chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; LITTLE TIRED; INTERMITTENT CHILLS OVER 2-3  WEEKS; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's blood type was A positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A/43A27A expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021 after vaccination, the patient experienced some tiredness which he thought might have been due to the weather or the pandemic. The patient also had slight chills intermittently over three weeks after vaccination before this report. The patient was unsure about the lot number that it could be 043A21A or 043A27A. On 24-APR-2021, the patient took IGG (Immunoglobin G) antibody test and got a negative result. On 25-APR-2021, the patient took another IGG (Immunoglobin G) antibody test and the result was negative. It was reported that the patient had been eating a higher than normal amount of protein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little tired on 03-APR-2021, and the outcome of suspected immunological vaccine failure and intermittent chills over 2-3 weeks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210451243 -Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine 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
It was reported, "A nurse reported that a 5 month old male received his first dose of Rota Shield, as well as, Acel-Immune, Hib-Titer and IPV vaccines on 6/22/99. On 6/29/99, the infant developed a pimply rash on his trunk, arms and legs. No treatment was given." From additional information received on 9/29/99, additional vaccine information was provided.
Severe headache, body aches, nausea, dizziness, stiff neck, chills alternating with sweats all lasted 36+ hours. Swollen lymph nodes began after about 18 hours and continued 48 hours+ post-vaccination. Sore arm began after about 3 hours and persisted 48+ hours post-vaccination. Treated with Tylenol and Ibuprofen and a full day of bed rest.
Felt a little sick; Chills; Joint aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever). At the time of the report, ILLNESS (Felt a little sick), CHILLS (Chills ), ARTHRALGIA (Joint aches) and PYREXIA (Fever) had resolved.            The patient was on low dose Fludrocortisone  in November of 2021, was not continuing the medication.  Concomitant medication list was not provided.  Treatment information was not provided.
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020.   No follow-up attempts are possible. No further information is expected.
Overnight, he was cranky with a low-grade fever and developed a red rash surrounding the injection site. Evaluation of his right thigh shows an area of erythema, which measures in its greatest diameter 13 x 10 centimeters, an area of approximately 10 x 10 centimeters is solid red with some slight induration and multiple excoriations.
This spontaneous report as received from a Registered Nurse refers a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in October 2015, the patient was vaccinated with VARIVAX (Merck) lot# L013827 exp. 21-APR-2017 (dose was not reported). The patient received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because the reporter did not wish to be contacted.
skin pale and warm and dry.  Lasted for at least 10 seconds.  Dizziness.  Patient returned to normal within15 minutes.  Drank 2 boxes of juice.  BP 124/86, HR 80 and regular, respiratory rate 16 O2 saturation 100%
hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in in the left arm on 04Jan2021 at single dose for covid-19 immunization. Medical history included ongoing acid reflux. The patient had no concomitant medications. The patient previous received the flu shot. The patient experienced hearing loss, ringing and pulsating in her ears on 05Jan2021, headache on 04Jan2021, chills on 05Jan2021. Treatment was none. She had the vaccine on Monday at work and some of the symptoms that she has had have not resolved. She was having ringing in her ears and hearing loss. Went to see them and had her ears looked at. Everything was normal. Got the vaccine on 04Jan2021. Ringing in ears and hearing loss: Had been very consistent with no improvement. If anything, it had worsened. She was going to re-contact her doctor. She was also going to ask, should she go on Prednisone or something. She was worried she was going to lose her hearing. Her doctor said that a hearing test may need to be done. History: Takes one medication that she has been taking for years. She has never had an adverse event to any vaccine before. She got the flu shot every year. She was expecting the chills and headache, but they resolved fast. The next vaccine was 25Jan2021, the patient was asked whether she should get the second dose. The outcome of events for hearing loss, ringing and pulsating in her ears was not resolved, for headache and chills was resolved on 06Jan2021.
pt recv vax 16APR97 & presented w/rt jaw swelling;2MAY97 referred to MD 2MAY97;phone call w/MD verifying labs only CBC done;grandma states whole neck swollen on 4MAY97;
Breakthrough COVID-19 Infection post vaccination. PCR test positive 03/31/2021
This case was reported by a physician via call center representative and described the occurrence of Guillain Barre syndrome in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician heard second hand information about that, the patient who was in hospital dying from Guillain Barre Syndrome secondary to SHINGRIX vaccination. The reported physician was not treated this patient and did not have any additional information regarding the patient. The physician requested specific information on this patient. The reporter asked for someone from GSK to follow-up with him regarding this specific patient.
4 hours of unconsolable screaming, followed by a temp of 100.3, followed by HIVES seen the next day in the ER on the 24th and then came to see me the 25th at which time, he was well again.
30 minutes after the vaccine my throat became scratchy and started closing; 30 minutes after the vaccine my throat became scratchy and started closing; My chest was tight; wheezing; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported for herself that a 53-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 03Mar2021 12:00 PM (age at vaccination was 53-year-old) as dose 1, single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included asthma, IBS-M, 16p Duplication, Occipital Neuropathy, anxiety, allergies from an unknown date and unknown if ongoing. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, patient had not tested for COVID-19. Patient had not covid tested post vaccination. The patient had known allergies with erythromycin and floxmax. Concomitant medications received within 2 weeks of vaccination was venlafaxine (VENLAFAXINE), ibuprofen (ADVIL 12 HOUR), gabapentin (GABAPENTIN), d-mannose (D-MANNOSE), colecalciferol (VITAMIN D 3) all these taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 12:45 AM, 30 minutes after the vaccine her throat became scratchy and started closing, her chest was tight, and she was wheezing. She took albuterol inhaler and Benadryl, and everything subsided within 20 additional minutes. No seriousness criteria reported. Treatment received for the events was albuterol inhaler and Benadryl. Outcome of the events was recovered on an unspecified date in 2021.
Received 2nd does of Moderna at approximately 8:30 AM on Wednesday, May 19. At around 8:00PM that evening my fever raised to 99.7 degrees. At 1:00 AM on Thursday, May 20 my fever went up to 101.8 at which time I took one adult dose of Nyquil. At 3:00 AM I went to the bathroom to drink more water and I passed out. My wife called 911 and I was taken to a local hospital, for treatment. My blood pressure had dropped to ~90/58. They could not find a vein in the ambulance to administer an IV but the hospital staff was able to. The hospital release me at about 9:00 AM on Thursday, May 20.  From about 8:00PM to 3:00AM I had experienced symptoms of severe fever, nausea, muscle chills, severe fatigue.
COVID rapid antigen was done and positive; COVID rapid antigen was done and positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 24Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 13Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation; adalimumab (HUMIRA), subcutaneous since 2021 (Batch/Lot number: unknown) at 40 mg cyclic (40 mg, q 14 days) for juvenile idiopathic arthritis. Relevant medical history included: "Juvenile rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID rapid antigen was done and positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The action taken for adalimumab was unknown. Clinical course: Later on 15Nov2021 date started not feeling well developing cough, fatigue, low grade fever with loss of taste and smell.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 19-APR-2017, during an office visit, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency and route were not reported) lot # L029113 with expiration date of 27-MAR-2017, for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient fainted a few minutes after receiving his 2nd shot. He was seated and slumped to the floor
Severe diarrhea with 101 fever after Rotateq immunization, starting on 9/5/07 for 3-4 days.
Child had vax at 10:30 had lunch at 12:00 noon c/o itching, eyes swollen, red & tearing, hives on face, scratchy throat at 1:00 pm. Benadryl 50 mg given. Within 15 mins hives and swelling was better. Mother took child to MD.
Itching. Was given Benadryl PO by Walk-in clinic. Observed for 4 hours. Sent home with family member.
Sore arm; Allergies have been out of control, (very very bad, much much mcuh worse); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HYPERSENSITIVITY (Allergies have been out of control, (very very bad, much much mcuh worse)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not reported.
anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Mom called on 1/9/03 and broke out with chickenpox last night on belly, back and neck. Did have a few symptoms on Monday and Tuesday.
1. inflammation - April 3-5, 2021 2. onset of dizziness April 5th - continuing today April 10th 3. onset  of unbalanced  feeling and worsening louder tinnitus in left ear     and new tinnitus right ear  -  April 5th -continuing today April 10th
Onset pain in upper outer arm where vaccine administered.  Persisting from time of injection, on/off to 1/13/09 was seen - note worse again.  Hurts to palpule deltoid muscle, use deltoid muscle.
weight gain; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of OBESITY (weight gain) and SWELLING (swelling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Obesity. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Feb-2021 to an unknown date and BUSPIRONE HYDROCHLORIDE (BUSPAR) from 12-Mar-2021 to an unknown date for Anxiety, SILDENAFIL CITRATE (VIAGRA) for Pulmonary hypertension.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBESITY (weight gain) and SWELLING (swelling). At the time of the report, OBESITY (weight gain) and SWELLING (swelling) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details were reported.   This case was linked to MOD-2021-326423 (Patient Link).
Information has been received from a certified nurse practitioner concerning two patients of unknown age and gender, who on an unknown date were vaccinated with PNEUMOVAX 23 (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date patients experienced severe reactions after administration of PNEUMOVAX 23. The outcome of the patients was unknown. The patients sought unspecified medical attention. The relatedness for the event was unknown for PNEUMOVAX 23. Attempts are being made to distinguish individual patients mentioned in this report. Additional information will be provided if available.
Hives; skin lesions; scale like skin that peals from the scalp and behind the ears; hair loss from pealing scalp skin; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 18May2021 at 13:30 (at the age of 25-years-old) as a single dose for COVID-19 immunization. Medical history included mild Klippel Feil syndrome, gastroesophageal reflux disease (GERD), mild arthritis in lower spine, allergies to pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172) on 27Apr2021 at 12:00 (at the age of 25-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20May2021 at 10:00, the patient experienced hives, skin lesions, scale like skin that peeled from the scalp and behind the ears, hair loss from the peeling scalp skin. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with antihistamine. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 02Jun2021 with negative results. The clinical outcome of the events was resolved with sequel.
Tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable male consumer (patient) reported that: An unspecified age male patient received first dose of f BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Expiration date: Unknown; Lot number: Unknown), via unspecified route of administration (Anatomical Location; not reported) on Jan2021 as 1st dose, single for covid-19 immunisation. The medical history and concomitants were not reported. On an unspecified date in 2021, after 10 days the patient tested positive for covid-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Covid-19 Positive). The outcome of the event was unknown.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
PATIENT DEVELOP CARDIOGENIC SHOCK  AFTER RECEIVED FIRST DOSE OF MODERNA  VACCINE ON THURSDAY  29 2021  PATIENT DIED
I felt a strong dosage of the Flu Shot like never before. Two days after receiving the Flu Shot   I was analyzing my body like I always do and noticed I did not feel a slight fever like I usually do after receiving the Flu Shot. About 1 hour after analyzing my body I started to hear ringing in my left ear. It's never been the same.
Patient reported headache and sore arm the day following the vaccine, then 2 days after she stated sore muscles and some shortness of breath with daily activity.  Day 3 post vaccine she noticed swelling under her arm and Day 4 she reports redness in her eyes.   Patient did not seek any medical attention she just wanted the information reported.
pt recvd vax 330PM @ 630PM started crying unconsolably; broke out in red whelps all over body; Gave APAP-vomited it up; mom called MD; told has to give DPH repeated the APAP a little p/11:00; leg where DPT was given was red & swollen;
Ichy bumpy rash mostly on arms and legs but patches everywhere raised red bumps. Tried benadryl oral and cream with little to no relief flares up when sweating they feel like pins and needles when clothes touch
vaccinated at approx 12:02, pt observed to faint,observed described by RN to"fall over left shoulder from chair face down and hit left side of forehead" VS assessed, 99/60, P48, R18, 02 sat 99%, sweating, pale, responsive, alert and oriented x 3, small dime size reddened area to above eyebrow and left upper lip area,911 activated, Pt able to swallow, drinking fluids, complained he felt "I felt chest pressure, arm hurt, felt dizzy, then I don't remember" VS at 12:06 118/80, P75, R18. EMS on site 1212,Accu check 85, SR as per EMS, no further complaints of chest pain, no shortness of breath. Pt agreed to go with EMS for evaluation at hospital, transferred to wheelchair, then to stretcher once outside arena at 12:20pm, wife present. 12:28 doctor made aware.