chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; Reactive to light and temperature; Skin rash localized to neck and face; Reactive to light and temperature; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself). A 43-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534) via an unspecified route of administration in left arm on 21Mar2021 16:00 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8734) via an unspecified route of administration in left arm on 11Apr2021 16:00 as dose 2, single (at the age of 43-years-old) for COVID-19 immunization. Patient was not diagnosed with COVID-19, prior to vaccination. Patient was not tested for COVID-19, since the vaccination. Patient was not allergic to medications, food, or other products. Patient was not pregnant at the time of vaccination. Patient medical history was reported as none. The concomitant medications were not reported. The reported seriousness of the events was non-serious. Patient did not receive any other vaccines in 4 weeks prior to the COVID-19 vaccine. Patient experienced skin rash localized to neck and face three days after dose 1 and dose 2 on 24Mar2021 08:00. Reactive to light and temperature 24Mar021 08:00. Resolved after dose 1 in 7-10 days. Relief through ibuprofen but not through topical cream. Patient self-administered ibuprofen to lessen swelling on 24Mar021 08:00. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Mother reports local vaccine reaction and 2 episodes of syncope/weakness. Patient was taken to the ER - Head CT-scan was performed with normal results. Pt was diagnosed with cellulitis at site of injection -treated with Clindamycin.
Our daughter was an A student, classes and early college. She now has a brain fog- she can't comprehend her work. She can't do any  work. She was fine until the vaccination.
Initial consumer report received on 18 Dec 2009: This patient received FLUVIRIN 0.5 ml intramuscular dose in early Nov 2009. On the next day the patient had experienced an achy pain from head to toe in addition to generalized muscle weakness. The patient also had some sores on the hairline of his head and had an itching in his groin that also disappeared as the other symptoms appeared. The patient does not know if this was coincidental or not. The side effects were diminished but not completely subsided.
Small amount of pain at injection. By next day injection site of deltoid was painful, red and swollen and progressed around shoulder and into chest area of the patient. Persisted for several days and resolved by the 5th day.
Pfizer/BioNTech/Treatment of COVID-19; Pfizer/BioNTech/Treatment of COVID-19/ Had COVID symptoms sore throat, stuffed-up head, fever, dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster) single (Lot number: FH8030), in left arm and on 23Feb2022 as dose 4 (booster), single (Lot number: ik9893) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 26Jan2021 as dose 1, single (Lot number: 012M20A), in left arm and on 25Feb2021 as dose 2, single (Lot number: 014M20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2000; SIMVASTATIN, start date: Dec1989, stop date: 17Jun2022. Past drug history included: Amoxycillin, reaction(s): "Allergy". The patient received past medications (unspecified) in Dec1989 and Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Jun2022, outcome "not recovered", described as "Pfizer/BioNTech/Treatment of COVID-19"; COVID-19 (medically significant) with onset 18Jun2022, outcome "not recovered", described as "Pfizer/BioNTech/Treatment of COVID-19/ Had COVID symptoms sore throat, stuffed-up head, fever, dry cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive; (24Jun2022) Negative; (25Jun2022) Negative; (28Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Had COVID symptoms 16Jun2022 sore throat, stuffed-up head, fever, dry cough. The patient had been tested positive for Covid-19 on 18Jun2022. Symptoms abated starting 19Jun. The patient's PCR test was negative on 24Jun and 25Jun. Symptoms returned 27Jun - sore throat, stuffed up head. The patient's PCR test was positive on 28Jun. The patient was prescribed with Paxlovid on 18Jun2022. Took according to directions for 5 days. The patient received Paxlovid as treatment for Covid-19 from 17Jun2022 to 21Jun2022.  Follow-up attempts are completed. No further information is expected.
Burning scalp; Very fast hair loss.; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0179) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01), administration date: 14Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: TRICHODYNIA (non-serious) with onset 2021, outcome "unknown", described as "Burning scalp"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Very fast hair loss.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of trichodynia, alopecia.  Additional information: Consumer stated he was calling to report side effects after receiving the Pfizer Covid vaccine in May. Consumer stated the side effects began last week but he has not taken any other vaccines and has not changed his lifestyle in any other way. Consumer also stated since his son also experienced the same side effects he figured he should report in case they are related to the vaccine. Consumer stated he does not have a question for Medical Information he would just like to report his side affects. His side effects started last week. He experienced Burning scalp and very fast hair loss. He doesn't know if we can add the notes to this report. his son had the same vaccine in different state same date in May and he got exact same symptoms in Aug. Exactly same symptoms but in Aug. When he got the symptoms last week he was very concerned because definitely it aligns up. They both are not on any medications, they both are very healthy. They have exact same symptoms. That's the son got in Aug and he got it now. So, to him get very concerned. Consumer further stated, So he get any kind of follow up because he need to know if anybody else will have same symptoms. He needs to know that. It's very sad. he need to know anybody else 'has symptoms' but is there a way for him to find out if anybody else reported this kind of side effect?"  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101504353 similar report from same reporter
Extreme fatigue; Sore arm; Nausea; Flu like symptoms; Pain in belly; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Extreme fatigue), pain in arm (Verbatim: Sore arm), nausea (Verbatim: Nausea), influenza-like symptoms (Verbatim: Flu like symptoms) and abdominal pain (Verbatim: Pain in belly). The outcome of the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain were not reported.   It was unknown if the reporter considered the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain to be related to Shingrix.     It was unknown if the company considered the fatigue, pain in arm, nausea, influenza-like symptoms and abdominal pain to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2023 The reporter did not consent to follow up.
7 days after receiving the Moderna COVID-19 vaccine, pt called to report redness starting at the injection site. Erythema and itching at the site expanded to 7x9cm plaque. Mild induration. No drainage, no fevers, no chills, no fatigue or systemic symptoms. Slight enlargement overtime.  Pt covered with abx for cellulitis, topical steroids, and antihistamines. Thought to represent a delayed hypersensitivity reaction.
Dose 1 of vaccine was received on 4/1/21. side effects were minimal (soreness, hot flashes). On 4/7/21 itching, redness and soreness started to occur at vaccine site. Cold compress was applied.  Itching, soreness, swollenness and redness begin to spread at injection site and got hard.  Patient will be making a visit to urgent care 4/10/21.
Vaccine administered 5 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 5 days after puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-332834 (Patient Link).
Numbness and tingling around lips  started 18 minutes following administration of injection and began spreading to cheeks.  Administered one epi-pen in left thigh.  Improvement of symptoms took 15 minutes post-administration of epi-pen.  Seen by PA on-site
within 1min of injection: Dizziness/Vertigo, Sense of impending doom, Elevated heart rate, Heat/chill waves
pain/sore at the injection site; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Blood pressure increased and High cholesterol.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue). On 30-Oct-2021, VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (pain/sore at the injection site) and FATIGUE (Fatigue) to be possibly related.    Patient race mentioned,  and anatomical location given as Deltoid. No concomitant medications were provided. No treatment medications were provided
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 108 of 190 adult male patients described by the reporter.  No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
began crying 2 hrs p/immun-cried for 4 hrs solid; felt warm to touch local reaction reddness & swelling @ site;
lymphnode at left arm, where shot was given, it resolve within 2 days. Narrative:
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves Adult female patient (age was not reported) who experienced drug allergies, while she received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced drug allergy. (Other relevant tests included no lab data.) Final diagnosis was drug allergies. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for drug allergies. List of documents held by sender: none.
For 2nd shot, I had multiple pulmonary embolisms and had to go to emergency room to have 35 blood clots removed.  Was told this was a side effect of the Covid vaccine.  For 3rd booster shot, I have had spinal stenosis within 2 weeks after receiving the booster shot.  I have lost motor control in legs and have severe pain in my back and thighs.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2015. Concurrent medical conditions included Wheelchair user.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was being treated with antibiotic and would consult HCP for advice when to reschedule second Moderna vaccine.  Concomitant medications were not reported.
Patient refers to Paramedic of shift, feeling dizzy, blurry vision and looks pale. Vitals are taken. Pressure 110/70, Pulse 59, Sat 98. Mother reports patient suffers from  anxiety.
Hives and swelling of tongue. 12/4/2009 records from Allergy MD, most recent visit 11/16/2009 with c/o's urticaria, swelling of face and tongue, headaches, cough and wheezing. Tx'd benadryl  12/9/2009 PCP visit 11/13/2009 patient with c/o's rash. itching Rx'd benadryl
admitted to  Hospital 9/06/2021 through emergency room with  fever, cough, SOB, loss of smell/taste, runny nose, congestion, vomiting, diarrhea, wheezing, headache, fatigue, myalgias, chills, memory issues, "brain fog". Still admitted as of 9/09/2021
I95.9 HYPOTENSION 8/6/2023 SEIZURE, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 8/6/2023 SEIZURE, UNSPECIFIED
pt recv vax 9OCT95 & exp nausea, lethargy, & feeling lousy;
I had a very regular menstrual cycle before receiving the shot and have not had one since and have no other reason to have stopped.
Left upper arm & shoulder; edema & warm with pain 6/10 with movement; itching; T 98.8 degree; tiredness; tender on palpation to underarm; motion was abnormal seen at TMC by medical provider 16 Jan 09- Rx BENADRYL & Ibuprofen
I was 6 week pregnant at the time of my second vacine dose. My 8 week ultrasound found that the baby was probably 6 weeks and they couldn?t find a hear beat. The miscarriage was confirmed on the 28 of May.
This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex smoker (smoker for 30 years and had quit 18 years ago), and concurrent conditions included: hypertension, thyroid disorder, asthma, cholesterol, COPD, and seasonal allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Age at time of vaccination 71 years old. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4, 99.9. On 06-APR-2021, the patient experienced stomach hurt, chills, fever, and headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach hurt, chills, and headache on 06-APR-2021, and fever on 10-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20220421138.
Feel a little weird, so very fatigue; Feel a little weird, so very fatigue; This is a spontaneous report from a contactable consumer (patient). patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had the first dose almost a week ago and when patient had the vaccine her arm wasn't even sore, she really doesnt feel like she had any reaction to it at all, but today which is almost a week since she had the first dose, she felt a little weird, so very fatigue and just wondering one could had a reaction to vaccine this far. Reporter seriousness for Feel a little weird, so very fatigue was unspecified. Outcome of the events was unknown.  Information about lot/batch number has been requested
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, also reported as on 21-SEP-2016, the patient was vaccinated with an unspecified dose of VARIVAX (Lot # K016132, expiration date 21-SEP-2016) (dose was not provided) which had been improperly stored. Concomitant medications were not reported. No adverse effects were reported and there was no PQC involved. This is one of several cases from the same source (MARRS # 1607USA006955 and 1607USA006956). Additional information has been requested.
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42 year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), intramuscular, administration date 15Jul2021 (Lot number: ER8735) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. No other vaccine in four weeks. The following information was reported: MYOCARDITIS (hospitalization) with onset 16Aug2021, outcome "recovering", described as "Myocarditis". The patient was hospitalized for myocarditis (hospitalization  from 2021 to 2021, duration: 1 day(s)). Therapeutic measure colchicine was taken as a result of myocarditis.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.