chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021 at 5:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2021 at 5:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.75   Concomitant products were not provided.  On 22-Oct-2021 Excursion time was reported at 8 am, 9 am and 10 am  with temperature as 32,32 and 32 degrees Fahrenheit respectively , total doses given for the day was 5, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 22-Oct-2021. 1 vials were sent to clinic. Vaccine BUD date was 29-Oct-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.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The vaccine made my right arm really sore and red, some stinging and itching also. The day I got the injection it put me in bed by that evening. I had headache, body aches, stomach upset for 2 and 1/2 days. I had to stay in bed most of the time.
Patient received the pediatric COVID vaccine instead of the adult vaccine. Patient didn't have any side effects and received the correct formulation on 10/18/23 per CDC guidelines.
Within 15-30 minutes of receiving injection, client c/o headache and stiffness in right arm, was seen in ER on 10/27/03. Prescribed Vicodin.
Child has not had any adverse effects or symptoms; dose of GARDASIL 9 was given to a 1-year-old.; This spontaneous report has been received from physician and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions previous drugs reactions or allergies and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis at dose of 0.5 milliliter (route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). Lot number 17775808 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number 17775808 does not match any company product as confirmed by lot verification team (product administered to patient of inappropriate age).   It was reported that child had no adverse effects or symptoms following administration of the vaccine.
Subsequent to receiving vax, the pt developed a fever of up to 101. Five days post vax, the pt developed a fine imprint macular rash on neck and trunk.
09/30 Major flu symptoms, weakness resolved. 10/01 to present-Right leg feels dead, does not move like normal, causing falls, interfering with ADLs and IADL s.
Received 1st dose of Moderna 04/04/2021 Received 2nd dose of Moderna 04/21/2021 Patient scheduled herself on the online system for her Booster, she was going to be out of town for her scheduled Booster. She did not realize there had to be 28 days between shots.  When called on 04/26/2021 - Padtient reports she is feeling "fine" and did not suffer any adverse reactions.
Severe redness in upper left arm and warm to touch. No induration. Note: when I gave injection to child. Child was very tense and hard to hold while giving injection.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; Possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
rapid heart situation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "two months after receiving second dose vaccine, whenever caller was laying in bed caller was getting an irregular heart beat every 3 to 4 days".  The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart situation".  Additional information: Patient was reporting that he had rapid heart situation a couple years ago, and he was noticing that it happened again a couple weeks ago, after he got the COVID 19 vaccine. Caller is 82 years old. He has a question. Caller also happen to make an unclear statement about his daughter and that Pfizer is making a profit. Caller disconnected prior to completion of transfer. No Additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101442725 same reporter/patient, different dose/AE;
1) That night after the vaccine I had chills and fever, and couldn't sleep  2) 4 days later i tested positive for Covid  3) 2 months after the shot and the Covid, I began experiencing tachycardia--- elevated heart rate, even sometimes when resting. I visited the doctor to check on my heart and there were no arrythmias and nothing abnormal she could find on an echocardiogram.
Myocarditis Developed fevers, chest pain and hematuria. Fatigue started the next day, night sweets the night after x 2 days, fever on 6/14, chest pain on 6/15. Troponin elevated, Echo with poor ventricular function, UA with hematuria.  Improving on NSAIDs
Message from patient:   I want to check with you on a side effect I experienced after my second Moderna shot - I passed out, without warning.  Yesterday at 2pm I had my second Moderna vaccination. I was fine until I went to bed.  I woke up in the night with chills, a headache, and overall tiredness.  The symptoms continued during the day today.  I was able to eat a bit and have been drinking water to stay hydrated since before I received the shot.  At about 2:30 (three hours ago), I felt like I was about to throw up.  The next thing was that I was on the floor on my back.  I knelt up and threw up.  Luckily my head landed on a plastic humidifier.  Currently I feel occasionally dizzy and occasionally nauseous, as well as having a headache and overall tiredness.  Another possible syncopal episode and vomiting the evening of 5/9.
Had a red spot where didn't get the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 06-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Had a red spot where didn't get the shot) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Had a red spot where didn't get the shot). At the time of the report, ERYTHEMA (Had a red spot where didn't get the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
Starting 48-hours after vaccine, neuropathy in feet. Over days, progressed to neuropathy up to thighs and in fingertips. Also had nausea and vomiting. Missed period for entire month (never happened in past). About one month in, fatigue began (very severe). Neuropathy abated except in fingertips. Very minor in feet now at times. Fatigue remains a major issue.
No additional adverse effect reported; expired ROTATEQ was administered to a patient; This spontaneous report was received from a nurse and refers to a 2-months-old patient of unknown gender. No information regarding the concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-JUL-2020, the patient was vaccinated orally with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 oral vaccine, lot # R033256, expiration date: 23-JUN-2020 for prevention of rotavirus.  No temperature excursion occurred. No additional adverse effect reported.
eyes were red; felt very cold; muscle pain; aches in their body; feeling warm; feeling feverish and warm; chills; A spontaneous report was received from a nurse concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling feverish/pyrexia and warm/feeling hot, chills, felt very cold/feeling cold, aches in their body/pain, muscle pain/myalgia, eyes were red/ocular hyperemia.  The patient's medical history was not provided. Concomitant medications reported were gabapentin for diabetic neuropathy every night, melatonin, antihistamine medication, for high blood pressure, vitamins, zinc, omega, glaucoma eye drops for drug use for unknown indication.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) feeling feverish and warm, chills, felt very cold. On 1 Mar 2021, the patient experienced the events aches in their body, muscle pain. On 2 Mar 2021, the patient experienced the events eyes were red.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling feverish and warm, chills, felt very cold, aches in their body, muscle pain, eyes were red was unknown.
No adverse effects were reported; the patient was inadventently administered a dose of MMRII which was reconstituted with expired diluent; This spontaneous report was received from a Pharmacy intern referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 26-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (albumin status of rHA(recombinant human albumin)) (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N023153, expiration date: 24-AUG-2019) subcutaneous for prophylaxis. The reporter mentioned that the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was inadvertently reconstituted with expired sterile diluent (lot # N027945, expiration date: 24-MAY-2019). No adverse effects were reported. There was no temperature excursion.
Following day, had minor lower body half aches and chills; Following day, had minor lower body half aches and chills; Typical arm soreness similar to flu shot.; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH 9899), via an unspecified route of administration in the right arm on 29Dec2020 at 15:45 at a single dose as COVID vaccine. The patient had no other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID prior to vaccination, and was not tested for COVID post vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. Past drug history included flu shot. On 30Dec2020 at 10:00 AM, the patient experienced typical arm soreness similar to flu shot. The following day, 31Dec2020, he had minor lower body half aches and chills. The patient received no treatment for the events. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Rapids hear rate; Trouble breathing; Shaking like a panic attack; Shaking like a panic attack; Soreness in her arm; A little bit weak; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing) and TREMOR (Shaking like a panic attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm) and ASTHENIA (A little bit weak). On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), ASTHENIA (A little bit weak), HEART RATE INCREASED (Rapids hear rate), DYSPNOEA (Trouble breathing), TREMOR (Shaking like a panic attack) and PANIC ATTACK (Shaking like a panic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use include Over the counter pain. Treatment information was not provided.
incorrect vaccine schedule followed- should have received all baby formulation (3 doses) or all pediatric formulation (2 doses), no symptoms.
Fever, chills, whole body aches, nausea onset 6 hours after injection. Fever reached 102 degrees overnight, came down to 100 by next morning at 9am. Body aches and nausea continue so far, 18h after injection (time of reporting is 18h post injection)
Unable to keep down water. Threw up 7 times. Temperature went up to 105 degrees. Uncontrollable screaming and shaking. I gave her ibuprofen at 5PM to try and control the temperature. Took her to ER at 6PM. I told the intake nurse she just received vaccines. I was not made aware of VAERS at all. They dismissed me as a first time mother. Let me sit there with a feverish baby, they administered Motrin. An hour later they gave me a small bottle of nonflavored Pediasure. They told me to go home and wait it out, and to keep giving her motoring and Pediasure. That's it.
C/O FEVER @103.5 X1 NIGHT/VOMITING X6 TIMES x1 DAY AFTER VACCINES GIVEN ON 10/27/2008. CONTINUE GIVEN MOTRIN FOR FEVER IF NEEDED BRAT DIET IF NOT BETTER TRTURN TO CLINIC.
Bad arm pain; Abdominal pain that would not go away; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm (serious criteria hospitalization) and abdominal pain (serious criteria hospitalization). On an unknown date, the outcome of the pain in arm and abdominal pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 74 years old at the time of reporting. The patient experienced bad arm pain and abdominal pain that would not go away. The patient was hospitalized for a week.
hives, blotches, urticaria-onset; 13AUG PM being treated w/steroids;
Redness swelling of injection site about 24 hours after injection, 48 hours out has redness, warmth, pain to touch on LA, 2 quarter size areas of red warmth on RA. LA - 5 1/2 x 5 1/4 inch redness.
Pt had apparent breath holding spell followed by seizure activity X 1 minute with rolling back of eyes and jerking of upper and lower extremities.
received mi first Shingrix vaccine / ended up with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the vaccine at the end of May 2020 and ended up with shingles on his or her left hand and was treated with antiviral medication on 5th July 2020.  The reporter stated that he or she might had to wait longer than the typical 2 to 6 months for his or her second shot.
Intussusception with vomiting, abdominal pain and bloody stool.  Treated with air-enema.  11/05/2008 MR received for DOS 10/7-8/2008 with D/C DX: Intussusception. Pt presented with 1 day hx of vomiting, bloody diarrhea, and episodic abdominal pain with crying. Ileocolic IS noted on US and tx with Air contrast enema which successfully reduced the IS. Observed o/n and d/c next day.
SARS-CoV-2 test positive; Faints; Chills; Headache; A spontaneous report  was received from a consumer concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine and experienced faints, headache, chills, and COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, prior to vaccination, the patient took a COVID-19 test and results were negative.   On 31 Dec 2020, the day after vaccination, the patient got instantly sick, she had a headache, chills, and faints.   On 03 Jan 2021, the patient went to the emergency room (ER) where she received unspecified treatment for the symptoms she was experiencing.  On 04 Jan 2021, the patient received a second COVID-19 test and received a positive result on 08 Jan 2021.   On 08 Jan 2021, the patient was hospitalized with reported COVID-19 symptoms of dehydration, cough, no appetite, and no taste. Treatment for the event included fluids, oxygen, and steroids.   On 11 Jan 2021, the patient was discharged from the hospital.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, faints, headache, chills, and COVID-19, was not reported.
Chart notes written on 4/16/2021: Patientis presenting for having muscle aches and back pain since she received the 1st Moderna vaccine on 03/26/2021. The patient states that her arm started hurting right after she got the vaccine but just over the past couple weeks it has gotten worse. It is red under her arm and not by the injection site.  Her whole body has been achy since the injection.  On Monday of this week she developed 3 areas of red itching round patches.  She denies any other causes for the hives.  She has been taking some tylenol for the muscle aches and this seems to help a little.
pt had febrile convuls (generalized tonic-clonic convuls) 40 hrs p/vax;