chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; Generalized vaccinia several days after wrestling with a friend who had recently received the smallpox vaccine; This literature case, derived from a full-text article, was received on 11OCT2022.  Literature citation:   A 20-year-old male patient developed "generalized vaccinia several days after wrestling with a friend who had recently received the ACAM2000 (smallpox vaccine, live)" (PT: Generalised vaccinia and PT: Secondary transmission).  Case report: The case of generalized vaccinia occurred in a 20-year-old man who presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received the smallpox vaccine. Polymerase chain reaction (PCR) of blood and vesicular swabs were both positive for the vaccinia virus. The patient was treated with povidone-iodine ointment and recovered without issue.  Author's comment: Cutaneous findings are a prominent feature of many rare infectious diseases, and recognition of these findings is often essential to diagnosis.  Company comment: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.; Sender's Comments: A male patient presented with painful erythematous umbilicated vesicular papules and plaques on the bilateral upper extremities several days after wrestling with a friend who had recently received ACAM2000. Patient was treated with povidone-iodine ointment, a broad spectrum antiseptic for topical use. Patient prior medical history or concomitant medications were not noted. The onset of generalized vaccinia and secondary transmission has been reported with ACAM2000 and cannot be ruled out, which is deemed serious and medically significant due to its probable relation.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose # and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Consumer calling on behalf of his wife who received GARDASIL 9 while pregnant. Inquiring if Merck had any additional information that we could provide.  Caller was directed to contact physician for additional information.   Unknown treating provider,; No other AE; This spontaneous report was received from a consumer and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On unknown date, the patient was pregnant with unknown date of last menstrual period and estimated delivery date (Exposure during pregnancy). No additional adverse event was reported.
Dr. gave this RN an written order to start pt on the HPV vaccination series. After reviewing the patient's medical record, this RN missed the fact that pt received a dose of Gardasil 9 on 1/2/23. This RN administered an additional dose of Gardasil 9 to the pt on 1/9/23 around 4:40 pm. The pt was notified and Dr. was notified immediately. The patient was monitored for 15 minutes after vaccination with no adverse effects noted. Per Dr., the pt's vaccination schedule should be changed, so pt will receive the second dose of Gardasil 9 after 2 months, and the dose given on 1/9/23 will be considered pt's first dose of Gardasil 9. Pt was informed of this plan and is agreeable.
Patient was seen on Friday 2/17 for vaccines DTaP and PREVNAR. On Monday, 2/20 grandmother noticed a staring spell with an right upward gaze. 911 was called by family and ED diagnosed her with febrile seizure with temp of 103.0. Patient seen in clinic 2/21 as seizures were becoming more frequent and lasting up to 30 seconds. Oxygen was administered and patient was transported to hospital where she was for 7 days. Per family, Neurologist thought there could be a correlation between the vaccines and seizures, as the child never had them before. She is now diagnosed with epilepsy and is on medication.
Dizziness; BPs 155/79 (pulse 79), 159/81 (pulse 81). O2 sats 94%, 96%.
24 hours after vaccine given fever of 102  chills, loss of appetite body aches head ache cough loss of taste and smell extreme tiredness. Lasting    8 days with  cough still present. Took Tylenol, doctor did a Covid test with negative results. I had Covid 19 previously in November 2020 with  same symptoms lasting 14 days
Started with a dry cough, body ache, bad headache, and just felt tired. I felt like I did an intense workout and had a hangover at the same time. I tested and tested positive for COVID. I called my doctor to get PAXLOVID and the request was put it and I took it for about a week and went through the whole regime and I felt better. A couple of days later it rebounded and all the symptoms came back. My whole household also got it from me and we are all vaccinated. It was all mild cases, like a strong cold. I feel that even though I am fully recovered now, I feel like I still get out of breath easier now even 3 months after. My daughter also in her 20s suffers the same thing and we are the only ones who also take anxiety medication so not sure if that is why. But that is about it, nothing to severe. After the rebound it lasted about another week without taking any medication.
5 minutes after the vaccine was administrated the patient complained of severe pain shooting down her arm, at a pain level of 9. She immediately started sweating and the pain traveled up to her jaw and down her back on the left side. She had difficulty talking because of the pain and then went into shaking and chills. This reaction occurred over a period of 30 minutes when her fiancé came in and took her to the ER. The doctor called the pharmacy and said it didn't look like an allergy but a dystonic reaction and treated her with Ativan and benadryl and the patient went home later that night.
punctured ipol temperature reached: 46.6 F duration of temperature excursion was 2 minutes with no reported adverse event; patient was given IPOL after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015(CLUSTER), 2023SA235023(CLUSTER), 2023SA235246(CLUSTER), 2023SA236046(CLUSTER), 2023SA235058(CLUSTER) and 2023SA234814(CLUSTER).  This case involves a 6-year-old male patient and punctured IPV (VERO) [IPOL] temperature reached: 46.6 f duration of temperature excursion was 2 minutes with no reported adverse event and patient was given IPV (VERO) [IPOL] after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 12-Jun-2023, the patient received a dose 3 of 0.5 ml dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot: W1A191M) (expiry date: 16-Feb-2025) via intramuscular route in the left thigh for immunization.  On an unknown date, punctured ipol temperature reached: 46.6 f duration of temperature excursion was 2 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 12-Jun-2023 the patient was given ipol after the temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  It was unknown if any lab data/test results available.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PT had just received MMR & TB tine; PT slumped over on table becoming rigid w/jerky movements of arm; color pale;  skin cool & clammy;
This initial spontaneous report was received from a physician referring to a 6 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 10:44 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Child shaking and teeth chattering with warm forehead and cold extremities at 1:20PM. Slept until 2:10PM and woke with rectal temp of 103 F at 11:45PM child vomited and had 104F rectal temp. To ER. Instructed to give Tylenol until afebrile and follow up with pediatrician.
Post vax the patient's left upper arm above the elbow is swollen and hot the touch. The area is starting to appear bruised. The patient is being treated with Tequin.
No sleep; Arms and legs felt like a gravel road; After second shot, hives all over her body except hands feet and stomach; Itched all over my body; Got little pain sparks all over my body; Face was flushed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (After second shot, hives all over her body except hands feet and stomach), FLUSHING (Face was flushed), PRURITUS (Itched all over my body), PAIN (Got little pain sparks all over my body) and INSOMNIA (No sleep) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.  Concomitant products included STRONTIUM CITRATE from 30-May-2017 to an unknown date for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FLUSHING (Face was flushed). On 07-Mar-2021, the patient experienced URTICARIA (After second shot, hives all over her body except hands feet and stomach), PRURITUS (Itched all over my body) and PAIN (Got little pain sparks all over my body). 07-Mar-2021, the patient experienced RASH (Arms and legs felt like a gravel road). On an unknown date, the patient experienced INSOMNIA (No sleep). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form and PREDNISONE from 10-Mar-2021 to 17-Mar-2021 at a dose of 1 mg four times per day. At the time of the report, URTICARIA (After second shot, hives all over her body except hands feet and stomach), PRURITUS (Itched all over my body), PAIN (Got little pain sparks all over my body), INSOMNIA (No sleep) and RASH (Arms and legs felt like a gravel road) outcome was unknown and FLUSHING (Face was flushed) had not resolved. Not Provided          Concomitant medications included Seraplex.   This case was linked to MOD-2021-039270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional events and patient treatment details were updated.
Received 6/28 @ 9:30pm, woke up not feeling ok 3:30am 6/29, vomited 5:30am, fever of 100.2 @ 6am, shaking, flushed, weak, hot to touch, tired, irritable, fever of 102.0 at 7:30am, vomited, hot to touch, tired, irritable, shaking, weak
Pt complaint of cough, Loss of smell taste and bilateral ankle swelling. Pt was advised to isolate, get tested and seek medical care for swollen ankle
Pt recvd 3 doses of Engerix-B vax titers were checked 6 months p/the last dose; & titer result was 7.6, indicating a low pos response;
I began with to be hoarse March 26th and slept normal. But then the next day I woke up with a sore throat. A bit of stuffiness, but that is kind of typical for me because it is always dry here. As it progressed my throat began to more sore and some sinus pressure beginning. That evening it started to become more severe congestion. What was notable that day and the next day, I sneezed a few times. My lymph nodes on both sides are still tender today. As the days followed my throat began to feel better but all other symptoms fluctuated. Nasal draining from both sides now, before it was only one side. It has been tough to blow my nose due to congestion. (I have had surgery for deviated septum). As of today I have been feeling pretty better. Monday and Tuesday I was fatigued and irritable and had lots of sinus pain and pressure.
sore arm; little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (little tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant products were reported.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-374119, MOD-2021-374165 (Patient Link).
Heart Palpitations and fluttering - strong pressure and felt like a baby kick.  This is happening quite often - daily and last anywhere from 1-30 minutes.  The episodes come and go at all times of the day.  It takes my breath away and can cause me to cough.  I am exhausted and it's impacting my work and home life.   I did a video doctor appointment on 4/15/21 with, PAC.    We determine at that time to let it "play out" and see how I felt.  After the 2nd vaccine on April 19 the symptoms increased.  It was at that time she had me come into the office.  We ran tests and she put me on a 24-hour heart monitor.  Those results were 'normal' With the continued symptoms, she referred me to, DO at the Heart and Vascular Center.  I saw him on 5/21 and he put me on a different heart monitor.  I had an echocardiogram on 5/27.
Information has been received from a registered nurse concerning a 17 year old female with no known drug allergies who was vaccinated with MMR II IM instead of SC. This does not comply with the recommended route of administration. There was no concomitant medication. The pt remained at the clinic 20 minutes after the immunization and complained only of burning at the injection site. She had no other complaints. It is not known whether the pt sought medical attention. In follow up, the nurse reported that"this was not an adverse experience." The nurse further explained she called to inquire about the route of administration of MMR II. Additional info has been requested.
Mild rash, fatigue, insomnia, swelled lymph nodes, and malaise.
Received INFLUENZA vaccine. Next day had painful, itchy, serious blister at site of injection. Site hot and swollen x 6 days. Serious blister decreased in size and then popped.
After receiving the Moderna Booster on 10/26/2021, my throat became scratchy on 10/30/2021. Thereafter my sinuses began to drain, headache, nauseous, sneezing, fatigue  and a feeling of unwellness for a total of 9 days. During the 9 days I administered over the counter products. On 11/4/2021 I worked half a day and on 11/8/2021 I contacted my medical provider.
Patient's elderly mother reported event to me about a week and a half after reaction of arm swelling at injection site - for which she visited PCP on 5/2. I contacted patient, but she did not return phone call.
Vaccine received 4 PM 11/17/03; pt stated within 4-5 hours vaccination site red and swollen, hot to touch, c/o severe pain and discomfort in upper arm 11/18/03. Took Ibuprofen. 11/19/03 came to local HD, right arm and area of redness, swelling and warmth from antecubital area upward approx 3 inches in inner arm.
Patient reports that her arm is still hurting, she said it was burning before and swollen. Now it got better but still hurts sometimes when she gets dressed and picks up her arm
24 hours of extreme flu like symptoms. Chills, fever of 100 all day, extreme fatigue, had to sleep on and off.  Worst part was severe pain in muscles and joints. I did not take any meds at all during this period but decided to ride it out with no meds.   No headache.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th November 2018, less than a year after receiving SHINGRIX, the patient experienced shingles, rash and discomfort. On an unknown date, the outcome of the shingles, rash and discomfort were not recovered/not resolved. It was unknown if the reporter considered the shingles, rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that she developed Shingles and shingles rash on the right side of her face and which wrapped around her right ear and underneath her right eye. The patient stated that, this was resolving, however, she still had some discomfort. The patient did not have any additional information. The reporter did not consent to follow-up. The patient did not want to provide her address and stated that any correspondence could be sent to her email.
Started with mild sore throat. From 11/10/09, severe sore throat, nasal congestion, bodayache, fever, runny nose, headache and dizziness.  Took, Theraflu x 2, saline gargle x 3, vit c tabs, paracetamol 500mg x1, steam inhalation x2 / per day.
received dose, the dose had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix and Havrix 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: 29-Jun-2022. Reporter's Comments: The pharmacist reported that a dose of Havrix was given to the patient and it was already expired.  The vaccine administration facility was the same as primary reporter.  The reporter did not consent to follow up. Additional Supportive Information: The patient received Havrix dose, which was already expired on 18th June 2022, which led to expired vaccine used.
Breakthrough case admission after 2 vaccines Moderna 3/18/21 Lot# 007B21A;  Moderna 4/15/21 Lot# 043B21A
Employee's right arm became sore, with muscle spasms to arm.  Orthopedic physician informed employee that vaccine got into nerves.
nausea; Fever; ill; This case was reported by a consumer and described the occurrence of nausea in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, fever and unwell. On an unknown date, the outcome of the nausea, fever and unwell were unknown.   It was unknown if the reporter considered the nausea, fever and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had nausea and little fever. The patient had no problem with 1st dose.  There is a discrepancy in the event ill in narrative given as lil that may be a typo error. As insufficent information we have so capture the event ill conservatively.
broke out in an itchy rash and large bumps around the injection site; broke out in an itchy rash and large bumps around the injection site; an itchy rash and large bumps around the injection site; This spontaneous report was received from the patient's mother referring to a 13 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On an unknown date the patient was vaccinated with first injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (syringe, dose, route, lot# and expiration date were not reported) for prophylaxis.    The patient broke out in an itchy rash and large bumps around the injection site about 30 hours after injection. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed. Device was not available for evaluation (Obtain reported as false). Outcome of all events was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all the events was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Developed area of erythema that involved the majority of the right thigh.  Developed small amount of erythema on day #1, yet noticed significant worsening by day #2.  Treated with benadryl and keflex.
24 hours after injection, pt experienced a red ring below the injection site. It was hot, red, and the muscle was stiff. It lasted 96  hours.