chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased heart rate, increased blood pressure, cold/clammy feeling, urticaria (neck), swelling in neck and chest.   At vaccine clinic area, Benadryl 50mg IM given.  Rapid response called via overhead page. Patient taken to ER from vaccine clinic.  In ED, given  famotidine 20mg IV, methylprednisolone 125mg IV.
Day 7  Itchiness around injection site Day 8 3 inch diameter redness and selling at injection site
right thigh swelled really badly, turned really red, fever of 101.1 ,vomiting, and couldn't walk and couldn't put any pressure on the right leg. Still can't walk and is super swollen on 7/24/2020.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 (Lot number: FF8841, Expiration Date: 30Dec2021) at the age of 67 years as dose 3 (booster ), single for Covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "eye infection" (unspecified if ongoing); "it was a diuretic" (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN taken for anxiety; LISINOPRIL taken for blood pressure abnormal, start date: Mar2010; NIFEDIPINE taken for blood pressure abnormal, start date: Mar2010; LABETALOL taken for diuretic therapy. Vaccination history included: Bnt162b2 (Second dose: given on 17Mar2021, manufacturer: Pfizer, lot number: EP7534. Information is on a sticker on the card for second dose. Expiry: unknown. NDC: unknown. Given at the (Facility name) at drive thru in right arm.), administration date: 17Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (First dose:  manufacturer: Pfizer, lot number: EL9266, expiration: unknown. NDC: unknown. Information for first dose is handwritten on the card. Given at the (Facility name) at drive thru in right arm), administration date: 22Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Flu vaccine (He usually get flu vaccine but he was late getting to it and the flu season was over so he didn't get flu vaccine). The following information was reported: RASH (non-serious), outcome "not recovered", described as "He indicates that a couple of months after the booster dose he noticed that both of his palms are bright red"; ERYTHEMA (non-serious), outcome "not recovered", described as "Caller's got red/all of a sudden right to the finger tips is shiny red". The events "he indicates that a couple of months after the booster dose he noticed that both of his palms are bright red" and "caller's got red/all of a sudden right to the finger tips is shiny red" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient noticed it two months ago. He had a doctor's appointment lined up so he followed up there. The doctor said it looked like a chemical burn, but caller wouldn't have a chemical burn for 2 months.
Three min after vaccine,  pt started feeling SOB racing heart.  BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety.  Friend P/U to take her to ER.  BP 144/92
tension and heart palpitation, beginning 4 days after my vaccination and continuing after 2 weeks, tension builds during the day and diminishes overnight, palpitation is intermittent with no apparent pattern
Pt experienced vasovagal syncope within 1 minute of receiving her second dose of pfizer. She retained lucidity within seconds and immediately vomited. She regained color within two minutes of the event, was able to drink some fluids, and regained homeostasis thereafter. She stayed and was monitored for further reaction for 15 minutes but maintained equilibrium and her mom took her out to get breakfast and then head home.
After 5-7 days I noticed a mottling in the arm that was vaccinated  and  veins in that arm appeared pronounced and bluish and sore arm  noticed after a hot shower and disappeared about an hour later. This reaction persisted several days
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Pain behind lt ear, then pt devel high cervical transverse myelitis; lt Brown Sequard Syndrome
101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, severe body aches,. tender nodes in neck, felt very ill, slept 24 hours, no appetite, itching.. I have improved but still itching and have hedache
Positive COVID19 tests 10/6/2021 and 10/19/2021
several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;
This spontaneous report as received from a pharmacist concerning that dialysis formulation of RECOMBIVAX HB (lot # 669494/0191AA) might have been administered to non-dialysis patients (hospital employees) inadvertently. Pharmacist reported that it may be about 5 employees who might have received dialysis formulation (40 mcg/ml) rather than regular adult formulation (10 mcg/ml). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Information has been received from a pharmacist concerning a 69 years old female patient with no drug reactions/allergies and with high cholesterol, who on 30-SEP-2012 was vaccinated with a dose of ZOSTAVAX 0.65 ml SQ in her left arm (Lot # 0255AE, Exp: 14-MAR-2012). No other co-suspects were reported. Concomitant medications included: LIPITOR. On 02-OCT-2012 the patient presented to the pharmacy with pain and swelling in her left arm where the injection was given. Ibuprofen was administered as a treatment. The outcome of the events was reported as not recovered/not resolved. No laboratory diagnostic studies were performed. The patient sought medical attention - she spoke with pharmacist. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Had fever of 102 about 5 hr after 2nd shot, headache, nausea, arm soreness. Lasted 4 days. Did not report to anyone cause I heard it may happen.  I just had a slight fever and arm soreness for the first shot.
Patient was given high dose flu vaccine (Fluzone High Dose). However, the high dose is only approved for those patients that are >65 years old. Patient is not older than 65, and therefore not indicated to receive that high dose flu vaccine. Patient was indicated for regular dose flu vaccine (Afluria).
Information has been received from a physician concerning a pt who was vaccinated with a dose of hep B vaccine recombinant in a foreign country. The reporter was "not sure of exact hep B vaccine the pt had." Subsequently, the pt developed Guillain-Barré Syndrome and "returned home due to this." Upon internal review, Guillain-Barré Syndrome was considered an other important medical event (OMIC). Additional info has been requested.
she wiggled and part of the vaccine squirted out instead of going into her with no adverse event; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious case received from a physician via the Agency (Reference number- 00334083).  This case involves a 2-year-old female patient for whom it was reported wiggled and part of the vaccine squirted out instead of going into her with no adverse event (Incorrect dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2020, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ477AB, expiration date: 30-Jun2021) once via intramuscular route in the right thigh for Prophylactic vaccination.  On the same day, it was reported that the patient wiggled and part of the vaccine squirted out instead of going into her (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was also reported that she moved her leg and the medication came out. No adverse event was reported.  Details of laboratory data not reported.  Final diagnoses was incorrect dose administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv vax on 10/16/98; 4 hr post vax pt exp nausea, fatigue, limb soreness & headache
Patient called pharmacy on Sunday morning (6/23/2019). Patient is complaining of pain on the entire right arm and shoulder. The pain started shortly after vaccine administration. Patient states that she cannot sleep at night because of the pain, and she is not able to move the affected arm and shoulder. Pharmacist recommended taking Tylenol and Advil for pain and also instructed patient to see a doctor. Patient reports that doctor approved the pharmacist recommendation and said the pain could be due to the needle damaging a nerve. Patient will contact her family doctor on Monday morning. Pharmacist will contact the same doctor Monday (6/24/2019) morning.
Pt was asked to stay for 30min observation. Approximately 10-15mins post vaccination, client developed hives and began coughing  which progressively got worse. Fire/EMS on-site and attended to client. Client was observed for an additional 45mins and given Benadryl. No relief from benedryl and pt transported to ER via squad where she was observed and released. 5/6/21-per mother, the clients pediatrician was notified and advised that the client not receive the second dose of vaccine unless in a controlled environment. Pediatrician. Additionally, client had continued with cough while in school which required a visit to the nurse and use of inhaler times 2.
Patient has not had an adverse reaction.  Her son took the patient out of the nursing home facility and had her vaccinated (Moderna) but did not let the administrators of the facility.  We went out 2 days later and gave her another Moderna vaccine.  The first dose wasn't logged in portal for us to know this.
Shingles like rash on opposite armpit/shoulder area of administration, reaction started approximately 1 week after admin.
About 30 minutes post shot, pt returned to clinic with itchy throat & "possibly" tight chest. Seen immediately in Urgent Care. Received full "reaction" treatment.
c/o nausea, sensation in left rib, dizziness.  Paramedics attended to him.  Upon reaching client, client was oriented to TPP.  Communicative.  Client was transferred to Medical Center for further review.  Vitals by paramedics: O2 sat 99%, B/P 150/87, HR 80 BPM.
REDNESS AND SWELLING PER PATIENT DAY AFTER INJECTION. PT STATES WOULD LIKE TO SEE MD TO BE ON SAFE SIDE.
Patient's wife called on 10/6/21 stating that he began feeling bad at 8 pm on 10/5/21 after receiving his vaccine earlier in the day. She reported that he was having horrible chills, headache, and body aches. She said he is continuing to feel poorly as of 11 am on 10/6/21. She reports that he went back to bed.
After receiving the vaccines, the patient had 2 occurrences of vomiting and 4 occurrences of diarrhea. His parent contacted the patient's allergist who advised that he may be allergic to the gelatin in the Varicella vaccine and will test him for this at his next visit. They were advised to give BENADRYL every 6 hours until symptoms resolve.
Pt.'s Mother states that after receiving the 2nd dose of Phizer 09/14/2021, started experiencing symptoms 10/2021 of nausea and fatigue. Scheduled Appt. with Primary 12/20/2021.
I received the 1st dose around 6:30pm on Tuesday, by 3:pm on Friday I felt a "cold" coming on.  By that evening I had a 101 temperature  with aches and chills.  The next day, I felt like I had the flu and lost my sense of smell.  My head was congested to where I got a headache and the coughing started.  On Sunday, I lost my sense of taste and continually sneezed and blew my nose. Today has been over a week and my coughing is still here but much drier, I'm not as congested, but I still do not have my taste or smell back.   I want to also mention, that the mucus has been clear with no yellow or green tint at all.  I didn't seek medical treatment, because I never had difficulty breathing, until I called them this morning after getting my negative results and was instructed to report here.
6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax:  headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Approximately 40 hours after my shot, I experienced severe vertigo. I was bedridden for the remainder of the day and was unable to keep any food or water down. Due to the intensity of the vertigo, I vomited everything three times over the course of the day. There were no chills or fever, just vertigo, nausea, and vomiting.
Information has been received from a physician concerning a 14 year old female with a history of fainting who on 04-DEC-2007 was vaccinated intramuscularly with her first dose of Gardasil.  The patient fainted while in the waiting room after vaccination.  The patient was instructed to raise her legs, which she did.  She recovered the same day.  Additional information has been requested.
Received flu vaccine 10-15-15. Had (L) deltoid pain several days then relief. Pain in (L) deltoid area resumed as gradual dull pain and developed weakness and difficulty with range of motion. Difficulty in lowering arm. Difficulty lifting weight.
Consumer reports that grandchild recvd HIB titer/OPV & 2 days later had fever 102 which lasted x 2 days; @ time of immun, pt was being treated for bronchitis; & was near the end of the regimen of Amoxicillin;
This spontaneous report was received from a registered nurse refers to an adult patient of unknown age. On 30-SEP-2014 the patient accidentally was vaccinated with COMVAX, 1 mL, intramuscular (lot # was not reported) instead of a dose of RECOMBIVAX HB. No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
Patient complains of widespread rash over most of body but most notably on his arms. This rash is itchy and skin appears red, dry, and flaky. Upon speaking to a nurse in our infusion center, she believes this is a longstanding issue; however, the patient reports this has either appeared or worsened in the last 3 weeks since his second Moderna COVID19 vaccine. Patient took diphenhydramine but did not like the side effects so a provider recommended daily Claritin to start.
First Attempt- Inserted needle into arm, nurse said that the fluid didn't work getting injected into the arm. The needle and syringe weren't screwed together tightly enough and the vaccination liquid was dripping between the two. So we tried another shot as she was sure nothing ever got inside the shoulder.  Second Attempt -  To the patient, it was unclear if the second syringe was ever filled up with vaccination fluid or there was just an injection of the needle into the arm with no vaccine. (If there is an antibody test to check if the vaccine was administered correctly after these two errors, that would be preferred)
pt recvd vax & had arm was swollen between elbow & shoulder & sore to the touch; applied cold compress & took apap; swelling lasted 2 days;
The first night (same day I got the J&J vaccine) I had a fever of 101.5 degrees, tight chest, mild difficulty breathing, strong body aches, strong chills, a splitting headache, and I couldn't sleep that night. By morning the symptoms were gone except a felt very week and still had a mild headache. The headache got bad again by 10:00AM. And grew worse and worse until it was excruciating. I took 800mg of Advil, a muscle relaxant, and 2 hours later a Norco. Nothing reduced the pain. I stayed up and cried all night. I asked a relative to take me to the ER, but they were unwilling. In the early hours of the morning, it started to reduce. The next day I was weak, and I had a mild headache for the next 2 days.
ARTHRALGIA; FATIGUE; DIARRHEA; CRAMPS; FEVER; HIVES; This spontaneous case (PVX2019-1381) was received from a nurse on 30-May-2019. It describes a 49-year-old adult female consumer who experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif (one capsule every other day; lot no: 3003240) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-May-2019. On 25-May-2019, she had diarrhea, cramps, fever, arthralgia, fatigue, and hives. She reported that the hives were spread on her lower body part (either the consumer's legs or stomach). She did not have any respiratory symptoms along with the hives.   Treatment of the events included Tylenol (acetaminophen; 500 mg) (as needed) for fever and pain as needed.  The consumer's medical history included asthma, mild reflux and insulin resistance. She was allergic to Cipro and ibuprofen.   Concomitant medication included Zantac (ranitidine) for mild reflux, Claritin (loratadine) for seasonal allergies, Metformin for insulin resistance, and an oral contraceptive. The past medication included she received yellow fever vaccine on 10-Apr-2019 for yellow fever prophylaxis and experienced mild arm discomfort, several loose bowel movements (BMs) and some mild abdominal cramping on the same day. She also received an old injectable typhoid injection in 1991 and had a red arm and fever from it.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events diarrhea, cramps, fever, and hives on 28-May-2019 while the clinical outcome of the events arthralgia and fatigue was unknown.  Company's Comment: In this case, it was reported that the consumer had experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Vanishing Needle Leaked; received less than half dose; This spontaneous case was reported by a health care professional and describes the occurrence of DEVICE LEAKAGE (Vanishing Needle Leaked) and UNDERDOSE (received less than half dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DEVICE LEAKAGE (Vanishing Needle Leaked) and UNDERDOSE (received less than half dose). On 24-Mar-2021, DEVICE LEAKAGE (Vanishing Needle Leaked) and UNDERDOSE (received less than half dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medications were not reported.
NAUSEA, VOMITING, EXTREME ABDOMINAL CRAMPS, MUSCLE AND JOINT PAIN, DIARHEA, ANAL BLEEDING, EXTREME FATIGUE, FEVER, HEADACHE FOR 7 DAYS.  TINNUITIS-CHRONIC . LEFT EAR WENT DEAF -2 DAYS, RIGHT EAR PLUGGED -2 DAYS, FATIGUE - CHRONIC
p/2nd dose of lymerix pt exp severe local react; inj site red, swollen; & itching; tx w/benadryl & ice;
The patient felt dizzy after injection.  After the patient laid down and was given juice the issue was resolved.
I tested positive for Covid-19 on  03/15/2023. I experienced productive cough, fever, headaches, body aches, tiredness, loss of appetite.