chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 103; chills; headache; metallic taste; fatigue; dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 09:30 (Lot number: FH8030) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dupytrens Disease" (unspecified if ongoing), notes: Dupytrens Disease; "Sleep Apnea" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8725, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 25Mar2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 09:30, outcome "unknown", described as "dose number: 3"; PYREXIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "Fever 103"; CHILLS (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "headache"; DYSGEUSIA (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "metallic taste"; FATIGUE (non-serious) with onset 03Dec2021 08:15, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, dysgeusia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Extreme nausea; Exhaustion; Swollen lymph nodes in neck; Swollen gums; Swollen gums that later blistered; Swollen tongue; Swollen tongue that blistered; Oral thrush; Sore muscles; No energy; Fatigue; Sore throat; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included stevens johnson syndrome. The patient had no known allergies. Concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), paracetamol (TYLENOL) and vitamins (MANUFACTURER UNKNOWN) (unspecified); all from unknown dates for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced sore arm at injection site and had no symptoms for 48 hours after the vaccination. After 48 hours, on 23Apr2021, the patient experienced swollen lymph nodes in neck, swollen gums that later blistered, swollen tongue that blistered, oral thrush, sore muscles, no energy, fatigue, sore throat and caught. On 26Apr2021, 5 days after the vaccine, the patient woke up with extreme nausea, exhaustion and no energy and there was no fever, stomach ache or rash. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at injection site, swollen lymph nodes in neck, swollen gums that later blistered, swollen tongue that blistered, oral thrush, sore muscles, no energy, fatigue, sore throat, extreme nausea and exhaustion was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Nausea started 14 hours after getting my second COVID vaccine. The nausea is still bad 3 days later. The vaccine also started my menstrual cycle a week early, despite me being on the birth control pill. The period that ensued has also been miserable including heavy bleeding, cramps, back pain, nausea, vomiting, and headaches. This is NOTHING like my typical period, usually lasts 3 days and is very light with minimal pms symptoms.
This spontaneous report was received via company representative from a pharmacist who refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. On an unknown date (one day after vaccination), the patient experienced injection site injection site redness and swelling. The outcome of injection site injection site redness and swelling was unknown. The relatedness between the event and suspect vaccine was not defined by reporter.
Pain at injection site as well as GI Issues such as intense cramping and diarrhea.
This spontaneous report was received from a pharmacy technician refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Pharmacy technician reported that on multiple unknown dates, the patients may have been vaccinated with improperly stored M-M-R II and properly stored sterile diluent (STERILE DILUENT) (dosing details, lot# and expiry date were not provided) for prophylaxis. She mentioned that M-M-R II underwent a temperature excursion at 72 degree F. No data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L037921, expiration date 31-MAY-2017 (strength and dose were not provided). The vaccine was exposed to the temperature of 34.2 Fahrenheit (F) degrees for 30 minutes. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
A report was received from a consumer on 10/09/02 reporting a 67 year old female patient who experienced convulsions, loss of consciousness and headache requiring hospitalization after receiving Fluvirn vaccine in 10/05/02. At 5:00 am on 10/07/02,the patient experience a severe convulsion, with foaming at the mouth after receiving Fluvirin on 10/05/02. The patient became unconscious and was taken to hospital by ambulance. The patient was kept in the A & E department for tests before she could be discharged. All blood tests were reported as normal. The patient was given paracetamol. On the same day, the patient was discharge to treat the headache. which developed when the patient regained consciousness. On the same day, the patient was discharged from hospital. The patient has received flu vaccine previous without any problems and has had no history of convulsions in the past. The patient recovered on the same day. There was insufficient information to determine the reporter's causality's assessment. UPDATE: A follow-up received on 10/24/02 from the health professional which stated the batch number and confirmed that the patient was not taking other medication and had no past medical history. On 10/09/02, the patient experienced grand mal seizure requiring hospitalization. A  CT-scan of the brain was included. This report showed a mild degree of atrophy, which mainly affected the temporal lobes. No other focal intracranial abnormality was seen. there was no abnormal intracranial enhancement. A little basal ganglia calcification was noted, which is felt to probably be of no significance. The patient received previous flu vaccinations in 2000 and 2001. At the time of reporting, no cause has been found and the patient had recovered. The patient was discharged the same day, 10/09/02.there was insufficient information to determine the reporter's causality assessment.
Family maintains child was vaccinated with 6 vaccines on same day and PPD. MD's office has record for 3 and PPD. Both family members present and witnessed an oral vaccine given. The father asked the doctor if giving 6 shots at once was too much. She told him no that somehow 7 had been given at once. Told to report a fever. Child in ER x4 starting 12/5/10. Hospitalized 12/20. Dx at discharge was Kawasaki's disease.
Diarrhea; Severe pain at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at vaccination site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at vaccination site). On 29-May-2021, DIARRHOEA (Diarrhea) had resolved. On 31-May-2021, VACCINATION SITE PAIN (Severe pain at vaccination site) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information included outcome of adverse events were updated to recovered.
Vertigo Severe lethargy No energy Headache  Night sweats Body aches Stomach ache
Low Platelet count; Immune thrombocytopenia; This serious case was reported by a pharmacist via call center representative and described the occurrence of immune thrombocytopenia in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 10M752F) for prophylaxis.   On 10-OCT-2023, the patient received Arexvy. In OCT-2023, 10 days after receiving Arexvy, the patient experienced immune thrombocytopenia (Verbatim: Immune thrombocytopenia) (serious criteria GSK medically significant). On 20-OCT-2023, the patient experienced platelet count low (Verbatim: Low Platelet count). The outcome of the immune thrombocytopenia and platelet count low were unknown.   It was unknown if the reporter considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   It was unknown if the company considered the immune thrombocytopenia and platelet count low to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The reporter called to inquire that any data available of any other patients having this type of reaction. The reporter reported a patient received an Arexvy vaccine and 10 days later experienced an immune thrombocytopenia.  On 20th October 2023, they ran labs and it showed very low platelet counts. The reporter did not consent to follow-up.
Patient given adult hepatitis A vaccine 1st dose 08/02/07; 2nd dose 09/11/07
1st dose 2 years ago, wants to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 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 Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: The pharmacist reported that a patient came to the office to get 2nd dose of Shingrix but 1st dose was given 2 years ago. The patient didn't get the 2nd dose at the time of reporting. The pharmacist wanted to know how to proceed. The health care professional didn't provide demographic details from patient neither lot number or expiration date of 1st dose of Shingrix. The patient did not get 2nd dose at the moment of reporting. The follow up was not ask to the HCP. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
fever, feverish, chills, muscle aches, runny nose, sore throat, cough, SOB, N/V, headache, fatigue
Bumpy rash on ankles, toes, fingers, only on extremities, started with ankles; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received second dose bnt162b2 (BNT162B2) via an unspecified route of administration, administered in arm left on 08Feb2021 13:30 (Lot Number: EL8982) as single dose for covid-19 immunisation. Medical history included Numerous Allergies, Sulfa allergy, certain nuts allergy. The patient historical vaccine included first dose bnt162b2 lot number: EK-9231, 12Jan2021 03:30 PM at Left arm single dose for covid-19 immunisation. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and tocopherol (VIT E). The patient experienced bumpy rash on ankles, toes, fingers, only on extremities, started with ankles on 09Feb2021 08:00. There was no event treatment for the event. Facility where the most recent COVID-19 vaccine was administered hospital. The outcome of the event recovering.
Pt. had erythema migrans type rash over entire body. Suspicious for and treated as Lyme. However, since the rash appeared 5 days of shot DDx would include reaction.
Within a few hours of vaccination, Luke developed a fever and muscle rigidity that lasted 48 hours. On 1/30 he developed a small red raised rash on his face, trunk (front and back), legs, and arms. As of today, 2/1, he has had 2-3 episodes of diarrhea every day starting on 1/30.  (I am unsure of the type and manufacturer of the Hep A and flu vaccines he received)
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 07-SEP-2022, the patient was vaccinated with improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, for prophylaxis (lot number: W016358, which was determined to be valid, with an expiration date on 16-NOV-2023) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 11.8 degrees Celsius (C), during a time frame of 1 hour and 45 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
they gave a 17 yr old FluBlok/ no AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported that they gave a 17 year old Flublok/ no AE (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 20-Aug-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1901 and expiry date: 17-May-2020 via intramuscular route in the right arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  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.
Severe hives. In the middle of the night I woke up to intense itching at my ankles, as I woke the itching had spread up my legs and when I got out of bed I noticed raised bumps (looked like mosquito bites) all over my legs and ankles.  This subsided after a few hours but then the bumps reappeared on my stomach and back, which also disappeared after a couple hours, then it was my arms in the same fashion.  Over the course of the next 4 days, the intensity of the hives grew until my right arm was essentially one big hive.  Come 3/15 the hives went away and never returned. I did not take any medication to qualm the itching or the hives. I had also not eaten any new foods, tried any new soaps, came into contact with anyone new since 3/7 (the day I traveled back after my military service and also the same day I received the vaccine).  The last time I have ever gotten hives was from a shot with sulfa in it when I was a baby and I have avoided it since then.
A blood test July - Kidney and doctor wanted to test two other time to confirm it. Last test for it was on August 1st - low number that shows it's a red flag for kidney. And that confirmed - a problem. They did an ultrasound -  ordered it - Imaging. I don't know  result of Ultrasound. Kidney Specialist  - I will see one but I don't have a date yet for the appt. I haven't had any symptoms with it - the doctor thought I was a bit dehydrated so he had me drinking more water but that didn't help change any of the blood test results. I'm not sick.
After a week of my first shot I have ringing in both ears. (Tinnitus)
After a 30 minute wait from the shot upon driving home  I had a feeling of a very tight grip on the back of my neck at the base of my skull.  It was really tight.  My ears itched.  This lasted 20 minutes.  That night I had severe bone and muscle pain in my upper legs.  I cried all night.  the next day I started taking Tylenol.  This helped.  My upper legs still hurt but I can stand it now.
2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; the area is itchy and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Single, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); Single, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Sep2023, outcome "recovering" and all described as "2.5 inch raised red itchy patch at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Sep2023, outcome "recovering", described as "the area is itchy and hot". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pruritus, vaccination site warmth.  Additional information: The patient was a physician and he received the Prevnar 20 vaccine 9 or 10 days ago. The patient had developed a 2.5 inch raised red itchy patch at the injection site. It was very red this weekend which was a week later and it scared the reporter. The area was itchy and hot and it was not as bad now but it was still bothering the patient. The patient put ice on it and it was a little better but it was still light red and pink and it was still bothering him but not as bad. The reporter just concerned because this was just the start of vaccine season, and the reporter was worried about the patient getting the Covid shot due to this reaction, along with the RSV and Flu vaccines. The patient never had a reaction, and he had had 4 Covid shots and after this reaction.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Next day so weak and lightheaded couldn?t stand up Body aches and pains Weakness and lightheaded for about 4 months.   Had to rest, take a nap every day previously not.  Pain in joints previously didn?t have.    Still have weakness and have to rest unexplained.  Already immune deficiency and infections worsened.
Shingles symptoms; shingles diagnoses by doctor on 11/15/2010
pt recvd vax; inc fever 101 to 106, shaking, chilling, sleepy, "mumbling & not alert"; to er;gave apap at 1pm & 10:30pm, t at er was 106;