chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a currently 44 year old female patient who was allergic to oxycodone. On an unknown date the patient was vaccinated with an unspecified Hepatitis B vaccine (manufacturer unknown) (dose and route were not reported). On an unknown date, an unspecified time after receiving the Hepatitis B vaccine (manufacturer unknown), the patient experienced an anaphylactic reaction that she described as angioedema and hives. The patient sought medical attention by seeing an unspecified physician. The patient recovered from the event on an unknown date. Additional information has been requested.
Swelling of lips within one minute.; Red blotches on face and neck; tingling in tongue and palate; This is a spontaneous report from a contactable physician, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension (HTN), lipids increased (reported as elevated lipids). The patient previously had shellfish and experienced shellfish allergy. The patient also had tree nuts previously and experienced allergy to nuts. The patient previously took fluvastatin sodium (LESCOL) and levofloxacin(LEVAQUIN), both on unknown date for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included amlodipine besilate (NORVASC), formoterol fumarate, mometasone furoate (DULERA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA) and vitamin d nos (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swelling of lips within one minute on 18Apr2021 at 15:45. On 18Apr2021 at 15:45 the patient also experienced red blotches on face and neck. She also had tingling in tongue and palate. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of swelling of lips within one minute, red blotches on face and neck, tingling in tongue and palate and included treatment at site, Benadryl 50milligram, next at emergency room, Solumedrol/Ben. The clinical outcome of the events swelling of lips within one minute, red blotches on face and neck, tingling in tongue and palate was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.
Sore arm. 16 hours after 2nd shot got 100 degree fever, aches, sore neck for two days. Then four days later got intense dizzyness, nausea, and vomiting for one day.
This spontaneous report as received from a medical assistant refers to a 66 years old female patient with hypothyroidism, erythromycin allergy, LIPITOR allergy and epinephrine allergy. On 31-AUG-2012, the patient was vaccinated with a single dose of ZOSTAVAX (lot # 672675/0068AE). Concomitant medications included CYTOMEL and SYNTHROID. The Medical Assistant stated that on 01-SEP-2012, the patient developed a swollen, blackened tongue. On 04-SEP-2012, the patient went to the office and was put on treatment with BENADRYL and saline gargles. The patient was advised to see an ear, nose and throat (ENT) specialist if the symptoms did not resolve at 1 week. Lab diagnostics were not performed. At the time of the report, the patient was recovering from swollen blackened tongue. Additional information has been requested.
Erythema, heat, tenderness & induration extending from deltoid to below elbow of left arm - began day after vaccines given.
Patient called pharmacy this am 6/17/19 (about 10am) she work up today with a raised red circle (the size of a quarter) at the injection site.  She also reported a non-itching rash on her legs.  I contacted her MD.  After noon today, the rash had grown to most of her legs and now upper body.
Systemic: Fainting / Unresponsive-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Fainted immediately after administration & came to within 1 minute. Vision impairment & plugged ears for approx 10 minutes afterwards. She remained in the observation area for 30 minutes and was fully recovered when she left the store.
Pt w/ hx of sulfa allergy. Pt c/o tongue swelling and throat itch.  BP 135/98, HR 95 -- > 121/83, 85.  Patient was administered 25mg IM Benadryl.  Patient stable and released from vaccination site with recommendations to f/u with their healthcare provider.
Patient asked to speak with me about a flu shot that he received on 11/09/2017 given by my colleague  Rph. The patient stated that he had has continuous pain as well as loss of movement in the arm that the shot was given in. This visit took place on 11/18/2017. I was concerned because from what he and his wife stated I thought that the shot may have been given into the shoulder joint above the deltoid muscle. I suggested that pt go to a Dr and speak with the immunizing pharmacist. I spoke with Rph  last week and asked if pt had contacted him. Rph stated that pt had not contacted him. The last information is speculative because I heard it from my pharmacy Tech.  She stated that she had spoke with pt's wife and that pt did go to a Dr. who administered a steroid shot. The Dr told pt that he may have to have surgery if the shot did not help.
First issue was severe neck and shoulder pain (nerve pain) which occurred the day after second vaccination. Primary concern occurred April 13.  Suddenly and unexpectedly went into cardiac arrest (V-fib). Suffered full cardiac arrest at least 3 times over a period of 12 to 24 hours.  Hospitalized for 8 days in cardiac critical care unit.  No previous history of heart issues. No family history either.  Treatment included dosing  with amiodarone, placement of an ICD (defibrillator/pacemaker) and presciption for amiodarone following hospital discharge.  Currently recuperating at home.
Day of vaccine usual soreness in right arm  Day 2-8 very itchy in upper arm around vaccine site but nothing visual.  Day 9 large swelling appeared at injection site Immense itching and very painful.  I have taken an occasional Benadryl and Ibuprofen
Rheumatoid Arthritis starting in left food then going to the other foot. Can't walk. On medication with predisone, methotrexate. Symptoms started small now pain and severe chronic swelling in ankles. MRI and surgery showed no signs of injury.
Patient had no adverse event or outcome. After administration, was discovered that vaccine refrigerator was out of temperature range. Patient is notified and offered re-vaccination.  Patient also got Tdap on 9/13/2021 that was later discovered to be in the same vaccine refrigerator that was out of temperature range. Also had no adverse event or outcome. Patient also notified of this and offered re-vaccination.
Localized reaction at injection site immediately, then Bumpy Rash on arms and three days later streaky rash along both shin bones
Pt received first dose of  Pfizer COVID-19 vaccine after already having completed vaccine series with Moderna COVID-19 vaccines on May 7, 2021 and 6/04/2021. Pt waited in observation area for fifteen minutes with no immediate adverse reactions observed or reported by patient while patient was in clinic.  Dr. notified of incident by phone call.
I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unable to rest. I felt like I had taken adrenaline or steroids and couldn?t sleep that might. The next morning I did not want to get out of bed. My body, particular along my spine, was in so much pain that I began crying. On Monday I called in sick to work. I had almost total numbness in my left arm arm, hand, and upper body. Periodically my heart would race and feel as if was about to beat out of my chest. I started to black out in the grocery store and continue feel dizzy and weak. This is my second day off of work and I have only gotten out of bed to perform essential tasks. I am nauseated and am having trouble eating. I feel like I?ve been run over by several cars and can?t feel my left pinkie. I don?t remember ever feeling this bad for any past illness.
TINGLING LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 14:15, the subject experienced tingling legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling legs was not reported. This report was non-serious.
myalgias, headache, chills, Tiredness, pain at the injection site for 36 hours
Narrative:  31 yo with PMH of obesity, HLD and hypothyroidism who presented to clinic for a widespread pruritic rash on 2/17/2021. This was attributed to second dose of covid19 vaccine (pfizer) on 2/12/2021. Pt stated that on 2/15/2021, she started to develop small bumps all over her ams and they have been progressively gotten worse and itchy. Pt tried hydrocortisone cream and benadryl spray OTC with no relief. Pt denied difficulty breathing or swelling. Denied changes with meds, fodos, soaps/detergents or new clothes. Denied fevers, chills, HA, vision changes, chest pain, constipation or diarrhea. Pt was prescribed benadryl 25 mg QID, famotidine 20mg BID, medrol dose pack at the urgent care clinic. Of note, pt denied any prior sever rxn to this vaccine or its components or a severe allergic rxn such as anaphylaxis to any vaccine or to any injectable therapy (first dose, 1/22/21, secon dose 2/12/2021, first dose was administered with no complications).
Sensation in face and mouth like eating something sour, continued for hours, particularly on left side. Still mild as of submitting this form
Large erythematous, raised papule appeared on left posterior arm early this morning; patient reports tenderness and minor itching.  No h/o fever, sore throat, palpitations, bone/muscle weakness, or headaches or dizziness. No medications or creams were taken/applied.
Per the patient, she received her 2nd COVID vaccine on 2/17/21 around 9:00 am.  She woke the next morning on 2/18/21 with severe "brain fog", exhaustion, dizziness, headache and nausea.  This was severe enough to cause her to "not be able to complete a sentence by 2/22/21.  She was taken to the ER at hospital for evaluation and then had follow up with me on 2/23/21 and again 2/28/21.  Most of her symptoms are dramatically improved now other than the exhaustion.  She still has minor headaches and occasional dizziness, but these are improved.  Thus, this feeling has been present for 11 days after her vaccine.  She had similar symptoms to a much lesser extent lasting 4 days after her first vaccine (also Pfizer given the same location on 1/27/21 EL3247).  She returned to her baseline health in between.
The next day I got quite sick with fever and chills and fatigue.  The second day I felt a little better and figured I was through the worst. The third day (48 hours ) I developed a lot of little mouth sores and ulcers on my tongue, under my tongue, inside cheeks of my mouth and the roof of my mouth...making eating difficult.  At the same time, I started to develop a lot of muscle aches in my neck and shoulders and my acid reflux got worse. I had already had covid  6 weeks before getting the shot.  I did not go for my second dose that was due last Friday.  I am still getting mouth sores and have been rinsing with mouth antiseptic.  My neck and shoulder pain is still evident and I have been going to my chiropractor for double sessions.  Prior to the vaccine, I was going every other week for maintenance, now I'm going twice a week but it has not resolved. It is presently about 4 weeks since I got the first shot.
Flu like symptoms lasting approximately 6 hours followed by intense joint pain lasting 24 hours. Soreness at the injection site continues today 5 days after event.
muscle pain in both arms, R worse than L. Slight dizziness for first 4 hours after vaccine. On and off minor headaches for the first 48 hours post vaccine
Patient had a sudden onset of blurry vision and a black visual scotoma in his right eye about 1 week after the vaccinayion. His dry macular degeneration was previously stable over many years of observation by his opthalmologist performing OCTs every 6 months. An urgent OCT after the change in vision showed dramatic changes. The visual changes have persisted and compromise his ability to read and perceive depth (3D).
Rash, reddening, pain, scaly layer of skin  from shoulder to lower than elbow, outer and inner arm. Face numb. Condition was worst on days 8-14. Lack of balance and sleep.
Oral Temperature 101.1 (improved with 1000mg of acetaminophen), body aches, fatigue for the next 12 hrs.
receiving an "adult" dose made from 2 pediatric doses / Tdap and HepB on the same syringe; Tdap and HepB on the same syringe; 20yo patient receiving 2 pediatric doses; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   On 4th March 2022, the patient received Engerix B pediatric and Boostrix. On 4th March 2022, unknown after receiving Engerix B pediatric and Boostrix, the patient experienced wrong technique in drug usage process, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong technique in drug usage process, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received an adult dose of Engerix made from 2 pediatric doses, a dose of Boostrix and a dose of Engerix. In the facility they had only pediatric doses, so they mixed two.  Healthcare professional was not sure if the patient received 1 dose of Engerix or if they mixed the vaccines, so it would have Tdap and Hepatitis B on the same syringe, which led to wrong technique in drug usage process, inappropriate dose of vaccine administere and inappropriate age at vaccine administration. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022041370:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: gj5342), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing), notes: mild hypertension; "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2023) Unknown results; (23Sep2023) Unknown results; (24Sep2023) Unknown results; (25Sep2023) Unknown results; (26Sep2023) Unknown results; (27Sep2023) Unknown results; (28Sep2023) Positive, notes: but could barley see the T line; (29Sep2023) Positive, notes: but could barley see the T line; (30Sep2023) Positive, notes: within 30 seconds of testing and since then; (01Oct2023) Positive, notes: within 30 seconds of testing and since then; (02Oct2023) Positive, notes: within 30 seconds of testing and since then. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient received a pneumonia vaccination in the left deltoid and flu vaccination in the right deltoid in the office on 12/21/15. She returned to the clinic 12/23/15 with complaints of redness to the left deltoid, with tenderness and warmth at the site. The patient was seen, evaluated, and treated for cellulitis of the left arm. She was given instructions to monitor the site for increased redness, tenderness, or swelling that would indicate the infection was getting worse. She verbalized understanding.
Fever of 102.3 degrees Chills Headache Body aches Left armpit/breast pain
10-28-17 patient wrote: "I was wondering if there was a way I could get the vaccine name and dosage for my flu shot on September 26, 2017 at High School at 6am. I was not provided with this information, and need to present it to my general care practitioner--since that day, I have had pain in my arm between my elbow and shoulder, sometimes to the point of being debilitating. It is preventing me from performing my job as I normally would sometimes, and I am not able to perform some of my recreational activities. I have never had an issue before, so this to me is quite surprising. I would appreciate it if you could respond in a timely matter. Thank you!"
she felt really really dizzy; Couldn't walk; Equilibrium was off; very tired; nausea; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really dizzy, couldn't walk, equilibrium was off, very tired, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Really dizzy, Couldn't walk, Equilibrium was off, Very tired, Nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), really dizzy, couldn't walk, equilibrium was off, very tired, nausea was unknown.
8/21/2022 Felt cold symptoms, sneezing, runny nose. Tested with an at home COVID-19 test, positive. Televisit with doctor. LAGEVRIO was proscribed, advised to take MUCINEX too. Fever peaking at 101 F, fatigue, and diarrhea lasting about 4 days before it started to get better. Symptoms gradually improved, over the next 4 days until they were gone.
Right upper arm, swollen, red and warm to touch. State had a Flu shot yesterday sent to see MD for evaluation. Unable to get vaccine lot # today. Phone call and was told  patient had pneumonia shot right arm.
rt brachial plexus neuropathy-sensory & motor loss radial & ulnar nerves;severe incapacitating pain rt upper extremity;hypertension
SHE DOES NOT RECALL MANY DETAILS. ITCHY RED RASH ON CHEST AND ABDOMEN, LESS THAN 10 SPOTS, POSSIBLE APPEARANCE OF BLISTERS. CAME AND WENT FOR ABOUT 2 MONTHS. NO TREATMENT AND NO MEDICAL EVALUATION OBTAINED. NO LESIONS FOR ABOUT 2 MONTHS.
Pt was given an extra dose of Pediarix instead of HepA#2. Pt has low grade fever, no other symptoms or treatments.
its a weird allergic reaction as it comes from few minutes to one hour after the dose; Bad Heartbeat; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0171), dose 1 via an unspecified route of administration on 27Apr2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, On 27Apr2021 Consumer stated, " had a shot couple of days ago or two days, its says its a allergic reaction, it goes for two days, it's says that it's a weird allergic reaction as it comes from few minutes to one hour after the dose, Again on Tuesday and Wednesday, Tuesday for whole day it was fine and working. It was fine, it hurt little bit It was regular shot and know have been. Today had still had like bad heartbeat consumer want to know, I know it says that severe reaction happened in few minute to hour for couple of days but started this bad heartbeat. The outcome of the event was unknown on an unspecified date.  No follow-up attempts are needed. No further information is expected.
On 7 May pt had hypoglycemia with 1st Moderna Vaccine.  Blood glucose was 49mg/dL following vaccination; she remained at facility and ate Honey Grahams provided.  The patient  ate  meal after departure (Egg McMuffin, hash brown and 1/2 cup of Sprite); blood glucose was 53mg/dL two hours after eating the meal.  Pt brought Glucose meter with these measures to appointment.   Pt went home and slept  with next BG  done in late afternoon of 159 mg/dL .   Pt had a diagnosis of diabetes but had stopped all medications for diabetes on March 15 2021 due to hypoglycemic episodes.
Abdominal pain with no determined cause.  Pain was severe and progressively got worse with nausea. Pain became severe and was also behind Left shoulder blade and chest pain.