chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mom stated pt lt leg sore;began limping 3 hr p/vax the following AM 11AUG95 didn't want to sit up or walk;color & warmth nl;sl fever;
Headache, Myalgia & Fever Narrative: Aches, chills, headache, fever for 2 days after 2nd dose administration
Had varicella and flu in (R) arm on 3-13-12, developed redness, warmth, pain following day that got worse. Came in to office 3-15-12 to be seen.
arm was a little blue after receiving injection; This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231, expiration date unknown), via an unspecified route of administration in the left arm on 12Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 vaccination. Medical history included "cholesterol."  The patient's concomitant medications included rosuvastatin calcium (CRESTOR) 10 mg daily. It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. On 13Jan2021 the patient added that his arm was "a little blue" after receiving the injection. Treatment information, if any, was not provided. The clinical outcome of vaccination site discoloration was reported as recovered on 13Jan2021.
I received the vaccine at 6 weeks pregnant,  with no health issues or complications. 3 days after getting the vaccine I started bleeding and proceeded to miscarry.
My adverse event relates to rashes and swelling developing at sites where I was previously stung by wasps (about a week earlier). Details and timeline below.  08/05/2021, ~7 pm  Stung by wasps three times at two sites (2 stings to left wrist, 1 sting to inside of left ankle). The sting sites were painful for about an hour. I had no allergic reaction and did nothing to treat the stings. The ankle site remained slightly swollen for a day or two following; the wrist site did not swell. Within 3-4 days following the stings, I was fine and had no symptoms of the stings. 08/11/2021, 6:20 PM  Received vaccination
he seemed fine after got shot. Took him to school at 1030 & by noon they were calling me to come get him because his legs were hurting. When got home did a albuturol breathing treatment at 1230. Another at 230. By 345 he was having trouble breathing, his face was swelling, getting rash, very rapid heartbeat.  I put his albuturol breathing mask on him to help as i called EMS. Went to hospital by ambulance & shorthy after was airlifted to hospital in another city. Spent the night there and improved to come home the next evening
pt died in home with hospice care; pt had a positive COVID test on 8/27/21; per death certificate COVID 19 was a condition contributing to death; causes of death were Cardiopulmonary arrest, Respiratory failure, Senile degeneration of the brain
On day 8, I started having extreme soreness at the injection site. As the day proceeded, the injection site became very red, swollen, painful to touch and a little itchy. Still feeling swollen on day 9, but definitely getting better.
My arm became very sore and hard to the touch.  My shoulder became inflamed and the inflammation became worse and worse.  I went into severe pain in my left shoulder couldn't move it.  Went to physical therapy and to the sports medicine clinic.  I am still in physical therapy 5 months later.  They diagnosed me with Frozen Shoulder. Very painful still receiving physical therapy and pain injections with steroids.
I received the vaccine on Friday afternoon, by Sunday night I have been experiencing numbness and tingling in my feet and hands. I feel like I?m having a hard time getting circulation to my hands. They keep feeling as though they are ?falling asleep?. It's now Monday afternoon, and they symptoms have not gone away.
"COVID arm" started to appear about 24 hours after vaccination. Hot, red, itchy  and about 2 inches in diameter. Took Benedryl to relieve symptoms. Also developed raised bump at injection site. After 48 hours post injection, inflamed area extended about 4 inches with same symptoms- no antihistamine or Tylenol taken at all.  Today, at 72 hours post injection, inflmamed area extends to about six inches with same symptoms- warm to touch, red, itchy, hard center at injection site. Took one Benedryl to relieve symptoms. This did not occur after first COVID shot. This allergic reaction only appeared after the second COVID vaccination. Vaccination was given in same arm as first shot exactly four weeks prior.
Itchy; Severe rash all over his body; Red especially in his arms, elbows, face, neck, ears, legs; This is a spontaneous report received from a contactable consumer (patient's mother) from the Medical Information Team. A 6-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, administration date 10Nov2021 14:00 (lot number: FK5127) at the age of 6 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medications included an unspecified flu nasal spray from 27Oct2021. The following information was reported: On 11Nov2021 08:00, the patient experienced severe rash all over his body and the patient was really itchy. The mother also noticed that the patient was red especially in his arms and elbows, then on a Monday (unspecified date in Nov2021), it started on his face and neck, and on a Tuesday (unspecified date in Nov2021), it was in his ears and legs too. The patient's mother started him on Zyrtec on Sunday night (unspecified date in Nov2021) and the doctor changed it to Allegra liquid 5mg once a day, so the patient does not get drowsy or sleepy to go to school during the day. Hydrocortisone 2.5% was used as needed for when the patient was very itchy on his elbow. The events were occurring more and more on the patient's body even with the medications. The mother was concerned for the patient, and his next shot was scheduled on 01Dec2021. The events resulted in emergency room visit and physician office visit. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Mom states that child woke up screaming and holding his legs into his body. Unable to calm and went to ER and was told it was "a reaction to pertussis in the DTAP that he had received earlier that day at the doctor's office". Went to ER at 22:30 and was given Motrin at ER.
patients received FluLaval QIV today after a temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: patients received FluLaval QIV today after a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Sept-2023 Doctor of medicine called and reported that 6 patients received FluLaval QIV on the day of reporting after a temperature excursion (total time of excursion was 112 hours). The reporter had no details regarding patients but gave consent for follow up. This is 1 of 6 linked patients reported by the same reporter. The patient received a dose of Flulaval QIV after temperature excursion, which led to incorrect storage of drug.
Flushed face, tight chest, throat irritation.  Then followed by pink eye 1 hour later, then later chills/fever, general malaise and headache. Next morning only headache and general malaise.
Patient received COVID-19 vaccine at 10:00am.  Developed facial swelling (lips, eyes, face) 2-3 hrs later.   Went to  ER on 5/19/21 @ 06:00.  Was given "2 shots" and observed x 3 hrs, then sent home with Benadryl.
Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination.  Patient is still admitted at time of writing.
2" square area of redness. Pt feels heat and discomfort. Gave BENADRYL 25 mg and- it every 4-6 prn redness, itching. And Ice PK apply 15 min each time (off 15 min) for heat and pain. Notified family dr.
developed diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "developed diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt's aunt state the lips turned blue & swollen from 645AM until 845AM on 18JAN95;
This case involves a patient (demographics unknown) who had flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Only time I ever got a flu shot. I got the flu! Haven't had the shot or the flu since". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome of event was unknown. There will be no information available on the batch number for this case.
Administered 10 doses of Moderna as a booster and later realized the vial was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 03 Jan 2022. Concomitant medications were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438675, MOD-2022-438677 (Patient Link).
Patient had hives, globus sensation. Had to go to ED for benadryl, steroids.
Patient signed up for an appointment for her Flu Age 65+ vaccine online for 10/21/2022 at 12:45PM. It was confirmed when she came in that this is what she wanted, and she filled out all necessary paperwork and signed the consent form. When we tried to bill for the vaccine at the end of the day, however, it was rejected saying that the patient already received the vaccine on 09/15/22. The pharmacist on duty called Patient, who stated she never got the vaccine that day (she left due to them not knowing which vaccine she received previously). The pharmacist on duty then contacted the facility, who said she did receive the vaccine that day. This was discussed with Patient, who then said she would talk to them and call us back on Monday, 10/24. On Monday, 10/24/2022, she called us back to let us know she did mess up, and accidentally asked for the flu shot even though she already had it. She thought she received something else when she was at the Pharmacy. She was concerned that she was in immediate danger, and I suggested to her that usually the recommendation if you are unsure is to still receive the vaccine, so I do not believe that she is in immediate danger. I suggested she let her provider know immediately, and she was encouraged to follow up with the pharmacy with any questions or concerns.
pt recv vax 4FEB97 rxn both inj sites, areas red & warm to touch;ranging from 12-14cm inj size;no tx
Tingling in both arms and hands, right arm tingling sensation was very strong for about an hour.  Lips went numb for about 45min
Psoriasis spots on right arm. Patient had never had psoriasis before. This was after the Pfizer BioNTech Bivalent vaccine injected on 1/10/2023- the system is not letting me select that vaccine.
raised rash on arms, thighs & ear lobes which gradually resolved, on12dec94 had another group of vaxs, & rash appeared. 30Jan95 f/u from ofc had cold 26dec /c sl fever, feeling very tired, in for IGG, cold improving, rash still present
dizzines lasting for 24 hr. 3 days after injectiion--then again 3 days later. tiredness ,chills.
Patient reports that he had fairly sudden onset of Fever of 103, sweating, fatigue, generalized aching approximately by 5 pm that day. He was weak.
Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21
Pt immed. reported a metal taste in mouth and tongue became numb. Pt was layed down and vitals were taken. No local reaction at site of injection. An Allegra 180mg was given PO. Vitals taken every 10 min which remained stable. Pt observed for 1 hour and released.
The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced chills on 02May2021, 24hours after the second dose but then it went away. The outcome of the event was recovered in May2021.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510504 Same reporter/drug, different patient/event.
her husband received the Covid vaccine last Friday and was positive for Covid 19; positive for Covid 19; This is a spontaneous report from a non-contactable consumer reporting for herself and her husband. This case is for the reporter's husband.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 08Jan2021 (Friday) and was positive for COVID-19 on 11Jan2021 (Monday). The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021024045 same reporter/product/event, different patient
4/7/21 patient presents to ED with severe left arm pain and neck pain, dopplar shows occlusive thrombus in left cephalic vein 4/9/21 patient goes in to cardiac arrest; found to have an INR>10 and concern for life-threatening bleed that required treatment with KCentra; intubated and sedated; liver shock, heart failure with reduced ejections fraction; troponin elevation 4/13/21: patient extubated; patient's wife informs Dr. that patient was vaccinated on 3/31 with Jansen product after seeing news reports regarding adverse events 4/16/21 patient expected to be moved out of CCU to medical floor
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 11-OCT-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
No additional AE information; A patient received dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 30-JUN-2020, a patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S022917, which has been verified to be valid, and expiration date reported and validated as 09-JAN-2021) as prophylaxis. A properly stored dose sterile diluent (MERCK STERILE DILUENT) was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The vaccine experienced a temperature of -12.1 Celcius (C) four 45 minutes, as record by data logger. There was no previous temperature excursion. No additional adverse event were reported.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
diagnosed with cancer; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose- 1, his first primary dosage of Pfizer 1), for Covid-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "diagnosed with cancer". Clinical course: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), >12 years  - 15/15 mcg per dose. HCP(Pharmacist) called regarding a patient who received 3 doses of the Pfizer-BioNTech COVID-19 Vaccine, monovalent gray cap formula. HCP stated that between the 2nd and 3rd Pfizer vaccine doses the patient was diagnosed with cancer. Reporter clarified that patient was diagnosed with cancer after second dose and then third dose was administered. HCP was asking if the patient should receive the Pfizer-BioNTech COVID-19 Vaccine, monovalent gray cap formula or the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula and also if the HCP should check the patient's immunity prior to receiving for his 4th dose. She would like to know which vaccine should the patient get if it's the Monovalent or the Bivalent vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Neoplasm malignant and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Developed itchy feeling at injection site 24 hour after administration - area swollen, red, hot to touch, felt like goose egg. As of June 4th - remains red & warm, swelling decreasing.
cold/cold like symptoms; pressure in head; little queasy stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EN6200) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 10Mar2021, outcome "unknown", described as "cold/cold like symptoms"; HEAD DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "pressure in head"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "little queasy stomach".  Additional information: The patient was scheduled for second Pfizer vaccine tomorrow (11Mar2021) and thinks she had a cold. The patient wanted to know if it's okay to take the second dose (11Mar2021). First dose was on the 18Feb2021 and 2-3 days ago the patient felt like she had a cold going on, had pressure in her head, little queasy stomach.   No follow-up attempts are possible. No further information is expected.