chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fever; Body Aches; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 26Feb2021 at a single dose (at the age of 38-years-old) for Covid-19 immunisation in a workplace clinic. Medical history included allergies, migraines, low vitamin D and penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrum and doxycycline and experienced allergies. The patient was not pregnant at time of vaccination. The patient took the first dose of BNT162B2 on 05Feb2021 10:30 in the left arm at the age of 38-years-old for Covid-19 immunisation. No other vaccine was received in four weeks. The patient did not have COVID prior to vaccination. On 27Feb2021 at 02:30 AM, the patient experienced headache, chills, fever, body aches and an episode of syncope which caused a fall. The events resulted in emergency room/department or urgent care. The patient had a CatScan, EKG, IV medications, blood and urine test. The patient was not tested for COVID post vaccination. The patient recovered from the events on an unspecified date.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-AUG-2016, the patient was treated by a physician, at the health care facility/office for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In May 2022, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) was resolving.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-576025 (Patient Link).
I had my vaccination on 10/29/2022. In 10/2022 I started to have heart palpitations. My spouse had just passed away in 09/2022. These increased over time and got very severe. I went to my doctor and I was administered an EKG and Echocardiogram. I was diagnosed with having Premature ventricular contractions and prescribed a low dose medication.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL.  She reported that the patient developed a delayed inflammatory response that started 3 days after vaccination.  She did not want to provide any further information about the patient or the delayed inflammatory response.  The patient's outcome was unknown.  Additional information is not expected.
Stroke.  I do not know if the vaccine was related or not, but the patient had a stroke and falls on 2/17/2021 and 2/18/2021 and was found to have two strokes.  He does have atrial fibrillation, but with the proximity to the second vaccine, I cannot tell if they are just related temporally or if there is a true risk.  Another patient at this facility had a stroke within same time frame post second Moderna vaccine, but not my patient, so I do not know if that was reported.  Due to new nature of this vaccine, I felt it important to report this event for further investigation.   Again, I am not sure if it is a true adverse reaction of the vaccine or not.
Patient having a focal seizure, like they were out of it a week after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) (seriousness criterion medically significant). At the time of the report, PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient having a focal seizure, like they were out of it a week after the first dose. No treatment information was reported.  Company Comment:  This is a spontaneous case concerning an elderly patient of an unknown gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine and was resolved after a week. No further details about the clinical course, diagnostic procedures and treatments were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542528, MOD-2022-542594 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly patient of an unknown gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine and was resolved after a week. No further details about the clinical course, diagnostic procedures and treatments were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Henoch-Schonlein autoimmune purpura appeared the morning of August 15, 2017. The purpura was located on both calves just above the inside of both ankles (photographs available). The purpura resolved over a two week period after an extremely itchy period.
Patient called pharmacy complaining of pain, swelling, at the injection sites felt hot to the touch. Pt tried ice for about 1 hr without relief. She then went to the ER where they stated she had, had a reaction to the vaccines & gave her an antibiotic, Prednisone & pain med. On 9-5-10 pt said she felt better.
feels like she's dying; flu like symptoms; low grade fever; aches; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 11:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient's mother reported that her daughter was experiencing flu like symptoms. Her daughter felt like she's dying. She has a low grade fever and aches. Her symptoms started today (22Apr2021). The outcome of the events were not recovered.  Information on the batch/lot number has been requested.
Light headed and dizziness for 1week; rapid heart rate; Right arm pit swelled for 5 days with pain; Right arm pit swelled for 5 days with pain; Left calf muscle twitching and pain; Left calf muscle twitching and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 12:15 (Lot number: fC3184) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "Light headed and dizziness for 1week"; HEART RATE INCREASED (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "rapid heart rate"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Right arm pit swelled for 5 days with pain"; MUSCLE TWITCHING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Left calf muscle twitching and pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased, lymphadenopathy, axillary pain, muscle twitching, pain in extremity.  Additional Information: It was reported that Light headed and dizziness for 1week, rapid heart rate, Right arm pit swelled for 5 days with pain,Left calf muscle twitching and pain started the day after vaccine and Has persisted now for over two weeks. Facility type vaccine: Pharmacy or Drug Store. if other vaccine in four weeks: No. No other medications in two weeks: None. ae treatment: Phycologist visit, magnesium. if covid prior vaccination:Yes. if covid tested post vaccination: No. known allergies :None. other medical history None.  No follow-up attempts are possible. No further information is expected.
The patient had previously received the Janssen Covid vaccine on 4/6/21 at another pharmacy and did not disclose this information beforehand. The patient has not notified us of any adverse reactions, but was advised to sign up with vSafe.
a  lot of sneezing 30 times in ten hours,  the first day after the vaccine. Short random headaches, three to four times a day, for 14 days.
THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Pt developed redness w/in 1 minute of vax; Enlarged to 3cm w/1/2cm raised white one; Hive resolved w/in 10min; No tx other than observation;
I broke out in hives all over my body. I have been having numbness in my right arm for 2 weeks. I used itchy cream for my hives and it did not get better. I would take a shower and they would get better.
This spontaneous report as received from a Nurse refers to unspecified number patients of unknown age. The reporter reported that ROTATEQ, VARIVAX, RECOMBIVAX HB, VAQTA, M-M-R II, GARDASIL and PNEUMOVAX23 which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered these products. No adverse effects have been reported. Lot numbers and expiration dates unavailable for all products. Additional information has been requested.
The patient received Hepatitis A vaccine alone on 5/19/06. Some 30 hours later she developed a pruritic rash over the entire trunk. Her mother gave her diphenhydramine orally and applied a first aid spray.  The next morning the rash was fading and a day later has disappeared. There were no other exposures to medicines, new foods, or stinging insects in the interim.
A nurse reported that a 52 year old female received an injection of Pnu-Imune 23 on 9/12/01. Subsequently, the patient developed a fever and body aches. She also developed an injection site reaction characterized by redness and swelling. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 473556. See MCN GQ6188520SEP2001.
Elevated metabolism, night sweats, and mild fatigue for three weeks so far, following first dose. Also, sore arm and medium fatigue for one day following first dose.
Pain and swelling in shoulder and subsequent mobility issues. Patient followed up 06/26/23 stating that pain and swelling went down but limited range of motion due to pain when shoulder is moved.
got the vaccine, had shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine and then had singles months later.  This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. THis case has been linked with US2021AMR205456 and US2021AMR205467 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205456:Same reporter US-GLAXOSMITHKLINE-US2021AMR205467:Same reporter
Prolonged uncontrollable crying and irritability greater than or equal to 3 hrs.
Patient got dizzy after 5 minutes of getting shot, had syncope episode and fell to ground. Patient was very pale and sweaty afterwards.
1. Hives 2. Facial swelling  3. Wheezing  4. Legs warm to the touch All occurring approximately 2 hours post injection and are still present 23 hours later.
On October 25, 2021 , I received the Pfizer COVID 19 Booster and on October 26, 2021 I received a phone call from a pharmacy advising me that the vaccine I received on October 25, 2021 contained Sterile Water instead of Sodium Chloride and that I should go back in to the pharmacy to get another vaccine.
Information has been received from a 77 years old female patient concerning herself. The patient's pertinent medical history was not informed. The patient's concurrent conditions included osteoarthritis and allergy penicillin, codeine, sulfa and environment (spring, mold, dust, fur). On 11-OCT-2016, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (lot #, expiration date, dosage and therapy route were not provided), administered in the right arm. Concomitant therapies included TYLENOL. It was reported that on 11-OCT-2016, reported as "since being administered the pneumococcal vaccine (manufacturer unknown)", the patient had had slight pain, but she attributed the pain to her osteoarthritis. The patient stated that it was hard to quantify exactly when the reaction began due to osteoarthritis. The patient also reported that on 18-OCT-2016, reported as "all day yesterday" she was in extreme pain. The same day (18-OCT-2016), reported as "last night", her right arm was killing her. She touched the area in the muscle where she had the shot and it was sensitive and sore. The patient did not seek medical attention, nor laboratory diagnostics studies where performed and no treatment for the adverse events was given. The outcome of injection site hypersensitivity was reported as not recovered due the patient's arm was still sore. The outcome of other adverse events was unknown at the time of the report. The causal relationship between pneumococcal vaccine (manufacturer unknown) and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for follow up was given.
arm kept itching; red swelling at the injection site; circular red blotch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm kept itching), VACCINATION SITE SWELLING (red swelling at the injection site) and VACCINATION SITE ERYTHEMA (circular red blotch) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (arm kept itching), VACCINATION SITE SWELLING (red swelling at the injection site) and VACCINATION SITE ERYTHEMA (circular red blotch). At the time of the report, PRURITUS (arm kept itching), VACCINATION SITE SWELLING (red swelling at the injection site) and VACCINATION SITE ERYTHEMA (circular red blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   Patient kept some cool compresses which helped.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient did not have any signs or symptoms after vaccine. He did have a pre-op exam on 06/27/2022 for oral surgery and appeared healthy at the exam and was approved to have surgery. He was seen on 09/19/2022 for a cough and did test negative for covid. Patient was also seen on 11/02/2022 for cough and fever. He tested negative for covid at this visit and was diagnosed with an ear infection.
Sick to his stomach; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated). At the time of the report, ABDOMINAL DISCOMFORT (Sick to his stomach) and NAUSEA (Nauseated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-231478 (Patient Link).