chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt bad, like really achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: ER2613) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Mar2021, outcome "recovered" (22Mar2021), described as "Arm hurt bad, like really achy". Therapeutic measures were taken as a result of pain in extremity.  Additional information: No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient clarifies that with the first one, her arm hurt bad, like really achy. States she never checked her lymph nodes then. States in her mind, they said her arm may hurt that day and she took Tylenol and it did subside. Treatment included slept with heat on her back and took Tylenol. No Physician Office or Emergency Room visit.  No follow-up attempts are possible. No further information is expected.
Reactions to first vaccine: swollen injection site, itchy injection site, and swollen forehead above left brow. Second vaccine swollen forehead above left brow and itching. Still exists currently.
Very little side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Very little side effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Keppra).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ADVERSE EVENT (Very little side effect). At the time of the report, ADVERSE EVENT (Very little side effect) outcome was unknown.            Concomitant medication use was not provided. No Treatment information was provided.   This case was linked to MOD-2021-033355 (Patient Link).
This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored VAQTA lot # K009506, expiration date 22-SEP-2016. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
She reports she had right arm pain the day following the injection (the arm she received the injection. She reports progressive worsening pain. Unable to use arm with lifting and certain movements. First saw a physician on 12/15/08.
Case number PHEH2016US008569 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 6 year old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly on 03 Oct 2015. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Fever 105.4 rectal 6/2/10. Fever 106.3 rectal 6/3/10. Seen in office CBC - bld culture - Treated with round the clock antipyretics.
reddish dark mark on her left arm; left arm at injection site red; left arm at injection site swollen; left arm at injectio site itchy; Irritable Bowel Syndrome (IBS) stared to act up/IBS was unusual and relentless; drainage from both eyes; eyes were blood shot; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore), EYE DISCHARGE (drainage from both eyes), OCULAR HYPERAEMIA (eyes were blood shot), IRRITABLE BOWEL SYNDROME (Irritable Bowel Syndrome (IBS) stared to act up/IBS was unusual and relentless) and VACCINATION SITE ERYTHEMA (left arm at injection site red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), BC powder, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), FAMOTIDINE (PEPCID AC), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (arm was sore). On 02-Apr-2021, the patient experienced EYE DISCHARGE (drainage from both eyes) and OCULAR HYPERAEMIA (eyes were blood shot). On 07-Apr-2021, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable Bowel Syndrome (IBS) stared to act up/IBS was unusual and relentless). On 09-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm at injection site red), VACCINATION SITE SWELLING (left arm at injection site swollen) and VACCINATION SITE PRURITUS (left arm at injectio site itchy). On an unknown date, the patient experienced RASH MACULAR (reddish dark mark on her left arm). On 04-Apr-2021, MYALGIA (arm was sore), EYE DISCHARGE (drainage from both eyes) and OCULAR HYPERAEMIA (eyes were blood shot) had resolved. On 16-Apr-2021, VACCINATION SITE ERYTHEMA (left arm at injection site red), VACCINATION SITE SWELLING (left arm at injection site swollen) and VACCINATION SITE PRURITUS (left arm at injectio site itchy) had resolved. On 28-Apr-2021, IRRITABLE BOWEL SYNDROME (Irritable Bowel Syndrome (IBS) stared to act up/IBS was unusual and relentless) had resolved. At the time of the report, RASH MACULAR (reddish dark mark on her left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-107127 (Patient Link).
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursions. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient experienced a hard bump the size of an egg mostly under the skin. It was red, warm to touch and swollen around the area. The patient notified the pharmacy where the vaccine was administered on 8/18/16 and reported that it has decreased in size and subsided since onset. The pharmacy called the pcp to notify the same day and followed up with patient on 8/19/16. She said it was getting better still and she doesn't feel sick but she will call her pcp as well.
Left deltoid red, swollen and warm to touch. Cold compresses for 15 minutes Q 2 hrs for 24 hrs then warm. Make appt. if not better.
About 25-40 min after receiving H1N1, student returned to imm. area c/o nausea, feeling groggy, HA. Alert, oriented to time, place, person, speech slow. Slouching in chair, pale, 110/64, P 92, R 16. Guardian notified to come to school. Child monitored x approx 60 min., did not worsen, did not improve, did not want to be evaluated in local walk-in, got out of chair abruptly and left.
Pt described feeling very achy in her hips and back and she was unable to sleep due to the pain. She stated she had to get her walker back out in order to walk. This started 2 days after she received the vaccine on 5/27/2018 and resolved about a week after the symptoms stopped. She also described feeling like there was something crawling all over her and itching all over. When she reported the adverse symptoms to us at the pharmacy it was 6/28/2018 and she  stated she still had a little  itching.
Patient noticed redness to the injection site about the size of a nickel the day after the vaccine. This persisted for a couple of days. On 12/30/20 in the afternoon, she noticed itching at the injection site and redness the size of a half dollar that was warm to the touch.
Diagnosis Bell's Palsy on 10/16/2021. Symptoms began 10/14/2021. I previously had Bell's Palsy once in April 2009. Completely went away after months w/taking Acyclovir antiviral med. This current case of Bell's Palsy being treated w/Acyclovir and Prednisone meds.
Blurred/ Double vision starting 2-3 weeks from second dose. Went to eye doctor 8 times in 6 months to correct vision. Vision is still not corrected. Still having blurred/ double vision a year later from second dose.
I had my vaccination on 09/10/2022. On 02/28/2023 I had a dry cough and I had extreme lethargy. I tested COVID-19 positive on 02/28/2023 with an at home COVID-19 test. I was prescribed PAXLOVD. I did get rebound COVID-19.
High temperature - didn't know anything. Chills, Ached all over. Couldn't get out  of bed without help. Believe first day I was  in and out of consciousness. I was by myself 1st  2 days.
headache; high fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00/A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with IBUPROFEN on 25-Feb-2021 for Symptomatic treatment, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant product included blood pressure medication and diabetic medication.
Lost my taste and smell; Lost my taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Sep2021 at 15:00 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Sep2021 at 15:00 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. On 29Sep2021 at 20:00, the patient lost her taste and smell. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, lost taste and smell was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
No additional AE reported; expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 19-JAN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S010729; expiration date 01-DEC-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). It was confirmed that the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) did not experience a temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
COVID-19; COVID-19; Pfizer / BioNTech dose 1, dose2, dose 3; Moderna, dose 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9809), on 24Feb2021 as dose 2, single (Lot number: EM9809) and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 35 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 as dose 4 (booster), single (Lot number: AS7143C) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Pfizer / BioNTech dose 1, dose2, dose 3; Moderna, dose 4"; COVID-19 (disability, medically significant), VACCINATION FAILURE (disability, medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure with Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure(LOE), covid-19, interchange of vaccine products  cannot be ruled out.
Patient present with growing, Red, rasied area L Upper arm beginning 6 days post Moderna COVID vaccine #1. Vaccine given 1/30/2021. Began with redness/itching on Fri 2/5/2021. Denies fever, no change energy - did a vigorous hike yesterday. Notes some itching.  No pain. Never had reaction to any vaccine in past.
10 days post injection got a covid arm rash at point of shot. 5 inch red oval warm, puffy.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for three patients. This is the second of three reports. A 75-year-old female patient received on 27Oct2016 10:35 PREVNAR 13 (NDC number 0005197101, lot number R45377, expiry date 01Dec2017) at 0.5 ml single dose in the right deltoid for routine vaccination. Medical history included thyroid, asthma, blood pressure, sleep apnea, all ongoing. The patient received influenza vaccine (manufacturer unknown), lot number A3AD2) on 20Oct2016 for immunization in her right deltoid. Additional concomitant medications included thyroid for thyroid, albuterol for asthma, SPIRIVA for asthma and propranolol for blood pressure, all ongoing. On 28Oct2016, the patient experienced redness, swelling and red spots on her right arm at the site of the injection, felt tired and sick. When the patient came back to the office for a sick visit unrelated to the vaccination on 10Jan2017, she reported that the day after she received PREVNAR 13, she developed redness, swelling and red spots on her right arm at the site of the injection. She felt so tired and sick that she stayed in bed and after about 2 days all of the side effects resolved on their own. Outcome was recovered on an unspecified date in Oct2016.
CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Gums swelling and pain-mostly above and behind upper two front teeth; Gums swelling and pain-mostly above and behind upper two front teeth; dizziness; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 11:00 (Lot number: 301308A) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; MUCINEX D; FLONASE [FLUTICASONE PROPIONATE]; EFFEXOR. Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=301308A,, prev_dose_lot_unknown=False,, prev_dose_administration_date=14Sep2021prev_dose_administration_time=12:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Right, arm}]), administration date: 14Sep2021, when the patient was 45 years old, for Covid-19 immunization; Influenza ([{other_vaccine_4weeks_product=Infl, uenza,, other_vaccine_4weeks_vaccine_date, =21Sep2021,, other_vaccine_4weeks__vaccine_loca, tion=Lt Arm}]), administration date: 21Sep2021, when the patient was 45 years old. The following information was reported: GINGIVAL SWELLING (non-serious), GINGIVAL PAIN (non-serious) all with onset 05Oct2021 14:00, outcome "not recovered" and all described as "Gums swelling and pain-mostly above and behind upper two front teeth"; DIZZINESS (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "dizziness"; NAUSEA (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "nausea"; HEADACHE (non-serious) with onset 05Oct2021 14:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of gingival swelling, gingival pain, dizziness, nausea, headache.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: Yes. other vaccine 4weeks details: other vaccine 4weeks product=Influenza, other vaccine 4weeks vaccine date=21Sep2021, other vaccine 4weeks vaccine location=Lt Arm, other medications in two weeks: Effexor, Flonase, Mucinex D, Probiotics  No follow-up attempts are possible. No further information is expected.
Approximately 18 minutes post injection, patient experienced itching and whelps on opposite limb as injection site. Diphenhydramine 25 mg chewable tablets given. Itching continued into legs and skin above lips. Prednisolone 40 mg liquid given. After 10 minutes, itching and whelps improved. Patient monitored for a total of 1 hr post injection.
CAN NOT HOLD ANYTHING WITH THAT ARM; ARM PAIN/ARM REALLY HURT WHEN TRIED TO GET THE NEEDLE IN/ SHARP PAIN AT VACCINE SITE; TURNED WHITE AS A GHOST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cellulitis, and concurrent conditions included: non-alcohol user, non-smoker, pacemaker, kidney disease, and tattoos. The patient was previously treated with potassium; and experienced drug allergy when treated with citalopram hydrobromide, gabapentin, morphine, nystatin, codeine phosphate/paracetamol, and bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the patient experienced turned white as a ghost. On 30-APR-2021, the patient experienced arm pain/arm really hurt when tried to get the needle in/ sharp pain at vaccine site. On an unspecified date, the patient experienced can not hold anything with that arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain/arm really hurt when tried to get the needle in/ sharp pain at vaccine site, and the outcome of turned white as a ghost and can not hold anything with that arm was not reported. This report was non-serious.
A non-serious spontaneous report of fever, vomiting, stomach aches, and weakness has been received from a pharmacist concerning a six-year-old female subsequent to H1N1. The patient's past medical history was not reported. The patient received H1N1 on 24-Oct-2009. On 30-Oct-2009, the patient experienced high fever, vomiting, stomach aches, and general weakness. The outcome of the events was not reported.
Fatigue; Chills; fever 101 degrees, I can get it down to about 99 degrees, but then it goes back up, ever since; Aches on the inside; sweats at night; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (fever 101 degrees, I can get it down to about 99 degrees, but then it goes back up, ever since), MYALGIA (Aches on the inside) and HYPERHIDROSIS (sweats at night) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESYLATE and ATORVASTATIN for an unknown indication.    On 13-Apr-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (fever 101 degrees, I can get it down to about 99 degrees, but then it goes back up, ever since), MYALGIA (Aches on the inside) and HYPERHIDROSIS (sweats at night). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK, q4h and IBUPROFEN ongoing since an unknown date at a dose of UNK, q4h. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (fever 101 degrees, I can get it down to about 99 degrees, but then it goes back up, ever since), MYALGIA (Aches on the inside) and HYPERHIDROSIS (sweats at night) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Email,Address,County,Concomitant medications,Ethenic group and race were added
Breakthrough COVID-19 case with symptom onset 9/1/2021: Muscle or body aches, Runny nose/Congestion, Cough (new onset or worsening of chronic cough) , Fatigue or tiredness, Headache. Hospitalized 9/1/2021-9/3/2021.  While in the hospital she experienced a problem with atrial fibrillation.