chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 6th day I developed what appears to be hives at the injection location . This is the 2nd day and it's definitely gotten worse. My upper arm is now swollen, red, hot and extremely itchy. It hurts  a little but the itchiness far exceeds the pain.
severe shooting pains up both arms, her hands hurt really bad; ANA positive; enlarged parotid glad on the left side and inflamed parotid glands; enlarged parotid glad on the left side and inflamed parotid glands; sciatica pain of the right side; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8735) via an unspecified route of administration at left arm on 19Apr2021 16:30 (46-year old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history depression, thrombocytopenia, severe IBS, carpal tunnel right extremity, and allergies to Penicillin, Sulfa drugs. Concomitant medications that the patient received within 2 weeks of vaccination included ONDANSETRON. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 29Mar2021 (46-year old at time of vaccination), at single dose, for COVID-19 immunization and experienced "there was a hole inside her left ear/ ear abscess", "thick yellow, clear puss and blood was oozing out of her left ear", "sciatica pain", and "nerve pain". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor Visit 24Apr2021 for sudden onset sciatica pain of the right side this time and got a cortisone injection that helped. CT Scan 25Apr2021 to figure out what is happening in patient's ear and showed enlarged parotid glad on the left side and inflamed parotid glands. Patient has severe shooting pains up both arms, her hands hurt really bad. Doctor visit 27Apr2021 followed up with ENT and he indicated patient needed to see rheumatologist for ANA positive test. Doctor visit 03May2021 Rheumatologist. 09May2021 labwork. Urgent care Doctor visit 14May2021 for severe sciatica pain that continues. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event sciatica and included cortisone injections, deep muscle massage/exercise. The outcome of the events was not recovered.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had an event of syncope after the injection and fainted in the chair. I assisted the patient to the ground and had them lie flat and elevated their legs using a chair. Patient regained consciousness and was responsive within 1 min.  I checked BP and heart rate (BP was 124/82 and Pulse was 76 b/m). Per store Policy EMS was called by store LOD. EMS arrived and took patient to local hospital. Pts was responsive when they left pharmacy.
Patient states after vaccine she felt discomfort and warm at site. Patient states she noticed redness the next day that kept growing in size. Patient states if keeps getting bigger and warmer. Patient states she tried rinsing her arm with warm water.
At least 12 hours after vaccine, I was feeling miserable (headache, fever, body aches), but was also feeling suicidal for several hours.  While I have suffered from depression most of my life and have been on and off medications over the years, I have not felt the need for medication for several years and have dealt with depression by talking to my therapist.  However, Monday night thru Tuesday, I really felt like I wanted to take my life. I cried and talked myself down, but had not had those feelings for many years (over 20 years).  I do not know if this was a side effect of the vaccine and do not know if anyone else has felt this way, but I thought I would share, in case others have also reported or felt this.
12 noon shot was given to Er nurse at work. 15:15- sore throat began with a dry cough. 16:15- upper airway swelling with hoarsness of voice. 17:00 RN went home ill and took Benadryl 50mg and inhailer. 21:00- throat tightness decreased.
pt recvd vax; next day arm swollen; 2nd day swelling spread to axilla & breast,fingers tingling arm throbbing, painfull to touch axilla area;
Information has been received from a registered nurse concerning about 12 female patients between 11-15 years old with no pertinent medical history and no drug reactions/allergies who were vaccinated with 0.5 ml of Gardasil (657736/0389U).  There was no concomitant medication.  The nurse stated that she noticed a trend with Gardasil (657736/0389U) in about 12 patients who complained of the arm numbness within seconds after receiving Gardasil.  No lab diagnostic studies were performed.  The patients were observed after the injection and all recovered before leaving the office.  No other symptoms were reported.  Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report.  Additional information will be provided if available.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.
Edema @ site 4 cm X 4 cm -immediate reaction , No SOB, wheezing, flushing, or tightness throat
patient had severe pain in the arm of the vaccine.  radiating into the neck and shoulder region.  no rash or redness or swelling were seen.  she did come into the pharmacy to ask how to treat the pain.  the vaccination was given at 11:10 am on 12-2-2022, she came back to the pharmacy the same day 12-2-22 around 3:30 pm to ask how to treat the symptoms.  supervising pharmacist called to check on patient 12-3-22, she stated the pain in getting better, however she is having known adverse reactions to the vaccine.  fever, body pains, and some lymph node swelling.  she has experienced the lymph node swelling with her previous shingrix vaccine.  she stated no other concerns.
pt came to clinic for immunization with parent. verified pt name, dob, and  allergies with parent. explained to parent what vaccines will be given. parent  verbalized understanding. Vaccines administered.  upon completion of the 3rd and final vaccine [HPV], pt got up and fainted. father  caught the pt. pt responsive, and observed. pt offered water, O2 sat 99%, P 84.  pt refused blood pressure check because of the squeezing pain.   after the incident the father stated that pt has a hx of fainting after vax when  pain is felt. notified father to let healthcare providers know ahead of time to  be aware of possible syncope.  pt returned to normal pallor and left in stable condition walking with father.
Patient stopped by the pharmacy today stating that she received the flu shot with us on 9/24/20. However, she is still having muscle pain until now in her left arm. When she sleeps on the left side she feels numbing pain throughout her arm. We advised her to see a doctor in case there is some inflammation. During the phone call to suggest her to see her primary doctor, she said she had contacted her primary doctor but she wouldn't be in until end of the month. She has talked to covering physicians who suggested taking some naproxen and seeing physical therapist.
Headache, Myalgia, Fever, chills, loss of taste Narrative:
Patient is a 60 y.o. female patient of local CNP with history of history of COPD, chronic hypoxemic respiratory failure, CHF, GERD, CAD, HTN, HLD, PUD, c who presented to the emergency department with shortness of breath, found to have COPD exacerbation, hypoxemia and hypokalemia   Acute exacerbation of COPD Acute on chronic hypoxemic respiratory failure: Chest x-ray past reviewed, hyperinflated lung, no airspace disease, radiology read noted bronchitis without pneumonia or edema IV then p.o. steroids, Symbicort twice daily, Spiriva, DuoNebs every 4 hours Levaquin Initially on BiPAP Currently at baseline she is on 2 L nasal cannula   Covid-19 Virus Infection Date of onset of symptoms: Shortness of breath Symptoms present on admission: Yes Date of covid positive test: 11/1/2022 Vaccination status: vaccinated Imaging: CXR no infiltrate Oxygen requirements on admission: BIPAP Current oxygen requirements: 2 L of oxygen through nasal cannula Medical therapy: remdesivir and steroids Consultants following: ID  Anticipated special isolation end date: 11/10/22 Follow inflammatory markers     Hypokalemia, severe, present on admission, improving Replete aggressively p.o. potassium Electrolyte replacement protocol BMP daily   NIDDM2 w/ hyperglycemia and peripheral neuropathy: Continue home gabapentin Holding glipizide Diabetic diet and insulin sliding scale  Lantus insulin during hospitalization secondary to IV steroids then resume glipizide on discharge.  CAD: Chronic chronic diastolic CHF: Essential HTN: proBNP 285 the time presentation Chest x-ray not consistent with pulmonary edema Guideline directed medical therapy Lasix 20 mg daily Toprol, Imdur, Aldactone   PUD: GERD: pantoprazole and sucralfate   HLD: Atorvastatin   Obesity, BMI 30.79, due to excess calories, with serious comorbidity: Encourage diet modification, active lifestyle, and weight reduction.   Chronic fatigue syndrome Physical deconditioning PT OT and social service consulted for discharge plan Home health care  We discharge patient home with home of care after improvement of his general condition and shortness of breath.  Patient to follow-up with PCP in 1 week.  Follow-up with pulmonary and ID as noted.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.) and PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated). On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.). On 27-Jan-2022, PRODUCT STORAGE ERROR (vial that was punctured and left at RT for 5 days/unrefrigerated vaccine administrated) had resolved. On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (inadvertently expired doses were administered to 8 patients.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported. Reported time of administration of vaccine was 2.30pm - 4.30pm. Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2022: Follow up received contains significant information. Patient initials, Dose number, Event verbatim were updated.
Vaccine received Thursday afternoon. Starting Sunday, I needed to wake her up at 11am- then she fell back asleep an hour later, and has had extreme somnolence since. She has been able to stay away no more than 4 hours at once, and usually it is more like 2-3 hours before needing to go back to sleep. This isn't just fatigue- it is the actual need to sleep. She has missed 2 weeks of school. We tried school today and she needed to be picked up due to falling asleep in class at the 3 hour at school point (4 hours awake) and had struggled to get to that point. This is the only symptom she has had.
pt states arm started hurting the day p/vax;came in clinic 23MAR99;lt arm swollen (about 4" x 4") & warm to touch;no drainage noted @ inj site;was referred to PMD for further eval;
reconstituted lyophilized powder with normal saline and administered; reconstituted lyophilized powder with normal saline and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K7K23, expiry date 3rd February 2023) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix. On 16th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacy reconstituted Shingrix lyophilized powder with normal saline and inadvertently administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
7:45 Metallic taste in mouth with tongue, throat, and sternum a little burning sensation and also around the lips--began to subside after 5-10 minutes.  Paramedics checked. ok to go home and take benadryl if needed.  Did not take.  At 9:00 pm skin on arms and upper body began to itch a little, noticed that I had 3 tiny raised hive-like, more like tiny bug bite without redness, only itching for approx. 5-10 minutes, one on left arm, one on left lower neck, and one at mid-waist left side.  Itching stopped within 5-10 min. and bumps were gone.  Should I take the 2nd dose on March 1st?
Headache Body aches ,Bleeding ear left side, swelling up under arm pit, dizznes. Double vision Narrative:  Other Relevant History:
Hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Lot number: Ff8839) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF8839), administration date: 30Sep2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 24Oct2021, outcome "unknown", described as "Hair loss".  Additional information: Since the vaccination, patient had not been tested for COVID-19. COVID prior vaccination: Yes. If COVID tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Presented with  cellulitis-like patch on left leg which developed about 8 days after receiving dose 1 of the Moderna vaccine. Treated with Bactrim DS, seen again in 1 week with some improvement but not resolved - erythematous area on the anterior aspect of the distal left leg.  Less erythematous and well demarcated as previously.  No induration.  Still somewhat tender to palpation. Suspicion for erythema nodosum. Returned to clinic in 1 week (about 2 weeks after dose 1) with fading and scaling well demarcated erythema distal left leg.  Above that she has a slightly indurated erythematous tender lesion approximately 1.5 cm.  She has an area of erythema on the right leg measuring approximately 2 cm.  This is not indurated or tender.  Received dose 2 on 4/17/21 and presented to clinic on 5/3/21 with a a large well demarcated area of erythema on both legs. Patient reports lesions "flared" after second dose, though today they are less painful and have not increased in size or number.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient experienced swelling at the injection site. The patient called the physician's office. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Results of tests: Positive; Results of tests: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (unspecified if ongoing), notes: other medical history: chronic back pain; "asthma" (unspecified if ongoing), notes: other medical history: asthma; "allergies" (unspecified if ongoing), notes: other medical history: allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021, outcome "unknown" and all described as "Results of tests: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2021) Negative; (02Dec2021) Positive.  Clinical course: No other vaccine received within 4 weeks, No COVID-19 prior vaccination, Covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372314 same product, patient, different AEs;
Low grade fever, headache, dizzy, extremely tired, chills, muscle pain and injection site pain.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Swollen arm; Arm hurts really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Arm hurts really bad) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     Patient had no allergies, had not tested positive for Covid 19 and did not take any concomitant medication.     On 21-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Arm hurts really bad). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Arm hurts really bad) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient stated that patient actively experienced above symptoms.
Tiredness; Soreness; A spontaneous report was received from a healthcare professional concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness / fatigue and soreness/ pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 7 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events, tiredness and soreness.   Treatment details included Tylenol and Advil.  Action taken with mRNA-1273 in response to the events was not reported.   On 12 Jan 2021 the outcome of events, tiredness and soreness was resolved.
Upper left arm began to swell and flesh became warm/tender to the touch approximately 3 to 4 hours after PNEUMOVAX 23 admin. Patient took TYLENOL and applied ice. He had an apt to see his physician the next day. His doctor prescribed KEFLEX 500mg 3 times a day for 10 days.
Erythema, tenderness, edema to right upper arm.  No drainage.  Blanching skin
Presented with SOB/weakness/non-productive cough; fully vaccinated; dx Covid PNA; treated with steroids, antibiotics, remdesivir, zinc, veletri infusion; intubated; initial covid dx 8/8; hospital admit 8/10; intubated 8/22; comfort care 8/24; died 8/24
Grand mal seizure. Sleepy that day, didn't eat much few days before seizure. Fell asleep and had seizure during nap. Seizure lasted a couple minutes. Blood work in ER okay. Patient is getting EEG and MRI.
shortness of breath, shaking, diarrhea, and today feeling really bad with chills with low grade fever, headache, and very fatigued and it feels like a bad flu and cough.
Client received 1st dose HPV vaccine to R deltoid at 1010 am. Lot 1775808. Vacccine given without incident. Client sat for 1-2 minutes talking to me following the injection. Client stated she was "fine" and got up to go the the administration desk to make an appointment and pay her bill. Talked to client while making appointment and she was appropriate and color was good. I left to go back to my desk and client asked for a glass of water. Client then passed out and fell to the floor. She hit her head on the floor. Myself and 3 other RN's from the clinic responded to the sound of her falling. The admin clerk called 911 and we initiated CPR. Client initially had a carotid pulse but no breathing. As we began to pull out our CPR mask, the clients lips were cyanotic and skin was pallorous. I was sternal rubbing her to try to get her to respond while RN's were getting CPR mask. After 1 min, client began to spontaneously breathe. Pulse ox was applied.  Client would initally have periods of apnea for 8-10 seconds but then breathe on her own.  RA sats 95% throughout the event. HR was initally 68 but went down to 44 and then quickly went up to 110's. Client was rolled onto left side and then vomitted. Throughout the event, client was AAO x 0. EMS arrived around 1025, and did a blood sugar. BS was 140's. BP 114/68. EMS tried to arouse her without success and she was transported via stretcher and ambulance to hospital.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "past stroke" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional Information: the patient is the reporter mother. No other vaccine in four weeks. No covid prior to vaccination and no covid test post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.