chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed hives twice that lasted for 3 weeks each; lymphadenopathy in her left axilla; This is a spontaneous report from a non-contactable health care professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 18Feb2021 (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient developed hives twice that lasted for 3 weeks each and also keeps getting lymphadenopathy in her left axilla. The events resulted in a visit to the emergency room/department or urgent care and a healthcare professional office/clinic visit. The patient was given steroids, allergy meds and other unspecified treatments for the event. The events recovered/resolved with sequel on an unknown date in 2021. The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Urticaria and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
diarrhea; bruising; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), FATIGUE (fatigued) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced CONTUSION (bruising) and FATIGUE (fatigued). On 29-Jan-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, CONTUSION (bruising), FATIGUE (fatigued) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking blood thinners.  No treatment information was reported.
increasing gen weakness x 2 days w/numbness in all toes & fingers & diff walking;dx GBS;tx w/plasma pheresis & disch to nursing facility for rehab;60 day follow-up received on 10/04/00 provided no additional data.
fatigue; Nausea; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) 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 FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) increased White blood count.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.
right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night because of the pain/I really can't sleep enough, I mean it's hurting; This is a spontaneous report from a contactable consumer. This 77-year-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date not reported) via unspecified route of administration in right arm on 03Feb2021 (at age of 77-years old) as single dose for Covid-19 Immunization. Patient medical history includes high blood pressure. Patient concomitant medications include Amlodipine (once a day) used for blood pressure from unknown date and ongoing, Hydrochlorothiazide, lisinopril (once a day) used for high blood pressure from unknown date and ongoing. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:EK9231, Expiry date not reported) via unspecified route of administration on 15Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, patient had shot at noon, she got the injection in her right arm, she developed the arm pain last night about 8 or 9 pm. She said it will feel better one minute, and then she will have a sharp pain going through her arm again. Patient experienced like her arm is hurting so bad; patient stated that I really cannot sleep all night because of the pain/I really cant sleep enough, I mean it is hurting. Patient right arm is unbearably painful after injection and stated that she did not let nothing get around the injection area and she rubbed her arm with alcohol.Caller verifies she talked with a man yesterday and reported this information and gave information on what was on her vaccine record card. Caller verifies she was not provided with any type of reference number.Upon follow up reporter stated that the reason she got it because she works at the hospital, what mandated, and she got it. Patient stated that, I am having a problem so I could get the paid today, okay but look can I rub my arm with some alcohol. Consumer was informed about Pfizer Medical information department.Treatment received for event by taking Tylenol. Patient underwent lab test and procedures include blood pressure measurement is high on unspecified date. The outcome of events was not recovered.   Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mom) that: new information include vaccination at right arm and updated age 77years on onset of reaction, concomitant medications,Treatment received for event.    Follow-up attempts are completed. No further information is expected.
Chest pains, vomiting, chills, aches, dizziness, swollen and red face and neck. Also hallucinating.
Headache, Myalgia, Fever, Fatigue, Chills Narrative:  Other Relevant History:
About 8 days after the injection, when all initial effects had resolved, the injection site and up into my shoulder began to ache. The following morning my upper arm was achey, swollen, and tender. It also itches slightly. These symptoms have continued through the day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 at 14:30 as dose 1, single (Lot number: EN6205), in left arm, on 31Mar2021 at 14:30 as dose 2, single (Lot number: ER 8732), in left arm and on 07Dec2021 at 10:15 as dose 3 (booster), single (Lot number: FJ8762) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; GLUCOSAMINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (30Sep2022) Positive, notes: Recurrence of Covid symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid used for treatment Of COVID-19. Known allergies reported as no.
No adverse event; It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.) and NO ADVERSE EVENT (No adverse event) 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.    On 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Patient was concern about the vaccination, received the first dose and going to receive second one. It was reported that they don't have new batch of vaccine, there was all overdue vaccines.  Although It's been two months since the expiration date, they prolonged the expiration date of the vaccine in stock and give the patient.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I experienced a painful, itchy rash at the injection site (which was apparently a normal reaction), and over the course of a few weeks that rash mostly disappeared but left a 1/4 inch diameter rash that never went away. I still have it as of May 31, 2013. Some days it itches a lot. Others the rash doesn't bother me. But it still has not gone away. I have never had any rash from eating any eggs or other foods or taking any prescription or over the counter drugs.
My wife was administered the tetanus vaccine intradermally instead of the PPD skin test. (Mantoux test) Erythema spread from the insertion site throughout my wife's forearm approx 10cm x 7cm. Further treatment was necesasry to help alleviate symptoms associated with this incident. My wife was prescribed a 6 day course of Methylprednisolone PO, PRN Claritin and anti-itch ointment.
Red blotchy spot at and around injection site; Slight bump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red blotchy spot at and around injection site) and INJECTION SITE INDURATION (Slight bump) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (Red blotchy spot at and around injection site) and INJECTION SITE INDURATION (Slight bump). At the time of the report, INJECTION SITE ERYTHEMA (Red blotchy spot at and around injection site) and INJECTION SITE INDURATION (Slight bump) had not resolved.            No concomitant medication or treatment information was provided.
pt recvd vax;lightheadedness,chills,tremors,stiff neck,nystagmus;intermittent tremors resolved p/ 1 hr;had 48 hrs of flu-like sxs w/ myalgia & stiff w/ fine motor activities;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced covid-19 symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 symptoms. This report was non-serious. This parent/child case is linked to 20210438886.
I received a flu vaccination around 10:00Am on Thursday 17 September  by 4:30 PM I was experiencing dizziness and muscle aches.  By 6:00 pm I was experiencing a high fever and sore throat.  The next day I was extremely fatigued and had hives on my upper body these were most prevelant on my face, and chest.  I took theraflu on Thursday night and Friday afternoon.  My symptoms lasted through Saturday morning.
Information has been received from a public health center nurse concerning a school-aged pt (age and gender not reported, who after age one, had been vaccinated with 0.5mL first and second doses of MMRII (Lot # not reported). Subsequently the pt developed rubella, which was confirmed by IgM. The pt had a reddish rash, swollen lymph nodes, but no history of fever. Unspecified medical attention was sought. The pt's outcome was not reported. It was also reported that the pt's sibling had been vaccinated with MMRII and developed rubella (WAES # 0403USA01315).  Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Information has been received from a registered nurse concerning a 12 month old female with no known drug allergies and a history of seizures at 38 hours of age that was treated with phenobarbitol for 6 months who on 05-Aug-2003 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot #644248/1145M). On 05-Aug-2003 the patient was also vaccinated with a dose of poliovirus vaccine (manufacturer unknown). There was no illness at the time of vaccination. On 19-Aug-2003 (also reported as 18-Aug-2003) the patient developed chicken pox with about 20-25 lesions located on her trunk. Symptomatic treatment was provided and the patient was treated with a prescription drug. No diagnostic tests were performed. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
pt recv vax & 24MAY95 exp muscle aches,hip pain,a stiff neck & general achiness;
As of the time of this report this pt has had a six month history of psychomotor retardation, clumsiness, lack of coordination, joint pain, migratory arthralgias.
Headache, bilateral pain along arms from elbow to hands, fever. All began approximately 15 hours after injection.
Report of fever, headache, body aches, lost of taste started day one post vaccination. Treatment: Tylenol and Ibuprofen.  Outcome: body aches, fever and headache has improved. Fatigue and lost of taste remain unchanged.
Has continued to have mild headache since he received vaccine on 1/6/2021 and has been taking Tylenol.
Date of death 11/26/2021.  Started feeling bad within 1 day of receiving the vaccine.
1day p/vax pt devel large 3-4" red & indurated tender area around inj site;
Heart palpitations, intermittent, extending to at least today (several weeks later) -- fluttering sensation in chest, several seconds apart, in groups of a few minutes at a time; these groups might happen once or twice a day or not at all. No shortness of breath or other discomfort.
hurt a little more than the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hurt a little more than the first shot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (hurt a little more than the first shot). At the time of the report, VACCINATION SITE PAIN (hurt a little more than the first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-416089, MOD-2021-416090 (Patient Link).
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. In approximately 2013 (reported as 'about two years ago'), the patient received her first dose of GARDASIL (dose, route, lot# and expiration date were not provided) and on 15-JUL-2015, she received her second dose of GARDASIL (dose, route, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Patient received 2nd dose of vaccine. right after the recommended 15 minutes wait, as patient was about to leave, he stood up and fell over. I responded by checking his pulse. He recovered while on the floor and said he felt dizzy and blanked out. Patient also said that he did not have breakfast before coming for the vaccine. I made the patient to wait for another 30 minutes to observe him. He left feeling better.
bell's palsy-90% complete paralysis 2 wks p/flu shot; no other neuro sx;
temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-contactable pharmacist. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), intramuscularly, administered in left deltoid on 20Jun2021 15:00 (at 27-year-old) as dose 1, single, for COVID-19 immunization. The patient had no medical history. No unknown allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cannabis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021 at 15:00, the patient experienced temporary loss of vision, sweating, pale skin, and shacking. The events resulted in emergency room/department or urgent care. It was unknown whether treatment was received. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the temporal relation, the association between the event blindness and vaccination cannot be completely ruled out.  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.
2 days after the vaccine, a blister started to form slightly above the sight and on the upper right shoulder.  4 days after on 10/8 the blisters where at worst.  skin peeled and dried on 10/15
Was vomiting violently the day after the shot and something (fluid, mucus) got stuck in my throat and I literally could not breathe for 1 to 2 mins. Issue resolved but was gasping for air.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 2:20 pm, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1: 132.50 (also reported 17 hours, 410 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
severe local reaction; not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck; not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck; This is a spontaneous report from a non-contactable physician (patient).  This 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experiencing a "severe local reaction" following the first dose of the vaccine. She described it as: not just a strong bicep inflammation, but it extended out to the shoulder and the back of the neck. The outcome was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
received an expired dose of Menactra with no reported adverse event; Initial information received on 08-Apr-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who had received an expired dose of meningococcal a-c-y-w135 (d conj) vaccine (Menactra) with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (strength, frequency, formulation, lot number and expiry date were unknown) not reported via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date, (latency: unknown) the patient received an expired dose of menactra with no reported adverse event (expired product administered) .  Action taken : not applicable.  Outcome: unknown  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 the guidelines. 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.