chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms were mild like a head/chest cold. Very limited coughing and no sore throat. On 05/14/2022 and 05/15/2022 I had a mild intermittent fever of around 100. On 05/15/2022, I tested positive at home and I scheduled an appointment for my PCPs office for 05/16/2022. I had another test done and that was positive. They told me to increase the low dose aspirin to 2 a day. They added XARELTO 2.5mg 2x daily, Dexamethasone 2 pills in the morning for 5 days and then 1 pill in the am for 5 days, Fenofibrate 160mg daily for 30 days, azithromycin 1 pill daily, PAXLOVID 3 pills am and 3 pills pm for 5 days and asked me to stop taking rosuvastatin until I test negative. Since then, I have been lying low and resting. I am feeling much better today. I am tired but not sleeping long enough due to change in meds.
The patient is a 44 year old male. He reported: Symptoms follow up on hospitalization for atrial flutter and ablation. Dates from 4-23-11 to 4-27-11. Encounter Background Information: 44 by o mobing soldier who visited the ER for feeling palpitations and was diagnosed with Atrial Flutter. He was hospitalized and was undergone ablation and released from the hospital on 4-27-11 on ASA 325 mg po daily. He was instructed to carry no more than 5 pounds for the next 5 days. He will follow up with Dr on 3 May 2011 at hospital. He feels fine with no complaints now. General/bilateral: Musculoskeletal system: bandages on in both inguinal areas. No bruises. No swelling dressings D/I/C.
approximately 2 days after receiving vaccine was administered resident developed swelling, redness and warmth at site of vaccination, following the 2nd dose on 3/13 she developed H/A, chills & fever
Headache, muscle pain, fever, neck pain, weakness, pain and itching at site of injection, etc.
Fever began at 10:30 pm lasted until 4:30 am reaching 104 degrees. Intense body aches, vomiting all night, headache, uncontrollable shaking, extremely elevated heart rate. Symptoms continued the next day, but fever came back around 9:30, and body aches are still bad.
Fever; Chest pain; Headache; Chills; feeling very sick; Cold; palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration on 26Jul2021 18:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, chest pain, headache, chills on 27Jul2021 and feeling very sick, cold, palpitations on Jul2021. She is calling because she got the first dose of Pfizer COVID-19 Vaccine on Monday that is 26Jul2021 at 6pm. She said, yesterday she had fever, she also experienced chest pain, headache and chills after the first dose and she is still feeling very sick today. So, she wants to know how many days will the side effects or the fever will last after getting the first dose. She is also asking if she can take Moderna Vaccine instead of Pfizer COVID-19 Vaccine for her second dose. She is not sure with the date, she said that her second dose is on 16Aug2021 as far as she can remember. She is still feeling very sick today. When informed Patient stated that Are you going to transfer me or should she tell you her concern. Okay I am just concerned because I didn't feel well since the moment I took the vaccine. I was perfect but now I have cold. I have all the symptoms of COVID-19. I have chest pain, I don't know how to say that 'palpitations' or something. I just want to talk to someone that can answer all this concern that I have now. I am also kind of mad because they gave me all the information after putting the dose instead of giving me the information before. When again asked the permission to probe further questions, patient stated that Well she tell me that somebody is going to answer of the questions through the phone now. I was also calling because I wanted to know like for the experience that you guys have, how long does it takes the fever and all this symptoms to go away. The outcome of events was not recovered.
for almost 2 months Dozens of Lymph nodes on left chest and left arm; dizzy spells; migraines; dazed,; nauseous; all I wanted was to sleep; drugged; Blindness; dehydration; This is a spontaneous report from a contactable consumer (patient). A (Age: 66 unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history included restless legs syndrome (RLS) and known allergies: Penicillin. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID prior to vaccination. It was unknown if the patient was tested for COVID post vaccination. On 29Mar2021, the patient experienced "for almost 2 months Dozens of Lymph nodes on left chest and left arm", dizzy spells, blindness, migraines, dazed, drugged, nauseous, "all I wanted was to sleep", going back to school and she barely made it on zoom sessions. She had to lie down to appear on zoom, lived at Doctor's offices, emergencies (Doctor or other healthcare professional office clinic visit, Emergency room department or urgent care) and still not out of it. The patient additionally experienced dehydration. The patient received "Ivy" for dehydration. The patient underwent lab tests and procedures which included magnetic resonance (MRI) brain: unknown result and magnetic resonance imaging (MRI) chest (chest scans): unknown result, as treatment for events. The outcome of the other events was reported as recovered with sequelae. The outcome of the event dehydration was unknown.  Follow-up attempts are completed. No further information is expected.
Most concerning syptom is heavy bleeding & clotting.  4/8/21: Moderna vaccine #2 4/21/21: IUD incursion  4/22/21: IUD cramping and spotting. The bleeding got worse little by little each day. 5/3/21: heavy period, with clots, soaking pad hourly. Clots wrapped around IUD and it came out 5/5/21: still bleeding and passing clots Started mini hormonal daily pill to stop or slow the bleeding.  Started 2 periods a month, like clockwork, at this point. One super light for three days, two weeks later, heavy bleeding for 3 days. One to two days within that 3 day period was heavy clotting and soaking a pad every 1-2 hours.    Had uteran ablation on October 15, 2021 to stop bleeding  Medium flow period started back up in November. If it increases to dangerous flows again, Hysterectomy is recommended by doctor.
Shot administered in left arm 9-28-12. Day after shot, patient reported arm become painful and sore and red at injection site. Pain extended down arm to finger tips and up to neck/shoulder area. Arm felt paralyzed. Recovered after 2-3 days.
A nurse practitioner reported that a pt received an injection of Flu Shield '00-'01. Following the immunization, the pt's INR (international normalized ratio) was increased. No further information was available at the date of this report. The reporter indicated that 2 or 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Rapid onset of fatigue following 15 minutes post observation time, guest sat in chair and notified staff (11:42). Took her own prescribed carbidopa prescription as she stated she was due for a dose and that fatigue is common feature of her Parkinson's and that she usually feels better 20 minutes after medication. She then reported shortness of breath that felt "different" than her usual shortness of breath so internal aid was called for. EMT staff assessed guest to find vital signs stable and able to speak full sentences. Guest reported feeling better at 12:15 and was moved by wheelchair to her ride to go home.
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue  Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes  3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees  8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
VOMITED THE THIRD DOSE; This spontaneous case (PVX2019-2255) was received from a consumer on 04-Sep-2019. It described a female consumer, who "vomited the third dose" (PT: Vomiting), while being on Vivotif capsule for an unknown indication.  Case report: The consumer took the Vivotif doses on 27-Aug-2019, 29-Aug-2019, 31-Aug-2019, and 02-Sep-2019, respectively. She threw up the third dose on 31-Aug-2019 and saw the capsule in the vomit. She stated that she did not vomit after taking the fourth dose on 02-Sep-2019.  Action taken with Vivotif with respect to the event was dosage maintained.  The consumer had recovered from the reported event.  Company's Comment: In this case, it was reported that a female consumer "vomited the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labeled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer  "vomited the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labelled as per CCDS.
Rash, papular bilateral lower and upper extremities. Also on trunk, 2 ml BENADRYL given in clinic. Pt's mother did not notice rash until morning after vaccines given. Also with low grade fever of 99.
Herniated disc; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-131-4429044-00.  An elderly female patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 10Apr2015 as 40mg/0.8ml (Batch/Lot number: unknown), as 40mg/0.4ml (1 in 2 wk) (Batch/Lot number: unknown) and (ongoing) as 40mg/0.4ml (1 in 2 wk) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "cervical spine surgery", start date: Jan2018 (unspecified if ongoing), notes: In Jan2018, the patient experienced cervical spine surgery. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization, reaction(s): "Spinal cord compression"; BNT162b2 (Dose 1, Intramuscular), administration date: 01Mar2021, for Covid-19 Immunization, reaction(s): "Spinal cord compression"; BNT162b2 (Dose 2, Intramuscular), administration date: 23Mar2021, for Covid-19 Immunization, reaction(s): "Spinal cord compression". The following information was reported: INTERVERTEBRAL DISC PROTRUSION (medically significant) with onset 08Jun2022, outcome "not recovered", described as "Herniated disc". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intervertebral disc protrusion.  Clinical course: Solicited report by a consumer of an elderly female with events of pinched spinal cord and cervical spine surgery and non-serious herniated disc from lumbar 3 to sacral area with humira 40mg/0.4ml (adalimumab). On an unknown date, the patient experienced pinched spinal cord. In Jan2018, the patient experienced cervical spine surgery. On 08Jun2022, the patient experienced herniated disc from lumbar 3 to sacral area. dates, pinched spinal cord and cervical spine surgery resolved. on unknown bnt162b2 (Tozinameran) was also considered suspect. Cervical spine surgery on Jan2018 was due to a pinched spinal cord. Herniated disc from L-3 to Sacral area. Physical therapy treatment for herniated discs. Causality: Herniated disc (Intervertebral disc protrusion). Causality as per reporter (Drug/Vaccine): possible. Check all appropriate to adverse reaction: Other medically important condition. Did event abate after stopping drug NA  Follow-up attempts are completed. No further information is expected.
Info has been received from an RN concerning a 6 year old male with no known medical history who on 11/6/99 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The morning of 5/24/05 (previously reported as 5/23/o5) the pt developed a rash all over his body with 30+ lesions described as classic varicella. The rash was on his face, back, chest, and extremities. Some lesions were vesicular. It was reported that the pt was afebrile. The pt was seen in the office. No lab or diagnostic tests were performed. It was reported that the pt received symptomatic treatment only. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional info is not expected.
Diagnosed Guillain Barre Syndrome, C/O fever, leg pain, numbness in feet. Pain elbows/shoulders. C/O'd dizziness, vomiting, lethargic. As of today we finally made contact again, after I have left messages. Diagnosis confirmed. Patient was hospitalized later with staff infection (new) and diabetes (new to her).  02/02/2007 MR received from PCP.  Office visit 10/06/2006 3 days s/p flu vax. given in local pharmacy.  Pt. has c/o leg pain (left worse than right) and toes going numb. PE: Muscle tone good, SLR normal, Right toes numb.  Tx.'d with Prednisone. By 10/09/06 pt. was feeling better but developed flu sx. Increased leg pain on 10/20/2006.  Pt. was hopitalized on 10/29/06 for abscesses of the tricep and groin. Treated with abx. Impression: 1) Abscesses of left triceps and left groin area with surrounding cellulitis.  2) New onset Diabetes Mellitus 3) Morbid obesity 4) COPD  5) Degenerative joint disease  6) Guillain-Barre syndrome.
Case number PHEH2012US025188 is an initial spontaneous report received from a nurse on 20 Dec 2012 and follow up information received on 13 Aug 2013 and follow up report from the nurse received on 11 Nov 2013: This report refers to a 25-year-old female pregnant patient. Her previous pregnancy history included normal vaginal delivery at 40 weeks gestation and elective abortion at 8 weeks. In 2010, her Pap test showed an abnormal result as positive human papilloma virus. Concomitant drug included prenatal vitamins daily. Her previous vaccinations were tolerated well without any adverse events. Her last menstrual date was on 11 Oct 2012 and expected date of delivery was reported as 18 Jul 2013. This pregnant patient was vaccinated with FLUVIRIN (batch number: 123104) at a dose of 0.5 ml subcutaneously on 17 Dec 2012 (at 2:15 pm). On 11 Jan 2013, she underwent Afp (alpha-fetoprotein) tetra prenatal test and result was negative. On 07 Jul 2013, the patient delivered a live male neonate via normal delivery. The delivery duration was reported as 4 hours 7 mins and it was full term. The neonate weight was reported as 3400 grams, height as 46.4 cm and Apgar score reported as 8 (at 1 min) and 9 (at 5 mins). No adverse event was reported following this administration error. The nurse reported the case as non serious and causality as not suspected with the FLUVIRIN vaccine. Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of events without success. This case is considered lost to follow up. Follow up report from the nurse received on 11 Nov 2013: The delivery details and neonate details were updated.
Dizzines, severe fatigue, injection site pain, mild nausea, headache, body aches/joint pain.
COUGHING AND HACKING STUFF UP; SWOLLEN LYMPH NODES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) 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 patient experienced coughing and hacking stuff up, swollen lymph nodes, and headache. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) not reported, and COVID-19 antigen test (NR: not provided) negative. The action taken with covid-19 vaccine was not applicable. The outcome of the coughing and hacking stuff up, headache and swollen lymph nodes was not reported. This report was non-serious.
PATIENT'S FATHER REPORTED AFTER PATIENT SAT DOWN IN OBSERVATION AREA, SHE REQUESTED A WATER. PATIENT AND MOTHER WALKED TO RETRIEVE WATER AND AS SHE ENTERED THE TENT PATIENT REPORTED DIZZINESS AND VISION DISTURBANCE. PATIENT STATED SHE BEGAN TO SEE BLACK AS SHE WAS SEATED. NURSE WAS CALLED OVER. DAD STATED PATIENT'S BODY SLUMPED OVER AND HE SUPPORTED HER IN THE CHAIR. THE NURSE WITNESSED FULL BODY UNCONTROLLABLE SHAKING FOR LESS THAN 20 SECS. LOC ASSESSED AND PATIENT WAS AOx4 IMMEDIATELY FOLLOWING THE SHAKING. NURSE ALSO OBSERVED PALE LIPS. FLUIDS OFFERED AND CONSUMED. MD & EMS PAGED. DAD REPORTED TO MD, PATIENT HX OF FAINTING. PATIENT BECAME PALER. MD ADVISED AGAINST PLACING PATIENT ON GROUND. GURNEY PROVIDED. PATIENT FEET ELEVATED. VS OBTAINED #1 BP: 76/48; #2 83/52, p: 60, RR: 16; O2: 98%; #3 BP: 85/53, P: 81 at 1540. PATIENT OBSERVED WITH FEET ELEVATED FOR LESS THAN 10 MINS. MD RECOMMENDED PATIENT REMAIN IN OBSERVATION FOR 15 MINS PRIOR TO LEAVING. PATIENT MOVED TO CHAIR SEATED UPRIGHT POSITION WITHOUT ASSISTANCE FOR 15 MINS. 15 MINS ELAPSED, MD MADE AWARE AND DECLINED TO REEVALUATE PATIENT AT 1555. PATIENT EXITED OBSERVATION AREA ACCOMPANIED BY PARENTS AND BROTHER WITH FLUID IN HAND IN STABLE CONDITION.
patient received 2nd dose of Pfizer Biotech vaccine instead of receiving Moderna vaccine.  Patient previously had 1st dose of Moderna elsewhere at another facility
Redness and edema on left upper arm few hours after receiving vaccine, no shortness of breath, no fever or chill. Axilla not affected.
The next day after receiving Shingrix the patient stated he became nauseous and developed a fever. He said she felt this way for two days.
No additional AEs or PQC reported; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-MAY-2022, the patient was vaccinated with an inappropriate stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023, administered subcutaneously for prophylaxis (strength was not provided).   Temperature 6F Time frame 30 Minutes Previous temperature excursion? No  No adverse events were reported.
Severe Burning as it enters my arm.  2 days later, both legs became very heavy, hard to walk and painful enough to keep me up all night for nights on end.
all over her body pain; lost mobility in her legs; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 21Mar2021 as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On 05Apr2021 the patient experienced all over her body pain , lost mobility in her legs. The outcome of event all over her body pain was not recovered while the outcome of event lost mobility in her legs was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101195270 same reporter/drug/event, different patient;US-PFIZER INC-202101196152 same reporter/drug/event, different patient;US-PFIZER INC-202101196151 same reporter/drug/event, different patient
PRIMARY AND BOOSTER DOSE IT WAS NO LONGER IN THEIR  SYSTEM; This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received from on 20-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: transplant, and concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that after receiving the Janssen Covid19 vaccine, Primary and booster dose it was no longer in the system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of primary and booster dose it was no longer in their system was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242725. This case, involving the same patient is linked to 20220742370. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20220735351-covid-19 vaccine ad26.cov2.s-Primary and booster dose it was no longer in their system. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY (immunocompromised), SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.