were considered recovered.; Reporter's Comments: This report refers to a case of syringe issue and underdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
Intense headache, moderate joint aches(ankles, knees, elbows, lower back), nausea, mild fatigue.
Shingles. Started  around a day after injection with severe pain in the right thigh and first rash appeared 4-5 days later.
A father reported that his 24 month old son received an injection of Tri-Immunol in 1988 and subsequently, developed a fever and a knot at the injection site. One week, post vax, he was admitted to the hospital; he received a spinal tap and was dx'd with viral meningitis. The child was later dx'd as having mild mental retardation. Follow-up information received from a healthcare provider on 3/8/01, idicated that the child received Tri-Immunol and Orimune on 8/20/87. On 8/23/87, he developed an abscess at the injection site. He was admitted to the hospital and the abscess drained. A culture was positive for Haemophilus influenzae B. He was discharged after 7 days. The abscess resolved by 9/7/87. A psychological report also received on 3/8/01, indicated that the child was tested to be within the mentally deficient range with associated impairment in adaptive behavior.
child began having fever breathing difficulty, congestion; Mom called MD 21MAR91 rx called in, saw MD @ office 23MAR91- bronchitis, more med, worse by 4MAR91 hospitalized w/pneumonia, stayed until 16APR91;
Day of shot, sore arm, tired. 2nd day, bpm went from 85 to 110. Stayed at 110 for 7 hours, no medical treatment sought (cost too high). Third day, today, bpm is still 95 but coming back down.
On way home from office, he started coughing and wheezing. Cheeks became red and he had little red dots all over body. Mom gave Albuterol for wheezing and Tylenol. He is taking Zyrtec and Atarax ghs. Mom to refill Epipen Rx immediately. Upper sxs of resp. distress Mom to give Epipen and call 911.