chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old female patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number U5979AA and Exp. date 13-Jun-2020) via intramuscular route in the left thigh on 05-Sep-2018. On 05-Sep-2018, the patient also received a dose of suspect INFANRIX lot number not reported via unknown route in unknown administration site. The patient's medical history was not reported. Concomitant medications included KINRIX for Immunization; PROQUAD for Immunization; and HIBERIX for Immunization. It was an actual medication error due to extra dose administered as patient was given ADACEL as well as INFANRIX at same time in error and both are Tetanus, Diphtheria, and acellular pertussis vaccines. No adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
He is an healthy male with no past medical history or meds who developed headache and vision changes worse in left eye 2 days after the 2nd dose of the vaccine and was referred by local optometrist to the emergency department for optic nerve edema. He was then sent to me, who confirmed he does have papilledema (swelling of bilateral optic nerves) worse in the left eye with inferior peripheral visual field defect. He has had extensive workup including labs and MRI of the brain to r/o other etiologies, which were all normal.
Red patch (R) lateral thigh. Painful and itchy. A minimally elevated red flat patch with induration 8-9 cm in diameter.
Tested NAAT positive for COVID 10/31/21 after being fully vaccinated.
Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 24 hours.  I am *not* submitting this report for the first dose.  Dose 2: Moderate headache over next day, mild fatigue over next day, moderate joint pain over next day, same discomfort/stiffness of R arm.    The one thing I wanted to report was my L shoulder.   I had pulled/torn it around Wednesday of the week and it hurt quite a bit when I put it in the wrong position, but it was otherwise fine.   However, post-second Pfizer shot, the pain in my L shoulder easily double or tripped for some reason as a reaction to the vaccine.   Basically, Friday before the shot, my should hurt a little bit but had been getting progressively better.  But post-second Pfizer shot, the same area that had mild pain before now felt like I had been stabbed in the shoulder or that I had re-torn the muscle and had done so in a significantly worse way.     It's not a big thing, but you may want to start asking people if they've recently had any muscle injuries prior to vaccination.  I'm now ~30 hours post vaccine and it is decreasing in pain, but the shot obviously had some type of impact on what bruising/swelling/tearing of my L shoulder that I had.  (Note that both vaccine shots were to the R arm and the L should was not related to that in any way.)
Patient came into the pharmacy the day after receiving flu shot complaining of arm pain that occurred immediately after receiving flu shot. The patient said he had trouble lifting his arm above his head and had pain in the vaccinated arm. I asked to see where the vaccine was injected, and it appeared to be in the correct location of the deltoid muscle. He called the next day saying that he had regained motion in his arm but was still feeling sore. I let him know it may take a few days for the soreness to subside, but he can take NSAIDs and apply cold compress on the area to help relieve the soreness. Then on 10/14/2023 the patient returned to the pharmacy and said that while he regained full motion in his arm, he is still experiencing arm pain almost 3 weeks later.
1. Dizziness 2 minutes after shot and ?felt weird?. This lasted around a minute and resolved. 2. Burning or cold sensation going up both sides of the back of my neck (maybe within 3 or so minutes of receiving vaccine). This just lasted a few seconds and resolved. 3. Felt heart rate increase. Measured heart rate after about 15 minutes it was 91bpm. My resting HR is typically in the 50?s or 60?s or lower. My heart rate jumped around, went back down to 60?s and then a few minutes later back to 91 bpm.  (I did not measure my heart rate immediately) 4. Tasted vaccine on anterior portion and tip of tongue. Still think I taste something.  Left after 30 minutes. Reported rapid heart rate to pharmacist. Went home. Didn?t feel great but ok. That night sore arm which worsened and then now improved today, no pain.  02/17 felt a little better. 02/18 felt nauseous and ?weird? in am. Felt better in pm. Today I feel ok.
Pain in muscles in both legs from top to bottom of leg severe.  Sometimes cannot walk the pain is so bad.
TOOK DOSES ON DAYS 1, 3, 4 AND 5; This spontaneous case report (PVX2019-2567) was received from a consumer on 14-Oct-2019. It described a female consumer who "took doses on days 1, 3, 4 and 5" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to schedule. The doses were taken on 10-Oct-2019, 12-Oct-2019, 13-Oct-2019, and 14-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took doses on days 1, 3, 4 and 5" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses on days 1, 3, 4 and 5" was considered as not applicable.
Red; Hot to touch; Itchy; raise in temperature; Large bump on injection site a size of tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Large bump on injection site a size of tennis ball). On 26-Feb-2021, the patient experienced ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature). At the time of the report, INJECTION SITE MASS (Large bump on injection site a size of tennis ball), ERYTHEMA (Red), SKIN WARM (Hot to touch), PRURITUS (Itchy) and PYREXIA (raise in temperature) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Developed pain in left arm from elbow to shoulder. Rates pain as a 5 out of 10. Also, itching in area of upper arm and shoulder. Pain and itching interfere with sleep and daily activities. Pain has remained steady, neither worsening or improving. Spoke with NP 11/30 who thought it was a pulled muscle. Saw MD 1/4/10, ADVIL x 10 days prescribed for muscle inflammation. Pain improved but returned when ADVIL stopped.
hives down her shoulders and across her buttocks/A few hives on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives down her shoulders and across her buttocks/A few hives on her right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (hives down her shoulders and across her buttocks/A few hives on her right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (hives down her shoulders and across her buttocks/A few hives on her right arm) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  The patient had a few hives on her right arm at the time of this report but otherwise it had cleared up.
I developed a slew of digestive, hormonal, and mood disorders since the administration of the Gardasil vaccines. I had no health issues prior to the vaccines and within a year of receiving them, I developed multiple food allergies, PCOS, OCD, anxiety, dysmennorhea, random episodes of lightheadedness and feeling like I am going to faint, and now I am dealing with possible infertility, since I am on an extremely restricted nutrient rich diet and have not been able to conceive a child in almost a year. I was given this vaccine against my will as an almost 18 year old, I objected strongly to it after hearing of others' reactions, and now the quality of my life is severely diminished. I have wasted thousands of my own money trying to get well and having to deal with adverse health issues as they come up.
Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was discharged home in a stable condition. BP 139/91, O2 sat 97 % RA, HR 68.
Developed Lipshtz ulcers and they increased in pain, swelling, and severity; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 01May2021 at 11:30 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, cleft soft palate repair, club foot repaired, syndactyly repaired and hearing loss right ear. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and gliclazide (CLARITIN) both for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 10Apr2021 at 11:15 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 22:00 the patient developed Lipshtz ulcers beginning hours after 2nd vaccine dose and they increased in pain, swelling, and severity. The event resulted in emergency room/department or urgent care on 04May2021, doctor or other healthcare professional office/clinic visit on 06May2021and pediatric gynecology visit on 07May2021. Therapeutic measures were taken as a result of the event and included treatment with steroid cream (MANUFACTURER UNKNOWN), lidocaine (MANUFACTURER UNKNOWN) and macrogol (MIROLAX). On 07May2021, the patient underwent unknown test (nasal swab) and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event developed  Lipshtz ulcers beginning hours after 2nd vaccine dose and they increased in pain, swelling, and severity was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Lingering headache; A spontaneous report was received from a other healthcare professional, concerning a 50-year-old female patient, who received Moderna's COVID-19 vaccine and experienced lingering headache.  The patient's medical history reported included coronavirus on Jun 2020. Concomitant medications were not provided.  On 30 Dec 2020, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 30 Dec 2020, after the vaccination, the patient experienced headache for about six days. The severity of the headache was unknown. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, lingering headache was resolved on 04 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Swelling, redness and pain at site of injection for 1 week; swelling and induration in about 3"x 6" area on arm.
APPROX 2 HRS AFTER RECEIVING SECOND SHINGRIX VACCINATION, PT STARTED HAVING MYALGIAS, NAUSEA AND VOMITING WITH SEVERE HEADACHE.   PROGRESSED TO CHILLS, MORE SEVERE HEADACHE WITH EXTREME PHOTOSENSITIVITY  AND FEVER.   PT DESCRIBED HEADACHE AS A 10 OUT OF 10 WITH PHOTOSENSITIVITY SO SEVERE PT COULD NOT OPEN HER EYES.   PT WAS SEEN FIRST IN URGENT CARE AND WAS GIVEN ODANSETRON 1 MG FOR THE NAUSEA AND WAS ADVISED TO GO TO ER.   PT WENT TO HOSPITAL AND EVALUATED, DIAGNOSES: MIGRAINE HEADACHE BROUGHT ON BY ADVERSE VACCINE REACTION AND ADVERSE REACTION TO SHINGLES VACCINE.   WAS GIVEN BENADRYL, REGLAN, TORADOL AND ATIVAN IN ER AND WAS FEELING BETTER AFTER WITH NO HEADACHE AND LESSENED BODY ACHES.
I had nerve pain 8 on pain scale on 1/7, mostly centered on my back along my spine but when it was at its worst it was anywhere my skin was in contact with anything. First started feeling like my back itched at around 6:30pm. At 8:30pm, I started feeling exhausted and feverish. I took my temperature, it was 100.6 F, I took acetaminophen (2, 650mg tablets).  My symptoms did not get better and I started having chills and pain like needles stabbing me anywhere my clothes were touching me. I went to bed at around 11pm and tried to sleep unsuccessfully until 3am, tossing and turning in pain anywhere my skin was being touched, before trying ibuprofen (600mg, the dose I take for my migraines) which seemed to help and I finally fell asleep.  Next morning woke up feverish, exhausted, and in pain again. Once again ibuprofen helped and I continued taking it every 8 hours for the next day until my symptoms were no longer coming back when the dose was wearing off. Last ibuprofen was probably 10pm on 1/8.
Mild nausea; Feeling hot; Intermittent left face tingling; discomfort on the left arm; Mild headache; mild achiness all over her body; A spontaneous report was received from a consumer concerning a 56 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced multiple events of felt hot, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea.  The patient's medical history included, fibromyalgia, traumatic brain injury (right side, occipital), 2 large thyroid nodules and osteopenia. The concomitant medications included fosamax and calcium, colecalciferol for unknown indication.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced felt hot, mild headache, intermittent left face tingling, discomfort on left arm and mild achiness all over her body.  On 29 Dec 2020, the patient experienced mild nausea. The treatment information included Motrin.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, felt hot was considered recovered/resolved on 28 Dec 2020.   The outcome for the events, mild headache, intermittent left face tingling, discomfort on left arm, mild achiness all over her body and mild nausea was considered as not recovered/not resolved.; Reporter's Comments: This case concerns a 56-year-old female who experienced NS unexpected events of limb discomfort, paraesthesia, and feeling hot and NS expected events of headache, pain, nausea.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Motrin. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient developed nausea, dizziness, SOB, blurred vision 30 minutes after receiving vaccine. Seen in Emergency Department. Provider did not feel symptoms a consequence of vaccine.
Relapse of Covid symptoms 4 days after completing Paxlovid; Relapse of Covid symptoms 4 days after completing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Relapse of Covid symptoms 4 days after completing Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07May2022 to 11May2022. No Known allergies.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Drug Ineffective and COVID-19 cannot be totally excluded.
Pfizer BioNTech Covid-19 Vaccine EUA. Pt stopped by pharmacy today and reported that morning after his 2nd dose (6/14) he began experiencing shortness of breath, chest tightness, and chest pain. He also experienced fever and chills which resolved by Tuesday. Shortness of breath, chest tightness, and chest pain continued and patient was still experiencing today (6/17). He took motrin/ibuprofen which helped relieve some of pain, but some still remained. Blood pressure at pharmacy today was 115/109 mmHg with a heartrate of 86 BPM. A few minutes later it was 120/96 mmHg with a heartrate of 101 BPM. Recommended patient follow up with primary care physician urgently and get checked out at emergency room or immediate care.
TOOK THREE UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2116) was received from a consumer on 15-Aug-2019. It described a female consumer who "took three unrefrigerated doses of Vivotif" (PT: Product storage error), while being on oral Vivotif (one dose every other day) for travelling to endemic area.  Case report: The consumer took three doses of Vivotif, which were no longer good to use. The doses were taken on Sunday, Tuesday, and Thursday. She would be leaving to the endemic area in a week.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses of Vivotif" was considered as not applicable.
Severe L-sided Bell's Palsy, onset 2/15/2021.  .  Per CDC recommendations we are reporting this to VAERS.
Palm-sized itchy rash surrounding injection site started about 7 days after the first Moderna injection. Accompanied by deep fatigue. The fatigue lasted about 2 days (managed with rest); the rash was mild (managed with cold compress and oral over-the-counter antihistamine) and lasted about 5 days.
chills, sweating, elevated body temp to 100.2 degrees, headache, light-headedness, acute weakness, would have fainted/blacked out if I had not been aware enough to ease myself to the floor.  symptoms lasted a few hours, i.e. 5 hours later, I was still too weak to stand and brush my teeth at a sink.  treatment consisted of sleep/rest until symptoms subsided.  it was 24 hours before I felt back to normal.
Flu symptoms.  Body ache. Chills. Fever. Starting at 8pm 8 hrs after shot. By 9am. Symptoms were gone
right arm is itching; it has swelling around it/shocked that it was so swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen). At the time of the report, VACCINATION SITE PRURITUS (right arm is itching) and VACCINATION SITE SWELLING (it has swelling around it/shocked that it was so swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
pt started crying @ 6PM  & was very uncomfortable &couldn't move legs or walk;cried non-stop from about 6PM-12MN;also had a high temp about 104;vomiting;cry was also high pitched;still has low temp;
Pt recv vax on 10/29/98; post vax pt exp red/swollen/ hot/tender vax site, fever (102.3)
This spontaneous report was received from an 18 year old male patient, as part of a marketing research program (manufacturer number MRK239), concerning himself. The patient was vaccinated with a dose of GARDASIL (lot# not reported) in AUGUST 2012. In AUGUST 2012, the patient experienced dizziness/faintness and pain in arm. The outcome of pain in arm and dizziness/faintness was reported as recovering/resolving. The reporter considered dizziness/faintness and pain in arm was related to GARDASIL. Additional information has been requested.
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported   This case was linked to MOD-2021-369020 (Patient Link).