chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSORIASIS  GETTING WORSE, LEGS, ARMS, BACK, NECK, HEAD HAS PSORIATIC PIMPLES AND PSORIATIC BREAKOUT; SKIN SLOWLY STARTED BREAKING OUT; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's past medical history included psoriasis, and concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had not taken any medication for many years. patient did not have no known allergies and did not have history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout. On APR-2021, the subject experienced skin slowly started breaking out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout, and the outcome of skin slowly started breaking out was not reported. This report was non-serious.
Patient was seen at 1:00 pm for 6 injections, including TB skin test. Patient fainted after 4th injection; nurse was present and stood in front of patient (who was seated) so he would not slide out of chair. Another nurse applied cold packs and wet paper towels. When patient regained consciousness he took one sip of cold water, then requested to lie on floor. Nurses assisted patient to floor where he laid on his back with his feet elevated on the chair while nurses continued to apply wet towels and cold packs. Patient was given lollipop and licked on it. Patient eventually requested to receive the other 2 vaccinations. One was administered sitting up in chair while patient sipped the rest of the cup of cold water, then patient requested to lie on floor again for the last injection. Patient remained on floor until he insisted that he felt ok and wanted to get up against advice of both nurses. Patient insisted that "this always happens" and refused to remain at the clinic for observation or to be assisted out to his car. Patient left treatment room on his own at 1:30 pm, and Nurse observed through window that patient walked successfully to his car, got in, and drove off. At no time did the patient fall or strike any part of his body on anything.
Full body hives, Dermagraphia diagnosed by dermatologist swelling prescribed 180 mg allegra, 25 mg Hydroxozine and Steroid Creams
Initially no issue at 1345hrs.  Approx mid night experienced extreme soreness in left arm and leg cramps.  Went to work at progressively experienced soreness in left shoulder, right bicep, cramps in both legs, headaches, soreness in lower back. Eventually left work with fever of 100 taken via Airport terminal standing thermometer station.  Left for home to take pain meds and reports event.
Swelling, redness and pain rt. upper arm to elbow x 2 days.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, and drug allergy (unspecified), and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Non-company suspect drugs included: nirmatrelvir/ritonavir ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 03-MAR-2023 to 08-MAR-2023 for covid-19 treatment. No concomitant medications were reported. On 2023, the patient experienced confirmed covid-19 infection. On MAR-2023, Laboratory data included: COVID-19 virus test Negative. On 11-MAR-2023, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
SIRVA r/t injection being given too high. Ongoing Left shoulder pain, weakness and sleep disturbances  since 1/27/21.  Cortisone injection given 10/11/2021.
1744 Patient received his 1st dose covid vaccine 1802  Patient notified PCT in waiting room that he was feeling lightheaded after he witnessed another patient have a syncopal event. Patient stated that he has passed out in the past during IV procedures.  Patient did become very pale and was staring off. He was able to verbally respond during the event with a few words. He reported that his hands were tingling and ears were ringing. Patient remained upright in a chair. He was given a cold paper towel and bottle of water to drink. He remained in the waiting  room until 1845. He ambulated around the clinic front. He left ambulatory in no distress. He stated he felt better.
I have experienced more bruising. I had blood work done. My B12, Iron, WBC counts were observed. All my levels were normal. My WBC was not but that was because I had a UTI. I did not receive treatment since the bloodwork was normal but I am still bruising very easily. I am also experiencing a change in my menstrual cycle and duration. I had my hormone levels checked which showed normal. I also have not received treatment for this. I am taking a hormonal supplement.
Bilateral rash and itchiness in palms and fingers. lasted 15-20min. Resolved with 10mg Cetirizine.
patient received vaccine on 10/28/08 and this morning found a flat rash on his legs and reddness around site of injection.  He stated today for the 1st time that he recently had a sinus infection and was taking Bactrim as an antibiotic.  He took his last Bactrim this morning.
SUDDEN ONSET CHEST PAIN  PT WAS TRANSFERRED FROM LOCAL ED TO ANOTHER FACILITY WITH AN ICU BED AVAILABLE
Deep chest pain; Maternal drug exposure; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 28Aug2021, two days after second dose of vaccination, the patient experienced deep chest pain. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event.  The clinical outcome of the event deep chest pain was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness with a small bump, now I have a bigger bump; redness with a small bump, now I have a bigger bump; allergy around the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 15:00 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 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) all with onset 01May2021, outcome "not recovered" and all described as "redness with a small bump, now I have a bigger bump"; VACCINATION SITE HYPERSENSITIVITY (non-serious) with onset 01May2021, outcome "not recovered", described as "allergy around the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site hypersensitivity.  Additional information: Reported as, patient received the vaccine on 23Apr but still have redness with a small bump, now patient have a bigger bump and allergy around the injection site that started 01May. On 30Apr patient had endoscopy and colonoscopy with sedation and sedation was administered in the hand right below where she received the vaccine, but she thought it was not due to sedation but for the vaccine. Patient did not had covid prior to vaccination, patient did not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got Pfizer 1st shot 22MAR though had the virus; Got Pfizer 1st shot 22MAR though had the virus; Had terrible cough; having heart palpitation; had fatigue cough slept for 2 days; loss of breath; saw fluid on her chest.; has swollen lymph nodes; 3 abnormal EKG; A1C at 10 which used to be at 8; Right side of her foot is tingling and swollen; Right side of her foot is tingling and swollen; has aching in right arm and from the clavicles to the chest . Left arm feels same way/having different type of pain other from her chronic pain from C7; Was also having protein in urine; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included the patient had neck surgery and several falls before.  The patient's concomitant medications were not reported. The patient got Pfizer 1st shot 22Mar2021 though had the virus and Doctor did not want her to have the antibody test. End up in hospital. Had terrible cough and Doctor ended giving antibiotic. Had heart check and Electrocardiogram (EKG) done. Was having heart palpitation. She saw a diabetes Doctor and nephrologist. Was ready to have back surgery 05May. Also had fatigue cough slept for 2 days and had loss of breath. Called CDC and told her it was normal and her body was building the immune system. Additionally Doctor saw fluid on her chest. Surgeon told her she had swollen lymph nodes. Now she felt better but still have the cough. She was having different type of pain other from her chronic pain from C7. She went to the ER had 3 abnormal EKG and glycemia was at 500 and A1C at 10 which used to be at 8, never saw this before. Did not have a heart attack. Right side of her foot is tingling and swollen. When legs swell has aching in right arm and from the clavicles to the chest. Left arm feels same way. Went for pre-op and surgery was cancelled due to all those bad results. Was also having protein in urine but now everything is good. Had genetic testing  but everything was negative. Also still having coughing and lost of breath. Doctor wanted her to take the 2nd dose. The outcome of the event coughing and lost of breath was not recovered, of other events was unknown.  Information on the lot/batch number has been requested.
Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose) 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 PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose) had resolved.            Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Constant dizziness,  migraines & elevated blood pressure (not typical) every day since injection.
I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof of mouth, tongue) feel numb. It is a little better, however, I still have numbness around my mouth and tongue. I don?t know if I should receive the second dose.
Pt received seasonal flu vaccine at 4:45 pm-Pt called pharmacy at 5:55 pm to report itching all over-pt said itching had started approximately 25 minutes prior to calling pharmacy-gave pt #2 25mg diphenhydramine-pt states she has epi-pen with her. Pt displayed no rash on body or at injection site-just feels itchy all over-has no problem with breathing. Checked on patient at 6:35pm-states not itching as much and a little sleepy. Checked on patient at 6:55 pm-states not as itchy as before and that she is fine-no rash observed. Checked on patient 7:15 pm-just her face itches a little - no rash or difficulty breathing-pt states she feels fine. Called pt on 10-31-09 at 9:15 am-pt has no itching, no rash, nothing at injection site-she reported having a headache.
No adverse outcomes or side effects were reported or observed by the patients who received the administered doses by an experienced HCP.; The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W031813, expiration date: 05-OCT-2024) was stored at 10.8 Fahrenheit for 8 hours, 23 minutes and 0 seconds with a supported temperature stability evaluation. There were not any previous excursions.  On 22-JUN-2023, the patient was vaccinated with that varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter via injection (strength, route of administration, and indication were not provided) (Product storage error). No adverse outcomes or side effects were reported or observed by the patient (No adverse event).; Sender's Comments:  US-009507513-2306USA012702: US-009507513-2306USA012560:
Information has been received from a 65 year old female with blood pressure and thyroid problem who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) about 1 year ago. Concomitant therapy included blood pressure and thyroid medications (unspecified). The patient also had reaction to the Flu shot year ago and that caused her arm to puff up. In December 2008, the patient developed shingles after receiving ZOSTAVAX (Oka/Merck). She considered it a milder case and it was on her right breast up and underneath her arm. There about 14-15 pustules and the nerve pain was not at all severe. She stated it started first as the nerve pain then the rash developed. The patient also had a reaction at the injection site at the time the vaccine was given. She developed a big, round, red mark on her arm. Subsequently, the patient recovered about 2 weeks after the reaction started. The patient sought unspecified medical attention. Additional information has been requested.
Narrative: 3rd dose of Moderva Covid Vaccine was given prior to confirming previous doses administered.
shivering; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced CHILLS (shivering). At the time of the report, CHILLS (shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Reporter did not allow further contact
Multiple pin point papules in 4-5cm square area surrounding injection site and on lateral arm. No crusting or infection, fixed in location.
Lymph swelling discovered on Ultrasound performed on 4/12/22 as part of a breast cancer work up
Patient became for clammy, dizzy, low pulse rate, low blood pressure, blue lips, somewhat incoherent
Extreme swelling at site of injection. Upper thigh has become 1.5 to 2 times it's normal size. Upper thigh is also very hard and has rash all over upper thigh. No itching but very warm to touch.
I have shingles now and did have the two dose Shingles Vaccine/ Suspected vaccination failure; I have shingles now; Internal nerve pain; It is so very miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, nerve pain and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 19-June-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient reported that it was so very true about the internal nerve pain. It was so very miserable. The patient had it now. The patient had two dose shingles vaccine and had shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
From initial information received on 05/20/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received TD ADS ADULT, Lot # U0522AA on 05/17/03.  The route and site were not reported. 24 hours later the pt developed redness, swelling and pain at the injection site. The pt also developed fever, chills, malaise and mild headache. The recovery status of the pt is unknown.
While sleeping my heart rate rose as high as 146 bpm.  My heart beat stayed above 120 bpm for several hours, 24 hours after I received the vaccine.  I was either sleeping, laying down or sitting.  The nurse at my doctor's office advised that I push fluids.  I drank 40 + oz of water and hours later my bpm eventually came down.  By the following morning, resting bpm was back to normal -- 68 average.  Outside of elevated heart rate, I had no symptoms.  No fever.  Only being tired.
A little congestion; Running fever, staying in the 100's; bad headache; This spontaneous case was reported by a pharmacist and describes the occurrence of NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (A little congestion), PYREXIA (Running fever, staying in the 100's) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100's (High) staying in the 100's.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Treatment information for rest two events were not provided by the reporter.   Reporter did not allow further contact
Adverse events = very high fever, shivering, body ache, severe swelling and pain of injection site. Duration = severe symptom: 2 days (still swelling of site). Treatment - Dr prescribed clindamycin, ZOFRAN, FIORICET.
From initial information received on 4/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a male patient (age not reported) received his fourth dose of IMOVAX RABIES on 3/15/04 due to a dog bite to his ankle. The lot number of the vaccine as well as route and site of administration were not reported. The following day, the patient experienced rash at the site of injection as well as intermittent itching like ant bites all over his body. Reportedly, the patient did not recover from these events. He received his first dose of IMOVAX RABIES as well as a dose of IMMUNOGLOBULIN HUMAN ANTIRABIES vaccine on 2/27/04 with no reaction reported. From additional information received on 4/26/04 from the patient, the patient's date of birth was provided. It was also reported that the dose administered was from a post-exposure series. The patient was vaccinated at a pubic health clinic/hospital and purchased the vaccine with public funds. The telephone number for the responsible facility was provided. Reportedly, the patient experienced a very swollen arm with the fourth dose of vaccination and two days later complained of pruritus throughout the entire body. The patient had also previously received a dose of TD ADS ADULT with no reaction reported. It was also reported that the patient has gone for a doctor's visit and still complains of pruritus.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 25-SEP-2018, the patient was vaccinated with an expired dose of VAQTA, intramuscularly, lot # N019924, expiration date 02-SEP-2018 (exact dose and anatomical localization was not reported). No adverse effects were reported.
Sore Arm, spot on opposite arm where previous JANSSEN vaccine was administered was also sore for several days