chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection site; injection site swelling; injection site redness or swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old male patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: ff259oh) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "pain at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 08Oct2021, outcome "unknown", described as "injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Oct2021, outcome "unknown", described as "injection site redness or swollen". Additional event: Complete user utterance for AE: immediated pain at the injection site, followed by injection site swelling, followed by injection site rednessinjection site pain, injection site swelling, injection site redness or swollen   No follow-up attempts are possible. No further information is expected.
Day #1 after vaccine vague pruritus then myalgias, redness at site. Day #2 Presyncope in hot shower. Worsened myalgias. Severe achiness. No fever. Day #3 Myalgias resolving. Redness at site spreading with increased localized tenderness.
Covid Infection; Covid Infection; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 22Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Drug Allergy: Demerol"; Darvon, reaction(s): "Drug Allergy: Darvon"; Darvocet, reaction(s): "Drug Allergy: Darvocet". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022 at 19:00, outcome "recovering" and all described as "Covid Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Negative, notes: Nasal Swab; (07Jul2022) Positive, notes: Nasal Swab; (09Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. Covid tested positive post vaccination. Facility type vaccine: Pharmacy or Drug Store.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced metallic taste in her mouth once vaccine was given.  Metallic taste left approximately 3 minutes after does was administered.  Client was cleared by EMS.
chest pains; heavy feeling on his chest; anxiety; The physician doesn't feel that the patient should get the second shot; This is spontaneous report from contactable consumer (patient's friend). A Nearly 20-year-old male patient of unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via unspecified route of administration, on an unknown date, as a 1st dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient felt upset and experienced chest pain, it was some kind of like heavy feeling on his chest. The nurse called it anxiety which was wrong and should have notified by the physician. After a few days, on an unknown date it went away on its own however the patient wanted to receive the second shot. It was reported that the reporter told to the patient to inform the doctor and do not take anything until speak to physician. On an unknown date, the physician said he needs an electrocardiogram (EKG) and may not be able to take the shot. The Patient underwent EKG and the results were fine. However, the patient was supposed to go back in a week. The physician also said if there was a slight problem, to call and will see the patient immediately. The physician also mentioned that there was a special meeting on with the doctors and pharmacy people, since 200 patients have been affected by this and 2% have been landed in the hospital with serious conditions. The physician doesn't feel that the patient should get the second shot. The patient also stated that he thought the Pfizer shot was the better shot. However, it may not be good for the younger people. The patient would like to reach out to him on this and wanted to know what was going on and what was this meeting supposed to accomplish and where was it being held and it should go on the news. The outcome of the events chest pain and Circumstance or information capable of leading to medication error was unknown. On an unknown date, the events anxiety and chest discomfort were recovered.  Information on the lot/batch number has been requested.
Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; bad arm swelling and pain; bad arm swelling and pain/leg pain; not feeling well having severe back pain; not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events in two patients. This is the second of two reports. A 67-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included vitamins nos. It was reported that the patient as well as the reporter had bad arm swelling and pain. By Wednesday the patient was not feeling well he was having severe back pain and leg pain and what not. At first they just thought it was a reaction as they read reactions could be and then the reporter started to get small cough but by Friday the patient went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday they both went and got tested, they did the rapid and what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. The patient underwent lab tests and procedures which included Rapid and PCR: positive on Jan2021. Therapeutic measures were taken as a result of bad arm swelling and pain, not feeling well having severe back pain and leg pain which included treatment with Tylenol. The outcome of the events was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092066 same reporter and drug, similar events in a different patient
within 2 weeks of 2nd dosage I started feeling nerve pain in left side of face. Also suffered from headaches and severe fatigue. over the next 3 months the pain got worse until I sought out my dr in early December.  By early January I lost all movement in left side of face. Was sent to Otylarangoloy dept at Mecical Center. Was told I had Bells Palsy, possibly due to reoccurance of shingles or another virus. I was told the use of my left face may or may not return. Now, In July, 7 months later I am still fully paralyzed on left side of face. My left upper lip and nostril are pushed to the right and I cannot lift left eyebrow. I feel this happened due to the vaccine due to the fact that I was staying at home due to covid and when I went out I wore a mask
Patient began hyperventilating after receiving vaccine. Observed by provider on site. No intervention required. Parent stated that this has happened previously with other vaccines.
From initial information received on 11/21/03 from a pharmacist regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of FLUZONE, lot number, route and site of administration not reported, on 11/14/03. That night, the patient developed soreness in his arm and shoulder. The Monday following vaccination, the patient developed a local rash around the injection site, some redness to the arm down below the elbow, and generalized pain between his shoulder and elbow. By 11/18/03, the rash was spreading down to the arm and on the chest and the child complained of many aching joints. The child was taken to a physician and received prescriptions for Zyrtec and Oraped. He also had some wheezing, but does have a history of asthma and normally takes Proventil syrup. By 11/20/03, the rash was getting worse and his joints were painful and swollen down to the knees. The child also had a swollen neck and slurred speech. He was brought to the emergency room and was admitted to the hospital. The patient's recovery status was not reported.  Please note the original date of vaccine!!!  If I sent anything to you only a year ago it was because you continued to pester us about the reaction and I probably told you we have no idea.  This is the inpatient pharmacy which oversees patients coming through the E.R. and we have no continuing contact with patient.  It is a wast of tax dollars for you to continually contact us about this matter.  Patient's physician is the only one who may know.  Per 60 day follow up: 60 days someone from your office contacted me! If you will please note I contacted you 3 1/2 years ago when the incident happened. I have no clue what happened to the child. Seems this is a little late to be following up!
Dizziness SITE INJECTION PAIN Narrative: PATIENT. REPORTS INTERMITTENT DIZZINESS. REFERRED TO PCP. PATIENT REPORTS THAT SHE WILL DO TELEHEALTH VISIT WITH PCP. PAIN IN INJECTION SITE THAT HAS IMPROVED.
Approx: 4-5 mins after giving injections pt had seizure involving all extremities lasting less than one min. Pt layed down cold compress applied to forehead O2 given to pt. Pt remained in our office for 1 hr after.
?Moderna COVID-19 Vaccine EUA  Approximately one week later patient developed hives and intense itching,
Left deltoid swollen, hard and red 5 hours post vaccination. Developed hives all over body. Seen by PA on 10/18/2017 diagnosed with Erythema Multiforme.
90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm weakness. she could not lift her arm above her head. she then developed severe dull, aching pain. the pain became sharp with movement. she could not sleep because of the pain. no redness or edema at the injection site. she is slowly regaining strength and range of motion in the arm, however the pain still remains and full strength has not returned.
Information has been received from a health professional concerning a 12 month old male who on 2/14/01 was vaccinated with varicella virus vaccine live. On 2/25/01, the pt developed a fever, irritability, varicella-like rash of 25-50 spots, "purplish flat lesions (resembling petechiae) on his face". On 2/26/01, the child was seen by the physician and was admitted to the hospital because of the purplish face lesions and the concern about possible sepsis. Sepsis and bacteremia were ruled out during the hospitalization. The pt's hospital course was uncomplicated and he was discharged. The discharge dx was probably "allergy to (varicella virus vaccine live). "The child is being treated at home with Benadryl every 6 hours. He was seen in the physician's office on 3/1/01 and all signs and symptoms had resolved with the exception of the facial lesions. The facial lesions were improving, but were not completely resolved. Additional information has been requested.  Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided."
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Constant Fibro flare,  Joint and muscle pain along with fatigue that won?t go away.
Sudden tiredness, stomach cramps, light-headed, dizzy, nausea, vomiting, diarrhea.
Patient fainted approximately 5 minutes after vaccine was given. She fell to the floor but was immediately conscious and able to answer questions. She was able to get up and sit in a chair. EMS was called and responded, patient declined transport to hospital. Vitals stable. She reports having fainted once after a blood draw. She was sweating, lethargic, and pale, but remained at the pharmacy for about 30 minutes, at which time she was feeling and looking much better.
Awakened at 10 am, incredibly itching hands, then hives up to elbows, hands and arms swollen, lip swollen, face swollen, and throat discomfort. When it first started I took BENADRYL, but it got much worse. I got out my EPIPEN (bee allergy) and went to ED. There they put in an IV and gave me BENADRYL and PREDNISONE. I went home with a prescription for PREDNISONE. The hospital report says adverse drug reaction, allergic reaction, anaphylactoid response.
Some symptoms she had at the time were: very fussy, high fever (104), bad skin rash, whelp where shot was given. Gave Childrens TYLENOL as suggested by doctors office, but she's had issues ever since then.
He had TDAP without issues 9/09 - but he developed PCR (+) Bordetella Pertussis 6/10.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-MAY-2015, the patient was treated at a hospital (it was not specified whether she was admitted; therefore, considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 15-JUN-2015, the patient was vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Client verbalized watery right eye without pain or discomfort.  Client evaluated by Rescue Paramedics onsite.  Client was observed for additional 15 mins.  Client released by Paramedics at 10:05 am after symptoms were resolved.
Received shot during period. i have had  a very regular menstrual cycle - to the day - and now, no period Since April 10, 2021. Onset of hot flashes and what appears to be sudden early menopause. Blood work dpne by my doctor shows nothing conclusive.
Pain, redness and swelling at injection site.  Diagnosed as cellulitis by physician who told the patient the pharmacy should be notified. Treated with cephalexin 500mg and methylprednisolone 4mg dose pack
patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer bivalent booster (34 days ago, patient received a Pfizer bivalent booster) and Pfizer (Pfizer primary series). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer bivalent booster.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster).    No concomitant information was reported. No treatment information was provided.
Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: El3247), via an unspecified route of administration, administered in Gluteus Medius Right on 31Jan2021 as single dose for an unspecified indication. Medical history included AFib, sleep apnoea, high cholesterol and drug allergy to Sulfa. Concomitant medications included apixaban (ELIQUIS), diltiazem (trade name not reported), atorvastatin (trade name not reported), paracetamol (TYLENOL) and melatonin (trade name not reported). The patient previously took atropine and experienced drug hypersensitivity. The patient experienced burning pain in left buttocks area, researched and thought it was a sciatica issue. Could not lay down, bend over or put weight on that leg. Used alternately ice and heat. No fever. Pain lasted over 48 hours on 31Jan2021 16:00. The outcome of the event was recovering.
MUSCLE TIGHTNESS; ACHES; FELT PRETTY CRAPPY; NAUSEA; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced muscle tightness, aches, felt pretty crappy, nausea, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt pretty crappy, nausea, muscle tightness, aches and tiredness was not reported. This report was non-serious.
Administered GARDASIL vaccine first and patient was fine. Immediately after administering MCV4 vaccine, patient fainted. Was unconscious for less than 5 min. When regained consciousness, war oriented to person & place, BP monitored. Gave patient juice and crackers. Patient did not eat breakfast before coming to clinic for vaccines. Patient reports that she has fainted before when getting blood drawn. Advised to follow-up with primary MD. Patient transported home by family member.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Dizziness, jaundice secondary to acute hemolytic anemia,  COVID-19 POSITIVE
Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of pre-syncope.
Sore arm. Can't lift arm up. Weakness, fever 100. Fainted.
No adverse events noted. After administration of 2nd Moderna COVID-19 vaccine. data entry staff noted that patient received Janssen COVID vaccine prior to starting Moderna series. Janssen vaccine given 4.27. 1st Moderna administered 4.29. 2nd Moderna administered 7/1.  Janssen vaccine was not disclosed prior to Moderna administration, and given by another health center.   Report submitted for record keeping only.
I was having a runny nose and congestion. It felt like the common cold. I took a COVID-19 Home Test on both Sunday and Monday and they were negative but that third day I did test positive. I reached out to my healthcare provider and they gave me Paxlovid to help with symptoms. The medication helped after about three or four days in. I am still quarantining and waiting to take another test to see if I am negative until I get to that week or ten day mark.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
rpt from anonymous person concerning pt who was vax & exp slight fever, tx w/tylenol; pt found dead next morning; COD unk; the rpt stated info was recv as "hearsay'' through small town grapevine & cannot be verified.