chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she was not due for her monthly menstrual period for another week, so she found, passing the clot, odd.; Blot clot/Very big blood clot, that passed out of body; Fever, of 102; Sore arm; This is a spontaneous report from a contactable Other HCP (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:00 (Lot Number: ER2613) as single dose for covid-19 immunisation.  Medical history included ongoing asthma , contraception. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for contraception from an unspecified start date and ongoing.  The patient previously took bactrim and experienced drug hypersensitivity. The blood clot only was for one day on 31Mar2021, and it was one blood clot. The patient went to the bathroom and it was passed, one time.  The patient was not due for her monthly menstrual period for another week, so she found, passing the clot, odd. The patient menstrual period did happen on time and it was normal. The patient was not due for her menstrual period for another week, and she takes birth control.  The patient contacted her Gynocologist, and it was confirmed that she was not pregnant, and states her menstrual period happened on time. The clot did not happen again. The patient had Fever, of 102 on 30Mar2021, the temperature resolved in a day. The patient took Aleve, drank a lot of water and napped, reclarifies, and the temperature improved. The patient experienced sore arm on 30Mar2021. The outcome of event Clot blood was recovered on 31Mar2021; outcome of event Fever was recovered on 30Mar2021; outcome of event Sore arm was recovered on 01Apr2021, outcome of other event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Thrombosis and Menstrual Disorder 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.
At 8:25am, client complained of SOB and dizziness, evaluated by EMS on site.  Client feeling better at this time.  At 9:00am  client released by EMS to home.  No further evaluation needed.
Additional booster: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date. Vial was initially stored in the refrigerator on October 24, 2022 and administered to patient November 28, 2022. No symptoms.
Fever 99.7 F, chills, muscle pain, fatigue, malaise, headache, GI disturbance
This is a spontaneous report from a non-contactable physician. A patient of unspecified age, ethnicity, and gender received a single dose of PREVNAR, via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pronounced local reaction with an outcome of unknown. No follow up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of productive cough in a 81-year-old female patient who received BOOSTRIX. Co-suspect products FLUZONE HIGH DOSE. Concurrent medical conditions included blood pressure high abd diabetes. Concomitant products included antihypertensive nos, insulin nos and diuretics nos. On 2nd October 2015, the patient received BOOSTRIX and FLUZONE HIGH DOSE. On 2nd October 2015, an unknown time after receiving BOOSTRIX, the patient experienced vaccine administered at inappropriate site. On 11th October 2015, the patient experienced productive cough. On an unknown date, the patient experienced feelings of weakness, tiredness and shortness of breath. The patient was treated with MUCINEX. On an unknown date, the outcome of the productive cough was not recovered/not resolved and the outcome of the feelings of weakness, tiredness, shortness of breath and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the productive cough, feelings of weakness, tiredness and shortness of breath to be related to BOOSTRIX. Additional details were provided as follows: This case was reported to a doctor. This case was reported by the patient's daughter. Concomitant medications included heart medicine, high blood pressure medicine, insulin and water pills. The reporter stated that the patient was not feeling well prior to receiving BOOSTRIX and FLUZONE HIGH DOSE. The reporter tried to get her mother to wait a couple of days before going to the pharmacy. On 2nd October 2014, at 11:30, the patient received BOOSTRIX in gluteal region of deltoid region, which led administration of vaccine at an inappropriate site. On the same day, the patient received FLUZONE HIGH DOSE vaccine. On 11th October 2015, 9 days after receiving the BOOSTRIX and FLUZONE HIGH DOSE vaccine, the patient was coughing up a lot of mucus (productive cough). In October 2015, less than a month after receiving BOOSTRIX and FLUZONE HIGH DOSE vaccine, the patient was feeling weak, tired and had shortness of breath. The healthcare professional was contacted and the patient was instructed to go to the emergency department if she continues to feel bad. The reporter was not sure if the symptoms which her mother was experiencing was due to taking BOOSTRIX or FLUZONE. The patient seems to feel that taking BOOSTRIX gave her the whooping cough instead of preventing it.
PNEUMOVAX 0.5 ml IM given Left Deltoid 10/22/18/ at 3:48pm. Patient called 10/23/18 at 8:40am with complaints of left deltoid redness, swelling, no fever, reported to PA. Patient instructed to TYLENOL as needed and ice to area as needed. On 10/25/18 at 9:07am patient reported, left arm redness and swelling persists and see/evaluated same day at 1:45pm by PA. Patient diagnosis left arm cellulitis was treated with steroids.
None noted or reported at the time of the event. No adverse outcomes noted. No signs and or symptoms noted at the time of the event or thereafter.
Complaint of tender knot in back of neck with pain radiating to her left ear.  Temperature of 101
red rash has appeared from the left shoulder down to the elbow and deep soreness into the left breast area
This spontaneous report as received from a pharmacist refers to her currently 60 year old sister. The patient's concurrent conditions included breast cancer and penicillin allergy (reported as upper respiratory distress). On 27-MAR-2015, the patient was vaccinated at unspecified pharmacy with ZOSTAVAX, lot # K007986, expiration date 03-SEP-2015, (dose, route and site of administration were not reported). Concomitant therapies included tamoxifen, propranolol, CITRACAL, ZYRTEC. On 30-MAR-2015, the patient broke out with red raised area near her ear. No lab tests were done. Attention via making appointment with her physician. During the visit, the patient was diagnosed with shingles. VALTREX was suggested as a treatment for the event. The outcome of herpes zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
awoke crying ate several bites of food; vomited-began jerking for several seconds; lips white; lethargic state for 10-15 mins w/difficulty arousing 1/2hr later appeared nl again;
No adverse event; Lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Lot that had been expired was administered to patient).    Person number was reported as 120798. Patient age was reported as 75 years 03 months. No concomitant medications were reported. Completion date was reported as 30-Jun-2022.     Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022 from the vial with lot number O70H21A.   No treatment medications were reported.
On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nostrils, burning throat. I went to sleep and later at 1 am in the morning I woke up and had an extremely painful sore throat.  The next day (Day 2) began the severe chest congestion and nasal congestion. This interfered with my asthma and ability to breathe. I also had body aches, and severe nausea and headache. Each day the symptoms seemed to increase not get better. Day 3 was severe enough for me to contact my physician as I didn?t feel it should be getting worse. I also had Diarrhea on Day 3. Finally I started taking Sudafed on Day 3 which helped alleviate the congestion symptoms while taking but I could tell it wasn?t better when the medication would wear off.  Day 4 the coughing was so severe my chest started to hurt and I started to have Armpit and breast pain  under the arm on the side of the injection site. Day 5 I started to get a severe Ear Ache in my left ear. I cannot be up and out of bed for more than a few minutes or the nausea gets too severe. Day 6 is today and I called my Physician again.  They agreed that the symptoms should not be lasting this long and had me rapid tested for Covid-19 which came back negative.  I went in for an office visit and it appears I have a secondary infection in my throat (possibly caused by the drainage).  They prescribed me Azithromyzcin for the infection,  Cough syrup with codeine for the cough, and Zofran for the nausea. They told me to alternate Tylenol and ibuprofen for the other aches and pains and to call them Friday if symptoms do not improve.  I have already missed 3 days of work and the doctor just wrote me a note for 3 days more off of work because I?m so nauseated I can?t move around.
Individual received Pfizer 5-11 year old dose. Should have received >12 year old dose.
pt recvd vax 26OCT93 & 28OCT93 devel a low grade fever, achiness, & extreme pain in arm; pt recovered from sx;
After first dose of Pfizer COVID vaccination patient reported throat itchiness. RN administered Benadryl 25 mg oral and monitored patient for improvement. Symptoms resolved and patient left clinic. No respiratory distress noted. Vocalizing without hoarseness or difficulty
Pt received KINRIX 2 days ago. This AM noticed red arm in deltoid area and was nauseated, no fever detected, then she started shaking, jerking and fell backwards and became limp, hit head when falling backwards. A seizure-like episode lasted less than 5 mins and 911 - called - VS stable, went to ER and referred to neurologist.
4-5 cm erythema, enduration on left thigh, noticed redness abd swelling left thigh 9-24-03 better today
low grade fever off and on (up to 99.8); Achiness; Chills; Arm a little sore; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 61-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, in the left arm on 25Feb2021 at 15:30 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history includes, patient had allergies to medications, food, or other products: sulf drugs, flagyl, seasonal allergies. Concomitant medication included tacrolimus, bupropion hydrochloride (WELLBUTRIN), ibuprofen, pseudoephedrine hydrochloride (ADVIL COLD & SINUS), levothyroxine sodium (SYNTHROID) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. It was reported that, on 25Feb2021, the patient experienced low grade fever off and on (up to 99.8), achiness, chills off and on for a couple of days and Arm a little sore. Patient had received treatment, Advil and Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.8 on 27Feb2021 and sars-cov-2 test (Nasal swab): negative on 27Feb2021. Patient was uncomfortable replying to query, as this was private information for her. Outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
She is constipated. GI Doctor sent GeneraLac and liquid Glycerin suppositories. So far, only she goes with the suppositories. Before the vaccines she used to do it everyday (twice per day).
Had headache plus swelling, redness, and pain at vaccination site for the first 3 - 4 days following vaccination and then it went away.  No symptoms for 2 days. Then vaccination site became red again and itchy, on 6th day after vaccination.  Still red and itchy as of 9th day after vaccination. Sinuses also slightly congested, plus a hint of headache.
Pain in her arm extending to the legs; felt so sick; chest pain; lips got swollen up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up). At the time of the report, PAIN IN EXTREMITY (Pain in her arm extending to the legs), MALAISE (felt so sick), CHEST PAIN (chest pain) and LIP SWELLING (lips got swollen up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant products included Thyroid medication. Treatment medication included Penedral.
Arm pain that has progressed, she describes this as muscle pain, not joint pain; Arm pain that has progressed, she describes this as muscle pain, not joint pain; She is not using her arm much now; This spontaneous case was received on 27-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-04336) and concerned an 80-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-2020, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine; dose: 0.5ml, anatomical location: right deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was P100261242 and expiration date: 30-Jun-2021.  On an unspecified day in Sep-2020, a week to ten days after receiving Afluria Quadrivalent vaccine, the patient developed arm pain that progressed. The patient described that pain as muscle pain and not as joint pain.   On an unspecified date in 2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient was not using her arm much. The patient did not receive any treatment medication.   At the time of initial reporting on 27-Oct-2020, the patient had not recovered from events.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment:The patient developed mobility decreased, pain in extremity and myalgia several days after vaccination with the suspect product, Afluria Quadrivalent. Chronology seems plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed mobility decreased, pain in extremity and myalgia several days after vaccination with the suspect product, Afluria Quadrivalent. Chronology seems plausible. The patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Patient received trumemba vaccine and approximately 45 minutes to 1 hour later, the  patient reportedly  felt nauseous, broke out in hives all over her body. She had a headache and felt dizzy as well. She reported that she  had pain from her  head all the way down to her groin area. I spoke to her over the phone during this episode. I instructed her to take  50 mg of benadryl and  800 mg  of ibuprofen. Her symptoms resolved in 45 minutes after taking those medications.
A day or two after receiving my booster shot, I noticed that I had a rash on the right side of my body. I had been wanting to get the shingles shot, so I knew what to look for when the rash appeared. I called my doctor and went to see an NP on Friday. She told me that it was definitely shingles. I was given Valacyclovir to take for 7 days. As of today, it looks like it's going away.
PT STARTED TO DEVELOP LT ARM AND SHOULDER AREA PAIN 12 HRS POST INJECTION. BY SUNDAY, NOTICED LT AXILLARY LYMPH NODE ENLARGEMENT
Breast Cancer diagnosis in Cancer diagnosis 12/28/2020, right breast, Ultrasound 03/05/2021. Ultrasound, 04/29/2021, I was preparing for a lumpectomy due to recent breast cancer diagnosis right breast, and the team noticed that was significant swelling in the left under arm. Since this was present of the on the opposite of the right breast cancer diagnosis. In preparing to care directive they decided it was no indication in left breast the assumption was that the lump nodes were produced because of the vaccination. I received a sonogram under arm left under arm and I am still being monitors. Still focus on the treat of the know cancer and it is still being monitored. Lymph node swelling was on same side of the vaccination. Ongoing treatment sonogram on May 17, 2022. Crate a base line with first test to second and third test would be needed.
The vaccine received, determined to have a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the manufacturer.
Patient started having symptoms of cough, shortness of breath, and chest pain 4 days prior to ED presentation. On initial presentation, patient was hypoxic to 84% on room air. He is currently 93% with 15L O2 by nonrebreather. The patient is positive for COVID-19 by rapid test. The patient has been given 6 mg dexamethasone PO and 2 g magnesium sulfate IV. Patient is being admitted to the hospital.
Fever, Chills, Extreme weakness (could not stand on own), nausea, extreme join pain, Severe headache (worse than any migraine), severe muscle aches (could not move), SWELLING OF HANDS, FEET AND ANKLES .  Called her health care provider on 2nd day.  They told her it was all normal.  Went to hospital urgent care  on April 21.  Was given a  PCR Covid Test that was reported negative 3 days later.  Given one anti-inflammatory injection and RX for cyclobenzaprine 20 mg.
Reddened inderated area around injectiono site approx 6-7 cm in diameter.
Sore arm for 24 hours.; Off label use; Booster 3 rd dose; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Sep2021 at 12:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension and known allergy to poison ivy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 26Sep2021 at 16:00, the patient experienced sore arm for 24 hours. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm for 24 hours was resolved on 26sep2021 at 16:00, after the duration of 24 hours.   The lot number for BNT162b2 was not provided and will be requested during follow up.
I started feeling pain in my left arm, neck, and lower left back right afterwards.  I called in and I was told that is a normal response.  I complained again, and I was told the same.  Finally, treatment began with a check up in February 2020.  This included adding diclofenac sodium which helped a little.  I rated  my pain at a 7/8.  It was getting so I couldn't work.  The pain worsened.  I had X-rays and a CT scan that revealed a tear, I believe in my muscle.  By April 2019 I was unable to work anywhere do to the pain and lack of sleep.  My APR tried cyclobenzaprine and that did not help.  She tried trazadone to help me sleep.  It did not help.  I had a total shoulder replacement on 11/9/2020 at the recommendation of a referral doctor, Dr.  I am still experiencing pain in my left neck and back.  The pain in my left arm has, so far, reduced to a 2/3.
little aching in the injection site(arm); This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that: a female patient of an unspecified age received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and expiration date were not reported) dose 2 via an unspecified route of administration, administered in Arm on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got the 2nd dose of Covid 19 Vaccine yesterday, she's feeling good and no side effects at all, a little aching in the injection site (arm) on an unknown date in Feb2021 but she said that it's fine. Want to know if she can take the prescription Cyclobenzaprine, just wondering if this drug will interfere with the vaccine. The outcome of the event resolved on unknown date in Feb2021.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
no adverse events, the family lied to get covid shot, child was only 17 years old wrote 18 on the form