chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered from a bad case of the shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 02-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine, the patient suffered a bad case of shingles. It was also specified that the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the reporting time, the outcome of shingles was unkwnon. The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Herpes zoster was considered to be disabling due to permanent injuries.
ACUTE STABBING LOWER BACK PAIN NEAR WASTE. PATIENT ATTEMPTED TO WALK OUT OF LOBBY SEVERAL MINUTES AFTER RECEIVING VACCINE, CALLED FOR HELP AND COULDN'T STAND. SHE SAT DOWN IN A CHAIR AND ASKED ME TO CALL EMERGENCY SERVICES, WHICH I DID. AFTER PARAMEDICS CHECKED HER OUT, SHE DECLINED TRANSPORT TO ED AND WALKED OUT OF STORE ON HER OWN POWER. SHE SAID THE PAIN WAS NO LONGER THERE.
6 X 7 cm area of erythema to right upper arm, no evidence of abscess
DIARRHEA THE FIRS SIX DAYS AFTER THE VACCINE RED RASH IN BOTH LEGS WITHIN THE LAST FEW DAYS
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014318, expiration date: 30-SEP-2017 and lot # M006112, expiration date: 16-NOV-2017, orally, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012399: US-009507513-1701USA001262: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001267:
Localized reaction left arm red and itchy. Pt to start on Benadryl; and call back if further tx needed.
SYMPTOMS ARE INSANE; FEVER FOR 2 DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included get sick quickly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:Unknown ,expiry:unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced symptoms are insane, and fever for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for 2 days, and the outcome of symptoms are insane was not reported. This report was non-serious.
Paresthesia left arm dermatome of T1.  Altered sensation when touching area only. No pain. Could be actual T1 disc and coincident to vaccine, but this is a first time event. Start date is uncertain as the paresthesia is only noted when rubbing/touching the area.  However, highly unlikely that the start was prior to the vaccine. Note that I intentionally lay in bed reading in a prone position prior to sleep which could compress the C's and T1. This a long time practice, and again, this is a first time event.
Temperature excursion involving Varivax, states there have been administered doses; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 28-JUL-2020, the varicella virus vaccine live VARIVAX began experiencing intermittent temperature excursion.  On 17-AUG-2020, the patient was vaccinated with varicella virus vaccine live VARIVAX 0.5 ml, Lot # T002843, expiration date 23-JAN-2022, For prophylaxis (Frequency and patient route of administration were not reported). The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.     There was digital data logger involved and  no previous temperature excursion was reported.
Employee states that she completed bathing and was drying off when she began to experience severe itching and stinging on her back.  She states that it felt as though she were being stung by hundreds of bees.  The took 50 mg of Benedryl, po without relief. Her husband then applied Benedryl cream to the area with no relief, she applied ice packs with no relief.  She then began to experience chest pain with tightness and sob.  She took 50mg po more of Benedryl and went outside to see if she could breathe any easier.  She instructed her husband to bring her blood pressure cuff. She states that she could barely hear a systolic pressure of 50 mm HG or so.  She then instructed her husband to call 911.  By the time the EMS personnel arrived the pain and sob had started to subside.  Her BP at that time was 120/98.   She did not go to the ER.  She states that at the time she did feel tha she was going to die.  She had never experienced this type of reaction before.She went to see her private physician on Monday, (4-28-2003.  He reviewed all medications that the client is currently on and suspects that the reaction was due to the smallpox vaccine since that is the only new event in her lifestyle. He started her on Zertec 10mg qd.  The current meds include:Zetia 10mg qd, Lotrel 5/20 1 q day, Provachol 80mg qd, Loestrin with Fe 1 qd.  In reviewing her medical history she gives a history of hypertension, high blood cholesterol, and both parents have a history of heart disease prior to being 50 years of age. Discussed with CDC.
45 minutes after administration I started feeling a heavy sensation in my tongue, felt swollen,  stuttering.  Felt like everything around me and myself was in slow motion.   Got home and took allergy medication and it got a little better.  The heaviness of the tongue lasted about 24 hours but never felt SOB.
Initial report was received on 07 and 16 February 2011 from a health care professional. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of DAPTACEL. The events for the other patient were captured in case 2011-00549. A four year-old patient with no reported past medical history and no illness at the time of vaccination had received a fourth dose right thigh injection of DAPTACEL, lot number C3515AA (route of administration not reported), a fourth dose left thigh injection of IPOL (lot number and route of administration not reported), a second dose left thigh injection of MMR II (Merck lot number and route of injection not reported) and a right thigh injection of FLUVIRIN (Novartis lot number and route of administration not reported) on 02 February 2011 and an unspecified amount of time later, experienced swelling and warmth of right thigh and was also limping. The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received from the health care professional on 12 April 2011. The reaction was on the right thigh and was swollen and warm. The patient was also noted to be limping. The events recovered on an unspecified date. Follow-up information was received 29 April 2011 from a health care professional. The lot number for IPOL was E0204. No additional information was provided at the time of the report. Documents held by sender: none
Gastrointestinal upset - diarrhea 3-4 times between 2:00-6:30PM on 10/10/23. Pain at injection site (left arm) began around 11:00PM on 10/10/23. Fever, chills, body aches, headache, stiff neck, extreme lethargy all began somewhere between 11:00 PM (10/10/23) and 1:00 AM (10/11/23) and continued through 11AM 10/11/23 despite taking Tylenol around 8:00 AM (10/11/23). Symptoms have gotten better since 11AM; however, I am still very lethargic, have a bit of a headache, and low-grade body aches. Injection site is still sore, but not nearly as bad as it was over night.
Patient vaccinated 10/24/13, on 10/25/13 in AM patient started with cough. Sunday 10/27 patient started with body aches, fever; headache. Fever up to 102 degrees F. Out of school Monday 10/28, Tues 10/29 1/2 day, Thurs 10/31 all day. Denies wheezing, vomiting, diarrhea. OTC medications taken: Ibuprofen 400mg. MUCINEX DM.
This spontaneous report was received from a registered nurse and refers to a 1 year old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapy were not reported. On 30-NOV-2017, the one year old patient inadvertently received a dose of GARDASIL 9, intramuscular for prophylaxis. No adverse effects were reported in the patient. The patient sought medical attention but no Intervention to prevent serious criteria was performed.
knee hurts; This is a spontaneous report from a Pfizer-sponsored program from a contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Mar2021, the patient experienced knee hurts and asked when he can take Ibuprofen after the dose 1 since his knee hurts. The clinical outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Dizziness most of the time specially at night; This is spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm, on 17Mar2021 at 07:00, (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included COVID-19 test on 08Oct2020, and the result was negative; nasal swab test on 07Nov2020 and the result was negative. Since the vaccination in 2021, the patient was tested for COVID-19  and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 00:00, the patient experienced dizziness, it was there most of the time especially at night. The patient did not receive any treatment for the event. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dizziness most of the time specially at night was not resolved at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hypersensitivity to flu vaccine. Large edematous area left upper arm 14 x 13cm.
About 30-40 minutes after the shot, I became extremely light headed, followed shortly by chest tightness.  So much so that I pulled over my car on the side of the road, used my inhaler that I very rarely use.  I also went to a store to get some caffeine, thinking it may help with my dizziness.  I was going to call the nurse line, but started getting better about an hour later.     My allergist has advised me not to get the 2nd shot.
Patient presented for Twinrix dose #2 with a friend also present in room to receive Twinrix dose #2. Patient given in each arm both doses of Twinrix prepared.
Unilateral swelling; Emergency Room visit due to lower leg swelling that started to get bigger and bigger; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 026AZ114) for COVID-19 vaccination.     No medical history provided by the reporter.  The patient's past medical history included Acid dyspepsia, Sleep disorder NOS and Mood elevated. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), TRAZODONE for Sleep deficit, SIMVASTATIN and TEMAZEPAM (RESTORIL [TEMAZEPAM]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at a dose of 15 mg. At the time of the report, OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) to be possibly related.    This is a report regarding adverse events for the first dose of the vaccine.  At the time of the report, the patient neither described additional/new adverse events for the second dose, not worsening of the events related to the first dose.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the evenst, a causal relationship cannot be excluded.
Patient presented on 12-21-05  11:35am complaining of continued pain in right shoulder area from Fluvirin injection received on 12-3-05. She also mentioned a decreased range of motion in the right shoulder area.
This spontaneous report was received from a nurse via poison and drug center refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-NOV-2017 at 15:23, the patient was vaccinated with RECOMBIVAX HB (strength, dose and frequency were not reported) lot # N006321 with expiry date 08-NOV-2017 for prophylaxis. On 12-NOV-2017, an exposure panel was done on the baby and the hepatitis B surface antigen screen came back positive and the hepatitis neutralization was confirmed. They are not sure if the test came positive because the baby just got the RECOMBIVAX HB injection. They are going to test the mother and baby but they are concerned about the possibility of giving RECOMBIVAX HB to the baby. It was unknown if the baby will receive any further RECOMBIVAX HB injections. The outcome of Hepatitis B surface antigen positive and Neutralizing antibodies was unknown. The reporter did not provide the causality assessment between the events and RECOMBIVAX HB.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 18Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Neck stiffness that went away after moving around; Minor tenderness at injection site; Achy-ness in arm; A spontaneous report was received from a consumer concerning a 69-year-old, male patient who developed neck stiffness, minor tenderness at injection site and achy-ness in arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection.    On 05 Jan 2021, approximately six hours after vaccination, the patient developed achiness in the arm. On 06 Jan 2021, 24 hours later the patient's arm was tender at the injection site. His neck was stiff but, went away after moving around.   No treatment information was provided for the event.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, neck stiffness, was considered resolved.  The outcome of the events, minor tenderness at injection site and achy-ness in arm,  injection site pain and pain in extremity was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
slight pain/pinching sensation near lymph-nodes on armpit of injection arm; Stiffness/soreness on arm near injection; Stiffness/soreness on arm near injection; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 12:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included norethisterone acetate; ferrous fumarate; ethinylestradiol (JUNEL FE) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, the patient experienced stiffness/soreness on arm near injection. On 29Mar2021, two days after injection, the patient experienced slight pain/pinching sensation near lymph-nodes in the armpit of injected arm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 30Mar2021 which included COVID test and the test result was pending. The patient did not receive any treatment for the events muscle stiffness, vaccination site pain and lymph node pain. The clinical outcomes of the events muscle stiffness, vaccination site pain and lymph node pain were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
10/31/2022 I had congestion, sore throat and coughing. 11/1 Fever peaking at 101. Symptoms got worse. 11/2 Consulted with the clinic who tested positive on a rapid COVID-19 test. Doctor prescribed PAXLOVID and MUCINEX. Felt better starting on 11/4 as symptoms diminished starting 11/4 and were mostly gone by afternoon of 11/5.
Information has been received from a physician concerning a male who on 22-MAY-2007 was vaccinated subcutaneously with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot XXXXXXXX). Concomitant vaccine therapy included PREVNAR. The physician noted that the patient was diagnosed with shingles after receiving measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process), dates unspecified. It was noted that the patient improved "after a shot of acyclovir (manufacturer unknown). Unspecified medical attention was sought, which included being seen by the physician on 12 MAR 2008. No lab diagnostic studies were performed. At the time of reporting the patient was recovering. There was no product quality complaint. Additional information has been requested.
Patient was dizzy, didn't feel right, called squad. Systolic BP was in the 230s. Patient taken to the ED,  noted to have left side weakness with facial droop and arm drift. Patient had Acute ischemic stroke,
Chronically ill patient resident of Rehab tested positive for Covid-19 on 01/17/2022 at facility.  Patient expired on 01/30/2022.
4/14 MMRV given 4:20pm 4/16 Temp 102 and febrile seizure AM EMS called See at Hospital
Febrile seizure. Normal labs and work up in ER immediately following event and normal exam in PCP ofice following day.
Patient came to pharmacy with a swollen right arm and extreme pain. She could not lift her arm. Her upper arm was red, warm to touch that was spreading.
Pt describes onset of shaking, chills, general malaise within several hours of the vaccine.  Muscle aches were severe, legs "buckling".  Malaise continued x approx 48 hours.  Complete recovery within 72 hours.  No medical attention sought.
PAIN, WARMTH, REDNESS AT INJECTION SITE.  PATIENT REPORTS HEADACHE, SWEATING, FEELING UNWELL
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th October 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The next day of vaccination the patients left arm was sore. The patient stated that the soreness had diminished some, however, her arm was still a little sore. The reporter did not give consent to follow up.
Rash developed on abdomen, treated with Benadryl for 1 day, resolved within 1 day