chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. The reporter stated that, symptoms of the patient's might be worsened. This case has been linked with case US2018180227 and US2018180225, reported by the same reporter.
Loss of taste and smell.  Not total loss, but chicken now tastes like it came from a toilet.   Laundry soap smell  now smells terrible.   BBQ. Tastes like toilet.
This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown dates the patient were vaccinated with improperly stored PROQUAD (Merck) lot # L034931; expiry: 03-MAR-2017. M-M-R II, K021152/ expiry. 02-NOV-2016, lot # L011528/ expiry: 03-APR-2017 was within recommended storage range at 32F. No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Metallic taste in mouth, fever, chills, aches and pains, exhaustion.   Extremely heavy period for every menstrual cycle since first dose. Abnormal amount of bleeding and pain.
Low grade fever, body aches. Patient state she woke up in the middle of the right with fever and body aches. Recommended alternating MOTRIN and TYLENOL, drink lots of fluids, get extra rest and if not better in 48 hours to call and be seen per doctors orders. Evidently fever is gone, arm is still sore.
This spontaneous report was received from a physician referring to a 62 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (lot #, expiration date, dose, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Patient was found unconscious the morning of 10/12 in the crib. Declared dead shortly after. Autopsy pending.
Patient has redness, warm surrounding injection site. Patient reported has soreness and itchy in the arm. The redness is growing from injeciton site to the lower arm. Pharmacist counseled patient to take Tylenol and benadryl cream/ capsule for the soreness and itching,
Redness at site started on day of injection. Redness, swelling, pain worsened.  Difficulty walking due to pain. Seen by MD two days after injection administered. Monitoring site and will recheck again in 48 hours.
This spontaneous report was received from a nurse practitioner and a registered nurse concerning a 7 month old patient. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 14-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection lot # M042324, expiry date: 10-JUN-2018, 0.5 ml once, intramuscular for prophylaxis (strength and anatomical location were not provided) instead of PREVNAR 13 injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). It also was reported that this PNEUMOVAX 23 was believed to also have had prior temperature excursions. No adverse effects reported.
Received flu shot received on 29 October at 0700.  Symptoms/Adverse Effects started on 29 October  at 1830 with left side facial numbness and  left eye heaviness feeling and left eye watering.  On 30 October at 0500 left side of body felt cool and right side of body felt warm.
head cold symptoms; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 08Mar2021, as dose 1, single for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient stated that he got the Pfizer vaccine on 08Mar2021 Monday after 15 hours of vaccination, patient experienced head cold symptoms, runny nose, Patient went to fact sheet and did not see it listed there. He went to site and reported the information. Patient was thinking maybe he was just having a reaction due to warmer weather and season allergies. Patient stated, he usually take a zyrtec, yesterday he felt like he was at the peak day and took a zyrtec, he felt totally normal today. Therapeutic measures were taken received Zyrtec. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Information has been received from a nurse practitioner concerning an approximate 35-year-old female with a history of motor vehicle accident that resulted in a back injury (according to the patient her back pain is not a chronic issue) who on 20-NOV-2007 and 21-DEC-2007 was vaccinated with her first and second dose of RECOMBIVAX HB.  On 22-NOV-2007, 2 days post vaccination, the patient experienced "body aches" that lasted for one week.  On 24-DEC-2007, 3 days post vaccination, the patient experienced "severe body aches".  The "body aches" have not resolved.  The discomfort is reported to be mostly in her hips and lower back.  The patient stated to the nurse that her "pain and headache were so bad last night that she was seen at the emergency room".  On 07-JAN-2007 the patient had blood work and a CT scan of the head performed in the emergency room.  The nurse practitioner reported that all of the patient's test and labs were negative.  The patient will be following up with her primary care physician.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Bruise, soreness, she is still sore and has a bruise after 10 days. She said the bruise was worse before and has improved.
Area around DTaP injection red with swelling, afebrile, itching. Patient sent to local hospital for IV antibiotic.
the back of her arm where she had the vaccine all the way down was swollen; puffy; slight headache; sore arm; it was really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (it was really bad), PERIPHERAL SWELLING (the back of her arm where she had the vaccine all the way down was swollen), SKIN SWELLING (puffy) and HEADACHE (slight headache) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011HZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included CLONAZEPAM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (it was really bad) and HEADACHE (slight headache). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (the back of her arm where she had the vaccine all the way down was swollen) and SKIN SWELLING (puffy). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (it was really bad), PERIPHERAL SWELLING (the back of her arm where she had the vaccine all the way down was swollen), SKIN SWELLING (puffy) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning a 65 year old female who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced skin reaction around the injection site.  The injection site was red, erythematous, indurated and the center of the site appeared bluish.  It was also reported that the patient "about a month ago" had a "huge, red, swollen reaction".  Additional information has been requested.
first dose of the covid vaccine yesterday and is having side effects; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing Previously had covid 90 days prior. The patient's concomitant medications were not reported. Caller took the first dose of the covid vaccine yesterday and is having side effects. Previously had covid 90 days prior and wanted to know if the side effects that she is feeling is because of her having covid. No FAQ. Read ISI. Cold transferred to due to hold times. Will fax AE from CEP: 159558. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (lot# L010595 and expiration date 12-NOV-2016) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
fever 102-103 x 2 days, pale, glassy eyes, h/a, stomach pains, no appetite; seen @ urgent care via MD: no treatment or meds ordered;
Tdap 5/31/11 was given to pt. Her arm became sore, and she stated it woke her up at night due to the pain. On 6/14/11 she came into the office and stated her mother told her when she was an infant she had a reaction to the tetanus combo vaccine.
A non-serious spontaneous report of the patient with a mild egg allergy received H1N1, several episodes of sneezing, runny nose has been received from a parent concerning a nine-year-old male, subsequent to H1N1, Intranasal. The patient's medical history includes mild allergy to egg. No concomitant medications have been reported for this patient. On 29-Oct-2009, the patient received H1N1, Intranasal for an unspecified indication. On 03-Nov-2009, the patient experienced several episodes of sneezing and runny nose. The outcome of the medication error was resolved and for several episodes of sneezing and runny nose it was resolving.
Two months after the second dose of the vaccine I started to have headaches. I was experiencing fatigue. I was having the headaches two to four times a week. I have not had a problem with headaches in the past. I was managing them with Tylenol and a cold washcloth over the face. I was newly diagnosed with Hypertension in April 2021. My blood pressure fluctuates between really low and really high. I am still working on treatment that controls the blood pressure.
PATIENT HAD WEAKNESS/UNEASINESS (MALAISE) PATIENTS SYMPTOMS RESOLVED BEFORE LEAVING
Became flushed 10 min after receiving vaccine. Felt like hair standing on arms. Dizzy, chest pressure - 1 hour post vaccination - itching from nipple line up - no hives or rash - injection site fine - took CLARITIN - itching resolved. Legs fatigued after working shift and very fatigued this AM. Elbows itching this AM.
Outbreak of Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Outbreak of Shingles) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Outbreak of Shingles). At the time of the report, HERPES ZOSTER (Outbreak of Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date in 2013, the patient received the first dose of GARDASIL injection administered intramuscularly (lot number and expiration date were not reported) for prophylaxis. According to the reporter, the patient received the second dose in 2014, a year apart. No adverse effects were reported.
Patient received Menactra (does #2) and Gardasil (dose #1) as part of well exam.  Within a few minutes of nurse leaving the room, patient fainted; regained consciousness right away and came out of the exam room crying. Patient may have hit head and complained of headache, but no obvious injuries on exam.  Later in the day, patient seemed upset and mother took her to the ER.  No studies were done in ER as patient was noted to be fine on exam.
REALLY BAD HEADACH THE DAY AFTER THE IMZ, THEN A BAD HEADACH FOR PROBABLY THE NEXT TWO DAYS, ABOUT A WEEK LATER NOTICED SOME PIMPLES ON HIS BACK THE RESOLVED AFTER A COUPLE DAYS OR SO
Patient alert and oriented prior to vaccine administration. He was able to answer assessment questions. Few seconds after vaccine was given patient was found uncoscious and pale. He regained consciousness a few seconds later.  EMS was called and vitals taken. 131/80 HR 84 98%. Patient regained orientation and was able to walk out of the pharmacy with mother. No further complaints voiced.
hives with yellowish center and raised border, largest 5 cm diameter, some confluent, distibuted over chest arms, ankles
Patient felt lightheaded (about to faint) about 10 minutes after the second dose of moderna COVID 19 vaccine.  We let her lay down and raised her feet and she said she felt better immediately.  She stayed at that position for about 20 minutes and  then sat and standed for a while until she was confident that she was fine and left the pharmacy.
Patient presented in ER with acute left sided numbness, Subsequent CT head on 11/26 showing subacute infarct at the right basal ganglia.  MRI obtained on 11/29 with anesthesia showing 3.5 cm ischemic stroke in right ventricular region extending into basal ganglia. He was started on Lantus as well as CR and SSI.  On discharge, CR was discontinued as PTA meds were resumed the day prior. ER visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Child developed symptoms of viral illness fever cough etc.  Within a month following vaccination child began doing what I can only describe as a twitch.  He also began ignoring people, and demonstrated other changes such as loss of language, and reduced desire to communicate verbally.
headache for five days; This is a spontaneous report received from a contactable reporter (Consumer).  A 77 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Apr2021 (Lot number: ER8733) at the age of 77 years as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "headache for five days". Therapeutic measures were taken as a result of headache. Additional information: Patient has been administered with BNT162b2 by a Nurse at the same time as his wife. Headache was treated with aspirin and Tylenol (Paracetamol).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444651 same reporter/drug, different patient, similar event
patient  felt palpitations noted and weakness with pt having some juice and crackers and feeling better as well. Pt was able to drive out as well with vitals sat 98% HR 89
Within a few moments of receiving Janssen vaccine, patient became nauseous and vomited. Provided cold pack and water to patient. Monitored for 30 minutes. All symptoms resolved within 10 minutes of event. Cleared to leave after 30 minutes, advised to call or go to local ED if symptoms return.
chills; injection site pain; myalgia; fever; fatigue; headache; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unspecified date the patient experienced chills , injection site pain, myalgia, fever, fatigue, headache. The patient underwent lab tests and procedures which included body temperature: 37.5 c on mild fever (37.5 C). The outcome of events was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
No additional adverse events reported; MA reports a dose of ROTATEQ was given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 6-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-NOV-2020, the patient was vaccinated with an imporperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1660954, expiration date 07-MAR-2021 for prophylaxis.  The vaccine had a temperature excursion of 48.4 Farhrenheit degrees (F) and 32.7F for 15 minutes and 47 hours respectively. There were no previous temperature excursions.
Fatigue; Headache; Body aches; Fever; Chills; Soar arm; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient 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 26Aug2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Aug2021, the patient experienced fatigue, headaches, body aches, fever, chills, sore arm and diarrhea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, body aches, fever, chills, sore arm and diarrhea were not resolved at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
no appetite; no taste; no smell; feeling weak; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), AGEUSIA (no taste), ANOSMIA (no smell), ASTHENIA (feeling weak) and CHILLS (chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DECREASED APPETITE (no appetite), AGEUSIA (no taste), ANOSMIA (no smell), ASTHENIA (feeling weak), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 31-Mar-2021, DECREASED APPETITE (no appetite), ASTHENIA (feeling weak), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, AGEUSIA (no taste) and ANOSMIA (no smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 test negative.     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.   As treatment patient also took steroids and sinus cocktails for the symptoms.   This case was linked to MOD-2021-211544 (Patient Link).
Vaccine1  large oval red and painful rash, approx 3?x 2? diameter at the injection site. Approx showed at day 7 post shot. Faded after 10 days.  Vaccine 2 vey large red  rough and painful rash, approx 7?x 5? in diameter on both legs next to knees in roughly same location.
Nursing home pt devel a stroke approx 1 month p/being administered flu vax, pt subsequently expired;
Patient seen in office on 12/16/22 reporting pain, redness and  swelling at the injection site ( Lt Deltoid) administered on 12/13/22. Patient diagnosed with cellulitis and prescribed with cephalexin 500 mg capsule, 1 capsule twice a day by oral route for 7 days.