chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; articulations pain; Cough; Fever; stomach pain; diarrhea; body discomfort; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Aug2020 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 55 years, administered in the right arm for COVID-19 immunization. The patient had no relevant medical history. The patient's 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: COUGH (non-serious) with onset 08Oct2023, outcome "not recovered"; PYREXIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Fever"; INFLUENZA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Flu"; ARTHRALGIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "articulations pain"; DISCOMFORT (non-serious) with onset 08Oct2023, outcome "not recovered" described as "body discomfort"; DIARRHOEA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Oct2023, outcome "not recovered" described as "stomach pain." Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza, arthralgia, cough, pyrexia, abdominal pain upper, diarrhoea, discomfort.  Additional information: Patient had no known allergies.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324030 same patient, different vaccine dose and events;
08/08/2002- Received phone call from mother, States child began vomiting around 6 pm 08/07/02. Also has swelling and redness left thigh, Had temp 101 -102 degrees F during nigh, 9/16/02 -Phone call to mother, States sx resolved by 08/10/02
29MAY90 pt vax 3rd dose;  did not seroconvert.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown date in 2013 (also reported as from 19-JUL-2013 until 17-OCT-2013), the patients were vaccinated with improperly stored doses of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
inj site is in lt deltoid which shows erythema, warmth, tenderness, pain & firm area of approx 25-30cm in diameter;alternate warm & cool compresses;OTc med for pain;
I have not had a period for the past 2 years. After the first dose, I started bleeding and cramping. I got the second dose and stopped bleeding but I am still cramping. I have an IUD and it is normal for me not to bleed or cramp.
Moderna COVID-19 Vaccine EUA - tenderness and redness near the injection site.  The redness is warm to touch.
Loss of hearing 2 days after Moderna vaccine.  Hearing "motor type" sounds also off and on.
6 days after my first vaccine, I went to sleep and noticed my armpit was sore. The next day while I was out I noticed my arm was itching and I looked at my left arm and noticed it was swollen and red. Later that night I broke out into hives on the left side of my face and neck and my left ear was hot and so red that it almost looked purple. My arm was also very sore to the point that I couldn't move it. Over the next few days I noticed that my neck started to get sore. About 2 days after the allergic reaction, my neck was so stiff and sore that I could not move it. I had to lay in bed and take muscle relaxers for about 3-4 days. I could never sleep through the night because every time I would turn over I would wake up from so much pain in my neck. It went away after about a week of medicine, rest and stretches. I also noticed that for about a week after the initial allergic reaction that I would have random bouts of inflammation that would last for a couple hours. This was my first dose and with the second dose I didn't have an allergic reaction, but I had the same reaction with my neck approximately one week after the second dose.
Moderna COVID-19 Vaccine EUA Nausea ongoing Vomiting 12 hours Diarrhea ongoing Gas ongoing Headache ongoing Fever 12 hours Chills 6 hours Injection site soreness 48 hours
After vaccine administration the pt was standing waiting w. his mother for the vaccine record, he fall backward hit the wall w. his head and slide down the wall, he was no immediately responsive, but in a few secs he resonded to his name, pt was clammy and nauseated, pt assessed by Dr, pt stayed about another 15 mins until he felt better. Pt had not eaten breakfast that am only had a granola bar. Pt had requested the injections in his thighs becaue he had a swim meet the next morning.
Information has been received from a physician concerning a 63 year old female patient with seasonal allergy, Erythromycin allergy manifests as rash and no pertinent medical history who on 21-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 in right arm and dose of ZOSTAVAX (Merck) in her left arm subcutaneously. Instantly post vaccination the patient had a pain shoot down her right arm and immediately spread around her body myalgias, camping in legs, dizzy, saw spots, syncope type of episode, sweaty, chills. The patient's blood pressure and heart rate were normal. The patient was monitored at the office for thirty minutes lying down. At the time of the report, the patient had fully recovered. Additional information has been requested.
Grand mal seizure.  No hx of seizures.  Multiple tests revealed no known cause.
Patient has significant rash, swelling and redness. Affected area stretches from elbow to shoulder.
Large red swollen area, warm to the touch and extremely sore.  3-29-10 area measures 45mm X 50mm.  Also firm to touch.  RN.
got sick with covid / covid test result: Positive; got sick with covid / covid test result: Positive; got sick with covid / covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Apr2021 (Lot number: EW0158) at the age of 23 years as dose 2, single and intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing); "cleft lip and pallet" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (disability, medically significant), COVID-19 (disability, medically significant), ILLNESS (disability) all with onset Jan2022, outcome "not recovered" and all described as "got sick with covid / covid test result: Positive". The event "got sick with covid / covid test result: positive", "got sick with covid / covid test result: positive" and "got sick with covid / covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (May2021) 100 bpm, notes: over 100 bpm at rest and without activity; sars-cov-2 test: (Dec2021) negative; (Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness. Clinical course: Patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient had not diagnosed with COVID-19.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events vaccination failure, Covid-19, Illness and suspect BNT162B2 cannot be excluded.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.
Low grade fever 101.5 that progressed to high-grade fever (103.9 - 104.6) for 72 hours. Patient was also lethargic.
A few hours after I began to feel very red in my face and it begin to get itchy and feel very hot and later that night I developed body aches and a headache I am a little bit of soreness in my arm but as of three days later my face is still red and itchy and has not gone down at all
?Covid  arm?. Hardening/itching/rash after 2nd  injection at injection site.  After  24 hours rash was  1? mostly to the right of the injection .  After 48 hours rash had spread to approx 4? diameter around injection site. Treated itching with  hydrocortisone. After 4th day  symptoms have resolved. No other symptoms experience after either vaccine
Encephalomyelitis; Ataxia; Gait Instability; This is a spontaneous report from a contactable consumer. This 42-year-old female Consumer (patient) reported for herself.   A 42-year-old non pregnant female patient received the second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0191) via unknown route administered in Arm Left on 01Jun2021 (at the age of 42 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Previously, the patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EW0171) via unknown route administered in Arm Left on an unspecified date in May2021 as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient had COVID prior vaccination. On 31Jul2021, the patient experienced Encephalomyelitis, Ataxia and Gait Instability. Patient visited clinic and emergency room due to the events and hospitalized for 5 days. The patient received treatment for the event. The lab data included Multiple Tests (MRI, Lumbar Puncture, etc) IV Ster and results unknown. Patient was tested for COVID post vaccination. Nasal Swab test was negative. The outcome of the events was not recovered.
Entire lateral upper arm is bruised from the injection point on the left deltoid down to approximately 1 inch above elbow.
Patient came in today (12/13/18) showing us a bruise and an area where a blister formed right next to injection site. He went to his SUBOXONE dr the next day for an appt showed them and he said it looks like a reaction.
PATIENT HAS BEEN EXPERIENCING PAIN IN SHOULDER SINCE THE MOMENT SHE RECEIVED VACCINE 3 MONTHS AGO. SHE STATES THAT SHE COULD BARELY MOVE HER ARM FOR SEVERAL MINUTES POST VACCINE. PAIN IS STILL OCCURING TO THIS DAY, HAS BEEN FOLLOWING UP WITH DOCTORS TO DETERMINE CAUSE.
Headache, Sedation, Fever, NauseaVomiting, Chills Narrative:
SOB FOR THE PAST 2 WEEKS WITH EXTERTION. SWELLING IN BILATERAL LOWER EXTREMITIES. URI SYMPTOMS AND LOSS OF TASTE AND SMELL FOR THE PAST 1 TO 2 WEEKS.   1ST COVID VACCINE 1/14/2021. 2ND COVID VACCINE 2/11/2021. BOOSTER 11/12/2021.
SIDE EFFECTS (UNSPECIFIED); NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced side effects (unspecified). On MAR-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well and side effects (unspecified) was not reported. This report was non-serious.
got flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date, patient had flu a few days later following the administration of INFLUENZA VACCINE. Had two flu shots - had flu both times, so now feel apprehensive about vaccines(Feeling abnormal).   It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction to the first dose). At the time of the report, VACCINATION SITE REACTION (reaction to the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-544281, MOD-2022-544280, MOD-2022-544280 (Patient Link).   Reporter did not allow further contact
Injection site redness, warmth, and swelling approximately 4.5 inches by 2.5 inches (measured by patient) with tenderness extending into neck and armpit.
Patient right arm is swollen, red, and hot. Swelling is 5cmX10cm. Localized shoulder pain. Has only had moderna covid19 vaccine X4. This was first Pfizer vaccination.
On the evening of October 7, 2020, I developed a firm bump in my left arm where I received the vaccine. It was itchy and uncomfortable. The next morning I woke up with a 3inch red circle that was slightly raised, firm,  warm to the touch, and itchy.  October 10, the circle is no longer raised or warm to the touch but still visible, itchy, and uncomfortable.
Administered in tendons above muscle in left arm, left arm covered in hives eve of 09/02/2005. tongue swelling and throat swelling 09/03/2005, 09/04/2005, 09/05/2005. Skin red all over hives on left side of face. Extreme muscle pain and systemic weakness.
Left arm pain, from vaccination site down to elbow and up through shoulder, can't exercise or lift objects with left arm for over 2 weeks
This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot number and dose unspecified), subcutaneously. On 03-OCT-2014 the patient was vaccinated with another dose of PROQUAD (Merck) (lot number and dose unspecified), subcutaneously. Concomitant medications were not reported. No known adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD (Merck) was not reported. Additional information has been requested.
Had a reaction to it, including swelling in the face and other; Had a reaction to it, including swelling in the face and other; This spontaneous case was received on 14-Aug-2021 from other non-health professional (reference number: NUS2021US122701) and concerned a female patient, of an unreported age.  The patient's concurrent conditions and concomitant medications were not reported. The patient had another side effect to unspecified product prior to Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) which resulted with the hospitalization.   On an unknown date in 2014, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration, indication and anatomical location: not reported). The batch number reported was 1309501.   On an unknown date, unknown amount of time after receiving Fluvirin, the patient had a reaction to it, including swelling in the face and other.   The outcome of the events was not reported.   The reporter assessed all events as related to Fluvirin. The patient had a reaction to it.  Company Comment: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.; Sender's Comments: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.
Moderna 3/4/21, 4/1/21. Positive on 9/3/22.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX (batch number P45M9, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right deltoid. The reporter had a consumer that developed soreness at the injection site the evening after receiving the SHINGRIX vaccine. They called the pharmacy to report that they were still experiencing the symptom 13 days after receiving the vaccine. The call was transferred to Medical Information. reporter believed this was the second dose for the consumer but cannot verify this with her records.
Patient states that since he received the flu shot he has had on & off shoulder pain until Thanksgiving. He went to the ER and is now receiving physical therapy at Hospital. Patient is paying out of pocket.
I was vaccinated about noon on Saturday, November 12 2005. By bedtime that night, my upper arm shot area was starting to get red. Sunday, my arm was itching and I started getting chills. Sunday night my arm was swollen and red shot area upper arm. Monday I had the nurse at the health unit check it. She advised me to go to my doctor. My doctor was out of town so his nurse looked at it. She said I needed to be seen by a doctor that day. I went to the clinic. The doctor there and both nurses above said I had cellulitis, The doctor prescribed oral antibiotics twice a day for ten days.
This spontaneous report was received from a nurse and health professional and refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
My brain shout down , could not comprehend could not process thoughts, could not understand when a person would talk, hearing loss. total confusion.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 05-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 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information were provided.  Patient had not reported any events.
Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a office person medical assistant. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because a dose expired which was hoping to be in a grace period. 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 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