chrisvoncsefalvay/vaers-outcomes huggingface dataset:
JANSSEN COVID-19 VACCINE   Patient received 0.5 mL Dose of Janssen Covid-19. Within 5 minutes of injection, patient began complaining of "dizziness." Patient sat down with water.  Patient then became unresponsive and was not able be aroused by myself (pharmacist) or wife, who was present. Patient began experiencing obvious Labored breathing (wheezing, gargling) while unresponsive. This prompted the pharmacist (myself) to administer one adult dose of epinephrine (0.3 mg) IM to the left thigh. Within 20 seconds, the patient became responsive and coherent and able to answer questions. However, the patient was unaware of what had happened. Paramedics were called. Patient was transported to (withheld) for evaluation.
piercing type headaches on right side and back of head; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (piercing type headaches on right side and back of head) and FATIGUE (extremely tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (extremely tired). On 15-Mar-2021, the patient experienced HEADACHE (piercing type headaches on right side and back of head). At the time of the report, HEADACHE (piercing type headaches on right side and back of head) and FATIGUE (extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.  Treatment drug include Tylenol for headache.
Information has been received from a registered nurse concerning a 7 year old male who on 06/11/1998 was vaccinated with a first dose of Varicella virus vaccine live SC in the left arm. On 04/03/01, the patient experienced Varicella that included 16 to 18 lesions on the face, back chest and extremities. The patient was treated with acetaminophen (Tylenol), diphenhydramine (Benadryl), and calamine lotion. Unspecified medical attention was sought. No further information is expected.
approx 4x5" area surrounding inj site lt upper arm-redness, swelling, warmth, itching, small bruise @ inj site-pt noted inc sxs since early AM p/removing bandaid
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4473268-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course included: Other medical history noted as not reported. Concomitant drugs was not reported. On an unknown date, the patient experienced COVID. The patient had covid and was in the hospital. She did not agreed to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Causality as per reporter (Drug/Vaccine) was noted as possible.  The reporter considered "covid-19" related to BNT162b2.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
pt recvd DTP/OPV/MMR & exp redness, hardness, & hives @ inject site-hives also on lt leg; referred to fam physician; tx w/antihistamines;
18 hours after the shot - chills, severe stomach cramps, total body aches, left arm pain (severe), hot flashes, fever 100., sever headache.  Felt bad through 48 hours post vaccination.
FELT IRREGULAR HEART BEAT, CALLED CARDIOLOGIST APPT MADE, FOUND TO HAVE NEW ONSET ATRIAL FIBRILLATION, HAD TO FOLLOW UP WITH ELECTROPHYSIOLOGIST MD, MEDICATIONS WERE CHANGED, STILL HAVE ATRIAL FIBRILLATION WVEN WITH NEW MEDICATIONS, PREVIOUS ATACAND AND BISOPROLOL DISCONTINUED, NOW ON DILTIAZEM, EDARBI AND ELIQUIS,,,
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 07-FEB-2013 the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
Hospitalized with shortness of breath, COVID +, twin pregnancy at 30 wks gestation
Entire injection arm (left side) was pruritic for 48 hours post injection. There was a hard, red, lump at the injection site.
Irregular vaginal bleeding.  Irregular because I?ve been taking birth control for 10 years and it occurred 2 weeks after my normal, regular menstrual cycle. Heavy amount of bleeding that lasted 4 days. Total days it occurred was 6, last two days were not heavy.
Pain to right eye with inability to fully close eyelid on Saturday evening (no vision changes). Numbness and tingling to right-side of face and cheek onset Sunday. Family medical history indicates sister has shingles.
Patient called today she experienced a reaction to the vaccine. On the day after, she had muscle pain and swelling at injection site with some nausea and fever.
Body bones aches, fever 101+ , sore arm, extreme fatigue.  This is my second day of symptoms. Waiting one more day with lots of water and Tylenol.
patient reports severe pain in left arm (site received) within hours of receiving vaccine. Pain was so severe it kept her awake the entire night the night of vaccine. Pain still persists 2 weeks later when using arm, pain resolved at rest.
arm was a little hurt (right arm, at the injection site) other than that; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 75 years). The patient medical history and concomitant medications were not reported. On 04Feb2021 caller stated don't have any problems after I take the vaccine, the next day I had it, my arm was a little hurt (right arm, at the injection site) other than that, have not experienced any other symptom/side effect. Caller asked that I am going to fly on the 19th, can I receive it earlier. My second dose is supposed to be on 24Feb2021. The outcome of the event was unknown.  Information on batch/lot number was requested.  Follow-up attempts completed. No further information expected.
Red, warm, indurated area of right deltoid 7cm L x 4cm W.
no adverse event; Dose 2 -17-Apr-2021, Dose 3 21-Jul-2021, Dose 4 30-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 -17-Apr-2021, Dose 3 21-Jul-2021, Dose 4 30-Oct-2021) and NO ADVERSE EVENT (no adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 -17-Apr-2021, Dose 3 21-Jul-2021, Dose 4 30-Oct-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 -17-Apr-2021, Dose 3 21-Jul-2021, Dose 4 30-Oct-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 -17-Apr-2021, Dose 3 21-Jul-2021, Dose 4 30-Oct-2021).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-675262 (Patient Link).
Headache, Sedation, Myalgia, Arthralgia, Rash, Red/Swelling/Itching/Rash @ injection site Narrative:  Other Relevant History:
On 09/30/2000, the patient developed a "swollen gland on the side of her neck, followed 2 days later with a single eruption and itching of her forearm. In the next 2 to 3 days, 7 additional eruptions appeared on her upper body. The patient was seen by a nurse on 10/04/2000. The lesions are dry with scab formation and erythema of areas. There were less than 10 lesions total. It was noted that on 09/06/2000 the patient was administered a Tb booster with a negative result. No further information is expected.
After the second dose a high fever onset overnight and lasting throughout next day. Temp of 102.2 with chills, headache, general malaise and exhaustion that slowly resolved over the course of hours until following morning. Overall 24 hours of symptoms.
8 days post vaccine administration left arm was red and warm at injection site and also 2 inches below administration site. 9 days post vaccination the area from the injection site and down 4-5 inches and a4 inches across was red and warm to the touch as well as tender/sore. 10 days post injection-the red area did not get grow past the line demarcation border the patient drew around the red area.
ITCHY RASH ON ABDOMEN AND BACK SEVERAL HOURS AFTER VACCINE WAS ADMINISTERED.  THIS WAS TREATED WITH BENADRYL AND HAS REMAINED LOCALIZED AND IS CLEARING.
Information has been received from a registered nurse concerning a male who on 21-SEP-2007 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (lot #655289/0958F).  In September 2007, the patient developed redness at the injection site of deltoid down arm to the elbow.  The patient was treated with KEFLEX.  The patient was seen in the physician's office on 24-SEP-2007.  At the time of the report, the patient had not recovered.  The registered nurse is requesting a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.
Patient presented 24 hours after vaccine with severe myalgias and muscle "burning", but no weakness, fever or other symptoms. Symptoms gradually improved over 2.5 weeks. Treated with Meloxicam 15mg daily, Increased fluids, activity as tolerated.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. 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.devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
Immediately after shots pt had red macules with no hives in face- no respiratory distress, no wheezing- given Benadryl 1.25ml at office and monitored for 20 min- no change in respiratory status- back to normal self.
Cold symptoms progressed to asthma exasperation and full bronchitis bacterial infection by 3/26/2011.
I had massive diarrhea; I vomited, lots of mucus; dry cough; voice started to crack; My throat became dry; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route, administered in Arm Right on 09Feb2021 16:15 (Batch/Lot Number: EN6201) as DOSE 2, SINGLE (age at vaccination was 37 years) for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported.  Historical vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1 administered in right arm on 12Jan2021 (Batch/Lot Number: EL0140) for covid-19 immunisation. The patient reported that on 09Feb2021, 05:00 PM, my throat became dry after an hour from getting my vaccine on Tuesday. On 10Feb2021, wednesday I had a dry cough and it was not continuous. Wednesday into thursday my voice started to crack and would come in and out. On 11Feb2021, Thursday, mid-afternoon (48 hours after vaccine) I had massive diarrhea and an hour later I vomited, lots of mucus. After vomiting my throat was no longer dry. Voice still coming in and out, and now had a cough. Friday morning (12Feb2021) voice is getting better, slowly, and the cough is going away. Friday afternoon (3:40pm I am filling out this form) a little more of a voice and just clearing my throat. It was reported that therapeutic measures were taken. Patient was advised to continue use of cough drops, Saline spray and rest. The outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Patient was vaccinated for COVID-19 on 2/22/21 and 3/15/21, so was fully vaccinated when testing positive for COVID-19 on 10/12/21.
Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.; Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 18:00 (Lot number: EW0177) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild hypertension" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ESCITALOPRAM; TOPIRAMATE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot  number=EW0168, lot  unknown=False, administration  date=15May2021, dose  number=1, vaccine  location=Left arm), administration date: 15May2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: APHASIA (non-serious), READING DISORDER (non-serious) all with onset 22Jun2021, outcome "not recovered" and all described as "Intermittent, ongoing anomic aphasia, with occasional difficulty in reading comprehension. Neither with any instance of prior presentation.". Therapeutic measures were not taken as a result of aphasia, reading disorder.  Additional information: Patient didn't received any vaccination prior covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up 04Aug2021: Follow-up attempts are completed. No further information is expected.
Patient received a child dose Pfizer (PEDS), but should have received an adult dose Pfizer. Child was 12yo at the time the vaccine was given.
Case number PHEH2014US025059, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 79 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscular at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Dizzy, headache, brown spot in vision - 30 mins. - fever 102 degrees x 9hrs. Headache and dizzy after 72hrs.
On 9/6/14 seen with varicella. Had varicella vaccine #1 on 4-25-14. (Failure to vaccine)
Headache, fever 101-102.3, tiredness, sore arm. Started almost 24 hrs after booster. Still spiking fever in afternoon/evening 11/4/21.
Itching wrists,  hands, and buttocks cheeks.  Slight swelling of fingers and upper lip.  Took 2 Benadryl tablets and itching subsided within 30 minutes.  Swelling took about 2-3 hours to return to normal.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. It was reported that Patient was not diagnosed or tested positive for COVID-19. It was reported that patient had no acute illness at the time of vaccination. It was reported that patient had no Chronic or long-standing health condition. It was reported that patient did not take any medication, dietary supplement, or herbal remedies at the time of vaccination. On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. Vial did not undergo any temperature excursions. No adverse event was reported. The vaccine given had a expiry date 18-MAr-2022 but the Moderna stability study showed the vaccine was active against COVID-19 for that date. No treatment medications was provided by the reporter.
left side of my neck, shoulder and underarm all became sore; carpal tunnel syndrome flared up; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of CARPAL TUNNEL SYNDROME (carpal tunnel syndrome flared up), PAIN (left side of my neck, shoulder and underarm all became sore) and VACCINATION SITE PAIN (Injection site sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Carpal tunnel syndrome.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site sore). On 22-Feb-2021, the patient experienced CARPAL TUNNEL SYNDROME (carpal tunnel syndrome flared up). On 23-Feb-2021, the patient experienced PAIN (left side of my neck, shoulder and underarm all became sore). At the time of the report, CARPAL TUNNEL SYNDROME (carpal tunnel syndrome flared up), PAIN (left side of my neck, shoulder and underarm all became sore) and VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment details were reported.   This case was linked to MOD-2021-067404 (E2B Linked Report).; Sender's Comments:  MOD-2021-067404:2nd dose AE
a scratchy throat, redness in her arm and itchiness in all of her body; a scratchy throat, redness in her arm and itchiness in all of her body; a scratchy throat, redness in her arm and itchiness in all of her body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (a scratchy throat, redness in her arm and itchiness in all of her body), PRURITUS (a scratchy throat, redness in her arm and itchiness in all of her body) and RASH ERYTHEMATOUS (a scratchy throat, redness in her arm and itchiness in all of her body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she is allergic to other substances. Concomitant products include Blood pressure and Thyroid medication. Treatment medication include Benadryl and Tylenol.
Patient received both doses of Pfizer COVID19 vaccine and post 14 days tested positive for COVID19 via nasal swab 05May
t100.8 p/2 day from inject date; blister area thick on lt deltoid @ immun site; (4x4 cm area) started red & swollen 1 day p/inject then blisters began 2nd day; 6APR92 has chicken pox onset 4APR92;