chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning after my shot maybe 12 hours later I woke up with a 104.5° fever and my right armpit was the size of a tennis ball and hurt a lot. I was extremely tired I could not go to work.  I did not eat all day but I did take a lukewarm shower and some Tylenol.. About 5 PM my fever broke and it still took another 24 hours for me to feel myself again. It has been five weeks and I still have a golf ball sized lump in my right armpit even after massaging it and exercising and sweating every day.
fever 100-101 F following 6hr - 7hr after immunization. 4 days after immunization eryth maculopapular rash continued until 7 day after immunization no URI or GI sx.
On Friday 10.06.2023, during a routine office visit as a new patient, pt. was administered Hep A instead of Hepatitis B. Medical assistant grabbed incorrect Hepatitis vaccine and administered to patient. Parents were notified as soon as vaccine was being documented, shortly after immunization was given. As per pt.'s father, he would like for Hepatitis B vaccine to be administered on Saturday 10.07.2023. On Saturday 10.07.2023, pt. returned for correct Hepatitis vaccine, pt. did not have any side effects, reactions or any other concerns.
This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced inflamed joints below legs. On 22-MAY-2021, the subject experienced can't walk. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced severe muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 24-MAY-2021, was recovering from fever, had not recovered from inflamed joints below legs, and severe muscle soreness, and the outcome of can't walk was not reported. This report was non-serious.; Sender's Comments: V0:MAC not required as per standard procedure as case was assessed as non- serious.
Doses administered less than one month apart; A spontaneous report was received from a consumer concerning a 66-year-old female patient who received two doses of Moderna's COVID-19 vaccine (mRNA-1273) less than one month apart.  The patient's medical history was not provided. No concomitant medications were provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021. On 10 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) in the for prophylaxis of COVID-19 infection.  On 10 Feb 2021, second dose administered less than one month apart from first dose. On 19 Feb 2021, the patient donated blood one week after receiving both doses of the vaccine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event doses administered less than one month apart was considered recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, batch # unknown,  with no associated AEs.
Pt developed red raised area right thigh 6 days post vax, c/o itching no other sx.
1 to 1 1/2 days after immunization, patient reports "shivers and chills". 5 days post immunization he had "bronchitis" with "temp of 99, nasal and chest congestion, productive cough with yellow phlegm". Symptoms essentially resolved after seeing his doctor and had 3 days rx of Z-Pak.
pt recvd vax 19OCT95 11PM & had a sz;pt holding rt arm where vax given; took gasps of breath & got tremors, frothed @ mouth & eyes rolled back in head;pain; gasped loudly several times & may have stopped breathing; sz
Sore throat-felt like there was a lump in the back of my throat when swallowing. 7 PM yucky feeling. 8PM Dry eyes. 8:30 PM chills, achy muscles, phlegmy cough and by 10 PM wave of nausea midnight achy muscles & joints
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
no adverse reactions; the child was administered GARDASIL or GARDASIL 9.; the child was administered GARDASIL or GARDASIL 9.; This spontaneous report was received from a consumer referring via a company representative to a 4 months old patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 24-AUG-2020, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration and wrong vaccine administered) (reported as it was unknown by the customer whether the child was administered quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)). The patient was asymptomatic at this point and no adverse reactions had been observed.
Had a localized rash at injection site; Red blotchy spot and itchy; Red blotchy spot and itchy; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jun2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included Asthma from an unknown date and unknown if ongoing Diagnosed when she was a baby, Gestational hypertension from an unknown date and unknown if ongoing Diagnosed 23 years ago, covid-19 from 2020 to 2020 Had Covid last year. The patient's concomitant medications were not reported. The patient experienced had a localized rash at injection, red blotchy spot and itchy on 21Jun2021 16:43. It was reported that, she received the dose around 3 pm and around 4:43 pm she had a localized rash at injection site that hasn't worsened. Caller wanted to know if she could use topical Benadryl after 1st dose of Pfizer Covid 19 vaccine. Consumer had no other questions during callback. Requested document to be emailed to her. The caller was calling about the covid vaccine. The caller just received the first dose today and she took the Band-Aid off and its red blotchy and itchy. The caller wants to know if she could she put benadryl on it. The caller doesn't want to take benadryl because she doesn't want to be sleepy. It was getting hivey and the caller doesn't know if it will get worse? It doesn't hurt its just a little itchy. It was not where the band aid was, it was right in the middle where the needle was, the caller's arm isn't too swollen yet. If the caller chooses not to get the second vaccine is it okay? Is it like not getting the vaccine? The caller doesn't want to go through this again. The patient had the vaccine at 3:00 pm and this event started at 4:43 pm. The spot is a little bit bigger than a quarter. When the caller took the Band-Aid off there was nothing there at all, but now the main blotch spot is about the size of a quarter and there are a couple of little pinpoint spots around it. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
This morning when removed band aid on right arm noticed red/swollen lump with faded red dots surrounding it. The area only hurts with palpation, denies fever or any other symptoms. No treatment given. Advised to seek medical treatment if concerned. 10/12/16 Follow up phone call. Still red, warm and hard. Not complaining at all. No fever or pain. 10/13/16 VM left.
TOOK FOUR UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1573) report was received from a pharmacist on 17-Jun-2019. It describes a female consumer who "took four unrefrigerated doses of Vivotif". She was receiving oral Vivotif (one dose every other day) (lot number: 3003278 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took all the four unrefrigerated doses of Vivotif. She took the last dose on 17-Jun-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.
Anxious following vaccine with vasovagal response but no syncope.  Reclined in car seat with pulse of 67 Blood pressure of 92/49 and oxygen saturation of 97%.  EMS and Dr on site.  Client felt better quickly and was released.  Advised to seek medical attention later if needed.  Client stated understanding.
Onset of adverse reaction and time unknown. Per records, the vaccine was given/documented on 8/22/13. The next note placed is on 8/26 with the patient calling in telling his adverse experience from the vaccination. His upper left arm has been swollen, hot, and very sore post 4 days now, and has actually moved down past my elbow to about mid forearm. Patient did not go to urgent care or ED or see PCP between 8/22 and 8/26. A Nurse on 8/26 called the patient back asking him to come to the clinic for the doctor to examine his arm. Patient declined, he is watching his grandchild. Patient scheduled an appointment on 8/27/13 at 09:30 to look at arm. Patient was instructed to go to ER if symptoms increase. Aspirin.
Initial report received from a health care professional on 26 Aug 2010: On 20 Aug 2010, this child received a intramuscular dose of only the MenCYW-135 liquid conjugate component of MENVEO (batch number: 1000022) without being reconstituted with the MenA conjugate component. The child did not receive the MenA lyophilized conjugate component. No adverse reaction had occurred following this administration.
Recent Covid+ infection. Fatigue/body aches, no appetite X2-3 days. Dx of Covid+ pneumonia and acute/toxic enchephalopathy. Tx w/ IVF, abx. Expired d/t "Severe sepsis and pneumonia secondary to COVID-19 infection"
I was fourteen weeks pregnant when I got the first dose of the vaccine. I was 21 weeks pregnant which was three weeks after the second dose of the vaccine, I started to have pretty strong contractions. On 02/12/2021 I felt my bag of water I went into preterm labor. I was put on bed rest and given Tocolytics, and remained in the hospital for twelve days. I remained at home until 03/03/2021 I had bleeding and became hospitalized again.  On 03/08/2021 I had a Placental Abruption which required an emergency C-Section. I was 25 weeks and five days pregnant. The baby has been in the NICU for eight weeks. I have recovered from my surgery Due Date-06-16-2021 Pregnancy-first Hospitalized 14 days after 02/12/2021 Hospitalized 03/03/2021 until 03/12/2021
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Extreme nausea and fatigue, vomiting approximately every 30 minutes, cannot retain fluids
Lightheadedness began 36 hours after injection, lasted about 36 hours. No treatment. Lightheadedness began again 7 days after injection, currently ongoing, so far it's lasted 3 days. No treatment sought so far. Other adverse reactions sore arm, chills, nausea, muscle aches resolved within a few days.
pressure in chest, discomfort - effects felt in 90 degree and above temperature, strenuous physical labor;  rest, stay out of heat;
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, route not reported). No adverse effects were reported. Additional information has been requested.
The day after the shot, when I woke up I could not get out of bed, I was achy and extremely exhausted, with a severe headache, these symptoms lasted for about 7 hours.  Then my arm started to have tingles go up and down my arm as if it was still asleep, this occurs several times in a given day. This symptom still has not gone away, it has been two months since the injection.  Is it possible the shot hit a nerve?
Joint pain in left upper extremity including hand, worst, elbow, shoulder, and into shoulder blade and neck. Joint pain has continued off/on (at least 3 days per week) since vaccination (now 16 weeks), mostly occurring from elbow to wrist/hand, but occasionally still affecting shoulder/shoulder blades/neck.
No additional AE/No adverse event has been observed as of yet; a medical assistant at the facility gave a two month old male child a dose of Gardasil 9 in the left leg on 16Dec2022; This spontaneous report was received from a physician and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-DEC-2022, the patient of 2-month-old was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis, in the left leg (strength, lot number, expiration date, and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event reported.
has been experiencing chest and back pain; has been experiencing chest and back pain; This is a spontaneous report from a contactable consumer (patient himself). A 37-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0618) via an unspecified route of administration in left arm on 21May2021 12:00 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0173) via an unspecified route of administration in right arm on 30Apr2021 as 1st dose single for COVID-19 immunization. Patient experienced pain in right arm after the 1st dose of the vaccine on 30Mar2021 (as reported). Patient was 37-years-old at the time of immunization. Vaccination facility type was reported as Pharmacy/Drug Store. Vaccine was not administered at military facility. Patient medical history and concomitant medications were not reported. Patient had been experiencing chest and back pain. It had been 3 days now. He asked was that normal, how long will it last. Patient stated that he just got the second Pfizer vaccine shot and is experiencing chest pain (22May2021 at 24:00) and back pain (24May2021 at 24:00). Is wondering if this is normal. He stated that he got the first vaccine three weeks before on 30Apr2021. Patient describing about the adverse events stated that the chest pain is spreading into his back. Stated that the right arm pain lasted for four days and he recovered completely. The patient did not receive any treatment for the adverse events. The adverse events resulted in a visit to urgent care. The outcome of the events was not resolved.  Information on Lot/Batch number is available; Further information has been requested.
Itch at the injection site; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at the injection site) and PYREXIA (fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Gout. Concomitant products included AMLODIPINE for Blood pressure high, ALLOPURINOL for Gout, VITAMIN D3, CAMELLIA SINENSIS LEAF (GREEN TEA [CAMELLIA SINENSIS LEAF]) and CORDYCEPS SINENSIS, PANAX GINSENG ROOT, PUNICA GRANATUM FRUIT (AGELOC VITALITY) for Supplementation therapy, VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (Itch at the injection site) and PYREXIA (fever). At the time of the report, VACCINATION SITE PRURITUS (Itch at the injection site) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was taking Ageloc. Treatment information was not reported.  The adverse events lasted for a few days before resolving.   This case was linked to MOD-2021-369276 (Patient Link).
This spontaneous report as received from a healthcare worker, refers to two patients of unknown ages and genders. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 18-MAR-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9, which ad a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursion had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
She got her vaccine, she probably ran fever during the night.  She got up the next morning and she took her temperature and on the 17th - 20th she ran from 99-102 fever, highest 102.9 and she started taking Tylenol back down.  Was achy, just did not feel great like if you had a bad flu.  On 21st she felt OK, wasn running a low grade temp.  On 10/22/23 she was sitting at work, doing her job and got dizzy, the room started spinning, the words were blurry and had to leave work over it and left around 3-4 PM, and did not stop until she went to bed.  She laid at 8:00 PM and the room was still spinning.  When she got up yesterday morning she felt ok, took the trash to the curb and woke up on the ground, does not remember being dizzy.  She cleaned up her cuts after that, drank some water, took her temperature and decided not to drive and decided not to ride her horse.  She works at a hospital and did not want to go there on her day off.  This morning she is not dizzy, feels a little off, not dizzy at the moment.  Her BP is really low today, 108/70, temp is 98.9 right now.  She is not taking anything for her symptoms.  She only took that while she was running fever.    She got her flu shot a month or so ago and other than a red spot on her arm she did not have a reaction.
Patient was given Pfizer Bivalent 5-11 COVID vaccine that had a BUD of 01/25/2023. Vaccine was administered 1 day after BUD. Spoke to Pfizer, they stated there is an additional two-day stability period beyond the 10-week BUD. This is considered a valid administration and the patient is not at risk for any harm due to this.
Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes Zoster for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sore throat can't hardly swallow. My throat was swollen, I couldn't hardly swollow. Head hurting really bad stuffy nose, couldn't breath. I was running a low grade temp. was hurting all over mu bidy. I took TYLONOL cold medicine it lasted a week.
Pt was seen in the ER for chest pain, troponin noted to be elevated. EKG were normal. Pt was admitted to pediatric cardiac ICU for serial troponin and EKG checks. Troponin downtrending and pt was discharged after 48hrs.  Echocardiogram was normal.
I had hives start at the injection site and further through my skin from the left side of my body from neck to knees. A severe migraine accompanied these hives and lasted for 5 days.
This spontaneous report was received from a licensed practical nurse referring to a 7-year-old patient of unspecified gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2019 the patient was vaccinated with VARIVAX first dose (dosage schedule, route, anatomical location, lot number and expiration date were not reported), indicated for prophylaxis. Then on 25-FEB-2019 the patient was vaccinated with the second dose of VARIVAX (drug dose administration interval too short).
Administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Kinrix and Kinrix 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: 18-Jul-2022 Reporter's comments: Licensed Vocational Nurse called to asked how to proceed?  Licensed Vocational nurse reported that patient was inadvertently administered an expired dose of Kinrix. The reporter did not consented to follow up. Additional Supportive Information: The patient was given an expired dose of Kinrix, which led to expired vaccine used.