chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 17Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "Crohn disease" (unspecified if ongoing), notes: other medical history: crohn disease; "Thyroid disease" (unspecified if ongoing), notes: other medical history:Thyroid disease; "known allergies: sheelfish" (unspecified if ongoing), notes: known allergies: sheelfish. Concomitant medication(s) included: TOPAMAX oral; SYNTHROID oral; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] oral; CYTOMEL oral; BENTYL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive; (19Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Chest pain and nausea  enough thru out the day that she sought medical care in the ER
Hard heartbeat with persistent arrhythmia. Lightheadedness because of arrhythmia. Trouble getting a deep breath because of arrhythmia.
Reported 7/23/09 - came to clinic to report pt got rash on arms, thigh after receiving vaccines. Pt took BENADRYL, used topical lotion for poison Ivy - 2 bottles on 7/10/09 till ?. Pt state pregnant did not tell nurse when nurse asked her before receiving vaccine - states she told her (nurse) she was not pregnant. Pt. states her preg test done with midwife - confirmed by urine test. No medical evaluation for rash - mom will take today to doctor.
threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 26-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up". Additional information: States that 2 (name withheld) days ago she had her 2nd Pfizer shot and her 26 year old granddaughter said to go home and do not do anything, just to go home and relax and get a good nights sleep and that she hopes she does not get sick like she was. Caller declines to report on her granddaughter. States she threw up and she is good now and perfectly fine. She had the Pfizer Covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A phone call was made to the patient a couple days after vaccination and she reported soreness in arm, fatigue and feeling hot starting the night of vaccination.
I got both shots / most hurtful of any shot I have ever had.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2021AMR088664.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got Shingles vaccine and experienced pain. The patient reported that it was most hurtful of any shot ever had. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088664:same patient (1st dose)
Patient had a minor reaction - reported feeling flush and hives.  Patient developed symptoms at 30 min waiting period.  She was given 50mg of diphenhydramine and observed for additional time.  Patient reported feeling better after receiving diphenhydramine.
This spontaneous report was received from a registered nurse referring to a 12 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Right thigh 3 x 2 1/2 cm w/ subcut. hematoma/muscular hematoma - apply dry warm heat (not directly to skin).
OVER THE COURSE OF TEN MINUTES FOLLOWING VACCINATION, PATIENT STATED SHE WAS FEELING LIGHTHEADED, BEGAN TO SWEAT PROFUSELY AND NEARLY FELL UNCONSCIOUS.
SWELLING IN THE FACE, VERY  SWOLLEN; LITTLE ITCHINESS, RASH SPREADING BIGGER AND BIGGER, SPREADING ON FACE, EAR, NECK AND ALL OVER HER BODY LEG, THIGH,  BACK, RASH BEING RED, ITCHY, ALL OVER HER BODY AND GETS WORSE WITH FRICTION; SEVERE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy at the time of vaccination. The patient experienced allergic reaction when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced swelling in the face, very swollen. On 20-AUG-2021, the patient experienced little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. On 20-AUG-2021, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe allergic reaction, swelling in the face, very swollen, and little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. This report was non-serious.
noticed erythema to the injection site.  Denies pain or pruritus.   (Got antibiotics . She followed up  with her PCP who told her it was a common reaction to vaccine.
immediate severe headache, BP spiked within 20 minutes to 210/110, lasted for approx 48 hours, had 2nd shot 02/03/21 and no reactions yet
Developed a hard lump (approx 4 inches around) at the injection site, red, warm, and pain extends up to the shoulder, pt took BENADRYL & iced the area, pain is better today & rash also, but still hurts & is red.
One year Hep A and varicella were given in left thigh. She had a hives like reaction, worse on left thigh that was documented and shown to pediatrician. No other symptoms and no other new exposures. Resolved with steroids and has no other issues
5 hrs p/vax temp of 100.1 screamed continuously x 5 hrs; parents describe a sz also; parents took pt to ER; CBC & spinal tap done; all lab neg; ER MD stated pt shoud only receive peds DT:
The evening of 07/08/08 pt's (L) arm where pt received Hep A and IPV earlier got red, swollen, and small water blisters in a small area on arm. Pt denies SOB, fever, sore throat or felling ill since shots. (R) arm looks normal. After applying ice packs and taking TYLENOL pt's Sx's went away by 07/11/08 evening.
We had a back-to-school vaccine clinic event on 8/12/2023. The child was given 0.2ml of the Pfizer bivalent (orange cap) non-reconstituted.  The patient was observed at the clinic for 15 minutes after the dose and no side effects were observed. The mom was counselled to watch for side effects when they get home.
This spontaneous report as received from a registered nurse. The nurse reported on unknown date multiple unspecified patients were administered M-M-R II that were stored improperly. No adverse effects reported. This is one of several report received from same source. Additional information has been requested.
Swelling under left arm in lymph node area appeared about 20 hours after the booster dose was administered. The area is also showing Fluid retention under arm and is very sore. Along with the under arm swelling the follow other symptoms were present the day after the booster dose: head ache, dizziness, nausea, fatigue, and tenderness at injection site.
Swollen round spot around the area; Extreme itching in left armpit; Swollen lymph node; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EP7533) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included cannabis sativa (MARIJUANA), mitragyna speciosa (KRATOM), vitamin d nos (VITAMIN D) and melatonin (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 7 days of vaccination i.e., on 01Apr2021 at 08:00 the patient experienced swollen round spot around the area where she got the vaccine, and initially extreme itching in left armpit that turned to a swollen lymph node. The patient did not receive any treatment for the events. 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 events swollen round spot around the area, extreme itching in left armpit and swollen lymph node was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019E21A) for COVID-19 vaccination.     Concomitant products included BETAHISTINE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with DIAZEPAM at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-065493 (Patient Link).
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 30.90.  Concomitant products were not provided.  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1 , on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM : 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  On 15-Apr-2021, excursion time was 09 AM, temp was 34, total doses given for the day were 188, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were moved to clinic. Vaccine BUD date was 09-May-2021. Vials only punctured right before administration.   Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
swollen lymph node in my right breast; Other inflammation episodes in my stomach and intestines have occurred; Other inflammation episodes in my stomach and intestines have occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: ER8734) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypothyroidism thyroid disease" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; JARDIANCE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: INFLAMMATORY BOWEL DISEASE (medically significant), GASTRITIS (non-serious) all with onset 01Jul2021, outcome "recovered" and all described as "Other inflammation episodes in my stomach and intestines have occurred"; LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "recovered", described as "swollen lymph node in my right breast". The events "other inflammation episodes in my stomach and intestines have occurred" and "swollen lymph node in my right breast" required physician office visit. Therapeutic measures were not taken as a result of inflammatory bowel disease, gastritis, lymphadenopathy.  Clinical course: In February of 2022 I began to experience extreme abdominal pain. I went for ultrasound and found out it was my Fallopian tubes were filled with fluid. My doctor thought it was old infection resurfaced but I am not sure if this. Also I had a swollen lymph node in my right breast in Aug2021. I was called back for extra cancer screening. Other inflammation episodes in my stomach and intestines have occurred. No other vaccine in four weeks.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS].  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Medical history was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Sore arm, 12 hours first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
rt superficial lower extremity thrombosis- redness, tenderness, swelling rt lower extremity.
11/1/21 ED note by Doctor: "Patient is a 55 y.o. female with PMH significant for asthma, chronic angle-closure glaucoma, hypothyroidism, chronic constipation and depression who comes to the hospital due to SOB after testing positive for COVID-19. Pt states that she has had an ongoing non-productive cough for the past month. States that she got the cough "after receiving my flu vaccine". On Friday 10/29, Pt went to clinic for appointment for cough. She was tested via rapid and PCR for COVID-19. The test results came back positive and she was informed of the results on Friday. Since Friday, pt has been feeling nauseous w/o any emesis. Pt has not had anything to eat for the past 36 hours. Pt was at home yesterday when she began to feel short of breath. She used her inhaler and nebulizer with no improvement. Pt decided to come to the ED today because she felt as though she could not breath. Pt denies any HA, CP, edema, fever/chills, diarrhea". Treatment: Remdesivir,  Decadron , O2. Pt is currently hospitalized.
Initial report received from a health care professional on 23 Dec 2009: This patient was vaccinated with FLUVIRIN on an unknown date. On an unspecified date post vaccination the patient experienced acute disseminating encephalomyelitis. The patient outcome was not reported.
Restless legs for 3 evenings. The first evening was the worst. They gradually improved. I still have a tingling sensation in my legs.
Suspected COVID-19 virus infection  With cough, shortness of breath, fever, headache sore throat and nasal congestion ED to Hosp-Admission Current   8/29/2021 - present (3 days) Hospital for COVID Chief Complaint Patient presents with ? Fatigue     1. COVID-19 pneumonia with weakness?patient be hospitalized. His ambulatory pulse ox was 90%. Because of that we will start him on dexamethasone along with remdesivir. I also consented him for convalescent plasma. He did receive both doses of Pfizer vaccine the last 1 approximately 6 months ago. Will check inflammatory markers. He does not have a pneumonia on chest x-ray. 2. History of COPD?not in exacerbation, he will continue with his home inhalers. 3. History of atrial fibrillation he status post pacemaker placement. Is currently not anticoagulated, unsure of the reason behind that he will need to follow with cardiology regarding that.
This spontaneous report as received from a medical assistant concerns an unspecified amount of patients (age and gender unknown). The patients' medical histories, concurrent conditions and concomitant medication use were not provided. On unknown dates the patients were either vaccinated with improperly stored PROQUAD, 1 DF (lot # M043306, expiration date 24-APR-2018 or M044719, expiration date 07-MAY-2018) or VARIVAX, 1 DF, lot# M047660, expiration date 02-DEC-2018 or lot# M041513, expiration date 11-OCT-2018) for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported. Temperature -14 degrees Celsius to -10 degrees Celsius, time frame: 5 hours 38 minutes. Previous temperature excursion = yes. The outcome of the event is unknown. Additional information has been requested.
Next day temp 103.2 rectal, due to age -> necessitated trip to ER.
Patient complaining of severe left side ache; discribes like a side ache when you run really fast, but worse.  Instructed patient to lay down on right side. Do so for about 5 minutes.  Related it was getting a little better.  Encouraged patient to stay in office for another 5 minutes.  No changes in severity or symptoms.  Ambulated out of office on her own, with family. 07/29/2010: follow up telephone call made to patient.  She states symptom lasted about 45 minutes.  No further problems.
Headache, Fever, lethargy Narrative:  Employee reports "extreme lethargy" in addition to headaches and fever after receiving the second dose of the vaccine. Reports using ibuprofen and Tylenol for symptom relief.
Headache- within 24 hours lasted for 3 days body ache- within 18 hours lasted for 3 days chills- within 18 hours, off and on for 3 days Fatigue- within 18 hours, lasted for 3 days
Very bright redness to area to majority of L shoulder, swelling, heat, and pain to sight. Also complained of general pain, nausea and headache and body pains.
Received DTI, CPX #2, MMR #2 at 10:37hrs, returned to clinic at 12:00hrs complaining of itching to right antecubital space and left shin.   No shortness of breath noted, ambulating without assistance.  Area of redness noted to right antecubital space and left shin.   Seen by Doctor ordered 12.5mg/5 ml Diphenhydramine P. O. now  and prescription sent to pharmacy.  Instructed if symptoms worsen contact clinic or to nearest ER.
severe swelling and redness from shoulder to elbow on left arm; pain. moved from injection site to interior aspect of left arm to elbow and slightly below over next 8 hours. fluid filled. applied ice. resolution began after 48 hours and is better but not completely resolved  by 12/13  10:30. Never had such a severe reaction to vaccines.
New breakthrough vaginal bleeding during times outside of regular period that did not occur before the vaccine was administered. This was resolved by using oral birth control pills, which were only taken for 2 months. However, this adverse event returned after the administration of the booster shot.
Broke out in hives, couldn't breathe (SOB) 1 hr after administration (imbilatory transfer to hospital for admin 515 PM.