chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, 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 included: "Muscular dystrophy" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of COVID after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 14Oct2022 to 19Oct2022.  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.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose and frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R;  112, 33, 0.555555556 and R; 344, 31, -0.555555556 and R; 224, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
pain at the injection site; Knot formed at injection site; fever of 103 degrees and would not decrease/ took her to ER; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old female patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, injection site nodule and fever. On an unknown date, the outcome of the injection site pain and injection site nodule were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site nodule and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 03-OCT-2022 Reporter's Comment: The reporter reported that the patient received Bexsero vaccine during the week of 26th September 2022. The reporter stated that after recieving Bexsero vaccine the patient experienced pain at the injection site, knot formed at the injection site and fever of 103 degrees, fever was not decreased so parents took the patient to the emergency room. The reporter did consent to follow up.
After injection pain in arm. Within 24 hours:   extreme muscle pain, runny nose, congestion, sore throat, hacking cough, headache, malaise, near incapacitation requiring bed rest.
Hepatitis A 0.5ml (Ped./ Adol.) 0.5 ml was given IM to 7 week old infant instead of PEDIARIX (DTAP, Polio, Hepatitis B) that was ordered resulting in an early dose of that specific vaccine. Parents have been notified and no harm to child as of the date of this report. Child has been recalled to return to office for PEDIARIX vaccine. Child will be monitored during routine office visits for sick and well child check-ups for potential long term effects from receiving the Hepatitis A vaccine early.
t105 down w/APAP to 102 x 24 hrs; some vomiting; fluid intake up; tx w/APAP supp;
Patient experienced severe arm pain, pain in back of neck and shortness of breath a few days following the injection.  The shortness of breath was brief (she used an albuterol inhaler once).  She also experience redness and swelling that lasted at least a week (still ongoing at the time of reporting).  She consulted her physician who prescribed some Benadryl orally to take.  She also experienced some mild fever (99.8F) lasting 24-48 hours.  She also had some achiness which lasted 24-48 hours.
low fever, URI, cough, anorexia;By 1MAY97 high fever, ear infect, tx w/amoxicillin;2MAY97 dx w/viral pneumonia, tx w/vantin;pt status is improving as of 7MAY97;MD office does not believe sx are r/t vax;family disagrees;
The pt's mother reported his left arm was red and swollen and "his left leg hurts". The pt was referred to a physician for evaluation. Stated there was no problem with his leg and the arm was just a local reaction and no treatment was required.
I presented to the doctor with the flu on Monday March 10 2008. The doctor said that it did not matter for the injection. The nurse was called and I was given the first injection. That night all through the night my arm became swollen and sore, I had intense pain in my lower back, groin and shooting pains down my legs. I had tingling in my feet and arms. The next day I nearly fainted when I sat up and every time I moved I had chronic dizziness coupled with ringing in my ears and black outs. Later that evening a red rash started to appear on my arm. I couldn't move my arm without extreme pain. I felt paralysed. A rash appeared on my lower back it looked like a heat rash. I had high fevers and intense pain lots of sweat and then I would feel very cold as if my spine was frozen. The back rash dissappeared but the arm rash increased in size. I went back to the doctor who said the rash would go down - the doctor did not administer anything. The rash did not go down. By the Thursday the rash had increased in size, my upper arm was swollen and itchy, I could not move my arm, I was pale, dizzy, feverish and I had pains in my back and legs. I had insomnia. I consulted a homeopath (as I no longer trusted the doctor) who administered china and apis and other herbs. It wasn't until I started taking these that the rash went down and the fever broke. During the month after the injection I suffered terrible insomnia and dizziness and pain at the injection site. During the two months after the injection I had inexplicable fatigue. Now, (5 months on) I experience a dull throb at the injection site, pain down my arm to my fingers with tingling. I am still experiencing intense fatigue and I believe my immune system is very poor.
2 hours after receiving the vaccine, patient experienced a very sore arm and was in and out of sleep all night. Pt was also nauseous throughout the night.
101 degree F fever, fatigue, headache, nausea, muscle and joint aches required bed rest and Aleve.  Fever down to 99 deg this morning, and symptoms resolved this morning
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment  medications were reported.
Patient hospitalized for shortness of breath on 2/11/2021. Patient had second dose of vaccine on 2/22/2021. Patient hospitalized on 3/30/2021 for coronary angiogram. These visits are within 6 weeks of receiving COVID vaccination.
Confusion, Dizziness, Headache, Nausea Vomiting, Runny Nose
Had to go to the urgent care because I was feeling ill and not able to do normal activities, when I arrived at the urgent care, I was advised to take ibuprofen or Tylenol and observe for a few hours. They said it's a normal reaction due to the vaccination and if I still don't feel well the next day I should come back. When I took Tylenol and slept on it the next day, I was feeling fine and back to normal.
Incorrect administration and dose of Td vaccine; 0.1 mL given intradermally instead of PPD for Tb testing. Patient experienced a reaction of swelling, redness and itchiness at the injection site.
Pt received vaccine and was walking around the store and passed out.  Pt was responsive , alert and oriented. 911 was called. Paramedics arrived and was checked out. They released her to go home without additional followup.
Extensive swelling of right arm with erythema. Complained of slight pain. Rx cold and warm compresses, Tylenol. Pt improved in 4-5 days.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 13-APR-2015, was vaccinated with an improperly stored dose of ROTATEQ (lot # K004921, expiration date not reproted) 2 ml, oral. No adverse effects were reported. Additional information has been requested.
Breakthrough COVID-19 infection on 10/06/2021 found on admission to the hospital s/p unwitnessed fall and rhabdomyolysis
In approximately November 1999, the pt experienced a pinpoint-type rash over the trunk, face, and chest.
Severe respiratory distress, tachycardia with dysrhythmia, hypotension, seizure and raised red areas across face, shoulders and sternal area.  Valium, Benadryl, Racemic Epi JN and Morphine given.  Time Course 1850-1930.
Fever ranging from 101.2 to 101.5 (measured orally periodically) lasting approximately 12-18 hours; associated chills and sweats. Muscle and joint stiffness, soreness, pain. Dizziness.
most of the vaccine went on the patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm). On 23-Jun-2021, DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
BAD BODY ACHES ALL OVER; COULD NOT SLEEP; DISCOMFORT; SORENESS IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced soreness in arm. On 12-APR-2021, the subject experienced bad body aches all over. On 12-APR-2021, the subject experienced could not sleep. On 12-APR-2021, the subject experienced discomfort. Treatment medications included: naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body aches all over, could not sleep, and discomfort on APR-2021, and had not recovered from soreness in arm. This report was non-serious.
Began with shaking chills 12 hrs post vaccination. Fever of 101F @ 0700 today with mild headache, body aches, fatigue and general malaise. Treating with Ibuprofen 400mg q6hprn.
Experienced tightness in throat 30 min. after receiving vaccines - Took BENADRYL and felt better after 1 1/2 hours.
Case number PHEH2014US024323 is an initial spontaneous report from a nurse received on 02 Dec 2014, and with a follow up reported from nurse on 19 Jan 2015. This report refers to a 59 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 05 Nov 2014 into left deltoid. The nurse reported that before vaccination the prefilled syringe of FLUVIRIN was stored at 49 degree F 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from nurse on 19 Jan 2015. Updated site of vaccination.
Reports she waited 15 minutes before leaving the building.  She said 7 minutes after getting the vaccine she felt tightness in her throat, but never had trouble breathing.  She did not tell the Healthcare workers but went to her car and sat for approximately an hour before coming in since it did not go away.  She said she had an epipen but never felt she needed to use it.
Patient had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours later. We were at the emergency room around 6:00pm and he was placed on a ventilator between midnight and 1:00am. He died 10 days later after experiencing clots that led to seizures and congestive heart failure. I have a death certificate if needed.
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen.  No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken.  Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 12:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:28 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Age of patient was reported as 72.64 for dose administered on 03-Mar-2021 and 72.71 for dose administered on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Patient received vaccine on 03-Mar-2021 at 12:11 PM and received other dose on 31-Mar-2021 at 01:28 PM. Batch number 014M20A underwent multiple temperature excursion on 03-Mar-2021 from 51 to 35 degrees Fahrenheit from 09AM to 01 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. No treatment medication were provided.
Red rash from injection site all the way down to elbow. Swelling of entire upper arm. Cellulitis diagnosis. Put on 10 days of cephalexin 500mg qid. 2 days later swelling of the shoulder and extreme pain. Put on prednisone 20mg. 2 weeks later pain still in shoulder limiting range of motion.
got the flu was after the shot; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves a 35-year-old and unknown gender patient who experienced got the flu was after the shot while receiving vaccine Influenza Vaccine (Flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch and expiry date requested.  On an unknown date, the patient developed flu (influenza) at unknown latency after the shot of INFLUENZA VACCINE.  It was reported that "how about natural prevention like good eating habits! FYI the only time in the last 35 years i got the flu was after the shot. Find out more about natural prevention not chemical crap."  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event influenza.
pt recv vax & w/in 5min of vax pt exp pain on inj, fainted was diaphoretic, SOB, & dizzy;ER visit was required tx w/IV med & 02;arm itched & exp numbness on the rt side of face & mouth & very pale;BP was fluctuating high to nl;exp abd cramp
Arm began itching; A Larger red spot around the injection site; inflamed around the injection site; Red spot around the injection site; Mild fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE PRURITUS (Arm began itching), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills). On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm began itching) and VACCINATION SITE ERYTHEMA (A Larger red spot around the injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 26-Jan-2021, VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm began itching) and VACCINATION SITE ERYTHEMA (A Larger red spot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Emergency C-Section - Stillbirth - 37 weeks. Pt has Tdap earlier in day.   05/01/2007 MR progress note received detailing the resusscitation attempt on infant delivered by emergency C/S for severe fetal bradycardia.  Upon arrival of the MD, no cardiac activity was visualized via ultrasound.  Upon delivery the infant was noted to have no muscle tone, no response, no reflex irritability and was blue/pale.  Resussitation was attempted x 30 minutes without success. 5/07/2007 Narritive Summary rec'd from hospital.  Pre and post operative DX was Placental Abruption.
Fever; Chills; Body aches; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any concomitant medication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient had fever, chills and body ache. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, chills and body ache was unknown at the time of report.   No follow-up attempts are possible; Information about lot\batch number cannot be obtained.