chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went on vacation out of state in late June. Around 07/01/2022, I woke up with a sore throat. I was later diagnosed with COVID-19. My symptoms were a lot like a head cold. I was extremely fatigued, stuffy, sneezy, and had a runny nose. I began taking PAXLOVID almost immediately after being prescribed it by my doctor. I quickly recovered from my symptoms and got over COVID-19 for more than a week. At that point, I basically came down with a second round of COVID-19, but it was different. I was testing negative until around the middle of July, when I tested positive for COVID-19 again. This time, I wasn't nearly as fatigued, but I had a lot of phlegm producing coughing. There was also some nasal congestion. Other than the lack of exhaustion, it was like the first round but on steroids. I had fevers and night sweats, chills. It felt like a combination of flu and cold. I think my fever got up to 103 degrees.
shakes; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN & MINERAL, NALTREXONE and PREDNISONE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified cholesterol medication and eye drops.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information was provided.
body aches and headache the morning after - took Tylenol.  Resolved within 24 hours after symptoms occurred. Headaches came back and still lingering (6 days after booster shot) early menstruation and heavy bleeding 48 hours after booster shot
pt devel fever during noc of 20NOV92 fever to 102 @ 6AM; 21NOV92 mom gave pt APAP & tepid bath; pt got stiff all over; eyes rolled back; teeth grinding, taken to ER; dx 1st febrile sz secondary to vax;
Body aches, temperature(101.1) Tylenol taken every 4 hours until temperature returned to normal
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING DELIVERY (Pregnancy) in a female 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING DELIVERY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING DELIVERY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by reporter.
Light headed, dizzy for 2days and headache, shoulder very sore and painful first day.
R deltoid area with edema, induration redness and heat (3x4cm area) with injection site in middle
started period last night consistently taken birth control and in the middle of the pack; This is a spontaneous report from a non-contactable consumer, the patient. A 22-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 12Apr2021 at 15:00(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included graves disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included JUNEL FE 1/20 taken for birth control from an unknown date for unknown indication taken within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm in Mar2021 at 15:00 as a single dose for COVID-19 immunisation. 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. On 12Apr2021 at 22:00 the patient experienced start of period last night after consistently taken birth control and in the middle of the pack. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event started period last night after consistently taken birth control and in the middle of the pack was not recovered at the time of the report.   No follow-up attempts are possible; information about lot number cannot be obtained.
I had shingles 13 years ago and now within 30 minutes of the shot I have an immediate report up of a shingles along the same area I had it the first time.
Sat in chair for flu shot. Started crying and became faint with headache, dizziness, loss of vision. Assisted to lay down with legs elevated and ice pack to neck. Vitals were assessed. Fluids were encouraged. Was slow to arouse and complained of not being able to see. Vitals were WNL. Mother is an RN and was able to take child home after 40 minutes. Was given TYLENOL and fluids at home. Napped when returned home and woke feeling some better with continued complaints of a headache. Was able to return to school the next day without any problems.
Mother emailed and called on 4/23/18- noted jaw pain x 20 minutes on 4/18/18, then 4/23/18, face tender to touch with worsening on opening mouth, stretching neck to either side. Swelling to both jaws/cheeks. Patient points to area "right under each ear lobe" when asked about pain. Treated with MOTRIN. Pain persisted. No fever.
aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose) in a 66-year-old female patient 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose). At the time of the report, MYALGIA (aches and pain all over the body lasted for 24 hours for first booster dose and 2nd booster dose) had resolved.            No Concomitant medications were provided. Patient received 2 Monovalent boosters. No treatment medications were provided.   This case was linked to MOD-2021-076249, MOD-2021-109926, MOD-2022-656439 (Patient Link).
patient broke out in a rash all over body with red bump. suggest patient take Benadryl and rash went away couple day later
labs results - severe neutropenia (04/01/21) WBC 2.3 - ANC 0.4 - night body aches, head aches, low grade temps intermittently - bone marrow biopsy - ultrasound.
1st dose on 09Feb2022, 2nd not received; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received st dose on 9th Feb 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 09Feb2022, 2nd not received).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2023 A retired cardiologist called in to report that he received a first dose of Shingrix on 9th Feb 2022 and then he did not receive the second dose. The reporter asked if he could receive the second dose or if he had to start over with vaccination. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Cellulitis around injection site (vaccinia vaccine) with lymphangitis and tender L axillary L arm scant drainage from vaccination site. Treated with Z-pack.
Pt reports that arm from shoulder to elbow turned red, warm, and itchy, local tenderness. Symptoms started in evening after injection. Pt took BENADRYL and used ice - to clinic if worsens.
2 hours after getting injection patient started having flu like symptoms. Could hardly lift arm. Patient took some Tylenol and has been feeling better.
Went into Atrial Fibrillation; had to take Amiodarone to stop the constant AFIB problem.  It subsided after about three weeks but not without developing hyperthyroidism from the Amiodarone. Now having treatment by my primary care physician
Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Patient was believed to be unvaccinated, was offered COVID vaccine and consented. After administering a full dose Moderna vaccine, state vaccine database records show that patient was given two doses of Moderna earlier this year (December 2020 and January 2021) at another location in town. Pt had no immediate adverse effects, but this should have been a booster dose (half dose), not a full 3rd dose.
Vaccination given 2/28/14, developed fever next day. Temp up to 105 degrees. Went to emergency room 3/9/14.
A part of the left hand from the pinky and up to the wrist grows numb and tingles.  The hand of the same left arm where shot was provided. I wouldn't consider this event as an adverse one, but that feeling in arm is constant and pretty annoying . No visit to a doctor nor hospitalization - obviously...
Pt received dose of penumovax 23 before prevnar 13 without any indications
generalized weakness,  hard time standing, fever, dizziness and sees black spots when trying to stand
EXTREMELY SLEEPY, SHORTNESS OF BREATH AND HEART PALPATATIONS. WENT TO THE E.R.  SHE WENT TO THE ER 3 DAYS
This spontaneous report as received from a physician refers to a 2 year old female patient with no pertinent medical history, no drug reactions and no known allergies. Physician stated she is a healthy 2 year old. On 16-APR-2013 the patient was vaccinated with VAQTA injection (lot # and exp date unspecified) (dose, route and anatomical location unspecified). Other suspect therapies included PREVENAR (dose, route, anatomical location and indication unspecified). There were not concomitant medications. The physician reported that on 17-APR-2013 received a call to her office stating that patient had a fever of 101. The patient was then brought into the physician's office on 19-APR-2013 and presented with facial swelling and wheezing. The patient was admitted to hospital at an unspecified location on 19-APR-2013. Physician stated that in April 2013 the patient's whole body started swelling and the patient "coded" while in the hospital. The patient required intubation at that time. At the time of the report the patient's outcome was reported as not recovered. Facial swelling, body swelling, patient "coded", wheezing and fever of 101 were considered to be disabling, medically significant and life threatening by the physician. Additional information has been requested.
fatigue malaise fever chills hit at 1 pm and lasted until 9 pm   fever highest was 102.6
Mother noticed a rash on left leg this time. Has Hx of Papular Acrodermatitis on previous VAERS form. No rash on body, no fever, fussy.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of M-M-R II (lot # L039551, albumin status rHA, expiration date 07-OCT-2017; dose and route were not reported). No adverse effects were reported. M-M-R II was not supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tachycardia-Mild
began with lips swelling progressing to tongue and facial swelling with rash. Have my own emergency kit from an anaphylactic reaction to shellfish, took 50 mg Benadryl, 8 mg methylprednisolone, and0.3 mg  epi sq injection. Waited 30 minutes, swelling continued, went to Emergency Department where I was  started on IV hydration with IV solumedrol, pepcid and lorazepam
Chills, headache, fatigue, and aches started around 9:00am on 11-9-21 and subsiding around 9:00am on 11-10-21 . Beginning around 5:00pm on 11-10-21 i began experiencing heart burn. Which has persisted as I am writing this at 09:57am on 11-11-21
Grandfather states swelling was not noticed until this AM. Left deltoid hand, hot to touch, swollen almost complete circumference, referred to ER.
patient reported a possible injection site reaction. site was itchy a few days after injection and patient noticed a rash developing. patient contacted us on 02/02/2021 to notify us. patient came in on 02/03/2021 where we observed a rash that was about 15cm x 5 cm. the rash was slightly raised, slightly red, and slightly warm. we drew a border around the rash, advised patient to take diphenhydramine and asked the patient to contact us today with the rash's progress.
Treatment of COVID-19: Paxlovid; Treatment of COVID-19: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Severe tinnitus, affecting hearing and sleep.; Affecting hearing and sleep.; Affecting hearing and sleep.; This is a spontaneous report from a contactable consumer, the patient. A 48-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 26Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 05Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe tinnitus, affecting hearing and sleep. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event severe tinnitus, affecting hearing and sleep was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 30-OCT-2013, the patient was administered with a dose of VARIVAX (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
vaccine was thawed on 1/11 and expired on 1/16 but was used to immunize patient on 1/22
Extreme rash (down to elbow), warmth day after vaccination by lessen. Rash continued by until 1-19-17.
This spontaneous report was received from a registered nurse referring to a 45 year old female patient. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 04-NOV-2016, the patient was vaccinated with the first dose of VAQTA (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 21-FEB-2017, the patient was inadvertently given the second dose of VAQTA 50/1.0 u/ml, lot # M031806 and an expiration date on 30-MAR-2018, (dose and route of administration were not reported)for prophylaxis. There was no adverse effect reported. Additional information has been requested.
It was a mild case. I had no fever but lost my sense of smell for a couple weeks. I had some headaches and some nasal congestion.
medical technician administered a patient with only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient to whom medical technician administered only the diluent part of HIB (PRP/T) vaccine [ACT-HIB] and the incident has been found 4 days after with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2023, the patient received an unknown dose (Booster dose, once) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ856AB expiry date, strength: unknown) via intramuscular route in unknown administration site for Immunization and was administered only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event (Product preparation error) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I spoke with the resident earlier in the afternoon and offered her covid and flu vaccine, according to our records she hadn't received a flu vaccine.  She agreed to both and I went to prepare.  I came back later, she refused at that time and I returned an hour and half later and administered.  After I did so, she then told me in surprise, I just received the flu vaccine last month, September at my Dr.'s office.  I called the PCP and notified then (and they verified that they had administered her flu dose there.)
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
experienced superclavicular lymph adonopathy; Route of administration: subcutaneously; This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) subcutaneously for prophylaxis (dose, anatomical injection site, lot number and expiration date were not reported) (incorrect route of product administration).   On an unknown date, the patient experienced "superclavicular lymph adonopathy" (lymphadenopathy) after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was unknown by reporter if the patient sought for medical attention, if she received any treatment or if any diagnostic laboratories or studies were performed.  At the time of the report, the outcome of the event and the causality assessment between lymphadenopathy and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.
Why do i feel so achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Why do i feel so achy) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Why do i feel so achy). At the time of the report, MYALGIA (Why do i feel so achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided. No concomitant medication was provided.   Reporter did not allow further contact