chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to Clinic on 7/26/17 after injection with red warm to touch, swollen right arm, Acute care provider saw patient and recommended patient to go ED, patient went to clinic was given Predisone and Benadryl and released. We called patient back on 7/27/17 to follow up care, pt reports increased swelling, patient was scheduled to be seen in our clinic. patient's blood pressure at the time was low therefore, EMS was called. Patient seen at JPS ED with  possible sepsis.
I had extreme nausea, bone crushing pain, fever 100.2,chillshot flashes,sweats headaches, joint pain and chest pain. Also exp arm rash right arm at the injection site. The symptoms lasted 36 hrs.
FRIDAY, 7/9/2021: ONE HUGE MENSES CLOT IN MASS AND LENGTH. FOLLOWED BY CRAMPING. LASTED MINUTES.  SATURDAY, 7/10/2021: SLIGHT PELVIC ACHE RANDOMLY THROUGHOUT DAY.  SUNDAY, 7/11/2021: AT 6:10 AM, TWO SMALLER MENSES CLOTS COME OUT. PELVIC ACHE ALL DAY.
Extreme pain in the arm that vaccine was administered. Unable to use arm for days due to pain. Still currently having shooting and throbbing pain in arm.
Mild flu like symptoms re fever up to 100.5, chills, and headache beginning about 12 hours after second dose and then lasting 24 hours
I received my flu shot on 10/6 after discussing pros and cons.  I experienced shoulder pain and soreness the next day which I knew was expected; however the pain has never gone away.  I am unable to sleep on my left side and the pain at night worsens.  I can't raise my arm straight up, hurts to rotate the arm.  I've used Tylenol Rapid Release, CBD Pain Cream nothing helping.  I contacted my PCP on 10/22 and saw him on 10/23.  I was referred to Physical Therapy but can't be seen until 11/3.  He mentioned that this is a rare side affect. (SIRVA) Should Injury Related Vaccine Administration.
Vaccine administered after cut-off time (6:00am) No adverse events reported per patient.
red rash and swollen arm at injection site.  Muscle aches, extreme soreness throughout upper back,  and ribcage on both sides
2wks p/vax pt devel hives (torso, arms, & shoulders) when this subsided had small chicken pox-like break out in same area these have left litlle scars
pt recv vax 22NOV96 & 23NOV96 pt exp a 1inch lump across which p/24hr became an indurated patch 3x5 inches on arm, fever, chills, sweating & pruritus;
The patient presents with Shortness of breath. Pt reports to have taken her oxygen saturation at home and was noted to be hypoxic. Pt is currently COVID-19 positive, states she tested positive yesterday. Pt is not anticoagulated. PMHx significant for HTN, PE. Pt denies chest pain, cough, nausea, vomiting, fevers, chills,  and all other acute systemic symptoms.  The onset was Few days ago. Patient is a 75-year-old female with history of hypertension, hyperlipidemia, prior stroke and borderline diabetes presents the ED with worsening COVID-19 symptoms.  Patient states she has been feeling ill for the past week.  She tested positive for COVID infection yesterday.  She reports a mild cough but significant shortness of breath.  She denies any fevers or chills.  She denies any nausea, vomiting or diarrhea.  Husband is also sick with COVID infection.  She had 1 Pfizer COVID vaccination last week.  Patient was monitoring her O2 sats and says they were dropping into the 70s at home.  She was initially on 10 L nasal cannula has since been transition to 60 liters/minute high-flow oxygen in the ED.  Laboratory studies are generally unremarkable other than sodium of 133, and a lactic acid of 2.2.  Her chest x-ray shows multifocal ground-glass infiltrates consistent with COVID pneumonia.  CT of the chest is negative for pulmonary embolus.  She does have moderate to severe bilateral ground-glass opacification and developing consolidation consistent with her known COVID pneumonia.
Patient stated he started having trouble breathing and became shaky about 5 minutes after the vaccine was given. An epipen, gatorade, and an icepack were given to the patient, and he immediately started feeling better.
Fever started a few hours after injection and became very high the morning after, lasted till about 5 pm the day after injection and then went away. Dr did say it will last a short time and go away.  Muscles and joint ache. No other symptoms like one would have with cold or flu (i.e., no runny nose, throat pain, etc. Took 2 Tylenol pills ever four hours.
COVID-19 vaccine booster given too early. Patient is 14 years old. The booster is not authorized until 16 years of age.
No adverse outcomes. Moderna vaccine was given to a 16-year-old, when only approved for 18 and over.
On December 30th my father tested positive for COVID.  He was reported asymptomatic by the care facility staff. He was given vaccine on Jan 14th and began feeling ill that evening. The morning of the Jan 15th the nursing facility had my father admitted to emergency and then to ICU. He stayed in the hospital for 10-14 days and then was released on hospice at the senior care facility. He passed away on Jan 31st.  I'm not sure if the sudden change in my father's health was due or made worse due to the COVID vaccine as the hospital was treating several symptoms,  but the timing seems suspicious. I have also not been able to get an explanation for why he was given a vaccine if he tested positive.  I do not know which vaccine was given, but needed to select one to submit the form.
7MAY fever, emesis; 8MAY sz generalized, for 1 minute w/fever;
chills; fever; loss of appetite; This is a spontaneous report received from a contactable reporter (consumer), Program ID. The reporter is the patient. A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Sep2023 as dose number unknown, single (lot number unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2023, outcome "unknown"; PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "fever"; DECREASED APPETITE (non-serious) with onset 2023, outcome "unknown", described as "loss of appetite".  Additional Information: The patient received the RSV vaccine on 23Sep2023 and experienced chills, fever, and loss of appetite. The patient asked how long symptoms subside from these adverse side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Had heart palpitations after 12+ hours of receiving the 2nd dose of Pfizer COVID-19 vaccine. I was sleeping and it woke me up in the middle of the night at around 215am, where my heart rate was in the 200s (I was in SVT). I then drank a liter of water and then urinate which helped me calm down. I also took Tylenol to help alleviate my pain. I was also sweating profusely.
soreness and difficulty for moving the arm in which she got the shot.; pain; her elbow is killing her; her elbow was sore and she can't lift anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jun2021 (Lot number: EW0178) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EWD182., anatomical location: left arm, Time the Vaccination Was Given: before noon), administration date: 30May2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "soreness and difficulty for moving the arm in which she got the shot."; PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "pain"; JOINT INJURY (non-serious) with onset Jun2021, outcome "not recovered", described as "her elbow is killing her"; MOVEMENT DISORDER (non-serious) with onset Jun2021, outcome "not recovered", described as "her elbow was sore and she can't lift anything". The events "soreness and difficulty for moving the arm in which she got the shot.", "pain", "her elbow is killing her" and "her elbow was sore and she can't lift anything" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, pain, joint injury, movement disorder.  Additional Information: Additional vaccines administered on same date was reported as none. Prior vaccination within 4 weeks and adverse events following prior vaccination was reported as none. The patient reported that that she is now feeling pain, soreness and difficulty for moving the arm in which she got the shot. Her left arm and her arm was fine before the shot and after the 2nd shot back on 20Jun2021, her 2nd dose, her elbow she can't even lift a cup. States her elbow is killing her and her doctor told her it's normal and it will go away with time. The patient stated she tried ice and heat and she did put a TENS meter, she put the pads on to see if that would help and it did not and she did that for a couple of days in Nov when it started getting worse.  No follow-up attempts are needed. No further information is expected.~
Pt received second dose of Moderna and was instructed to be monitored for 30mins by provider.  Within 20mins, pt c/o dizziness.  VSS.  Pt waited an additional 10mins.  Pt was stable and stated that they felt ok at the end of the intended observation time.  Pt stable and released from the vaccination site. Medications: unknown to this writer PMH: Neurofibromatosis, type 1       Allergies: none
Peculiar taste in mouth/bitter taste in mouth; Altered taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth). At the time of the report, DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they received first, second and booster dose of Moderna COVID-19 vaccine and shortly after receiving the booster dose, they began to have peculiar taste in mouth, altered taste in mouth, and bitter taste in mouth.
On 2-19-09 donor reported a rash she developed following a Hep B injection she received on 2-17-09. Rash on 2-18-09 stretched across abdomen and up into axillary on Lt side. Rash occurred the evening of the injection.
he was given Fluzone quadrivalent subcutaneously with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00329501) and transmitted to Sanofi on 23-Oct-2020.  This case is linked to case 2020SA301398 (same reporter).  This case involves a 3 years old male patient who received 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number: UJ533AA and expiration date: 30-Jun-2021) via subcutaneous route at an unknown administration site for prophylactic vaccination on 20-Oct-2020.  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to Inappropriate route of vaccination.  At the time of reporting, no adverse event was reported.  Disclaimer: 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 or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
Patient with reports of severe chest discomfort 2 days after 1st pfizer vaccine.  Found to have elevated troponin in the 5's.  Coronary CTA ruled out ACS.  Dx = Myocarditis in setting of recent Pfizer vaccination.
Extreme pain to injected arm a few hours later lasting for about an hour, arm sore to the touch for two days, feverish feeling and body aches 12 hours later.
About 2 hours after the shot my lungs started  rattling then I had trouble breathing.  I used my rescue  inhaler  several times do I could breath as I could not get my breath. Then a fever and head started to tingle.  I feel as if I have covid again or the flu and in the night I felt so sick that I was going to die.
Significant burning during injection- resolved 1 minute after injection 2 hours post injection subdermal linear hyperpigmentation at injection site- still present 01/14/21- no treatments
developed "scratchy throat" on 12/26/21- tested positive for covid on rapid home test
17Oct03, 1015 a.m.. + rash and swelling to neck, arms and legs bilaterally. denied difficulty breathing initially. given 25mg Benadryl. Symptoms subsided. At 1430, member came back to medical with reoccuring symptoms. Transported to hospital for further evaluation. Symptoms subsided in waiting area and no further treatment rendered.
Patient was erroneously given the wrong vaccine. Management, provider and patient was notified immediately. Provider consulted patient and then correct vaccine administered.
patient reports when she woke on 6/5/20, she "could not see" and "had black in front of my eyes and white spots" No LOC, patient laid down and felt better
Red dot at the injection site; She describes the area as bright red bulbous blood blister wart type area; it grew to large size as bold as blood vessel; She describes the area as bright red bulbous blood blister wart type area; The area was nicked and began to bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 26Jan2022 (Batch/Lot number: unknown) at the age of 12  as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization.  The following information was reported: HAEMORRHAGE (medically significant) with onset 2022, outcome "unknown", described as "The area was nicked and began to bleed"; VACCINATION SITE RASH (non-serious) with onset Jan2022, outcome "recovered" (2022), described as "Red dot at the injection site"; VACCINATION SITE VESICLES (non-serious), SKIN PAPILLOMA (non-serious) all with onset 2022, outcome "unknown" and all described as "She describes the area as bright red bulbous blood blister wart type area"; VACCINATION SITE SWELLING (non-serious) with onset 2022, outcome "unknown", described as "it grew to large size as bold as blood vessel". The events "the area was nicked and began to bleed", "red dot at the injection site", "she describes the area as bright red bulbous blood blister wart type area", "it grew to large size as bold as blood vessel" and "she describes the area as bright red bulbous blood blister wart type area" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of haemorrhage, vaccination site rash, vaccination site vesicles, vaccination site swelling, skin papilloma.  Clinical information: Patient who was seeking information on a adverse reaction her 12-year-old son experienced with the Pfizer Covid 19 vaccine booster dose.The mother and son both received the booster dose injection on 26Jan2022. The mother only experienced a red dot at injection site that eventually went away. Her son she states had a red dot at the injection site that was only a small red dot for 5 weeks after injection. She states that at week 5.5 or 6 the dot grew seemingly overnight. She describes the area as bright red bulbous blood blister wart type area. She states that it didn't hurt but grew. The area was nicked and began to bleed. She reports that it bled for over 2 hour straight. He was taken to the ER and has also seen his pediatrician twice since then for this issue. The pediatrician does not know what the area is. She states that everyone at the doctors over was concerned with the area and stated that they had never seen something like this. Patient had not taken any prior vaccination within 4 weeks. The patient had not taken any medication for treatment.  The lot number for bnt162b2 was not provided and will be requested during follow up.
103 F fever, sweats, large (15cm diam) localized erythematous skin reaction at point of injection.
pt became ill 7FEB97 w/t102 os;given Ibuprofen @ that time q 6hr;became ill 3PM;taken to hosp t105;last dose of Ibuprofen was given 9AM;pt recv Ibuprofen/APAP rotating q 4hr since ER visit;11FEB97 mom reports pt doing fine now;
Low-grade fever, achy, fatigue next day. Recovering on day 2. Day 3 began menstrual-like cramps in lower back (though I am menopausal), loss of appetite, fatigue. Cramps continued for about 48 hours, then gradually began to improve, though still experiencing some lower back cramps on day 7.
Pt woke up with throat closing/swelling and sore. pt also reported hives on whole body, itching in the middle of the night. the next day the hives were more isolated predominantly on the chest, neck and head.
Three months later, I woke up what I thought it a bad cold, congestion, headache, body ache, low fever (101 degrees). I took a COVID-19 test and it was negative, I took another test on Monday and it was positive; I called the doctor and she prescribed PAXLOVID for 5 days, I took another one yesterday and it was negative.
Patient felt light headed, her vision went dark, felt n/v, hot sweaty . we have her sat on the floor, got her some water and some pretzels. She felt better after awhile and begin to feel better after .
Patient experienced bloody mucous when blowing nose 3 days post vaccination for dose 1 and 2, with duration of 2-3 days.
Fever up to 102.5 three hours after getting immunizations. 2 days later developed redness, swelling and increased warm in the same arm. Redness extends from site of inject to elbow. Fever has persisted without any URI symptoms  Patient also previously had febrile seizure after Dtap immunization 2 years ago prior to coming to our office.
Nearly fainted morning after vaccine after rising. Dizziness and lightheadedness. Nausea and sweating. Tingling in fingers. Episode lasted about 10-15 mins followed by chills and fatigue.  Slept for about two hours. Less severe episode upon rising again. Felt headachey, tired, and feverish throughout day and day after.
vaccine was shipped on 30-Oct-2019 and delivered on 04-NOV-2019, had a shipment delay, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA308921, and 2019SA309165 (same reporter).  This case involves a 72 years old female patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020) via intramuscular route in the right deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, 1 dose of Fluzone Quadrivalent and 3 doses of Fluzone High Dose had been administered to patients.  At the time of reporting, no adverse event was reported.  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.
Felt like crap; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like crap) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CEFALEXIN (CEPHALEXINE), TRAMADOL, FENTANYL, LOVASTATIN, CYCLOBENZAPRINE, CLONAZEPAM and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like crap). At the time of the report, FEELING ABNORMAL (Felt like crap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-025545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-jun-2021 , contains no new information
Patient came to pharmacy for vaccinations: shingles and flu. The patient claimed she had COVID shot ata couple months ago so the technician double checked in and there was no proof of vaccination. Consequently, based on the technician's depth of research the patient was informed that there was no evidence of having her COVID vaccine done. Therefore, the patient was setup for a COVID vaccine (Pfizer) to be done today. I, the pharmacist, proceeded to prepare and administer vaccinations to patient. After giving the patient her covid vaccine I showed her the vaccination record card and she immediately responded saying that she has the vaccination record card already. I informed the technician of the event and at that point the technician looked up patient's history. We found that the patient did receive COVID vaccinations (Moderna).
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare office consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
4"x4" area of induration, erythema left posterior upper arm tender to touch warm to touch, no drainage, no streaking (afebrile), tx: cool compress, ibuprofen, Keflex 500 mg once po tid x7d