chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weight gain/his weight started to go up; his abdomen is getting larger; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier: US-PFIZER INC-2021539741.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "keto and intermittent fasting" (unspecified if ongoing); "intermittent fasting" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "weight gain/his weight started to go up"; ABDOMINAL FAT APRON (non-serious), outcome "unknown", described as "his abdomen is getting larger". Relevant laboratory tests and procedures are available in the appropriate section. Patient complained weight gain after receiving both doses of the Pfizer-BioNTech Covid-19 Vaccine. He said that it happened to him, his friends, and to the other people he knows. He said he monitors his weight every Monday, and that he keeps a record of it. Back in Feb, he said he was at a specific weight. Then on Mar, after receiving the vaccine, his weight started to go up. He mentioned that he did not change the diet he was on which was keto and intermittent fasting so he is concerned about why he gained weight. He said his abdomen is getting larger.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (REBOUND OF COVID); This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old male. Initial information was processed with additional information received on 19-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 03-AUG-2021 at 12:00 on left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 39 years old. Concomitant medications included cold and flu (dextromethorphan hydrobromide/doxylamine succinate/guaifenesin/paracetamol/phenylephrine hydrochloride/pseudoephedrine hydrochloride). On 28-JUL-2022 at 23:45, the patient experienced fevers and headaches (confirmed covid-19 infection) which lead to confirmed clinical vaccination failure.  The patient received non-company co-suspect drug Paxlovid (form of administration, route of admin, batch number, and expiry date were not reported) dose was not reported, administered from 28-JUL-2022 to 01-AUG-2022 for treatment of COVID-19.  On unspecified date, patient experienced rebound of covid symptoms with fevers and headaches after initially getting better and tested positive for covid again. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with Paxlovid was withdrawn on 01-AUG-2022 . The outcome of the confirmed covid-19 infection(rebound of covid) and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000247202.; Sender's Comments: V0-20220837250-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
p/vax pt exp faint feeling;pulse full & regular;not pale, resp nl;waited 30min in office-said feeling better;went home mom stated cont to feel dizzy;p/24hr devel wheezing;went to ER;better p/ 48hr to 72hr mom says;
Local redness of (R) arm (10 X 12 cm) without tenderness.
Pt developed redness and a bump at injection site. Recommended treatment - warm compresses on immunization site.
Raised nodules and redness at site of injection extending to surrounding areas up to the middle of the arm 1 week after vaccination. Itching also present.
And Atopic dermatitis. Treatment: Prednisone 20 mg BID, diphenhydramine 25 mg QID.
1st dose over 3 years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Nov-2022 Reporter's comment: Pharmacist reported that if a patient received her first dose of Shingrix vaccine over 3 years ago and has not receive her 2nd dose. The reporter asked that we need to restart the series. Called pharmacy but health care professional was not available.  Completed adverse event with just data provided as conservative. Since it was just this message there were no patient's or vaccine's identifiers, no opportunity to request follow up. Not sure if a patient was in fact involved. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. In worst approach case was kept valid with event incomplete course of vaccination considering that patient was involved and did not receive her 2nd dose.
This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of M-M-R II injection, intramuscular route in error (lot# and expiry date not reported) for prophylaxis (inappropriate route of vaccination). No known adverse effects. No product quality complaint (PQC) was involved.
Patient received the Moderna Covid 19 EUA vaccine @9:59, at 10:30 reported heart racing & palpitaitons.  Vitals: 10:35 135/80 HR 75 O297%, 10:40 150/82, HR 71, O2 96%, 10:50 136/86, HR64 O296% Patient history of diabetes, takes Glipizide and Hypertension, takes Bystolic.  Patient reported she was very nervous about vaccine. Patient reported feeling better by 10:50 with no more palpitations and was released home with her spouse.
I have had ongoing, intermittent side effects of fever, body/joint aches, chills. It happened first within 12 hours of the second dose and lasted a day. It has reoccurred 3 times since then. Each time I tested negative for COVID but it's the exact same 'after effect' from 2nd dose.  I also have a sharp pain when breathing in deep in my mid-back/chest area. This is ongoing and intermittent more frequently.
Patient received vaccines yesterday, this afternoon the patient broke out with a red splotchy rash on his arms and legs.
Fatigue; Nausea; Mild body aches; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Sep-2021. On 15-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On an unknown date, the patient experienced FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches). On 12-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, FATIGUE (Fatigue), NAUSEA (Nausea) and MYALGIA (Mild body aches) outcome was unknown.            Treatment medications were not reported.  Concomitant medications were not reported.  Patient mentioned her fetus was healthy at the reporting time.   This case was linked to MOD-2021-073888 (Patient Link).
Client called office to report nausea, vomiting x3 events and mild headache.
pt recvd vax & the same day, exp flu-like sx w/nausea, fever, chills, & stiff neck; pt recovered from these sx 3 days later;
Fast onset of fatigue, joint pain, headache, pain of lymph nodes. Quickly worsening over 5 hours, remaining for approximately 30 hours.
Patient came in 02/27/2013 to tell me he still had pain in his left arm. Painful when lifting it up. He said it started after his flu shot in September.
pt recvd vax & had t 103; had sz & ear infection; pt dx w/ otitis media;
I received the 2nd Moderna shot Monday night at 6:45pm. By mid-day Tuesday my fever got up to 100.9. Headache  3 days Tue-Thurs), injection site soreness which was sore to touch and hot, swollen lymph nodes in the same armpit which were sore to touch, slight shortness of breath (3 days), and some sinus pressure also existed.  I have EPV and C677T MTHFR so I was extremely hesitant to get the shot due to concerns of being able to detox it.   I have not had COVID-19 prior to receiving these vaccines. I took 250 mg Glutathione days before and after the shot to assist with detoxification.
Pt states arm hurts still 9/18/15 can't sleep on left side.
Information has been received from a physician concerning a 43 year old female nurse with hypertension and a history of chickenpox when younger and no history of immunodeficiency or immunosuppressive therapy, who on 10-DEC-2007 was splashed in her one eye upon administration for a child with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658022/0823U). Concomitant drug therapy included metoprolol succinate (TOPROL XL). On that same day moments after the event, the patient felt a burning sensation. The patient removed her contact lens and flushed eye with normal saline. The patient sought medical attention through a physician who reported no abnormalities. The burning sensation disappeared but the patient went to an emergency room for an evaluation. A blood test was performed and the patient was released. On that same day the patient was recovered. Additional information has been requested.
Chills; Fever; Bodyaches; injection site pain; Is there anything I can take to ease the discmfort; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, general body pain, injection site pain and discomfort. On an unknown date, the outcome of the chills, fever, general body pain, injection site pain and discomfort were unknown.   It was unknown if the reporter considered the chills, fever, general body pain, injection site pain and discomfort to be related to Shingrix.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was not comfortable to provide personal information. The patient took 2nd Shot of shingrix and experienced chills, fever,  body aches, injection site pain and asked for treatment of this discomfort.
Headache, Myalgia, fatigue, lethargic, "foggy brain" Narrative:  Other Relevant History:
Headache, aches all over body, stiff neck with pain. Symptons occured 2 weeks after vaccinations. Both seasonal and H1N1 were given at the same time.
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
Pt recvd 3rd dose of Engerix-B & on 24JAN91 exp HBSAB neg; recvd 4th dose Engerix-B 08FEB91;
Breakthrough case admission after 2 vaccines Pfizer 3/2/21 lot# EN6200;  Pfizer 3/23/21 lot# EN6207
broke her my wrist; swelling; Pain; Sore arm; Inflammation in her wrist; This is a spontaneous report from a consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 15Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received her first dose of the Pfizer vaccine and then then broke her wrist the following day (unspecified date in Mar2021) and got her stitches removed on 16Mar2021. The doctor told her to take Aleve 3 of them three times a day for swelling and pain and to start physical therapy. She was also instructed to take Aleve three times a day for inflammation in her wrist. Patient stated she heard Aleve and the vaccine were not supposed to be taken. My second dose was on 5Apr2021. She questioned that, are we not allowed to have Mammograms, magnetic resonance imaging (MRI) and X-rays. She had no reaction only a sore arm for a day but nothing else happened. She only took 2 Aleve because she did not want it to interfere with the vaccine. Patient visited Physician office due to events broke her wrist and inflammation in her wrist. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 days p/shot had sore throat constantly 3 wks later bad cold? which lingered on & on; this is 3rd yr exactly same thing happened;
Pt. felt tightness in throat, able to speak fine. No distress noted. BP 120/76. 1 pm Pt. received 25 mg. BENADRYL P.O.
Tested positive for COVID-19 between doses of the Pfizer vaccine; Tested positive for COVID-19 between doses of the Pfizer vaccine; This is a literature report.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus nephritis" (ongoing), notes: on immunosuppressant therapy. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Tested positive for COVID-19 between doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: normalized after overall, notes: resolution of her illness; Heart rate: normalized after overall, notes: resolution of her illness; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tachycardia. Concomitant products included NORVASC and metoprolol. On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever. In April 2018, the outcome of the heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever were recovered/resolved. It was unknown if the reporter considered the heartbeats increased, increased blood pressure, injection site pain, influenza-like symptoms and fever to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on an unknown arm. The patient experienced flu like symptoms, rapid heartbeat, fever, arm soreness at injection site and elevated blood pressure up to 160/90 mm Hg. The patient reported that he had to increase his doses of Metoprolol and NORVASC to counteract the rapid heartbeat and elevated blood pressure. The patient reported that all these experiences resolved within 2 to 3 days after SHINGRIX vaccination. The contact details of the physician were provided.
p/vax pt devel severe red rashes around the entire upper arm of the inj site;pt devel significant dependent edema extending from the pt elbow to the wrist;tx w/ATB & recovered w/in 48hr;
Narrative: Patient was at an outpatient clinic to receive 2nd dose of the Pfizer COVID vaccine. While in the waiting area 15-30 min after immunization, she began to have symptoms of hot flashes, itching, tingling bilaterally in her arms,  nausea, and feeling faint (no syncope). She was taken to the treatment room where she received 1M diphenhydramine and 1M Solu-Medrol. She was then taken to the nearest ED where symptoms have improved and she was given IV fluids and PO Famotidine.
Increased heart rate; slight lightheaded; headache; sore arm and neck; sore arm and neck; extreme lethargy; This is a spontaneous report from a contactable other-healthcare professional (patient). A 31-year-old female patient (not pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9263), via an unspecified route of administration at site of left arm at 15:00 on 22Jan2021 at single dose for covid-19 immunization. Medical history included bursitis, chronic migraines, high blood pressure and fibromyalgia. Concomitant medication included methocarbamol, colecalciferol (VITAMIN D), loratadine and omeprazole, all received in two weeks of vaccination. The patient experienced increased heart rate, slight lightheaded, headache, sore arm and neck, extreme lethargy at 15:30 on 22Jan2021. No other vaccine received in four weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No Covid prior vaccination. No Covid tested post vaccination. Not known allergies. The outcome of events was recovering.
Information has been received from a consumer concerning a 17 week old female with no pertinent medical history reported and no known drug allergies/reactions who on 12-APR-2010 was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). There was no concomitant medication. Within 12 hours after receiving ROTATEQ, on approximately 12-APR-2010 the patient experienced severe diarrhea, dehydration, reduced urine output, loss of appetite, vomiting and irritability. The patient's mother states that she "took her daughter to the emergency room on Sunday 18-APR-2010, but she was not admitted". Laboratory tests performed included stool studies (results not provided). The patient's mother also stated that her daughter received ROTARIX as her first vaccination against rotavirus gastroenteritis on 02-MAR-2010 and did not experience any adverse effects after receiving that. Therapy with ROTATEQ was discontinued. The patient's severe diarrhea and dehydration and reduced urine output and loss of appetite and vomiting and irritability persisted. Additional information has been requested.
pt exp severe localized pain in the inj site & the entire arm for 24hrs following vax 28MAR95;pt exp arm pain x 1wk;
Moderna dose was given after Moderna vial was kept in the refrigerator for 40 days.
Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J vaccine in November 2021. Past adverse reactions to the above products included No adverse reaction with J&J vaccine.   In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.). At the time of the report, ACCIDENTAL OVERDOSE (Patient received the J and J vaccine in November and received the Moderna as a booster last night. Gave the 0.5ml dose to the patient.) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were provided. Patient reported that, patient received the Moderna as a booster and 0.5ml dose. Patient concerned that got the full Moderna dose and not the booster dose. No treatment medications were provided.   This case was linked to MOD-2022-486909 (Patient Link).
Swollen painful upper arm, chills, malaise, dizziness for the day of the injection through two days afterward.
Shortness of breath, stabbing pain located in left abdoment bottom of rib cage for a 5 week duration.  Chronic pain in left arm muscle (tip of syringe).
Vaccine adm. 8/16/02 at 1410-c/o numbness and decreased muscle control approx 2400 8/17/02. Also c/o facial swelling. Was seen in Emerg. Dept 8/18/02. Dx. with Bell's Palsy. Notified of events 8/19/02. pt seen by MD 8/20/02 and Tx with steroids and antibiotics. Mother notes 8/21/02 no signs of improvement at this time.
After 2 hours, lips and tongue started tingling and swelling. Took Claritin. 4 hours after that, got very dizzy and unwell. Had trouble breathing. Went to nearest Emergency room, about 8 minutes away.  Breathing became very labored and noisy. Treated with oxygen, prednisone, and Benedryl. After about 1 hour, was stabilized and sent home with a quick taper course of prednisone, rx for Epi pen.
(R) arm, red swollen, under arm, neck and back pain, diarrhea, malaise, low grade fever.
Information has been received from a nurse concerning a 24 year old female who on 11-MAY-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661953/1130x), intramuscularly. The patient developed a rash at the injection site about 6 inched in diameter. No laboratories studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Erythematous patchy area with mild tenderness on vaccine site. Tx: cold, wet washcloth.