chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a White and Hispanic or Latino male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, patient experienced the headaches, stuffy nose and sneezing. On 29-Sep-2021, patient experienced the Covid-19 symptoms (suspected Covid-19 infection and suspected clinical vaccination failure). On 01-OCT-2021, patient lost sense of taste and smell and decided to get tested for Covid-19. On 01-Oct-2021, patient tested for Covid-19 infection. On 02-OCT-2021 (Reported as Saturday) the test resulted positive for Covid-19. It was reported that, physician was notified and there was no change in lifestyle of patient". On 04-OCT-2021, patient experienced the chest congestion, fatigue and body aches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000195816.; Sender's Comments: V0: 20211006541-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
symptoms of nausea and lethargy; symptoms of nausea and lethargy; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 75 (unspecified unit) old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID-19 immunization. It was reported that the patient experienced symptoms of nausea and lethargy a week later in Jan2021. Outcome of the events was unknown. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Pt developed a red rash swollen & itchy at injection site, approximately 3-4 inches & redness is starting to spread along the backside of the arm (left arm), some soreness as well.
This spontaneous report was received from a healthcare worker (also reported as Office Manager) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dosing details unspecified) (lot # K015463, expiry date: 09-JUL-2017; lot # L014429, expiry date: 15-MAR-2018; lot # M001814, expiry date: 15-JAN-2018). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Syncope symptoms; became pale; sweating; dizziness. Recovered in 15 minutes. Fire department came to check all the vitals. Patient and his wife declined to go to the hospital. His wife reported that he ate the night before and was on empty stomach. The same symptoms occurred when patient received the tetanus vaccine before.
big welt that lasted about a week; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. The patient's concomitant medications were not reported. The historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient experienced big welt that lasted about a week on an unspecified date. Clinical course was reported as consumer calling about the Pfizer COVID-19 vaccine who says she had a friend post on social media asking about the vaccine to talk about side effects, and most people seemed to have none. She says she doesn't know them, but one person wrote after the second shot they had a big welt that lasted about a week, and she doesn't know if this would be a normal side effect or something. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
developed shingles 3 days after first vaccine shot; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04May2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021 at 09:00, the patient developed shingles 3 days after first vaccine shot. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Jun2021, the patient underwent lab test and procedure which included antigen test (test type: nasal swab) and the result was negative. The clinical outcome of the event shingles was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt complained of left upper arm redness, swelling and pain. The pt also experienced a hard knot in the center and the right hand still feels numb post last Anthrax vax. The pt also complained of a sore throat.
Headache Chills MYALGIA PYREXIA Fatigue FEELING COLD  INSOMNIA LETHARGY Injection site pain HEART RATE INCREASED  ARTHRALGIA HYPERHIDROSIS ASTHENIA  Tinnitus
Patient received RECOMBIVAX B vaccine x 2. Given RECOMBIVAX and PEDIARIX same day. No adverse effects.
Delirium, inability to move/leave bed, intense headache, intense muscle and joint pain, nausea, confusion, varying hot/cold skin. It was worst from 9:30 pm on the day of the vaccination through 11 am the next day, but I'm still feeling some of the symptoms now (28 hours later)
Pt recv vax on 8/19/98; on the same day pt exp headache, fever (100-102.5) for 2 dys; decreased appetite &weak.  Pt to M.D. on 8/22; dx=viral illness.  On 8/25 pt headache continued; no other sxs; pt return to M.D. if headache continues.
Immediate wheal and redness near injection site (of DTAP,MMR). Benadryl given, resolution wheal but cont redness. Observed 30 min.
2 hrs after swelling in lips, numbness tongue, express care, allergic rxn in mucous glands according to express care doctor.
Case number PHEH2013US023984 is an initial spontaneous report received from a nurse on 12 Nov 2013 with a follow up information received from a health care professional on 16 Dec 2013. This report refers to a 16 years-old female patient. Her medical history and concomitant medications were not reported. her vaccination status was uptodate. This patient under 18-years of age was vaccinated with a 0.5 ml intramuscular dose of FLUCELVAX (batch number: 008011A, expiry date: 30 Jun 2014) intramuscularly in the left deltoid on 07 Nov 2013. No adverse event was reported following the maladministration. Follow up information received from a health care professional on 16 Dec 2013: Reporter information, patient demographics (gender), batch number and site of vaccination updated. Following an internal review on 18 Aug 2014 for the information received on 16 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Red  area approximately 4? diameter at injection site approximately one week following injection. Itchy, slightly raised area. No warmth at site or other symptoms related to the vaccine.
Tremors to arms, lower mandible and legs. Headache behind eyes. Reports "feels dazed" - alert, oriented x3. Recall is good.
This case was reported by a healthcare professional (pharmacy technician who was also the subject's mother) and described the occurrence of motor tic in a 3-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Historic vaccination included HAVRIX; GlaxoSmithKline: unknown; unknown given on an unspecified date when the subject was 2 years 9 months old. On 8 November 2011 at 14:00 the subject received 2nd dose of HAVRIX (unknown route, unknown gluteal). On 8 November 2011, 30 minutes after vaccination with HAVRIX, the subject experienced motor tics in the eyes, feet and hands. The subject's mother took him to the emergency room on the night of 08 November 2011 and was advised to see the regular physician on 09 November 2011. At the time of reporting the event was worse.
Parents noticed redness and swelling at injection site 10-12 hours after vaccine administration. Area warm to touch. Elevated temp. of 100. Swelling increased x2 days to double the size of pt arm. Area of swelling extending from shoulder to below elbow. Area warm to touch.
Spot on forehead bothering me, could it be shingles without a rash; Tingly hurts; Tingly hurts; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort, tingling and pain. On an unknown date, the outcome of the discomfort, tingling and pain were unknown.   It was unknown if the reporter considered the discomfort, tingling and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that he/she had both of the shingles vaccines. So he/she had this spot on his/her forehead it was bothering him/her. The reporter stated that he/she could not see a rash but it tingly hurts. The reporter stated that he/she could not see anything there and enquired that could that be shingles without a rash. Additional supportive information: No follow-up was possible as no contact details were available.
pt recv vax; arm burned during shot; pain started 2nd week especially when lifting and lateral movements in arm and up to shoulders;denies any pain at site; shoveling hurt arm; took acetaminophen; pain better now, seems to be going away;
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 and dose 2 GARDASIL on 29-SEP-2010 and 01-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Initial misuse report received on 02 October 2013 from a health care professional. An adult, whose medical history and concomitant medications were not reported, received a dose of FLUZONE. It was reported that adult patient received 1.0 ml of FLUZONE instead of 0.5 ml. No reaction was reported. List of documents held by sender: none.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 12-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 21-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound of Covid symptoms two days after negative test; Negative, notes: Rebound of Covid symptoms two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Anti-viral Product Paxlovid for COVID 19 Treatment started on  29Dec2022 and stopped on 03Jan2023. No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Sep-2020 and the estimated date of delivery was 17-Jun-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Jan-2021, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter). On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE PAIN (soreness around the injection site) and INJECTION SITE ERYTHEMA (redness size of a quarter) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: events were added in the event tab.
7 days after receiving the vaccine, Thursday Feb. 4th, yesterday, I developed an itch at the injection site. By the afternoon I noticed a penny sized lump forming. I did not notice any other symptoms. Today, day 8, it is the size of a baseball.  It is hot and a little achy. I have been occasionally putting ice on it. I am going to take a Benadryl today hoping that helps.
her arm started tingling/she was getting some tingling in her feet/getting all the sporadic tingling; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 28Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient is pregnant at the of vaccination, if patient was diagnosed with COVID prior vaccination, and if patient received other vaccines within four weeks prior to COVID vaccination. The patient received Pfizer COVID vaccine last Monday and a few hours afterwards her arm started tingling. A few days later she was getting some tingling in her feet and she's getting all the sporadic tingling that is not going away. She's not even sure if she should get the second shot of the vaccine. Outcome of the event was not recovered. It was unknown if patient has been tested for COVID-19 since vaccination.  Information on the lot/batch number has been requested.
Pt reporting, swelling, itching redness and hot to touch however she said there is discoloration at site of injection looking similar to a tan on that part of the body and has been that way for 1 week. She reported tenderness but no pain or other accompanying symptoms. Told patient to contact provider as it sounds like possible capillary puncture and bruising but due to her transplant history I told her to contact MD for f/u.
Pt has a PMH of rheumatoid arthritis and is steroid dependent. Pt presents to the ER with fever, weakness, and a one day history of a cough. Chest xray revealed possible pneumonia and pt was found to be COVID positive.
Pt. states that after receiving the 3rd Booster of Phizer 09/27/2021, started experiencing symptoms 10/01/2021 of Pain throughout the back area, ?Pinched? rib feeling on the right side. Primary visit 10/26/2021 recommendation of X-Ray (Arthritis) PT ordered ( Missed due to being Hospitalized). Admitted Hospitalization 11/01/2021-11/05/2021 due to pain throughout the back, Blood Clot in the left leg located. Steroids and Muscle Relaxers Elaquix Prescribed, Discharged 11/05/2021. Still experiencing slight pain throughout the back area.
Patient reported being in his relatively normal state of health until he received a flu vaccination at a "roadside stand".  He alleged that approximately 2-3 days after this vaccination he developed worsening weakness, altered mental status and trouble breathing.  The patient was taken to hospital via EMS on 11/21/06 where he was found to be in acute respiratory failure.  The patient was admitted and during the patient's 14-day stay, he underwent multiple treatments & tests.  The patient's condition was treated medically and his condition progressively improved to the point of discharge to a rehab facility on 12/04/06.  Upon chart review and discussions with the patient's physicians, it was believed that the patient's condition might have been caused by the flu vaccination he allegedly received in mid-November.  No information is known as to where the patient received the alleged flu vaccination or the exact administration date.  While hospitalized the patient described the location of the vaccination as a "roadside stand".   5/25/07 Received hospital medical records which reveal patient experienced altered mental status & not feeling well for approx 5 days, body aches & malaise w/decreased oral intake & problems walking, difficulty breathing & increasing confusion.  In ER patient was hypoxic on RA, O2 applied, was lethargic & extremely dry, wheezing & tight lungs, distended abdomen & was disoriented.  A presumptive dx of infectious delirium & acute renal failure was made & started on IV antibiotics after cultures.  Admitted to ICU, 11/21/06-12/4/06.  Treated w/continued IV antibiotics, IV steroids & inhalers.  Neuro consult felt bilat LE weakness c/w GBS s/p flu vax.  Heme, GI & Pulm consults done.  Progressed & was transferred to rehab facility on continued nasal O2 with PT/OT.  FINAL DX: COPD, oxygen dependent; pneumonia, distal weakness, possible GBS; HTN; BPH; mild acute renal failure, resolving; abnormal LFTs, resolved; thrombocytopenia, resolving; essential tremor.
The red area was warmer to the touch then other areas of the skin; Large red areas around the injection site / Redness covered about 1/2 of their upper arm, from shoulder to 1/2 way to elbow; The red area were somewhat swollen; This spontaneous case was received on 16-Oct-2023 from other non healthcare professional (reference number SEQW23-03428) and concerned a 5-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023 , the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm, dose and route of administration: not reported) for influenza immunization.The batch number was not reported.  On 15-Oct-2023, one day after receiving Flucelvax  Quadrivalent the patient experienced a large red area around the injection site, redness covered about 1/2 of their upper arm, from shoulder to 1/2 way to elbow, it was warmer to the touch then other areas of the skin and somewhat swollen.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: One day after receiving Flucelvax Quadrivalent the patient experienced vaccination site swelling, vaccination site erythema, and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for the events, based on chronological and anatomical plausibility.; Sender's Comments: One day after receiving Flucelvax Quadrivalent the patient experienced vaccination site swelling, vaccination site erythema, and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for the events, based on chronological and anatomical plausibility.
Patient complained of shortness of breath neck soreness and tingling in arms and hands, and pressure on his chest. 911 was called and patient was taken via ambulance to hospital.
Hospitalized on April 27, 2021 with blood clots in my lungs.
Tingling in lips and swelling, tingling traveled under both eyes, up into her head, it also traveled down her right arm.  She experienced weakness on her right side,  She also thought her ears swelled to the point that she had to remove her hearing aids.