chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm and had injection site muscle pain. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field of Argus (not recovered) and the outcome reported in the source document (recovering).
Began about 21 hours after injection with weakness and mild muscle aches all over. Over next 2-4 hours weakness and aches worsened and also felt scratchy throat and sometimes mild chills. Slept about 3 hours, woke still feeling sick, took 2 Tylenol and had light supper, then slept all night. Better but still weak next morning (3/24), rested in day, nearly normal by evening 3/24.
stronger reaction; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown gender elderly patient who experienced stronger reaction (adverse reaction) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious stronger reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "it's supposedly stronger for those of us over 65. something I'd never experienced before. My reaction was worse than either of my 2 Covid-19 vaccines."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date after 2 days, the patient recovered (felt fine) from the event.
enlarged lymph node; body aches; Chills; Milld Fever; slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 046821A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-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 LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache). At the time of the report, LYMPHADENOPATHY (enlarged lymph node), MYALGIA (body aches), CHILLS (Chills), PYREXIA (Milld Fever) and HEADACHE (slight Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-385661 (Patient Link).
Skin rash & pain, swelling at injection site. Treatment: Diphenhydramine 25 MG PRN.
No additional AEs were reported; 9 month old patient received GARDASIL 9; This spontaneous report was received from a nurse referring to a 9-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 02-MAY-2023, the patient was vaccinated with 1 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration and anatomical site of vaccination were not reported; lot number 1775827 has been verified to be valid, expiration date reported and established as 27-JUN-2024) as prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Fever for 3-4hrs, injection site was red, swollen and hot the day aftr the shot.  Pt complains of headaches moving down her back through her pine.  Pt was referred to central Texas Medical Center ER.  Pt's mother states that Pt was seen in ER, given ABx for sinus infection, and is feeling better and back in school. 09/18/2008
THE PATIENT STARTED ITCHING ALL OVER ABOUT 10 MINUTES AFTER RECEIVING THE VACCINATION.  SHE WAS GIVEN DIPHENHYDRAMINE 25MG ORALLY.  HER SISTER CAME AND PICKED HER UP. SHE WAS STILL ITCHING AT THE TIME.
felt super tired; Sore arm after received covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after received covid vaccine) and FATIGUE (felt super tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after received covid vaccine). In September 2021, the patient experienced FATIGUE (felt super tired). In 2021, VACCINATION SITE PAIN (Sore arm after received covid vaccine) had resolved. At the time of the report, FATIGUE (felt super tired) had not resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624295 (Patient Link).
Pt came into office 7-30-10, symptoms began 7-27-10. Today site of right thigh with 8-9 cm diameter of redness, warm to touch and tenderness.
Eyes have been bothering me/eyes have waste; 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 OCULAR DISCOMFORT (Eyes have been bothering me/eyes have waste) 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.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Eyes have been bothering me/eyes have waste). At the time of the report, OCULAR DISCOMFORT (Eyes have been bothering me/eyes have waste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Fever. Chills.  Muscle aches. Nausea. Vomiting.
Bruised injection site, Mild nosebleed, blood on qtip from ear, petechiae around belly button.  Bruised arm remains, other symptoms are gone
On 03/09/2021, after having my second Covid vaccine, I had chills and was very fatigued but that went away by 2:30 PM. The next day, 03/10/2021, I awoke after sleeping very deep and when I went to walk, I PASSED OUT, hit my head and wrenched my neck. I put on an watch later that morning and within a few hours it alerted me that I was in Atrial Fibrillation. The AFIB came on with a vengeance. My heart rate was high and I headed to the ER about 6:00 PM. I was diagnosed with AFIB and was admitted to the hospital and put on medication. I saw my own cardiologist for a few months. The AFIB continued to get worse during the spring and I went to an electrophysiologist and it was suggested I get an ablation but it  but it couldn't be scheduled for three months due to the EP's full schedule. During the summer I had events where I would feel like I was going to pass out unless I sat down.  If effected my work because I would have episodes where I just had to sit all day due to how I would feel. I had two (summer & fall 2020) episodes prior to my 2nd Covid shot, but nothing was really ever diagnosed except one time the monitor recorded an SVT - Paroxysmal Supraventricular Tachycardia. The second Covid shot really changed my life and not for the better. I finally had my heart ablation on 11/4/2021. Now I wait, in the blanking period, to see if it was successful or not. I'm very concerned about getting the booster shot -- fearful it will make me have another heart situation.
hepatic thrombosis - Pt is a 51 y.o. female with a history of hyperthyroidism s/p radioactive iodine ablation who presents for abdominal distention with MR liver revealed extensive Hepatic, portal, SMV thrombosis consistent with acute Budd-Chiaria. Patent IVC. S/p DIPS/thrombectomy w/ IR
Moderna vaccine was administered outside of facility - reported by patient  I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 7/19/2021 ACUTE ST ELEVATION MI, UNSPECIFIED I21.9 ACUTE MI 7/17/2021 ACUTE ST ELEVATION MI, UNSPECIFIED I23.6 MURAL THROMBUS OF HEART POST ACUTE MI 3/2/2022 ACUTE ST ELEVATION MI, UNSPECIFIED I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 7/19/2021 ISCHEMIC CARDIOMYOPATHY W UNSPECIFIED CHF STAGE B I21.9 ACUTE MI 7/17/2021 ISCHEMIC CARDIOMYOPATHY W UNSPECIFIED CHF STAGE B I23.6 MURAL THROMBUS OF HEART POST ACUTE MI 3/2/2022 ISCHEMIC CARDIOMYOPATHY W UNSPECIFIED CHF STAGE B I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 7/19/2021 ABNL ABDOMINAL IMAGING I21.9 ACUTE MI 7/17/2021 ABNL ABDOMINAL IMAGING I23.6 MURAL THROMBUS OF HEART POST ACUTE MI 3/2/2022 ABNL ABDOMINAL IMAGING I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 7/19/2021 RENAL MASS I21.9 ACUTE MI 7/17/2021 RENAL MASS I23.6 MURAL THROMBUS OF HEART POST ACUTE MI 3/2/2022 RENAL MASS
Patient was given 0.5mL instead of 0.25mL of Moderna vaccine per CDC guidelines of 4th dose. Patient notified via phone by Public Health Nurse. Patient denies adverse affects at this time.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that, he and his wife took the initial Pfizer COVID vaccine and the bivalent COVID vaccine last Oct and had a sore arm. His wife started taking Miralax (propylene glycol) and possibly had a reaction to it. He wanted to know if vaccines have the same product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, Dizziness, Headache, Chills, Fatigue
-Very sore arm resolved in 3 days. -Ongoing brain fog that is not improving (irritability, fatigue, depressive symptoms, difficulty concentrating/thinking, lack of energy, diffiuclty with vision). Symptoms began within 24 hours and remain over 3 weeks later with no improvement and some days are becoming worse. -Nausea and poor digestion (loose stool), lack of appetite that began within 24 hours and have not improved.
She had no problem with the COVID19 vaccines other than a sore injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site). At the time of the report, VACCINATION SITE PAIN (She had no problem with the COVID19 vaccines other than a sore injection site) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-643408 (Patient Link).   Reporter did not allow further contact
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/16/21.  No adverse events have been reported by patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Anti viral drug Paxlovid was given orally to patient from 06Jul2022 to 11Jul2022 as a treatment for Covid-19. The patient did not have any known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  l the reported events Drug ineffective ,covid 19  cannot be completely excluded based on temporal association and known drug safety profile
41, woman, 127 pounds  Covid -arm rash on right arm about 1 week after receiving the first dose or shot of Moderna Covid-vaccine
Consistent fever of 102 or more; severe chills and body aches; nausea; throbbing headache; back and neck pain; racing heartbeat 111 bpm; burning eyes; swollen lymph nodes/glands; fatigue/weakness. All started about 10 pm on the night of vaccine. Progressed throughout the night. I have been taking Tylenol and ibuprofen to lessen the symptoms but it's not doing much. Difficult to sleep yet exhausted. Still experiencing all symptoms at 4 pm next day.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a big reaction after receiving SHINGRIX. The healthcare professional (HCP) reported that the adverse reaction as reported to her from a colleague, however no further details of the exact reaction or further patient information was provided to HCP about the event. The HCP reported, she could obtain further details and provide them as follow up report as a later time. No further information was available regarding the event at this time.
Fever 99.7 second day only; starting second day hives, 4th day hives appearing all over body.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 at 08:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took penicillin for unknown indication and experienced penicillin allergy. Concomitant medications taken within two weeks of vaccination included melatonin (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); both from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 12:00, the patient experienced fever 99.7 (units unspecified) on second day only. Starting second day on 21Apr2021 at 12:00, the patient also got hives, fourth day she experienced hives appearing all over body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever 99.7 (units unspecified) second day only was resolved on 21Apr2021, while that of starting second day hives, fourth day hives appearing all over body was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax;to er w/ erythema & induration on rt arm around inject site;pcn given for possible cellulitis17nov94 condition much improved;pt was attributed to an adverse rxn & cellulitis was ruled out;
rash on his right leg and also on his left leg; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer COVID vaccine yesterday. He stated that everything was okay at first and he went and took a bath and when he got out, he noticed a rash on his right leg and also on his left leg on an unspecified date. He would like to know if this was a reaction from the vaccine. He called his primary doctor and the nurse or secretary told him to call Pfizer to confirm. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
administered vaccine that was "not stored properly"/"room temperature since Monday"; got very ill for a few days; loss of energy; general malaise; nausea; chills; it was "not stored properly", "room temperature since Monday"; administered vaccine that was "not stored properly"/"room temperature since Monday"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days) and ASTHENIA (loss of energy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday") and POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"), ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PRODUCT STORAGE ERROR (it was "not stored properly", "room temperature since Monday"), POOR QUALITY PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") and EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday") had resolved and ILLNESS (got very ill for a few days), ASTHENIA (loss of energy), MALAISE (general malaise), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. Not Provided      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 assessments.   No concomitant medication was reported.  No treatment medication was reported .    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow Up document was received on 01-Jun-2021 which contains Updated outcome of the event as recovered and concomitant medication.; Sender's Comments:
URI symptoms reappeared 11.8 and started having fever's on/off, few episodes of vomiting but otherwise good appetite, in general good energy level and remained playful. Fever continued (not daily) until 11/16 without any obvious origin, 11/16 blood cx done, urine cx done, eventually positive xray for early infiltrate on 11/16.
Patient developed big bump, redness and pain the whole left arm after 2 days after receiving the PNEUMOVAX 23 vaccine.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.