chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with a vaccine that had experienced a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion). On 03-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not provided.
Caller took Paxlovid; Caller took Paxlovid; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2022 as dose number unknown (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), outcome "unknown" and all described as "Caller took Paxlovid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt called pharmacy 4 days after treatment to report redness that was warm to the touch , and a hard nodule under the skin at the injection site.
Heart rate was rising; headache; tiredness; shingles; fever; sore arm; swelling; red blotches all over her arm; itchy rash; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, SWELLING, RASH MACULAR, RASH PRURITIC, and INFLUENZA LIKE ILLNESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Anticoagulant therapy, FAMOTIDINE for Gastroesophageal reflux disease, PROBIOTICS for Stomach upset.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC. 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS and PYREXIA. On 13-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 04-May-2021, the patient experienced FATIGUE. On an unknown date, the patient experienced HEART RATE INCREASED and HEADACHE. On 05-Feb-2021, INFLUENZA LIKE ILLNESS and PYREXIA had resolved. At the time of the report, PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC had not resolved, HEART RATE INCREASED, HEADACHE, and FATIGUE outcome was unknown and HERPES ZOSTER had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 above (High) pulse rate never dropped under 90.         Patient took Tylenol and Benadryl for her treatment. Concomitant medications taken were Vitamin D 5000 units 3 tablets a day, Vitamin B-12 1000mg 1 tablet daily, Vitamin C 750mg Chew 2 a day. On 28Jul2021, patient will have an appointment with the lung specialist to check up on the ground glass cancer 10 years ago. Action taken with mRNA-1273 in response to the events were Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Patient email id was updated. Drug start date was updated. New adverse event was updated.  Lab data was updated. Concomitant medication was updated
The day after the vaccination I had a low grade fever, chills and body aches that continued 5 days after.  About 3-4 days after the shot began having shooting headaches and an abnormal stiff neck.  I went to the ER 8 days after the shot for the painful headaches.  They suggested high doses of ibuprofen.  In this period I should note I got 2 COVID tests, testing negative not believing it came from the vaccination.  The pain in my neck, left shoulder and head began to give way to a numbing feeling, with swelling in the head and face with very swollen lymph nodes.  I was able to see my doctor 2 after and began herbal and homeopathic medicine to ease the reaction.  As it was describes to me some immune system reaction has attacked my nervous system in my neck causing swelling in the brain stem.  Incredible discomfort, pain,  and weakness continues now 5 week after.  My inflammation has gone down and the headaches have subsided.  Stiff neck, a "frozen" type shoulder, and lymphatic swelling in my neck is still present.
This spontaneous report was received from a Registered Nurse, referring unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified number of improperly stored doses VARIVAX  for prophylaxis (lot number  M006156 with expiration date of 05-FEB-2018 and lot number M033213 with expiration date of 13-JUL-2018) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse effects were reported. The doses of the vaccine experienced a temperature excursion greater than -15 Celsius (C) degrees and less than -10 C degrees range for 10 minutes and there was a previous temperature excursion with the same temperature range for 70 hours and 50 minutes, and  another temperature excursion with a temperature greater than -10 C degrees and less than 8 C degrees for 16 hours and 40 minutes. The aforementioned temperatures were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012972:
Vasovagal syncope at 7:30pm on 7/14. Patient was lightheaded immediately prior to event and woke up on the floor. HR 45, BP 94/46 immediately after event. EMS was called. Blood sugar was normal. Patient's family brought patient to ED for evaluation. Patient was back to baseline in the ED. Of note, patient also reporting right axillary swelling and pain after vaccination (that started on 7/13)
Inflmmatory rash on right forearm, waist and left forearm and face/neck.  Extremely itchy; new ones still appearing after 4 weeks
Typical side effects within the first 48 hours- pain at injection site, fever, headache, fatigue, body aches. On day 8 post injection I experienced chest tightness and pain, deep breathing restriction, loss of appetite, tingling in hands and feet, menstruation onset (after 10 months of menopause), anxiety.
Very little pain at the injection site; A spontaneous report was received from a physician concerning a 60 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced very little pain at the injection site (Vaccination site pain).   The patient's medical history was not provided. Relevant concomitant medications included propranolol, adderall, atorvastatin, alprazolam, lisinopril, ticagrelor, vitamin d2, aspirin, pork thyroid, paroxetine, bupropion, zolpidem: and testosterone injections used for unknown indication and Torsemaid used as blood pressure medication.  On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient stated that he had no side effects, only very little pain at the injection site (Vaccination site pain). No treatment information.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, little pain at the injection site, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
From initial information received on 05/27/2005 from a patients parent regarding an adverse event, it was reported that a 19 year old male patient received a dose of Menomune A/C/Y/W 135 vaccine, lot number unknown, administered in the arm on 05/25/2005. To days later on May 27 2005, the patient wake up with a red, flat race on his face and a slight fever. The patients family physician was called. At the time of this report, the patient had not recovered from these events.
Patient vomited approximate;ly 5 minutes after immunizations were completed. Reported he felt fine 15 minutes after vomited episode.
brain surgery; ended up paralyzed from the mouth down; contracted staff infection from hospital during his stay; Hospitalisation; DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS,; DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS,; This case was reported by a consumer via interactive digital media and described the occurrence of sus[ected vaccination failure in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bacterial meningitis (serious criteria GSK medically significant), brain injury (serious criteria hospitalization and GSK medically significant), paralysis (serious criteria GSK medically significant), staphylococcal infection (serious criteria GSK medically significant) and hospitalization. On an unknown date, the outcome of the vaccination failure, bacterial meningitis, brain injury, paralysis, staphylococcal infection and hospitalization were unknown.   The reporter considered the vaccination failure, bacterial meningitis and paralysis to be related to Meningococcal B vaccine. It was unknown if the reporter considered the brain injury, staphylococcal infection and hospitalization to be related to Meningococcal B vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient received meningococcal b vaccine and experienced bacterial meningitis. The reporter stated not to believe on vaccine his son got meningitis it did not protected his son. The patient went in to brain surgery on his sixteenth birthday and ended up paralyzed from the mouth down, also contracted staphylococcus infection from hospital during his stay.  This case was considered as vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not provided. The information regarding consent to follow up was not reported. This case was linked with case US2020AMR232425, US2020AMR232424, US2020AMR232426 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter
pt recv vax 1/2 hr post vax devel vertigo, dizziness & paresthesia (tingling sensation) proximal to the inj site;2hr post vax exp distal paresthesia;reporter stated that sx were relieved following an intake of food-pt skipped breakfast
reports the day after vaccination she had tenderness at site and a low grade fever. She developed a small rash (size of a quarter) at the injection site that was warm to the touch.  The following days she developed swelling and enlargement of the lymph node above the clavicle, followed by swelling of additional lymph nodes. She did develop a lacy pink raised rash over the area, that burned.
Patient was given a Monovalent Pfizer COVID vaccine instead of a Bivalent.   Patient notified. Will contact her to re-immunize in 2 months.
Had DTP 2 days ago complained of redness and swelling at the site of the vaccine injection.
Later that evening after the shot he took a shower and noticed a rash around his testical area.  The rash had been getting worse but did not tell us, his parents, until this morning around 9:00 am, 6/22/19.  He was then given some benadryl to help combat the rash and told to take a shower to get off any lotions he kept putting on it.  He says the rash is getting better and starting to go away.  He said the rash was at its worst Wednesday night into Thursday.
about 2 weeks after receiving my first dose of the Moderna COVID-19 vaccine, the injection site has become slightly swollen, warm, and red. It's slightly larger than a quarter.
13OCT achy all over (10-12);rash over entire body;swelling of face & neck;14OCT weak, bloodshot eyes, joints hurting, vision impaired;16OCT rash almost gone, still weak, achy joints;19OCT achy joints;
Chest pain/pericarditis symptoms beginning approx 7 days post vaccination.  Fever of 101. Given NSAIDs and narcotic pain relief. Hospitalization length unknown (still in hospital).  10/30/06 Received medical records from hospital which reveal patient contacted cardiology outpatient clinic for appt on 10/10 which was 14 days after his return from deployment with c/o chest pain & tendonitis of shoulder.  Seen in cardiology clinic on 10/12/06 with dx: pericarditis s/p small pox vax.  Chest pain now 2/10, constant & worse supine, tx w/Motrin.  No DOE & + occasional palpitations.   Was to have echocardiogram & Holter monitor as outpatient, continue Motrin & rest. Dx: pericarditis s/p small pox vax, overall improving.
23/Life threatening illness (immediate risk of death from the event); This is a spontaneous report from a contactable physician (patient).  An adult male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in arm left on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy or drugstore.  Medical history and concomitant medications reported as none. In Apr2021, the patient had near death experience reported as "23/life threatening illness (immediate risk of death from the event)"-PENDING CLARIFICATION which requires doctor or other healthcare professional office/clinic visit. The event was considered as life threatening and causes disability or permanent damage. It was unknown if treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. The patient recovered from the event in Apr2021.    Information regarding the lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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 noticed swelling upper right eye lid initially then little whitish  bumps (2 small) on the lower eye lid.My doctor thought it was a growth gave me a antibiotic. I exp some drainage from eye and bumps lasted 3 weeks.
This case was reported by a healthcare professional and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergies, hypercholesterolemia (chronic), hypertension (chronic), hypothyroidism (chronic), insomnia (occasional), sinusitis (occasional) and vitamin b complex deficiency. Concurrent medications included SYNTHROID, AVAPRO, PREMARIN, SINGULAR, ALLEGRA, NASONEX, ASTELIN spray, IMITREX, TRANXENE, PARAFON FORTE, AMBIEN, Aspirin, B12, and Thyroid supplement. On an unspecified date in 2010 the subject received a dose of FLULAVAL (.5 ml, unknown). On an unspecified date in 2010 the subject received a dose of FLULAVAL (.5 ml, unknown). Less than one month after vaccination with FLULAVAL, the subject experienced overall joint pain. The subject sought medical attention on 28 October 2010 approximately one and a half weeks following vaccination. At the time of reporting the outcome of the joint pain was unspecified. Follow-up information was received via the reporter (office manager) on 23 November 2010. It was reported that the female subject was 59 years old at the time of the event. FLULAVAL was given on 08 October 2010, at the subject's, husband's place of work. The events of joint pain and fatigue began on approximately 15 October 2010. Achyness was also reported. Joint pain resolution occurred on 10 October 2010. The events were not considered to be serious. It was reported that the subject was not ill prior to receiving flu vaccine. There was nothing in the subject's history that would appear to suggest any correlation with signs and symptoms of joint pain and sudden onset of achyness. No history of alcohol or tobacco use. It was noted that all previously mentioned concurrent medications were taken by the subject for over 2 years. It was reported that it was rare for the subject to take IMITREX.
Patient moved as injector was administering the vaccines and some of the dose was lost from end of needle onto patient arm before being fully inserted into muscle
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 24-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA001261.
Fever 100.5, hard chills, headache, nausea, myalgia, arthralgia, insomnia
04/25/02 Generalized hives and temperature of 102 degrees F. Given Benadryl and top hydrocortisone. Hives were gone by the afternoon. Treated by parent. Not seen by physician.
Pt vacc. w/Engerix-B developed pain and numbness down arm radiating into neck.  Diagnosed as pinched nerve in neck.
Thought I should let you know I was vaccinated on April 8 with Janssen (J&J).  I had a severe reaction - chest pain and back pain for the entire day.  I alerted Drs., but I'm sure it should be reported.  I took my ZyrtecD prior to vaccine, which I'm sure helped in some manner.  I was better on Friday with lingering back pain.  Today I am down with bad headache and stomach pain, but I am aware there is a current stomach bug.
Dose 1 in 2020, is back for another dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 2020).   On an unknown date, the patient 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter enquired that, if the patient got one dose of Shingrix in 2020 and was back on 16th February 2022 for another dose, did the patient require a 3rd dose in the 2 to 6 months time frame. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional disconnected the chat before call center representative could ask for demographics.  No additional information was available. The reporter did not consent to follow up.
Information has been received from a physician and nurse concerning a patient who in 2001 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced a breakthrough case of shingles. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that another patient (WAES0409USA01273) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.