chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXTREME REDNESS AT INJECTION SITE FOR 3 DAYS EXTREME PAIN AT INJECTION SITE FOR 3 DAYS, ITCHING/HARDNESS AT INJECTION SITE FOR 3 DAYS, RASH ON LOWER PORTION OF INJECTION ARM FOR 3 DAYS, REDNESS ON UPPER PART OF LEGS FOR 3 DAYS, ICE APPLIED TO INJECTION SITE INTERMITTENTLY FOR PAST 48 HOURS, DIPHENHYDRAMINE TAKEN EVERY 6 HOURS FOR PAST 24 HOURS WITH NO REDUCTION IN REDNESS, PAIN MEDS HAVE LITTLE TO NO EFFECT ON PAIN LEVEL.
Redding, warmth to the left of the injection site. Approx size of a penny. Next day, Redding, warmth in same area but larger approx half dollar size. Not in shape, but just in size.
Customer not able to administer full .5ml dose / no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff).  This case involves a patient (demographics not reported) who was not able to administer full 0.5ml dose, while the patient received QUADRIVALENT INFLUENZA VACCINE (Flu unit dose vials) (Lot number U6655AA).  It was an actual medication error due to vaccine underdose.  It was reported that the customer was not able to administer full 0.5 ml dose. The office has contacted medical affairs department regarding the issue, unsure if it is a customer administering error or not.  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mental health issues; breathing issues; over heating during exertion; getting me angry at this point; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: Ewol76) at the age of 28 years for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1; Lot Number: Er8730), administration date: 29Mar2021, when the patient was 28-year-old, for COVID-19 Immunization. The following information was reported: MENTAL DISORDER (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "Mental health issues"; DYSPNOEA (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "breathing issues"; ANGER (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "getting me angry at this point"; HEAT EXHAUSTION (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "over heating during exertion". The patient was hospitalized for mental disorder, dyspnoea, heat exhaustion, anger (hospitalization duration: 2 days). The events "mental health issues", "breathing issues", "over heating during exertion" and "getting me angry at this point" required physician office visit and emergency room visit.  Clinical course: The events were assessed as life threatening due to "immediate risk of death from the event." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks prior to the COVID vaccine: "no nothing no toxins until this." Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: post vaccination=Nasal Swab. Therapeutic measures were taken as a result of mental disorder, dyspnoea, heat exhaustion, anger.
Started at about 6PM on 2/6/2021, I felt pain throughout my whole body. All of my muscles ached. I was very tired. It got worse through 2/7, so I went to the doctor on 2/8. The doctor tested me for COVID, and the results were negative. My symptoms began to subside on 2/9, and I was able to go to work on 2/9.
I have been having unexpained pain all over my body; have a general feeling of unwell; particularly my joints; I am always tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired). The patient was treated with Physical therapy for Pain; Physical therapy for Malaise; Physical therapy for Arthralgia and Physical therapy for Fatigue. At the time of the report, PAIN (I have been having unexpained pain all over my body), MALAISE (have a general feeling of unwell), ARTHRALGIA (particularly my joints) and FATIGUE (I am always tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. It was reported that patient was very active prior to injections and progression was very fast. No improvement even after physical therapy, medication helped a little in beginning but are no longer very effective.
Pt developed rash immediately after receiving LAIV that is currently being treated with diphenhydramine as prescribed by physician.
Initial case was received on 04 August 2010 from a healthcare professional. A 13 year old male patient received on 13 August 2008 an intramuscular injection of ADACEL (lot number C2631AA). On 13 August 2008, the night (also reported as evening) of the vaccination, the patient experienced a fever (NOS), vomiting, and a headache. He experienced 2 episodes of hallucinations, where he felt things crawling on him and he had 2 episodes where his left eye turned inward. The patient had no illness at the time of the vaccination. Pre-existing medical conditions included asthma and a peanut allergy. No concomitant medications were reported. No adverse events were reported following prior vaccinations. The patient was seen by a physician (date and results of visit not reported). He recovered on an unspecified date. List of Documents held by Sender: None.
Information has been received from a consumer concerning a 9 yr old male, with no medical history and no allergies, who was vaccinated, when he was 2 1/2 or 3 yrs old, in approx 1999, with a dose of varicella virus vaccine live. There were no adverse events following prior vaccinations. Within the last two to three weeks, in Apr 2005, the pt experienced chickenpox. It was noted that the receptionist or nurse was informed that the pt had chickenpox, and she said she would record it in the chart. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that the family called to state that the pt developed chickenpox on 22Apr05. It was reported that a neighbor, who was a pediatrician, evaluated the pt and indicated positive exposures, developed a mild reaction. It was reported that the pt recovered on 30Apr05. Additional information is not expected.
Headache, Myalgia, NauseaVomiting, Erythema, at injection site, Chills Narrative:
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a large case of generalized varicella.
covid_test_result=Positive; covid_test_result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 10Feb2021 as dose 2, single (Lot number: EL3247) and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 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 05Apr2022, outcome "unknown" and all described as "covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive, notes: Unknown.   Additional information: It was unknown if the patient diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced symptoms as fatigue and myalgia on 05Apr2022. It was unknown if treatment to ae. It was unknown if patient COVID tested prior vaccination. Patient was COVID tested post vaccination on 05Apr2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a causal association between reported events drug ineffective, Covid-19 and suspect BNT162B2 cannot be excluded.
after his second dose of Pfizer's COVID vaccine his eye has been red since then; getting eye discharge; Fever; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0162 & Expiry date not reported) via an unspecified route of administration, administered in Left arm on 20Apr2021 at 10:45 (at age of 31-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) includes paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number ER8734, Expiry date not reported) via an unspecified route of administration, administered in Left arm on 30Mar2021 at 10:30 (at age of 30-years-old) as single dose for COVID-19 Immunisation. Caller that he just reported this using the website for him having problems due to the COVID vaccine. Well, he can't be too sure that it is from the COVID vaccine. After his second dose of Pfizer's COVID vaccine, on 21Apr2021 at 23:45(1 day 13 hrs after vaccination) Patient experienced his eye has been red since the second night. He did have a little bit of a fever that started and then that night he had eye discharge and it was red. He mentioned all of that in the online report he wanted to be enquired in general should he go somewhere for medical advice or is this a common symptom and should he wait it out? Caller asking if this has this been reported previously? Or should he get medical advice from his provider. Patient did not receive any treatment for red eye and eye discharge. The Outcome of the event red eye, eye discharge was not recovered; event fever was unknown.   No follow up attempts are needed. No further information expected.
muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: EW0176) at the age of 73 years, in left arm for Covid-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Concomitant medication(s) included: PRAMIPEXOLE; METOPROLOL RETARD, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovered" (29May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: Tested positive with symptoms for Covid 10May2022; (22May2022) Positive, notes: On 22May2022 started showing symptoms again and tested positive; (29May2022) Negative, notes: Tested negative on 29May2022. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included Paxlovid started on 10May2022 to 15May2022. Clinical course was reported as, patient tested positive with symptoms for Covid 10May2022. Doctor prescribed Paxlovid and started that day, felt fine after a couple days with no more symptoms. Completed Paxlovid 15May2022. On 22May2022 started showing symptoms again and tested positive. Doctor could give me nothing. Ill with fever, chills, aches, pains and tiredness for 5 days. very runny nose and chest congestion lasted another week. Tested negative on 29May2022.
Received vaccines, approximately in an outdoor back to school event, 10 minutes later became dizzy, told mother he was going to faint.  Mom eased client down, minor abrasion, posterior left calf, did not fall.  Other event staff, came and asked to nursing assistance.  This nurse responded.  Client, alert and oriented, clammy, and pale,  Per mom, Client had not gone to bed until 4:30 that morning and had not anything to eat or drink since awakening.  Juice given.  Client then became nauseated and vomited juice given.  Unable to lay person down, outside, asphalt wet from recent rain.  Client accompanied by two nurses inside church lounge.  Client became unconscious, carried into lounge.  Feet elevated, client immediately regained consciousness, alert, answered all questions appropriately.  Additional juice given, color good, skin dry.  After several minutes client feeling better, client sat, stood and walked with standby asst of two.  Client walked to mom's car with standby asst of two.  Mom advised to give client food with protein immediately and push fluids.  Advised to have client rest with feet up for a few hours.
This spontaneous report as received from a consumer concerning her 75 years old husband. The patient's medical history included 4 operations in his back and 2 hernias. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) in 2008. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown), LANOXIN and allopurinol. The consumer reported that since 2008, the patient had been in pain up to this time. He had pain on the right side of his chest and along his spinal cord. He also had hard time resting. His sleep patterns were on and off. The patient was treated with laser injections and acupuncture. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
I was unable to stop bleeding at site; went to ER for help; hemorrhage at injection site; gelfoam applied with bandages; 11/29/2018.  Bleeding continued through the night; went back to ER on 11/30/2018 for additional help.
Dizziness; Nausea; A spontaneous report was received from a Consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events nausea and dizziness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, nausea and  dizziness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Extreme abdominal pain went to the Emergency room. CT scan diagnosed to be Edema of small intestines. Treated with pills to slow down intestine and bowel movement every few hours for 3 days. Pain relieved the next day.
swollen; 1st dose of Moderna vaccine on 07May2021 in left arm and that time it was hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen) and VACCINATION SITE PAIN (1st dose of Moderna vaccine on 07May2021 in left arm and that time it was hurt) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, PROPRANOLOL HYDROCHLORIDE (PROPANOL [PROPRANOLOL HYDROCHLORIDE]) for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PERIPHERAL SWELLING (swollen) and VACCINATION SITE PAIN (1st dose of Moderna vaccine on 07May2021 in left arm and that time it was hurt). At the time of the report, PERIPHERAL SWELLING (swollen) and VACCINATION SITE PAIN (1st dose of Moderna vaccine on 07May2021 in left arm and that time it was hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-213335 (Patient Link).
Vaccinated on December 30th, 2020 then noticed itching on January 7th. 5 cm area of redness and selling at injection site. Larger are of redness on January 8th (8 cm).
This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. On 03-APR-2017, the patients were vaccinated with improperly stored ZOSTAVAX, lot # M039453, expiry date 19-DEC-2017 (dose and route not reported). Digital data logger was involved. The product was stored in temperatures between 15 and 46 degrees Fahrenheit for 4 hours before its administration to the patients. Previous temperature excursion was not recorded. The pharmacist confirmed that sterile water diluent (unspecified lot and expiration), used to reconstitute the vaccine, was properly stored. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish to be contacted.
developed swelling of tongue; dyspnea; skin rash; This is a spontaneous report from a non-contactable consumer.   A 35-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This is a call from CDC this morning regarding a new case, the patient was administered vaccine and developed swelling of tongue, dyspnea, skin rash on an unspecified date in 2020, then treated with dexamethasone, diphenhydramine hydrochloride (BENADRYL), via intramuscular (IM) epinephrine in emergency room (ER). The outcome of events was unknown. She will alert him each time there is a report of severe hypersensitivity for his awareness. Further, the CDC is in the process of appointing a contact who will be able to meet with us regularly on this topic. Their conversation was amicable and demonstrated a willingness to work closely with us as we navigate the issue of hypersensitivity.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported information is limited. Based on the temporal relationship and the description of the events, swelling of tongue, dyspnea, skin rash, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
Low grade fever with chills, headache, neck stiffness, pain behind eyes, sensitive skin (from fever), muscle aches and cramping, severe fatigue.  Pain in arm and stiffness. Started 5 hours post injection and continued to intensify despite tylenol over the course of 36 hours.  After 36 hours the symptoms began to subside.
Patient came in for his 2nd dose of the Moderna COVID19 vaccine.  He was accidently given a dose of the Pfizer COVID19 vaccine instead.
had couples of days of bad symptoms thought had COVID but had no fever; had couples of days of bad symptoms thought had COVID but had no fever; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced had couples of days of bad symptoms thought had covid but had no fever. The patient underwent lab tests and procedures which included body temperature: normal on but had no fever, sars-cov-2 test: positive on friend around 40 years old had couples of days of bad symptoms thought had COVID but had no fever. The outcome of event was unknown. Information about the Lot/batch number has been requested.
Pt recvd vax 12JUN91 & approx 48hrs following vax pt's mental status deteriorated; over days pt became less & less responsive; pt hospitalized late JUN91; MRI & EEG & LP all nl; Pt dependent on parents & functioning @ 4th grade level;
My 11 year old daughter had her last HPV shot on a Friday. Today she is experiencing dizziness and fatigue. At dinner she looked at her plate of food and said she doesn't feel right. She has been asleep for a few hours. She had plenty of sleep last night and ate breakfast and lunch. I strongly believe her symptoms are related to the vaccine she has less than 24 hours ago.
103.5 temp for several hours Body aches Chills Nausea Vomiting
Experienced no side effects immediately after injection, except for arm soreness. Exactly 1 week following injection, a light red area formed at the injection site that was warm and itchy to touch. These symptoms are still present, but subsided 3 days after.
Onset of green, mucousy, diarrhea, which has not resolved as of today (07APR2016). Occasionally has 'coffee ground' blood in stool along with green mucous.