chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of meningitis / encephalitis, approximately one month after TD administration. To my knowledge, no other etiology of encephalitis was found (under care of different MD at a different facility). Per follow up, patient moved.
Received her first dose of the Pfizer COVID-19 vaccine on Sunday May 16,2021 at around 2:50 pm. At around 7:20 pm on May 16,2021 she stood up to walk to the bathroom. She began feeling nauseous when she stood up. While she was washing her hands, after going to the bathroom, she began to have difficulty with her vision. She describes white and blue dots obstructing her vision in both eyes. She also began to experience loud tinnitus. She described hearing multiple frequencies.  The problem with her vision and the tinnitus continued as she walked through our house to a couch where she laid down. The vision problem and tinnitus continued while she laid on the couch. Her breathing was rapid but she thinks this may have been due to the stress caused by her other symptoms. This episode lasted for several minutes and then the vision problem resolved. The tinnitus continued for several minutes after the vision problem resolved. The intensity of the tinnitus slowly decreased until it finally stopped. The following evening, she experienced tinnitus for a few minutes but it was less intense than it was the previous evening. She very rarely has experienced tinnitus in the past. She has very infrequently experienced brief episodes of orthostatic hypotension when she was dehydrated. When this event occurred, she felt like she was well hydrated. This event lasted much longer and she has never experienced this problem with her vision in the past.
Area of tenderness, induration, redness about 15cm x 10cm developed 1 day after injection. Fever 101 degrees F.
Patient indicates that area where the vaccine was administered is red, warm, pain, fever, and burning.  Went to the doctor on 10/21 and 10/23/15 and they gave him antibiotics in an IV.  Now he is taking oral Cephalexin 500, Dologen and anti-inflammatory.
another one she got a killer headache with that Tylenol could not get rid of; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing), notes: GERD; "Had gall bladder removed" (unspecified if ongoing). Concomitant medication(s) included: ESOMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: EN6202, Expiry: 30Jun2021), administration date: 05Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "She was exhausted", "felt awful for a few days in a row", "She threw up in the middle of the night", "She got a killer headache"; bnt162b2 (DOSE 2, SINGLE, Lot: EP6955 , Expiry: 30Jun2021), administration date: 26Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "She was exhausted", "felt awful for a few days in a row", "She threw up in the middle of the night", "She got a killer headache". The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "another one she got a killer headache with that Tylenol could not get rid of". Therapeutic measures were taken as a result of headache. Additional information: She got a killer headache with that Tylenol could not get rid of and had that a day or two and then after the immunization, she would feel better the next day after 2-3 days of misery, she would wake up feeling perfectly normal the next day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311369 same reporter/patient, differnet vaccine dose;
SORE ARM; Tiredness; Hurting for like 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 21-Jan-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 INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days). At the time of the report, INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days) outcome was unknown.
Hard swelling and soreness at injection site (left deltoid), persisting for 6 weeks.  Pain increases in upper left arm and shoulder after physical activity.
Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives covering face, chest and arms. Given 50mg Benadryl and 40 mg Pepcid. Symptoms resolved a little over an hour post injections
throat feels tight, tingling palms, elevated heartrate.  Evaluated by EMS-Cleared
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No information on patients medical history, concurrent conditions and concomitant medications was provided. On unspecified dates, sometime in June 2017, the patients received improperly stored VARIVAX lot # M048203, expiry date: 07-DEC-2018 (dose, route of administration were not provided). The sterile diluent (STERILE DILUENT) (lot number N003192, expiration date 05-JUL-2019) used to reconstitute the VARIVAX was properly stored. Digital data logger detected that the vaccine was stored in temperature from 15°F to 46°F for 2 hours. There was no previous temperature excursion. No product quality complaint was involved in this case. No symptoms were reported. Additional information has been requested.
Headache, Fever, HA, VERY LOW GRADE FEVER, Narrative:
On 8/21 just sore arm on 8/22 shortness of breath with pain in my back and chest pain coming and going that is still continuing as of today . I have had blood work and chest X-ray with no findings . Requesting a cat scan that was denied from my insurance. Going today to have a test done at the hospital
Follow up appointment with physician after ER visit for febrile seizures. Received immunizations 5/15/00, seizures 5/16/2000.
double vision; droopy eyelid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cranial nerve disorder.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid). At the time of the report, DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal. In February 2021, Computerised tomogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included birth control pills.  No treatment information was reported.
administration of only Liquid Component; administration of only Liquid Component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30th November 2023) for prophylaxis.   On 21st October 2022, the patient received Menveo. On 21st October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's comment: The patient care technician asked information about the administration of only the liquid Meningococcal CWY component without using it to reconstitute the lyophilized A component.  The reporter asked if patient had to be revaccinated. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid Meningococcal CWY component without using it to reconstitute the lyophilized A component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 06/10/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than 50 pox and a low grade fever.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Just over 24 hours after vaccine patient states she developed systemic itching, racing heart, sob and fatigue which resolved in less than 24 hours.  She did not seek care and was fine when she reported these symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated that several patients refuse to get the second dose of the SHINGRIX series. The pharmacist did not mention any specific patients.
Injection site pain, swelling, hot, sore About a week after, itching at injection site
Two complex seizures; An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 06Feb2021 (at the age of 88-years-old) as a single dose for COVID-19 immunization. Medical history included atrial flutter from an unspecified date and unspecified if ongoing. It was reported that the patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (within two weeks) included warfarin sodium (COUMADIN). It was reported that the patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. The patient experienced two complex seizures, serious for hospitalization, on 10Feb2021. The clinical course was reported as follows: "Two complex seizures confirmed by ED (emergency department) physician. No history of seizures. Negative CT head and labs. Unclear if seizure was related to COVID vaccine 5 days prior." It was reported that treatment was not received for the event. The clinical outcome of the event two complex seizures was recovered/resolved on an unspecified date. It was also reported that the patient had not tested positive for COVID-19 post vaccination.   No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizures cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
"Patient was admitted to hospital service with confusion post her second coronavirus vaccination.  The symptoms started about 3 hours after she received the vaccination.  She felt weak and very restless.  Her family noted her to have global confusion.  She had no focal neurologic deficits.  She was brought to the emergency department.  Head CT did not reveal any acute findings.  Her generalized weakness and restlessness slowly resolved and she felt back to her normal state by the date of discharge on March 30.  She was not noted to have an infectious process.  Coronavirus testing was negative.  Of note patient with a chronic normocytic anemia.  Iron studies were sent and iron and ferritin were within normal limits with a low percent saturation of 11.  Folic acid and B12 were within normal limits."
Pericardial Effusion caused by Pericarditis. Diagnosed as Ideopathic. No attempt to link to Vaccine.
Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.; Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 17:35 (Lot number: EW0177) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Apr2020 (ongoing), notes: Verbatim: Anxiety; "Depression", start date: Apr2020 (ongoing), notes: Verbatim: Depression; "stomach pain" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM taken for anxiety, abdominal pain upper, start date: 14May2021 (ongoing); ESCITALOPRAM taken for anxiety, depression, start date: 14May2021 (ongoing). Vaccination history included: Bnt162b2 (LOT: Caller reports as EW02 or 07, 15., Time the Vaccination Was Given:5:35 pm , Anatomical Location of Administration of Pfizer vaccine considered as suspect: left upper arm, sick feeling in her stomach and stomach pain), administration date: 21Apr2021, for COVID-19 immunization, reaction(s): "sick feeling in her stomach", "stomach pain". The following information was reported: JOINT STIFFNESS (non-serious), PAIN IN JAW (non-serious) all with onset 21May2021 18:30, outcome "not recovered" and all described as "Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.".  Additional information: Reporter states it feels like her jaw is tight constantly, after the second vaccine. Reporter stated that she got her second vaccine on Friday and she just told her doctor, her effect was not going away. Reporter stated that ever since she got the shot, she had been having weird jaw pain and stiffness. Reporter further stated that it feels like her jaw is tight constantly. she didn't had any other side effects, but this effect has been very noticeable and hasn't eased up. Prior Vaccinations within 4 weeks patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are possible. No further information is expected.
Patient was given an undiluted 0.2ml dose of Pfizer pediatric dose.  Realized the error approximately 45-60 minutes after.  Contacted patient's parent and checked on patient's status. Per parent, patient is normal.  Parent will monitor patient and was instructed to take patient into hospital if symptoms are severe like chest pains, lethargy.  Informed parent, that we will follow up later the evening.
Left arm swollen below elbow heat, called Dr. advised to put ice packs and monitor.
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
Following AM on waking, noticed reddened, hot, swollen, itchy area approximately 6"x4" upper arm, around site of injection. Took Benadryl with ice to area. Resolved in 3 days.
Received the injection on January 22, Friday. Rash on Left Arm by injection site on Sunday night about 10 PM and it was gone by Monday morning. I did nothing for the rash. Blood Pressure increased at night on Sunday, Monday and Tuesday At 3:30 Am Wednesday my BP went to 214/110 so I went to the Hospital. Doctor in the hospital gave me 5 mg of Amlodipine.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.   This case was linked to US-MODERNATX, INC.-MOD-2022-625471 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Live follow-up received with additional no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-625471:Wife case
This case meets vaccine breakthrough criteria review.  SXS SOB, COUGH, CHEST CONGESTION
Localized pain. Suspect SIRVA. Ongoing treatment. Pain has not resolved. Currently in therapy.
experiencing inflammation under the ribcage; Hardness under the skin; a lump below the injection site, under the vaccination site there is a hard lump; as if the fluid had dropped and made a bump and it is the size of an olive; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive), INFLAMMATION (experiencing inflammation under the ribcage) and VACCINATION SITE INDURATION (Hardness under the skin) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LOSARTAN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive) and VACCINATION SITE INDURATION (Hardness under the skin). On an unknown date, the patient experienced INFLAMMATION (experiencing inflammation under the ribcage). At the time of the report, VACCINATION SITE MASS (a lump below the injection site, under the vaccination site there is a hard lump), SWELLING (as if the fluid had dropped and made a bump and it is the size of an olive) and VACCINATION SITE INDURATION (Hardness under the skin) had resolved and INFLAMMATION (experiencing inflammation under the ribcage) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains significant information including updated previous events outcome to recovered/resolved and added a new event.
Patient reported back a few minutes after the shot with itching and throat closure but was conscious and breathing. Patient was moved to a chair and refused epinephrine. Patient was instead given Claritin chewables followed by Benadryl and water. After about 15-30min minutes the itching and throat symptoms subsided significantly but not entirely and patient remained under observation for the next hour. Patient requested to return to her desk about an hour after the initial allergic reaction. Patient was also given the Fluzone lot number and other information to report to her PCP. Patient remained concious and talking the entire time.   She reported this incident was extremely similar to a prior allergic reaction to the Moderna Covid vaccine but had never happened with a flu shot before. The prior incident caused skin itching and mild throat closure for an entire week and was treated under her PCP recommendation with Benadryl every 3-4 hours. She plans to visit her PCP.