chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient  states that the first SHINGRIX vaccine given on 8/14/2018 also given him a flu like symptoms effect - low temperature & shivers after 5-6 hrs when vaccine was given but did not reveal info at the time of the second immunization. The 2nd SHINGRIX dose  on 2/5/2019 patient state he thought it was given too high on his arm that causes more pain (excruciating) per patient in the first 15 hours and he experience cold feeling waist down and very hot feeling waist down but he also mention no flu symptoms. Per patient  the pain lasted for 3 days but he totally recovered at this time.
Sudden onset of chills, temp of 102.5, generalized body ache, weakness, nauseous, loss of appetite, dizziness, headache.
-On 1/11/21 at 930AM los angeles time, I received the COVID19 Moderna vaccine. At about 1030AM I had a very bad headache and was extremely nauseous for about 3 hours and felt like vomiting but did not vomit. This went away at about 1230pm and I felt my tongue get cold and a metallic taste which went away within the hour of onset. The nausea, headache, and metallic taste was gone at about 1-2pm on 1/11/21. I had a sore left arm on the injection site, which is to be expected and went away within 3 days. On 1/18/21 around 1pm, my arm started to feel itchy at the exact site of the injection from 1/11/21, and there is now (1/18/21) a red rash like appearance on that left arm where the Moderna covid vaccine was injected. Possible delayed local allergic reaction.
On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives.  Burning right side .. (back) then the shingles 3/22 called doctor...
This spontaneous report from a contactable clinical coordinator communicated to a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA on an unspecified date at single dose. The patient medical history was and concomitant medications were not reported. The patient experienced fever, flu like symptoms, and did not feel well on an unspecified date with outcome of unknown.
I had the usual crappy day after my 2nd dose. Feverish, fatigue, etc. On Saturday night (5/1), I had sex with my husband and broke out in hives. The next day, I started a prednisone pack. It started easing up later that day and was mostly gone by Monday. We had sex again on Tuesday (day 3 of prednisone) and the hives started again but were not as bad as the first time. Today (5/13) I saw an allergist. She thinks I may be allergic to seminal fluid. We are going to do some experiments to see if that's the case. If so, I will have had an allergic reaction during my first sexual activity 2 days after getting the second dose. It could be coincidence but I wanted to bring this to your attention ASAP in case others are reporting it or something similar.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, negative (Negative) Negative, negative (Negative) Negative and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was unknown if the patient taken other medications/products within 2 weeks of starting COVID-19 treatment. The patient reported possible rebound of COVID-19 , 11 days after completing paxlovid he felt well for 1 week and tested negative twice and then felt sick again and tested positive again Device Date was reported as 03-Jun-2022  Company comment: This spontaneous case concerns a 34-year-old male patient with no  medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-may-2022 to 17-may-2022. She was tested positive 11 days after the treatment with Paxlovid. It is reported that patient felt well for 1 week and tested negative twice and got sick again and tested positive again. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old male patient with no  medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-may-2022 to 17-may-2022. She was tested positive 11 days after the treatment with Paxlovid. It is reported that patient felt well for 1 week and tested negative twice and got sick again and tested positive again. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
approx. 24 hours after vaccination was given, employee complained of skin hot to touch, red area, tenderness and swelling from site of injection (deltoid) to anitcubital space.  He would be interested to know what he possibly reacted to in the vaccine.  No reaction from the influenza vaccine given in the other arm.
I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01) 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 09-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01). On 09-Jan-2022, EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
The pt received the first and second IM doses of Lymerix to prevent Lyme disease.  Nine days post 2nd dose and 79 days post receiving 1st dose, the pt experienced photosensitivity type rash on his neck, shoulders, chest, and lower extremities. A MD visit or ER visit was required. He was treated with prednisone and Claritin.  The most recent information, received on 8/18/99, reports the condition of the pt is resolving.
No Adverse effects noted at this time. 4 month old was given a varicella and a MMR vaccine.
Fever, 103-deg F 13-17 hr post dose, chills, body aches, headache. Headache persisted 2 days post dose. Low fever up to 36 hr post dose.
Hives, that move every 2-3 hours.   Been going on now for about 1 and a half weeks.  So far they have prescribed me prednisone for 7 days.  Let see if this helps.
Experienced soreness at injection site, body aches, fever, headache, and nausea. By the next day all symptoms were gone besides soreness at injection site
Hurt her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hurt her back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K2(or Z)0A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to a certain BP medication (name not provided)).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced BACK PAIN (Hurt her back). At the time of the report, BACK PAIN (Hurt her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Information has been received from a physician's assistant concerning a 17 year old female with hypersensitivity and anxiety, who on 11-JAN-2008, was vaccinated with the first dose of GARDASIL, and vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # 0947X) on 25-SEP-2008. Concomitant therapy included sertraline HCL (ZOLOFT), hormonal contraceptive (unspecified) and albuterol. On 05-OCT-2008, the patient experienced muscle soreness, numbness and tingling of left arm. The left arm was painful with movement. An exam in the office on 13-OCT-2008 revealed decreased strength of the left hand grip. The patient was prescribed a tapering course of prednisone and rest. The patient was not recovered by the time of this report. The patient visited office for medical attention. Additional information has been requested.
received a dose of Twinrix on October 23, 2020 by mistake; received a dose of Twinrix on October 23, 2020 by mistake; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-year-old female patient who received HAB (Twinrix) (batch number AHABB397AB, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd October 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Twinrix at the age of 6 years by mistake, which led to adult product administered to child and accidental overdose. The patient was waiting to receive another dose of Twinrix but healthcare professional realized that Twinrix was for adult patients. The reporter consented to follow up.
He got his vaccine, he had some fatigue, was doing well, and then roughly 5 days later he began to develop very substantial orthostatic hypotension pre and post prandial, light headedness, a lot of shortness of breath, and very noticeable irregular heart beat, and has had numerous episodes of that and getting better.  Over the last couple of days has been getting worse, more reactions.  It tends to vary with the temperature.  He had in the past very occasional orthostatic hypotension, very mild.  In cooler weather he has never gotten it.  It is bad right now, and wipes him out physically.   From the first symptoms it got worse and worse for a week, then started improving quickly, and in the last couple of days seems to be reversing again.    He thinks he is having indications of myocarditis, and is worried that it will go into something worse.  He has a friend who is having the exact same symptoms having had the 4th vaccine.    1st vaccine had fatigue and minor arm soreness, and slept a lot and went away after a couple of days.  He then had the next 2 and had no real problems to complain about.
3:00 arm began to swell with pain down whole arm, pain has resolved some. 1/19/2021 temp 99.-- couple hrs later 100. then 105., temp has been constant at 104.; today temp 105. and has a headache. Has f/u scheduled with PCP. Fatigue, tiredness
(r) SIDE FACE DROOPING SWOLLEN SLIGHTLY NUMB  PREDNISONE 20MG FOR 5 DAYS THEN 10 MG 5 DAYS  INCLUDING SPEECH AND PHYCIAL THERAPY
This case was reported by a pharmacist and described the occurrence of hives in an adult female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  On an unspecified date, the pt received an injection of Engerix-B.  AT an unknown time post-immunization, the pt experienced hives. The event resolved after an unspecified period of time.
After receiving the vaccine, while sitting In the recovery area, the client vomited.  RN  was present at time of incident and client was cleaned up. Client's pulse taken and was regular.  Client seen by medical director- Dr.. Client began drinking water, no further treatment or issues noted.  Client denied any further feelings of nausea.
This spontaneous report as received from a registered nurse refers to a 59 year old female patient. On 04-DEC-2014 the patient was inadvertently vaccinated with a pediatric dose of VAQTA (0.5 ml, once, intramuscular, lot # K008252, expiry date:24-OCT-2015), In 2013 (exact date unspecified, reported as about a year ago) the patient was vaccinated with a first dose of VAQTA (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects reported. Additional information has been requested.
Arm is hard and stiff.; Arm stiff; fever; chills; muscle aches; sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.; Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face; Arm is swollen and when pushed, it is hard and stiff.; has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.) and PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Glycopyrrolate and Vyvant.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face), VACCINATION SITE SWELLING (Arm is swollen and when pushed, it is hard and stiff.) and VACCINATION SITE BRUISING (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Arm is hard and stiff.) and MUSCULOSKELETAL STIFFNESS (Arm stiff). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face), VACCINATION SITE SWELLING (Arm is swollen and when pushed, it is hard and stiff.), VACCINATION SITE BRUISING (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her), VACCINATION SITE INDURATION (Arm is hard and stiff.) and MUSCULOSKELETAL STIFFNESS (Arm stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old female patient who received fourth in series dose of PENTACEL (lot number: C5551AA and expiry date: 10-Oct-2019, liquid vial C5409AA,expiry date 10 Oct 2019, package lot C5551AA, expiry date 10 Oct 2019) (dose and dose in series was not reported) via intramuscular route in the right thigh on 22 Jan 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; and PROQUAD. It was a case of actual medication error due to extra dose administered as patient didn't need was the IPV portion of the vaccination. She was not due until the July 2020 for the IPV, the last dose was given in 2017. There were no reported reactions to the shot. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Aches and pains; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, MYALGIA (Aches and pains), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6202), on 14Apr2021 as dose 2, single (Lot number: EN0169) and on 08Dec2021 as dose 3 (booster) single (Lot number: 33030BD) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  clinical course: Other medication in 2weeks: Yes, Known allergies: No.
a 77 years old female patient received a dose of Adacel vaccine/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA284008 (same reporter).  This case involves a 77 years old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6202BA via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD).  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Seen at Medical Treatment Facility on 17June06 for vesicle on right wrist. 1.5cm without erythema. Diagnosed as possible secondary innoculation site following smallpox vaccination on 9June06.
Flu like symptoms; hot; pain from the shot in his muscle/ muscle ache; fatigue; weakness; feverish; didn't feel well; headache; pain; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 21st August 2019 23:00, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain. On an unknown date, the outcome of the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling hot, muscle pain, fatigue, weakness, fever, feeling unwell, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine at 3:30 PM on a Wednesday. At 11:00 PM that evening, he was hot, had pain from the shot in his muscle, had weakness, fatigue, was feverish, had muscle aches with not much of a headache. By 24th August 2019, he still did not feel well but his symptoms resolved by that Sunday 25th August 2019. The patient did not consent to follow-up and refused to provide any demographic information or name. No additional details were provided.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: recommended pt to take benadryl and contact health care provider if symptoms getting worse
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Merck & Co., Inc. reference number 00804190) from a contactable pharmacist and physician. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, in Mar2018, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling at site of injection with itching on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events.
Atrial Fibrillation Cardioversion (shock treatment) 07/27/2021 xarelto 20 mg 04/19/2021 Amiodarone 200 mg 04/19/2021 Cardioversion brought heart back in to rhythm but after about 3 months heart rhythm became erratic, and still is out of rhythm.
Within minutes 2-3 client became pale, eyes rolled back, limp and disoriented.  Clonic/tonic like activity.  Client was disoriented for 3-4 minutes.
C/O soreness left thigh with swelling dt pink. Dad notes improvement today from last night. Advised to rest as child has been running, playing and to use ice/cool compresses. F/U in 24 hours swelling left thigh with some area of dt pink no heat, drainage.