chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right Upper arm near injection site was swollen to about golf ball size. Minimal erythema. Advised cool compresses and Motrin
This spontaneous report was received from a physician via a company representative and refers to a 6-month-old female patient. No information about patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 06-JUL-2015, the patient was orally vaccinated with the third dose of ROTATEQ lot # K023535, expiration date 22-MAY-2016 (dose was not reported). On 22-JUL-2015 (also reported as "while using ROTATEQ"), the patient experienced intussusception and on the same day she was hospitalized for the event. The patient was released from the hospital the following day (23-JUL-2015). The outcome of intussusception was reported as recovering. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90,  pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN  took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%.  1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN  advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.
Information has been received from a physician concerning a 58 year old female patient who on 12-SEP-2011, was vaccinated in the left deltoid with the third dose of RECOMBIVAX HB thimerosal free (lot# 669935/0569AA, expire on 01-NOV-2013). The physician reported that his patient had a delayed reaction to RECOMBIVAX HB after the third dose. The patient experienced "a fair amount discomfort at the time of the injection". Two weeks later "on 26-SEP-2011", the patient had increasing pain, swelling, induration at the shoulder ("6 cm lump"). There was no erythema, the patient was afebrile, but the area was slightly warm to the touch. There was not treatment given to the patient. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested.
I woke up  at 0330 with chills and my injection site arm swollen and my lymph nodes under the same arm swollen. I can barley put my arm down.
DIFFUSE RED RASH, MALAISE, HEADACHE.  EVALUATED IN THE ED AND GIVEN IV SOLUMEDROL AND BENADRYL.
One day after vaccine, had hives, seizure and stomach pain. Two weeks later, had a viral infection with pinpoint rash and fever. Eyes get fixed. Body goes limp. Last episode 9/20/02. The annual follow up received on 9/10/03 states still has episode every 3 to 4 months. Eyes roll back and he goes limp. Last one in June. Some delay in speech noted. He has allergies to milk and dairy products.
Patient's daughter, reported her arm is still significantly sore today after more than a week since vaccination. Recommend patient sees a doctor.
severe hives; skin rash on arms; This is a spontaneous report from a contactable consumer (patient), in response to Non-HCP letter sent in cross-reference case. An 86-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200 and Expiration date was not reported), via an unknown route of administration in right arm on 16Feb2021, as 2nd DOSE, SINLE for COVID-19 immunization. The patient received of BNT162B2 (Lot number: EN5318 and Expiration date was not reported), dose 1 via an unknown route of administration in right arm on 26Jan2021, as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced severe hives and skin rash on the arm day after second dose of vaccination, mostly in the arms. Skin doctor recommended vera cream, anti itch pill, an ointment. Patient was still experiencing the event. The patient visited physician office for treatment of events. There was no surgery planned prior to vaccination. There were no predisposing factors, and no culture was performed. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Herpes simplex outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Shingrix. On 21st December 2022, 78 days after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Dec-2022. Reporter's Comment:  The reporter stated that the patient with a herpes simplex outbreak after 1st dose of Shingrix.  The reporter stated that dose was administered on 4th October 2022. The reporter gave consent to follow up.
Hives at site of injection, R arm, measuring 8-9 cm, also itchy hives on neck and chest
Vaccine administered on 4/24/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
Hives episode: Torso, upper legs,  arms, scalp, eye lids came up in red raised blotches. Took an antihistamine tablet before going to bed, Hives nearly gone by morning. Inside ears, throat and down into body feels very hot.
left arm numbness and tingling 2 d later, persistent as of 10/5/2021, right arm electric current started 2 weeks later and persists
Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. Body aches, weakness, fever, chills, headache, and sore arm at injection site. These symptoms lasted until Monday 2/15/2021. I took Acetaminophen for the above symptoms. I left work early Friday night and called employee health Monday morning.
fatigue, right sided neck pain Narrative:  headache has been relieved by acetaminophen or ibuprofen; rash resolved with the use of diphenhydramine
woke up right palm was orange; cuticles were orange too; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too). At the time of the report, SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Macular papular and macular vesicular area on face 3-4 mm in size, 1 macular papular on the center of his back approximately 4 min in size, diaper area with a pink 2-3 mm papules along waistline and groin.
lesions emerged on right flexar surface of forearm, then left extensor surfaces of thumb, digits 4-5.; assymetric maculopapular rash, starting C6 midline posterior cervical skin (2x3cm circular red raised plaque with vesicles in middle)/On 04Jan2021, noted similar maculopapular rash; Vesicles firm on day 1, intensly pruitic, then broke with clear serosanguinous drainage and healing; This is a spontaneous report from a contactable physician.  A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:15 at, single dose at left arm for COVID-19 immunization.  Medical history included seasonal allergy from an unknown date and unknown if ongoing.  Concomitant medications included methylcellulose (CITRUCEL), and ibuprofen. On 30Dec2020, it was noted the patient had assymetric maculopapular rash, starting C6 midline posterior cervical skin (2x3cm circular red raised plaque with vesicles in middle). Vesicles firm on day 1, intensly pruitic, then broke with clear serosanguinous drainage and healing. On 31Dec2020, lesions emerged on right flexar surface of forearm, then left extensor surfaces of thumb, digits 4-5. On 04Jan2021, noted similar maculopapular rash on lateral waist lines. No history of atopy, allergies, asthma, or any diseases whatsoever. No history of rash. No new irritants, animals, household products, foods etc. The outcome of the events was recovering.
Information has been received from a physician concerning a 72 year old female with hypertension, osteoporosis, cholesterol high, penicillin allergy and folate low who on 09-JUL-2008 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included PLAVIX, LEXAPRO, MAXZIDE, CRESTOR, K-DUR, PREDNISONE, MSD, FOLTX, AVAPRO, TRICOR and TOPAMAX.  Subsequently "within 10 days", the patient experienced a headache characterized as "brain freeze in the front of the forehead above her eyes"  after receiving ZOSTAVAX (Merck).  Laboratory diagnosis test studies included a magnetic resonance imaging, and blood tests were performed and her physician could not find anything wrong.  The patient's headache persisted.  It has lasted 8 weeks so far it only goes away when she take pain medicine.  Additional information is available.
Fever and chills occurred 9 hours after injection and lasted for 4 hours. Mild fever the next morning with body aches and fatigue and moderate pain at injection site. Following day slight headache and remaining pain at injection site. Today very mild pain at injection site (3 days later)
joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer. A 51-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 04Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 25Jan2021 (lot number and expiry date unknown), at single dose, for COVID-19 immunization. Medical history included type 2 diabetes mellitus (reported as "t2dm"). The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The patient experienced joint pain, muscle ache and fatigue in Jan2021. Treatment for the events included APAP. The patient was tested for COVID-19 post vaccination in Jan2021 thru nasal swab with unknown results. The patient was recovering from the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of clamminess in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included heart disease, unspecified. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced clamminess, exhaustion, weakness and shivering. On an unknown date, the outcome of the clamminess, exhaustion, weakness and shivering were unknown. It was unknown if the reporter considered the clamminess, exhaustion, weakness and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient had heart disease, otherwise he was healthy. The reporter stated that her husband (patient) received a dose of SHINGRIX shot day before the reporting and he was exhausted, weak and shivering also he was clammy. The reporter asked that were these normal symptoms. The reporter was informed that as per the prescribing information, these were common adverse reactions. They might last 3 to 5 days and told that for medical advice refer the patient to his medical doctor.
Awoke screaming in middle of night, painful leg where shot given, screaming lasted over an hour  not able to calm child down.
small bumps, like little rashes; Itching all over the body; Itching at the injection site; Rashes all over the body, especially ankles and behind knees; This spontaneous case was reported by a nurse and describes the occurrence of RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 15 milligram. On 15-Feb-2021, RASH PAPULAR (small bumps, like little rashes), PRURITUS (Itching all over the body), VACCINATION SITE PRURITUS (Itching at the injection site) and RASH (Rashes all over the body, especially ankles and behind knees) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-021656 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Lt leg became red & swollen 4 hrs p/DTP given; No fever; Taken to ER & was told it was a local rxn; cold compresses recommended;
Open ulcer got worst; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer (Open Ulcer) and Prostate cancer. Concurrent medical conditions included Penicillin allergy (allergic to penicillin). Concomitant products included OMEPRAZOLE for Ulcer.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain). The patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE (SIFROL) ongoing since an unknown date for Ulcer, at a dose of Double twice a day for 10 days. At the time of the report, ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain) outcome was unknown. After receiving his 2nd Moderna vaccine, his open ulcer got worst and 2nd shot was the worst. No treatment medication was provided.   This case was linked to MOD-2022-565213, MOD-2022-565270 (Patient Link).
PATIENT BECAME DIZZY, NAUSEATED, WARM AND FELT LIKE HER ADRENALIN WAS RUSHING ABOUT 10 MINTUES AFTER THE VACCINE WAS GIVEN.  SHE PROCEEDED WITH DRY HEAVES, DIZZINESS CONTINUED.  TRANSPORTED TO THE EMERGENCY ROOM.
Entire left upper arm is swollen, tender and red. Hurts really bad from the shoulder to the elbow.
Developed fever of 102 at time of onset; parent was unable to control effectively with Tylenol for following 48 hrs.  Pt. seen by pediatrician the following day, diagnosed with viral illness and not treated with meds.  Pt. very lethargic, and fussy when awake.  Temp spiked to 105 in early a.m. on 11/21/09; pt. taken to ER, diagnosed with pneumonia, only chest x-ray done for diagnostics.  Pt. placed on liquid broad-spectrum antibiotic, is currently feeling better and fever-free without use of NSAID drugs.
Severe rash at injection site and spread about 5" radius.  Red, raised, warm; grapefruit sized.  Started shortly after vaccine and continue for 2+ weeks as severe, then now more mild but still present.
enlarged and tender right axillary lymph nodes.  I took Advil (200mg) for pain and rest my arm
BRUISING--STILL THE SIZE A LITTLE LARGER THAN QUARTER, AND VERY SORE TO THE TOUCH NO SIGNS OF SWELLING
After the first shot I developed pain in my arm, in my nerves. When I had a second shot, I developed pain on the other side. Almost 3 years later I still have pain in my nerves, I developed tremor there and pain in my fingers and wrists completing simple tasks
Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP8732) via an unspecified route in left arm on 02Apr2021 at 12:00 (at the age of 46-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history of patient included Crohn's disease. Concomitant medications included rosuvastatin calcium (CRESTOR), glucosamine (MANUFACTURER UNKNOWN), mesalazine (LIALDA) and mesalazine (CANASA) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route in left arm on 12Mar2021 at 09:30 hours as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 20:00, the patient had swelling/soft lump under left arm pit and tender to touch. No treatment was given for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling/soft lump under left arm pit and tender to touch was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was nervous about getting the vaccine to start but she seemed fine right after the shot. She walked over to another chair to sit down. About a minute or two after sitting down in the chair she passed out and started having a seizure. Myself and another adult in the room got her safely to the floor. The seizure lasted just a few seconds but she was sweating and white. We called 911 and kept her calm and sitting while waiting for the paramedics to arrive. She slowly regained color in her face and was feeling better by the time paramedics arrived.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient was previously treated with booster dose of covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 10-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26. cov2.s (Dose number in series 2).  The patient additionally received secondary booster of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 08-SEP-2022) dose was not reported, 1 total administered on 24-APR-2022 for prophylactic vaccination which was inappropriate schedule of vaccine administered and off label use (Dose number in series 3). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious.
Rash. Spotty. Fever on 09/02/2011 taken to the hospital.  They think measles or chicken pox caused by shot given.
Hospitalization for hypoxic respiratory failure/COVID-19, CAD S/p 3V CABG, recent DES x1, atrial fibrillation on Eliquis, acute renal failure, hyperkalemia,  altered mental status, GERD, chronic lumbar back pain on dates 11/3/2023- 11/6/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Developed hives at neck. The next day, had swollen lips in the AM. No breathing problems. Had tacos with sour cream, lettuce and tomato for dinner before hives developed. Had same meal the next night without symptoms. Hive-like rash was seen on exam of left thigh but otherwise a normal exam by 6/30/01 PM.
Started having diarrhea, then vomiting, by 12/4 he had runny nose and cough as well, then on 12/5 he went into having seizures.
Generalize hives, chest tightness, fatigue and facial swelling that occurred less than 24 hours after his immunization.
Recevied Pediarix & Prevnar 13 3/6/19 On 3/11/19 - red rash (blotchy on body) w/pimples. 3/12/19 generalized swelling including tongue. Treated w/ Benadryl.
Presents with AFib RVR, and a chest x-ray with extensive bilateral pulmonary infiltrates,bacteria as well as pyuria. COVID +. Acute respiratory failure with hypoxia.  Secondary to pneumonia-community-acquired pneumonia versus COVID versus combination.  Oxygen supplementation.Completed Remdesivir & dexamethasone. Complete Vaccine 2/23/2021.
Symptoms started 1 week prior to hospitalization.  He was admitted to the Hospital May 23 or 24th with suspected alcohol withdrawl symptoms but upon routine testing all results came back negative for alcohol or drugs.  From there the hospitalist ordered numereous testings of the brain.  MRI could not rule out a stoke but could not verify. treated him for GBS since symptoms started 4 weeks after the covid shot was given.  He remained in the hospital for 3 months and was moved to a nursing home.  He is still unable to stand or put much weight on his legs.  He has been handicapped since May.