chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included congested in nose. The patient experienced drug allergy when treated with acetylsalicylic acid, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-MAR-2021 09:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, diphenhydramine hydrochloride, loratadine, and pantoprazole sodium sesquihydrate.  On 27-MAR-2021, at 17:00 the subject experienced chills till 20:00. On 27-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 C. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 27-MAR-2021 20:00, and the outcome of fever was not reported. This report was non-serious.
-HEART RACING/HEART FLUTTERS FOR A FEW HOURS DURATION ON JANUARY 29, 1 DAY AFTER VACCINE ADMINISTRATION -FATIGUE LASTING 4 DAYS FOLLOWING COVID-19 VACCINE ADMINISTRATION
no adverse event; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion of 10.8 fahrenheit degrees for 1 hour and 39 minutes.  On 06-OCT-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W017574, expiration date: 29-NOV-2023 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.  This is one if several cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA002172: US-009507513-2210USA002083: US-009507513-2210USA002276: US-009507513-2210USA002508:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose number unknown, single (Lot number: Fj1620) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid for COVID-19 from 11Jan2023 to 16Jan2023.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer, describes the occurrence of product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039A21A) for COVID-19 immunization. No medical history provided. Concomitant products included vitamin 15 for an unknown indication. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time). At the time of the report, product dose omission issue (not receiving the 2nd dose of the Moderna COVID 19 vaccine on time) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Chest pain; Chills; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), CHILLS (Chills) and MYALGIA (Body aches) 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 CHEST PAIN (Chest pain), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHEST PAIN (Chest pain), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition was provided).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition was provided).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced TOOTH INFECTION (Tooth infection). At the time of the report, TOOTH INFECTION (Tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       15 days post vaccination, the patient reported that he had a tooth infection. The patient stated that the symptoms were ongoing.   Treatment information included an unknown dosage of Amoxicillin   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
chronic intermittent blurred vision. typically in right eye but sometimes in left. Has only happened in both eyes at the same time one time. Optometry instructed me to use lubricating eye drops and gave updated eye glass prescription. new glasses lessened the severity of the blurred vision and eye drops sometimes help reduce duration of blurred vision episodes, but do not reliable resolve the issue at the occurrence.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot # L030442, expiration 19-DEC-2016, dose and route were not reported) (incorrect product storage). The vaccines were stored in temperature of 33F for 9 hours and 50 minutes. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Chicken cooked a certain way does not taste right; was told that he had Covid four months ago after the second shot; was told that he had Covid four months ago after the second shot; This is a spontaneous report from a contactable nurse (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 (lot number was not reported) as single dose, dose 2 via an unspecified route of administration in 2021 (Lot Number: EWO175) as single dose, both at the age of 62-year-old for covid-19 immunization. There were no medical history and concomitant medications. It was reported that on an unspecified date in 2021, the patient went to get an antibody and was told that he had Covid four months ago after the second shot. The patient reported that in Jul2021, chicken cooked a certain way did not taste right. Stated that if it was broiled that he could taste it. Stated that he ate different vegetables. Stated that he is a homecare nurse for his better half who has cancer. Stated that they were into smoothies and eating good. Stated that he had not had smoothies in 3 months because he had not had the desire. Stated that he was back into the habit of eating bananas, grapes and strawberries. This was after the second shot. Stated that he tells himself every morning that he would make a smoothie but he did not had desire. Stated that when he gets hard he gets hard. Outcome of the event covid was recovered in 2021; did not taste was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Injection site warm to touch; Injection site pain; Injection site swelling; Fatigue; Chills; Headache; Muscle pain; Joint pain; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, and CHILLS in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, CHILLS, HEADACHE, MYALGIA, ARTHRALGIA, and NAUSEA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, CHILLS, HEADACHE, MYALGIA, ARTHRALGIA, and NAUSEA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/84 (High). On an unknown date, Body temperature: 97.9 (normal). On an unknown date, Heart rate: 82 (normal). On an unknown date, Respiratory rate: 16 (normal).     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.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter details updated, patient demography updated, first dose details updated, event details were updated, lab data detail updated. On 16-Jul-2021: Email correspondence received and it contains No New Information.
Patient has a rash over arms, legs, and on stomach. She had flu like symptoms on Monday and continued into yesterday. The flu like symptoms have improved. The rash has not. She wanted to report it.
Patient has deep pain inside deltoid muscle so severe it is waking him up at night. No reports of swelling, bruising, edema, or redness/erythema. Patient had hernia surgery on 1-7-2020 and admits to limited movement (voluntary) since then. Patient reported adverse events on 2/3/2020 at 3:47PM.
Soreness/ pain in arm with tingling. Employee states she felt like arm was asleep but sensation wouldn't go away. Couldn't lift arm up and pain/soreness in deltoid region only through November.
swollen armpit glands; lymph nodes; swollen armpit glands and lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to Penicillin. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 50 -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 19Apr2021 at 15:00, the patient experienced swollen armpit glands; lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen armpit glands; lymph nodes and included treatment with pain reliever. The clinical outcome of the events swollen armpit glands; lymph nodes was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rapid heart beat around 3 o?clock in the morning woke me with symptoms of the feeling that my heart was in my throat. My face felt flushed. I was able to monitor my heart rate and temperature but was not able to rest well for several hours. I had a doctor?s appointment at 8 o?clock the next morning and reported the symptoms to him. I saw a cardiologist several weeks later and inquired about the potential for a vaccine to cause the palpitations but receive no answers to the possibility of a vaccine response causing rapid heart rate. I occasionally will have a heart palpitation, as probably most of us do, but I have never had a sustained situation like this that lasted for several hours.  Below are the notes I took and the data I collected during this time.  10/21/20 2nd shingles shot yesterday: restless night with headache; hot; up 3x to go to bathroom; sinuses raw from pressure in head and ?heart? in head; palpitations  - [ ] 3:52am 137/80; 94 - [ ] 128/74; 86; irregular HB - [ ] 97 O2 - [ ] Temp-98.4 - [ ] 4:00am 128/70;87; irregular HB - [ ] 6:31 am  132/83;98
Patient reported about one hour after receiving the Pneumovax injection yesterday she noted swelling, warmth, and redness in her upper left arm near the injection site. This spread down the arm to the elbow region. She denied any other symptoms. It felt better after a bath. This morning she took one Allegra D. She stated the swelling/redness is much improved today. She was examined by Dr. today and conservative measures were recommended at this time. She was advised to report to the emergency room for worsening of symptoms, and agreed to this plan. She had a Pneumovgax 10 years ago. Box # 9 not filled out as patient's symptoms were improving when seen today but were not totally resolved, unable to accurately complete this box as it is only one day post injection.
Patient states they experienced arthritis pain in their hands and a possible flare-up of Multiple Sclerosis symptoms after receiving this medication. Patient did consent to follow up.
Mom called, T. 100.5, somewhat fussy. Advised TYLENOL q 6 hours. Call if symptoms worse.
*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gabapentin *Extreme exhaustion and sleepiness *Body ache: Tylenol *Headache- Tylenol *Extreme thirst *Nausea: Ondansetron  *Vomiting  *Constipation: Senna with Docusate Sodium *Weakness *Some difficulty breathing
Extreme pain, unable to walk without difficulty, swelling at injection site. On day 2 (today, 8/10) - there is a huge red welt at the site of the Polio injection.
I experienced Tingling across my face, more predominantly around my mouth and forehead. There also was tingling across the front of my collar bone down both arms to my fingertips. I got a mild headache and felt overall "wrung out"; a sense of weakness and lethargy. These feelings began as I was leaving the Vaccination Clinic (approximately 17 minutes after receiving my shot) and was walking to my car. They  lasted about 2 & 1/2 hours from beginning to end. After that I felt just fine.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per product indication. The reporter stated that, she had heard of people getting shingles after receiving SHINGRIX. The reporter would not provide any contact information and disconnected before anything could be clarified. The reporter herself had not received SHINGRIX. This case was considered as suspected vaccination failure as the details regarding vaccination schedule and time to onset for the event were unknown. This case has been linked to the case US2019GSK030926, reported by same reporter.
lightheaded right after shot for 30 ninutes, then chills for the whole night after. The next day, headache and then respiratory symptoms with dry cough and 02 sat down to 93%. More headache and body aches/fatigue that day. Insomnia for two nights after the injection.
Spacey, inability to think right, hypervigilent, couldn't sleep. Lasted 24 hours
Got COVID on 5/13/2022. Positive antigen test. Taking Paxlovid.
Shortness of breath, chest tightness, confusion, memory loss, extreme fatigue, exercise intolerance, sleepiness, and unrefreshing sleep
Manager report a temperature excursion for PROQUAD and VARIVAX and were administered to patients prior to having them evaluated; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, for prophylaxis (lot # T003707 has been verified to be a valid lot number virus vaccine live (oka/merck), expiration date reported and establish as 30-JAN-2022) (strength, route of administration and anatomical location were not provided) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, route of administration and anatomical location, lot number and expiration date were not provided).   The temperature of storage and time frame of the excursion were unknown. Also, if a digital data logger was involved, and if there was a previous temperature excursion were not provided.
Post vaccination patient lost consciousness, had involuntary muscle movements. mother was worried same reaction patient had during anaphylactic reaction to tree nut allergy and insisted to use the epipen patient had on hands and rph administered epipen and contacted paramedics
Increased confusion/dizziness today.  Increased weakness.  Withdrawn affect.  Incontinent of urine/stool.
Severe side effects for 5 days including. Then 7 days later an ischemic area was noted in my RIGHT EYE.
expired Havrix  administered; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The reporter wanted to know if the patient needed to be revaccinated. The reporter connected with the agency. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Cold; Sore throat; Fever; storage time in freezer exceeded; storage time in freezer exceeded; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non-healthcare professional reported for a 14-year-old male patient (reporter's son). A 14-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), via an unspecified route of administration on 24Jun2021 (Batch/Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient's medical history included celiac disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced cold, sore throat and fever. It was reported that about 12-13 days later, the patient experienced a cold, sore throat and fever. Reporter asked if these symptoms have been reported. As per the reporter they have been notified that the Pfizer COVID-19 Vaccine that her 14-year-old son received was invalid due to storage time in freezer exceeded and a pharmacy staff member suggested that her son retake the vaccine. The reporter asked would storage over the recommended time decrease the efficacy of the Pfizer Covid 19 Vaccine. The outcome of the events was reported as unknown.  Information on Lot/Batch number has been requested.
This spontaneous report as received from a medical assistant refers to 6 unspecified patients of unspecified demographics. On an unspecified dates, the patients received doses of improperly stored VAQTA with lot# M011116 and expiration date 17-MAY-2017 and RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017; both via intramuscular route. The excursions for both vaccines totaled 10 hours at 31 F. No adverse effect reported. No product complaint involved. No further information available. Additional information has been requested.