chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates since 10-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses VAQTA (lot # K012457 with expirationd date of 04-JUN-2017, dose, strength and route unknown). No adverse effect reported. This is one of the two reports received from the same reporter. Addditional information has been requested.
Pt received a 1st dose onset of dizziness, headache, muscle aches, nausea, the next day she experienced onset of events that resolved, /wout treatment
Vaccines given at 2:40 pm. 2 hives right ant thigh at 2:44 pm - Gave 3/4 tsp. BENADRYL. Hives resolved - never reoccurred.
Narrative: COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 10/18, Pfizer, dose #3 10/15 COVID swab, result: not detected 12/27 COVID swab, result: detected 1/6 COVID swab, result: detected 12/26 pt cc: rhinorrhea, sore throat exposure: unknown
patient received bivalent booster in error. Was supposed to get 2nd monovalent COVID vaccine
Warm risk throughout body, similar to contrast in a CT scan. Lasted 3 minutes. Had mild body aches next day.
Headache, Myalgia, Fever, neck pain, right arm pain Narrative: Called PMD advised if it continues to  call back.
I contracted COVID-19 4/26/2022 with symptoms of headache, fatigue, diarrhea, widespread inflammation and pain, myalgia, fever of 100.9, elevated heart rate, congestion, muted sense of hearing due to fluid/head congestion, sore throat, and I was ill for 10 days. I went to the Clinic on day 5 of illness and was not prescribed any medication after I tested positive for COVID-19 that day. I still have minor runny nose, but all other symptoms have resolved.
Mild fever & immediate severe gas w/ pain & crying, vomiting, and diarrhea same day gas & diarrhea & crying continued for 2 wks. diarrhea & some reflux issues still present sleeping & eating schedule were also altered due to reaction (i.e. more sleeping, less eating) natural delivery & breast fed - no gastro issues before the administration of this vaccine.
Suspect COVID vaccine breakthrough case Pfizer dose 1 on 1/18/21 and dose 2 on 2/8/21
Severe headache for about 5 hours and drastically sleepy. My hands broke out with blisters and cuts.  I could not bend them.  It spread on the front and back of both hands.  They are still messed up.  I have to take showers and clean with gloves on my hand because even water burns it.   I have to wear white cotton gloves all around after I wash, clean, and medicate my hands.  My entire lifestyle is effected because I am now limite din wha I can do or it takes a lot longer.  I can't perform my job as normal.  Itcould be a disability but I can't afford to not work, so I deal with it.
Moderna COVID-19 Vaccine EUA Severe rash, welts, burning, chills; occurred 1 week after injection. Visited Clinic; placed on Prednisone, Hydrocortisone, &  Benadryl.  Next day rash spreading & worse,  again visited clinic  & prescribed Famotidine 20 mg; Zyrtec - 10 mg; Hydrocortisone
Within two days started feeling off so took bp Fluctuating BP with high spikes sporadically with more intense thumping and wooshing Thumping / wooshing of pulse in head between ears into my neck all the time Feel heart beating more strongly in my chest with activity or bp increase or stress Constant pressure in head goes from forehead to back and between ears  Constant tension in neck predominantly on left back side Episodes of body shaking with bp & rate spikes, now body shaking with bp spikes Funny feeling / tingling in back of neck sometime comes with bp spikes
Case number PHEH2016US023514, is an initial combined report spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 26 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1618701, expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 10 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. No adverse event was reported following this medication error (incorrect product storage).
At 9PM I started having rigorous chills,body heat/aches. I took two Extrastrength Tylenol, went to bed. One hour later the chills stopped but the heat/aches continued for several hours. At 8:00 AM I took two more Tylenol and had no more problems.
Information has been received from a nurse referring to an unspecified number of unspecified patients. The nurse reported the patients were administered improperly stored doses of PNEUMOVAX 23 (lot # L036437, Expiration Date 18-MAY-2017, dose and frequency unspecified) on unspecified dates (incorrect product storage). Excursion details were as follow: temperature 0 degree Celsius, time frame 192 hours. Additional information has been requested.
Presented with nausea and vomitting, abdomen pain and diarrhea. Underwent vascular surgery. Tested positive for covid febrile given remdesivir and dexamethasone. Pt discharged home with steroids and antibiotics.
p/ pt recv vax 3/16/98, 2 days later  exp pain at inject site & approx 4 vesicular lesions in a circle around inject site & 1 right at inject site. pt had no other systemic sx
Dull headache 6:00 pm on. Sever lower back cramps, 9:00 pm start Chills, 9:00 pm start
I was awakened by profuse sweating, fever, muscle aches and a heartbeat of 102 bpm. When I went to bed my heart rate was 63. It is normally 57-70. I drank 40 ounces of water and went back to bed trying breathing techniques to reduce heart rate.  When I awakened, I had muscle aches and a cough. After eating lunch, I started to feel better around 2:00 p.m.
Information has been provided from a physician concerning a female patient who on 13-FEB-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/MercK) (lot # 663333/1555X). The physician stated that the patient developed a case of shingles in the buttocks and groin area after receiving the vaccine. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Follow up information has been received concerning and 81 year old female patient with no medical history, allergies and no recent exposure to chickenpox or shingles who on 13-FEB-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot # 663333/1555X), 0.65 mL in her right hip, Concomitant therapy included NEXIUM, felodipine, and SYNTHROID. On 23-FEB-2009 the patient developed a case of shingles. The patient enrolled in the Varicella Zoster Identification Program to identify if VZV is present, and if present, to identify whether it is associated with the wild type VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain. The patient developed rash described as a case of herpes zoster at gluteus mid-thigh dermatome. On an unspecified date the patient recovered. Additional  information is not expected.
I have had terrible underarm and breast pain including nipple pain on my left breast since by second vaccine. It feels worse than after giving birth.
Pt recved pneumococcal vax on 2DEC91 & 3DEC91 devel a local reaction w/warmth, edema & erythema from the inject site to the elbow; had a swollen bursa, pain & fever in the arm; pt was seen by a MD & later recovered;
09/09/2022  12:10PM I got my shot.  I walked home, sat down on my couch.  I had a little bit of a headache. I was feeling very tired.  I feel asleep for an hour and a half.  When I woke up, my entire body was very sore. Injection site, both shoulders, both arms were sore.  I had swelling in both fingers, my fingers felt very tight.  My chest cavity felt strange and sensitive. My lower back became very sore, my arms became sore, and mostly both legs, terribly sore around my knees.  I stayed sore for a few days.  The left side of my body was the most sore. Yesterday my left leg was very sore, especially my kneecap. My knees and chest cavity were very sore.  The pinky on my left foot has been swollen. I also experienced shivering uncontrollably the day after the shot, 4 times and it would last 5 minutes each time.
intense muscle paid the next day/ongoing muscle aches and pains; felt terrible; tiredness/fatigue; difficulty focusing and foggy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Took two. At the time of the report, MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy) outcome was unknown.            Concomitant product usage were also not provided.
Pt felt left side of face go numb from nose to chin. Started about 10 minutes after vaccine given. Lasted 4 hours. No other symptoms
Heart racing felt short of breath on 12/18/2021  when I went to the ER early morning but later that afternoon I started having fever body aches and noticed slight swelling in left under arm pit On 12/19/2021 still had slight swelling under arm pit and had a headache. 12/20/2021 no more swelling under arm pit still have a headache and throat is a little itchy
Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved by Tylenol through the following Tuesday (5 days after vaccine). Hot flashes are intermittent. Also feel fatigued starting Saturday 1/2, improved 1/3, worsening 1/4 into 1/5. Sore arm for about couple days, very mild.
Dad says 5-10 minutes after vaccine patient started having symptoms.  Patient said it felt like she couldn't breathe, like her throat was closing off.  Patient walked with staff member to EMS ambulance ~50 feet away.
feel like doing things one day but next day they feel lousy; Don't have any energy; got worse after receiving the Moderna COVID-19 vaccine; blew up with fluids; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids). At the time of the report, FEELING ABNORMAL (feel like doing things one day but next day they feel lousy), ASTHENIA (Don't have any energy), VACCINATION COMPLICATION (got worse after receiving the Moderna COVID-19 vaccine) and OEDEMA (blew up with fluids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contained new events - Vaccination Complication and oedema and updated product information.
This spontaneous report was received from a registered nurse and refers to a 12-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N017686 with expiration date on 02-FEB-2020 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 27.4 degrees Fahrenheit for 4 hours and 30 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA003239: US-009507513-1712USA003240.
Varicella zoster; Rash 2 months after the first dose of Shingrix.; This case was reported by a physician via call center representative and described the occurrence of varicella zoster in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included varicella. Previously administered products included Zoster vaccine (specified this patient had received the Zoster vaccine many years ago, and that she had varicella this year) and Valacyclovir (dermatologist prescribed her to take Valacyclovir, wich made dissapear the varicella rash).   On 27th September 2019, the patient received the 1st dose of Shingrix. On 12th November 2019, 46 days after receiving Shingrix, the patient experienced varicella zoster and vesicular rash. On an unknown date, the outcome of the varicella zoster and vesicular rash were unknown.   It was unknown if the reporter considered the varicella zoster and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed a vesicular rash over the right heap. The health care professional asked if the patient should receive the 2nd shot. The health care professional thinks that the rash following the first dose of Shingrix means that the patient has Varicella Zoster again. The patient did not receive the 2nd dose yet. The reporter consented to follow up.
Left shoulder injury related to flu Vaccine  Administration. She reports " I think the vaccine went to high and went into my bursa. It hurt at the time, but I just thought it was normal flu pain., Then that evening I could barley move my arm. I am still having pain and have to use my other arm to lift the arm above my head".   On exam : Left arm deltoid area no redness, swelling, ecchymosis. Slight tenderness with palpation. Able to bring arm above head in full ROM with assistance, grimaces with ROM.  Hand grip strength 5/5.  She reports taking Ibuprofen 400mg/day and just started using Diclofenac gel. She reports pain on scale of 1-10 is a 5.
pt recvd vax; red, swelled & erythema for 72 hrs w/ swelling down to 1-2" above elbow of Lt deltoid;
He states his arm hurt some on 10/15 and 10/16 after getting his first Covid shot but the pain became worse on Sunday, 10/17. States he has not been able to work this week due to the pain and not being able to move his arm like usual. Reports swelling at injection site.
Began with tiredness and intermittent chills in the late afternoon, early evening.  Felt very ill, very hot around 9.30 pm, and took my temperature.  It was 99.0 degrees (normal for me is 93 to 94 degrees).     I began to feel very slightly nauseous off and on during the night.  Continued to take temperature during the night and finally, it dropped to 97.5 at 5 am in the morning.  I felt very bad at 11.30 pm on the 6th.  I still feel very tired and ache-y.  Need to stay in bed.  I also had a lot of stuffy-ness in my nose.
Some soreness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had some soreness at the injection site. The reporter consented to follow up. This case linked with US2020AMR014607, reported by same reporter. This case linked with US2020013944, reported by same reporter for the same patient.
doses given after temperature excursion; Vaccinated after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccinated after excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccinated after excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion). On 28-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccinated after excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The facility had a 20 minute excursion in the freezer where the Moderna COVID 19 vials were stored in.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: 5 days of negative tests; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in 2 weeks. Anti-viral details:  product=COVID 19 Treatment, brand=Paxlovid. Treatment start date on 18Nov2022, Treatment stop date on 22Nov2022. Fever returned, sore throat returned, tested positive again after 5 days of negative tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; Vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 06Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: OBF21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; LISINOPRIL; TYLENOL; OMEGA 3 FISH OIL [FISH OIL]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin; Septra, reaction(s): "Known allergies: septrac", notes: Known allergies: septrac. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive; (Oct2022) Negative, notes: I had 2 negative tests that were taken 48 hours apart; (Oct2022) Negative, notes: I had 2 negative tests that were taken 48 hours apart. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient has received Paxlovid for the treatment of Covid-19 from 28Sep2022 to 03Oct2022. 4 days after completing Paxlovid, and 24 hours after she had 2 negative tests that were taken 48 hours apart, her COVID symptoms returned and she had a positive test on 07Oct2022, it was not recovered.  No follow-up attempts are possible. No further information is expected.
My Left arm has been hurting ever since, I can Not reach my arm up very high with out EXTREME PAIN and can NOT reach behind me .  ITS HORRIBLE PAIN , ever since i got my 3rd MODERNA shot.
Initial report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HD (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none.
Hypersensitivity  high blood pressure,  blood sugar,  fatigue,  lightheaded,  bacterial infection
No adverse effect reported; a toddler patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a 12-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 19-DEC-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection (dose number, route of administration and anatomical location were not reported; lot number S021924 has been verified to be valid, expiration date reported and validated as 15-JUL-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. No adverse effect reported.  The temperature/time frame registered with data logger was of 15 degrees fahrenheit to 46 degrees fahrenheit, 24.3 degrees fahrenheit, multiple, and there was no previous temperature excursions.