chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse refers to a 2 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 24-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
pain in left armpit.; had pain in my left armpit. Then it went around to the chest area. It was very painful. If I hiccupped I would experience extreme pain.; felt the pain in my back area after that; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, arthritis, knee and hip replacement and allergy nos. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient had allergies to medications, food, or other products but cannot remember what it was exactly. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 11:00, approximately 24 hours after the vaccination the patient experienced pain in left armpit which then went around to the chest area. It was very painful. If patient hiccupped, he experienced extreme pain and also felt the pain in back area after that. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with pain killer tramadol. The clinical outcome of the events pain in left armpit which then went around to the chest area and pain in back area were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated w/FLUOGEN developed seizures pt mentally retarded w/a hx of seizure disorder but none since 1966, had a seizure 3 days after receiving FLUOGEN. 7 seizures since then. Only med Zantac.
nausea transient x2-3wk;sore elbows, shoulders, neck, shoulder blades x4wk;numbness in both hands x4wk;low grade temp 100 x 2wk;
administered the kinrix vaccine at an inappropriate age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 12th Apr 2022 Reporter's Comments: The medical assistant reported that an unknown patient was administered the Kinrix vaccine at an inappropriate age.
2 days p/vax devel a nodule @ site of DTP inj;red, hot, sensitive to touch; no fever;to hlth dept 23AUG & referred to family MD;no action by MD;
pt recvd vax & approx 10 mins later became very irritable & fever of 103-104 devel; tx included APAP q 4 hrs; 14OCT93 10AM MD called parent-child was sleeping & afebrile recovered;
Local reaction. Left deltoid area red, swollen, hot with some pain 4 x 5cm.
CHILLS; HEADACHE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345547.
Rash on chest, back and both arms 24 hours after and still have it 48 hours after. It does seem to be a little less noticeable after 48 hours.
I got it/ got bad case of the shingles/ suspected vaccination failure; got bad case of the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rituximab for product used for unknown indication and prednisone for product used for unknown indication.   On an unknown date, the patient received Shingrix, rituximab at an unknown dose and frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with rituximab was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The reporter had not been able to find information on whether or not to get Shingrix vaccine if he/she got it when immune compromised in 2019 when he/she got the vaccine. The patient got bad case of the shingles after taking prednisone and rituximab. The patient stated did not want to get vaccine again if he/she did not need it though. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
constant runny nose; Mild fatigue; constant watering eye; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female non-pregnant patient received at workplace clinic BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via unspecified route of administration in right arm on 18Feb2021 10:00 AM (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient was healthy at present she had cancer (ovarian) with chemotherapy on 2013 (also reported as 7 years before the present report) and she had cancer (breast) with radiation 6 years before the present report on 2015. No COVID prior vaccination was reported. The patient's concomitant medications administered in two weeks included anastrozole (ARIMIDEX), calcium carbonate (CALTRATE) and centrum multivitamin, all from unspecified date. No other vaccine administered in four weeks. As per known allergies it was reported that the patient previously received penicillin, sulfa drugs and she experienced rash with both, vancomycin and she experienced intolerance, codeine and she experienced vomiting. On 18Feb2021 04:45 PM (as reported) the patient experienced constant runny nose and constant watering eye, both over the course of about 6 hours in the evening after the vaccination (as reported) and mild fatigue. No treatment was received due to events. Patient was not tested for COVID post-vaccination. The outcome of the events was resolved.   No follow-up attempts are needed. No further information is expected.
4MAR93 530PM emesis x 6-7; message left @ MD's home; fever not checked but was hot; pt fretful, slept about 1 hr that noc, no oral intake; pt collapsed, eyes starring & glassey, lips blue, no breathing 2-3 minutes;
09/12/22 presents to ED for "altered mental status". PMHx of "schizophrenia, thrombocytopenia, prior ESBL UTI, HAP"
severe headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm, on 15May2021 12:00 PM (at the age of 41-years-old) at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and/or any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 on 24Apr2021 (at the age of 41-years-old) administered in left arm for COVID-19 immunisation. After four days from taking a second shot, on 20May2021 at 16:00 (as reported), the patient started feeling severe headache, it was getting worse until the reporting day (25May2021). The event was reported as serious due to life-threatening event and 2 days of hospitalization from May2021 to May2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included COVID test, nasal swab on 22May2021: negative. Therapeutic measures were taken as a result of the event and included treatment with blood thinner medicine injected. The patient had not recovered from the event.   Information on the lot/batch number has been requested.
hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine.  She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine).  A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally excluded. 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.
Had hives; This is a spontaneous report from a contactable consumer or other non hcp who reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that first time she had dose 1 of vaccine and had hives, the EMT gave benadryl. She asked if she should get the second dose. The clinical outcome of the events was unknown.  It was unknown if the reporter was a health care professional. It was unknown if the reporter the prescribing HCP.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Patient received the monovalent covid Pfizer vaccine instead of the bivalent covid Pfizer vaccine.
Itching/both arms near her wrist area only were itching like crazy/her back was itchy; two red welts, almost like hives on her body; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318, expiry date: not reported), via an unspecified route of administration at left upper arm on 28Jan2021 17:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included ongoing macular degeneration and thyroid disorder. Concomitant medications included levothyroxine for thyroid and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient got the vaccine on Thursday 28Jan2021. Thursday and Friday she was fine. However, Saturday morning (30Jan2021) when she woke up she had two red welts, almost like hives on her body and a little bit of itching. Then, the wee hours of yesterday morning (Sunday morning) both arms near her wrist area only were itching like crazy. She was calling to see if it would be okay to take Benadryl for the itching. No one she has called yet has been able to answer her question. She tried contacting the hospital where she got the vaccine. The patient further reported that she noticed the two red welts like hives on her body on Saturday in the morning (30Jan2021) when she woke up, exact time not specified. This has gone away. It went away sometime yesterday (31Jan2021). These were also itchy. She noticed the inside of her arm by the wrist area in the early morning hours yesterday were extremely itchy. She thought for sure she would wake up with red welts but there wasn't any. Her arms are fine. Now, her back was itchy. Her back now was the only thing now really itching. She placed Cortisone cream on her back and it helped. Her back was still a little itchy, but not as bad. The patient scheduled for her second dose on 18Feb2021. Therapeutic measures were taken as a result of itching/both arms near her wrist area only were itching like crazy/her back was itchy. On 31Jan2021, the patient recovered from "two red welts, almost like hives on her body" and was recovering from itching.
Within 10 minutes of the vaccine, numbness and swelling started traveling up from the injection site to the left side of my neck and jaw/cheek area. By 30 minutes afterward, it had made my whole arm feel numb including my fingers.  I took Tylenol and Benadryl and iced the areas.  Swelling and numbness persisted for the next 3-4 hours. I was fine the next morning as far as I could tell.
anaphylactic reaction; This spontaneous case was reported by a nurse and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. Patient was taking Benadryl because she had a slight reaction to first and second dose, it was an anaphylactic reaction that required observation not hospitalization.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-019001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 19 Apr 2021 included no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was vaccinated for covid shot and was waiting in a chair and started to feel hot. She said she was having a hot flash but then did feel well. she started to loose consciousness and sweat , she was cold to the touch and clammy and pale. Bp was 79/58  PULSE  119 eyes dilated and then became pin point. she had slurred speech but she could hear and tried to respond. second bp was 102/ 76 p 103.  SHE REPORTED SEEING SPOTTY AND BLACK SPOTS .  SHE EVENTUALLY CAME BACK TO AND REGAINED COLOR. OVER 30 MINS.
Difficulty breathing; Hot flashes; Diarrhea; Dizziness; Unable to sleep; Intense Chills; Joint pain; muscle pain; Headache; Nausea; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dizziness. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced intense chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced muscle pain. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, hot flashes, diarrhea, dizziness, unable to sleep, intense chills, joint pain, muscle pain, headache, and nausea on 2021. This report was non-serious. This case, from the same reporter is linked to 20210420860.
Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021.  Went home and started to have light headedness, sweaty palm, hot flashes.  She has been drinking water and ate before and after receiving the shot.  No reactions to other vaccinations.  Has history of anxiety and depression.
Numbness on right side of face, with drooping lips & dribbles liquids. Also noted right upper arm, shoulder & neck were numb. When presented to ED at 0830 on 1/20/2010, right Arm was OK with equal grip blilat. However, noted to hae right sided facial droop. Unable to wrinkle forehead, unable to smile or close right eye.  Decreased sensation upper & lower right face, extra occular movement intact, no tongue deviation noted & equal shoulder shrug.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "Cephalosporins allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures Paxlovid Treatment (start date: 20Aug2023, stop date: 25Aug2023) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300292668 same patient different drug/events;
Became pregnant before moderna booster. Received booster and a few days later had pain and some bleeding. Two weeks later pregnancy resulted in miscarriage.