chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age (reported as Age: 17; Unit: Unknown) received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Outcome of the event was unknown.
few days after taking the vaccine his foot started swelling, fingers started turning black and also from his ankle down it was turning black, went to ER had a lot of blood clots
Person has a rash over his chest area since night of flu shot. He has taken hydrocortisone 1% cream which has not relieved his symptoms. He will start taking BENADRYL today.
Vaccine Pfizer-BioTech Covid-19 Vaccine expiration date 09/30/2022 was administered to the patient by Agency on 10/03/2022.
sore throat; congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) in a male 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. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
I woke up Tuesday morning, December 6, 2022, with a significant sore throat and generally not feeling well. I took a COVID-19 test and it was positive. I took MUCINEX and ADVIL and went back to bed. My fever was 102. I did not have a cough or congestion. I did have severe diarrhea. I had a tele visit with the doctor and I began PAXLOVID on December 6, 2022. On Sunday, December 11th, I was feeling better. I remained to be worn down and fatigued. The following week around December 21st, I started to cough and feel horrible again. I had a fever again. On December 27th I visited the doctor because my throat felt constricted. I was given an inhaler and two antibiotics. I have terrible brain fog, dizzy and continue to feel shaky.
achiness & discomfort at the injection site; achiness & discomfort at the injection site; This is a spontaneous report from a contactable female consumer (patient) via Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown) on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, she received the first dose of the vaccine for covid-19 immunisation.The patient experienced achiness and discomfort at the injection site on Feb2021, non serious and described as follows: she received both inoculations and got the 2nd dose on 05Feb2021. She stated she was currently experiencing side effects like achiness and discomfort at the injection site. The final outcome of the events was reported as unknown. Patient wanted to know if can take Tylenol or Advil and also reported that she put a wrong date on her VSafe. No follow-up attempts are possible, information about batch number cannot be obtained.
Late 2nd dose on 25May2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   Previously administered products included Shingrix (On 9th August 2019, received first dose.).   On 25-MAY-2023, the patient received the 2nd dose of Shingrix. On 25-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose on 25May2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter reported that the patient received late second dose of Shingrix vaccine. Vaccine administration facility was the same as primary reporter  The reporter did consent to follow up via email. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Enzyme abnormality (liver enzyme).    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 ADVERSE REACTION (side effects). At the time of the report, ADVERSE REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
I went on a cruise, and I got the Covid before boarded or so I assume I got on the ship. Because it was a requirement to even board is why I believe I was positive before getting on. I started feeling sick by the end of November and I was so tired and having so much fatigue. I went to see a medic while on the ship because I didn't trust my COVID-19 cabin test. The medic tested me and I was positive so I was stuck in isolation on the cruise in my cabin for 2 days. The cruise dates where 11-22-2022 to 12-06-2022.
Vascular headache probably secondary to MENACTRA vaccine. Severe headache onset within minutes of vaccination. Vomited once. Treated with Ibuprofen 800 mg every 4-6 hrs.
This spontaneous consumer report (initial receipt: 03-Jan-2012) concerns a 73-year old male patient, who had a medical history of high blood pressure and allergy to tomatos and grapefruit. Concomitant medications included fexofenadine, omeprazole and high blood pressure med (medication). On ??-Aug-2011 the patient received AFLURIA. He also received 1 time ZOSTAVAX subcutaneous injection for shingles prevention. On ??-Aug-2011 the patient had an outbreak of what he believed to be chickenpox. He had tiny red spots (blisters) and clear liquid came out. He also stinging and itch continuing since vaccination. Treatment included salve fluocinodine 0.05%. The event outcome was not reported.
Mother reported patient was w/out fever but started vomiting about 8:00pm then became semi-unresponsive and started "jerking arms & legs". Patient continued this through the night even when asleep.
fever 99.9  headache, chills, nausea, achy  all over, sweats, miserable
No adverse events noted 8/12/21 via mychart.  phone number in chart not correct, unable to reach patient/parent.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: AJ6739) at the age of 60 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Crohn's" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Metformin, reaction(s): "Known allergies: Metformin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Mar2023 to 14Mar2023.
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 19-DEC-2014 the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX, (dose, route, lot number and expiration date not reported). This was purely a medication error. No adverse effect reported. Additional information has been requested.
Patient was normal and little nervous before vaccination. After receiving vaccinations about 2 minutes patient stated he could get up and was shaking. He was pale and sweating. Pharmacist Rima left the room to get another pharmacist. Patient mom reported she saw him passing out and eyes rolling. Patient was conscious after and had difficulty breathing but return to normal after a few minutes. We gave him a ice pack and called 911 to be ready on hand but was not dispatched. Patient rested in the room and left on their own.
ill w/flu shot; went to MD & treated for URI- thought it was flu shot; treated w/ATB terrible sore throat; 10NOV-23NOV;
Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Patient was given vaccine beyound 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was given vaccine beyound 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022).    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after date.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-SEP-2017, the patient was vaccinated with an expired dose of PROQUAD expiration date: 22-SEP-2017 (dose, route of administration and lot# were not reported). There were no adverse symptoms reported. PROQUAD did not have any temperature excursions prior to administration.
On 22 September had no significant medical history or concurrent conditions. Concurrent vaccination include pneumococcal vaccine and an unspecified vaccine each given in the left leg on the same date, 22 September 2006, as Pediarix. On 22 September 2006 the subject received 2nd dose of Pediarix at 0.5 ml intramuscularly, in the right thigh. An unknown amount of time later, on the same day of vaccine administration, the subject developed "a knot at the sight of administration of the Pediarix." This was considered to be a medication error. It was thought that the vaccine went into fat instead of the muscle. At the time of reporting  the outcome of the events was unspecified.
Sedation Injection site reaction, chills Narrative: Extreme swelling at injection site (left deltoid) and lymph nodes (both submandibular and axillary) and extreme fatigue and chills.
Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PATIENT CALLED ON 8/24/21 AND STATED THAT ON 8-12-21 SHE STARTED HER MENSTRIAL CYCLE 2 WEEKS EARLY AND BLEED HEAVY FOR 7 DAY AND THEN STARTED BLEEDING MORE THAN NORMAL, ON DAY 3, 8-13-21, SHE HAD HIGH BLOOD PRESSURE 150/115 AND IT IS USUALLY ON THE LOW SIDE, HER O2 WAS 91,  SHE STATED THAT SHE HAD A MUSCLE SPASEM IN HER RIGHT LUNG AND HEART PALPITATIONS, CHEST WAS HEAVY AND SHORTNESS OF BREATH.  TODAY 8/24/21 SHE SAYS HER BP IS STILL HIGH AND STILL A LITTLE SHORT OF BREATH BUT NOT AS BAD AS BEFORE.  WE STRONGLY RECOMMENDED THAT SHE SEE A DOCTOR.
lt arm sore started 11NOV96 unable to turn steering wheel, afeb, no edema, no erythema;yellow bruise 3-4mm, deltoid muscle, very hard when arm is relaxed;
SLEPT MORE THAN USUAL; MORE TIRED AND DRAINED THAN USUAL; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced slept more than usual, and more tired and drained than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more tired and drained than usual and slept more than usual was not reported. This report was non-serious.
Hard painful lump post injection (day 1), itching and redness 7 days post injection.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medications were provided.   No treatment was reported for the events.
Splitting headache; Nausea; Redness and swelling on left arm at injection site.  It looks like a red knot.; Redness and swelling on left arm at injection site.  It looks like a red knot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.), HEADACHE (Splitting headache), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) 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 30-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.). On 02-Nov-2021, the patient experienced HEADACHE (Splitting headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.), HEADACHE (Splitting headache), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.) outcome was unknown.            Concomitant medications were not provided.  Treatment information included Nausea relief.
Received the first COVID vaccine on March 18 and two days later I suddenly lost hearing in my left ear. This was near total hearing loss. I could only hear a slight buzz when putting a phone to my ear and listening for the dial tone. Went to my health care provider a couple of days later. They cleaned both ears and examined for any obvious problems. This seemed to improve the hearing in the ear slightly. Physician's Assistant said the hearing loss was most likely a reaction to the vaccine and advised giving it two weeks to see if it improves. Hearing didn't improve much (if at all) throughout the remainder of the week. Over the weekend of March 27-28 hearing seemed to be improving. This morning, March 29, hearing has noticeably improved and I can carry on a phone conversation using my left ear. Hearing is not back to normal yet but it is much better than a few days ago.
47 yo female received Moderna  vaccine  via IM L/upper arm (Deltoid) at 10:54AM.  Itching started 10:54Pm.  Pt reported at 11:07 AM.  Pt states late report was to see if itching will stop.  So far itching on L/upper arm and chest.  At 11:am pt was itching all over.  11:20 AM Benadryl 25mg via IM given.  EMR medical staff contacted.  Pt refused to go to E.R.  On advice of EMR.  Pt will go home and continue with Benadryl for itching.  Reports no shortness of breath.  Pt was discharged at 12:00 non when a family member picked her up on a private vehicle.  11:15 V/S: B/P 158/96, P 8, RR 20, O2 sat 99%.
Patient came to appointment with clinical pharmacist on 6/27/2106 at anticoagulation management clinic. Patient is taking warfarin. Pharmacist noted patient had left shoulder bruise from pneumococcal vaccine that was given 5 weeks prior to this appointment. Pharmacist was surprised to still see a bruise from vaccine administration. Patient declined referral to PC or UC for further evaluation. Pharmacist added reaction into patient's chart.
vaccine leaked out during administration of the injection; needle was not snuggly attached to the syringe; A spontaneous report was received from a nurse practitioner concerning a patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced needle that was not snuggly attached to the syringe/MedDRA PT: device connection issue and vaccine leaked out during administration of the injection/MedDRA PT: underdose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Jan 2021, the patient received unknown dose number of mRNA-1273 (Lot # not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, upon administering Moderna vaccine, the needle was not snuggly attached to the syringe; therefore, some of the vaccine leaked out.   Action taken with mRNA-1273 in response to the events was not provided.  The events needle was not snuggly attached to the syringe and vaccine leaked out during administration of the injection were considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Headache, Myalgia, Arthralgia, Chills, fatigue Narrative:
Has localized swelling and redness with pain. Home care of BENADRYL, MOTRIN and cold compress.
Starting getting swelloning in (R) arm pit, neck, some weakness in neck, headache and runny nose.
Pain at the injection site; Itchiness at the injection site; Painful rash on the arm of injection and traveled to chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Painful rash on the arm of injection and traveled to chest), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and COVID-19 virus test on 20-Dec-2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site). In January 2021, the patient experienced RASH (Painful rash on the arm of injection and traveled to chest). At the time of the report, RASH (Painful rash on the arm of injection and traveled to chest) had not resolved and VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the events included diphenhydramine.
H1N1 influenza shot reaction ringing ears, Parasites infection 3 weeks later. Soreness, couldn't lift right arm or dress self. Arm frozen and lost feeling on one side. Breathing problem. Went to Emergency 3 weeks later still problem. Took x-rays and was given therapy. Allergies other Flu shots.
INFLAMED RASH, UNCONTROLLED SCREAMING, LOSS OF APPETITE, SEVERE DROOLING WHILE EATING, TEMP OF AT LEAST 104 UNCONTROLLED BY TYLENOL AND MOTRIN, NOT  BEING ABLE TO SLEEP, TOTALLY INCONSOLABLE. THIS WENT ON FOR THE WHOLE WEEKEND AND WENT THROUGH TO MONDAY.