chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriatic arthritis aggravated/ Psoriatic Arthritis Flare Up; This is a solicited report from a non-contactable female consumer (patient) based on the information received by Pfizer(MFR Control No. 21K-163-3890876-00).   A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at CF for Psoriatic Arthritis. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. On an unknown date, the patient experienced Psoriatic Arthritis Flare Up with Humira (adalimumab). COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. The outcome of the event was unknown.   The causality by the reporter to the event Psoriatic arthritis aggravated/ Psoriatic Arthritis Flare Up for Humira was no reasonable possibility and for PFIZER-BIONTECH COVID-19 VACCINE was not reported.   Information about Lot/Batch number is requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the Psoriatic Arthritis Flare Up and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees; patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 017B21A and 030A21A) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (was stored in the refrigerator since 7Mar2022 in temperatures between 2 to 8 celcius degrees) to be not related.  It was unknown if the patient had concomitant medications taken at time of vaccination and or at the time of the adverse event. The vial was stored in the refrigerator since 07-Mar-2022 in temperatures between 2 to 8 degrees Celsius The vial did not undergo any temperature excursion. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. It was unknown if the patient experienced a similar event in the past. No information on treatment medications was reported.   This case was linked to MOD-2022-539513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Significant follow-up information received: Case was upgraded to valid. Additional reporter, patient demographics, suspect details (1st, 2nd and 3rd vaccination details) were added. Event onset date, reporter causality for the events and i-narrative were updated.
sore arm the next day after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Lot number: EL8982, Expiration Date: May2021) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "slight heart problem" (unspecified if ongoing); "thyroid elevated" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Feb2021, outcome "unknown", described as "sore arm the next day after the vaccine".  No follow-up attempts are possible. No further information is expected.
The vaccination was billed as toddler. What was given was the Pfizer pediatric vaccination. This was discovered after the parents had left the building.
Developed a petechial eruption in face. Not itchy. He was instructed to visit PCP.
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) 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 UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.
For three days I had body aches and fever. Now they are gone, but since this morning I feel left chest pain and uncomfortable when I move or speak.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with 2018SA226820, 2018SA226818, 2018SA226819, 2018SA226816, 2018SA226817 (same reporter). This case involves an unknown age male patient. The vaccine was reported to have an excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f, vaccines were used before they found out about the excursion. The patient received MENACTRA. This is actual medication error case as the patient received vaccine which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect MENACTRA lot U5833AA, exp date 25-February-2019 via intramuscular route in unknown administration site. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
pain in the back of her neck; pain in the site of injection; headache; chills, she felt like she was freezing; too tired, too fatigued; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (pain in the back of her neck), VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 031H21A, 003A21A and 006M20A) for COVID-19 prophylaxis. The patient's past medical history included Broken leg. Previously administered products included for Drug use for unknown indication: Shingles. Past adverse reactions to the above products included Pain in arm with Shingles. Concurrent medical conditions included Dust allergy. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, HYDROCODONE for Pain. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued). On 17-Jun-2022, the patient experienced NECK PAIN (pain in the back of her neck). On 16-Jun-2022 at 2:00 PM, VACCINATION SITE PAIN (pain in the site of injection), HEADACHE (headache), CHILLS (chills, she felt like she was freezing) and FATIGUE (too tired, too fatigued) had resolved. On 17-Jun-2022, NECK PAIN (pain in the back of her neck) had resolved. It was reported that the patient did not experience any COVID or was tested positive. No treatment medications was reported. This case was linked to MOD-2022-593081 (Patient Link).
My left arm hurt a little bit just like the 1st treatment on 3/23/2021 but a week later my arm started hurting a lot more, and I have a lump or swelled up where I got my shot.    It still hurts and often difficult to raise my arm to put on shirts.
Had soreness at site of 1st one, 1 month, post vax, no redness or swelling or heat. Had local swelling, redness, soreness, systemic headache, increased temperature, aching all over and joint pains after 2nd one. Follow up information received 06/15/2001: Continues to have pain at injection site. Radiates up into neck and shoulder. When site is palpated, cause pain in other shoulder. No redness, swelling, hardness or heat noted at site.
Initial case was received on 04 November 2010 from a healthcare professional. A female patient (age not reported) received on 29 October 2010, a subcutaneous injection "in the flabby part of the arm" of INFLUENZA vaccine (lot not reported). The next day on 30 October 2010, she experienced red, hot, hard spot at the vaccination site. On 01 November 2010, the site was "only bruised." No pre-existing medical conditions and no concomitant medications were reported. It was unknown if the patient recovered completely. Follow-up information was received from the health care professional on 03 January 2011. The patient was 22 years old, and had no illness at the time of vaccination. She received FLUZONE (lot number UH223AC) on 28 October 2010 (previously reported as 29 October 2010). The event recovered in an unspecified date. The reporter had no additional information at this time. Documents held by sender: None.
He has been extremely fussy and will sleep for very brief increments. He has started waking up screaming. Prior to the vaccinations, he was always a happy baby and had no difficulty sleeping for long periods of time and never woke up screaming.
Patient received the small pox vaccine on or about 21 Feb 08;  on or about 1 March 08 he started having chest pains; he presented to medical attention on 4 March 08 and had diffuse ST elevation on ECG.  Cardiac enzymes positive with a peak trop of 33.  His myopericarditis responded well to Motrin.  Echo was normal.  He was discharged from the hospital after two days chest pain free.
Started to get Headaches on one side of head.; Upset Stomach for the past week and a half.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient experienced headaches on one side of head and upset stomach for the past week and a half. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches on one side of head and upset stomach for the past week and a half was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient woke up with a very sore left arm. She called asking if it should be this sore. Explained that the PNEUMOVAX can be sore, but she continued to describe an abnormal swelling. The patient was advised to see call her md. Staff saw her today and diagnosed her with cellulitis which she says she believes was definitely caused by the PNEUMOVAX 23. She prescribed her cephalexin 500mg every 6 hours for 10 days.
Right side of face (specifically lips) extremely swollen. Begun at 5am following morning following previous day 11:20 am injection received. Face swollen, left arm could not lift (at all), body temp rise to 101.1, pulse oximeter dropped to main number 73 number to right (small) 76- numbers were 95 + 98 2.5 weeks prior when positive for covid. Could not move without feeling dizzy/weak,extreme fatigue, slept for 18 hours  day following injection when symptoms began. Face swelling (lips increased) 2 doses (2 pills per dose)4 hours apart of Benadryl did not reduce swelling. PC prescribed prednisone & took 4 pills initial dose (day 1), swelling decreased within 6 hours. Following day - extreme fatigue, stomach ache, nausea
Woke up with Migraine early in the morning and brain was very foggy.  Extreme fatigue and had trouble functioning and brain wasn't connecting thoughts.  This lasted the day following the jab and the day after that.  About a week later, started having difficulty breathing.  Had trouble catching my breath through -out the day and I wasn't doing anything at the time.  That lasted about 10 days.
Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
just a little woozy or weary.; irritation in the muscle; just a little woozy or weary.; On site achiness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (just a little woozy or weary.), MUSCLE DISCOMFORT (irritation in the muscle), FATIGUE (just a little woozy or weary.) and VACCINATION SITE PAIN (On site achiness) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Sensitization (to things put in the system).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (just a little woozy or weary.), MUSCLE DISCOMFORT (irritation in the muscle), FATIGUE (just a little woozy or weary.) and VACCINATION SITE PAIN (On site achiness). At the time of the report, DIZZINESS (just a little woozy or weary.) and FATIGUE (just a little woozy or weary.) outcome was unknown and MUSCLE DISCOMFORT (irritation in the muscle) and VACCINATION SITE PAIN (On site achiness) had resolved.            No concomitant medication was provided by reporter.  Patient got the Moderna booster 3 times. Patient didn't have too much ill effect. Patient was trying to schedule medical appointments after and want it to be effective. Patient was an older person. Patient was highly sensitive to things put in the system.  No treatment medication was provided by reporter.   Reporter did not allow further contact
itching, swelling, redness edema @ lt arm inj site in AM of 17JAN98 lessened by AM of 18JAN98;pt screamed for 45min on 19JAN98 PM, & had inc in itching, c/burning @ site PM of 19JAN98;itching & burning cont 21JAN98;
2nd dose of vaccine rec'd Tuesday afternoon, there was hurting between breast bone, felt really weak, aching, BP went up, and didn't feel well.
Redness, swelling at the site of injection 3x5 cm in diameter, warm to touch.
he started breaking out with Shingles/ lack of effect; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 14-OCT-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: he started breaking out with Shingles/ lack of effect). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient self-reported this case. The patient stated that, he had his first dose of Shingrix and started breaking out with Shingles. The reporter consented to follow up.
Moderna COVID-19 Vaccine EUA - Broke out in severe hives which resulted in burning sensation all over the body from head to toe, occurred 24 hours after vaccine was taken. Progressively got worse.
blurry vision 1st day.  asthma attack 1st night inhaler worked. next morning.  Massive severe headache (almost as bad as the spinal headache from my 1st child) , chills, fatigue, nausea.  Called PCP and he gave me Tylenol with codeine for the headache and a prednisone for the asthma even though it was under control.
Patient called stating that she received the Havrix vaccine in October and has been experiencing severe pain ever since requiring physical therapy and acupuncture. She states that she is a nurse and the she immediately felt that the vaccine was administered too low and not in her deltoid.
A bumpy itchy rash started first in my arms and after in wrists and hands so i took 2mg of betamethasone and after 45 minutes another tablet of 1 mg. After 2,5 hours the rash calmed down on the upper part but it started on legs, tighs and foot. I was on fire and to have a bit of relief i put a wet cloth on the skin and i took another tablet of 1 mg of betamethasone and 1 of benadryl allergy. Around 11 pm the rash stopped and the skin became normal. I slept with no problem, but the next morning after 20 minutes I woke up the rash started again in all the body so I took 2 mg of betamethasone and 1 benadryl allergy. I went to the vaccination center but there wasn't any doctor, only a nurse that told me to keep on taking antisthamine and corticosteroids.  It calmed down around 12 am and started again in the late afternoon.I took a benadryl, i used the wet cloth and around 10 pm stopped. Night with no problem, but around 9.30am the rash started again so i took 1 mg of betamethasone and 1 benadryl. Around 1 pm calmed down and at 2pm i took 2 benadryl. Around 8 pm i had some itchy spot on the legs but it didnt turn out in rash. Today after 30 minutes i woke up i had some spots on the legs, i took a benadryl and after 1 hour disappeared.
Pt reported numbness to left side of throat 10 minutes post-vaccination. Vital signs as follows: BP 120/77, HR 74, O2 100%. Pt denies SOB. Pt given 10ml benadryl x1 PO. Pt observed for 30 minutes total. Numbness resolved before leaving the clinic.