chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart racing could feel heart beat in my head. Face ears and lips turned read. Labored breathing. Light headed. Fatigue. Itchy all over.
A non-serious spontaneous report of administration to a 16-month-old was received from a health professional in a physician's office concerning a 16-month-old male, subsequent to H1N1, Intranasal. The child had no medical history and had not received any concomitant medications. On 15-Oct-2009, a nurse inadvertently administered H1N1, Intranasal to a 16-month-old. The reporter stated that the child had no problems post the receipt of the H1N1 vaccine, no signs or symptoms ever developed, and at the time of this call the child remained well and healthy. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: information regarding patient's medical history and concomitant medications was reported.
This spontaneous report has been received from a nurse practitioner referring to a female patient of unknown age. The reporter refused to answer information regarding the patient's medical history, drug reaction or allergies. On different unknown dates, the patient was vaccinated with the three doses of GARDASIL (route, lot #, and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, and after completion of the schedule of vaccination, the patient was diagnosed with high risk human papilloma virus (HPV) non 16/18. Product quality complaint was not involved. At the time of reporting the outcome of high risk HPV non 16/18 was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected because the nurse practitioner did not want to be contacted.
Patient states the pharmacist who administered the vaccine gave it too low on her arm. She pointed to halfway between her shoulder and her elbow and the spot the vaccine was given. Patient states she has been experiencing nerve pain ever since including numbness and tingling.
Information has been received from a nurse practitioner concerning a 66 year old female patient with no known drug reactions/allergies and asthma who on 15-DEC-2008 was vaccinated subcutaneously into the left deltoid with a 0.65ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ADVAIR. The nurse reported that on 22-DEC-2008 the patient experienced injection site pain, redness, tenderness and swelling. The patient sought unspecified medical attention by phone. At the time of reporting the patient was not recovered. Additional information has been requested.
Within 5-10 minutes after vaccine given, patient started feeling tingling of the hands and fingers.  Shortly after, she felt the need to clear her throat because she felt like there was a furball in her throat.  She drank some water, which didn't help.  She then started feeling hot and became flush.  She then felt her inner ear and tongue swelling.  Shortly later, she felt chest pain and felt like she couldn't breathe.  She was given IV Benadryl 50mg, IV dexamethasone 4mg, and IV Pepcid 20mg without symptom resolution.  Epipen was administered by vaccine clinic staff, and the patient felt a little better.  Her shortness of breath continued and her chest felt heavy as she was transported to the ED.  She also complained of blurred vision, which could have been due to Epipen administration.  In the ED, the patient still felt that her throat was tightening up.  She was given IV Pepcid 20mg, IV Benadryl 25mg, IV SoluMedrol 125mg, racepinephrine & albuterol nebulizer.  By 2150, she felt better.  By 2257, she did not have any more tingling in hands or weakness and she stated she felt she was back to normal.  Patient discharged home in stable condition at 2336.
Arthralgia, Constant pain at injection and weakness, difficulty in overhead movements Also numbness and tingling Narrative:
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ) which was used for the reconstitution of VARIVAX (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, units and frequency not reported) (lot # N022981 and expiration date: 23-AUG-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 10 hours (product storage error). The vaccine VARIVAX also had previous temperature excursion at a temperature from -14 degree Celsius (°C) to -10 °C for 11 hours and 30 minutes. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This one of 6 reports received from the same reporter.; Sender's Comments: US-009507513-1803USA004759: US-009507513-1803USA004613: US-009507513-1803USA004757: US-009507513-1803USA004758: US-009507513-1803USA004761:
I started feeling tired and lethargic about 1900 and then about 2000 i started feeling extremely cold and couldn't get warm. it continued through the night. I kept  getting up al night with the sweats and the chills. It is now approximately 48 hours later and I am  still lethargic and experiencing a low-grade fever 100, muscle ache, it feels as if I have  the flu
Information has been received from a consumer concerning her daughter, a 23 year old female with no known pertinent medical history or drug reactions/allergies, who in approximately June 2008, was vaccinated with a first dose of GARDASIL 0.5 ml. Concomitant therapy included hormonal contraceptives (unspecified). Soon after receiving her first dose of GARDASIL the patient experienced some minor itchiness. In approximately August 2008, the patient was vaccinated with a second dose of GARDASIL 0.5 ml. The patient experienced severe itchiness over most of her body, rash and hives. The patient was prescribed ZYRTEC, which was a big help. The patient would be seeing an allergist in the near future. Additional information has been requested.
Sore arm, body aches, Nausea, Head ache, Chills.
Migraines came full blown; Excruciating headaches; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as Age: 39, Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Family history includes her mom having history of migraines. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Dec2020 for COVID-19 immunization and experienced Tingling, throbbing, and pressure on the top and back of her head. The patient received the second of the vaccine on 15Jan2021 and stated the migraines came full blown on an unspecified date in 2021. She also reported experiencing excruciating headaches on an unspecified date in 2021, in which she called off work today and has visited urgent care. The patient stated that she does not have a history of migraines. She wanted to know the percentages of people who have experienced headaches in both age groups. She also stated that her mom has a history of migraines. The outcome of the events was unknown.   Information about lot/batch number has been requested.
1st dose Injected arm - prolong skin pain.... spreading to the elbow.  During second injection, the pharmacist stated that develop a rash and to report it.  After my second dose, itchy and rash like and   Swollen. By the elbow.  painful to the touch around the elbow.
Patient was 17 at the time of administration, recommended is 18 years of age. Her father states she has had no adverse reactions or symptoms.
Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath; enough chest pain to be concerning in the area of my heart; shaking; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8787) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included sliding hiatal hernia with acid reflux, hypoglycemia, cholesterol high, intermittent high BP over the last year (blood pressure high) and food allergy (onion, bell pepper). The patient previously took Vicodin on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Xanax on an unknown date and for unknown indication and experienced drug allergy. The patient previously took Paxil on an unknown date and for unknown indication and experienced drug allergy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN,20mg), vitamin d nos (MANUFACTURER UNKNOWN), mefenamic acid (ADVIL), acetylsalicylic acid (ASPIRIN) and cyanocobalamin (B12) all from unknown date and for unknown indication. Prior to the vaccination, it was unknow whether the patient was 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. On 09Apr2021 at 15:30 the patient experienced Pretty unpleasant shortness of breath - like a band around her chest - can't take a deep breath; enough chest pain to be concerning in the area of her heart, and her heart feels like it's full of cement; shaking. No therapeutic measures were taken as a result of the events. On 09Apr2021, the patient checked Blood pressure and the result was 126/69(units unspecified). On 09Apr2021, the patient checked Pulse and the result was 78(units unspecified). On 09Apr2021, the patient checked Pulse oximetry and the result was 94-96(units unspecified).The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Pretty unpleasant shortness of breath- like a band around my chest - can't take a deep breath, enough chest pain to be concerning in the area of my heart and shaking were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
On 8/16/00, the pt had a fever of 101, red spots on neck, and irritable. On 8/17/00, the pt went to the ER with fever and was told it was a viral infection. On 8/18/00, the pt had a fever of 103, saw family doctor and told she had a viral infection. Child much better in afternoon.
Tired out; This case was reported by a consumer and described the occurrence of tired out in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes and blood pressure high. Concomitant products included metformin and metoprolol.   On 7th February 2023, the patient received Shingrix .5 ml. On 9th February 2023, 2 days after receiving Shingrix, the patient experienced tired out. On 10th February 2023, the outcome of the tired out was recovered/resolved.   It was unknown if the reporter considered the tired out to be related to Shingrix.     Additional Information: GSK Receipt date: 11-Feb-2023. Reporter's Comment:  This report was submitted via the online direct entry reporting system. The symptoms were not treated. The reporter did not consent to follow-up. Note: No overdose was considered as an event as no medication error reported in the case clarification was raised for the same.
Patient received four vaccines, left exam room to walk to lab and patient passed out, hit door frame and exam table corner before landing on ground. After 1 hr. 15 min observation and patient still unable to sit-up or stand, still complained of seeing spots and nausea was transported to ER by ambulance.
p/vax pt exp T103 & sought unspecified medical tx;in MD office pt had T102.3 & rosy cheeks & was clinging;
Urticaria like rash all over the trunk. Applied Calamine lotion and Fluocinolone body oil ( 0.1%).  After which the rash started to fade. Was gone by the next day with no other symptoms developing, or the rash getting worse.
7/5/21 G2P1001 at 39+0/7 weeks GA by 1st trimester US not c/w LMP. Direct admit IOL for chronic HTN controlled with oral antihypertensives
Weight gain of 15-20 lbs. Swelling in left hand, arm, under armpit, and under breast. Has not improved, only has gotten worse within 3 months. Was put on antibiotics bactrim and zovox. Did not improve.
Developed neck myalgia, as well as in shoulders and arms; progressed to facial weakness, dysarthria and extreme weakness and gait ataxia (over 3-4 days). Information received from the 60 day follow-up states re-hospitalized 3-2-06 to 3-4-06 with recurrent facial and lower extremity weakness.
I took my 2nd covid shot Pfizer. Within 10 minutes I started feeling a weird tingling in my upper lip and head after a little while it went away then I'm driving home and realized my rt side of my face is numb got so tired went home took a nap woke up it's still a little numb and my vision is blurred a bit and stiffness in my rt arm mind you I had this shot in my left arm. Not sure if It'll go away soon or not did call my on call the told me to go the the ER to be checked for neourological issues but I'm not able to drive at the moment I don't have anyone else to take me so I'm waiting for the morning to see if it gets any better with sleep the numbness did lessen from when it wfirst started but it's still there I'm just hoping this is not a long lasting effect
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5ml single-dose (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour) , the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pfizer vaccine was administered subcutaneously, rather than IM.  No local reaction versus bruising at site of injection and no post-vaccine systemic symptoms such as fever, HA, myalgias, etc.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T000886, which has been verified to be valid, the expiration date was reported and validated as 29-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
I felt burning/inflammation as it traveled through my mind from injection, to my arms and to my feet, but, my left foot kept burning, so when the 15 minutes were done, I asked to stay longer.  I was directed to EMT? Nurse, and no shortness of breath or nausea, but was told that some people have that reaction, waited 10  minutes more, allowed to leave the facility
Approximately 3 hours after my injection I became very lethargic and my heart began to race.  I had fever of 101 and became very weak and tired.  I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours.  On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever.  My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection.   I felt weakness for approximately 3 days after the injection.  I am currently recovered from all symptoms as of  March 22, 2021.
Information has been received from a registered nurse concerning a child who over a year ago in approximately 2010, was vaccinated with a dose of RECOMBIVAX HB (Lot #, expire date and route not reported). Registered nurse stated that four days later after receiving RECOMBIVAX HB in approximately 2010, the child had an adverse reaction. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Mother called stating child has just developed a red nonraised nonitching rash all over body Md instructed mother to give Benadryl oral and Tylenol oral.
Pt reports 7/10 sharp pain to left side of neck behind ear when swallowing beginning approx. 15 minutes after vaccine administered. Patient states the pain has gradually improved. After 30 minutes, patient reports the sharp pains have subsided and now rates her pain at 5/10. Pt reports pain occurs only when swallowing. Pt denies any difficulty breathing, chest tightness, or cough. There is no hives, redness, or edema noted to (L) side of neck. Pt denies any chest pain, dizziness, blurred vision, or headache. Pt's vitals are stable BP 118/82, P 81, O2 98% and R 16. After 55 minutes, pt reports the pain is "a lot better." Educated pt to continue to monitor and notify PCP of persisting or worsening pain as well as any edema not resulting in increased SOB. Also educated pt to go to the ER should she experience any sudden difficulty breathing, chest pain, dizziness, hives, etc. Pt verbalizes understanding.
Pfizer Dose 1 7/6/21 (EW0198) Pfizer Dose 2 7/27/21 (FA7485) COVID Positive 1/18/22  1/20/22: 70-year-old male patient with a history of COPD, severe emphysema (not dependent on any oxygen at home), CAD, hypertension, dementia, chronic tobacco and alcohol dependence return to the emergency room after 1/18/2022 visit due to complaints of worsening generalized weakness and fatigue.  The patient was seen on 01/18 in the emergency room with similar complaints of weakness, confusion.  Patient has underlying dementia.  He was also noted  to be hypokalemic and tested positive for SARS-CoV-2 infection on 1/18/2022.  Patient had potassium replaced and discharged home.  However since after returning home where he lives with 2 other male roommates, patient has not been eating or drinking very well and has not been taking his home medications.  The patient was brought back to the emergency room due to complaints of extreme generalized weakness and fatigue.   In the emergency room, the patient is noted again to have a potassium of 2.4 with elevated creatinine levels. Patient had potassium replaced in the ER and since he is extremely weak and fatigued, patient is admitted to the hospital. Patient has not required any oxygen or has complained of any fever/chills/cough.  The patient is on room air with a pulse ox of 99%.  Patient is awake, alert and oriented to name only.  He is unable to actively described his symptoms.  Most of the history is obtained from the emergency room provider.  2/11/22: 70-year-old male patient with a history of COPD, severe emphysema, hypertension, CAD, alcohol induced dementia, chronic alcohol and tobacco dependence was admitted to the hospital on 1/20/2022 with complaints of generalized weakness and fatigue.  Patient was tested positive on 01/18 with the SARS-CoV-2 infection.  Patient was never hypoxic during the course of hospital stay and was not placed on any steroids or remdesivir for treating the SARS-CoV-2 infection as his respiratory status was stable.  Patient also noted to acute renal failure on admission which subsequently resolved with fluid infusion and electrolyte abnormalities corrected.  Patient was placed on the CIWA scale as he has a history of chronic alcohol dependence to prevent any withdrawal seizures. Patient's case was discussed with his ex-wife was POA for patient.  It was decided by her that the patient should be enrolled in hospice care as the patient was not significantly improving with oral intake and did not want to work with PT/OT.  Patient has been oriented only to name for most part during the course of hospital stay.  Case manager did work with the patient's ex-wife and the patient has been accepted the long-term facility with hospice care.
recurrent headaches/ Headache pain; right eye pain; Dose Number: 1: 21Sep2021; Dose Number: 2: 22Sep2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2021 at 17:00 as dose 2, single (Lot number: 30130BA) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertentsion" (unspecified if ongoing), notes: Other medical history: Hypertentsion. Concomitant medication(s) included: CARVEDILOL. Vaccination history included: pfizer (Dose Number: 1, Batch/Lot No: FC3182, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 21Sep2021, when the patient was 40-year-old, for COVID-19 immunization, reaction(s): "right eye pain", "headaches". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Sep2021 at 17:00, outcome "unknown", described as "Dose Number: 1: 21Sep2021; Dose Number: 2: 22Sep2021"; HEADACHE (non-serious) with onset 23Sep2021 at 00:15, outcome "not recovered", described as "recurrent headaches/ Headache pain"; EYE PAIN (non-serious) with onset 23Sep2021 at 00:15, outcome "not recovered", described as "right eye pain". The events "recurrent headaches/ headache pain" and "right eye pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, eye pain.  Additional information: It was reported that, patient experienced headaches within days of receiving first dose 21Sep2021, and recurrent headaches, right eye pain ever since until the day. Patient had most days out of the week with headaches, most hours of the day with headaches and never had a history of headaches. Patient had to visit ophthalmologist and had MRI performed on brain. The patient received MRI, daily medications (MEDs) for Headache PAIN. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201112994 Same pateint/vaccine/event, different vaccine dose;
Patient developed a 103 F fever 30 minutes after vaccine and had a febrile seziure.
mom called & had been crying all day since vax given AM of 21NOV95; had been given APAP w/o relief;advised to call MD called parent next day