chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).   The reported stated that the vaccine was improperly stored (temperature -14.1 Celsius degrees for 12 minutes). There was no previous temperature excursion. No adverse effects were reported.
Stomach pain; Diarrhea; Tiredness; Weakness; This case was reported by a consumer Shingrix GSK and described the occurrence of stomach pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2021, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced stomach pain, diarrhea, tiredness and weakness. On an unknown date, the outcome of the stomach pain, diarrhea, tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, diarrhea, tiredness and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The patient got the Shingrix vaccine on 28th August 2921 and since then he had been experiencing stomach pain, diarrhea and tiredness/weakness off and on.  Note: Discrepancy is present regarding year of the vaccination was reported as 2921 but has been conservatively added as 2021 as 2921 is a future date and seems to be typo error, hence considered as 28th August 2021.
Pt accidentally given 3rd hepta B 4 months after initial vax.  No adverse reactions
No additional AE; Nurse reporting an AE for a five year old that was given 2 doses of PROQUAD instead of PROQUAD and KINRIX.; Nurse reporting an AE for a five year old that was given 2 doses of PROQUAD instead of PROQUAD and KINRIX.; This spontaneous report was received from nurse,referring to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with two doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 05 milliliter, (lot # W012729 has been verified to be a valid lot for PROQUAD, expiration date: 16-OCT-2023),  for prophylaxis (strength, and route of administration were not provided) instead  diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (Overdose) (Wrong product administered). No additional adverse event was reported.
Patient feels throat possibly swollen and had difficulty breathing 20 minutes after Tdap. Patient only ever had this one vaccine. Mom never vaccinated in past.
Pt describes initial bruising 1-2 days after vaccine and then very painful upper left arm beginning 1-2+ weeks after vaccine. Currently still experiencing pain, particularly while raising arm.
His whole arm got extensively painful and swollen the night following the injection and still not resolved. Patient is referred to see a doctor.
Swelling at site increasing to size of palm, large hard lump very warm, chills and fever, diarrhea, aching all over throughout the night and next day swelling and redness still present one week later.
Pt presented asking about large (red/swollen) inflamed area on same arm as Zostavax was given and same area pt stated was going to see doctor at urgent care at advise of PharmD on duty at pharmacy. Shot given and 2 different antibiotics were given to pt for arm reaction on 10/13/13. Shot for Zostavax given on 10/10/13.
My symptoms started with sore throat, head congestion, sneezing. That evening it progressed to a feverish feeling, body aches, and chills. That next morning, I took an at home COVID-19 test that was positive. I called my doctor and the physician assistant prescribed PAXLOVID. I took that for 6 days. My symptoms started improving the first day. I became negative with testing after completing the PAXLOVID regimen. The sneezing also caused a sharp pain in my left hip and groin area.
AFTER I had completed my VAERS report to disclose my unexpected and unusual reaction (a period), approximately two days later, additional symptoms appeared. The VAERS system does not allow updates electronically, so I am documenting them now and will then recap dose two reactions. This is also why I waited longer to disclose side effects following the second shot because I wanted ample time to observe effects before jumping to report. Additional side effects after dose one included: inflammed lymph nodes all over my entire body - the neck was particulary swollen, which potentially then caused a neck rash, swollen gums, jaw pain and headache. There was also an odd 'pulsing' feeling in my limbs (arms and legs). After dose two, I immediantly had a fever the next day. Highest peak was 102.6 - I took a tylenol and stayed hydrated all day and by the next day, no fever (I did not have a fever after the first shot). I still had the unexpected period (again, I have an IUD and do not have periods) although this one was more 'fluid' than the previous 'sticky/thick' period the month prior. Less severe lmph node swelling this time (all over body), still had a very itchy rash on neck that lasted a couple of weeks and then went away. And finally, my left eye has developed a small twitch that has not stopped and occurs throughout the day.
Pt was given HIGH DOSE FLUZONE 11/3/15. That same evening developed bad headache fever chills sweats x 12 hours.
Numbness to right arm; This is a spontaneous report from a contactable nurse (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerBiontech; lot number: 4c9231) intramuscularly at right arm on 30Dec2020 at 09:45 AM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was nursing Home/Senior Living Facility. No relevant medical history and concurrent conditions. No known allergies (no allergies to medications, food, or other products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numbness to right arm on 30Dec2020 at 03:30 PM. The event was reported as non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of event was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 included COVID test post vaccination (COVID test type post vaccination: Nasal Swab; COVID test name post vaccination: Color) on 29Dec2020 was negative.  No follow-up attempts are possible. No further information is expected.
3/6/2021 Expired at facility receiving Hospice Services since 8/1/2020. Hx Covid-19 June 2020. Prior to death: Resident began refusing meals and failing overall. On, 2/18 began with jaundiced skin, no other symptoms. ADPOA, Hospice APRN and MD updated. Comfort measures maintained as resident continued to have slow decline.
I don't recall having side effects from immediately, but a day or so later I noticed that my heart rate was high and it normally runs around 70-75 when I take my blood pressure. I took my blood pressure and my rate was 105-106 and it was worrisome. I did go to urgent care and my heart rate started to go back down and then it took about a week for my heart rate to gradually drop back down to what's normal for me. It was just a little bit of a worrisome response.
Infection with SARS-COV 19. Cough, congestion, runny nose, fever, headache, sore throat, fatigue, chills, muscle aches.
Mom reports that patient had fever of 101-102 on 12/21/21-12/23/21.  Mom reports that the rash popped up on his trunk around 12/22/21.  Mom reports that he was scratching at it.  She has pictures on her phone.  It appears to be a confluent, pink macular rash on trunk and face.  But patient does appear to be scratching at it on the pictures and video.  Mom reports that he also had a bright red line on his right thigh where he got his Varicella vaccine on 12/13/21.
Patient developed hives and pruritus secondary to influenza vaccine. Patient was instructed to take BENADRYL. Symptoms are remitting.
PATIENT FAINTED . PARAMEDICS WERE CALLED. PT HAD LOW BLOOD PRESSURE AT SCENE . BLOOD PRESSURE RETURNED TO NORMAL WITHIN 30 MINUTES. PATIENT DID NOT GO TO ER. PER PATIENT HE IS REALLY AFRAID OF INJECTIONS AND HE ATTRIBUTED THE FAINTING TO HIS FEAR. TWENTY FOUR HOURS AFTER EVENT PATIENT SAYS HE IS FINE WITH NO ADDITIONAL SYMPTOMS.
Patient was given 0.5 ml instead of 0.25 ml. Patient called on 1/19/2022 and denies any problems since vaccination. Letter sent also
DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 07/26/2022.
Extremely altered menstrual cycle. Very abnormal heavy bleeding, severe cramping and pelvic pain, altered spacing of menstrual cycle. All symptoms started with first period after second dose of vaccine and have persisted over the past year. Over the last two months, I have noticed slight improving but not complete resolution of symptoms and return to my previous normal cycle. I have not visited my OB/GYN about these symptoms yet and plan to discuss in my next annual exam.
Felt a little flu-ey; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient put off having the vaccination because they felt they had antibodies.) in January 2021 and Hip surgery (Bad back.). Concomitant products included PARACETAMOL (TYLENOL), GABAPENTIN, TRAMADOL, IRON, OLMESARTAN, ATORVASTATIN, LORATADINE and MONTELUKAST for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was unknown.   This case was linked to MOD-2021-344232 (Patient Link).
Patient noted when he removed the bandage after the vaccination, there was a significant amount of clear fluid tinged with blood between his skin and the bandage.  He stated the bandage bubbled due to the volume.  He stated the vaccination itself was pretty painful, unlike his other shots.  He did not experience the post vaccination side effects of a sore/swollen arm or systemic effects like fatigue, headache, fever or chills.  He noted he DID experience arm soreness and fatigue with the first dose.  This lack of side effects and the volume of fluid he witnessed when removing the bandage, the patient does not feel he received a full dose. He did not report this to the administering pharmacy for 6 weeks.
Swollen arm; soreness of entire arm; swollen sore lymph nodes; sore throat; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FA6710) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing); "RA" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "Allergies: PCN" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28Jul2021, outcome "not recovered", described as "Swollen arm"; PAIN IN EXTREMITY (non-serious) with onset 28Jul2021, outcome "not recovered", described as "soreness of entire arm"; LYMPHADENOPATHY (non-serious) with onset 28Jul2021, outcome "not recovered", described as "swollen sore lymph nodes"; OROPHARYNGEAL PAIN (non-serious) with onset 28Jul2021, outcome "not recovered", described as "sore throat"; HEADACHE (non-serious) with onset 28Jul2021, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, lymphadenopathy, oropharyngeal pain, headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 10 year old male patient who on 08/01/2003 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/21/2004, the patient developed breakthrough chickenpox with 50 to 500 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
Patient received influenza vaccine with a pediatric size needle. Patient was instructed they should seek another influenza vaccination IM
back of throat itchy; experienced back of throat itchy and constricted; sore arm; feeling "crappy" like a truck ran over her for 3 days; This case was reported by a consumer via call center representative and described the occurrence of itchy throat in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy (shellfish allergy and seafood allergy experienced in the past as well).   In August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2020, less than an hour after receiving Shingrix, the patient experienced itchy throat and throat constriction. On an unknown date, the patient experienced pain in arm and feeling unwell. Shingrix was discontinued. On an unknown date, the outcome of the itchy throat, throat constriction, pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the itchy throat, throat constriction, pain in arm and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received the Shingrix shot into the left arm. After vaccination, the patient experienced back of throat itchy and constricted. It reminded her of her shellfish and seafood allergy she had experienced before.  It happened within 20 to 30 minutes and lasted for 30 minutes (she was in the car and driving).  The patient also experienced sore arm and feeling crappy like a truck ran over her for 3 days.  Per advice from the doctor, the patient did not and would not plan to get the 2nd Shingrix dose. The reporter did not consent to follow up.
Last Hep B administered 2/10/05. On 3/15/05, patient woke up and right arm was bent at elbow. She could not raise arm; could not straighten out. Saw MD at that time. Elbow was swollen, fingers tingle. Has pain in upper arm when trying to raise arm. Pain in upper arm at night in bed. Per follow up report-Have not seen this person since she initially reported this to us. Had been seeing orthopedic doctor.
had the shingles vaccine & got shingles/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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 reported as follows: The case was reported by patient's sibling. The age at vaccination was not reported. The patient had the Shingles vaccine and got the shingles 3 years later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Significant swelling, Pain with numbness, decrease in mobility of Left arm, nausea, Vomiting, Chills, temporary fever (client did not report temp, difficulty sleeping, headache.  Client took two Tylenol 500 mg morning of 9/17 recommended to take 600 mg OTC ibuprofen 2-3 times daily. Follow up this afternoon.
The injection site became swollen, red, and hot to the touch. Pt. saw primary care physician and was given antibiotic ointment.
This is a spontaneous report from a contactable nurse practitioner reporting on behalf of the son. A 17-year-old male patient received TRUMENBA intramuscular, in right shoulder, on 19Sep2016 at about 14:00 at 0.5 ml, single for meningitis pain. No other vaccines were administered 4 weeks prior to 19Sep2016. Medical history included asthma since he was 8 years old. The patient previously took on unknown dates influenza vaccine for prevention of the influenza and TRUMENBA for meningitis pain and experienced no adverse event. Concomitant medication included influenza vaccine, taken on unknown date, for prevention of influenza. The patient was not taking any other medications. On 19Sep2016 at about 20:00 the patient experienced entire body aches, severe headache, chills and fever at 101. The patient missed his school and his sports due to the events. Fever was treated with MOTRIN but the patient continued to have it even on treatment. The patient had fever for so long and if it would continue the reporter would have taken him in to the Emergency room. The other events resolved on an unknown date in 2016. Laboratory test: none.
Scratchy throat; sinus pressure; sinus pressure and congestion; achy; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 301308A; Anatomical Location: Left arm), administration date: 25Aug2021, when the patient was 62-year-old; Covid-19 vaccine (DOSE 1, MANFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "Scratchy throat"; PAIN (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "achy"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "sinus pressure"; SINUS CONGESTION (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "sinus pressure and congestion"; FATIGUE (non-serious) with onset 23May2022, outcome "recovered with sequelae", described as "tired". Therapeutic measures were taken as a result of throat irritation, paranasal sinus discomfort, sinus congestion, pain, fatigue.  Additional information: The patient had no known allergies. It was unknown if patient received any medication within two weeks of vaccination. Therapeutic measures were taken as a result of the events which included treatment with Paxlovid from 24May2022 to 29May2022.
Vx not  mixed with conjugate; Vx not  mixed with conjugate; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a child female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vx not  mixed with conjugate) and inappropriate dose of vaccine administered (Verbatim: Vx not  mixed with conjugate). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The Nurse practitioner (NP) reported a dose of Menveo was administered to a patient after it was mixed with something other than the liquid conjugate portion of Menveo. The reporter consented to follow up via email or mail - address and email provided were in HCP details. The patient received Menveo after it was mixed with something other than the liquid conjugate portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
4/13: dose administered. 4/14: severe headache, dizziness. 4/18: severe diffuse swelling, redness, heat across entire deltoid, bicep, and upper arm. Primary care physician visit; treated with diphenhydramine and topical hydrocortisone.
Arm swollen from wrist to shoulder. Treated in hospital with IV antibiotics for cellulitis.
25Mar91, 24Apr91 pt vax;  2 days after 1st dose pt exp n/v/d for few days.  Events reoccured after 2nd dose.
The patient broke out in a red hot confluent rash/erythema from her neck to the inner thighs, encompassing the back, chest, abdomen and trunk.  It is not on her face, arms, hands or below the knees.  There are no wheals or singular eruptions.  It resembles a "steven-johnson" type rash.  There are no blisters, bullae or necrolysis.
This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient started therapy with a "low dose steroid" (unspecified), and on an unknown date, while the patient was on this therapy, he/she was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. The ZOSTAVAX dose was reconstituted with sterile diluent (lot # and expiration date were not reported). It was unknown, if the "low dose steroid" (unspecified) caused the patient to be immunocompromised prior to receiving ZOSTAVAX. It was reported that could not be ruled out that an immunocompromised patient was given ZOSTAVAX which was outside of the prescribing information. No adverse effects were reported. Additional information has been requested.
Vaccine administered after use by date. Efficacy study done by Moderna and vaccine deemed effective and no re-vaccination needed Moderna Case Unknown.
Left arm swollen, redness - 25cm x 10cm. No induration, fever and otherwise feels well. Notes swelling yesterday.