chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right 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: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative, notes: test negative on 10Jul after taking paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, had symptoms go away and test negative on 10Jul after taking paxlovid 01Jul-06Jul. Weak positive and mild symptoms returned 11Jul2022. No known allergies. The patient received other medication within two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MILD HEADACHE; MILD FEVER; MUSCLE SPASMS ALL OVER BODY FROM TONGUE TO LEGS CONTINUOUSLY INCREASING IN SEVERITY BUT NOT ASSOCIATED WITH PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 16:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced muscle spasms all over body from tongue to legs continuously increasing in severity but not associated with pain. On 21-MAY-2021, the subject experienced mild headache. On 21-MAY-2021, the subject experienced mild fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from muscle spasms all over body from tongue to legs continuously increasing in severity but not associated with pain, mild headache, and mild fever. This report was non-serious.
lethargic for 1-2 days w/visual disturbance of spots in front of eye;mom treated w/ASA;bitten by racoon that was not tested;5SEP95 f/u recovered;
Cardiac Fibrillation; Myalgia; Fatigue.  Information has been received from a 64 year old male with no medical history or allergies who on 02 JUL 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck).  Concomitant therapy included atorvastatin calcium (LIPITOR), irbesartan (AVAPRO), and esomeprazole magnesium (NEXIUM).  On approximately 13 JUL 2007, the patient began feeling very fatigued and he was experiencing muscle aches all over his body.  For one night only, on approximately 13 JUL 2007, he experienced heart fibrillation.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously sumitted on 9/24/2007. Follow-up information received from the physician indicating that the patient was extremely lethargic 48 hours after the vaccine lasting 4 - 5 days, also extreme muscle aches. It is unknown if the exteme muscle aches resolved. No illness at the time of vaccination. No further information is available.
11/7/09 eating chicken lip swollen, (L) facial weakness to urgent care. Dx Bell's palsy, CT head-neg, treated with prednisone & VALTREX. Did develop (R) arm & leg weakness not seek treatment until 11/12 - to ER. 11/13 admit to hosp - Tx with SOLUMEDROL 1 gm IV daily.  11/30/09 DS for DOS 11/13/09  11/17/09.  Final DX: Encephalitis.  Pt was hospitalized with a 5 days hx of facial diplegia most prominent on the left, tongue movement and weakness, dysarthria, and right hemiparesis.  Upon physical examination Pt had hyperreflexia throughout with a positive left Babinski.   Pt's physician considered the diagnosis of brain stem encephalitis although WBC was normal.  TX was given with Solu-Medrol.  Pt discharged with 81mg Aspirin.  Pt's improved partially and will be followed up if the neurological symptoms reappear.
Loss of consciousness for about 15 minutes, bystanders called an ambulance, get back to myself, transported to hospital.
Patient lost color on his face, starting crying and was shaking so much. He had a high fever for 3 days, vomiting large amounts. Patient slept for most of the day for about 2 days. Patient would not walk for 2 day his legs were hurting him.
EMPLOYEE RECEIVED FLUZONE VACCINE 0.5 ML AT APPROX 12PM. AT APPROX 4 PM DEVELOPED WHEEZE, COUGH, EYE IRRITATION. SEEN IN ED, RECEIVED NEBULIZER TREATMENT AND RX FOR MEDROL DOSE PACK.
Small rash (~.5 in) came on late evening on Dec 9 on the left arm, about 1.5 inches from the injection site. The next morning had spread to about 3 inches. By that evening it covered most of the upper arm and was noticeably warm to the touch. I went to the doctor the next afternoon and was diagnosed with cellulitis and prescribed Doxycycline, which I took for seven days. After a day of Doxy the heat was gone and rash had faded, by two days it was gone.
I have swelling in my face; I had fast heartbeat; I had a rash over my body; allergic reaction; This is a spontaneous report received from a contactable consumer (patient). A 70-year old patient of unspecified gender received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included aspirin from an unknown date for an unknown indication, rosuvastatin (CRESTOR) from an unknown date for cholesterol, vitamin D from an unknown date for an unknown indication, vitamin C from an unknown date for an unknown indication, and pantoprazole sodium sesquihydrate (PANTRO) from an unknown date for stomach medicine. The patient also took high blood pressure medicine. The patient previously received dose 1 of BNT162B2 (lot number EK5730) on 14Jan2021. On an unspecified date "maybe a week after her last shot 04Mar2021" the patient experienced swelling in the face, fast heartbeat, and rash over the body. The patient had been looking at the papers. The patient got both Pfizer shots and had "all of this." The patient visited a doctor several times and went to the emergency care and then primary doctor. The patient was diagnosed with allergic reaction. The patient kept breaking out. The patient broke out on the arm again. The patient received treatment for the events. The outcomes of swelling in the face, fast heartbeat, rash over the body, and kept breaking out were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within 15 minutes of receiving the shot I began to tremble and feel hot and dizzy. I ached all over and my ears began to ring. I was ill for at least 2 weeks but slowly recovered except for the tinnitus, which I still have. The tinnitus has grown progressively worse to the point that it's hard to hear over it. I've gotten a seasonal flu shot every year all my adult life and had never had any reaction before 2017.
4 days after vaccine: armpit began to get sore with small lump in apartment (sometimes I have this reaction when I am fighting off an infection) 5-6 days after vaccine: armpit continues to be sore, lump does not grow in size 7 days after vaccine: left arm at injection site is itchy and dry, put vacceline on it to reduce dryness, about 1 hr later noticed it was lumpy with hives and read, took a benadryl and went to bed 8 days after vaccine: injection site remains red, and warm but has not grown in size, remains a minor dry itch
administered after 16 hours of reconstitution/ administered after temperature excursion; administered after 16 hours of reconstitution; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA437A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug and wrong technique in drug usage process. On an unknown date, the outcome of the incorrect storage of drug and wrong technique in drug usage process were unknown.  Additional details were provided as follows: The age at vaccination was not reported. the physician reported that a nurse administered a dose of Menveo after 16 hours of reconstitution, which led to incorrect storage of drug and wrong technique in drug usage process. The reporter consented to follow up.
pt recv vax & exp wide spread redness, itching & pain @ test site;disappeared in 48-72hr p/tx w/cold packs & in some cases topical hydrocortisone cream was applied;
This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. The patients were vaccinated with improperly stored GARDASIL. No adverse effects reported. Additional information has been requested.
Pt recvd vax & w/in 2 hrs hand felt hot then progressed from tingling sensation to pain & numbness; resolved w/steroid meds;
Achy, chills, fever 100.9 - 102.5 for 3 days.
Injection site high on shoulder, shooting pain down arm and to neck. Now experiencing intense shoulder pain.
Pfizer vaccine was administered outside of Facility- reported by patient  I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 9/10/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 9/10/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 5/21/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/10/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 9/10/2021 THROMBOCYTOPENIA, UNSPECIFIED. I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 9/10/2021 THROMBOCYTOPENIA, UNSPECIFIED. I95.9 HYPOTENSION 5/21/2021 THROMBOCYTOPENIA, UNSPECIFIED. J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 THROMBOCYTOPENIA, UNSPECIFIED. J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/10/2021 THROMBOCYTOPENIA, UNSPECIFIED. I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 9/10/2021 RESPIRATOR DEPENDENCE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 9/10/2021 RESPIRATOR DEPENDENCE I95.9 HYPOTENSION 5/21/2021 RESPIRATOR DEPENDENCE J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 RESPIRATOR DEPENDENCE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/10/2021 RESPIRATOR DEPENDENCE
Was given a pediatric dose to a 14 year old. Patient was instructed to come back in for second injection.
Red, warm, itchy area at site of shingles shot given 10/8/13.
pt has URI prior to onset of Guillian-Barre symptoms. He has rheumatoid arthritis & was receiving gold therapy concurrently. He was given the flu vaccine on 23Oct89
Headache; Back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Back muscle pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Back muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, MYALGIA (Back muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Itching starting on feet, progressed to red rash and generalized itching.  Pruritis eventually waxing and waning.  I saw pt on 8/17 and there was no rash remaining.  Patient also complained of skin sensitivity and burning, which had resolved by 8/17.  She had a headache on 8/15.
VACCINE ADMINISTERED FROM A PUNCTURED VIAL KEPT AT REFRIGERATION TEMPERATURE FOR 7 HOURS AND 26 MINUTES; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant. The patient experienced drug allergy when treated with chlorhexidine, clindamycin, doxycycline, oxazolam, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes was not reported. This report was non-serious.
Tdap injection in right arm started to itch and turn red right away. I then developed a large golf ball sized lump at the injection site. I had a flu shot in the left arm. I am not sure of the exact brands of each vaccine.
Having tingling in right lower arm and right lower leg after the second covid shot, which took place 8/19/2021
I have pain in my testicles and they are sensitive. I didn't have any pain days prior and I have not been physically active since Saturday where I could of possibly hurt myself.
Pt. said her arm was hurting & numb. She said she also has vertigo & vomiting. Pt is pregnant. 10/19->pt went to orthopedic MD.
swollen lymph nodes in the arm of the injection; Chills; Aches/body ache; headache; Body temperature/Fever; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a male patient. 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on 03Feb2021 (at the age of 49 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via unknown route of administration on unknown date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter husband received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks ago. On an unspecified date in Feb2021, he had pretty much all of the symptoms-swollen lymph nodes in the arm of the injection, fever, chills, body ache, headache and those started about 12 hours after the vaccine and they lasted about 36 hours. The patient was a little achy and felt fine to do day to day stuff. However 3 weeks later, her husband had chills and aches again but no fever, at 97. It was also reported that she wants to know if this was normal. The lab data included body temperature was 97 on an unspecified date in Feb2021. The outcome of the events chills and aches were not recovered and other events were recovered on an unspecified date in Feb2021.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Injection site pain started 3 hours after injection. 8 hours after injection - fever of 102, chills, muscle spasms, fatigue, weakness and vertigo. Tylenol breaks and keeps fever near 100. Injection site pain and swelling expanded, red and raised with itchiness 48 hours after injection. Oral Benadryl was added to treat.  Arm pain and redness happened 8 days after the first injection and resolved within 2 days without intervention.
Pt developed an injection site reaction on left arm characterized by swelling and tenderness, and low grade fever that resolved in two days. Pt then developed migrating arthralgia - joint pain and swelling or redness.
sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 017C21A and 030C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-565868, MOD-2022-566260 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received contain No new information
Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; This is a spontaneous report from a contactable physician. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 18Dec2020 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications were not reported. The patient experienced paraesthesias in a trigeminal nerve distribution starting 3 days after vaccination on 21Dec2020 18:30.  The patient underwent lab tests and procedures which included Nasal Swab/Antigen rapid: negative on 25Dec2020. Therapeutic measures were taken as a result of the event that included Medrol dose pack and famvir. Symptomology was mild, 80% improved one week later. Clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received her Moderna  Covid 19 vaccine  6 days prior to the 28th day that it was due.
Fever 103F at 11 PM, following immunizations (PEDIARIX, HIB, PREVNAR, ROTATEQ) in the morning.  4/7/09 Received ER medical records of 3/27/2009. FINAL DX: acute febrile illness Records reveal patient experienced irritability, fever.  Family member sick w/cold s/s.  Left thigh injection sites noted to be bruised, erythematous & indurated.  Tx w/antipyretics & defervesced.  D/C to home on continued antipyretics.
I received my first Covid Vaccine in my left arm at approximately 10:30 AM, January 14, 2021.  That night (or the next night), I experienced a tingling sensation in the left arm (from where the left arm attaches to the shoulder) down to the elbow.  The tingling sensation can be described as like when your arm "goes to sleep".  The following day, the tingling sensation was no longer from the shoulder to the elbow, but from the elbow to the tips of the fingers (the thumb and first two fingers).  The sensation would last perhaps 20 seconds and then dissipate.  That type of an episode would occur a number of times each day (several times/hour). There is no question in my mind that the tingling sensation  Additional information for Item 18:  was due to the vaccine.  I expected that the tingling sensation would eventually resolve itself, so I patiently waited for things to get better.  While I was waiting for the episodes to get better, my second Covid vaccination was scheduled at the same location three weeks later on February 4, 2021.  Although I was still experiencing the tingling episodes, I had the second vaccination on February 4th in the opposite (right) arm.  I had no reaction at all from that second vaccination (Pfizer Lot Number EL9262).  As time passed, the tingling sensation from the elbow to the fingers in the left arm did not go away and so I made an appointment to see a Neurologist.  I saw Nurse Practitioner on March 29, 2021.  Two nerve tests (nerve conduction study and electromyogram) were scheduled for the next day.  The results of those tests did not show issues that could be associated with the vaccination.  On April 8, 2021, I had a follow-up appointment with NP and it was decided that I would be put on Gabapentin (one 100-mg capsule, three times a day).  The tingling sensation was minimally improved over the next month and so  on May 6, 2021, NP said to increase the dosage and take two 100-mg Gabapentin capsules, three times a day.  The tingling sensation has improved greatly since May 6th, but I have not yet been weaned from the Gabapentin.  Therefore, I do not know if the tingling episodes will resume when I cease taking the Gabapentin.  My next appointment with NP is August 10, 2021.  I assume at that time she will decide to wean me off of the Gabapentin and the final outcome will be known in the days after that weaning.
I got significant nerve pain on my left side of my head. It was really painful. The pain the went away after the second shot.
Patient called on Mon. 10-29-12 to report reaction after getting Flu vacc. At site of injection his muscle was achy for 1 1/2 day onset 4pm/same day. By midnite patient had explosive, watery, severe diarrhea, lasting 3 days (until Tues 10-23-12).
This spontaneous report as received from a Nurse Practitioner refers to a 4 month old male patient. No medical history or drug reactions/allergies were reported. On 25-JUL-2013, the patient was vaccinated with the first dose of ROTATEQ (lot#, dose and route not provided). Around 25-JUL-2013, after receiving the first dose of ROTATEQ the patient "vomited after every feeding for 2 weeks and more after that dose", and also was irritable. The patient did not seek medical attention. The vomiting stopped around 08-AUG-2013. On 27-AUG-2013, the patient's mother brought him in for another dose, but they think the dose was not given. Additional information has been requested.
Moderna COVID?19 Vaccine EUA. Localized swelling and redness in the arm where vaccine was injected.  First noticed 8 days after administration of vaccine.  Still present three days later.  Specific symptoms include: redness, skin warm to the touch, hard swelling - visibly obvious.  itchy.