chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had COVID-19 pneumonia while in the hospital; had COVID-19 pneumonia while in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003869.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2022 as dose 1, single (Batch/Lot number: unknown) and on 04Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "had COVID-19 pneumonia while in the hospital". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2022) Blood pressure increased to 200s, notes: Blood pressure increased to 200s; Oxygen saturation: (2022) Low blood oxygen, notes: Low blood oxygen.  Clinical course: On 14Oct2022, it was reported that a patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient. The patient had the second dose on 04Apr2022. It was reported, the patient then had heart palpitations and blood pressure increased to 200s. It made the patient sick. Body was buzzing inside and then had the shakes, was shaky and ill. It was also reported that Pfizer had a bad batch of the COVID-19 vaccine which was never recalled. Patient also had COVID-19 pneumonia while in the hospital and low blood oxygen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A report has been received from a health professional concerning a male patient born on 19-Jun-2009. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST QUADRIVALENT started on 28-Aug-2013. A Registered Nurse in a doctor's office reported that they have had six cases of influenza A in individuals who had received FLUMIST QUADRIVALENT.  She did not have patient demographics, information of the FLUMIST used, or MD information. She stated the Registered Nurse told her that two individuals were staff members of the clinic. Registered Nurse said the positive tests were in the past few weeks. He was tested positive on Monday, not treatment. The outcome of the event of Influenza A was unknown. The reporter considered the event of influenza A to be non-serious. Laboratory values are available.
stinging at injection site during and after the injection; 58 year old was administered with first dose of MMR II; This spontaneous report was received from a patient's husband regarding his wife who was a 58-year-old female. It was reported that patient has no pertinent medical history and drug reactions or allergies. Concomitant medication included unspecified thyroid, cholesterol and glaucoma medications. On 26-APR-2019, the patient was vaccinated with first dose in series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# and expiry date was not reported) for measles protection along with sterile diluent(MERCK STERILE DILUENT) (lot# and expiry date was not reported) (Product administered to patient of inappropriate age). On 26-APR-2019 (also reported as during and after the injection), patient experienced stinging at the injection site (vaccination site pain). It was reported that no treatment was given for the treatment. The patient did not seek any medical attention. The outcome of vaccination site pain was reported as recovered/resolved. The outcome of the event product administered to patient of inappropriate age was unknown. The causality of the event vaccination site pain with respect to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent(MERCK STERILE DILUENT) was not reported.
Mom reports visible blood in stool - went to ER for BRBPR. Had h/o hemoccult (+) stool since 1 mo old, but none visible. Sees GI.
10 days of increased irritability, intermittent screaming from apparent pain, vomiting formula, increased drooling
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On an unknown date between March of 2016 through May of 2016, the patients were vaccinated with improperly stored pediatric and adult doses of RECOMBIVAX HB (dosing details were not reported) (lot # L048208 expiry date 15-Sep-2017 and L038018 expiry date 13-SEP-2017). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Hot,red itchy arm. Swollen area about 5 inches in diameter. Very itchy. Had been a week and is slightly less red today
Pt given DTAP, immediately cried after then became pale and dropped heart rate 130-140 down to 80's - episode lasted 3-4 minutes - pt placed on O2 2 liters PSO2 and sent to ER via ambulance. EKG NL. Pt kept overnight x 24 hrs then discharged home.
Pain in entire right thigh, thought I pulled a tendon, thought it was tendonitis on right leg around knee; knee bursitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDONITIS (Pain in entire right thigh, thought I pulled a tendon, thought it was tendonitis on right leg around knee) and BURSITIS (knee bursitis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Mar-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced TENDONITIS (Pain in entire right thigh, thought I pulled a tendon, thought it was tendonitis on right leg around knee). 25-Mar-2021, the patient experienced BURSITIS (knee bursitis). The patient was treated with IBUPROFEN for Bursitis, at a dose of 1 dosage form. At the time of the report, TENDONITIS (Pain in entire right thigh, thought I pulled a tendon, thought it was tendonitis on right leg around knee) and BURSITIS (knee bursitis) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided by the reporter.  Treatment also included ice packs on the knee.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Completed ADR Form: Contact details Updated, Event out come updated, and treatment medications updated.
cardiopulmonary arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 91 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for covid-19 immunization; Bnt162b2 (Dose number 2), for covid-19 immunization. The following information was reported: CARDIO-RESPIRATORY ARREST (death), outcome "fatal", described as "cardiopulmonary arrest". The reporter believed booster killed patient. The patient date of death was unknown. The reported cause of death was cardio-respiratory arrest. She died of cardiopulmonary arrest within 48 hours of getting booster, she had nothing acute going on. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died of cardiopulmonary arrest
Immediately post vax, the pt experienced seizure activity with clonic movement of upper arm and loss of consciousness. The pt was dx in the ER with syncopal episode. Upon internal review, seizure activity with clonic movement of upper arm was considered to be an important medical event. It has been determined that WAES00100590 is a duplicate report of WAES 00102006. Therefore WAES00100590 is being deleted from our files and the reports consolidated into WAES00102016. Follow up on 03/28/2001: "Patient date of birth and Lot # for vaccine 1 is not provided."
Red rash around where I was injected. Took anti allergy medicine an hour ago, waiting on results.
pt recvd vax;devel inject site reaction & swelling, erythema & red streaks on deltoid; rxn worsened w/ extreme pain & swelling in elbow area;
Case number PHEH2014US025010 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 34 years old female patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 11 Nov 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursions. No adverse events were reported following the maladministration.
pt recv vax 1996 & JUN97 pt exp 20-30 lesions;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: gh9294) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: ej1685), in left arm, on 05Jan2021 as dose 2, single (Lot number: el3246), in left arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: other medical history: mild asthma; "seasonal allergies" (unspecified if ongoing), notes: other medical history: seasonal allergies; "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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2023) Positive; (27Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient had other medication in 2 weeks. Patient received anti viral therapy with brand Paxlovid which was started on 07Apr2023 and stopped on 11Apr2023 for treatment of COVID-19. On 17Apr2023 started with runny nose, which increased over the next 24 hours. COVID home test on 18Apr2023 positive. Cough, malaise, fatigue, diaphoresis and dizziness developed over the next 24 hours. Fatigue, mild SOB, dizziness continue as of 28Apr2023. COVID test negative as of 27Apr2023.  Conclusion of Previously Completed Investigation: The complaint for pfizer-biontech covid-19 vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot FK9893. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2 and the reported events covid-19, drug ineffective cannot be excluded.
Rash from jaw bone down front and side of neck to breast bone.   Took 2 Diphenhydramin HCI 25 mg capsules about 3pm to relieve itching. Next day rash was still present but did not need to take medication.  On Sunday there was still a light rash, no medication needed.
Inflammation and swelling in both lower legs.  Capillary bleeding.  Prescribed prednizone by doctor to address symptoms.
Suspected occipital neuralgia on the left side, mid skull starting approximately 12 hours post vaccination and sustaining for approximately 10 hours post onset.   Symptoms were a sharp pulsating pain in the back of the skull, left side, approximately every 30 seconds followed by a corresponding twitching sensation in the left eye/jaw.  Always possible it?s a coincidence / unlucky timing but woke me up and never experienced something like it - just reporting in case a pattern is later observed.  By 10 am (7 hrs post being awoken by it, seemed to subside but was still intense in severity in the early active/awoken hours)
This spontaneous report as received from a Medical assistant via field representative and refers to a female patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9, dose 1, 1 DF for prophylaxis. Two days later, she came back to office and complained of headache. The outcome of headache was unknown. The reporter did not provide the causal relation of event with respect to GARDASIL 9. No product quality compliant (PQC) was present. No further details were noted.
Patient was given undiluted pediatric dose .2ml dose given No reactions noted.  Patient notified and rescheduled for 8 weeks for full booster, per CDC guidelines
Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs.  Had these adverse effects on and off for over a week.  The second week after the shot felt numbness in my face.  After about one month these events are mostly gone. Still have occasional  fire bursts under my skin but only one or two not my entire arms or legs.
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The reporter stated that, the patient received an expired dose of Bexsero which led to expired vaccine used. The reporter consented to follow up.
15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I checked my Watch and heart rate was 127. I had a similar reaction with the first shot on 3/24/21 and was told by staff that it was probably due to  hyperventilation and panic after they took my vitals. I did not seek medical attention the second time as the burning sensation disappeared quickly and I was able to lower my heart rate through breathing exercises. I left the medical location about 15-20 minutes after the episode and drove home without incident.  I had moderate arm pain and  fatigue the rest of the day. On the morning of 4/22/2021, I woke up feeling well except arm pain. At around 7:45  that morning, I had a sudden shaky episode where my watch registered heartrates from 105 up through 153. My hands tingled and  they developed  a significant tremor. These symptoms are typical for me during a panic attack. I took 1/2 of a Clonazepam and did some breathing exercise and was able to get my heart rate back to normal (in the 70s) within 10 or 15 minutes.
This spontaneous report as received from a nurse practitioner refers to a 18 year old female patient with no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, expiration date, dose, route not reported) in the deltoid at the proper location. Concomitant medication included oral birth control and multi vitamin. On an unspecified date in 2013, after receiving GARDASIL the patient felt achy and had a large mass at injection site. The patient visited the nurse practitioner on an unspecified date and stated that she had been experiencing headaches and joint ache in her shoulder, at the time of the visit the patient said it was currently more of "generalized body aches". There was no palpable mass at injection site during the patient's office visit and that the patient did not have any adverse effect after receiving the first dose of GARDASIL. Nurse practitioner drew lab work on an unspecified date in 2013 to verify that "nothing else was going on" with the patient, these included a Comprehensive Metabolic Panel and Complete Blood Count (CBC). The results were normal. The outcome of the joint ache in her shoulder, headaches, achy at injection site and generalized body aches was reported as not recovered. Additional information has been requested.
Initial unsolicited report received from a consumer via other company (pfizer) (under the reference number: 2016286705) on 09-JUN-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Hypotensive, hypoxic. gurgling respirations. unresponsive. not producing urine
Patient said he started to have small red dots from mouth and neck down to back and went to see a dermatologist who diagnosed it as being shingles.
FELT SICK; This spontaneous report received from a consumer concerned multiple patients. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested . No concomitant medications were reported. On an unspecified date, the subject experienced felt sick and stayed in bed for 24 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick and stayed in bed for 24 hrs was not reported. This report was non-serious.
7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator was on 26-Jan-2022. It was reported that patient received Moderna booster dose .25 No Concomitant information was reported. No Treatment information was reported.
This spontaneous report was received from a nurse via a company representative concerning a current 11 year old female patient. On an unknown date the patient was vaccinated with a dose of hepatitis A vaccine (manufacturer unknown) (dose, route and lot# not provided). On an unknown date the patient experienced "an allergic reaction". At the time of the report, the patient's outcome was unknown. It was also reported that in late April 2015, the patient experienced syncope after received her first dose of GARDASIL (MARRS # 1505USA002375). This is one of several reports received from the same source. Additional information has been requested.
Extreme hair loss; arm was tender for the next 4 to 5 days; Arm was a little sore, little achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Extreme hair loss), TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEN) and PROGESTERONE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-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 ALOPECIA (Extreme hair loss), TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired). At the time of the report, ALOPECIA (Extreme hair loss) outcome was unknown and TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included hormone replacement therapy.  The patient began experiencing extreme hair loss after the second dose which became extensive a week later after vaccination. She reported losing a handful of hair.  Treatment information was not provided.
Cellulitis; severe local swelling. Tx: Keflex/Prelone/ ?
Rash and tenderness at site of injection 9 days after vaccines given with fever. Fever/vx reaction concern-rash on leg, here w/mom.