chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness; lethargy; lack of appetite; muscle pain in my left calf similar to having sliver of glass in the muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 16:45 (Lot number: EW0181) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Gender Dysphoria" (unspecified if ongoing); "Obesity" (unspecified if ongoing), notes: obesity (35.22); "Hyperlipidemia" (unspecified if ongoing); "Elevated blood pressure reading" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 02Jul2021, outcome "not recovered", described as "soreness"; LETHARGY (non-serious) with onset 02Jul2021, outcome "not recovered", described as "lethargy"; DECREASED APPETITE (non-serious) with onset 02Jul2021, outcome "not recovered", described as "lack of appetite"; MYALGIA (non-serious) with onset 02Jul2021, outcome "not recovered", described as "muscle pain in my left calf similar to having sliver of glass in the muscles". The events "soreness", "lethargy", "lack of appetite" and "muscle pain in my left calf similar to having sliver of glass in the muscles" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, lethargy, decreased appetite, myalgia.  Additional information: Reported on 02Jul2021 he had standard reactions including soreness, lethargy, lack of appetite. However, he had experienced an additional side effect of muscle pain in my left calf similar to having slivers of glass in the muscles. This was the only side effect that had continuously persisted since 02Jul2021 and did not relieve easily. He had to stay constantly motioned such as walking or wear a brace to ease it just enough to keep the pain rating down from an 7 or 8 to a 3 or 4. Again stated he had a rather intense reaction to the first dose of the covid-19 vaccine on 26Jun2021 and it was advised by the pharmacist at the second dose appointment to submit the reaction as it was still persistent. He was still having frequent occurrence of the reaction. He simply wished to know if he should have any concern over this reaction as my doctors and the pharmacist did not have any immediate advice. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Diverticulitis, had diverticulosis and after shot developed -itis but was informed that it more than likely caused by eating seeds. Had some trail mix and thinks that is what caused it.  The  infection has passed and back to normal.
patient already received his first vaccine and developed a fever; This is a spontaneous report from the Pfizer sponsored program received from a contactable consumer or other non hcp.  A 96-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single (age at vaccination was 96 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient already received his first vaccine and developed a fever (unspecified date). It was reported the patient is scheduled to receive is second vaccine tomorrow. Dr. told him to wait and receive his vaccine 2 weeks later due to fever, wanted to cancel appointment and was questioning is this okay. The outcome of fever was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse and refers to a 3-month-old male patient. The patient's medical history included respiratory syncytial virus infection. The patient did not take any concomitant medications and did not have drug reactions or allergies. On 31-MAR-2017, the patient was vaccinated with a first dose of ROTATEQ one dose orally, lot # M034799, expiration date 01-FEB-2018 for prophylaxis. On an unspecified date in approximately April 2017 (reported as sometime after receiving the vaccination), the patient was prescribed oral prednisone (manufacturer unknown) for an unspecified reason. The patient's last dose of prednisone (manufacturer unknown) was on 28-APR-2017. The outcome of the adverse event and the relatedness between the event and vaccination with ROTATEQ were not reported. Additional information has been requested.
Nausea, severe vomiting, head ache, high fever, fatigue, body aches, chills, running nose, cough, shortness of breath
Dizziness, weakness, increased BP.  Sent to hospital.  Bill generated.  See enclosed.
got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report received from patient. A female patient of an unspecified age received at second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced and got the second dose of the Pfizer COVID vaccine after 5 days later, tested positive for COVID-19 and tested positive for COVID-19 on an unspecified date. The report was received as, caller was calling on behalf of her daughter who has been exposed to COVID-19 after receiving the first dose. "My husband and I got the second dose of the Pfizer COVID vaccine and a 5 days later, tested positive for COVID-19. My daughter has tested negative, but she lives in the house with us. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The events were assessed as medically significant. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I started experiencing innappropriate affect and lost control of emotions. I would cry innappropriately or laugh at things innappropriately. I began experiencing brain fog and memory loss. Then i began experiencing vertigo that impaired my spacial reasoning. On Tuesday 3/9 I lost the ability to see objects far away. on 3/10 I woke up and was unable to read close up, or distinguish letters. The vision and vertigo has continued. I have to shut my eyes completely to walk without becoming sick. I can not be in a busy room with movement or my eyes will hurt. I can not read anything with font smaller then size 18. I can not watch TV because i can no longer see far away. I can not drive a car due to the motion., and i cant see the objects as they move.
I woke up feeling real stiff like the tin man. I was really sick an unable to get out of the bed. I did not go to the doctor. I took over the counter medications. My food taste horrible. I felt like they gave me COVID-19. The aches and pain in my joints were so bad. I started to have heart palpitations after I had the joint pain. My symptoms improved after about 6 months. I went to the doctor for my knees recently and they said that I had bone on bone where I believe they are indicating I have no cartilage in between the knees. If this was there before, I did not have any issues with it. I feel better but I still feel like the shot accelerated my aging process. I am like an old woman all of a sudden. I went to the doctor 2 months ago and had an X-Ray completed. That's where they detected that I had bone on bone in my knees and recommended surgery.
4/8/21: Vaccine Received - 6:oopm  By 9:00pm, patient begins suffering from intense headache, hearing loss in both ears, and blurred vision.  For the ears, it was as if someone had taken ear plugs and coated the ear drum with them, making it hard to hear.  Headache was treated with an ice pack on the temple for immediate site relief.  Began to feel tired and worn out while in bed, loss of vision begins to occur as well.  Body aches begin.  4/9/21:  Patient is woken up from intense body spams throughout the entire body.  Once awake, the entire body was spasming, causing the patient to be unable to control his body, and all extremities.  After sipping some water for about an hour, the spasms subsided in all areas of the body except for the legs and shoulders.   4:00pm patient begins to feel extremely nauseous, begins having increased bowel movements including rapid diarrhea, and extreme stomach cramping.  Deep body aches and pain continue.  4/10/21:  10am: patients body begins to become covered in hives all across his skin, inside his mouth, under his feet, and in his hair.  Hives continued to grow, with no reddening of the skin however.  This was treated with Benadryl for the remainder of the day; hives subsiding around 6:15pm. Dehydration also occurred, and hospital treatment for IV saline bag was soon to be utilized had the patient not been able to rehydrate himself.  Body aches continue
Patient received the vaccine Sept 21, 2020. On Sept 24, 2020, she came thru our drivethru saying that she had the shot Monday and was experiencing a hard lump at injection site and warmness. I asked her if she had ever had an allergic reaction to eggs or to flu vaccines before. She said no. I did ask her if she was having any shoulder pain or if she had any pain radiating down arm. She was able to move arm. She said she noticed the lump and heat on Sept 22 but the heat started getting worse today. I did recommend she followup with her physician. She gave me permission to contact her Physician Assistant on file.
pt recv vax mid-OCT97;DEC97 pt devel an influenza A inj;dx was made via an unspecified lab test;this is 1 of 3 pt from this site to devel influenza A following receipt of flu vax lot# 4978172;
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805530 was cross linked to original cases 201804863 due to same reporter.
After receiving the Pfizer vaccination I developed Covid 19 and called my physician I was tested and the test was confirmed positive. My physician prescribed PAXLOVID and the illness ended.
7/7/04: Pt received Td left deltoid. 7/8/04: developed inflamed deltoid at site of injection with achiness, malaise, fever for next 5-6 days.
EMS narrative:  RESPONDED TO A SPECIAL EVENT1 CALL AT VACCINE CLINIC SITE- CONVENTION CENTER, FOR A 33 Y/O F, CC OF AN ALLERGIC REACTION. PT AMBULATED TO SE1 FIRST AID STATION AND REQUESTED SPECIAL OBSERVATION DUE TO ADVERSE/ALLERGIC REACTION AFTER HER 1ST COVID-19 VACCINE INJECTION. PT STATED THAT SHE HAD SWELLING ITCHING AND HIVES AFTER THE 1ST INJECTION, AND HER SYMPTOMS DEVELOPED PAST THE 15 MINUTE OBSERVATION WINDOW, AND PERSISTED FOR THE NEXT 1-3 HOURS, WITH PROGRESSIVE RELIEF FROM ADMINISTERED BENADRYL. SE1 AT THAT TIME ADMINISTERED 1 25MG ORAL BENADRYL, WITH POSITIVE EFFECT ALBEIT SLOW EFFECT. PT ARRIVED AT FIRST AID IMMEDIATELY AFTER RECEIVING HER SECOND VACCINE DOSE, AND REPORTED NO IMMEDIATE SYMPTOMS. AFTER 15 MINUTES PT STATED HER BACK AND EXTREMITIES WERE " A LITTLE ITCHY, AND SHE FELT PIN PRICKS IN HER FINGER TIPS." PT DENIED ANY SOB, CP, NAUSEA, VOMITING, HIVES, OR AIRWAY IRRITATION/COMPROMISE. PT WAS ADMINISTERED 25MG ORAL BENADRYL AT 1015, AND PT WAS OBSERVED FOR 45 MINUTES. PT STATED SHE FELT MUCH BETTER AND DID NOT WISH TO BE TRANSPORTED AT THIS TIME. PT WAS INFORMED OF THE CONDITIONS OF REFUSAL AND THAT NOT SEEKING FURTHER MEDICAL TREATMENT COULD BE DETRIMENTAL TO HER HEALTH, UP TO AND INCLUDING DEATH. PT WAS ADVISED SHE COULD CALL 911 ANYTIME IF HER CONDITION CHANGED OR WORSENED. PT STATED SHE UNDERSTOOD AND SIGNED THE PAPER REFUSAL FORM.
Had a fever of 104. Lot of soreness in her arm. A follow up report received 9/18/2002 adds: Dx sore throat. Rx Amoxicillin, Tylenol Elixir
become a diabetic/ raise your sugar level; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I just have one question for you. I don't wanna give my information. I received Pfizer injection about a week ago and I have a question." Consumer was informed about the Pfizer Medical information department and consumer stated, "No, it is nothing like that. I want to know if taking the second part of the Pfizer injection. Do you get, if you are not diabetic become a diabetic with this injection? Does it raise your sugar level?" Consumer hung up the call abruptly. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient noticed a rash on her legs in the shower 3 days after her vaccine. It was purpura, she went to the emergency department and she was diagnosed with vasculitis.
Nine days after my shot, my hands and feet were excessively itching. During the 10th and 11th day, the itch moved to my entire body with a rash and hives on different parts of my body. I was on prednisone for 5 days, and the rash and itching has gone down, but still continues. I have to take an allergy med (Allegra) everyday.At first I was taking Allegra once a day and Benadryl every 4 hours. I no longer have to take 2 allergy pills to manage the itching, just one daily, but I can't let up on that one. I also have to see an allergist and continue to see my doctor, since the prednisone doesn't stop it.
It was reported that a pt experienced redness at the injection site and swollen lymph nodes, sometime after receiving a TD vaccination. (No specifics were provided).
Injection site left deltoid was firm, warm,tender,and edematous measuring 6cm x 6cm.Left supraclavicular area edematous, spongy,and tender 48 hrs following tetanus injection pt.sought treatment. Also complained of general malaise and fatigue. She was afebrile: temp. oral 97.8
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On approximately 11-AUG-2014 (reported as since 11-AUG-2014) the patients were vaccinated with an improperly storage (Oka/Merck) VARIVAX, subcutaneous. No adverse effects reported.   Follow up information has been received on 03-SEP-2014 from licensed practical nurse. She stated that 7 doses of (Oka/Merck) VARIVAX with lot number K002046 expiration date 10-FEB-2016 has been given to unspecified number of patients (patient's identifiers or dates of vaccination were not available at the time of report). It was also reported that 10 doses of (Oka/Merck) VARIVAX (with lot # J011125, expiration date 05-SEP-2015) and 10 doses of (Oka/Merck) VARIVAX (with lot # J006358, expiration date 23-MAY-2015) were improperly stored (not given to date). This is one of several reports received from the same reporter. Additional information has been requested.
reports fine red rash appeared on face, hands & chest 10 days p/vax; rash became more pronounced & pt was seen by MD 8FEB93 & was dx as measles reaction; 10FEB92 puffy face dx allerg react; pt peeled p/rash cleared;
This is a spontaneous report received from contactable reporter(s) (Pharmacist). An elderly male patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHYLPREDNISOLONE, start date: 16Mar2022, stop date: 18Mar2022; HYDROCHLOROTHIAZIDE; LISINOPRIL; DIVALPROEX. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 18Mar2022, outcome "unknown" and all described as "indication=Treatment of COVID-19 / acute COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient was prescribed Paxlovid for acute COVID-19 infection and on day 2 of treatment began having multiple episodes of non-bloody, non-bilious vomiting. He was found to be hyponatremic secondary to vomiting, attributed to COVID-19 infection, as well as possibly Paxlovid, with other medications contributing to hyponatremia - chiefly methylprednisolone, hydrochlorothiazide and divalproex. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
patient received an early 3rd dose of Twinrix when folowing the standard schedule; Extra dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received HAB (Twinrix) (batch number 2pg39, expiry date 19-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 924E7, expiry date 18-AUG-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX), HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUL-2023, the patient received the 3rd dose of Twinrix and the 3rd dose of Shingrix. On 21-JUL-2023, an unknown time after receiving Twinrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received an early 3rd dose of Twinrix when folowing the standard schedule) and extra dose administered (Verbatim: Extra dose administered). The outcome of the drug dose administration interval too short and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US-GSK-US2023100587   Additional Information: GSK Receipt Date: 21-JUL-2023 Registered nurse reported that patient received an early 3rd dose of Twinrix when following the standard schedule.  The patient received 1st dose on 19th May 2023 and 2nd dose 23rd June 2023. On 21 July 2023, the patient received the 3rd dose of Twinrix which led to shortening of vaccinations schedule. The patient that received the 2nd dose of Shingrix on 23rd June 2023 and received a third dose on 21st July 2023, which led to extra dose administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Pt received 2nd dose Moderna on 6/13/22.  Pt states having arm soreness for 1 day.  After the soreness disappeared, pt noticed numbness in the left arm at the site of injection.  The numbness radiated up near the neck and down the arm.  the pt had been rubbing/ massing the arm and taking IBU.  But still no relief.  Pt has been seen by MD in June & July to rule out stroke.  She has been cleared by her MD.  Pt states having decreased arm function and ability to carry items. Reported arm numbness issue to pharmacy on 8/1/22.
Typhim was administered to a 13 month old child with no reported adverse event; Initial information received on 21-Jul-2021 regarding an unsolicited valid  non-serious case from an other health professional and physician via Agency (under reference number 00692273).  This case involves a 13 months old (unknown gender) patient who was given TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (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 medication included YELLOW FEVER VACCINE LIVE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 20-Jul-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Total, lot T1A671M and expiration date : 17-Feb-022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day latency).  It was reported that " She reports that the child tolerated the immunizations well and no adverse events have been reported. Case placed in proxy for callback or email, call came in just before 6pm, not able to transfer. Nurse says that Typhim was administered to a 13 month old child. She wants to find out what side effects they should look out for.  Outbound call made at 1:33pm on 22jul2021. Caller was in a meeting. Voicemail left with contact and case number."  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 the 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.
After the vaccine, within minutes had dizziness, loss of vision, syncopal episode in hallway leaving the exam room.  Loss of consciousness for several seconds.  Headaches for 2 days.  Staring episodes, stiffness, non-reacting intermittently next few days.  Weakness and body aches.