chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 59 year old female pt received first dose of Fluzone given IM in the left deltoid on 1/22/03. On 1/27/03, the pt experienced headache, malaise, congestion (nasal, chest), rhinorrhea, chills and fatigue that continued to the doctor's visit on 1/30/03 and was given a vitamin B12 shot, Tamoflu and Humabid treatment. The pt was not taking any medication and had no illnesses at the time of vaccination. The pt has no pre-existing medical conditions. No lab/diagnostic test were performed. It is not known whether the pt recovered from the events.
my jaw bone going to my ears it's hurting; my jaw bone going to my ears it's hurting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my jaw bone going to my ears it's hurting. Consumer stated, Pfizer, I had a Pfizer shot. I did not needed a number. Consumer stated, I was just trying to see if anybody complaint of, my jaw bone going to my ears it's hurting and I am just trying to see is that a symptom. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Itchy at the injection site; injection site was hard; Injection site pink; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CALCIFICATION (injection site was hard), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J02A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling). On 07-Jan-2021, the patient experienced VACCINATION SITE CALCIFICATION (injection site was hard). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the injection site). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CALCIFICATION (injection site was hard), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Injection site pink) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included warm compress.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
inflammatory arthritis caused by the BNT162b2 COVID vaccination / flare of existing disease; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "inflammatory arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRITIS (medically significant), outcome "unknown", described as "inflammatory arthritis caused by the BNT162b2 COVID vaccination / flare of existing disease".; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Arthritis. Case will be reassessed when 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.,Linked Report(s) : US-PFIZER INC-PV202200097379 Same Article, drug, event and different patient.;US-PFIZER INC-202201280036 Same Article, drug, event and different patient.;
A few hours after receiving the vaccine the employee had limited range of motion in the left arm.  Range of motion improved a few weeks later but not at 100%.  The employee says if he moves his arm a certain way, he feels some tension at the injection site.  On today, there is no swelling, redness or tenderness noted at the injection site.
Approx 1 week after first vaccine: Hard lump under skin at injection site Injection site is warm to the touch, somewhat tender, and mildly itchy
This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml. At the time of injection with TWINRIX, the subject experienced arm and shoulder pain. The reporter stated that this seems to be a recent problem, not experienced in the past and that it seems to occur irrespective of the person giving the vaccination or the technique used. subjects complain of a sudden, brief, but significant shooting pains to the elbow or sometimes up into the shoulder and neck. The reporter felt that a logical explanation would seem to be the fact that the Hepatitis A/Hepatitis B vaccine uses a larger volume (1.0ml) that many other vaccines (0.5ml), but it does not explain why these events have not happened in the past with this vaccine or why it does not happen when the same vaccines are given as separate injections. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source. This case A0732483A serves as the master and other linked cases include A0732491A, and A0732492A. Additional linked cases include A0732500A, A0732501A, A0732515A, A0432528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/2021 my right leg began to swell terribly and then on 4/6/2021 it was discovered that I had one big and many small blood clots in my right leg.
Pt stated that she experienced extreme pain and swelling at the injection site and entire arm was red and swollen. Symptoms continued and worsened, unrelieved by pain relievers, so she went to ER for treatment.
Initial unsolicited report received from a physician on 16-Aug-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5459AA, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed redness at injection site larger than ink circle and fever of 99.9 F and pain in arm. Ultrasound performed and findings were multiple small lymph nodes inferior axillary region of pain- (no sonographic abnormality in the vaccination site). The patient's other laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
She received her second COVID  injection at about 1330 this afternoon. During her wait period, about 15 minutes after receiving the shot, she was lightheaded, dizzy, felt like she would pass out.  Observers noted that her skin was very flushed and her heart rate was greater than 100.   Her current symptoms are lightheadedness, dizziness with a sensation like the room is spinning, severe nausea, and generalized malaise
passed out; bad cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4263104-00.  An 88-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 40 mg,1 in 2 wk (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (prolonged hospitalization) with onset 25Jan2022, outcome "recovered" (2022), described as "passed out"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "bad cough". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (2022) Unknown result; X-ray: (2022) Unknown result. The action taken for BNT162b2 and adalimumab was unknown.   Causality for Humira (Adalimumab): The reporter's causality for the events of passed out and bad couch was not provided. The other company's opinion is that the events of passed out and bad couch are not assessable.  Causality for Pfizer Biontech covid-19 vaccine (Tozinameran): The reporter's assessment of the causal relationship of "passed out" was Possible and "bad cough" was not provided with the suspect product(s) BNT162b2 at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug 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.
TOOK VIVOTIF WITH A MULTIVITAMIN; This spontaneous case report (PVX2019-2624) was received from a nurse on 21-Oct-2019. It described a female consumer who "took Vivotif with a multivitamin" (PT: Product administration error). The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took Vivotif with a multivitamin.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company's Comment: The causality of the event "took Vivotif with a multivitamin" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with a multivitamin" was considered as not applicable.
Narrative: Pt states that shortly after receiving vaccine, his blood sugar went to 500-600's, which is unusual for him. He was hospitalized overnight and was treated. Patient also states that he started having difficulty swallowing following the vaccine.
Case previously recorded as MA2009-5220. Initial case report received from a physician via MedComon 19 OCT 2009. A 2 year-old patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no.: NA09-008308.
Patient indicated dark red 2"x2.5" swelling approximately 3-4 inches down from injection site. Day 3 post-injection, swelling is down slightly from day 1 post-injection but is still large and warm to touch.
Inadvertent administration of Pediarix (DTaP, IPV, HBV) when not indicated
WARTS ON LEFT MIDDLE FINGER STARTED SHRINKING NOW ALMOST COMPLETELY GONE; SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included two warts on left middle finger for a long time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced warts on left middle finger started shrinking now almost completely gone, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the warts on left middle finger started shrinking now almost completely gone and side effects was not reported. This report was non-serious.
11-2-11 developed "shingles" (blisters on top of left hip) lasted through November & went away very painful. 1-1-12 developed painful blisters on right hip not much pain.
pt recv vax 24OCT96 & 3NOV96 pt exp a rash w/15 lesions on trunk & back, sl fever & mild resp involvement;
Left upper arm and shoulder swollen, red and warm.  Duracef, cool compress, Alevert 5 mg daily until swelling goes down in UCC.  Ok to substitute Benadryl per pkg directions.
(L) arm - swollen, redness, warm and hard to touch. (KINRIX vacc caused this).
1 week post injection: redness and swelling at site and pain in left axillary lymph nodes
Patient reported hives on the back of neck and on arm where shot was administered appearing 2 days after vaccination. Itchy, but no fever and unresponsive to diphenhydramine. Has not worsened after 2 days when reported on 10/8. Recommended watching and waiting. If hives spread, told them to be see at ICC or ER and to follow-up with MD on Monday if no improvement.
Patient tested positive for COVID-19, symptoms: Neck pain, sinus pressure, loss of smell, headache, fatigue, nausea
This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 3. A patient of unspecified age, gender and ethnicity received TRUMENBA on an unknown date, singe dose. Relevant medical history and concomitant medications were unknown. On unknown date, after vaccination, the patient experienced redness two inches below injection site in blotches. Clinical outcome of the events was unknown at time of this report. No follow up attempt possible. No further information expected.
Incorrect product storage; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Incorrect product storage) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 PRODUCT STORAGE ERROR (Incorrect product storage). At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Palpitations and arrhythmia, while sleeping, light headedness, nausea, noon mid day 10/3/2017. walked to hospital for .6 miles while at hospital was resolved.
I took the vaccine on January 29th. I felt some soreness the following day, but that went away by the nest day. On February 4, I started to develop itching and a rash about 3 inches in diameter.
Confined to bed; Loose bowel movements; Feverish; Weak, tired; nauseous; GI upset; Muscle twitching; Tinnitus; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching) and BEDRIDDEN (Confined to bed) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic kidney disease. Concomitant products included ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, VITAMIN B12 NOS and MAGNESIUM OXIDE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 07-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 16-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous). On 19-Apr-2021, the patient experienced DIARRHOEA (Loose bowel movements). On 27-Apr-2021, the patient experienced BEDRIDDEN (Confined to bed). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Tinnitus), ABDOMINAL DISCOMFORT (GI upset), MUSCLE TWITCHING (Muscle twitching), BEDRIDDEN (Confined to bed), DIARRHOEA (Loose bowel movements), PYREXIA (Feverish), FATIGUE (Weak, tired) and NAUSEA (nauseous) had not resolved.            Treatment was not provided. Patient used Vitamin B2, Turmeric as a Concomitant medication.   This case was linked to MOD-2021-060221 (Patient Link).
patient was scheduled for Pfizer Bivalent but received Pfizer Monovalent in error.  Patient did not report any adverse reactions
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is note expected because the physician did not wish to be contacted.
Patient was given the wrong vaccine, was supposed to receive Meningococcal. Did not have any reaction to receiving the Prevnar 13.
Possible early menstruation / Early period started today; Experienced severe cramps; Fatigue; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 28Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, IBS (irritable bowel syndrome), migraine and year-round respiratory allergies. Concomitant medications included liothyronine sodium (CYTOMEL) for unknown indications from an unknown date. The patient had also received 3 allergy shots (unspecified) vaccine on 20Apr2021 in the left and right arm, for unknown indication. The patient previously received ciprofloxacin (CIPRO), levothyroxine (SYNTHROID), blue dye, almonds, sesame and latex for unknown indication on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced usual side effects of low-grade fever and fatigue for about 24-48 hours. On 02May2021, the patient experienced severe cramps. The patient was due for periods on 08May2021, but on 03May2021, the patient experienced early menstruation in addition to usual side effects of low-grade fever and fatigue. The clinical outcome of the events low grade fever, fatigue was recovered on an unknown date in 2021, while that of the event severe cramps and polymenorrhoea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
had covid, both tests came back positive,sick; Lack of drug effect; cold; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid, both tests came back positive,sick), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (cold) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (cold). In August 2021, the patient experienced COVID-19 (had covid, both tests came back positive,sick) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (had covid, both tests came back positive,sick), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) positive.         He got Covid-19 positive along with his wife and daughter at the same time in August.  No concomitant and treatment information were provided.  Company comment: This case concerns a 55-years-old male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-415978 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up information contains reporter details, patient demographics and event details added.; Sender's Comments: This case concerns a 55-years-old male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.