chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling the size of a golf ball, it was not at the injection site by further down the arm.
Approx 4 hours after receiving vaccine, developed swelling in face (eyes, nose, cheeks, ears) and painful red rash hot to the touch localized only to face and ears (did not spread to neck).  Feels very much like a severe sunburn.  Almost 24 hours after vaccination, rash condition persists.  Have additional normal side effects as well:  itching, headache, flu-like symptoms, lethargy, but no fever anywhere else on body except for face and ears.
had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021; had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162B2 (Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 05Mar2021 at 10:30 AM at age of 45-year-old at single dose for covid-19 immunisation. Medical history included hypertension. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine received. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Concomitant medication included amlodipine besilate/ benazepril (5-40mg). The patient had COVID symptoms on 20Mar2021 and diagnosed with COVID on 22Mar2021. Lab tests and procedures included Lumiradx sars cov2 ag test (nasal swab) on 22Mar2021 showed positive. No treatment was received for the adverse event. The outcome of event was unknown.  Follow up are needed. Information of lot/batch number available.
Pt c/o chest pressure and left arm numbness starting within 10 minutes of vaccination.  Assessed by onsite RN and supportive care given.  Pt declined EMS and taken to Urgent CAre by a friend.  Diagnosed with anxiety.
Severe shortness of breath, Severe body ache, Severe fatigue, Sent by ambulance to the hospital ER.
sore throat; fever/low-grade fever; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had the first vaccine last month (pending clarification) then experienced sore throat and fever. The patient mentioned, "I got the Pfizer vaccine on the sixth which is Wednesday (pending larification) and over the weekend before that, it was new year's eve we went camping, of course, we were outside but we had canopy because it was raining and there were people keep showing off but I never had any symptoms or I've never heard from anybody that they have symptoms but since I had a sore throat even before so like a week and a half now, but since I got the vaccine I had a low-grade fever." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Seen by doctor in another city; had red, fine rash on trunk of body, lasting 4 days.
Approximately 8 hours after the vaccination I begin to feel itching, burning sensation in my left wrist area surrounding the site of the surgery on Jan. 4 for skin cancer.  This increased over the next few hours and by the next morning my lower forearm was involved.  The surgical site was about 2 inches long, stitches had been removed ten days before and the wound was mostly healed.  The rash extended from the wound site toward the wrist about 2 inches, radiated laterally along the length of the wound about 2 inches on either side and up into the upper forearm another 3 inches.  There were small blisters within the rash as well.  I initially tried a cortisone cream I had left over from a previous wound.  This seemed to inflame the rash even more and I stopped.  I then applied some of the antibiotic cream I used when the wound was fresh and actively treated.  This seemed to reduce the inflammation some.  After 2 days I contacted my dermatologist who prescribed Triamcinolone Acetonide 0.1 % External Cream.  I have been taking this for 24 hours, 3 applications and the rash is beginning to dissipate.  My dermatologist  indicated I was the third patient to have a rash on the same arm with a surgery and a Moderna shot, in the same arm.
Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second 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 25-Feb-2021, the patient experienced PAIN (Body ache). At the time of the report, PAIN (Body ache) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Site: Pain at Injection Site-Severe, Systemic: enitre arm pain to the point of TEARS and unable to use arm day 2-Severe, Systemic: Headache-Severe, Additional Details: Day of Vax = Arm pain in upper arm..but NEXT DAY = entire Arm pain / unable to move it arm at all with Severe Migraine (" I get headaches but never migraines") ...pain level enough to make me cry.
Entire upper torso turned red and mottled. Itchy. Was given benedryl by anesthesia.
Vaqta administered to 2 month old child; no additional adverse effects; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) injection (dose, route of administration, lot number and expiry date were not reported) for prophylaxis. No additional adverse effects were reported.
Syncopal episode after receiving TDAP, MENACTRA, FLUMIST, HEP A.  Regained consciousness after few seconds.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Apr2021 as dose 2, single (Lot number: 04B21A) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2000; MONTELUKAST, start date: 01Jan2020; LORATADINE, start date: 01Jan2000; AMLODIPINE, start date: 01Jan2020; FAMOTIDINE, start date: 01Jan2020; BUPROPION, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (24Jul2022) Negative, notes: On 24Jul2022 covid test was negative; (25Jul2022) Positive, notes: On 25Jul2022 woke up with a sore throat, the covid test is positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical information: COVID-19 Treatment included paxlovid from 15Jul2022 to 20Jul2022. Other medication in 2weeks included levothyroxine, Montelukast, loratadine, amlodipine, famotidine, bupropion.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported events Vaccination failure , COVID-19  cannot be completely excluded based on temporal association and known drug safety profile
Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine; had the COVID vaccine at least the first one, it was Moderna, uh she started in Feb; Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine; she went 2 days without the medication and had a migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): AGN278931 (Allergan).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; atogepant (ATOGEPANT), since Oct2021 (ongoing) (Lot number: W05836, Expiration Date: Nov2023). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid 19 vaccine (COVID vaccine at least the first one, it was Moderna, uh she started in February), administration date: Feb2021, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 2021, outcome "unknown" and all described as "Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 2021, outcome "unknown", described as "had the COVID vaccine at least the first one, it was Moderna, uh she started in Feb"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "she went 2 days without the medication and had a migraine". The action taken for atogepant was dosage not changed.  Additional information: Her issue was she was on the Qulipta, this is for Qulipta, uh she was taking the Qulipta for 12 days, and then um she uh she started in mid october, she went 2 days without the medication and had a migraine. She's now been back on it for 1 week. The lot number is W05836 and the exp date is Nov2023, 2023. Patient had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine. It was unknown whether the patient was pregnant and breastfeeding. The patient did not hospitalized or was hospitalization prolonged as a result of the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown demographics. On an unknown date in February 2016, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) to prevent shingles. On an unknown date in October 2016 (reported as "about a month ago"), the patient developed a mild case of shingles. The outcome of the mild case of shingles and the relatedness between the mild case of shingles and ZOSTAVAX were not reported. Additional information has been requested.
luer-lok broke during preparation and injured the employee preparing the vaccine; luer-lok broke during preparation; Initial information received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves an unknown age and unknown gender patient where luer-lok broke during preparation and injured the employee preparing the vaccine and luer-lok broke during preparation after receiving vaccine influenza quadrival a-b vaccine [Fluzone qiv].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date in Aug-23, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UT8069MA) via unknown route in unknown administration site (dose, strength and expiration date : not provided) for Immunisation.  On an unknown date in Aug-23, the luer-lok broke during preparation and injured the employee preparing the vaccine (accident at work) and luer-lok broke during preparation (product quality issue) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (luer-lok broke during preparation).  At time of reporting, the outcome was Unknown for the events.
Flu-like symptoms - headache, body aches, chills, slight fever, nausea.  Lasted about 8 hours. After about 4 hours, took 1 ibuprofen. Symptoms continued for another 4 hours then subsided.
Information has been received from a physician concerning a 12 year old female patient, who in 2010, was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). Physician stated that during an educational program in a nearby school, the patient approached her to relate her experience after receiving the first GARDASIL injection. The patient fell into a coma-like state and was hospitalized for treatment (date unspecified). Physician reported that the reaction occurred within an hour of the injection. It was reported that the therapy was discontinued and the patient was not reintroduced. At the time of the report, the patient's outcome was recovered (unspecified date). The office contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number, date of event, hospital name, and healthcare provider name and contact information. Additional information is not expected.
The patient had Chills; The patient had Fever; The patient had Headache; The patient had joint pain; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (The patient had Chills), PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 029L20A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 2 UNK. On 03-Feb-2021, the patient experienced CHILLS (The patient had Chills). 03-Feb-2021, the patient experienced PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain). At the time of the report, CHILLS (The patient had Chills), PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Implant), the reporter did not provide any causality assessments.   No Concomitant medicines were provided. No treatment information was provided.
Initial unsolicited report received from a nurse on 31-Oct-2017. This case involves a female patient (age between 30 to 90 years), who was vaccinated once with 0.5 ml FLUZONE QIV) via intramuscular route (batch number: UT5899LA, expiry date, dose in series and site of administration not reported) in arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the experienced severe arm pain following vaccination. Arm pain was so severe that it was difficult to move the arm. Lab test was not reported. It was reported that PARACETAMOL (Tylenol) did not help reduce the pain and were given OXYCODONE (Oxicodone). Patient may also took METHYLPREDNISOLONE ACETATE (DEPO-MEDROL INJECTION) 31-Oct-2017, patient's events were resolving. Documents held by sender: none.
severe vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP patient's granddaughter).  A 83 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 20:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 25Mar2021, outcome "not recovered", described as "severe vomiting".  Additional information: Report is not related to a study or programme. When ask to report caller states she would rather spend that time calling the doctor and she doesn't have time right now to report. No further information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever, body aches, malaise, irritability, lightheaded, sinus infect, congestion 4mo duration;
Patient started to slump in chair - RN observers attended to patient and alerted Lead to situation - STAT team called overhead.  Pt appeared distressed and SOB, leaning over - coarse LS were audible - VS taken 142/82 HR103 SpO2 98%,  as EpiPen administered into L thigh upon rapid assessment followed by 25mg IM Benadryl per protocol. ED STAT team arrived approximately 2 minutes later - who immediately transported patient to the ED for evaluation and treatment.   Chart review indicates patient further treated with Solu-Medrol, fluids and pepcid.  And released after 1400 with no further s/sx.
Hallucinations; Wanting to speak but couldn't speak; out of body experience; This is a spontaneous report from a contactable consumer, reporting for herself.  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 08:45 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included thalassaemia from an unknown date, drug allergy (unspecified) from an unknown date, food allergy (unspecified) from an unknown date. The patient's concomitant medications were not reported.  Past vaccination history included first dose of BNT162B2 on 02Apr2021 at 07:45 in the left arm for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hallucinations on 23Apr2021 at 23:00 with outcome of recovering, wanting to speak but couldn't speak on 23Apr2021 at 23:00 with outcome of recovering, and out of body experience on 23Apr2021 at 23:00 with outcome of recovering. The patient did not receive treatment for the events.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I received the 2nd dose of vaccination on 4/17/2021. Around middle of May, I started notice many redness pimples are around the injunction area. They were not super big, but they were very itchy. I had both doses  injected on my left arm. But, my redness reaction were appeared on both of my arms.
This spontaneous report was received from a physician regarding a 6 month old male patient. There was no information about concurrent condition and historical medication. On 21-JAN-2016, the patient was vaccinated with a small drop of ROTATEQ lot # L008574, expiration date- 22-NOV-2016, orally (incorrect dose administered). No concomitant medication was reported. On 21-JAN-2016 (also reported as immediately after administration), the patient experienced vomiting reported as faint pink emesis. The physician reported that on an unknown date in January 2016, the patient was still having vomiting episodes with other foods, like bananas (food allergy). The physician stated this vomiting could be due to another unspecified issue with swallowing and not ROTATEQ. No treatment was given for the adverse events. The outcome of vomiting was reported to be not recovered and the outcome of vomiting episodes with other foods, like bananas (food allergy) was unknown. The reporter did not assess the relatedness of events to the suspect therapy ROTATEQ. Product quality complaint (PQC) was not filed. Additional information has been requested.
Patient is pregnant and was given Heplisav-B vaccine instead of Recombivax Hep B immunization.  Unknown risk to fetus due to administration.
Inadvertantly pt recvd vax of 0.5cc IM & devel arm pain @ site p/24 hrs; then devel h/a & general malaise day 2-5, which resolved felt like the flu;
Dizziness anxiety, brief palpitation reported. States her BP is normally 90s/60s BP immediately after injection 119/83, HR 90s Narrative: Employee reports immediately following injection that she felt "lightheaded & strange". She remained alert & oriented, verbal & answers questions appropriately.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 21-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 15Oct2015; PROZAC; WELLBUTRIN; SPIRONOLACTONE. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDs". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 as the patient received PAXLOVID since 26Oct2022 until 31Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: testing negative after finishing PAXLOVID.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swollen lymph nodes for two weeks after COVID booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes for two weeks after COVID booster.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting-starting 8 hours after immunizations given-reported to our facility the morning after.