chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme confusion; anxiety; scared; injection hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (extreme confusion), PAIN (injection hurt), ANXIETY (anxiety) and FEAR (scared) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Meningitis in 1972 and Neurological complication associated with device in 1972. Concurrent medical conditions included Anxiety on 08-Jan-2021.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (injection hurt). On 07-Jan-2021, the patient experienced CONFUSIONAL STATE (extreme confusion), ANXIETY (anxiety) and FEAR (scared). At the time of the report, CONFUSIONAL STATE (extreme confusion), PAIN (injection hurt) and FEAR (scared) had resolved and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a pharmacist concerning an adult female client with an unknown previous vaccination history who was Pneumovax 23 (lot unknown). Subsequently the client experienced a "severe local site reaction" and "induration the size of a softball." It was reported that the client sought unspecified medical attention. No other information was available at the time of call. There was no product quality complaint involved. It was reported that two other adult females experienced local site reactions and induration after administration of Pneumovax 23 (lot unknown) (WAES0412USA01332 and WAES0502USA00005).  Additional information has been requested.
Feel like I have a cold; Hoarse voice; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice). At the time of the report, NASOPHARYNGITIS (Feel like I have a cold) and DYSPHONIA (Hoarse voice) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication provided.  Patient called with a hoarse voice and apologized saying it was due to the COVID shot. Feels like a cold as well.  No treatment information mentioned.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 9:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 9:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.86.  Concomitant products were not provided.  On 24-May-2021, at excursion time 8 AM, temperature was 35, at excursion time 9 AM, temperature was 35. Total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-May-2021, vial was moved to clinic on 24-May-2021. 1 vial were sent to clinic. Vaccine BUD date was 02-Jun-2021. vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 3 vial were sent to clinic. Vaccine BUD date was 17-Jun-2021.  On 24-May-2021, vials were stored in cooler 1, at following time and temperature respectively, 8AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  No vial had undergone any temperature excursions. There were no adverse reactions to the vaccine as reported by the patient. Reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains Non significant information. Added: secondary reporter details.
Patient came to the pharmacy with non-itchy, non-painful flat red rashes on her left arm (upper arm and forearm) below the vaccination site. She reports that they appeared approximately 2-3 days after her booster dose. She also reports new onset fatigue that does not interfere significantly with activities of daily living. Both sets of symptoms have persisted for the past 2 weeks since vaccination.
As the evening/night progressed after the injection was given, I started to feel a headache and body aches.  During the night, I am positive I had a fever and chills, but I felt too poorly to go get the thermometer and check my temperature and just went back to sleep.  When I woke the morning after the injection, I had full blown headache and body aches, but I did not feel as though I had a fever anymore.  I slept the entire day after the injection.  The 2nd day after the injection, I still had mild headache and body pains, but also felt a little dizzy and stayed in bed again.  By the 3rd day after the injection, I was back to normal and went to work.  During the worst part of the headache and body aches, I took NyQuil to sleep.
On 10/24/00, in the evening, she noticed her arm was swollen just below the shoulder, extending to elbow and 3/4 diameter around arm. It felt sore and hard. She saw a doctor who said it was either cellulitis, infection or allergy. Pt was put on Cethalxine 500mg BID X 10 days.
Severe Tinnitus; Slight soreness at injection site on 06Feb2021; This is a spontaneous report from a contactable consumer, the patient.  A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 06Feb2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization.   Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and simvastatin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oxycodone hydrochloride/paracetamol (PERCOCET) on unknown dates for an unknown indication and experienced drug allergy.  The patient experienced slight soreness at injection site on 06Feb2021 and severe tinnitus on 08Feb2021 at 05:00; both reported as serious for disability.  The tinnitus was further described as intermittent and constant buzzing and vibrations in right ear only. No other issues or symptoms. The patient did not receive any treatment for the events. The clinical outcomes of the tinnitus and slight soreness at injection site were not recovered.
parent called said small black & blue area 1/2" diameter lt arm some swelling;father brought pt to clinic exam by RN;
Narrative: Symptoms:  & Cardiac Arrest; Death Treatment:  EPINEPHRINE
Spoke with pt. dad. Pt had Hep A and typhoid injections about an hour ago and he is complaining of headache at back of head, nausea, cold hands and shaking arms. I encouraged that they call his physician and seek medical help. Dr. aware.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, fever, chills and general body pain. In April 2018, the outcome of the injection site pain, injection site itching, fever, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching, fever, chills, and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The fever and chills lasted about a day and a half. The body aches, injection site pain and injection site itching lasted over a week. No further information was reported regarding the event.
red swollen upper arm from armpit t elbow, itches. first noticed 10/19/99 while at work. suggested call MD office.
Vaccine administered Sat 2/4/17, on Sunday morning injection site was itchy, patient scratched it, put ice on it. Rash similar to bulls eye and was darker red and swollen in center. About a 3 inch rash. Patient felt out of it on Monday and Tuesday. Patient has asthma and was wheezing on Monday and Tuesday as well.
Patient returns call states he received a pneumonia vaccine today. Now his arm is swollen, red and hot. States it is about baseball size. States it is now getting itchy as well.
Patient came back to pharmacy 3 days after receiving the immunization complaining of muscle pain, throbbing of hand veins and a stabbing pain on the left side of her body.
This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PNEUMOVAX23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Two days after receiving her booster,  developed a 4 by 4 centimeter bump on her forehead.  She did not believe that she had bumped her head on anything, and there was no evidence that a bump had occurred (no redness or bruising then or after).  There was also no tenderness to the bump, and she felt completely fine (no fever or other complaints).  By the time we took her to the doctor the following morning, the bump had decreased in size by a lot, and it appears to be going away.  While her pediatrician was unsure what would have caused this, she felt that it was not likely vaccine caused but still recommended that we report it in case others have experienced something similar with the Pfizer vaccine. Had no noticeable side effects from the initial two Pfizer doses, but she did feel a little tired and achy the day following her booster shot.
This spontaneous report was received from a nurse refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored  ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 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 involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
Woke up with fever next day. Left arm was swollen, red and bothered pt. Mom took pictures. Lasted 6 days gave her steroid cream and motrin
Patient's brother, age 4, came down with chicken pox 4 days after patient received the vaccine.  Pt had >103.5 fever 9 hours after the shots and was lethargic for 24 hours.  The fever was resolved about 8 hours after it peaked.  The brother broke out in chicken pox 4 days later.  He had two crops of 15 spots, one on chest, the other on his left arm, on successive days, no fever but malaise and runny nose for 3 days (so far).  We expect another couple days of same symptoms.  He takes systemic Benadryl every six hours.  I recognize this may be independent of pt's vaccination but I thought I'd report it anyway.  He was innoculated for varicella at age 3.  I don't remember if he was innoculated against it before that.  The doctor's office said he was vaccinated on 9/1/02.  He also received vaccinations the day pt did - DTaP, MMR & IPV.
CHEST PAIN; MUSCLE WEAKNESS; CHILLS; FATIGUE; FOGGY HEADED; WAS UNABLE TO SLEEP; FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 09:50 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced foggy headed. On 29-APR-2021, the subject experienced was unable to sleep. On 29-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 29-APR-2021 17:00, the subject experienced muscle weakness. On 29-APR-2021 17:00, the subject experienced chills. On 29-APR-2021 17:00, the subject experienced fatigue. On 30-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle weakness, fatigue, and chest pain, had not recovered from foggy headed, and fever, and the outcome of was unable to sleep and chills was not reported. This report was non-serious.
Dizzines/Vertigo/Nystagmus/Outer body feeling Intermittent, severe symptoms approx. 1 month apart from each other
Information has been received from a licensed practical nurse concerning an approximately 11 year old female patient with irritable bowel syndrome and no drug reactions or allergies who on 06-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (Lot# not reported, expire date 27-OCT-2010)). On 31-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot# not reported). On an unspecified date, the patient was diagnosed with Crohn's disease after receiving VARIVAX (Merck). There was not concomitant medication. It was also reported that the patient's varicella titer was found to be negative. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. On follow up information received on 22-NOV-2010, the medical assistant reported that the patient's Crohn's Disease was unrelated to the dose of VARIVAX (Merck). Follow up information has been received from the medical assistant concerning the female patient who on 06-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (Lot# 647259/1137N). On 31-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot# 662450/1385X). It was reported that there was no adverse reaction. The GI doctor wanted to know if having Crohn's disease was going to effect the VARIVAX (Merck) from working. Patient had Crohn's had nothing to do with VARIVAX (Merck). GI doctor did not feel Crohn's was from the VARIVAX (Merck). No further information is available.
Patient is a 30 y.o. female Patient received Covid vaccine at immunization site.   During 15 minutes post-monitoring period: Please see additional note below regarding counseling points, monitoring, and interventions done.     COVID-19 Vaccine Adverse Reaction                          Reaction due to: First dose of vaccine Symptoms: Difficulty swallowing, Throat tightness, Dizziness/Lightheadedness, Shortness of breath, Lip and/or tongue swelling How long after administration did the symptoms start?: Immediately (within 15 minutes) Interventions: Additional monitoring, Education provided regarding symptoms and home care, Other (comment) (pt used her own epi pen with improvement, given 50mg oral diphenhydramine) If reassessed, patient's condition: Improved (improved with epi pen) Disposition: Education and follow-up phone number (given follow-up precautions)  Pt experienced throat and tongue swelling 10-12 minutes after Pfizer COVID19 vaccine that improved with the use of her own epinephrine pen.  Symptoms rapidly improved. Pt was given 50mg oral diphenhydramine. BP 136/86 hr 93, SaO2 100%.    Was counseled on when to seek emergency medical attention. I advised pt to be evaluated by allergy specialist prior to her second dose and pt says she already has one via facility. Has her fiance to drive her home. 30 min observation with periodic vitals.    11:40a BP 120/76  11:45a BP 126/70 HR 86, SaO2 99%
ond dose in her muscle at all but that it might have gone into the fat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and administered in arm left, administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Cholesterol high" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol increased; AMLODIPINE taken for hypertension. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Apr2021, outcome "unknown", described as "ond dose in her muscle at all but that it might have gone into the fat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..
Had diarrhea 6-10 days after Rotateq very watery deferred vaccines in future.
One day after varicella vaccine at injection site (L) upper arm 5cm area of induration with redness, warmth and tender to touch. Treatment BACTRIM DS BIDx7-10d. Started BACTRIM 8/21/18.
vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient reported he previously filled out a lengthy ADR form and had no interest in filling out another form. He only reported the above response via email.  No treatment was provided by the reporter.   This case was linked to MOD-2021-020244, MOD-2021-020244 (Patient Link).
Watery eyes (3days straight), fatigue (1 week) sore throat/headaches (1 week), sore injection site (1 week)