chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female who on 01-AUG-2007 was vaccinated with the first dose of Gardasil.  On 01-AUG-2007 the patient experienced muscle tenseness in her arms, legs and torso, tremors and a weak pulse.  Subsequently, the patient recovered from muscle tenseness in her arms, legs and torso, tremors and weak pulse on the same day.  Medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 15 year old female who on 01-AUG-2007 was vaccinated IM in the right deltoid with the first dose of GARDASIL vaccine (0530U). On 01-AUG-2007 the patient experienced muscle tenseness in her arms, legs and torso, tremors and a weak pulse. Subsequently the patient recovered from muscle tenseness in her arms, legs and torso, tremors and weak pulse on the same day. Medical attention was sought. Follow-up information received from a Registered Nurse reported that post vaccination the patient was walking out of the room and fainted to the floor. Her posture was almost like a seizure. The patient recovered in 3-5 minutes. The patient was monitored for 30 minutes. Additional information has been requested.
Patient is a 18 y.o. male who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 026B21A on 4/8/2021.  The patient experienced the following reaction(s) during the immediate   of observation:  Reports feeling dizzy and faint.  Patient was treated/managed as follows:   Vitals are as follows: 150pm: BP-128/58 HR: 60 O2: 97% 200pm: 140/80 HR: 80 O2: 98%  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.  Pt escorted to car by RN
heart racing; GI/ Stomach problems; muscle tremors; weakness; pain in her eyes; head feeling foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Nov2021, outcome "not recovered", described as "heart racing"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "GI/ Stomach problems"; TREMOR (non-serious) with onset Nov2021, outcome "not recovered", described as "muscle tremors"; ASTHENIA (non-serious) with onset Nov2021, outcome "not recovered", described as "weakness"; EYE PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "pain in her eyes"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "not recovered", described as "head feeling foggy". The events "heart racing", "gi/ stomach problems", "muscle tremors", "weakness", "pain in her eyes" and "head feeling foggy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 10nov2021, adverse event was Forwarded and withheld, reporter provided verification of contact address on 09Nov2021. on 09Nov2021 reporter wife received 1 Pfizer vaccine shot, She was having ongoing issue -heart racing, GI/stomach problems, muscle tremors and weakness, pain in her eyes, head feeling foggy, and more. She is very scared these symptoms have been caused by the vaccine. She has been to the cardiologist (2x), GI Dr (endoscopy), been to ER 3x, tons of bloodwork. All normal. We are not anti-vax and this was not political. do not know where to turn and looking for help.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid-19 positive; Covid-19 positive; This is a spontaneous report received from a Pfizer sponsored program Pfizer from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose for COVID-19 immunization. Medical history included exposure to Covid-19 (her boyfriend was covid positive). Concomitant medications were not reported. The patient got Covid-19 positive as her boyfriend was covid positive. The patient had 1st dose last 18Feb2021 and 2nd dose will be on 11Mar2021. Boyfriend didn't take any vaccine. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 91-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9262) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore in her arm".  Additional information: Serious: No and NDC number of covid vaccine was unknown
Rash; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in the right arm on 21Feb2021 (at the age of 73 years old) as dose 2, single for COVID-19 immunisation. The patient has no medical history. The patient reported that he takes about 4-5 other medications. On 28Feb2021, the patient developed a rash after he got the vaccination. He said he couldn't just scratch so he went to a doctor. The doctor said it was possibly from the Pfizer shot. The patient was given prednisone to see if it would deal with the rash, and still not had deal with the rash. The patient also stated that he only took 5 pills of prednisone, but it still did not get rid of the rash. The patient has not recovered from the event.  No follow-up attempts are possible. No further information is expected.
Client's care giver stated she was not as talkative following vaccination, was dizzy and lethargic (Client was in a wheelchair in her van in the 15 minute waiting area from the drive thru event) VSS and not recorded. No LOC for client. Due to extensive  list of allergies, client was transported by EMS to ER.
Myalgia, Arthralgia, Pain and swelling at the injection site Narrative:
Extreme fatigue, spinal joint pain, muscle aches, foggy brain and chills but no fever. The spinal joint pain began in my sacral area and over the next 4 days migrated up to the low back, then to the rib cage, then to the neck.  Muscle relaxants were ineffective. Oral steroid decreased the joint pain over a  5 day period.
Severe headache; Nausea; This case was reported by a consumer and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received Shingrix. On 26th January 2023, less than a day after receiving Shingrix, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the headache and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that the patient had severe headache, nausea after receiving Shingrix. The patient received any other product. The patient symptoms were not treated. The reporter was consented to follow up.
Patient had a number of ED visits and was admitted to the hospital. ED visits include 3/18/21, 3/29/21, and he was admitted on 3/31/21 and transferred to another hospital. These visits are within 6 weeks of receiving COVID vaccination.
ONSET 1 hour after injection. --Swelling of face/hands/arm/feet. Surface veins in hands were black. Tingling of tongue and throat. Severe headache. Body aches. Extreme fatigue.  Pregressing over the three hour period - treated with Benedryl, caffeine, ibuprofin, bed rest for 48 hours.    Symptoms cleared by 72 hours.
PATIENT PRESENTED WITH A CELLULITIS TYPE RASH (RED AND CIRCULAR) ON 12/18/2018--PATIENT STATED DOES NOT ITCH OR HURT- SLIGHT WARMTH TO THE TOUCH--PATIENT WAS ALARMED BY THE RASH LASTING AND GETTING BIGGER.
11/11 2 1/2 in red, swollen, hot, itchy area right deltoid 48 hours after injections. DTAP and IPV administered (11/9)
On morning following immunization he noticed his calf muscles were tight. The evening his ankles and feet were swollen without tenderness. His ankles felt stiff due to swelling. All symptoms resolved after four days. There was no change in activities due to any symptoms. He also noted redness and swelling at the injection site.
Patient is a 30-year-old female with past medical history of chronic abdominal pain, type 1 diabetes, gastroparesis, end-stage renal disease on dialysis, drug-seeking behavior, hypertension to the ED for 3-day history of nausea vomiting diarrhea ( has dark red stool) and abdominal pain. She responded well with supportive care. She had hypertensive urgency and BPs>201/121 on admission. She required couple doses of IV Hydralazine to bring it down her BPs. She tolerated well to HD and is tolerating to po diet. She also had hypoglycemia on admission and now BS improved once she started to eat. She has chronic nausea and abdominal pain from her gastroparesis. Not sure is she had some narcotic withdrawal component. She didn't have any bowel obstruction of fecal impaction. It's been challenging with multiple hospitalizations with similar issues and other complex medical problems. Mom is trying her best to support her Dtr, patient at home.
Vomiting x2, diarrhea x5, irritability and loss of appetite over 5 days post injection. Side effects ongoing at time of report. Behavior normal outside of discomfort.
Pancytopenia; Diarrhoea; Information was obtained on a request by the Company from the Agency via regulatory authority (AU-TGA-0000484456) concerning a 2-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported.  It was reported that lethargy, temperature, and anemia were observed. The patient was not breast feeding and not eating enough solids also would not take bottle what cause weightloss over 2 years from injection. The patient was on the lowest percentile with leukemia. Treatment: the patient presented anaemic and unable to walk properly lethargic. Outcome: treating for leukemia at hospital - outcome was unknown. Notes: on 04-DEC-2019, the email acknowledgement was sent to mum. The notes were requested at hospital, checked if needed notes from other facility but transferred info should be at hospital. Note to us got missing info from notes, vaccines given, dates given, reactions noted, oncology history (hx) etc. On 13-DEC-2019, information from 04-DEC-2019, was reviewed volume 2, vaccines: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date were not reported), pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX HEXA) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) were given on 25-JUL-2017 awaiting further information from region. On16-DEC-2019, the region rang with info. There was no measles, mumps, rubella (MMR) given at 04-DEC-2019, no question of an error made. Vaccine was given on 25-JUL-2017 and diarrhoea was experienced just after, that was self-resolving. On 15-SEP-2019, the child was transferred to hospital and diagnosed with precursor B-cell acute lymphoblastic leukemia (preB ALL) after had been poorly for some time previously with pancytopaenia and unwell for the "6/52" previous. She had not received any vaccines since 2017. Follow-up received on 18-DEC-2019: diarrhea was reported to general practitioner (GP) on 29-JUL-2017, as an issue post vaccination. Diarrhoea was self-resolving. No treatment for diarrhea was given. On 15-SEP-2019, child had been unwell for "6/52" and flown to the hospital after GP found pancytopaenia on screening for being generally unwell. The patient was diagnosed at the hospital with preB ALL. The child had been under the care and remained so for ALL at the hospital under the oncology team. Treatments remained ongoing at present.  The outcome of diarrhea was reported as recovered/resolved. The outcome of pancytopenia was unknown.  The Agency considered the events to be possibly related to the suspect vaccines.
Chills and extreme lethargy began after first dose and have continued unabated, 4 - 5 times per week, until today.
Numbness and tingling in the arm that received the dose; Numbness and tingling in the arm that received the dose; This is a spontaneous report from a contactable consumer (patient's wife) reported for a male patient (husband) that a 41-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0187, Expiration date: not reported), via an unspecified route of administration in upper left arm on 29May2021 as single dose for COVID-19 immunisation at pharmacy and received second dose of BNT162B2 on 19Jun2021. The patient's medical history was reported as none. Concomitant medications were not reported. On an Unspecified date in 2021, after the first dose, the patient experienced numbness and tingling in the arm that received the dose which has not gone away. The reporter report a side effect that 'after' her husband (patient) receiving the second dose of the Pfizer vaccine (COVID 19 Vaccine) yesterday, she have the card in front of her so she have the number of the LOT that was administered both the first time and the second time. He actually had the side effect from the first dose as well so, she wanted to report for both the shots." The outcome of the events was not recovered.  Follow-up attempts are needed. Information on Lot/Batch number was available, additional information has been requested.
Information has been received from a person working in a physician's office concerning two patients who were vaccinated with a dose rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot #657665/1460U).  In December 2007, "in the last two weeks", the two patients experienced bloody stools.  The patients recovered with no hospital visit or hospitalization required.  Upon internal review, the patients' bloody stools were considered to be other important medical events.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Within two minutes of getting the shot injection I passed out while sitting outside into a bush. My uncle picked me up, however, I went into a seizure for the first time in my life. My uncle thought I was going to to die in his arms while he was holding me. I had a vivid vision experience while I was unconscious. When I came back I felt like my fingers couldn?t move (it was like the joints were sticky). In addition, I felt mentally changed and shook after that experience. I later had weird feelings in my body feeling like electric nerves strange pain in the inside joints of my knees. ^Almost like static electricity. On another note to add, I got the bad rash months before I got the first vaccine after having sex multiple times with my partner who had gotten the Jansen Vaccine (to my acknowledgment) while I was unvaccinated at that time.
Fever 101-100.8, extreme lethargy, extreme headache, nausea, emotional,  swollen arm.
Felt like a constant cold/cold like symptoms; experienced Covid; experienced Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308322-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "experienced Covid"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Felt like a constant cold/cold like symptoms". The action taken for adalimumab was unknown.  Clinical Information: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event of Covid was not provided. The reporter's causality for the event of felt like a constant cold/cold like symptoms with Humira (Adalimumab) was a reasonable possibility.   The reporter's assessment of the causal relationship of the experienced Covid and Felt like a constant cold/cold like symptoms with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
4" x 2" area redness-surrounded by Lt pink 1 cm border. Swollen-tender. no itchy better with Benadryl
Patient initially presented to the hospital with weakness.  2 to 3 days prior to admission she developed cough.  Her cough is progressively gotten worse. Yesterday she noticed worsening of her lower extremity edema along with weakness and shortness of breath. She has been vaccinated for Covid x3. Yesterday she fell in her home. She also endorses nausea and vomiting along with poor p.o. intake and lack of appetite. Weakness was her main reason for presenting to the hospital.  When she arrived to the hospital her vital signs were stable. Her lab work was remarkable for AKI on CKD with creatinine of 2.3, metabolic acidosis, glucose of 35, elevated troponin at 0.26 and elevated BNP at 2600. Rapid Covid test positive.  No pneumonia seen on chest x-ray.   Cardiology was consulted for assistance with diuresis, recommendations to initiate milrinone infusion. This was started but patient became very hypotensive and hence effective diuresis could not be continued. She also had worsening renal function and did not qualify for hemodialysis; her hypotension could not support this procedure. She was subsequently switched to dobutamine infusion to see if this would help initiate diuresis but remained hypotensive. She subsequently started becoming more obtunded with systolic dropping to the 60s and had to be transferred to the ICU for pressor supports. At presentation no CODE STATUS was established. With clinical deterioration her listed emergency contacts was reached -her daughter, and following my discussion with her she made decision was to keep patient full code as patient could not voice her desires at the time. She had central venous access and outflow placed for close hemodynamic monitoring and initiated on vasopressor supports after transfer to the ICU. However she continued to have progressively declining blood pressures with MAP less than 50 while on 4 vasopressors, which was no longer compatible with survival. Palliative care saw in consultation today 1/6/2021 with her daughters and rest of family and decision was made to transition to comfort care measures with palliative extubation which took place at 10:40 A.M. Patient subsequently expired 2 minutes after extubation at 10:42 AM.
Given PREVNAR 13 on 5/6/13. 1 day developed low grade fever, local site reaction size of a quarter.
Persistent daily headaches for 4 weeks so far following the vaccination. Treated with OTC pain reliever and antinflammatory medications, then the Medrol dose pack and butabital for pain, followed up with neurologist after no relief and treated with migraine medicines including Imitrex injection and an infusion of a cocktail of medicines designed to get rid of persistent headaches, no response, currently taking extra strength tylenol to help with the pain from headaches
nausea; vomiting; diarrhea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Unspecified immunity deficiency (due to blood panel problem) since an unknown date.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (sore arm). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhea, Nausea and Vomiting, at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. patient currently takes lots of medicine to low immunity.
Arm swelled and large (2?) red raised circle around injection spot. Lasted for over 2 weeks. Hot to the touch. Painful to raise arm. Ears ringing . Bloody nose and constant dried blood clots in nose.
stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left deltoid red and swelling noted within 24 hours of immunizations administration. Site progressively worsen the next 24 hours. Three days after injection. Temp 99.5 left arm swollen from deltoid to anticibital painful and red.