chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a 70 years old female patient. The patient had a medical history of 2 stents and a drug allergy to penicillin and sulfa. On an unknown date (at least 2 years ago) the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. Concomitant medications included pravastatin sodium and lisinopril. On an unknown date (two weeks after the injection) the patient experienced a blistering rash on her left hand up to her wrist. Her healthcare professional told her that she had shingles. She still had some pain and tingling in her feet. She was treated with a shot of prednisone. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was not provided for ZOSTAVAX. Additional information is not expected.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient is experiencing pain deep inside upper arm and numbness/tingling of pinky and ring finger that is making it difficult for her to function properly
erythema, redness and swelling that went from the upper arm into the axillary area; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old male patient who experienced erythema, redness and swelling that went from the upper arm into the axillary area (Inflammation), while he received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HEPATITIS B VACCINE .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA via intramuscular route in the left deltoid and a dose of suspect HEPATITIS B VACCINE (HEPATITIS B VACCINE) lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious erythema, redness and swelling that went from the upper arm into the axillary area (inflammation) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and HEPATITIS B VACCINE.  Other relevant tests were not reported.  Final diagnosis was erythema, redness and swelling that went from the upper arm into the axillary area.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for erythema, redness and swelling that went from the upper arm into the axillary area.  List of documents held by sender: none.
Swelling about 1 inch high at injection site / diameter of a baseball at injection site; 1st dose maybe 1Aug20212nd dose yesterday 8Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) 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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site). On 08-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-314674 (Patient Link).
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV), [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805418 was crossed linked to original case 201804863 due to same reporter.
Doses were accidentally administered to patients from the punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) and Pfizer (2nd dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  The caller reported that, on 13-Dec-2021 a vial of the Moderna vaccine was opened and was not disposed of properly. And on 14-Dec-2021, 3 doses were accidently administered to patients from he punctured vial. She reported that the vial was refrigerated the entire time but it was administered approximately 18 hours post puncture. The caller stated that none of the patients have reported adverse reactions to this expired dose.   This case was linked to MOD-2021-414582 (Patient Link).
Mo stated no fever the 1st day or swelling @ site; started vomiting 2-3 times on 16NOV91 w/t99 R @ 8PM vomited inc APAP given then @ 9PM pt was just lying down & not responding; t105 then had sz; ER MD felt URI;
I began having mild pain in left axilla on 1/12/21 after receiving vaccine on Friday 1/8/21. The pain increased gradually and by Friday the lymph nodes in my left axilla were visible swollen and quite tender.  On Saturday morning 1/16/21 I had a faint red rash at site of injection.   By Saturday evening the rash was raised and more red.   I felt extremely fatigued on Saturday and Sunday.   On Sunday morning 1/17/21 rash was still quite red but no longer raised.  The rash was less red and less tender on Monday 1/18/21.  Rash barely visible on Tuesday 1/19/21.  Swelling in axilla has decreased since Saturday 1/16/21 but is still visible but to a much lesser degree than Friday/Saturday.
just received her 'third dose' of the pfizer covid vaccine today; developed a pain like an 'appendicitis'; developed a pain like an 'appendicitis'; her stomach turned and then she vomited; her stomach turned and then she vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 2021, stop date: 2021, notes: Covid 19 infection lasted about 4-5 days, she isolated for 10 days. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021, outcome "unknown", described as "just received her 'third dose' of the pfizer covid vaccine today"; APPENDICITIS (medically significant), PAIN (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "developed a pain like an 'appendicitis'"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 21Dec2021, outcome "unknown" and all described as "her stomach turned and then she vomited". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: tested negative twice afterwards; negative, notes: tested negative twice afterwards.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Approximately 15 minutes after vaccines administered, client got up from chair where he was sitting and said 'could you tell me where I can find a bathroom and started to walk toward mother, he fell and hurt his chin on the floor. Apparent fainting. He was lifted to a chair and soon revived up with whiffs of alcohol & name calling to which he responded.
Patient received Pfizer COVID vaccine on 1/7/21 (lot # EJ1686), 1/28/21 (lot # EL1283), 11/17/21 (lot # FD0809), and 5/18/22 (lot # FP4554). On 6/3/22, patient was admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia secondary to COVID-19 pneumonia. On 6/7/22, patient was discharged back to the assisted living facility.
Symptoms like described with Parsonage Aldren Turner Syndrome.  Severe arm pain in brachialis.  Happened over night.  Intense.  Trouble straightening arm.
pt died at home after having a positive COVID test; per death certificate, pt died of the following causes of death:  HRF, Pneumonia, COVID 19 Viral Infection
Patient received his third dose of Pfizer on 11/12/2021, was admitted to the hospital on 02/07/2022, Diganosed with COVID19 on 02/07/2022, and passed away on 02/17/2022. Patients death is currently being investigated by the Mortality Review team to determine if this death was COVID19 related.
18SEP96 pt started screaming couldn't breathe, eyes were swelling, skin bright red & hives;seen in hosp ER-treated for allerg rxn;held over for observation 3-4hr;becoming congested again;
c/o of intense swelling & pain p/the inject; applied warm pack & gave Ibuprofen; pt to MD clinic the next day;
Information has been received from a physician concerning a 4 month old male who on 08-Feb-2005 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 649553/0509P), in the thigh. Concomitant therapy that included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), in the same thigh, and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. Subsequently, the patient developed a blister about 3 cm in diameter at the injection site surrounded by erythema. The patient was receiving local treatment for the reaction. The patient was seen in the emergency room but was not admitted. At the time of the report the patient was receiving treatment. No product quality complaint involved. Additional information has been requested.
Rash at injection site: First noticed 2/4/2021 at 9a (22 hours after vaccination). 2.25 inches, red, swollen, sensitive to touch, circular 2/5/2021 at 6a (43 hours) 3.25 inches, redness expanding distally, pain 1/10, warm 2/5/2021 at 3p 3.9inches, angry red, very warm.  2/5/2021 at 9p 3.9inches (no change) redness decreasing, swelling reduced
Swelling of arm from armpit to elbow and a hard spot at site of injection (sub-cutaneous, right arm).
Severe eczema started on face and "spread" through the entire body. Red itch rash.
Pain at injection Site immediately.  Pain continues intermittently  to present time. Pain is at shoulder and also more often Between should and elbow of left arm.  Shot administered to left arm.
I noticed increased pain, swelling and redness at the base of my right hand baby finger into the hand (palm side up)- very painful to the touch, can't bend' can't use.
On April 24, patient started not feeling well while away from home in the early afternoon.  Later noticed some balance issues and some memory problems.  The next day, balance issues continued and had noticeable mouth drooping on left side first noticed by daughter who was visiting and son-in-law.  Was taken to the hospital and diagnosed with a stroke.
PATIENT WAS 17 YEARS OLD AND RECEIVED MODERNA WHICH IS NOT FDA APPROVED FOR PATIENTS UNDER THE AGE OF 18.
Rash - Full Body Most prevalent on Left Arm but also outbreak face, back, arms legs  No pain, no itch - took Benadryl
bilateral leg weakness, fatigue hours after vaccine. next  day pain in legs with feeling feverish and general fatigue. pain focused to the back of knees and calves.  legs still feel weak and sore.
PAIN IN EXTREMITY; MOBILITY DECREASED; ERYTHEMA; SKIN WARM; PYREXIA; OEDEMA PERIPHERAL   Information has been received from a physician concerning a 5  year old white male with no known allergies or medical history, who on the morning of 21-SEP-2006 was vaccinated SC in the left tricep with a first dose of measles virus vaccine live (Enders Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process). There was no illness at the time of vaccination. On the morning o 22-SEP-2006 the patient was seen at the physician's office with a low grade fever, swollen and tender arm, new redness on arm, the patient's arm felt warm to the touch and the child was not using his arm. On 23-SEP-2006 the patient returned with increased swelling and redness in his arm.  He had a temperature of 100 degrees, his elbow was swollen and the patient continued to not use his arm.  The physician advised to have the arm monitored.  There were no diagnositc tests performed.  The patient did not return to the office.  It was reported that the patient and his siblings had not had any adverse events following prior vaccination. No further information was provided.  Additional information has been requested.
Mar, Apr 1991 pt vax;  1 day after vax devel pruritis which intensified over 2 weeks.  Tx w/ meds.  Noted to have rash on arms, legs, thorax, & back.
Had redness at injection site of flu vaccine, followed by flu-like Sx + face swelling the next morning. Resolved with BENADRYL.
Developed paranoia, delirium, hallucinations lasting 2 days after immunizations.  10/22/2007 MR received for DOS 9/12/2007for D/C Dx of Psychosis NOS, R/O pharmacologic precipitant.  Pt presented to ER with the sensation of wetness on her chest.  Pt was refered to Psychiatry for further eval as pt was having hallucinations. Pt reported not feeling well for several days prior to admission.  The night following her Hep A&B vax pt could not sleep and began hearing things, became SOB, and c/o numbness in her arm and worsening irritability.  Pt was having delusional beliefs. Admitted with dx Acute Psychosis, anxiety, HTN, cervical dystonia. Pt had a consult whose impression was that physical sx are part of the psychiatric symptom complex, maybe tactile hallucinations.  Possible paranoid delusions, consider bi-polar disorder.  Non-specific ECG abnormalities. Pt was recommended to remain in hospital for a full workup including an MRI, however pt signed out AMA
Patient diagnosed with Breast Cancer within the year; This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix a year before the date of reporting. The pharmacist asked how to proceed with 2nd dose of Shingrix. It was reported that, within the year after receiving Shingrix, the patient was diagnosed with breast cancer . The health care professional (HCP) was unable to provide full details. The reporter did not consent to follow-up.
Mom described child w/fever for 2 days to 102 or more, prolonged crying (unconsolable for 2 hrs & shaking like a convuls-maintained consciousness-activity was more like shivering;
Patient was given the Pneumonia vaccine Wednesday 10/30/2019 afternoon around 12:40pm. At the time of injection she had no reaction. Patient called into the office Friday 11/1/2019 with complaints of the injection site being "hard as a rock, sore and swollen." She also stated the pain was slightly better than yesterday. It was documented in the chart and physician has been informed.
Ophthalmic Burning; Ophthalmic stinging - Information has been received from a consumer who is a 48 year old caucasian female cma who on 23 Mar 2000 inadvertenlty got varicella virus vaccine live in her eyes when giving the vaccine to a child (waes 00040037) the same day of vaccination, the cma experienced burning and stinging of the eyes which was treated by flushing with water in a shower.  The patient contacted the poison control center who recommended flushing again with water.  Follow up information from a physician indicated that by the afternoon of 23 mar 2000 the eyes looked normal without increased tearing and no other problem afterward.  The patient subsequently recovered.
Pt. received immunizations including Flu, mother arrived home approximately 20 mins later where it was noted that she was covered with hives and had facial swelling diarrhea and lethargy. EMS called and administer Epi .15mg and 7mg of Benadyl. Patient was transported to ED where she was observed for 4 hours and discharged home
Next day after Pfizer 2d bivalent Covid booster intense right jaw pain; few days later extreme gum irritation near upper molars; extreme tinnitus starting day after vaccine and still present
GOT COVID; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20210852596.
Swollen tongue, shortness of breath, dizziness, light-headedness, shaky, difficulty swallowing, headache, muscle weakness, tingling in arms and legs
Patient  had what appeared to be a seizure within 5 minutes of receiving vaccination.  Per sister-in-law:  he has a history of "fainting" with shots, but to me, it did not appear as a "fainting" episode since he became rigid and his eyes rolled back while he remained seated.  9-1-1 emergency services was called and patient was taken to the local E.R.
had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long; had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.). In October 2021, EXPIRED PRODUCT ADMINISTERED (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long) and PRODUCT STORAGE ERROR (had the 2nd jab of moderna, About 10 days later the hospital called and said the vaccine wasn't expired but had been in the fridge 7 days too long.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-427852 (Patient Link).
joint pain; muscle pain; headache severe; This case was reported by a nurse via sales rep and described the occurrence of joint pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced joint pain, muscle pain and headache. On an unknown date, the outcome of the joint pain, muscle pain and headache were unknown.   It was unknown if the reporter considered the joint pain, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced joint and muscle pain that felt like there was a golf ball in her arm. The patient also experienced severe headache.
Narrative: Symptoms: Seizures Treatment: SODIUM CHLORIDE ONCE NS x 1 liter
pt is c/o intermitten rash 2 days after the vaccion. + itchy, macular rash
pt recv vax JAN97 & 23MAY97 pt to hosp w/diff walking;pt was dx w/cerebellar ataxia, inflammation of the white matter of the cerebellum;A polymerase chian rxn revealed that the CSF was neg for varicella zoster virus;
I experienced body aches, headache, anxiety in my chest (once), tiredness.  One other thing that happened that may not be related is that my secondary implant eye socket became very sore and swelled up.  It could of been for another reason but the timing was uncanny.  I am feeling fine now and none of my reactions were that troubling.  I have experienced about 3 times a sudden feeling in my  body that made me think I wonder if that was the vaccine but I am feeling great now and all is good.  Thank you so very much for all the research and production of these life saving vaccines.