chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, 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: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 19Oct2022 to 24Oct2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
About 10 minutes after receiving the vaccine, patient fainted while he was walking in the store.  Ambulance was immediately called and they arrived within 10 minutes.  Patient regained consciousness prior to ambulance's arrival.
Accidentally gave the patient an undiluted injection of the Pfizer Covid vaccine.  Checked in with the patient and they were feeling fine.  The only reaction was a localized reaction on the arm at the injection site.  Nothing different from a properly administered dose.
listening to a slow ceiling fan motor whooshing and constantly hears it in both ears; began experiencing hearing loss, noise disappeared suddenly in both ears; very deadening sound in both ears; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via intramuscular route of administration on 01Apr2021 at 09:30 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included blood clot in leg almost 10 years ago. Concomitant medications included rivaroxaban (XARELTO, strength: 20 mg) taken for blood clot in leg and other unspecified medications. The patient previously took silodosin (RAPAFLO) a number of years ago for urination and he broke out in hives. Patient had no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had first shot done on 01Apr2021 at 09:30. On the evening of 13Apr2021 at 19:30, he kind of got a very deadening sound in both ears and then began experiencing hearing loss, noise disappeared suddenly in both ears. He woke up the next day (14Apr2021 at 05:00) with what he described as listening to a slow ceiling fan motor whooshing and constantly hears it in both ears. He called his doctor because he thought it may disappear but his doctor instructed him to see an ear and throat doctor about this (for clarification). He called to report the events and to know if it's safe to get the second dose of the vaccine. The outcome of the events was not recovered.
I developed a headache, body aches, fatigue, chills, nausea and 101.4 fever.  I started with the headache on 3/5/2021 and I had the other symptoms when I woke up on 3/6/2021.  My fever broke at 6:00 PM on 3/6/2021 and I felt much better after that.  Woke up on 3/7/2021 with fatigue only.  Felt normal on 3/8/2021.
This spontaneous report as received from a physician refers to a female patient of unknown age with no medical history and no drug reactions/allergies. The patient was vaccinated with 2 doses of GARDASIL at another unspecified practice 6 years ago (in 2006). No other co-suspects were reported. There was no concomitant therapy. In June 2012, the patient had an abnormal PAP smear and colposcopy reveled CIN1 (cervical intraepithelial neoplasia) and condyloma due to HPV. The patient will be monitored with PAP smears every 6 months. The patient sought medical attention by office visit and was given no treatment for AEs. The outcome of adverse events was reported as recovered/resolved. Additional information is not expected.
Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 77-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1284; Expiration Date: Apr2021) (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced fever, chills and nausea. There was no treatment received for reported events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Not sure if delayed reaction because it was a week out.  Symptoms included delayed injection site pain, fatigue, headache, muscle pain, chills, joint pain, 99.2 temp, injection site red (delayed and only on 7th day), nausea, feeling unwell, dizziness, weakness, and hives which were relieved with Benedryl.    Most of the symptoms began on Monday, February 8th and worsened on Tuesday, February 9th with hives.  There was no shortness of breath or respiratory issues.  Injection site was only tender on day of injection but tender and red on the 9th only.  Fatigue, headache,  hives continued on February 10th along with a slight bout of diarrhea.  Called clinic and they requested he go in and be tested for Covid-19 and results should be known in 2 days.  February 11th seemed to be better and as of 10:00 a.m. PST no hives but still itching and slight fatigue.  Again,  didn't know if it could be a reaction since it is a week out or something else.
I was having severe abdominal pain, I went to Urgent Care, and ER and my blood pressure went down to 89/48, they run tests and showed that my appendices were badly infected, they did surgery, and the Doctor said an abscess in the upper & lower abdominal. I was full of infection. I had no pain until 3 hours I arrived to ER, they don?t believe the appendix cause the infection, it was the other way around, they could not explain what caused infection and they put strong IV antibiotics, I was in the hospital for 5 days. When they sent me home, I had a tube to drain the infection for 12 days. Then I was cleared, the infection was completely done.
Patient was given Bivalent Pfizer 12+ for 1st primary dose.  No treatment.  No side effects or adverse events.  Returned today for 2nd dose.  Was informed of the error and given a monovalent Pfizer 12+ as recommended.
Lymph nodes swollen in underarm of arm used for vaccine.  Started about 8 days after vaccine.  Still somewhat swollen at 13 days.
Patient had lip swelling 2 to 3 days after having the Moderna Covid vaccine.
pt tested positive for COVID on 9/4/21, then admitted to hospital on 9/10/21; pt received 2 Pfizer vaccines on 3/26/21 & 4/17/21
Mom calls 11/16/06 to say arm at site if immunization is red, warm swollen, sore to touch, and has low grade fever.  Treatment recommended: ibuprofen,warm moist packs to site
FATIGUE/FELT TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. On 14-MAR-2021, the subject experienced fatigue/felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue/felt tired was not reported. This report was non-serious.
THE RESIDENT WAS ADMINISTERED 3 DOSES OF THE MODERNA VACCINE. THE RESIDENT RECEIVED A DOSE OF THE VACCINE  PRIOR TO ADMISSION TO FACILITY ON 05/14/021. THE FACILITY WAS UNAWARE OF VACCINATION STATUS AND THE RESIDENT HAD NO RECALL OF RECEIVING THE VACCINATION. THE RESIDENT DID NOT EXHIBIT ANY ADVERSE REACTION OR ANY SIDE EFFECTS FROM THE 3RD DOSE OF THE VACCINE.
arm sore; no strength on his arm; pain in his arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm), FATIGUE (fatigue), MYALGIA (arm sore) and MUSCULAR WEAKNESS (no strength on his arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033b21a and 026d21a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN from an unknown date to 19-Jul-2021 for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm), FATIGUE (fatigue) and MUSCULAR WEAKNESS (no strength on his arm). On an unknown date, the patient experienced MYALGIA (arm sore). On 20-Jul-2021, FATIGUE (fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in his arm) and MYALGIA (arm sore) had not resolved and MUSCULAR WEAKNESS (no strength on his arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Burning sensation; Pain in the right shoulder and armpit; Pain in the right shoulder and armpit; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old),as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after receiving the 1st dose, the patient experienced burning sensation, pain in the right shoulder and armpit.The patient would like to know about taking the second shot, would it be needed after 42 days.  Outcome of the events was unknown  Information on the lot/batch number has been requested.
4/20/2021- I awoke to fatigue, nausea, and a 101.9 temperature. 4/23/2021- After seeing no signs of improvement, I visited my primary care physician, who had blood drawn for tests. Morning of 4/26/2021 ? I was contacted by my primary care physician?s office with results of the blood work. I was referred to a gastroenterologist due to critically high liver enzyme levels. My AST(ASGOT) was shown to be 825. Afternoon 4/26/2021: The gastroenterologist explained that my AST was roughly 40 times higher than normal. He said levels this high could not be caused by hepatitis A, B, C, or Auto-immune hepatitis. More blood was drawn at the gastroenterologist?s office. The results showed: Bilirubin Total of 2.2, Bilirubin Direct of 1.38, Alkaline Phosphate of 360, AST of 1,222, ALT of 2,314, Ferritin, Serum of 737. The gastroenterologist told me to go to the hospital if I developed jaundice or became too fatigued to get out of bed. 4/28/2021? CAT scan. Results were inconclusive. 5/2/2021- Developed jaundice.  I spoke with the gastroenterologist?s office and got appointment for 5/4/2021. The gastroenterologist changed his mind and had me admitted to hospital on 5/4/2021. While in the hospital blood was drawn frequently.  Peaks levels reached during the hospital stay were as follows: Bilirubin Total of 14.0, Bilirubin Direct of 11.53, Alkaline Phosphate of 346, AST of 1,522, ALT of 2,550. I had an ultrasound and endoscopy performed while in the hospital. The endoscopy looked at my bile duct, liver, and small intestine. Tissue was taken from the small intestine which ruled out celiac disease. Tissue was taken from my liver and biopsied.  The gastroenterologist said the liver appeared to have suffered medication induced hepatitis. He said, in his opinion this was caused by the Pfizer COVID-19 vaccine. At the time I was taking no other medicine other than a once a day multi-vitamin.  5/7/2021 I left hospital. 5/18/2021-Latest blood work results: Bilirubin Total of 14.7, Alkaline Phosphate of 369, AST of 268, ALT of 593. Future: I have an upcoming appointment with a hepatologist to determine extent of liver damage.
A medical assistant reported that a 75 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined and Pnu-Imune 23 vaccines on 05/02/00. One week later, the patient developed an injection site reaction characterized by redness and soreness at the site of the TD administration.
Eye swole shut; short of breath; numbness in toes; lips tingling and cracking; lips tingling and cracking; light sensitivity; major headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Apr2021 01:00 (at the age of 38 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no medical history and no concomitant medications. No known allergies were reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. The reporter reported that, on 27Apr2021 06:45 allergic reaction that has been progressing for 5 days now. Eye swole shut, short of breath, lips tingling and cracking, light sensitivity, major headaches and numbness in toes. As a treatment patient received a steroid shot and a prescription. The events resulted in emergency room/department or urgent care. The outcome for the events was recovering.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a physician administered zoster vaccine live ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
2 days post administration pt devel t102, lethargic, stiff neck; dx ear infect, meningitis, poss; hospitalized for 7 days;
Syncope. Vitals. 96/62, 50, pulse ox 97. Revived with ammonia salts, O2 administered by nasal canula. Supportive therapy administered. Vitals 102/65, 74, 100% O2 sat. RR 16. Released to mother 40 min later. Sent for head CT.
pt recv vax 23JAN96 & 22FEB98 pt devel a mild case of varicella w/approx 7 lesions on trunk & low grade fever;
Headache mainly across the eyes; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache mainly across the eyes) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache mainly across the eyes). At the time of the report, HEADACHE (Headache mainly across the eyes) outcome was unknown.            Treatment information was not reported.
Patient presented his arm to a pharmacist at a pharmacy location other than the one that administered the vaccination. His arm was red, inflamed, and warm to touch. About 4 inches in diameter.
Hematuria 12 hours after receiving GARDASIL dose #2 on 7/19/2010 urinalysis prior to vaccine (7/19-no RBC no WBC) urinalysis 7/20 10-12 RBC/HPF and 20-25 WBC/HPF.
17NOV felt achy, tired, no energy, dec appetite indigestion about 1130PM, diarrhea w/cramping, nauseated; no vomiting; took immodium; 18NOV dizzy, feels bad; t101.2;
Flu shot received around 10:15 am (11/6/02).  Aches noted by 3:00pm, chills by 4:00pm.  Went home early from work.  Sour stomach, threw up at midnight. Slept poorly. Tired and achy next day, able to hold down food and worked 4 hours. Never had such a reaction to a flu shot before.
got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Patient received first dose of Pfizer vaccine and waited 30 minutes after.  About 28 minutes later developed itching to forearms and swelling in hands. EMT gave IV Benadryl and patient became dizzy- transported to ED
Patient reported dizziness and feeling faint around 6 hours post-vaccination. When patient called to report the adverse event the day after the injection (5/19/2021), he stated he still felt this way but much better compared to the prior day when he received the injection.
Tingling in feet & lips & throughout body, visual sxs-blurred, sensativity, eye pain, numbness in arms, hands, face, muscle weakness & twitchs. Increased DTR's. 9/6/99, felt nauseated & tired.
Fever, cried all day and night, sometimes inconsolable. Further pertussis vaccination withheld.
Nausea, diarrhea, fatigue, tingling in hands and arms.  Lasted 4-5 days. Caused to miss work.  Contacted PCP but did not go in for visit.
reports not much of reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (reports not much of reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (Patient has high blood pressure a year ago from licorice tea).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reports not much of reaction). At the time of the report, VACCINATION COMPLICATION (reports not much of reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406577, MOD-2021-406578 (Patient Link).
after receiving the 2nd Moderna vaccine and was waiting for 15 minutes, patient started feeling rapid heartbeat, dizzy and was nauseated. She was given a bottle of water to sip on and was monitored. After another 15 minutes  she felt a little dizzy but not the other symptom. after 30 minutes patient said she was fine and was told we will follow up with her. 2 hours later patient said she was having pain in her chest while breathing and it was a 6-7 on a scale of 1-10.  Told the patient to contact her doctor and she said that she  did not have a regular doctor. Informed the patient to go to the emergency room and she said will try to go to the ER. Will follow up with the patient tomorrow
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with improperly stored dose of ROTATEQ oral (dose and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Recieved vaccine on 1/13/2021. Site of injection red and swollen 2nd day after shot. Arm feeling better until 1/22/2021. On the 22nd site became itchy with redness 2in.X 1  1/2in with it increasing in size.