chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-SEP-2008 the patient was vaccinated with VAQTA dose 1 (route, dosage and lot number unknown). The medical assistant reported that the patient was seen on 16-JUL-2013, seeking the 2nd dose of VAQTA. The patient was not administered the 2nd dose of VAQTA because the medical assistant was unsure if 2 doses were necessary. No adverse effect reported. No further information was provided. Additional information has been requested.
Patient participated in Shot ex event offered by clinic.  Patient did not self book via online portal and walked in clinic.  Patient initially received 1st dose of COVID vaccine on 04/15/20 which was Moderna lot #042B21A.  Patient did not realize until after receiving 2nd dosing that she had received a different vaccine when she questioned staff.  Admin, Screening and Immunization staff did not realize patient had received other vaccine as 1st dose as well while completing administrative and screening functions.   Patient was observed for allotted observation time and left shot ex.  Nursing staff was able to speak to DHA and CDC staff regarding vaccine adverse event.  Additional information/guidance was received and not further care was required for patient due to vaccine differences, no further immunization is required as new guidance now states patient has completed vaccine series.   This information was shared with patient as well.
It was about 10-15 minutes after flu vaccine was given to patient, she and her mother were in the lobby to schedule a follow up and patient passed out while standing next to her mother, fell backwards and hit head on floor.
Patient came into our clinic and she had the primary series of Moderna in "private". She came for her booster with her parent who requested Moderna to complete the series. She was given the booster dose of 0.25mL and it was then identified that she was only 14 years old and not eligible for this vaccine. We will input the patient into system directly, since Moderna will not populate. We have also reeducated the vaccinating nurse and referenced the binders on site that have all the vaccine doses information, as well as provided remediation training and testing. Patient was monitored for 30 minutes and reported no side effects from the vaccine.
Patient describes "frozen shoulder". Has shoulder pain and limited mobility 2 weeks post immunization. Pt says she has MD appt.
The day after I got the shot, I was driving and all of a sudden my heart raced  and I got VERY dizzy and my vision was darkening.   I also had ringing in my ears. I felt like I was going to pass out. It scared me.  I put on my brakes and started to pull over but by the time I started to pull over, the dizziness was slowly starting to clear up.  I had a "foggy" feeling in my head for about a half hour after so I went to my friend's house and sat down and drank some water. Then I went home.  I have had no incidents since then.
This spontaneous report was received from a license vocational nurse refers to an unspecified number of patients of unknown age and gender.  The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with an unspecified doses of COMVAX, injection, lot # J013884 and expiration date 19-AUG-2016, (route of administration and anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Tongue swelled that evening, he was treated in ER with Cortisone and Benadryl and problem resolved by the next day.
Onset in the late afternoon/evening.  Tennis-ball sized swelling in left thigh, at site of DTaP vaccine, which causes the contour of the thigh to jut out at the hip.  Also some mild swelling of the right thigh, at site of IPV vaccine.  Mild pain/discomfort.
3AUG95 245PM pt recv vax & 4AUG95 about 3-4AM noticed swelling feet w/redness; no diff breathing;
Fever over 104.5 x 2 hrs & crying; Tx w/baths & APAP @ home;
Initial unsolicited report received from a consumer on 18-NOV-2016. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUZONE HD batch number and expiration date not reported, intramuscularly, in left deltoid on an unspecified date (reported as October). Patient previous dose reported as unknown. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (reported as October), following the vaccination, the patient's left arm was swollen from the injection site to the elbow. Lab data and corrective treatment were not reported. On an unspecified date, the patient recoevered from the event (Back to normal after a week). List of documents held by sender: none.
On 07/13/2001 in the AM the patient developed small dots on her stomach, which worsened in the PM. On 07/14/2001 the rash spread to her face with swelling. The patient was seen in the ER and was given a shot to stop the swelling. The patient was then treated with Cortisone and Benadryl. The rash was raised like hives. The patient improved after treatment at the ER.
Patient had redness, soreness and heat from injection site down past elbow for 1 week.
4 hours after vaccine given: cough, headache, itchy and red eyes, fever and chills, body aches, fatigue, skipped heartbeats. A 69 year old male with no PMH presents to the ED for evaluation of cough onset this afternoon. Pt states that he received an influenza vaccination this afternoon. He states that 2 hours after the vaccination, he reports cough, headache, chills, and bilateral knee pain. Pt denies any shortness of breath and any fever. He notes that he did not have any sxs prior to today. He also states that he started taking Meloxicam today. He does not report taking any blood pressure or high cholesterol medications. Pt has no other complaints at this time.
Received  first dose of Pfizer , within 1 minute fathe noted she "passed out". Called staff to car ad observed pt with clonic/tonic movement of hands, eyes closed, respirations slowed but even pulse approx 58/min. Responded to verbal Stimuli. Said she felt failt, lips pale, skin clammy. 911 called had additional same incident 9 minutes later.   Transferred pt to medical facility by ems after 2nd episode .
MMR recvd 12JAN93 & eyes began hurting around 21JAN93; eyes are not blurry has not been rubbing them; uses glasses to read; reports inc pain w/light & w/fine work; some h/a;
Frozen arm that turned into numbness and tingling in both arms and hands; Frozen arm that turned into numbness and tingling in both arms and hands; Had an outbreak of shingles; Swelling; Burning; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:30 hours as dose 1, single for COVID-19 immunisation. Medical history included polymyalgia rheumatica and heart conditions from an unknown date and unknown if ongoing. Patent family history included father had everything, was overweight and diabetic, and died at 58 years old and mother died at 91 years old from bone cancer. Patient mother and brother both had polymyalgia rheumatica. Concomitant medication(s) included meloxicam taken for swollen ankles from an unspecified start date and ongoing. Patient had no prior Vaccinations (within 4 weeks). Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. On an unspecified date of 2021, after the first dose, patient had a mild side effects, patient had an outbreak of shingles and after the shingles was treated and went away, he was left with a frozen arm that turned into numbness and tingling in both arms and hands. Patient had polymyalgia rheumatica in the past, but rheumatologist told him this wouldn't cause numbness and tingling in both hands, only one side so they don't think that was what was going on. Patient still having this in both hands and swelling and burning. Therapeutic measures were taken as a result of outbreak of shingles and treatment included unknown medication. Patient had physician office visit for shingles. Patient had no emergency room visit for the events. The outcome of outbreak of shingles was recovered on an unspecified date of 2021, and unknown for rest of the events.
Patient received some of the vaccine but not the entire 0.5 ml dose; Vanish point needle sent in the ancillary box malfunctioned; A spontaneous report  was received from a nurse practitioner concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vanish point needle sent in the ancillary box malfunctioned and the patient received some of the vaccine but not the entire 0.5ml dose.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, during vaccine administration, the vanish point needle sent in the ancillary box malfunctioned and retracted too soon. The patient received some of the vaccine but not the entire 0.5ml dose.  Action taken with mRNA-1273 in response to the events was unknown.  The events, vanish point needle sent in the ancillary box malfunctioned and the patient received some of the vaccine but not the entire 0.5ml dose, were considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device malfunction for mRNA-1273 (lot # unknown). There were no reported AEs associated with this case of incorrect dose administered and device malfunction.
Pt recvd vax & devel hypotension, lightheadedness, & tachycardia 2 1/2 hrs p/vax;
Dizziness; Tiredness; Stomach pain; Headache; Feeling sick; This is a spontaneous report received from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 15:00 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included gastritis from an unknown date and unknown if ongoing. Patient said he had bad gastritis for a while and cyclic vomiting syndrome from an unknown date and unknown if ongoing. It was reported that patient has cyclic vomiting syndrome adult, which was diagnosed two months ago. Patient concomitant medications were not reported. He got no other vaccinations in the four weeks prior to getting his Pfizer coronavirus vaccine shot. On 26May2021 the patient experienced dizziness, tiredness, stomach pain, headache and feeling sick. The patient got his first dose of the shot, he is not sure what it was, yesterday, and he is having some side effects that are common, he would like to know how long they will last. He later clarified that the shot was the Pfizer coronavirus vaccine. Patient said he doesn't have his vaccine card with him to provide NDC/LOT/EXP from it, his vaccination was at 3PM. He said his side effects were basic dizziness, tiredness, stomach pain, headache, and feeling sick. His side effects started next morning when he woke up. Patient just took pills for stomach pain and let it pass. Therapeutic measures were taken as a result of stomach pain. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. Information on the batch number not available.
given two days after the expiry date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 329J9, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 18-JUL-2022 Reporter's comments: The patient was given Rotarix two days after the expiry date. The reporter consented to follow-up. Additional supportive information : The patient received a dose of Rotarix which was already expired, which led to expired vaccine used.
No adverse event on patient; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager regarding a 13-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) (Product storage error). There were no additional adverse events (AEs) reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
No additional adverse events reported; a 23 years old patient received a dose of PROQUAD instead of VARIVAX and MMRII as recomended per his age.; This spontaneous report was received from a nurse referring to a 23 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 09-DEC-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml,  lot # S030213, expiration date on 25-MAR-2021, for prophylaxis (strength, route of administration and anatomical location were unknown); instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as recommended per his age. No additional adverse events were reported.
49 year old male received pediatric dose VAQTA in error; 49 year old male received pediatric dose VAQTA in error; This spontaneous report was received from a 49 years old male consumer referring to himself. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 16-SEP-2016, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T001419, expiration date 06-JAN-2021; route was not reported) for prophylaxis (underdose and product administered to patient of inappropriate age).
This is a literature report for the following literature source(s): "Guillain-Barre Syndrome with Rapid Onset and Autonomic Dysfunction Following First Dose of Pfizer-BioNTech COVID-19 Vaccine: A Case Report". A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "Rapid Onset and Autonomic Dysfunction". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information. 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.
I had a severe reaction to the shingles shot I received on Monday, March 19. Extreme fatigue - began about 4 hours after the shot. I slept 9 straight hours until my alarm went off, and I hit the snooze button 3 times. I could barely stand up or open my eyes as I stumbled to the shower. After my shower I crawled into bed freezing, aching all over, eyes burning. Even odder it felt like each layer of my skin was burning - not like fire, but a chemical burn. I could not move for most of the day - it was almost like my body was paralyzed. I could not read, or watch anything for hours. I slept most of the day. I woke up for a couple hours, watched something, ate a bit, but then fell into a stupor at 7:30 pm and once again slept until the morning. I woke up with a horrible headache and back ache and still found it hard to stand up and walk. I finally felt a bit ok by the afternoon. The shot site was sore and warm, but no rash.
Flu like sypmtoms, 103 temp, sore, weak, couldn't get out of bed b/c of fatigue. Did not seek any treatment only took Aleve, 24hr recovery.
Fever 102.5 with hard Rigors  chills x 15 hours, back and hip pain, body aches, fatigue, elevated liver enzymes.  I missed work the following day due to fevers and hard chills.  Had fever x 48 hours .
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/19/21 (EN6207) COVID Positive 12/22/21  12/22/21: Patient is a 71-year-old female who originally presented to the emergency room with some chest pain symptoms and went on to develop some shortness of breath and dyspnea.  Along with this the patient had noted several days of her stools being dark black in color with no bright red blood per rectum.  No fever, chills or night sweats are noted with no abdominal pain complaints.  Patient denies any recent changes to her medical regimen and denies any recent travel.  Patient does have recent exposure to COVID-19 yesterday with a family member that has tested positive.  At the time the patient was seen at the bedside she is currently denying any chest pain symptoms but does endorse some ongoing shortness of breath and dyspnea. Patient had denied any hematuria, hemoptysis or hematemesis.  Patient's medical history, current medications, imaging studies, vital signs, laboratory data and emergency room records were personally reviewed.  Case was also discussed directly with the emergency room provider.  Repeat chest x-ray was also discussed reviewed which showed significant worsening versus the initial chest x-ray and may have been related to fluid overload given the patient's history of severe heart failure with her last ejection fraction being 35-40%.  12/31/21: Patient is a 71-year-old female with past medical history of CAD, type 2 diabetes, hypertension, history of PE, hyperlipidemia, hypothyroidism, dextrocardia situs inversus, Chronic HFrEF presented to the ED on 12/22/21 with shortness of breath, chest pressure and complained of dark stools.  Patient admitted for acute hypoxic respiratory distress secondary to COVID-19 pneumonia, acute metabolic encephalopathy, new AKI, concern for upper GI bleed and and NSTEMI.   - CT head negative.  Encephalopathy resolved.  - There was a concern for NSTEMI, Cardiology was consulted and the thought was patient is elevated troponin was secondary to acute anemia.  Recommendations for patient to follow up with Cardiology as outpatient.  - Patient presented with a hemoglobin 6.6 and receive 2 units RBC.  Hemoglobin has remained stable.  Patient had EGD and colonoscopy without acute finding.  Patient will need to follow up with GI for biopsy results.  Given patient's extensive cardiac history Will continue aspirin and Plavix, the risk extensively reviewed.   - Patient also tested positive for COVID-19.  The patient did require supplemental oxygen however shows wean to room air.  Cultures negative.  Patient did not receive remdesivir due to renal function.  Patient completed antibiotics.  Patient will be discharged on Decadron.   - Patient also noted to have acute kidney injury. Nephrology was consulted.  Nephrotoxic medications was discontinued.  Renal function did improve.  Foley has been removed patient has been able to void.  Patient will follow-up with PCP or Nephrology as needed.   Precautions return to the ED extensively reviewed with patient and family at the bedside, they have verbalized understanding.
This spontaneous report was received from a pharmacist via company representative referring to a 68 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were unknown. Approximately in October 2016 (also reported as "about a month ago"), the patient was vaccinated with PNEUMOVAX 23 (Lot number, expiration date, dose and route were not provided) in the arm (unspecified). Approximately in October 2016 (also reported as "about a month ago"), the patient's upper arm and shoulder became puffy, swollen and redness after receiving PNEUMOVAX 23. The patient sought for medical attention; she went to primary care physician. At the time of the report, the outcome of peripheral swelling and erythema was reported as recovered/resolved. The reporter did not assess the causal relationship between the adverse events and the vaccination with PNEUMOVAX 23. Additional information has been requested.
Severe arm pain later in the day after injection. Was unable to sit up or walk around. The next day, severe pain spread to other arm and neck and back with a headache and fever. The injection site was swollen and a rash was present for about 4 days.
Ring like rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Ring like rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Ring like rash). At the time of the report, RASH (Ring like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. No concomitant medications were reported.