chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician concerning to multiple patients of unknown age and gender. The patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). The physician reported that he had seen several cases of breakthrough shingles in people who received ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested. This is one of several cases received from the same reporter. (MARRS#1211USA002353).
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room.  Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related.  My arm hurts quite a bit today  but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
COVID vaccine was administered that was past the use date. The vaccine was given on 10/24/2023 and the vaccine was over the time period. There was no harm to the patient.
Heplisav-B Given After High Temperature Excursion; Initial Report Received on 23-Feb-2021  A nurse reported that a 76 year-old male (race and ethnicity not provided) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization past the 8 hours of exposure time allowance to room temperature.  No other medical history was reported.  No relevant concomitant medications were reported.    On 22-Feb-2021, the patient received a dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 43528-003-05 and serial number 451427834640) to the left deltoid at a doctor's office from a medical assistant. The doctor's office was closed the previous week due to a power outage. There was a note placed on the vaccine refrigerator of "do not use vaccine" because the vaccine temperature was out of range (16.3 C° or 61.3 F°) past the 8 hours of exposure allowance time to room temperature. However, the medical assistant did not see the refrigerator sign and gave the HEPLISAV-B vaccine to the patient.  The patient reported no adverse reactions or side effects.     No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I had pain and stiffness in my right elbow. These symptoms is still ongoing as of today. I got a doctor appointment to see what is going on with my elbow.
The patient was brought to the ED by EMS on 9/16/23 after sustaining a fall. He was getting up to use the bathroom, felt dizzy, and fell. He was unable to get up due to generalized weakness. His daughter, who he lives with, called EMS. In the ED, he was found to have hypoxia to 90% and fever to 100.4 F. A rapid COVID PCR test performed in the ED resulted positive. He was put on supplemental O2. Ultimately, the patient was admitted 9/16/23 - 9/18/23, with discharge diagnosis including COVID 19 pneumonia. During his admission, he was able to wean off supplemental oxygen.
2 d after shots given returned to office c/o rxn and 1 d - right upper lateral arm, + edema, + mottled erythema, + induration - next day improved but temp 102 F.
body aches; Fever of 102; chills; left arm pain at injection site; This is a spontaneous report from a contactable consumer, the patient.  A 74-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER8736), via an unspecified route of administration, in arm left on 06May2021 at 11:45 as dose 2, single (age at vaccination 74 years) for covid-19 immunisation. Medical history included PSVT, osteoporosis, prediabetes and was allergic to contrast dye, shellfish, paramenobenzoic acid (PAPA). The patient did not have covid prior vaccination. No other vaccine was administered in four weeks. Concomitant medication(s) included verapamil and vitamins since an unknown date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0151), via an unspecified route of administration, in arm left on 13Apr2021 at 12:30 as dose 1, single (age at vaccination 74 years) for covid-19 immunisation and experienced fever of 99, headache, body aches, left arm pain at injection site. After the second dose, on 07May2021 at 18:30 the patient experienced fever of 102, chills, body aches, left arm pain at injection site. The patient underwent lab tests which included body temperature: 102 Fahrenheit on 07May2021. No therapeutic treatment was taken for the events. The patient was not tested post covid vaccination. The outcome of the events was recovered.  No follow-up attempts are possible, no further information is expected.
No adverse outcome.  Was given DTaP-IPV outside of age range 4-6yo.
5/2/05 Received first HB vaccine. 5/3/05 Late afternoon/early evening, started experiencing sore throat and lower back pain. 5/4/05 Above symptoms still present but lessened. 5/5/05 Back discomfort subsided. Sore throat developed into cold.
Patient had vaccines administered on 1/28/20.  On 1/30/20, she presented to clinic with redness, swelling, and warmth to left thigh.  The symptoms had started the previous day and got worse with time.  She was diagnosed with cellulitis of the left thigh related to a vaccine reaction.  She was treated with Bactrim oral suspension.
husband is bedridden and coming through an ambulance; This is a spontaneous report from a contactable consumer (Patient wife) from sponsored program. A 74-years-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. Medical history included, patient had a severe COPD and multiple strokes even before the first dose of the vaccine; both from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after first dose of the vaccine, the patient experienced bedridden and coming through an ambulance. Reporter stated that patient is coming home from the hospital tomorrow (at the time of report, unspecified date). He needs to get his second shot but his husband is bedridden and coming through an ambulance. Reporter would like to know that if a nurse can come to their house to administer the second dose for patient. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd March 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 02-MAR-2023 Reporter comment: The nurse reported that a patient received a 2 days expired dose of bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of bexsero vaccine which led to expired vaccine used.
This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-OCT-2015 - unknown stop date, Batch no: 11349221A, Route of administration: Intramuscular, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-OCT-2015, after starting / treatment with AFLURIA the patient received 1.0 ml IM dose of AFLURIA/Overdose (non serious, outcome: Unknown). No adverse reactions have been reported. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Not provided.
This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a consumer concerning her 11 year old daughter with asthma and sulfonamide allergy and a history of yeast infections who in approximately November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included ALLEGRA, SINGULAIR, ADVAIR, NASONEX, PROZAC. Subsequently, it was reported that the patient's "yeast infection has become more severe." Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information was received from a physician who reported that her office did not administer the vaccine to the patient nor had the patient addressed the event with her. The patient's mother was notified to provide the name of the ordering physician. No further information is available.
Diarrhea; A spontaneous report was received from a nurse on 18JAN2023. On 12JAN2023, a 62-year-old female patient took the first dose of Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) followed by the second dose on 14JAN2023 and third on 16JAN2023 for immunisation. The patient subsequently had "diarrhea" (PT: Diarrhoea).  The patient had no medical history /conditions. The patient was allergic to penicillin and sulfa drugs and also had seasonal allergies.  Concomitant medications included Flonase (fluticasone propionate; nasal spray daily) and Zaditor (ketotifen fumarate; eye drop daily).  On 17JAN2023, in the evening, the patient had diarrhea which continued until 18JAN2023 around 7:30 AM. Reportedly, the patient took Imodium tablets (duration, dosage or number of tablets were not specified) which helped with her diarrhea and as of 18JAN2023; 9 AM, she no longer had diarrhea. Additionally, the patient did not take any lab work or diagnostic tests. It was reported that the patient had not taken the last dose of Vivotif yet.  The patient had recovered from the reported event on 18JAN2023. Action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer developed diarrhoea following the administration of third dose of Vivotif. She had recovered from the event at the time of reporting. Considering the case information, the causality of diarrhoea is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer developed diarrhoea following the administration of third dose of Vivotif. She had recovered from the event at the time of reporting. Considering the case information, the causality of diarrhoea is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was inadvertently vaccinated with two doses of VARIVAX simultaneously (route and site of administration, dose, lot# and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
Within 24 hours of receiving the vaccine, everything started to smell weird and taste very abnormal. I ended up getting oral thrush which I was treated for but I still have a residue on my tongue that I have to scrub off or I end up feeling sick and everything tastes and smells ?metallic?. Don?t know how else to describe it.  But I?m miserable.
First 10 minutes directly after administration: arm pain, dizziness, nausea. Felt like I was going to pass out for about 5 minutes. Felt basically normal by the time I left the facility and my arm has not been hurting since.   Approx 8:00 PM onset of headache, progressively worsening thru ~11:00 PM and plateauing. Headache was less by ~8:00 AM, and took Ibuprophin at 9:00 AM to further alleviate.   Approx 9:30-10:00 PM onset of chills and shivering, progressively worsening thru ~11:30 PM. Chills lasted through the night, but shivering stopped around 12:00 AM after turning the heat up and putting on more clothing, beanie, and blankets.   Fatigue is ongoing (as of now, ~22.5 hours after administration), but may be a result of poor sleep due to the chills overnight.
Teeth were becoming brittle, yellow/brownish no matter how much I brushed. Was given a mouthwash by dentist, while stating I didn't brush my teeth enough (2007) left side had all molders removed. W/having others breaking while eating food
Information has been received from a physician concerning a 14 year old female with allergies to amoxicillin and ZITHROMAX and a history of acne who on 01-AUG-2011 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 669308/0636AA, exp date 17-AUG-2013) and on the same day was vaccinated with her second dose of VAQTA. Concomitant therapy included minocycline. The physician reported that on 01-AUG-2011 the patient became syncopal and laid down in the office for about two hours, this was able to prevent a seizure. During this time she was dizzy and wobbly with cyanosis in her hands. Her blood pressure was slightly low and she had some shortness of breath. As of evening on 01-AUG-2011, she went to the emergency room and was given fluids. Her hands still had cyanosis. The patient performed lab diagnostics and the result showed blood pressure and oxygen were slightly reduced. At the time of report, the patient did not recover. Follow-up information has been received from the physician concerning the patient. The physician reported that within 10 minutes of vaccination, the patient had syncopal episode, possible tonic-clonic movements due to that syncopal episode. The patient was alert and oriented shortly after. The patient was wobbly for 2-3 hours. The patient went to emergency room, had electrocardiography and blood work- both had results within normal limits. The patient was wobbly, unsteady the day after vaccination. The patient's hands were still blue, but not painful, not tender. The health care professional contacted during telephone follow-up could not supply the following information: lot number for secondary suspect therapy, current recovery status, and hospital name. Syncopal, dizzy, wobbly/ unsteady, cyanosis in her hands, blood pressure low, shortness of breath and oxygen slightly reduced were considered to be other important medical events and disability or incapacity by reporter. Additional information has been requested.
felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) outcome was unknown. Not Provided          No treatment information was provided.  No concomitant medication was provided.
On 9/17/99, the pt developed a rash. The pt was afebrile.
A couple of days after getting the vaccine I developed tinnitus 24 hours a day nonstop to the point that I could always hear it no matter what was going on. (TV, people talking) Its always present I even lost hearing for a few months into the summer. After summer it wasn't as loud but still present. I hear the ringing day and night. I had been doing V-Safe check in's and I didn't think for a second that it could be related until I did more research and found that other people have had the same symptoms.
Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism.  The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
at about 10pm on the day of the vaccination I began experiencing very strong chills, my temperature was 99.1F (my typical temperature is 97.6F). I took 400mg of Advil, got covered with a few blankets and went to bed. I kept waking up through the night and at some point (around 2am) I checked and was running a fever of 101F. I woke up in the morning (8am) with no fever but feeling malaise, muscle soreness and a headache, which lasted through the next day but no fever nor chills. I woke up on the second day after vaccination still having slight headache and a fatigue. No fever nor chills. This is my condition at the time of writing this report.
Ten hours after injection I began fever and chills.  From 2 AM-5 AM I had a temperature of 105 degrees, severe rigors with severe achiness, headache
Flu like symptoms; Extreme headache; Tired; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Extreme headache), FATIGUE (Tired) and MYALGIA (Body ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K2019) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Extreme headache), FATIGUE (Tired) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Extreme headache), FATIGUE (Tired) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: No New information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.
Initial case received from the patient's mother on 01 May 2014. A 2-year-old male patient, with no reported medical history and no reported concomitant drug, had received 2 doses of FLUZONE in 2005 (batch number U1746AA, expiry date 30-JUN-2006) at his own HCP. Since time of vaccination in 2005, the patient has "not been the same". It was stated that the patient was talking prior to the vaccination and that after vaccination he did not talk. The patient's outcome was reported as unknown. Documents held by sender: none.
BP 203/105. pt was admitted to ED for high level of care; patient stated she was "not feeling well"; This is a spontaneous report from a non-contactable pharmacist (patient).  A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 29Mar2021 (Lot Number: ER8727) as dose number unknown, single (at the age of 76-years-old) for COVID-19 immunization. Facility type Vaccine was the Hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient experienced Covid prior vaccination. On 29Mar2021, the patient stated she was "not feeling well", BP 203/105. Pt was admitted to ED for high level of care. Adverse events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 203/105 on 29Mar2021. Unknown if the patient received treatment. The outcome of the events was unknown. Unknown if the patient was Covid tested post vaccination. The case was considered as serious (medically significant).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events Blood Pressure high, malaise and the suspect drug BNT162B2.  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.
Knots in legs at injection sight, no pain noted when spot is touched, waiting to see if knots will disappear, been rubbing and applying warm compress
The patient presents to the hospital today with cough, shortness of breath, weakness. Diagnosed with COVID-19 on 01/25/2022. Symptoms started 01/20/2022. Was on azithromycin as well as Molnupiravir for least the last 3 days. CT chest shows bilateral infiltrates in lungs. CT angiogram could not be done due to allergy to iodine. V/Q scan - The probability of pulmonary embolism is very low. DVT scan negative. Continues to be on 3 L.Continued on dexamethasone. Does not qualify for remdesivir - symptoms more than 10 days.