chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and gender. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The pharmacist reported that, on unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M042499 with an expiration date in 17-APR-2018), subcutaneously, for prophylaxis (strength, dose, and frequency were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). The vaccine data logger measured a temperature between minus 14°C to minus 10 °C for a time frame of 17 hours and 53 minutes. Additional reported excursions were of 9°C to 8°C for a time frame of 17 hours and 12 minutes. A previous temperature excursion was between minus 9°C to 8°C for 12 hours and 2 minutes. No adverse effects were reported, and there was no product quality complaint (PQC) involved. Additional information has been requested.
chills, body aches, lethargy. it lasted 12 hours, advil and naps helped
I noticed a week after my Vaccine I took a bath and I noticed it was a little lump in my left clavical, I went to the Dr. and they gave me an x-ray of the infected area.  The Dr. thought it was an infected lymphoid but it was not it was an cyst my nogel. After a few weeks it went away on it's on.
After getting the Pfizer-BioNTech COVID-19 Vaccine he had difficulty opening the eyes; had ticks of the eyes or blepharospasm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ASTHENOPIA (non-serious), outcome "unknown", described as "After getting the Pfizer-BioNTech COVID-19 Vaccine he had difficulty opening the eyes"; BLEPHAROSPASM (non-serious), outcome "unknown", described as "had ticks of the eyes or blepharospasm".  Additional Information: This was two weeks after getting the covid vaccine.Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report.This has been reported to the FDA and VARES.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to a female patient of approximately 34 years of age. No relevant medical history of the patient was reported. On an unknown date in June 2007 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (also reported as vaccination) (lot number and expiration dates were not reported), at an other facility. Albumin status was unknown. The patient received the second dose of vaccination on an unknown date in July 2007. No concomitant medications were reported. On an unknown date in 2010 the patient's antibody titers revealed low immunity. The nurse was not able to clarify if the low immunity was to one or all the three antigens. The patient had sought medical attention by visiting the office. There was no product quality complaint (PQC) involved. The outcome of antibody titers revealed low immunity was unknown. The causality of the event was not provided. Additional information has been requested.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old pregnant female with no previous pregnancies, no medical history and no known drug allergies who on 22-JUN-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 1487Y). The patient also was administered MENACTRA during the same visit. No adverse effect reported. The urine pregnancy test was performed and the result was positive. Ultrasound was performed on an unknown date and the result was unknown. The patient's LMP was 25-MAY-2010 (also reported as 26-MAY-2010) and estimated delivery date was 01-MAR-2011. The outcome of the patient's pregnant was unknown. Follow-up information has been received from the healthcare who reported that the pregnancy was terminated. Upon internal review, pregnancy terminated was considered to be an other important medical event. Additional information has been requested. This is an amended report, SAE "pregnancy terminated" was added. "Upon internal review, pregnancy terminated was considered to be an other important medical event." Was added to narrative.
Swelling. Red. Itch. Hard. TDAP given at Public Health Dept.
Received vaccines documented below at approximately 1400. At 1700 the same day the patient developed fever to 104 F. Was taken to an ED, where he was documented to have an 8 minute generalized tonic-clonic seizure and then a second seizure with left sided shaking (unknown duration).
Information has been received from a registered nurse referring to four patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ orally (dose, dose number and lot# were not reported), which was improperly stored. No adverse effects were reported. On 19-OCT-2015, a telephone call was placed to the registered nurse, who was unable to provide the patient's identifiers at that time. Follow-up information has been received from the registered nurse on 20-OCT-2015. A 9-week-old patient (gender unknown) was vaccinated with an improperly stored dose of ROTATEQ lot# L000571, on 02-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product, event information and narrative were updated.
The pfizer monovalent and bivalent vials look alike. The Monovalent vial was pulled from the fridge instead of the bivalent vial. The pt was here to get the bivalent vaccine
Received pneumococcal vaccine on 12/7/04 called office on Thursday c/o redness/swelling arm pain, MD treated with ABx Dx with Bacterial cellulitis.
Swelling, erythema nam that left upper arm - seen at ER.  Started on Keflex for cellulitis.
never received a second Shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was reported by patient's husband.  The patient stated that 2 years ago the patient received only one single dose of Shingrix. The patient stated received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not consent to follow up.  This case had been linked with US2022178660, US2022AMR179084, US2022AMR179087, US2022AMR179086 same reporter. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
This is a spontaneous report from a contactable consumer. A male patient, age unknown, received the 5th dose of PREVNAR on an unspecified date. Relevant medical history included IGA deficiency. Past product history included four doses of PREVNAR on unspecified dates. Concomitant medications were not provided. It was reported that the patient did not develop any antibodies. Therapeutic measures taken as a result of the event included treatment with a dose of PNEUMOVAX23. Sometime, thereafter, the patient developed antibodies. No follow-up attempts possible. No further information expected.
Fever of Tmax 101.9 F since 2:40 Am, last night after Men B VC in pm yesterday w body and joint pain, nausea, heavy head, abd pain, had tylenol at 8am, feels better now, only had Gatorade, no reaction after first MenB VC. ROS: no cough, no cyanosis, no vomiting, no diarrhea, no sob, no sick contact.
Cannot walk; Cannot move arms; Still ill with gas; Initial information received on 14-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (reference number: US-SA-SAC20210202000763).  This case involves a 69-year-old male patient who experienced cannot walk (gait disturbance), cannot move arms (mobility decreased) and still ill with gas (flatulence), while he received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose (double) of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious cannot walk (gait disturbance), cannot move arms (mobility decreased) and still ill with gas (flatulence) (unknown latency) following the administration of INFLUENZA VACCINE.   The patient was hospitalized for these events for 90 days (in hospital 3 months).  It is also reported, the patient was rest home over a month.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for cannot walk and cannot move arms and not recovered for still ill with gas (going on 5 months now).  Information on the batch number was requested.; Sender's Comments: This case concerns 69-year-old male patient who experienced gait disturbance, mobility decreased and flatulence after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 43-year-old male patient who received HAV (Havrix pediatric) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2023, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 24th January 2023, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were 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: 24-JAN-2023 Reporter's Comments: Medical assistant (MA) reported they inadvertently administered a Havrix pediatric dose to an adult patient. MA confirmed dose was administered in the HCP facility on date of reporting. Medical assistant inquired how to proceed. Did not consent to follow-up. Additional Supportive Information: The adult patient was administered with Havrix pediatric, which led to accidental underdose and adult use of a child product.
Tingling and itching. Narrative:  Presented 1/25/2021 for 2nd in series COVID-19 vaccine. Reported that after the 1st had developed full body tingling and itching. Denied any respiratory symptoms or rash. She was requested by Dr. to get allergist clearance prior to 2nd vaccination.
PFIZER COVID VACCINE #3 GIVEN 9/7/2021, LOT #FF2589; requested medical records from Clinic Hospital, was only send records of death; pt admitted to hospital on 7/1/22 and dc'd due to death on 7/1/22;  pt had a positive COVID test 5/27/22 at Clinic; COD on death records show CHF, COPD, ARF with hypoxia, pulmonary HTN; no other information
Patient is here for high dose flu shot and pneumonia injection. Vaccination questions completed with patient. Vaccinations given, one in each arm. Patient monitored for a few minutes after stating he wanted to rest for a moment after receiving injections. Stated he was feeling fine but has felt faint before after receiving injections. Nurse left room for less than 30 seconds and returned to gross movement of arms and legs, rapid eye movement and groaning. Called for doctor. Drs  arrived. Patient appropriately answered multiple questions by provider, but patient was pale, diaphoretic and weak. Patient sipped water and cold compresses applied to forehead and neck. Patient vomited. Vital signs and glucose obtained. Glucose = 140. Continued to monitor patient. Patient attempted to sit up after approximately 10 minutes. Patient returned to an slightly elevated position after feeling faint and nauseous again. Patient again vomited. Vital signs obtained again (see documentation). Patient rested another 15 minutes and was cleared to leave by Dr. Per, follow up in 3 weeks.
I was extremally tired for over 2 months; when my cycle started I had heavy bleeding for 6 days when I typically only bleed for 4 days; I had spotting for 14 days before my period (with no pain) and very light; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0167, Expiration date: not reported), via an unspecified route of administration in arm right on 04May2021 at 16:00 (at the age of 40-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EIR8729, Expiration date: not reported), via an unspecified route of administration in right arm on 13Apr2021 at 16:00 (at the age of 40-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 01Jun2021 at 12:00 AM, the patient experienced extremally tired for over 2 months, taking multiple naps a day. Stated that, the effect she wanted to report was a change to her period. Stated that, she had spotting for 14 days before her period (with no pain) and very light, then when her cycle started, she had heavy bleeding for 6 days when she typically only bleed for 4 days. Stated that, she was not pregnant or sexually active and this was the first time this has happened to her and it was the month after she had her second shot and stated that, by the way the tiredness has gone away too. Treatment was not received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Administered the listed vaccines in the following order; MENACTRA, VARIVAX, HAVRIX, and GARDASIL 9 on 9/18/17 at approximately 9:50 AM. After administration of GARDASIL 9, client sat in chair with eyes closed. Patient stated he was feeling "ok". When father asked client why his eyes were closed, client started to respond and immediately client's eyes began to roll and he became unresponsive. Client was warm, clammy with a pale greenish skin tone. Assessed client's vital signs BP 80/54, R 16, P-52 and applied ice pack to client's forehead and back of neck. Continued to assess client's alertness and orientation by verbal and physical stimulation. Client continued to come in and out of consciousness and was able to verbalize his full name and DOB. Client was given apple juice and assisted to recliner chair. Monitored client for approximately 10-15 minutes.  Reassessed client's vital signs and orientation. BP 101/68, R 16, P 68. Client was alert and oriented x3 and able to ambulate without difficulty. Client denied dizziness, headache, visual disturbances and nausea. Client stated he was "feeling better" and ambulated without assistance with father. Noted in medical chart that client is prone to fainting after vaccine administration and encouraged client and father to inform healthcare personnel of precaution prior to vaccinations. Client and father verbalized understanding, denied any questions or concerns and exited clinic.
I was fine the first couple of days then I started having high blood pressure, I checked my blood pressure, and it was high, and it was getting higher and higher. I went to the urgent care, and I was told that my blood pressure was very high that it was very dangerous. I got a shot to control my blood pressure, I stayed for 3 hrs. until it was controlled, and I was released after that. I did take Tylenol for a bad headache that I was also having.
I was sick with a fever, then I started having menstrual bleeding shortly after the 2nd dose. I was then having longer, heavier, clottier periods and never stopped I want to say after July. I had a ultrasound in June and they said I had fibroid tumors all over my uterus - which came out of nowhere. They put me on different medications for the bleeding and nothing was helping. By September and I was done and told my doctor I wanted a hysterectomy and they did it in October 25th. I was bleeding for a month with only 4 days without bleeding. The medications they were giving me helped for a little bit but only for a short time. The Doctor said she had seen other patients with similar bleeding issues but not as bad as I was having. My uterus was so big it was measuring 15 weeks. She had to cut it up when they did the hysterectomy because it was so inflamed and huge.
Received vaccine around 0900 on 25 Jan 2021.  At some time early in the morning of 26 Jan she experienced headache and felt very tired so stayed home from work. During the morning she mainly slept however had some Motrin and a banana around 0830 due to feeling feverish. She went back to sleep until about 1030. When she woke up, she still felt feverish and then noticed her pulse started racing a few minutes later. Her husband took her BP but her pulse was reading ?error?.  She then put on her iWatch and had a pulse of 210. She felt very sweaty, hot and ?weird??like she might pass out but I did not have any pain other than my throat felt tight.  She went to the ER. Within about 30-40 minutes of the onset of SVT she was given adenosine and converted with a 6mg dose.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt has been experiencing uncontrollable bloody noses. Pt has never experienced these in the past. She is having large blood clots coming from her nostrils and her mouth. Pts behavior is not bringing on bloody noses. 1st instance pt was sitting in the car when blood and blood clots started pouring from her nose and she started spitting out clots of blood.
Pt. received FLUZONE on 11-6-2013. Left arm was rash, hot, swelling at site of injection.
7:00pm- start to feel really cold, develop a high fever and chills and eventually go home to lay down.  8:30pm- uncontrollable shaking and high fever maintains and I develop I very bad migraine, I can't feel my arms or legs and everything sounds like my head is underwater (I think this might have been a migraine but I've never had one). When I stand up my vision goes black, and I develop joint pain, muscle aches, and very bad nausea.  9:00pm - I take 500mg of aspirin and all of my syptoms persist for ~30 minutes when suddenly my fever breaks and I'm sweating underneath my 3 blankets and I can think again as long as I don't move my head. Everything still sounds weird and my stomach and joints still hurt but I go to sleep. 4:00am- wake up crying from the headache and with a fever again so I take 500 more mg of aspirin and set an alarm to take more at 10am.  10:00am- I feel exhausted and really weird, I take only 250mg of aspirin and sleep the whole day.  4:00pm - I wake up feeling so much better. Kind of achy and still very nauseous, my ears still ring when I stand up.   4:00pm yesterday - now: I kept movement at a minimum and was still nauseous throughout the day but was able to eat at around 9pm. I think I may have had a low grade fever on and off last night but the headache has thankfully stayed away and other than a little bit of arm soreness and weakness I feel back to normal today.
His doctor prescribe antibiotics for his allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies). At the time of the report, HYPERSENSITIVITY (His doctor prescribe antibiotics for his allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient took Moderna COVID 19 vaccine 5 days ago and his doctor prescribe antibiotics for his allergies. No concomitant medication information was provided
Patient's left arm had a large, warm, red welt with pain the next day after IZZ were given. Came in to clinic to see PA, cold compresses done and given Benadryl, Triamcinolone Acetonide Cream, and Ibuprofen.
Tinnitus, constant ringing in my ears. Over 2 weeks now. Saw my PCP yesterday.  Was prescribed 10 day Prednisone treatment and Cephalexin 500mg 2daily.