chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of fever in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), meningitis vaccine and strain not specified Meningococcal ACWY vaccine (Non-GSK). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC. On 6 August 2013 the subject received 1st dose of CERVARIX (1 dose, unknown route, unknown arm), 2nd dose of Meningitis vaccine (unknown details). On 6 August 2013, on the same day as vaccination with CERVARIX and Meningitis vaccine, the subject experienced fever and headache. On the morning of 9 August 2013, 3 days after vaccination with CERVARIX and Meningitis vaccine, the subject experienced vomiting. At the time of reporting the events of fever and headache were improved. The event of vomiting was unresolved. Follow up was received from the physician on 3 September 2013. The physician considered this case to be non-serious. The physician reported that viral illness could have been associated with the events of fever, headache, and vomiting. However, the physician did not report the onset dates of the viral illness. The physician reported that the subject did not use alcohol or tobacco. On follow up, the physician reported that it was unknown if the subject had experienced any adverse events following previous vaccinations; however, previously, the physician reported that there were no reactions to previous vaccinations.
Transverse myelitis/idiopathic; This is a literature report.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 22Jan2021, outcome "recovered", described as "Transverse myelitis/idiopathic". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Consistent With transverse myelitis; Magnetic resonance imaging head: showed T2/FLAIR white matter hyperintensities and, notes: global atrophy. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events 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. ,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug/event; different patient;
received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042j21a) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The type of dose was reported as a booster dose. Each vial was thawed the day before the appointment 3-May-2022, 07-May-2022 and 10-May-2022 Dates of administration of vaccine were 11-May2022, 4-May-2022, 8-May-2022 The vial did not undergo any temperature excursions. No treatment information were provided.   This case was linked to MOD-2022-565522, MOD-2022-565551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Significant follow-up received : Added patient demographics and type of dose as booster.
w/in 5min of vax pt had an episode of stiffening that included rigid sz w/being pitched off the exam table onto the floor;bruised the lt side of face & had a period of loss of consciousness of less than 5min;diaphoresis;inability to respond
Initial report received from a health care professional (nurse) on 25 May 2010: This patient was vaccinated with expired S-OIV FLUVIRIN (batch no: 102136P1A), (dose: 0.5 ml) intramuscularly on 24 May 2010. No adverse reaction had occurred.
Had a lot of sinus; Bloody nose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3248), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient had the Covid vaccine shot last Friday (08Jan2021) and then Saturday patient started with symptoms and now patient had a lot of sinus and patient had a bloody nose in Jan2021. It was asked if people have been calling in with this as a side effect of the COVID. The outcome of the events was unknown.
Plural Effusion left lung, and Cough diagnosed by Dr. on 06/16/2021.  Both symptoms started approximately 4 days after 2nd COVID 19 vaccination on 06/07/2021.
1st dose 3 and half years ago, is yet to receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received 3 and half years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by the son-in-law for her mother-in-law. The age at vaccination was not applicable for this report. The patient yet to receive the second dose, which led to incomplete course of vaccination. The reporter did not give a consent to follow-up with health care professional. Therefore health care professional contact information was not collected. The reporter provided his email address. The reporter stated that first dose given intramuscularly and did not reported about batch number and expiry date and anatomical location and date of administration. The reporter did not consented to follow-up.
This spontaneous report as received from a pharmacist refers to an infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-JUN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves 5-10 patients (specified number not reported, age and gender not reported) who received vaccine ADACEL that was too long in transit. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No concomitant vaccine administered. On 19-Nov-2018 and on 20-Nov-2018 the patients received a dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6103AA expiry date: 25-OCT-2020) via intramuscular route in the deltoid nos. It was a case of actual medication error due to incorrect product storage. 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 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.
Developed severe stomach pain that afternoon and into the evening and overnight; diagnosed with acute pancreatitis the next morning at the ER.
This spontaneous report was received from a consumer reporting on her 18 year old male patient (the reporter's nephew). No information about the patient's medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017, approximately at 3:30 PM, the patient was vaccinated with a second dose of meningococcal vaccine (reported as "Meningitis B booster") (dose, route of administration, lot number and expiry date not provided) during a scheduled doctor's visit. As a second dose that day, he was accidentally vaccinated with GARDASIL (dose, route of administration, lot number and expiry date not provided). He was not planning to get the GARDASIL and he had never received this vaccine before. When the patient came out of the exam room, he told his mother that the nurse asked what he was for and he said "he really didn't know". The nurse claimed that the patient said he was getting GARDASIL, however the patient had never heard of this vaccine. On an unknown date, in approximately May 2017, the patient's arm was red, hot and the area of redness was about the size of deck of cards. The outcome of the events was unknown. The relatedness between the event of arm being red and hot and GARDASIL was not specified. Additional information has been requested.
Pt recvd 1 dose of Engerix-B & had inject site pain shortly p/dose; 2 days later devel a measles like rash on trunk & arms along w/fatigue & felt warm; did not receive tx; doesn't feel well;
Fever, ErythemaMultiform, Diarrhea, arm soreness with swelling Narrative: Fever 103, diarrhea, arm soreness and swelling at injection site
Patient is a 62 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - itching of the shoulders. Denies use of new clothes, chemicals, lotions. The symptoms started 15 minutes post vaccination. Endorsed that she feels like having the same reaction when drinking wine and takes benadryl for the itching.   Hypertensive otherwise VSS. Physical exam unremarkable. Given Cetirizine and pruritus resolved
Energy level down to 60%; Exhaustion; Feeling chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Post Covid Exhaustion) on 23-Dec-2020. Concurrent medical conditions included Chills since 26-Dec-2020 and Brain contusion (Brain fog) since 26-Dec-2020. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, ROSUVASTATIN CALCIUM (CRESTOR) from 20-Mar-2021 to 15-Jun-2021 for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills). At the time of the report, ASTHENIA (Energy level down to 60%), FATIGUE (Exhaustion) and CHILLS (Feeling chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         Patient reported taking Statin for his cholesterol.  Concomitant product Crestor statin was used for an indication stated as heart prevention. No treatment information was provided.  Patient stated that he was recovering from COVID from January through March with exhaustion, chills and brain fog. He was at 90percent energy prior to vaccine. Then dropped to 70 percent post vaccine which had continued through June/ July. The patient stopped statin to see if that had caused the drop in energy, but after 1 month off, it had not appear to have been the causing for the events. The patient reported that the combination of prior antibodies from COVID and the antibodies from the shot had overloaded his neural system..   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up added on 13 JUL 2021 & it contains the upgraded information of reporter like name,email,city & contains patient weight,height,Medical history details & a new event also added. On 25-Jul-2021: Follow-up received contains significant information. The lab data was added.  The outcome of the events were updated from unknown to not recovered/ not resolved.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 4/7/2023 MALAISE AND FATIGUE CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 4/7/2023 WEAKNESS
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patients were administered improperly stored doses of oral ROTATEQ (Lot # L035637, expiration date 09-JUN-2017, dose was unknown) orally on the following dates: 12-APR-2016 (1 dose), 14-APR-2016 (1 dose), 15-APR-2016 (2 doses), 18-APR-2016 (1 dose), 19-APR-2016 (1 dose), 22-APR-2016 (1 dose), 02-MAY-2016 (1 dose), 10-MAY-2016 (1 dose), 18-MAY-2016 (1 dose), 23-MAY-2016 (1 dose), 25-MAY-2016 (1 dose), 31-MAY-2016 (1 dose), and 03-JUN-2016 (2 doses). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
my left arm where I received the vaccine very sore all the way his into my hand; painful wrist, fingers/hand pains on both as well as left shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Survived Uterus Cancer 2021", start date: 2021 (unspecified if ongoing); "Known allergies: Statin" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number=1, product=COVID 19, brand= Pfizer , lot number= FC3182, administration date=24Aug2021, administration time=02:00 PM,, vaccine location=Left arm), administration date: 24Aug2021, when the patient was 80-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose number 2; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number 3; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Apr2022 at 16:00, outcome "not recovered", described as "my left arm where I received the vaccine very sore all the way his into my hand"; ARTHRALGIA (non-serious) with onset 25Apr2022 at 16:00, outcome "not recovered", described as "painful wrist, fingers/hand pains on both as well as left shoulder". The events "my left arm where i received the vaccine very sore all the way his into my hand" and "painful wrist, fingers/hand pains on both as well as left shoulder" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: After the second Booster on 25Apr2022 I experienced my left arm where I received the vaccine very sore oll the way his into my hand. That we for over two months now for the past month I am also experiencing very painful wrist, fingers and hand pains on both as well as left shoulder. Very painful. Arthritis pain meds do not work have had different test no results so far. The only relief is from Tylenol which takes around 6 to make it tolerable. I am as lost as my doctors as to what to do. Please advise. Miserable. Adverse events start date: 25Apr2022, Ae treatment: Celebrex and Arthritis creams
PATIENT GOT VACCINE, IMMEDATELY FELT DIZZY AND PASSED OUT FOR COUPLE MINUTES. hUSBAND WAS BY HER AND RPH.  CALLED 9-1-1, SHE FELT OK AFTER 15 MINUTES. PARAMAEDICAS CHECKED HER OUT AND SHE WAS FINE.    PATIENT DID NOT EAT ANYTHING ALL DAY AND WAS PROBABLY DEHYDRATED,
1. Face went numb  2. Trouble swallowing ( feels like something is in throat) 3. Every time I work out neck and jaw muscles cramp 4. Suddenly developed TMD ( went to dermatologist to confirm) 3. Symptoms have been constant 4 months  4. Severe dry mouth  5. Fast heart rate  6. Anxiety.
In the morning following the injection, I felt tired, there was some pain around the injection site, also felt chilled.
About 4 days post vaccination the patient reported a burning in her lungs.   It has cleared up some, but when she works outside and exercises, she feels a burn.
THE INJECTION SITE BECAME RED AND SWOLLEN FOR 4 DAYS THEY TOOK IBUPROFEN TO HELP AND THE ARE BECAME BETTER
Erectile dysfunction: Major decrease in nighttime or morning erections. Major increase in inability to gain an erection upon physical contact. Shrinkage of the testes and recess of the penis much more prevalent. Began soon after the inoculation and have persisted to present.  Major increase of tenderness of gums (very little before shot) and consistent gum bleeding whenever brushing teeth began soon after inoculation and 1 time event of small blood clots coming out of gums 5 month after shot. No change was made in brushing habits, tooth brush type or diet in the transition from not having these symptom to having it other than receiving the vaccine.
Bumpy red rash started on face and spread to back and abdomen, also fever. Rash lasted for 3-5 days. Fever treated with ibuprofen and resolved after 2 days. Nasal viral culture for measles sent to lab and results for negative for measles.
arthritic pain in the distal interphalangeal joints of both hands; arthritic pain in the distal interphalangeal joints of both hands; Pyrexia/fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (She thinks the patient had his first dose in middle of Jan2021), administration date: Jan2021, when the patient was 71 years old, for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "arthritic pain in the distal interphalangeal joints of both hands"; PYREXIA (non-serious) with onset Feb2021, outcome "unknown", described as "Pyrexia/fever"; CHILLS (non-serious) with onset Feb2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: She wants to know if arthritis has been reported after the Comirnaty vaccine. She reports that a male aged 71 or so reported arthritic pain in the distal interphalangeal joints of both hands. She does not have specific dates that he received the vaccine but reports it was soon after the second dose. New event Pyrexia/fever, chills. Again, she was not sure at this point whether patient feels it's getting worse. Patient does mention the pain regularly, but caller was not sure if the pain was persisting/improving/worsening. She knows patient's pain was really bad because he was putting Voltaren on it. Caller doesn't think the Voltaren helped much. Caller doesn't recall patient having any severe reactions with either dose. Patient had some pyrexia, the usual things that a person gets after the first and second dose. Patient was not really sick. Thinks patient got chills and fever and it went away. Nothing that caller would think was unusual.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During the clients post vaccination observation period, she was reported to have experienced  slurring of  speech by her daughter who was with her. She was immediately evaluated by  EMS who did not identify any slurring of speech, but did note bilateral hand tremor associated with anxiety. Vital Signs were reported as stable and there was no further evidence of adverse reaction. Client was monitored for an extended observation period and deemed stable. Further evaluation at emergency department declined.
Systemic: Abdominal Pain-Medium, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted within a minute of receiving vaccine. I was able to get her to the floor with assistance of a customer.  Advised tech to call EMS. Took 2-3 minutes for her to rouse.  Patient was still extremely confused and started complaining of abdominal pain and other symptoms so I administered an epipen in case any allergic symptoms were developing that she was not explaining.  I told patient i was administering epipen and why and she consented.  Paramedics took her to ER. Recovered fine.
1 of 3 pts who recvd DTP/HIB/OPV exp an acute severe inject site reaction @ the DTP site; reaction included erythema, swelling, hot to the touch & pain; also had irritability; resolved w/in 24 hrs; treated w/APAP/cold compresses;
Initially it was swelling (entire arm between shoulder and elbow). Lasted for about a week. Fever, fatigue.  Several weeks later I developed RA symptoms.
My daughter had the GARDASIL HPV shots and since then her health has deteriorated. She has shortness of the breath, severe headaches, sore joints, enlarged tonsils, tonsil stones, fatigue and bad cramps. I fear for her future and wonder how long this medication will be in her system. Will she eventually get better or will she have more symptoms in the future. She had seen several specialist doctors and none have helped her to be herself again. Any suggestions of how I can get this out of her system? Where do I go for help?