chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received intramuscular injection of 0.25 ml Fluzone influenza vaccine at 1145. Client observed his mother receiving flu vaccination at 1157. Client laid down on clinic floor. Nurse completed the mother's vaccination and immediately attended to client who appeared to have a vasovagal reaction. Clerical was directed to call 9-1-1, related to client's father's history of reactions to immunizations; though client had received two doses of influenza vaccine in the previous flu season. Oxygen was administered in a blow-by fashion while pulse and blood pressure were taken. Client began arousing at 1158, skin was cold and clammy. When emergency personnel arrived at 1200 client was alert and oriented, though continued to be lethargic. When client's father arrived at 1202 client was alert and oriented X3 and greeted father with a smile. Apical pulse at 1201 was 114 beats per minute. Blood pressure using pediatric cuff was 84/50 and pulse was 120 beats per minute. By 1207 client was talking clearly and walking steady. Emergency personnel and nurse concurred that patient experienced syncopy and did not need to be transferred to hospital. At 1230 client went home with mother and father, smiling and talking as they went.
A physician reported that a 5 month old infant received an injection of Prevnar and subsequently developed an injection site reaction characterized by redness and swelling approximately 4 inches in diameter. The infant recovered. Additional info from the physician on 07/03/01 provided the lot # and date of the vaccination.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 45-year-old male. Neither medical history nor concomitant medications were reported. On 26-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 06Sep2023 to 10Sep2023 as treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I started feeling congested and had a cough.  I also ran a temperature of 102 degrees.  I went to doctor and had influenza-A and was put on Tamiflu and Benzonatate cough medicine.
Vertigo resulting from Benign paroxysmal positional vertigo resolved within 4 days.
(R) arm redness, swelling, hot to touch from deltoid to midshaft, treated with ice & Ibuprofen.
Patient developed brown spots above upper lip that appeared to crust over and itch; also developed these right below lower lip; these are getting better as of 2/19/21 but are still there;  patient contacted  doctor on 2/18/21 re this
On Tuesday night I went to bed with a cough. When I woke up the next day my cough was worse, my throat was sore, and I had a slight headache. I took a home COVID-19 test, and it was positive. My doctor advised I use TYLENOL and MUCINEX to help with the congestion. This was yesterday and today my throat is a little sore still but not as bad as it was. I will be making sure I get plenty of liquids as my doctor advised as well. I did have my flu shot the same day that I had my COVID-19 Bivalent shot, but I do not have the information for that shot.
Severe headache.  Severe pain in muscles and joints.  Severe pain in neck, shoulders, hips and back.  Fever
HYPERtension, Tachycardia, PETECHIAE, HEAT AND PAIN AT THE INJECTION SITE Narrative: ED AND EOH PRESCRIBED PROPRANOLOL AS NEEDED
Got second shot and got them a second time/Suspected vaccination failure; Got second shot and got them a second time; Got the 1st shot and got it; It was awful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient's friend.  The age at vaccination was not reported. The patient got the Shingle shot and got shingles. Then physician recommended a second Shingles shot and she got shingle again second time and it was awful for the patient. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Client brought to observation area after J & J vaccination to left deltoid.  C/O dizziness, nausea, sweating.  Initial O2 sat of 87% (note extremities cool to the touch.  Placed on 10 LPM NC at 100%   At 1028 am 98/69 blood pressure 100% O2 sat on 10 LPM  1031 am 98/69   Client then on RA and continued at 100%   Client c/o mild dizziness.  Later ambulated to bathroom without aide   He works at the college and will rest in his work room.  He reported very mild dizziness, MAEW, NAD, Speaking in full sentences.  1103 am VS of 113/72 64 22   Client directed to call 911 for difficulty breath and f/u with a health care provider as needed.  Note client stated he does not have health coverage presently  Client DCd home at 1105
Full body rash and hives; Full body rash and hives; Swelling in fingers from the hives; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 04May2021 at 12:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to cats and dust mites. It was reported that the patient was not that aware of known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 13Apr2021 at 12:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient underwent Nasal swab and the result was negative. On 07May2021 at 06:00, the patient experienced full body rash and hives and swelling in fingers from the hives. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and which included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events full body rash and hives and swelling in fingers from the hives was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Upon waking the day after the booster I observed extreme redness similar to a sunburn that was bilaterally affecting all major lymph node regions of the head/neck, axillary regions, groin regions as well as the insides of arm where they bend and belly button. His upper back is also broken out in a rash that spans down to the mid thoracic region.
Bloody diarrhea multiple times since the shot was administered, it?s not an emergency so we haven?t gotten to a doctor yet
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. In 2011, the patient was vaccinated with ZOSTAVAX (dose, route, lot number). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles while on ZOSTAVAX. No treatment information was reported. The outcome of the events was reported as not recovered/not resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
He had flu-like symptoms after receiving the vaccine on Monday 3/29. He woke up on Tuesday 3/30 with fatigue and a low-grade fever. He was scheduled for a routine doctor's appointment late Tuesday afternoon. At the doctor's office he had a seizure, which caused him to lose consciousness for 15 seconds. Upon waking, he was transferred to the Hospital. He was released later that day. On Wednesday 3/31, he experienced a headache & went to the hospital. He was admitted and stayed in the hospital for 2 nights.  An MRI found micro-bleeds on his brain. He was treated with lamotrigine and sent home with a prescription for 25mg/twice daily. He has a follow up appointment with a neurologist in 3 weeks.
After receiving the dose in the morning, that evening patient developed chills, fatigue and hip/joint pain.  Chills lasted 2-3 days with the onset of headache as well.
Information has been received from a physician and a school nurse concerning a 8 year old male who on 06-FEB-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3).  It was also noted that the child was vaccinated with a dose of measles viurs vaccline live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 07-MAR-2002. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a "more severe case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
Vomited 30 minutes after receiving vaccine.  Headache that night and severe nausea and stomach cramps. Diarrhea the next morning. No appetite, nausea, headache, fatigue, severe sore arm at injection site. As the week progressed I became sicker and sicker having vomiting, hot flashes, chest pressure, chills, dizziness, pain in left and right arms, pain in neck and shoulders. By the weekend I was unable to keep any food or liquids down, so I went to the ER and received tests and medicine. All this past week I have been fatigued, nauseous, had headaches, chest pressure, extreme tinnitus, stomach cramps, congestion, hot flashes, constipation. Went to family doctor on Friday, had more tests done and she said I had an adverse reaction to the vaccine. I also had three Covid tests done locally at the hospital and doctors office during this period. All were negative.
After 1 3/4 hours 1. headache, 2. thirsty, 3. throat pain, 4. cramping of legs, 4. generalized weakness, 5. weakness of arms seen by doctor evaluated: drinking fluids well, drowsy, BP 94/64, HR 64\mm, RR 18 to 20/min. No diaphoresis, no voice change (cercious/no SOB/ No chest pain. Negative pulses, no pain circulatory gen. normal after treatment.
Red area 1.8 x 1in at injection site. Gave Benadryl. Kept extra 30 minutes had decreased in size to .75x 1.8 hrs less red.
This study case was received from the investigator in a trial on 15 April 2014. A male subject with no reported past medical history had received on 24 March 2014: ACAM2000 (lot number, route and site of administration not reported), Typhoid vaccine (lot number, route and site of administration not reported) and TWINRIX (manufacturer, lot number, route and site of administration not reported) and 7 days later was found to have on 31 March 2014, lightheadedness. The subject had no associated chest pain or shortness of breath. ECG was normal and Troponin I level was not performed due to hemolysis on 08 April 2014. The subject did not seek medical attention. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of lightheadedness was considered an other important event and possibly related to vaccination.
Patient received his flu vaccine on 9/8/2017. He went to the doctor on 10/5/2017 d/t 2-3 day history of progressive weakness to the point that the patient was unable to stand at his doctor's office.  His mentation/behavior was declining. Neurology was consulted and ordered MRIs. d/t the patient not being able to lay still they intubated him. An LP was done which showed increased protein suggestive of *AIDP (acute inflammatory demyelinating polyneuropathy). He was started on IVIG in the ICU, and began to show improvement rapidly. He was extubated 3 days later. He continued to work with PT/OT to improve over time. He was discharged on 10/16/2017 with home therapy.
NO ADVERSE REACTION REPORTED. Patient given 0.5ml dose but indicated for 0.25ml BOOSTER DOSE ADMINISTRATION DOSE ERROR.
Pt received H1N1 and seasonal flu injectable vaccines on 12/18/09 and within 1-2 days had worsening muscle and joint pain. She has underlying rheumatoid arthritis and fibromyalgia
Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Additional Details: got several small red areas on arms.
Patient felt faint, then proceeded to faint. I caught patient and sat her down. Called 911. She came to about 5 -10 sec. later. 911 cleared patient.
A spontaneous report (United States) was received from  a consumer concerning a 40-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and fatigue.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch # 025l20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection on 27 Dec 2020.  On 27 Dec 2020, the patient experienced headache and fatigue after receiving the vaccine.  No treatment information was provided as per patient she has not taken any medications.   There was no change planned in the dosing schedule of mRNA-1273 in response to the event.  The events, headache and fatigue, were not recovered/resolved.; Reporter's Comments: This case concerns a 40-year-old female patient on unknown age who experienced expected non-serious events of Headache and Fatigue. The events occurred on the same day after receiving first dose of mRNA-1273, (lot # 025l20A). No treatment was given for the events. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
The pharmacist who spoke to patient on 8/24/16 documented this: "Patient had an adverse reaction to flu HD vaccine, reported uncontrollable shaking and jaw shakes for the entire evening on the date of administration. Patient states the adverse effect only happened that evening, she felt run down for the next day, but no longer having shakes. She has been in contact with her doctor." --- Note that patient received the vaccine on Monday 8/22/16, and she notified our pharmacy 2 days later on Wednesday 8/24/16.
Vise-like headache; Nausea; Severe fatigue; Cough; was so fatigued that I slept most of the time except to use the bathroom or to drink fluids.; This is a spontaneous report from a contactable consumer, the patient. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 02Mar2021 at 09:00 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 09Feb2021, as a single dose for COVID-19 immunisation. On 12Mar2021 at 03:00, on the 10th day after receiving the second shot, the patient woke up with a vise-like headache, nausea, severe fatigue, and cough. The patient was so fatigued that she slept most of the time except to use the bathroom or to drink fluids. The patient had to make herself get out of bed. These symptoms persisted for 24 hours and then disappeared as fast as they came. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vise-like headache, nausea, severe fatigue and cough was recovered on 13Mar2021 at 03:00.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of sciatica in a 59-year-old male patient who received SHINGRIX (batch number 455KD, expiry date 31st May 2021) for prophylaxis. On 8th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, 5 days after receiving SHINGRIX, the patient experienced sciatica. The patient was treated with prednisone (Prednisone Dose Pack). On an unknown date, the outcome of the sciatica was unknown. It was unknown if the reporter considered the sciatica to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient was started on Prednisone dose pack for sciatica 5 days after receiving his 2nd dose of SHINGRIX. The pharmacist said that the patient did not feel the event was related to SHINGRIX vaccine.
This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA002653: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA011215.
First day of covid symtoms on 01/24/2022.  Tested positive 01/25/2022.  Symptoms included dry cough, tiredness, no temperature, and runny nose.  Tested positive on 02/06/2022 and 02/07/2022.  Tested negative on 02/09/2022.  Treatment included bed rest, isolation, and use zinc, vitamins C,D, and D3, melatonin.  Used Ivermetin paste (approximately 2MG per day) for first five days.  Doctor was not consulted during this time.
Dose leaked on the arm while administering; Dose leaked on the arm while administering; feels that the right quantity of the dose is not administered; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered). On 11-Mar-2021, UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered) had resolved. Not Provided          No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
pt began rubbing eyes & forehead 10min p/vax w/development of transient urticaria on fore head, rt arm, erythema around rt thigh inj site & rt knee;given DPH;