chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "mild arm soreness".  Additional information: Serious: No. Patient calling to ask if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like I need to cough but can't. It's sort of like an asthma like feeling?" Describes dry cough. Also has arm soreness at the injection site. He received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. Patient was also the reporter. The patient reported that he was having a side effect but he was not sure if was from the vaccine or maybe he caught COVID. There was a product complaint to report. Patient states that he had four Pfizer COVID vaccines total.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax; t 101 next day; eyes swollen, crusty (almost swollen shut); red/face puffy; chest "tight" feeling; could not sleep;
Patient was administered 0.3ml vaccine dose direct from vial (not diluted with NSS).  The event was at 9:40am approximately and we were able to reach the patient at 2:30pm, which said she was ok, but experienced an episode of strong diarrhea. Doctor of patient will be called to be informed of the incident.
When symptoms started, I had running nose, cough, tested positive at home after having a home test for COVID-19. I went to the clinic they gave me PAXLOVID. I home tested this morning, and I was negative.
Stiffness; Swelling; Crippled; skin disorder; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling), MOBILITY DECREASED (Crippled), SKIN DISORDER (skin disorder) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling), MOBILITY DECREASED (Crippled), SKIN DISORDER (skin disorder) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Crippled) was resolving and SKIN DISORDER (skin disorder) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that in 2021, the patient experienced crippled.  No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No specific follow-up information recorded.
Diarrhea; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The events which patient experienced upset stomach and diarrhea was not related to vaccine.The scheduled second dose for the patient was on 30-MAR-2021. She asked can she postponed and for how long her second vaccination and if her diagnosis for upset would be stomach infection or COVID can she made the second injection or not.
Tingling and discomfort at the injection area which is now 40 days after injection.  This is continuous all day, and it is most noticeable when I am trying to go to sleep.  I am concerned this may lead to other arm related issues in the future.   The vaccine provider should provide some remedy for this.  Please advise what I need to do.
This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she got the first dose and currently taking Metro prednisone and Clindamycin because of Streptococcus. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving home was as if I was under the influence. Day 3 - Extreme fatigue and sever body aches Day 4 - Slightly better, but still not able to resume normal activities Day 5 - Tried to resume normal activities (bike ride), but I have to stop due to extreme fatigue and severe muscle cramping. Day 6 - Actually felt normal Day 7 - Back to 100%...
Pt c/o sore arm. Pt woke up between 1-3 am on 7-14-10 with a headache. Pt took MOTRIN with no relief at 7am took MOTRIN again. Pt c/o shivering which started at 915am. Pt states office temp 68 degrees. Pt took ASA at 12N. 1215pm pt states shivering starting to resolved. Pt also c/o feeling lightheadedness since 8am or 9am  and still has it. Pt eats very light. Pt never took temp.
Pt tested positve for COVID on 11/11/2021.Chief complaint, cough, nasal congestion.  56y.o. male presenting to the emergency department for chest pain. Patient also admits to shortness of breath. Patient admits to congestion and rhinorrhea for 1 week. Positive for back pain and nausea.  Troponin normal, EKG normal sinus rhythm, no signs of ischemia, no arrhythmia and non-specific ST-T changes. Treatment: Decadron and Toradol.  Stable for discharged.  Discharged to home.
Spikevax. Patient reported redness, swelling and warmth at injection site. She reported that the reaction has gotten bigger since the day of injection. I counseled her to use Tylenol, ice packs, and to continue to monitor and follow up with a physician when she can.
Patient had received vaccine on 03/16/2021 (LOT 1805025), but didn't notify provider giving vaccine today; spoke with patient and husband  to let them know to monitor for any adverse effects and go to ER for anything life threatening. There was no reactions noted after patient left clinic. Called and spoke with patient two and a half hours later.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 19-NOV-2013, the patient was vaccinated with M-M-R II (lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported tha the M-M-R administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
She got her 2nd Pfizer dose around 12pm on 7/10/21 (1 st dose given on 6/19/21 at our pharmacy) .  Around 11pm on the night, she started having an intermittent  chest pressure. She took ibuprofen and was able to sleep  through the night.  She took  a total of 4 doses of ibuprofen. By the morning of 7/12/21,  the symptoms went away and she has been feeling fine since then. She did not seek a medical treatment.
Day after having my second vaccine I have experienced Tinnitus. Some times it sounds almost like a siren is going off and will last several minutes. I have had it in both ears. It wakes me up at night and I can?t get back to sleep. Have had to use a white noise machine to sleep. It has gotten better in my left ear but still very loud in right ear. It has made me very anxious and on edge. I have also been experiencing vertigo. It comes and goes. I have not fallen down from it yet.
Patient received BEXSERO vaccine 5/25/17 at 1340. Called into office 5/26/17 at 1445 with symptoms of soreness, tiredness and joint pain. Information was given to office RN triage.
Fever, chills, body ache.  Started about 12 hours after vaccination and lasted about 12 hours.
Client is 17 years old and was inadvertently given a dose of Moderna vaccine (18+). Mistake was not caught during patient's time at the clinic, and the parents notified us today of this event. This RN is reporting the error. Client saw a doctor in-office to discuss next steps (family's own decision).
Began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine.; A slightly uneasy stomach; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortble through the night; fever at 100.8 F; First dose: 22Mar2021 and second dose:04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number EW0164), intramuscular, administered in deltoid right (arm right) on 04Apr2021 at 02:00 PM (age at the time of vaccination was 26 years, she was not pregnant at the time of vaccination) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER2613), intramuscular, administered in right deltoid (arm right) on 22Mar2021 at 02:00 PM (age at the time of vaccination was 27 years) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included allergies to medications, food, or other products: Antibiotics: penicillin, septra, zithromax, amoxicillin, arithromycin. The patient's concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Prior Vaccinations was none. Relevant tests were none. The patient began feeling sensitive to the touch approximately 5-8 hours after receiving the vaccine. She began to feel a little run down close to 11 pm local time. Went to bed but had a hard time falling asleep due to feeling very cold and uncomfortable through the night on 04Apr2021. Finally decided to get up 4 hours later, 4:30 AM, took temperature, had a fever at 100.8 F. And a slightly uneasy stomach. Took acetaminophen but took about 1 hour to work. Temperature dropped to about 99.6 F. And stomach subsided. Continued to drink water, temperature dropped again to 98.8 F. No other reaction occurred. She did not receive treatment for other adverse events. Since the vaccination, she had not tested for COVID-19. 8 hours after second dose patient feeling under the weather fever 101.6 after midnight. Took Ibuprofen at 1am. Fever resolved within 24 hours. The patient underwent lab test and procedure included body temperature that was 100.8 F and 101.6 on 04Apr2021 and on unspecified date it was 99.6 F and 98.8 F. The outcome of event fever, slightly uneasy stomach was recovered in Apr2021, feeling sensitive to the touch, hard time falling asleep, feeling very cold and uncomfortable was recovering.   Follow-up attempts were completed. No further information was expected.
THE PATIENT CAME INTO THE PHARMACY AND WAS CONCERNED ABOUT REDNESS UNDER THE INJECTION SITE (DELTOID) THAT EXTENDED ALMOST TO HER ELBOW JUST 2 DAYS AFTER HER FLU SHOT. AFTER EXAMINATION IN THE PHARMACY, IT LOOKS LIKE THE PATIENT POSSIBLY HAD AN ALLERGIC REACTION OR HAD BRUISING DUE TO A NEW MEDICATION. THE AREA WAS VERY RED AND WARM TO THE TOUCH. THE SOURCE OF THE BRUISING IS CURRENTLY UNKNOWN AND IT CAN'T BE CONFIRMED AT THIS TIME BUT THE PATIENT WAS ADVISED TO GO SEE A DOCTOR AS SOON AS POSSIBLE TO PROPERLY EXAMINE THE AREA. THE PATIENT WAS THANKFUL AND UNDERSTANDING.
Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023; No adverse event; patient received expired monovalent first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired monovalent first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: Unknown, <30 days Date(s) of administration of vaccine: 13MAR2023).    No concomitant medications were reported. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursions. No treatment medications were reported.
Associate received Pfizer covid vaccine  (lot EJ1685 Exp 03/2021) and 27 minutes later complained of shoulder/back pain traveling down her arm.  She was transported via wheelchair to ED triage for further assessment.  No cardiac issues identified; she was monitored in ED ~2hrs and symptoms almost completely resolved per ED note.
Tdap administered on 8/18/08. On 8/19 next day, had fevers, chills, nausea and seen at Convenience Care medical center for same.  Nausea lasted all week, large local reaction with heat,swelling in left deltoid at administration site.  Had photophobia, crown headache. Missed three days of work.
I had shortness of breath, chest pain on my left side, and malaise that started roughly 20 minutes after the shot. Malaise lasted for two days after the shot with the chest pain intensifying each day and peaking around 7 days after along with my blood pressure reaching 174/94. 35 days later I am still having chest pain and it is hard to sleep through the night.
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II, (lot#, strength, dose frequency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical Course: As a therapeutic measures, the patient have taken Paxlovid from 02Jun2022 to 07Jun2022.  Follow-up attempts are completed. No further information is expected.
Redness and edema at site of MCV4 with itching reported over his body.
Information has been received from a medical assistant concerning a 51 year old female patient with osteoporosis and sulfonamide allergy, who on 01-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663881/0197Y). Concomitant therapy included (BONIVA), cephalexin, lovastatin and (VICODIN). On 02-APR-2009, the patient notice "a lump, redness, swelling and warmth at the injection site where ZOSTAVAX (Merck) was given". On 03-APR-2009, the patient had a slight fever, soreness and mild body aches. The area was still warm to touch. The patient had an office visit. At the time of reporting, the patient had not recovered. Additional information has been requested.
Patient received the monovalent Pfizer COVID vaccine as a booster instead of the bivalent booster
Expired Menveo Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 30th November 2022) for prophylaxis.   On 6th December 2022, the patient received Menveo. On 6th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The reporter was clinic manager. The reporter reported that, patient received a dose of Menveo and the dose had expiration date November 2022. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Menveo ,which led to expired vaccine used.
pt received 0.2 ml of undiluted pfizer (5-11) as second dose
Per mother's friend, symptoms started Wed., 08/29/01, in the evening, complained of redness, swelling, and soreness in the left leg. Tylenol was given for treatment of symptoms. Friend brought baby for shots with permission by mom.
It was reported that a 34 year old female received Fluzone 98-99 sometime between 10/9/98 to 10/12/98. Reportedly sometime after the vax, the pt experienced systemic reactions of headache and nausea. From additional information received November 2, 1998 it was reported that the pt's symptoms lasted 48 hours. Reportedly the pt recovered from this experience.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 02:00 as dose 1, single (Lot number: HD9835) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing); "HLP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient has no known allergies. Anti viral COVID 19 treatment Paxlovid, started from 05Oct2023 to 10Oct2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Patient received vaccine and now had to receive a pace maker for blockage. On no medication only change to life was vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ATRIOVENTRICULAR BLOCK (medically significant), outcome "unknown", described as "Patient received vaccine and now had to receive a pace maker for blockage. On no medication only change to life was vaccine". The patient underwent the following laboratory tests and procedures: Heart rate: Unknown result. Therapeutic measures were taken as a result of atrioventricular block.  The information on the batch/lot number for BNT162b2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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