chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tenderness around the sockets of eyes; Aches and pains; Mild neuralgia; Fluctuating temperature that spiked as high as 101F; Fatigue; Chills; Small headache; This is a spontaneous case from reported by consumer to agency (ID number: SEQ19-03387) and initially retrieved on 27-Sep-2019, concerning a 52-year-old, male patient.  The patient's medical history included mild hypertension. The patient's concomitant medications included Aspirin (acetylsalicylic acid) for unknown indication. The patient had received flu vaccine shots for several years without reactions.  On 25-Sep-2019, the patient was administered Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml route of administration: intramuscular, anatomical location: deltoid, batch number: 261201, expiration date: Jun-2020) for influenza prophylaxis.  On 25-Sep-2019, the same day of vaccination, the patient developed adverse reaction to the Flucelvax. The patient developed aches and pains, a fluctuating temperature that spiked as high as 101F, and had tenderness around the sockets of eyes. Patient also experienced mild neuralgia and small headaches throughout the day, chills and fatigue.  On unspecified date, the patient started treatment with Aspirin 2-3 tablets every 4 hours. The patient reported that Aspirin only helps for a few hours, and than the high fever returned. The patient reached out to general practitioner (GP). GP suggested to the patient to go to and urgent care clinic, as he was worried about the headaches and intracranial bleeding. The patient advised GP he would wait until Sunday morning to see if he is better before going. GP indicated it was ok to wait until Sunday. Patient noted that the event were ongoing, usually started in the afternoon. The patient also reported, he hasn't had the fatigue he had for the last two days and no chills. Tenderness around the eye sockets continued.  The outcome of the events fatigue and chills was resolved, on an unspecified date.  The outcome of the event tenderness around the sockets of eyes, fluctuating temperature that spiked as high as 101F, mild neuralgia, small headaches, aches and pains was not resolved.  The reported did not provide seriousness but assessed this events as related to suspect drug.; Sender's Comments: A 52-year-old, male patient has experienced eye pain, pain, neuralgia, pyrexia, fatigue, chills and headache associated with Flucelvax QIV. Chronology seems suggestive. Reportedly, the patient had received flu vaccine shots for several years without reactions. Events suggest presence of flu like symptoms, although this event was not reported. Having in mind provided information, causality is assessed as possibly related to all events.
Headache/ headache all the day/ head hurt more; Body ache; This is spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/ lot number and expiration date were not reported (consumer stated KW0171, patient don't know it's, see patient could not read those 31. May be its 0171; O or D, patient don't know), NDC number, UPC number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced sick for 2 days with fever and like a flu type symptoms. It was reported that the patient had second dose of the Pfizer shot on Friday (on an unspecified date in May2021). Patient got like headache and body ache on an unspecified date in May2021, but body ache was away, but headache did not seem to, it was not a severe or worst, but you know was bothering. The patient body ache was gone but headache like not on the temple kind of thing and still experiencing. The patient did not want medical and wanted to know that was still part of this. The patient has been a day off from work for, patient mean they gave a day off, but patient have had 3 days off then the patient was experiencing all days off headache all day. The patient wanted to report but did not need go through hospital. The patient just wanted to know was that part of the side effects that people were experiencing. The patient further stated that the head hurt more on talking with Pfizer drug safety. Patient stated, "patient was calling because patient was wondering, had second dose on Friday and patient was experiencing body ache and headache, body aches went away but headaches patient was still experiencing. Since, patient mean it's already been what Friday Saturday Sunday Monday and today Tuesday and patient was still getting, patient was still having headaches." The patient enquired was this a part of a side effect because the headache did not want to go away. The outcome of the event headache was not resolved and resolved on an unspecified date in May2021 for the other event.  Information about lot/batch number has been requested.
Arm was all swelled up; Red arm; Sore red swollen arm; Arm started to itch; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Sore red swollen arm), VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (Sore red swollen arm) and VACCINATION SITE PRURITUS (Arm started to itch). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm). On 22-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. On 01-Feb-2021, PERIPHERAL SWELLING (Sore red swollen arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm started to itch), VACCINATION SITE SWELLING (Arm was all swelled up) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.            Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up information was received on 07 Apr 2021 had more details about patient, suspect drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reported lip swelling, throat itching and a little hard to breath 30 minutes after injection.  1.5 hours later, patient developed itchy rash on arms/cheeks/neck.  No intervention needed.   Symptoms resolved a few hours later on their own at home.  Patient did not report to MD until 6/7/21
p/vax pt exp bump at inj site; ER noted soft knot about size of nickle in diameter & raised about 10mm;
no known adverse effects; a patient received a dose of PROQUAD 5 days before the patient's 1st birthday; This spontaneous report was received from a registered nurse, referring to a 11-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 30-NOV-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection as prophylaxis (dosage regimen, route of administration and anatomical location were not reported; lot number and expiration date were unknown by the reporter) 5 days before the patient's first birthday (product administered to patient of inappropriate age). No known adverse effects.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 15-MAY-2018, the patient was vaccinated with an expired dose of VAQTA injection, lot number N012324 with expiration date on 05-APR-2018 for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Pain/Swelling @ injection site, Chills Narrative:
-Pt was given COVID19 Vaccine at 9:06AM 2/8/1982. -Immediately, pt felt tight in her chest. -Pt was taken into observation room by myself (PA-C). -She sat down and took off her mask and took a few deep breaths.  -She said she had some tingling in her throat.  -She coughed a few times.  -After 1 minute and some deep breaths, she felt much better and the tightness & tingling went away. -Denied itchy & watery eyes, difficulty breathing, chest pain, itchiness, swelling, rash.  -No rash or swelling was visualized.  -Throat tinging subsided after 10 minutes.  -Vitals were normal throughout entire encounter. -Pt was evaluated by myself and observed by myself for 30 minutes. -Pt was also evaluated by Dr.  -Discharged after 30 minutes.
Developed fever to 103 24 hour after receiving vaccines which resulted om a febrile seizure
This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received BEXSERO. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received BEXSERO and Hepatitis B vaccine. On an unknown date, an unknown time after receiving BEXSERO and Hepatitis B vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not provided. The field representative reported on behalf of healthcare professional that the patient received BEXSERO and Hepatitis B vaccine on same day (date unknown, manufacturer of Hepatitis B vaccine was unknown) and had been experiencing days of pain. No further details were provided. The healthcare professional would like contact via phone as soon as possible.
light headed; Dizzy; Nausea; Tired; Weakness; Headache; Stiffness in her arm; A spontaneous report was received from a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lightheaded, dizzy, nausea, tired, weakness, a headache and stiffness in her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, about 3 minutes post injection, the patient stated she was light headed, dizzy, nausea, tired and weakness. Later in the evening she developed a headache and stiffness in her arm. She stated that  she had to leave work due to how bad the light headedness, dizziness and nausea was. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, lightheaded, dizzy, nausea, tired, weakness, a headache and stiffness in her arm, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SEIZURES; This spontaneous report received from a health care professional concerned a 22 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-AUG-2021, after the vaccination the patient experienced seizures, and also undergone blood pressure and Electrocardiogram (EKG) and was hospitalized for 1 day. The results for blood pressure and EKG were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210802724 -Covid-19 vaccine ad26.cov2.s-Seizures. 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).
vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Travelled a day after vaccine, gradual GI inflammation, went to bleeding, after 6 weeks returned home and got colonoscopy. Since treatment has returned to normal. Given steroids for about a month
Patient received an intramuscular dose of an oral vaccine. Patient recovered well without incident; she was just fussy on the day of receipt of 4 IM injections (instead of 3 with 1 oral dose) with a small knot on both sides where the injections were administered.
pain in the arm from last night and today/a lot of pain in his arm; 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 54 year-old male patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "not recovered", described as "pain in the arm from last night and today/a lot of pain in his arm". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The patient reported that, he received it yesterday (04Aug2021) and he was having a lot of pain in his arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Papular rash, neither pruritic nor tender, progressing over approximately 1 week from bridge of nose to entire body spreading caudally. Rash faded in same rostral to caudal pattern.
Patient began experiencing body aches and headache last night (same day as vaccines). Patient took some ibuprofen and then went to bed early. Patient had a rash develop today and started having a 101.2 fever.
Varicella resurgence, shingles on back and spine causing severe muscle cramping and nerve pain.
Sore arm, Fever, chills, migraine, body aches, felt like I was dying. If improvements to the vaccine are not made, I will not be getting a booster shot. I'm pretty sure I'm not the only person that feels that way. That vaccine is ridiculous, nothing has ever made me feel that bad in my entire life. I am also concerned that I may be pregnant right now although it has not been confirmed by a test.
Pt was given MMR vaccine and within 2 minutes a 1.5 cm urticaria was present with 1 cm of redness surrounding the injection site on the (L) arm mom instructed to give BENADRYL q 6 hrs. Pt active with no mental status changes or activity changes.
vaccinated on day 46 with second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated on day 46 with second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.
This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
has been a rash throughout body; Very itchy; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER 2613) (age at the time of vaccination was 51 years and non-pregnant at the time of vaccination) via unspecified route of administration, administered in left arm on 19Mar2021 03:45 PM as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included hypothyroid, allergies, exzema, high blood pressure and the patient have known allergies to penicillin, rocephin, latex, MI, MCI, fragrance, BOP. Concomitant medications levothyroxine 125, losartan 100, metformin 500, Si. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. It was reported that the biggest side effect for both vaccines has been a rash throughout body. Very itchy. Spots all over face, torso, legs, arms, rash, itchy spots after both vaccines. The rash remained for weeks after first dose and continues today with new spots on a daily basis. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information was expected.
he received his first dose of the vaccine on 14Mar2021 and tested positive for Covid  a couple weeks after the first dose on 24Mar2021; This is a spontaneous report from a contactable consumer (patient, self-reporting) via Medical Information Team. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown and expiration date was not reported), via an unspecified route of administration on 14Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received his first dose of the vaccine on 14Mar2021 and tested positive for COVID a couple weeks after the first dose on 24Mar2021. He did not have any symptoms or anything. He was tested because he had an exposure. He asked if he can still get his second dose on Saturday. He stated he was going to go up there on Saturday and talk to them. He stated that he got an invitation for Saturday to receive his second dose but he was having an issue with the thing using the link that they sent him. He wanted assistance. He stated he cannot use computers and declined the website from the attached document. He stated he will just go up there and talk to them. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
At approximately 42 hours after vaccination developed a rash covering approx. 50 to 60% of body. resolved in less then 12 hours after taking oral Benadryl and Benadryl cream.
States the gland under her chin is swollen. She feels it when she swallows but no trouble swallowing or breathing. No rash, hives, fever, nausea, HA or any other symptoms.
no patient experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, lot # 1660666, expiration date 22-MAR-2021, (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9,4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005638: US-009507513-2006USA005595: US-009507513-2006USA005639: US-009507513-2006USA005636: US-009507513-2006USA005635: