chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US022545 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medication were not reported. On 10 Nov 2014, she was vaccinated with an expired dose of FLUVIRIN (batch number: 1206901) via intramuscular route. No adverse event was reported following this administration error.
She received this vaccine on Monday 8/15/22 and came in on Thursday 8/18/22 to report that her arm had become red and itchy and warm to the touch. The upper right arm was visibly red from almost the shoulder to the elbow. This is the arm she had the covid vaccine in. She said this had also occurred after her second dose as well but wanted to let us know it had happened again. This looks like it could be "Covid arm" but I advised her to keep an eye on it and contact the doctor if it appears to get worse.
new onset moderate cough lasting  approximately 24 hours.  Start time: 2/6/21 noon;  End time: 2/7/21 noon.
Day after vaccine started having severe itchiness and rash on various area of body, none at injection site however.  Approx. 1 week later called allergist who prescribed prednisone 4 mg dose pack.  Already taking zyrtec and continued with zyrtec and adding singulair.  Apprx 2 weeks after initial vaccine called allergist again and was seen by allergist who ordered some blood tests and again prescribed same prednisone.  Also started taking an additional dose of claritin.  Rash continued to get more and more severe until on Saturday Sept. 18th woke up with severe edema in arms most noticeably left arm.  Went to urgent care facility and was treated for skin infection with a 1 gm Rocephen shot and a prescription for 500 mg cephalexin. Also took 4 benadryl during course of the night.  Next day no improvement and went to emergency room at Hospital where I was prescribed additional prednisone 20 mg, hydroxyzine 25 mg as needed for itching, ambien as needed for sleep.  Pepcid and Benadryl.  Not sure of outcome yet as I'm only on day 1 of treatment.
Hard lump (approximately 2 inches) formed in deltoid. Pt felt it move to bicep. Arm became red and hot. Fingers became numb. the following Tuesday, symptoms resolved.
Event-pancreatitis  Symptoms - abdominal pain / abdominal swelling / unable to eat went to emergency room 4/30/2021 - bloodwork & cat-scan -- prognosis was Pancreatitis currently waiting for follow up with gastro doctor on 5/5 -- liquid diet until I can see the doctor
Patient received Arexvy (RSV vaccine) and Afluria (flu shot) in one arm and the patient had reddness and swelling from the injectionsite all the ay down to elbow. Patient is also having some pain in the arm.
Patient reported dizziness at 1130. Patient denied shortness of breath. No rash present; patient denied itching, burning, or pain. At 1145, patient denies diziness or any other symptoms. Patient ambulated with steady gait noted.
Child became syncopal after shot. Mom at child?s side. Child stated,? I?m going to faint,?. Child curled up into mom?s lap; airway patent, skim warm and dry. Episode lasted three minutes. Child up and walking, smiling, choosing stickers. Mom remained at child?s side. Mom stated, ?She always does this,?.
Pt presented with fast heart rate and slight swelling in fingers on RT. hand. Pt. was ambulatory and A\O x4. Pt. walked to Private Treatment area for monitoring. 3 sets of vitals were taken. Pt. stated that her Tongue was starting to feel slightly swollen 3:01 PM. and as well Hive/leasion was noticed on the 2nd digit of RT. hand. Pt. was given 25mg benadryl By on site Dr. at 3:01 PM. After 20 min Pt. Felt Better. And leasion started to Disappear. Pt. vitals monitored for an additional 30 min and Released to home. Pt. advised to seek further medical attention if needed. BP 137/87, P 87, Resp. 15, SPo2 98%. 2:59 BP 134/84, P 83, Resp. 16, SPo2 98%. 3:10 BP 125/75, P 81, Resp. 16, SPo2 99.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3247), on 15Feb2021 as dose 2, single (Lot number: EL3247) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
pt reports feeling tingling & fullness in face, numbness in head which radiated into shoulders;recv oral antihistamine from PMD;sx resolved by 630PM on 11/19/99;felt no 2-3 days later;
Rash over upper arm and back. Area sensitive to the touch. 2nd shot in series caused his "lymph nodes" to become tender, but did not seek treatment.
Patient presented to the ED and was subsequently hospitalized for a motorcycle accident within 6 weeks of receiving covid vaccination.
Local reaction 3" X 4" knot/bump on left arm.  Treatment warm compress, BENADRYL of 6 hrs.  CEPHALEXIA antibiotic received in 3 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 11Jun2022 as dose 4 (booster), single (Lot number: PM7553) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteopenia/porosis" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "almonds" (unspecified if ongoing); "soy" (unspecified if ongoing); "gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; RESTASIS; ESTRIOL topical; VITAMIN D3; FISH OIL; MAGNESIUM. Past drug history included: Known allergy: ciprofloxacin, reaction(s): "Known allergy: ciprofloxacin"; Known allergy: levaquin, reaction(s): "Known allergy: levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Tested negative twice over ensuing days; (13Sep2022) Positive, notes: COVID 19 Treatment; (25Sep2022) Positive, notes: Symptoms returned 25Sep and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 14Sep2022 to 19Sep2022 for treatment of COVID-19. Other medication in 2 weeks product was Estriol topical lotion. Symptoms began 13Sep2022, started Paxlovid 14Sep2022 and finished course. Tested negative twice over ensuing days. Symptoms returned 25Sep2022 and tested positive. Rheumatologist prescribed Paxlovid for a second course 27Sep2022 (currently taking).
Slight fever, muscle aches in area of injection, extreme fatigue Symptoms began around 2:00 a.m. night following 2nd injection of Pfizer Covid19 vaccine. Lasted approximately 18 hours with diminishing symptoms. Back to normal 48 hours after injection
A little Side Effect after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A little Side Effect after First Vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A little Side Effect after First Vaccine). At the time of the report, VACCINATION COMPLICATION (A little Side Effect after First Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Adverse events for patient 10/13/2017 Reported to me by husband at 5 PM. Pt. was administered FLUZONE HD on Saturday, 10/07/2017. Monday pt. had stomach pain and husband took to Urgent Care where they said reflux and treated with PRILOSEC. Thursday morning pt. passed out at home and husband took to Hospital - EKG, CBC, blood pressure, blood sugar all checked and normal sent home with meclizine for vertigo (which she has had in past) but also said could be residual from flu vaccine to report it. Thursday evening pt. complained of feet hurting to husband and he used Epsom. Friday morning pt. ankles swollen. Pt. called cardiologist and was told since checked at E.R. that he was not concerned at this time, but to report flu vaccine adverse event to us. Friday evening husband reports to me and said she now has bruising on right breast and outside of both ankles and scratch on bottom of one foot. He had already talked to cardiologist. Doctor and myself think bruising related to fall. Sent an email to protocol doctor at 5:45 PM to notify. Husband is to keep updating us.
It didn't start right away. I wake up with wheals all over my body one day. This started after my third dose and I have been dealing with this all the way through my fourth dose. I have had a few instances with anaphylactic shock. My lips will swell up. I had to go to the emergency room and got an epinephrine shot on 9/7/22. I had to be monitored for several hours. They prescribed hydroxyzine, and recommended ALLEGRA. No other medications. Since 9/7/22, after the epinephrine shot, and round of steroids, I haven't had the hives. My doctors theory is people with immune system issues are having issues with hives after receiving the vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eye discomfort), PAIN IN EXTREMITY (soreness on her arm), INDURATION (hardness on her arm), FATIGUE (fatigue chills hardness on her arm a high fever) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported.). On 01-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INDURATION (hardness on her arm), FATIGUE (fatigue chills hardness on her arm a high fever), PYREXIA (fever) and CHILLS (chills). On 02-Mar-2021, the patient experienced OCULAR DISCOMFORT (eye discomfort) and PAIN IN EXTREMITY (soreness on her arm). At the time of the report, OCULAR DISCOMFORT (eye discomfort), PAIN IN EXTREMITY (soreness on her arm), INDURATION (hardness on her arm), FATIGUE (fatigue chills hardness on her arm a high fever), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a 17 year old female with no medical history or drug allergy who was vaccinated with 1st, 2nd and 3rd doses of GARDASIL in April 2007, October 2007 and December 2007, respectively. There was no concomitant therapy. In December 2007, after receiving the third dose of GARDASIL, the patient experienced irregular periods and severe pain during menstruation. She was hospitalized on 01-JAN-2008 and informed that she had cysts in her ovaries and she would no longer be able to conceive. The doctor advised her that GARDASIL had caused these problems. She was not recovered at time of reporting. The patient went to hospital for medical attention. Additional information is not expected.  6/12/09 Medical records received DOS 2/7/08. Referred to OB-GYN for management of ovarian cyst.  7/23/09 Hospital records received, consist of multiple ER visits, DOS 6/25/08 to to 4/18/09. Assessment: Anxiety Attack, Chest Wall Pain, Tobacco Abuse Disorder. Urinary Tract Infection. Smoke Inhalation. Facial contusion, chest wall contusion. Patient presents with shortness of breath and chest discomfort, anxiety. Pelvic pain and cramping, distressed. Inside burning home, cough, smoke inhalation. Dysuria, distressed, UTI. Assault, hit in face and abdomen, face pain, ecchymosis, neck pain. Abdominal pain, nausea, vomiting, fever, leukocytosis, cervical tenderness on motion, purulent discharge from cervix. Epigastric pain.  ICD-9 Codes: 786.50  300.00  786.52  305.1  465.9  789.00  786.09  987.9  E890.2  786.05  599.0  V71.6  920  922.1  E960.0  288.60
Patient received the Monkeypox vaccine on Monday of the week (8/29/22) and on 9/1/22 went to a routine appointment with hematologist and his oxygen saturation was noted to be 80%. Patient was overall asymptomatic but sent to the emergency room at hospital. Patient noted to have methemoglobinemia. Other pertinent medications/exposures were ruled out. Only new thing for the patient was receiving this vaccine.
Woke up with bloody nose morning after vaccine; sore arm; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not take any other vaccines in four weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 09:30, the patient woke up with bloody nose, the morning after the vaccine and other symptom was sore arm. Therapeutic measures were not taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events- bloody nose and sore arm was recovered on 13Apr2021.   No follow-up attempts are possible. No further information is expected.
Next day - Dizzy feeling of faint Red rash covering full body and still lingers 4 days later Day 5 slight nose bleed  Non of these have been serious enough to see a Doctor  But rash is itchy and annoying
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-AUG-2012, the patient was inoculated ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-OCT-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed cephalexin, gabapentin, valacyclovir, and aspirin for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Patient had an episode of vasovagal near-syncope in the first 5 minutes after vaccination.  She had no injuries and was observed in clinic until she felt better, at which time she went home with her mother.
1) really sore at injection site for 3-4 days 2) developed (assumed, no doctor visit) tendonitis in that shoulder for one month, at worst pain extended from right side of neck to elbow. Treated with occasional ibuprofen.   NOTE: diagnosed with tendonitis left shoulder some years ago and this felt same but shorter duration and less severe pain.
Pain, swelling, hardness, tiny sores, and itching at injection site 7 days after injection. Swollen area/hardness is about 3' across. Arm hurt on days 1-2 after injection, but resolved until day 8.  There are also a few raised, itchy spots on my legs beginning around day 7. These consitions remain unresolved on day 9 after injection (today).
Fussy, crying after vaccination, fever, thought related to teething, on 11 day rash appeared, 12 day woke up with full hives taken to doctor who recommended Zyrtec for a week and mother also gave child Benadryl for itchiness. On 13th day, hives on stomach blended together so in hives from privates to head. Today pt only has some bumps on head that swell when crying or mad. However Pt having problems being still while nursing.
Patient received a Covid Bivalent Pfizer vaccine before initiating or receiving a primary series.
Pain at site in arm,  March 16th (day after)   Diahhrea & low grade fever March 17th, 18th Friday, March 19th,  itching at injection site on left arm, no pain just very, very itchy Took Immodium,  Wed 17th & 18th and Tylenol for low grade fever, sweating. Took Benadryl Sat. 20th after topical did nothing, Today, March 21st. No pain in arm just continues to itch at injection site
weakness; I was so cold; the top of my head hurt so bad, it was like pounding; lost my taste buds; My skin burnt like a 2nd or 3rd degree burn; My teeth were chattering; Diarrhea; Gastro pain; Stomach pain; I am sleeping 12+ hs a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding) and AGEUSIA (lost my taste buds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetic, Blood pressure high and Fibromyalgia. Concomitant products included GOLIMUMAB (SIMPONI) for Autoimmune disorder, HYDROCHLOROTHIAZIDE for Blood pressure high, ALBUTEROL [SALBUTAMOL] for COPD, METFORMIN for Diabetic, OXYCODONE for Pain, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (I am sleeping 12+ hs a day). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain) and ABDOMINAL PAIN UPPER (Stomach pain). On 18-Mar-2021, the patient experienced HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering) and FEELING COLD (I was so cold). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, DIARRHOEA (Diarrhea), GASTROINTESTINAL PAIN (Gastro pain), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (the top of my head hurt so bad, it was like pounding), AGEUSIA (lost my taste buds), THERMAL BURN (My skin burnt like a 2nd or 3rd degree burn), CHILLS (My teeth were chattering), HYPERSOMNIA (I am sleeping 12+ hs a day), ASTHENIA (weakness) and FEELING COLD (I was so cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Patient recieved vaccine on Monday.  Called pharmacy reporting that she had redness and swelling at immunization site that was growing in size.  Pharmacist recommend patient go to urgent care to determine if injection site was infected.
PATIENT GOT THE MODERNA COVID 19 VACCINE, SHE IS 16 YEARS OLD
occasional slight dizziness; fever with 99.7 body temperature; chill; She had a sore arm; she felt foggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill). On 20-Mar-2021, the patient experienced DIZZINESS (occasional slight dizziness). At the time of the report, PAIN IN EXTREMITY (She had a sore arm), FEELING ABNORMAL (she felt foggy), DIZZINESS (occasional slight dizziness), PYREXIA (fever with 99.7 body temperature) and CHILLS (chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.7 (High) 99.7.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: non-significant follow up appended. AE Update: Email address provided.
Throwing up evening of shot and next morning. Rash on diaper area. Maculopapular lesions that may represent varicella. Allow no contact with unvaccinated persons. No medication needed. No other intervention required.