chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an unspecified reporter via a company representative referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2017 (reported as "in the last two weeks"), the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Unit, for prevention of shingles (dose, route, lot # and expiration date were not reported). On an unspecified date in 2017 (reported as "in the last two weeks"), the patient experienced cellulitis on an unspecified site. It was stated that an unspecified treatment was given for the adverse event and that the patient was hospitalized for 5 days, then released from the hospital and was admitted again for an unspecified length of time at an unspecified time. At the time of reporting the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between cellulitis and ZOSTAVAX was not provided. Upon internal review cellulitis was determined to be a medically significant event. Additional information has been requested.
The patient is 16 yo, given Moderna as an error. F/U with patient: no fever, no headache, no swelling in the Right arm, only pain controlled with Tylenol
pt recv vax;devel local rxn characterized by reddened area,w/ rash,area about "hand-sized",affecting site & shoulder;
States that she and her husband both have Covid and the doctor put them on Paxlovid; States that she and her husband both have Covid and the doctor put them on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "States that she and her husband both have Covid and the doctor put them on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Result: Positive;  Unit: Not Provided She took a test on Wednesday and it was positive. Caller states that she started Paxlovid last night. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Reporter states that they both had IV Therapy yesterday that really helped them.  States it was called a Covid Cocktail and consisted of Lactated Ringers, Vitamin C, Glucagon, Vitamin B12, and others are unknown. Reporter mentions that for herself, her pulse was a little high yesterday and her pulse ox was a little low; she thinks she was dehydrated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be completely 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.
she has been feeling sick.; Cough; Runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patients daughter) reported for mother. A 52-years-old female patient received BNT162B2 (Batch/Lot Number: EW0153 Expiry Date not provided on card and NDC number were Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:45 (age at vaccination 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included blood pressure increased from an unknown date and unknown if ongoing takes a medication for high blood pressure, from an unknown date and unknown if ongoing. Family Medical History Relevant was none. The patient did not have history of previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for blood pressure measurement, start and stop date were not reported. On 26Apr2021 the patient experienced she has been feeling sick. The patient daughter was speaking on behalf of her mother. The patient received the first dose of the Covid-19 vaccine. The second dose is scheduled tomorrow. She has been feeling sick since Monday with a cough and runny nose. Cough was reported as worsened. She has been taking antibiotics for two days. Is it ok to take the second dose. The patient had been taking Amoxicillin 500mg three times daily. Her mother doesn't know why she was prescribed the medication. It was prescribed a while back, but she has only been taking it for the past two days. The patient did not visited to Emergency Room and Physician Office. The patient does not have a specific doctor. She was seen by different providers at the clinic. The outcome of the event feeling sick was unknown and cough outcome was not recovered and runny nose outcome was recovering.  No follow-up attempts are needed. No further information is expected.
Experienced vomiting, diarrhea, nausea, severe, abdominal cramps and dehydration as a result of other symptoms which increased dizziness and light headedness for 4 days.  Right thigh became larger than left leg. Burning sensation in inner thigh. As of this date, still larger. When 2nd booster was administered on 6/16/2022, leg became swollen and very painful. Size did not decrease, vascular was done, no DVT. Leg is considerably larger.
She had numbness and tingling in her left leg and foot about 5 minutes after getting her shot and the developed numbness and tingling in her right foot about 10 minutes after the shot
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 20-DEC-2014 the patient was vaccinated with an improperly stored VAQTA (lot # 59N59, expiry date 05-SEP-2016) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
An initial report was received from a healthcare professional on 22.Nov.2012 and concerns a 43-year-old male patient who on 20.Nov.2012 received the first dose of VIVOTIF (batch no.: 3000414, expiry date: Mar.2014) as a prophylactic vaccination. The patient had no relevant medical history and concomitant medications. Following administration of VIVOTIF, the patient started passing mucus and blood (streaks) in his stool. The events had never happened before; he had no medical history of them. The patient was not on other drugs either. He did not feel 100% as well, but had no fever. The outcome of the event was not reported. The events were considered non-serious. Follow-up was received from the consumer on 20.Dec.2012. The patient reported that he had no abdominal discomfort, no fever, and was not unwell. He was advised to take no further VIVOTIF. He did not see the General Practitioner as recommended. He reported that the events resolved within 3-4 days without intervention.
Patient with PMH of epilepsy, alcohol use disorder, CVA, dementia presented to ED with witnessed seizures while in bed. History of non-compliance, multiple admissions for seizures previously.
Patient was administered ActHIB Vaccine on 4/13/23, the vaccine expired on 4/7/23. Patient has no adverse reactions to the vaccine.
Sudden onset hot; chills; fever; headache; body aches; fatigue; weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 17:30 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Adhesive, reaction(s): "Allergy". The following information was reported: FEELING HOT (non-serious) with onset 2021, outcome "not recovered", described as "Sudden onset hot"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of feeling hot, chills, pyrexia, headache, pain, fatigue, asthenia.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been COVID tested post vaccination as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got the flu shot and for the first time in 50 years got the flu anyway; Initial information received from on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who got the flu shot and for the first time in 50 years got the flu anyway after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a serious got the flu shot and for the first time in 50 years got the flu anyway (influenza) (unknown latency) following the administration of Influenza Vaccine. The patient was hospitalized for this event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot and for the first time in 50 years got the flu anyway).  Outcome: Unknown   Seriousness Criteria: The patient was hospitalized for this event for seven days.; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves a patient of unknown demographics who got the flu shot and for the first time in 50 years got the flu anyway after receiving vaccine Influenza Vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Mild, eczematoid rash of biceps region, just medial and distal to injection site.
Menstrual spotting and cramping, joint pain (knees, hips, shoulders), chest pain adjacent to injection arm, severe pain at injection site, headache, chills without fever, muscle weakness in arms and legs, loss of appetite, fatigue. Symptoms are ongoing.
used the recommended diluent but was not able to administer it together with the lyophilized powder with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient and reporter reported that she used the recommended HIB (PRP/T) VACCINE [ACT-HIB] (diluent) but was not able to administer it together with the lyophilized powder, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose 1 at a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (frequency: once, Strength: standard, expiry date: 06-Oct-2023 and lot: UJ792AA) via intramuscular route in the right thigh for immunization.  On 09-Jun-2023 the patient used the recommended diluent but was not able to administer it together with the lyophilized powder, with no reported adverse event (product preparation error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Information has been received from a licensed practical nurse concerning a 22 year old female with a medical history of knee operation in 2004 who on 09-OCT-2008 and 26-MAR-2009 were vaccinated with the first dose and second doses of GARDASIL (LOT# 659435/1265U and 661846/1312X respectively). Concomitant therapy included hormonal contraceptives (unspecified birth control pill). After the patient received the second dose, on approximately 08-APR-2009 the patient experienced dizziness, fatigue and general weakness. On an unspecified date the patient had workups done by her general practitioner and a neurologist, results were reported as negative. The patient was not hospitalized and was not recovered. Additional information has been requested.
Flushing, facial swelling, difficulty breathing, mast Cell mediator release and irritability
I received a flu vaccine on 10/17/16, on 10/18 - 19/16 I had blurred vision, heart palpitations, chills, fever, flu-like symptoms. Tingling in both upper arm/shoulders. Fluttering in the chest area which I get when I have had previous flu shots. I got very nauseous for 2 days.
Initial report received on 04 April 2008 from another manufacturer, reference number not provided. The initial reporter to this manufacturer had been a health care professional. An adult patient received an injection of an unspecified pertussis vaccine, manufacturer not reported, lot number not reported, on an unspecified date as a child. At an unspecified time post-vaccination, the patient developed cerebral palsy. "No other information is available at this time." Additional medically relevant information was not provided.
side effect as she received the last shot yesterday and she was really suffering; she was too dizzy; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022, the patient experienced IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy). At the time of the report, IMMUNISATION REACTION (side effect as she received the last shot yesterday and she was really suffering) and DIZZINESS (she was too dizzy) outcome was unknown.     No Concomitant medication reported. No Treatment medication reported.
Report bilateral leg heaviness mainly to the calf region and mostly of the right leg that is constant started 2.5 weeks ago.  There is no bruising, or feeling of warmth of the lower extremity. He denies chest pain, leg pain, SOB, HA or blurred vision. Reports movement makes it better and inactivity makes it worst. Treatment: None , Outcome: Does not interfere with ADLs
No initial symptoms. Arm did not hurt. Felt fine initially. A week later, my left eye started to water profusely and itch as if I'd gotten something in it. Within the hour, lymph nod in front of left ear swelled up to the size of a bean. The next morning, additional nods swelled up under the ear by the jawline. The eye was no longer watering, but was and continues to experience sharp pain like pins stuck in it, very painful. Some blurring of vision.  It is only in one eye still. Eye is not red. Eye is not watering. It shows no signs of visible conjunctivitis, but  very irritated. The following day the left side of my face is swollen along with swollen glands.  Additionally, a rash ahs developed along my hairline, on the upper bridge of my nose, and on forehead. The rash on my nose presents like blisters, almost like poison ivy rash. I was not exposed to poison ivy. I do not have acne, so the outbreak on my forehead is unusual.  The rash has gotten progressively worse and spread every day since the onset of these symptoms four days ago. I still have no fever. No armpit swelling. Never experienced this before. There was no clear cause of this nor any known infection. Suspect it could be immune response to 1st covid-19 shot. I was very healthy when I took the first shot.  Was advised to take a Covid-19 test as the eye hurting is apparently a rare symptom of the virus. Took test yesterday. Awaiting results. But I have no respiratory symptoms. No fever. Do have some mild diarreah since receiving the vax. Feel fine physically other than these very painful facial symptoms.
sore arm for first 24 hours; nausea; low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm right on 31Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications of the patient were not reported. Patient previously received diphenhydramine (BENADRYL), oxycodone; acetaminophen (PERCOCET) all from an unknown date for an unspecified indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent a COVID-19 virus test, nasal swab on 20Dec2020, result of which was negative. On 03Apr2021 at 16:00 the patient experienced sore arm for first 24 hours, nausea and low-grade fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of pain in arm, nausea, low grade fever was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Severe headache, dizziness, weakness, nausea, vomiting, body aches, fever, pain and swelling at injection site.
This is a spontaneous report from a contactable medical assistant on behalf of a physician. A 82 years old female patient received PREVNAR 13 (lot. J80527, exp. date 01May2015) on 23Mar2015 at 10:30, 0.5ml single dose intramuscular on upper left arm. 24 hours later, the next day, the patient experienced fever 101 Fahrenheit and elevated white blood cell count at 19,000 and she was hospitalized for the events. The patient was administered antibiotics of unknown name while in the hospital. The outcome of the event fever was reported as recovering while for the event elevated white blood cell count was reported as not recovered.
Per patient's wife:  I thought the discomfort and pain will go away, but as of today (written on 1/9/20), it is still hurting. He has severe pain every time he move his left upper extremity.  He has been taking Ibuprofen 400mg po every 6 hours.    Patient did received a flu shot in the right arm on the same day.
I had a sore arm, and I felt a little tired for two days after receiving the vaccine. On 12/01/2022, I started not feeling well with a fever, sore throat, congestion, dizziness, cognitive impairment and diarrhea. On 12/02/2022, I tested positive for COVID-19 with a home test. I contacted my doctor and got a prescription for PAXLOVID. I tested negative for COVID-19 on 12/17/2022. As of today, I get very tired after doing normal activities and I have headaches.
Patient said she felt very dizzy and she couldn't see (blurry vision).  She said her ears were ringing and her legs felt really tired like she just went on a long walk.  She was perspiring and felt like she was going to vomit.  Within 5 - 7 minutes she was feeling better.