chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WHEN GIVING THE VARICELLA IMMUNIZATION INTO THE (R) LEG, AFTER ADMINISTERING THE SHOT A LARGE WELT APPEARED AND AREA BECAME SWOLLEN. THERE WAS BLEEDING. THE SITE WAS RUBBED & MASSAGED. THE MOTHER REQUESTED FOR NURSE TO CEASE RUBBING AND TO CALL THE DR. THE DOCTOR WAS IMMEDIATELY CALLED. UPON THE DR. EXAM. THE SITE HAD DECREASED IN SWELLING & THE PT WAS PLAYING & IN NO DISTRESS 20 MINUTES AFTER THE SHOT.
Pharmacist reported patient received first dose at age 9 and did not receive any further doses; missed dose; This spontaneous report was received from a pharmacist and refers to a 9 year old patient of unknown gender. The patient's medical histrory, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. The pharmacist had questions regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) missed dose. Pharmacist reported that patient did not receive any further doses. Doctor's office called in prescription for 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to pharmacy and pharmacist wanted to clarify recommended dose schedule with only 1 dose given prior to filling hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prescription on 14-JUL-2020.
Severe cough w/wheezing. Severe headache-extreme tiredness constipation-numbness in left hand and arm diarrhea.
I received the COVID Vaccine at 12:30 PM. My temperature had been increasing all afternoon along with my heart rate. At roughly 8:40 PM, my temperature increased dramatically to approximately 38.9C. This may have happened over a relatively short period of time, since it was 37.9 C at approximately 8:00 PM. My heart rate increased to 150 bpm and I became dizzy. After a minute, my heart rate decreased to roughly 115 bpm.  Unsure whether to call EMS or not, I called a friend, who is a Dr. at the local hospital (Dr. is a colleague we do research together.) Dr. was concerned but provided information on what to do and when to call EMS or be driven to the ER. I spent the rest of the evening with a pulse between 105 and 110 and my temperature hovered around 38.9C until at least 12:30 AM.   The next day, my heart rate had decreased to roughly 80 bpm and my temperature to approximately 37.8C. I spent most of Tuesday sleeping. Today (Wednesday May 12, 2021) my heart rate is down to roughly 76bpm. My temperature is holding around 37.2C.   I have reported this to the CDC through the COVID vaccine reporting app.   My resting pulse is usually 62 bpm with a waking pulse of 58-60. My normal temperature is 36.5-36.7C. I have a wellness exam schedule for Monday. Dr. is not my regular GP, but was available at a time when my regular doctor was not available.
Woke up having diffculty breathing was gasping for air, took a him outside and then put him in the shower and seemed to allow for better breathing. Sounds almost like he has croup.
pt recv vax;pharmacist reported that bile was found in the urine test of a female pt following vax;
pt recvd vax; pt devel itching & swelling w/in min after vax; pt also devel fever, arthralgia, & chills;
This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. It was stated by the medical assistant that on 11-MAY-2015, the adult patient was vaccinated with a pediatric dose of VAQTA 0.5 ml, intramuscular (lot #, dose and frequency were not reported), instead of the adult dose of 1.0 ml of VAQTA. Concomitant therapies were not reported. At the time of the report no adverse effects were reported. Additional information is not expected since there was not consent from the reporter to be contacted.
Patient reports being at home the evening of the immunization and experiencing extreme gastrointestinal side effects including nausea and diarrhea. Patient also reports redness and irritation at the administration site with associated soreness. She called to alert me at the pharmacy the next day, I confirmed that she was feeling better and condition was improving. I checked on her today 10/26/2018 and she reports still feeling "under the weather" but is still improving from the previous side effects. Complete recovery from the aforementioned side effects is unknown at this time of reporting.
Pain right side of neck in to right ear; Pain right side of neck in to right ear; Pain right side temple; Heartburn; This is a spontaneous report received from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the first vaccine dose.   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 29Aug2021 at 10:30 (Batch/Lot Number: FC3184) as a single dose for COVID-19 immunisation at a pharmacy or drug store. Medical history included pemphigus (affects mucosa areas) and allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glucosamine, methylsulfonylmethane (MSM WITH GLUCOSAMINE) and fish oil (OMEGA 3) and other unspecified vitamins. Past drug history included drug allergy with codeine and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Aug2021 (after the first dose of the vaccine), the patient experienced pain on the right side of the neck into the right ear. Then a couple days later in Aug2021, the patient had pain that lasted for 3 days on the right side of the temple, located in that area only. Also, heartburn was pretty bad and lasted 3 days, then went away. No treatment was received for the events. That was the only issues with the first dose of the vaccine. Since the vaccination, the patient has tested negative for COVID-19 in 2021. The outcome of pain right side of the temple and heartburn was recovered on an unspecified date in 2021. The outcome of events pain right side of neck into the right ear was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265356 Same reporter/SD, Different potential/AE
Case number PHEH2016US028921, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 57 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
pt recv vax & w/in several wk became pregnant;pt elected to have a therapeutic abortion on 25JUL96;no further info was provided;
Sore arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Age at vaccination:60 years) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient medical history was penicillin allergy and concomitant medications were not reported. The patient previously took allergyx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient had not received other medications in two weeks. On an unspecified date, after the 1st shot she experienced mild side effects of sore arm. The event outcome was unknown.
Patient had redness and swelling to right thigh on side. Patient was give diphenhydramine HCl 12.5 mg/5ml, to take 5 to 7 ml PO every 6-8 hrs PRN for itching. Mother states that day vaccine given patient was itching on injection site, patient scratched and then developed the redness and swelling.
Severe swollen testicles.   Went to ER AT 4am lasted 5 days
Patient experienced dizziness for 7days a week after 1st dose.  She doesn't know if it's due to an ear infection.    Patient had received an a prescription to treat an ear infection during the same duration.  She feels better now.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
I got a Tetanus shot after an injury I sustained at work. Within twelve hours, the vaccine caused nerve damage and I lost the strength in my left arm for six months. It was a very pain situation were I would experience shooting pains, throbbing and my arm would go numb. I couldn't lift much of anything and if I tried I would drop the item, even if it was a pen. I recovered completely but what could happen next time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; NEXIUM [ESOMEPRAZOLE SODIUM]; ROSUVASTATIN. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (14Jan2023) negative, notes: Tested negative for COVID on day 4 and day 6; (16Jan2023) negative, notes: Tested negative for COVID on day 4 and day 6; (19Jan2023) positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Jan2023 to 15Jan2023. Clinical course: COVID symptoms were gone by day 3 after starting paxlovid. Tested negative for COVID on day 4 and day 6. Symptoms returned on day 9 and tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
10cm x 10 cm irregular shaped area of localized redness, swelling and increasd warmth at and below injection site.
Fever of 104, macular erythema within 12 hours of receiving 4 month vaccine.
Information has been received from a pharmacist referring to a 45 years old female patient. The patient had no drug reaction/allergies. The patient's pertinent medical history was unknown by reporter. On 07-APR-2016 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot # K010466, expiration date 23-MAR-2016, strength and dose were not reported) intramuscularly. Concomitant therapies included HUMIRA and IMURAN. On 28-JUN-2016 the patient's "titers" were drawn and the result of the lab work showed that "the patient's titers were not as high as they should be". There was no treatment given to the patient. The outcome of the event was unknown. Reporter's causality was not reported. Additional information has been requested.
Severe headache, body aches, fever up to 102.3, chills, sweating, nausea. This lasted until 5/13. The fever abated to 101.8 with Tylenol. Pain at injection site both to touch, upon movement, and just sitting still.
Pt recvd DTP/HIB 16JUN92; pt vomited on 17JUN92; on 18JUN92 pt devel t101; mom gave pt APAP; pt woke up w/sz; mom took pt to hosp ER & was told that pt had tonsilitis;
Client received Sinovac COVID vaccine, no reaction. Sinovac vaccine unavailable in the US, Janssen given as an alternative on 09/15/21.
5 days post vax the pt experienced arthralgias, myalgia's, fatigue, low grade fever persistent for 1 week. Symptoms resolved completely.
Home antigen test was positive; Home antigen test was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "s/p partial thyroidectomy" (unspecified if ongoing); "s/p cholecystectomy" (unspecified if ongoing); "he has OSA" (unspecified if ongoing), notes: he has OSA on CPAP; "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Home antigen test was positive". The patient underwent the following laboratory tests and procedures: Positive airway pressure therapy: OSA, notes: he has OSA on CPAP; SARS-CoV-2 test: negative; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information:If vaccine received: Yes.Other medication in 2weeks: Unknown.Anti viral details:Product:COVID 19 Treatment, Brand:Paxlovid, treatment start date 27May2022,treatment stop date 31May2022, Indication:Treatment of COVID-19, administrator route:Oral. Adverse event: Patient took Paxlovid for 5 days and then tested negative on home antigen test. On Day 12, he developed nasal congestion and mild headache, no fever. Home antigen test was positive. Symptoms this time even milder than before.Adverse event start date: 07Jun2022 04:00 PM.If patient recovered: Recovering.If treatment ae: No.Known allergies: no.vaccine lot unknown reason: Not available/provided to reporter at the time of report completion for all suspect vaccine products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Arm swollen and painful for about 5 days.  Now 18th day, arm still slightly swollen on half of upper arm and itchy.
This spontaneous report was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored VAQTA (strength, dose/frequency, lot # unspecified). Concomitant medication was not reported. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient reported that after receiving first dose of the COVID-19 vaccine (Moderna), that he felt horrible for 3-4 weeks. He has not felt the same as before he received the vaccine. He has lasting fatigue that has gotten no better and is not going away.  Patient was seen in our office on 10/19/2021. No treatment was given at the time of that visit, patient was instructed to return to our office as needed.
I gave patient his pediatric dose around 5pm and when he was sitting in the waiting area, around 5:20pm, my technician ran over to me and told me she had an emergency and the patient is passing out. I went and assessed the situation to see if he was having a reaction or fainting and noticed he was having syncope. I raised his legs and ran to grab cold backs for his wrists, neck, and face, we gave him something to drink while I directed another technician to call 911. We stayed with the patient, he was reactive and doing okay until paramedics arrived and then we let them take over the rest.
CANT WALK; BURNING WITH FEVER; CANT KEEP FOOD DOWN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cant walk, burning with fever, and cant keep food down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cant walk, burning with fever, and cant keep food down. This report was non-serious.
First day of vaccination I was having a fever of 100.8 and The second day after the vaccination I had headache for everyday for the next couple of weeks, I decided to get care from a doctor and NP stated it was a migraine, She gave me Nurtec for the migraines.
Fatigue; headache; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 98.5 (normal) temperature was normal around 98.5 degrees F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was done with oxycodone.   Reporter did not allow further contact
I'm having phantom smells that started around December 25, 2022. I called my doctor to get in to find out what may be going on. My doctor has referred me to an ENT that I am currently looking for a doctor who will take my insurance.
Tinnitus; Fuzzy head; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-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 TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired) had not resolved.            No relevant concomitant medications was reported.  Treatment information included antihistamine.
120/78 9:40 HA - ibuprofen 400 BTC 10 amn dizzy with headache.
they got their booster vaccine; The person told me they got a rash all down both sides of their neck and onto their shoulders the day they got their booster vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Oct2021, outcome "unknown", described as "they got their booster vaccine"; RASH (non-serious) with onset 17Oct2021, outcome "recovered" (2021), described as "The person told me they got a rash all down both sides of their neck and onto their shoulders the day they got their booster vaccine.".  Additional information: Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown patient been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.