chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and his wife concerning a 20 year old female patient, with no pertinent medical history and no drug reactions or allergies, who on 12-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot #08662 - lot # not valid as reported, expire date not reported), 0.1 ml, intradermally, instead of administering TUBERSOL. There was no concomitant medication. On 12-NOV-2010 the patient was experiencing a localized "wheal and flare" reaction with redness and swelling at the site of the injection. There were no laboratory diagnostics studies performed. The patient sought medical attention; she was monitored by physician in the office. At the time of the report the patient had not recovered. Additional information has been requested.
blood clots in both her legs.; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) based on information received by Pfizer from agency (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-075012), license party for apixaban (ELIQUIS).   A 91-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunisation; and apixaban (ELIQUIS), oral from an unspecified date (Lot Number: 1795397; Expiration Date: Aug2023) to an unspecified date, at 2.5 mg, 2x/day (BID), then oral from an unspecified date (lot number and expiry date: unknown) to an unspecified date, at 5 mg, 2x/day (BID) for deep vein thrombosis (DVT)/ blood clots. The patient's medical history and concomitant medications were not reported. Patient was on Eliquis for blood clots. The patient received the COVID vaccine and within few weeks, she developed blood clots in both her legs. The reporter did not provide causality assessment. The clinical outcome of the event was unknown. Action taken with apixaban was dose increased.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: BMS medical evaluation comment: This 91-year-old patient had leg thrombosis after receiving apixaban therapy and COVID vaccine. Elderly age and underlying thrombotic risk are significant contributory factors for leg thrombosis in this patient and hence it is considered not related to apixaban. Additionally, COVID vaccine could be a confounding factor for the reported event.
1) Patient Received vaccine MMR on 8/21/19 seen @ office 8/23/19 with itchy rash urticaria on trunk. Initially 50mg Benadryl taken 2) Patient referred to allergy specialist & seen within 4 hours. Dx skin rash drug eruption vs allergic contact dermatitis vs idiopathic urticaria. Per allergist dx skin rash - drug eruption vs allergic contact dermatitis vs idiopathic urticaria. To start Zyrtec or Xyzal one pill BID until Rash & itching controlled - then once a day. Also Prednisone taper 30mg day one, 20 mg BID & taper down over 8 days. May need skin Bx if no improved. To follow up @1 week - Patient has not returned for follow up.
Within 10 minutes after vaccination began to get flushed, nauseated, body shakes symptoms resolved after 15 minutes
Pt had TD on 09/07/04 states Left deltoid started to swell and became hot and painful 3 days after injection. States saw pt 1 wk later and treated with Prednisone.
The following day was not feeling well, took some ibuprofen, later in the day the parents discovered that he had some redness and swelling of the deltoid.  Skin is clear, warm and dry.  Has area of redness of about 10 cm in diameter over the right deltoid, no induration fluctuation.  Symptom care discussed, recommended Claritin, ibuprofen or Tylenol.  Cold packs to affected area, follow-up as needed.
meets criteria for vaccine break through. EE vaccinated 12/22/20 and 1/12/21 with Pfizer covid vaccine, but sx on 3/29/21 with positive test 3/31/21..
Had a reaction for three days which is a rash on his body; Rash has worsened; This is spontaneous report from a contactable consumer. This 77-years-old male consumer (patient) reported that.  A 77-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 05Mar2021 at 11:40 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 09Feb2021 (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes type 2 diabetes mellitus from an unspecified date and unknown ongoing and concomitant medications include Janumet. Past drug event includes metformin induced unknown reaction, He used to take Metformin before he took Janumet, but his HCP changed him to take Janumet. On 06Mar2021, after the vaccination, the patient experienced rash on his body. Caller states the rash has worsened and is on his back and he has to take Benadryl for it and he used the Benadryl diphenhydramine HCP 25mg for two days; states he used the Benadryl one 06Mar2021 and one on 07Mar2021. Patient received the 2nd dose of the Pfizer Vaccine three days ago which was Friday 05Mar2021 and the rash began the next day on 06Mar2021. The outcome of the events was not recovered or resolved at the time of this report.  No follow-up attempts possible. No further information expected.
Thigh swelled; Thigh turned blood red; Temp shot up to 102; Had a blood curled scream for hours / screaming; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of swelling of legs in a female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced swelling of legs, redness of legs, fever and screaming. On an unknown date, the outcome of the swelling of legs, redness of legs, fever and screaming were unknown.   It was unknown if the reporter considered the swelling of legs, redness of legs, fever and screaming to be related to DTP vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter ststed that after vaccination with DTP  vaccine, the patient's thigh swollen and turned blood red, the temperature shot up to 102 and had a blood curled scream for hours. The reporter reported that, the patient's ob doctor and rimary care said it would be too great of a risk for the patient to take it.      Lab Comments: Lab test performed on an unknown date
Anaphylaxis 30 minutes after injection. Lasted 2 minutes. Came back 20 minutes later for 1 minute. Went away on it?s own both times. Currently pregnant, due November 10.
This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 30-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced enlargement of lymph nodes and product use in unapproved population. On an unknown date, the outcome of the enlargement of lymph nodes and product use in unapproved population were unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 29 or 30 years old. The patient wanted protection from shingles. The patient worked with insurance to gain approval for use outside of approved indication of 50 years and up, which led to product use in unapproved population. The patient had reaction of swollen lymph nodes after 2nd dose of SHINGRIX. The reporter did not agree to follow up from GlaxoSmithKline.
approx 3 1/2hr p/vax pt devel itching on legs around inj site;approx 1hr later itching & red rash devel on arms & trunk;pt was scratching areas;mom brought child back to hlth unit for observation;pt exp red splotches;ear & cheeks flushed;
Patient guardian registered for vaccination on our website and received a link to schedule.  Registration was completed by guardian/parent with same name and DOB 8/23/1976.  The 15 year old presented with the person who scheduled the appointment to the vaccine clinic.  The Check point checked the eligible person in (because they had an appointment) and they proceeded to registration. At some point the scheduled individual was able to say that the ?15 year old? had the appointment and was registered.  From there the patient was able to get vaccinated. The patient was then able to come in and get second dose.
SMALL CELL CANCER 13.33MM IN STOMACH AREA; SMALL CELL CANCER 13.33MM IN LUNG AREA; This spontaneous report received from a patient concerned a 50 year old White Caucasian and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient had no known allergies. The patient had no known drug allergies and had no previously known medical conditions. The patient had no current medication use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021 (3 days after vaccination), the patient had stomach pains and was admitted to the hospital. They found patient had small cell cancer 13.33mm in stomach and lung area. The patient did not think it was due to the vaccine or might be the vaccine brought out the symptoms, but patient was not sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small cell cancer 13.33mm in stomach area and small cell cancer 13.33mm in lung area was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210815327-covid-19 vaccine ad26.cov2.s - Small cell cancer 13.33mm in stomach area, Small cell cancer 13.33mm in lung area. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient states at injection site, a pimple" like pustule with white head has appeared. Patient says sterile technique by the pharmacist was used (vigorous alcohol swabbing and sterile bandage). His MD will continue to monitor, patient is not too concerned.
Immediate Severe burning with Injection, told by pharmacist normal for some...thought I was going to passout hurt so bad. Severe arm pain. Over next few days swelling rectangular shaped, showed pharmacist, again dismissed as normal reaction. Over next few weeks continued arm pain and swelling, as wll as other symptoms, numbness, tingling, burning up to shoulder with decreased range of motion. Then neck started hurting with decrease in range of motion as well. Went to Chiropractor, Xrays-assisted with neck slightly, but continued with pain and decreased range of motion in neck and right arm. Started to correlate onset of neckpain and shot as pain fromn neck down shoulder into lower arm. Went to Medical DR. CONTINUE
08Jan98 Pt recv 1 dose vax 26Jan98 Pt devel herpes zoster. Rash was zoster-like vesicular & papular. Itchy w/3 clusters of lesions 20 lesions each. 04Feb98 Pt presented to MD.PCR analysis revealed inadequate sample. See comments
Pt received vaccine on a Thur - On Fri and Sat developed pain and rash began. Started small, but by Sun rash became bright red and rash grew to the elbow from inj. site. On Sun pain started to diminish. By Mon rash started to lighten and go away. Pt is now recovered.
about 10d later developed redness and itching at the injection site.  self resolved in a few days
have a situation on my arm. it is swollen, hot, and the size of 2 o3 half dollars put together; have a situation on my arm. it is swollen, hot, and the size of 2 o3 half dollars put together; headache; tiredness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. It was reported that the patient had a situation on her arm, it was swollen, hot and the size of 2 "o3 half dollars" put together on 14Jan2021. It was also reported that the patient experienced headache, tiredness  and muscle pain on 14Jan2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from a healthcare professional regarding a 19 month old male patient. The patient did not have any relevant medical history, drug reaction/allergies and concomitant medications. On 25-MAR-2016 the patient was vaccinated with VAQTA 25/0.5 injection, 0.5 ml intramuscularly (lot # N003011, expiry date: 15-NOV-2017). That same night the patient began having a fever, reaching 102 degrees that continued through 25-MAR-2016 and resolved on 26-MAR-2016. On 25-MAR-2016, the patient also developed hives in an unspecified location. The patient's mother (name unspecified) gave the patient BENADRYL and ZYRTEC (doses and manufacturer unspecified) on 26-MAR-2016, which did not help as stated by mother. Hence the patient visited the physician's office to seek medical attention on 29-MAR-2016 and was given ORAPRED. No laboratory diagnostic tests were performed. The reporter stated that the hives were resolving but have not completely disappeared at the time of reporting. Causality assessment was not reported. There was no product quality complaint. Additional information has been requested.
hives in the throat area; itchiness in the throat area; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who experienced hives and itchiness in the throat area after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Mar-2023, the patient received an unknown dose (Booster) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, route, administration site, expiry date and lot number) for Immunisation.  On an unknown date, the patient developed an event of hives and itchiness in the throat area (urticaria) (throat irritation) (latency: unknown) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the reported events
14:30 vaccine administered pt became     flushed,tachycardia,thick tongue.tingleing in lips and through out body. Pt evaluated in Occ Health.  Remained in Occ Health untill 16:00.Pt. was given 25mg.po of Benadryl and a repeat dose in 20 min.Sent home with a 50mg po dost to be taken at HS.HR decreased flushing decreased.Felt fine to drive no grogginess.Fol up next day 6/11/09,mild rash on face and arms.
Fainting (called 911) Fever. Feeling of being very cold. Nausea Extremely restless legs Intense pain in side- turned out to be an appendicitis.
I had COVID 19 in July but after vaccine, severe chills, body aches, temperature, and headache
lost taste and smell; lost taste and smell; I got covid; I got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Apr2022, outcome "unknown" and all described as "I got covid"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 16Apr2022, outcome "unknown" and all described as "lost taste and smell".  Clinical Course: Forwarded as an Adverse Event by the team on 18Apr2022. Reporter provided verification of contact address on 16Apr2022. Customer Verbatim: Just wanted to let you know she got Covid on 13Apr2022. Her booster was 20Sep2021. She had symptoms and just lost taste and smell today. She think she need to let people know they need to get 2nd booster. It was a shame that the 2nd booster decision didn't come out earlier.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
7pm chills, fever 102.4, stabbing muscle pain in random places, achey knee joints, rapid heart palpitations, slight headache chills ended around 10pm, fever started to go down at 10:30, palpitations decreased as the fever declined.  Tylenol at 7pm, Aleve 10:45pm,   Woke the next morning with a headache - drank some water, it has subsided  The heart palpitations were concerning
Pain, swelling, redness, hot around area of injection. Headache. Nausea.
This spontaneous report was received from a certified medical assistant, concerning three (3) patients of an unknown age and gender. Medical history and current conditions were not reported. On 04-FEB-2015, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that was exposed to supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
lower abdominal cramping; achy joints in arms; chills; very, very tired instantly; stomach pain; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMITRIPTYLINE, ATORVASTATIN, LEVOTHYROXINE, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PLANTAGO OVATA (METAMUCIL CITRON) and Dicyclomine as needed for IBS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 26-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), CHILLS (chills) and FATIGUE (very, very tired instantly). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), FATIGUE (fatigue), CHILLS (chills) and FATIGUE (very, very tired instantly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Approximately 15 minutes after receiving her vaccine, patient reported feeling "light headed".  When I was called to help her, she had fainted.  She was able to slowly respond to us and was breathing.   We placed her on the floor laying on her side.  A cold compress was placed on the back of her neck and a pillow was placed under her head.  9-1-1 was called.  When EMS responded, she had normal blood pressure and blood sugar, but was still feeling "out of it".  She was place on a stretcher and taken to the ambulance, but did not get transported.  She had a family member pick her up from the clinic.  She was able to walk from the ambulance to the car on her own.
I had coughing, extreme sore throat, loss of taste, smell and vomiting.
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug adverse event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted on 2/27/21 with acute encephalopathy and suffering progressively worsening mental status. He was admitted for over a month through 3/31/21 where he was eventually discharged on hospice before passing on 4/5/21. His hospital course consisted of treating community acquired pneumonia/bacteremia from hemodialysis catheter placement. Patient continued to have positive cultures despite antibiotics due to a found vegetation on the aortic valve. He experienced functional and cognitive decline over his admission. Comorbidities include vascular dementia, h/o stroke, ESRD on HD, HTN, DM2, HLD
Maculopapular rash on trunk spreading to arms and legs. + Rhinitis, + erythema B/L eyes. Symptoms started 12 days post MMRV vaccine.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Waldenstrom's macroglobulinemia.  No known allergies reported. Concurrent medical conditions included Fatigue.  On 17-Sep-1921, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram once a day. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.  No concomitant medication details were provided. No treatment medication details were provided.  Primary reporter contact for lot number information was not available.  The reporter's causality for the event of fatigue was not provided with IBRUTINIB (IMBRUVICA).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.