chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came in the pharmacy concerned she felt a small lump on the back of her left arm where she received her vaccine. Upon examination is was red, inflamed (size of lemon) and warm. Her doctor was called who informed her to come in so they could look at it. Cephalexin was prescribed and OTC Ibuprofen.
Swelling at the injection site, fever. AUGMENTIN given for seven days. Reaction to PREVNAR 13.
A health care provider reported that an unidentified person received Flu Shield (2001-2002) vaccine. The pt was reported to be in a hospital bed. The pt experienced a "serious reaction to Flu Shield and may die". No additional information was available as of the date of this report.
pregnant at time of vaccination O13.4 - Gestational (pregnancy-induced) hypertension without significant proteinuria, complicating childbirth
6/29 Early AM Fever started and also occurred the next night 6/30 by 7/1 noticed bumps forming on face, head and neck. Each bump described as small with a water point that breaks then scabs over. As of 7/2 vesicles are spreading to low back belly and legs. States she a about 20 and is feeling better no fever last night or today.
This spontaneous report was received from a certified medical assistant and refers to a 29 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 08-JAN-2016, the patient was vaccinated with the third dose of RECOMBIVAX HB, lot number L029631, expiration date 14-AUG-2017, (dose, anatomical location and route were not reported) that experienced temperature excursion. There was no concomitant medication reported. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 19 months old child patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Child became weak, dizzy, cold sweat, pale, almost fainted, pupils pin point. B/P 84/50. Treated with ammonia inhalent, cold clothes, fluids. Recovered slowly over five minutes. Pupils remained pinpoint but B/P 90/58. No failt.dizzy.
Heavy period; A normal period for me last 3 days and I typically have higher than 28 day cycles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 17:00 (Lot number: 0733847-10389) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product-COVID 19, brand-Pfizer, lot number: 0729293-10389,, administration time: 04:00 PM,, vaccine location: Right arm,, dose number: 1), administration date: 10Aug2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Heavy period"; MENSTRUATION IRREGULAR (non-serious) with onset 08Sep2021, outcome "not recovered", described as "A normal period for me last 3 days and I typically have higher than 28 day cycles". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Adverse event: I have had a heavy period almost every single day since a week after getting the second vaccine on 31Aug2021. It started around 08Sep2021 and it's still persisting today (30Sep2021). On 08Sep2021 it lasted till 15Sep2021. Spotted a little and started back up 17Sep2021 and lasted until 26Sep2021 and started again today at on 30Sep2021. I am very concerned. As this has never happened to me. A normal period for me last 3 days and I typically have higher than 28 day cycles.  Follow-Up (08 OCT2021): Follow-up attempts are completed. No further information is expected
Swelling in left arm down to hand and fingers. My hand and fingers went numb until I took Tylenol. Less than 24 hours I was in severe pain. Felt like my bones hurt. Swelling on the left side included my armpit and left side of the torso down to the waist. The pain stayed for another day. Felt like I had the flu. Swelling in the armpit and upper left torse stayed for about three weeks. Wednesday, March 17 I went to the ER for chest pains, throat tightening, pain from my shoulder to my hand on the left side.
This spontaneous report was received from a male patient of unknown age reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 22-FEB-2019, the patient was vaccinated with a a crystal clear appearance (product colour issue) VAQTA 50U/l.0ML(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. No adverse events were reported. At the time of the report, the outcome of product colour issue, was unknown. The reporter di d not mention the causality assesment between the event of product colour issue and VAQTA vaccination.
limp, gray, pale, poorly responsive, emesis, 4hr p/shot possible sz;
Blood on their stool was found; Patelet count has been going down; A spontaneous report was received from a healthcare professional concerning a 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased.  The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included sacubitril valsartan sodium hydrate, ivabradine hydrochloride, sitagliptin phosphate, Isosorbide mononitrate, Clopidogrel, and Rosuvastatin.  On 11-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027720A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8/Feb/2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  A week or two after the second dose, blood in his stool was found and happened 5 times approximately, and platelet count went down and then went slightly back up. The patient does not have any bruises, no fever,  or any other reactions. The patient was on blood thinners, but once he complained about the blood in his stool, they were stopped.  Treatment details were not provided.    Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of events,  received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased, was considered recovered resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding all other etiologies, a causal relationship with the event cannot be excluded
Please note that I previously received the first dose of Pfizer but had an allergic reaction. I was receiving the Jansen per cdc guidelines. Severe aches and all over body cramping. Chills, nausea and vomiting. Fever up to 101.2 which reduced after acetaminophen. This is the next day, fever is gone but unwell
Today, parent reported that evening of vaccination on 5/2/2011, child had fever for several hours at 104 degrees F. Highest temp. 106 degrees F, unrelieved with TYLENOL. Mother reported ER visit but could not state what treatment was given other than more TYLENOL.
Initially pain at injection site; headache; Next day had body aches; low grade fever 100 degrees; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at first dose left arm on 18Dec2020 08:00 at single dose for covid-19 immunization. None medical history. No Known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. There was no other vaccine in four weeks or two weeks. The patient experienced initially pain at injection site next day had body aches, low grade fever 100 degrees, and headache on 19Dec2020 07:30 AM. Patient received acetaminophen as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were non-serious.  Information on the lot/batch number has been requested.
Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use were also not provided No treatment information was provided
Moderna COVID-19 Vaccine EUA Main issue is metallic taste in mouth still comes and goes Noticed it immediately after vaccine Then noticed it 1-2 days later Since then, metallic taste seems to come and go throughout the day each day  Other more minor issues that resolved: fatigue, headache, dizziness, fever, arm pain
The first night I experienced pain on the injection site of the arm. Tongue was very swollen the next day. I went to the emergency room and was given medication.
high fever; chills; uncontrolled shivering; diarrhea; fatigue; malaise; confusion; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 17:45 as dose 5 (booster), single (Lot number: GH9693) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MEDICATED BP" (unspecified if ongoing); "HYPOTHYROID" (unspecified if ongoing); "UNPROVOKED DVT" (unspecified if ongoing). Concomitant medication(s) included: XARELTO; SYNTHROID; BENICAR; VALACYCLOVIR [VALACICLOVIR]; AREDS; VITAMIN B12 NOS. Past drug history included: Doxycyclin, reaction(s): "Known allergies: DOXYCYCLIN". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: PAA156051; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM), administration date: Jan2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Location of injection: Arm Left; Vaccine Administration Time: 10:30 AM), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3, SINGLE; Lot Number: FD8448; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: Aug2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (DOSE 4, SINGLE; Lot Number: FM7553; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: May2022, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CONFUSIONAL STATE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "confusion"; DIARRHOEA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "high fever"; MALAISE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "uncontrolled shivering"; ABDOMINAL DISCOMFORT (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "upset stomach". Therapeutic measures were not taken as a result of pyrexia, chills, chills, diarrhoea, fatigue, malaise, confusional state, abdominal discomfort.   Follow-up attempts are completed. No further information is expected.
fever, spiking 103, 3 hrs post inject; 2nd day feeling better; 3rd day no fever or h/a;
2.5 cm lesion on the rt brain stem; paralysis on lt side of body; Pred given;
Information has been received through the pregnancy registry for varicella virus vaccine from a physician concerning a 35 year old Caucasian female with a herniated disc who on 21-MAY-1999 was vaccinated with one dose of varicella virus vaccine live (site unknown). On 03-AUG-1999 the pt learned that she was pregnant. An ultrasound was done on 16-DEC-1999 was within normal limits-normal growth/no abnormalities. Illnesses noted during pregnancy included conjunctivitis and the flu. The pt  took acetaminophen and hydrocodone bitartrate (vicodin) from 20-APR-2000 to 21-APR-2000 for the herniated disc. On 03-MAY-2000 the pt delivered a healthy baby boy . Results of the newborn screening panel were all normal at the time of delivery. The rest of the text content has to do with the infant and Dr visits for him
Started with a headache.  Developed fatigue and achiness.  Fever, chills, increased heart rate, pallor.  Temperature max 103 F, lasted 2-3 days.
WEAK, LABORED BREATHING, DIZZINESS. EVALUATED BY EMS-CLEARED
pt recvd vax on 18nov94; 2 hrs later, pt shaking, breathing heavy, cold hands/feet; lips bluish, listless lasted 5min; seen at clinic; t 101.2; fever lasted x 2 days;macular papular rash on trunk on 3rd day;
Severe swelling and redness of arm for 1 week. Ongoing hypersensitivity reaction including itching, food and medication sensitivity that the patient never experienced prior to receiving the vaccine.
felt achy and sore on 5.14.2021 and on 5.15.2021 by the night of 5.15.2021 I was throwing up wen to the ER and was told my liver enzymes were almost 800 in which I was admitted to the hospital.  I stayed in the hospital until 5.18.2021
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out fell on the floor face down paramedics took the pt to the hospital
1st dose Moderna vaccine, had covid in Dec that lasted until mid January and the vaccine caused the same symptoms as covid, extreme headache, sinus build up, respiratory discomforts, discomfort in limbs, fatigue, weak on feet, dizziness, muscle pain, vomiting, diarrhea, joint pain, ear buzzing, and I'm supposed to get 2nd dose in 19 days and I don't know if I can tolerate it.
After 4 days of patient receiving the vaccine, mom contacted primary care provider via message and stated "It?s been 4 solid days since Jagger got his booster shot and he has a massive headache, no fever but cold and ache, stomach hurts, no vomiting, nausea, double vision, dizzy, confused or can?t think straight, extremely tired. His arm is pretty swollen still. I had him stop the menocycline after Sunday morning because some of the symptoms seemed from it, but they aren?t going away."
10/24/02 Fever and cough for 1 day. Received Prevnar vaccination 8/30/02 and 10/23/02. Diagnosed with Invasive Pneumococcal Disease
pt recv vax 5AUG98 & awoke next morning w/a red rash @ site, spreading down arm to elbow;pt c/o itching but denies any pain;
I had horrible joint pain beginning that evening.  So bad that I could not sleep.  My hands, hips, and feet were the worst.  The pain has subsided somewhat over time,  but is very bad certain days.   It really bothers me in that it has suddenly changed my daily activity, lifestyle and comfort level.  My hope was this would go away, but it is approaching 11 months with little change.  I also wish to denote that I received my booster a few days ago.  I received the Pfizer and had nearly no reaction to it.  I only had mild discomfort at the injection site...
Mild headache by late afternoon. By 11pm I had very bad chills, that were followed by nausea, then muscle and joint aches. This also happened after the first shot two months ago. Then I had a fever of 101. This time, I don't think there was a fever, even though I had chills. Rough!
Infected bursa. Inflamed (R) lower arm. Clindamycin IV and PO.
diagnosed with Hashimoto's Thyroiditis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program.   A female patient of an unspecified age received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), both via an unspecified route of administration on unspecified dates as single doses for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was recently diagnosed with Hashimoto's Thyroiditis on an unspecified date. The patient stated she has started taking medication for the Hashimoto's Thyroiditis but did not disclose the medication name. Patient was interested in getting a Covid 19 booster but wanted more information. Outcome of the event was unknown. The lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.
My sister took the shot and then she got shingles/Suspected vaccination failure; Then she got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 4-June-2022 Reporter's comment: This case was reported by a patient's sibling via interactive digital media. The patient took shingles shot and she got shingles not longer after. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Pt received first Pfizer COVID 19 vaccine on 5/8/2021.  Pt became ill with COVID and was admitted to the hospital for treatment on 5/15/2021.
blacked out; Nausea; chills; sweating; muscle weakness; arm pain; fever; fell; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318) via an unspecified route of administration on Right arm, at the age of 32-year-old, on 27Feb2021 13:15, single dose, for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease.  Concomitant medication included esomeprazole magnesium (ESOMEPRAZOLE [ESOMEPRAZOLE MAGNESIUM]) and garlic supplement.  The patient previously took amoxicillin and experienced drug hypersensitivity and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6198) on 06Feb2021 13:15, at right arm, at the age of 32-year-old single dose for covid-19 immunisation.  On 28Feb2021 at 04:00, 15 hours after the shot was administered, the patient experienced nausea, chills, sweating, muscle weakness, arm pain, fever, fell and blacked out twice. The patient did not receive any treatment in response to the events. The patient was not diagnosed with covid prior vaccination and was not tested for COVID post vaccination. Outcome of the events was recovering at the time of the report.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported loss of consciousness 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.
04/13 30-60sec after the shot felt a metallic taste in mouth that she cant get rid of it got intense after 45 mins, and numbness in nose and lips started 1:00p.m. Recommendation: none pt. was just calling to report reaction she is an RN
COVID Vaccine Breakthrough Case  Pfizer Dose 1 5/6/21 (ER8736) Pfizer Dose 2 6/11/21 (EW0164) COVID Positive 9/1/2021  9/1/21: Presented to ED. 41-year-old man who presents with acute onset of nosebleed about an hour prior to presentation.  He presents with severe bleeding from the nose which was not controlled by compression at home, onset approximately 1 hour prior to presentation.  He had also noticed petechial rash over his trunk and extremities during the course of today, as well as bruises to his face and eye without prior trauma.  He also notes bleeding from his mouth from intraoral lesions which were noted upon awakening.  He denies any fever, bone pains, sore throat or significant lymph node swellings.  He denies any family history of hematologic disease or malignancy.  He presented to the emergency department where laboratories remarkable for platelet count of 1000.  Epistaxis course controlled with the application of a nasal rocket soaked in TXA and epinephrine.  He will be admitted to the hospitalist service for further treatment and hematologic evaluation.  9/7/21: 41-year-old man who presents with acute onset of nosebleed about an hour prior to presentation.  He presents with severe bleeding from the nose which was not controlled by compression at home, onset approximately 1 hour prior to presentation.  He had also noticed petechial rash over his trunk and extremities during the course of today, as well as bruises to his face and eye without prior trauma.  He also notes bleeding from his mouth from intraoral lesions which were noted upon awakening.  He denies any fever, bone pains, sore throat or significant lymph node swellings.  He denies any family history of hematologic disease or malignancy.  He presented to the emergency department where laboratories remarkable for platelet count of 1000.  Epistaxis course controlled with the application of a nasal rocket soaked in TXA and epinephrine.  He will be admitted to the hospitalist service for further treatment and hematologic evaluation.  While on admission his ITP workup was negative but he tested positive for COVID which could be the cause of his thrombocytopenia  He is s/p 3 doses of IVIG and 4 days of IV steroids  Oncology was available by phone consultation and ENT was consulted for epistaxis and he had his nasal packing removed 9/6  Patient's platelet count improved on above treatment. Today platelet count is 39 k with no active bleeding  Patient was cleared for discharge by oncology to follow up next week mon and tuesday. Case managers to set up appointment  He was also advised to follow up with ENT  Patient developed some hiccups and will be prescribed baclofen with follow up with his PCP