chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID - symptoms; tested positive Oct 13, 17 and 19; This serious initial spontaneous safety report was received by Novavax on 19-OCT-2022 from a patient/consumer via contact center.  A male of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 02-AUG-2022, intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 23-AUG-2022.  No medical history was reported.  No concomitant medications were reported.  On 10-OCT-2022, after receiving both the doses of vaccine, the individual experienced COVID symptoms and tested positive for COVID-19 on 13-OCT-2022, 17-OCT-2022 and 19-OCT-2022 (PT: Vaccination failure) (Serious: Medically Significant). At the time of reporting, the individual stated that he was currently recovering from COVID-19, and that his symptoms were in remission since 13-OCT-2022.   Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 13-OCT-2022), SARS-CoV-2 test (Result: Positive; 17-OCT-2022) and SARS-CoV-2 test (Result: Positive; 19-OCT-2022).  At the time of reporting, the event outcome of Vaccination failure was recovered/resolved on 02-AUG-2022.  Lot number for dose 1 and dose 2 was not provided in the report.  This report is associated with product compliant (Private).  No additional information was provided.; Sender's Comments: This male of an unspecified age experienced: Vaccination failure after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL.  The event Vaccination failure was reported as serious.  Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Patient received 1st dose Moderna Lot#040B21A  on 4/19/21 in left deltoid. No adverse reaction reported by the patient.   On 5/17/21, patient was due to receive Moderna 2nd dose. Pt in error received Pfizer vaccine (lot #EW0158) instead of Moderna dose.  On 5/17/21 around 4pm, patient reports that she started with red swollen itchy lips, headache, and nausea
Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: patient states that exactly 5 hours after receiving vaccine she went into respiratory distress, she had an albuterol treatment at home which she used and it relieved her distress..then stated that it happened again 5 days later..she says she sometimes has some breathing problems in the fall but never to the degree that it happened after the vaccine...lots of wheezing and gasping for air, no other adverse effects
On 02/10/2023, I felt malaise.  Coughing, runny nose, a mild case.  I took Paxlovid the day I was tested, 02/12/2023. After five days, I felt fine.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovered/resolved and the outcome of the injection site warmth and incomplete course of vaccination were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX on left arm. The day after receiving the 1st dose, the patient developed swelling in the left arm and the left arm was warm to the touch. The swelling was from the shoulder to the elbow and lasted for approximately 10 days. The pharmacist wrote on the paper that the patient could get the 2nd dose of SHINGRIX between 22nd October 2018 and 22nd April 2019. The patient realized, the day of reporting that it had been almost 8 months since she got the first dose and not 6 months the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day.  In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years for Covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative, notes: Took home COVID test on Tuesday, NEG; (10Jun2022) Positive, notes: Tested POS for COVID on home test. Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child slept for 6 hours straight following vaccination , and ran a fever for almost 48 hours (vaccination took place on Thursday -fever from Thursday until Saturday). Child had diarrhea for two weeks following.
pt recvd vax; exp soreness at inject site & welts/rash following immun; recovered
This case was reported by a pharmacist via call center representative and described the occurrence of hand swelling in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On 20th September 2018, 1 days after receiving SHINGRIX, the patient experienced hand swelling. On an unknown date, the outcome of the hand swelling was not recovered/not resolved. It was unknown if the reporter considered the hand swelling to be related to SHINGRIX. Additional details were provided as follows: The next morning the patient had swollen hands (both hands). It had been 5 days and they were still swollen.
This spontaneous report received from a patient via a company representative concerned a 21 year old male. The patient's weight was not reported and height was 69 inches. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced felt like could not walk, where muscles would not be able to hold up, sweating profusely, difficulty speaking, throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, body shaking, muscle weakness, severe chills, headache, fever of 102.5, felt tired/exhaustion, and pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 102.5. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, headache, felt tired/exhaustion, and pain at injection site (left arm) on JUL-2021, body shaking, muscle weakness, and severe chills on 16-JUL-2021, and fever of 102.5, and the outcome of felt like could not walk, where muscles would not be able to hold up, sweating profusely and difficulty speaking was not reported. This report was non-serious.
1st vaccine: Pain at injection site. Arm pain. Rash 3-4 days after injection on injection site. Swelling near collarbone 8 days after injection. 2nd vaccine: Arm, axillary pain, headache, boy aches, fever, rash  at injection site.
DIZZY; CHILLS; FEVER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included antiphospholipid syndrome.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, chills, and fever on 09-APR-2021. This report was non-serious.
Patient suffered severe soreness. Could not lift arm for 2 days, had soreness for 2 weeks. Had a large lump that was raised for several days. Bruising occurred around the injection site in a round pattern, about the size of a half dollar.
Cardiopulmonary arrest; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 14Mar2021 (12:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hepatitis B. The patient's concomitant medications were not reported. The patient previously took tenofovir. On 14Mar2021 (21:00), the patient had cardiopulmonary arrest. The reported event had resulted into emergency room/department or urgent care visit. The patient was hospitalized from Mar2021 to an unspecified date due to the reported event, and was reported to be life-threatening. The patient was intubated in response to the event. The patient had a negative SARS CoV-2 test both on 14Mar2021 and 15Mar2021. The outcome of the event, cardiopulmonary arrest, was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information provided and a temporal association, a causal relationship between the event cardiopulmonary arrest and BNT162B2 cannot be completely 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I went to sleep mode; I could not move my body; collapsed; I have lost movement in my legs at that point and I have to be in the wheel chair and I have shaken in my body; Burning sensation in my chest; my head feels fuel like it is inflamed and I was wondering; Blood clots; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in APR2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in April2021, after 4 hours of vaccination the patient went to sleep mode, could not move body, collapsed, have lost movement in legs at that point, have to be in the wheelchair and have shaken in the body, burning sensation in chest; head feels fuel like it is inflamed, was wondering and blood clots. The patient was hospitalized on an unknown date in April2021 for all the events. The patient was admitted in the hospital different weeks at a time for the past two and half months now. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot not be requested.
This spontaneous report was received from a registered nurse refers to a 0 month old male patient. on 11-JUN-2014 at 03:54 am (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 deg (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 deg (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
MODERNA COVID VACCINE #3 GIVEN 12/3/21, LOT #060H21A; pt had a positive COVID test on 1/26/22 from Walgreens in Cordova, TN; went to ED that day; was on RA and doing ok so he was dc'd to home; 2/12/22 pt back to ED via EMS with AMS and increasing SOB; O2 supplementation; CXR showed COVID; given ABX; in renal failure; DNI; admitted; dexamethasone; rapidly worsened; transitioned to GIP hospice; pt passed away in hospital
left finger tingling, persistent numbness without neck pain, radiating from upper arm to distal arm
Complaint of generalized hot flash 15 minutes after getting vaccine shot. Patient  felt better after 5 minutes after event  episodes.
As soon as the patient got home from the clinic she was very listless, sleepy and vomited several times. This lasted 4 to 5 days during which her parents took her to the ER several times. They reported that the ER performed several tests which were all negative. They found no cause for her symptoms. After approximately 5 days she was able to start eating and she recovered.
reddened swelling, sl. tenderness (L) arm site of vaccination to r/o cellulitis
Breakthrough case admission after 4 vaccines  Pfizer 3/18/21 Lot# En6207;  Pfizer 4/8/21 Lot# Ew0150;  Pfizer 12/10/21 Lot# Fj8757;  Pfizer 6/29/22 Lot# FP7150
Swelling , redness and pain in arm; Vertigo and nausea; Tiredness
Telephone call received by RN, from (client) requesting a call back from Health Department on 11/02/2017 due to having pain in L arm and shoulder after receiving vaccines x3 when at the immunization clinic on Wednesday, 10/25/2017. Client reported that on Saturday, 10/28/2017, she went to the Urgent Care due to worsening pain in L shoulder joint and that provider there advised that, per client, the "injection site was too high and too far back and missed the deltoid." Urgent Care provider advised client to go to ER if signs and symptoms worsened and to call Health Department. Client reported to RN that she has increased pain and decreased mobility in her left shoulder. RN encouraged pt. to go to ER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULTS. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 on 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
GARDASIL 9 was administered to pregnant female; This spontaneous prospective pregnancy report was received from an office manager and refers to a pregnant female patient of unknown age. No information was provided regarding the patients's concomitant medication, medical history, concurrent conditions or drug reactions/allergies.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (dose number, route of administration, anatomical injection site, lot# and expiry date were not reported) for prophylaxis. The last menstrual period and estimated delivery date were not known. The pregnancy outcome was pending. The outcome of exposure during pregnancy was unknown.
Diarrhea, NauseaVomiting, Fatigue, Insomnia, nightmares Narrative:
Since my vaccine i have been brain fogged and not feeling like myself. When i workout i feel as though i could pass out. I feel unwell and fatigued.  This is bullshit and this vaccine is bullshit!  I wish more than anything that i could go back in time and undo what i did by getting this.  For 3 months after my second dose i couldnt even drive. I had to have my daughters father come live with me and my daughter because i couldnt take care of her!
Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number unknown, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The healthcare professional stated that the Twinrix was administered to an employee 2 days after the expiration date. The reporter declined to provide the patient's date of birth and did not had the lot number. The reporter provided an expiration date but was not certain that it was correct. The reporter consented to follow-up via mail. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21). This then progressed to numbness in lower body (4/12/21), the numbness then became weakness and inability to walk (4/26/21). I was then hospitalized 5/5/21 and had many, many tests. Ultimately I have been diagnosed with neurosarcoidosis and am currently undergoing treatment.
10/2/12 Pneumonia vaccine was given to pt. 2 days later saw MD for sore left arm. Left arm examined and noted to be red and hot over 8x6 cm area.
On 5/9/00, pt reported he felt he has a rash due to the Hep-B vaccine. Pt states that rash started 2 days, post vax. It is an intermittent rash that becomes very itchy when playing basketball or showering. Pt states rash is all over body. He was referred to Occupational Medicine, who determined his rash was related to the vaccine.
This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine used) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Nov 12 , 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12 , 2021, patient administered expired product (expired vaccine used). On Nov 12 , 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recv vax 12MAR97 & pt became feverish p/vax;pt had another sx @ home & mom took pt to ER;
mom went to change diaper (had watery stool) @ 730AM on 22JAN93 & noticed a red swollen rash on back of lt arm, rt arm & couple of rashes on legs;  had allerg react;
Swelling around eyes 1 hour after the dose was given and then swelling in cheek and upper face. No trouble breathing.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or before 08 September 2006, the subject received a dose of Infanrix at an unspecified site of injection (dose number and lot number not provided). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 08 September 2006, the subject experienced "a large localized reaction" at the injection site of Infanrix. The outcome of the event was not reported.
Temperature, chills, left body aches, left ear pain, left neck pain, chest pain, extreme swelling of the left inside of throat
The morning after the shot I realized that my supraclavicular lymph nodes were sore to the touch and swollen
I contracted COVID-19 19 4/20/22 with symptoms of congestion, nasal drainage, cough, mild fever on the second and third days, myalgia, loss of taste, and I am still experiencing head congestion and stuffy nose as of today 4/28/22.
Received polio and PPSU in left arm 7/2/10, woke with fever and achy feeling 7/3/10 upper L deltoid swollen, hot and aches. Progressive area enlargement till 7/4/10 and gradually reduced in size and discomfort. 7/6/10 warm slightly raised 4x6 inch area at deltoid, reddened. Decreased discomfort and no fever. Ibuprofen q 6hrs- Saturday and Sunday A.M. took last dose - On ZYRTEC as usual. Does not know dosage.
p/vax pt devel inj site rxn by redness;swelling warmth & pain; tx w/APAP & ice
On 04/13/01, this patient's mother called at 12:30 stating the infant hadn't stopped crying since he was given the immunization 04/12/01. No fever or rash, gave the infant Tylenol. She couldn't see what was causing him to cry, no transportation to bring him to the MD. The mother promised to carry him to the PMD. The grandmother noted his left thigh was swollen and the infant's thigh was rubbed with alcohol and he stopped crying. The infant was not carried to the PMD and as of 04/19/01, no other problems.
Leg pain, difficulty walking, bending knees, leg and feet numbness, leg weakness, feels tight, muscle twitching, etc. More prominent in the right side of body