chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 50 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: (unspecified date) Negative, notes: Tested negative last week a couple of times including PCR test; (22Aug2022) Positive, notes: Tested positive again on 22Aug22. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2 weeks. Patient was received Paxlovid dated from 12Aug2022 to 16Aug2022 for Treatment of COVID-19. Patient had COVID Rebound. Tested positive again on 22Aug22. Tested negative last week a couple of times including PCR test. Follow-up attempts are completed. No further information is expected.
The booster shot was given too early (less than 6 months). No adverse reactions occured.
did not receive the second dose at 6 months; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the Doctor of medicine. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter asked if the patient should still receive the second dose or do they have to restart the series. The reporter consentd to follow up via postal.
FOOT AND HAND GOT PARALYZED; CARPEL TUNNEL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total was administered on AUG-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced foot and hand got paralyzed, and carpel tunnel. Patient reported as, he had surgery for carpel tunnel but it came back and was unable to use hand or feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from foot and hand got paralyzed, and carpel tunnel. This report was serious (Other Medically Important Condition). This case is a duplicate.  Additional information was received from patient on 22-JUN-2023. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number; Sender's Comments: V0: Foot got paralyzed, hand got paralyzed, carpel tunnel. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Information has been received from a female consumer who on 22-DEC-2009 and 26-FEB-2010 was vaccinated with a first and second doses of GARDASIL (route and lot # not reported). On 17-MAR-2010 the patient experienced a seizure. The patient was now experiencing temporary paralysis in all four limbs. The patient's outcome was not reported. Upon internal review, seizure and temporary paralysis in all four limbs were determined to be other important medical events. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 18-NOV-2013, the patient was vaccinated with M-M-R II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient that was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother called to report arm where flu shot was given red and tender to touch and hot to touch Pt seen by M.D.-Advil, Benadryl and warm compress
That afternoon after vaccine, I took a nap and was fatigued which was normal like the other vaccines. I was a little tired the next day. But on 04/23/2022, I was very nauseous, body aches, headaches. On 4/24/2022, I did not have body aches but had a fever of 100 and was very weak. I called my doctor on 4/25/2022, I got an exam and I got a flu, COVID-19, and RSV test and was negative. I had a fever of 99.1, a headache, nausea, and was weak. Today on 4/26/2022, my temp is 99.1 with weakness and lethargic. I am concerned because I am running a low grade fever. I was advised by my doctor that if the fever persists to call back.
Fever, chills, muscle soreness, fatigue, injection site and surrounding soreness for days, nausea, stomach pain, headache
1ST dose: 3/2/21 5 pm  headache sore left arm 4 days. benadryl/tylenol ok on 3/7/21. mild  anxiety short of breath. general allergy. 2nd dose 3/30/21 : 4 PM 3/31/21: severe migraine -r hydroxyzine/tylenol hydrated ok. vitamins zinc, probiotics some cough - nose allergy seasonal.  5TH APRIL :itchy hands, arms, some pain on right hand. mild headache. 14TH APRIL 2021:  woke up noon : severe headache, blurred vision, malaise, right hand frozen, pain, burning  sensation upto upper right arm. itch. Cold pack treatment, numb pain on left finger tips. contact welts, red patches, hair nose eyes blurry dbl vision watery itchy - bitter taste in mouth. lower  right leg toe nerve pain burn on toe. pinched nerves. upper arm.
arm red (egg-size) at site of vaccination. Very sleepy-then whole body broke out in a red rash (bumps on back)-itchy, burning-felt sick, tired. Lasted 2 1/2 hours-still have one red breakout on back.-Treatment: Prednisone, hydrocodone; hydroxyzine; Momestasone; Fuorate ointment; Aveeno-anti-itch concentrated lotion.)
Pt devel t103 R @ 12noon & to 104 R by 2PM; temp remained approx 24 hrs & then resolved; inconsolable cry started @ 2-3PM & lasted till 12 noon next day pt was started on APAP;
severe crippling headache, high heart rate, arm completely went red and she couldn't move it and it was painful, have a hurtful cough cant take deep breaths
Information has been received from a Medical Assistant concerning a 60 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Concomitant therapy included "unspecified cholesterol medication". It was reported that on an unspecified date the patient had increased liver enzyme levels. The patient sought unspecified medical attention. It was reported that the patient had elevated liver enzymes at the time of the report. Additional information has been requested.
acute onset vomiting and lethargy, starting early morning 12/10/22. Vomited 6-7 times initially and forcefully and after every attempt at feeding over the next several hours.  Taken to ER, admitted for forceful vomiting and dehydration, evidenced by poor urine output.  Testing in ER showed possible adynamic ileus. Significant weight loss. Subsequently admitted to Hospital with moderate dehydration, recurrent emesis. Hospital course. improved over 24 hours  with IV fluid and slowly increasing feedings, discharged 12/11/21 and followed up in office 12/13/22 and found to have had a significant weight loss.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "82 YO male sent to hospital from another facility due to lethargy, found to have covid as etiology.  He was placed on IVF support with significant recovery to baseline.  Did not require covid-specific treatment and had no hypoxia.  Will transfer back to subacute rehab today for ongoing rehab."
Administered outside the age guidelines. Moderna is approved only for age 18 and above. Patient did not report any adverse reactions in regards to symptoms or side effects.
Sweating, chills, fever, the month of march rash came on top of both my feet moving up legs to knees. Cough that does not seem to get any better.
Stepfather reports Khuyen. Oral temperature 104 deg. F, Scattered rash "bumps under left upper arm", Carried into ER . ER report-oral temperature 39.0 C (1022) . Diagnosis- Prexia Febrile, Illness, microscopic, Hematuria medication-oral Tylenol gr X
No adverse event; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 19-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose: 1st booster dose. No concomitant medications was reported. No treatment medications was reported.
Administered Tdap to left deltoid of seated client.  Client stood to leave, took a couple of steps, lost consciousness momentarily and fell to the floor striking head.
Information has been received from a physician concerning a 15 month old male who at 15 months of age was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live. Subsequently, 21 days later, the patient developed 10-15 lesions all over the body. No further specifics were provided. Unspecified medical attention was sought. No product quality complaint was involved. on 03-Sep-2003 a registered nurse reported that the patient may have been a case study that was discussed by several physicians during a meeting. The event could have occurred years ago and there was no way to trace the original case and it was most likely already reported when it originally took place. No further information is expected.
PATIENT REPORTS SEVERE FLU-LIKE SYMPTOMS BEGINNING APPROXIMATELY 12 HOURS FOLLOWING VACCINATION. STATES SHE WAS BEDRIDDEN FOR 2 DAYS WITH HEADACHE, BODY ACHES AND FEVER. SYMPTOMS GRADUALLY ABATED IN THE FOLLOWING DAYS.
Raised bump, bruise, swelling, stiff arm, warm to touch, weakness in the arm.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001032: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393.
Ear Eczema: dry peeling skin inside ears; skin peeling; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 44-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9629), via an unspecified route of administration, administered in Arm Left on 05Feb2021 15:15 (Age at vaccination: 44-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history was reported as none. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19. Had no Allergies to medications, food, or other products. On 08Feb2021 08:00 The patient experienced ear eczema: dry peeling skin inside ears. Patient was not received any treatment for the events. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Pain at time of administration and bruising days after (3 inches in diameter), muscle stiffness of deltoid and neck.
Recurrent eosinophilia; worsening thrombocytopenia - began to require platelet transfusion, then had CNS bleed
The signed paper work is noted that he received his booster shot which is a half dose, but the documentation in his chart states he received a regular full dose. Can not guarantee or verify what dose he did receive but it is possible that instead of a half dose booster he did receive a full dose. Patient denied any adverse effects or side effects from receiving a full dose.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:15 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Age of patient was reported as 88.92 and 89.00.  The vial was initially moved to the fridge on 09 Mar 2021 and proposed beyond use date was 08 Apr 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
I had Upper respiratory drainage, coughing, wheezing, fatigue and i took over the counter medications and after a few days i was feeling better & i also used my inhaler
numbness and tingles in armed or pant in all my fingers; numbness and tingles in armed or pant in all my fingers; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: Mar2021), via an unspecified route of administration on 18Dec2020 at 44-years-old at a single dose for COVID-19 immunization.  The patient's medical history was reported as none. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), misoprostol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. On 19Dec2020, the patient experienced: "numbness and tingles in armed or pant in all my fingers."  The patient stated, ''I got my shot (COVID Vaccine) at work yesterday around 3 pm. Since 1 O 'clock this morning I have numbness and tingles in armed or pant in all my fingers, can won't go away.'' There was no treatment received. The patient reported that she worked in an emergency department as a technician. The patient underwent lab tests and procedures which included body weight: about 190   on an unspecified date.  The clinical outcome of the events was not recovered.
Fever up to 102 degrees 5 days post TDAP imm. Muscle aches and weakness moderate fatigue mild to moderate malaise symptom onset 5 days after imm.
02/26/2023 I had a mild sore throat, head ache, fatigue, and  slight fever. After testing positive for Covid-19 i reached out to my doctor and was prescribed Paxlovid. Symptoms lasted 4 days.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: PATIENT LIGHTHEADED AND PALE AFTER ABOUT 10-15 MINS AFTER VACCINE GIVEN. PATIENT WAS RESPONSIVE. PATIENT WAS GIVEN ORANGE JUICE AND AN ICE PACK UNTIL EMT ARRIVED. EMT ARRIVED AND PT BLOOD PRESSURE WAS LOW. PT TAKEN TO NEAREST ER FOR FLUIDS.
Patient was given benadryl 50mg IM and Pepcid 20mg PO.
Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in 2016 (reported as "since August 2016"), the patients were vaccinated with doses improperly stored PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Had a rash at site of injection - MD confirmed with patient that this was adverse effect - cortisone PRN.
Very sore arm at injection site, fatigue, brain fog, shivering, neck and shoulder pain, headache
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of a unspecified age and race received a single dose of PREVNAR 13 on an unknown date for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced rash on the injection site. The event was resolving at time of report. No follow up attempts possible. No further information expected.
extreme sweating; Severe Chills; Muscle Ache; Ear Ache; This is a spontaneous report from a contactable consumer. A 73-year- old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown), via an unspecified route of administration administered on arm left on 09-FEB-2021 09:30 as a single dose for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown), via an unspecified route of administration on 19Jan2021 11:15 AM as a single dose for covid-19 immunisation. The patient medical condition included moderate Cholesterol. There were no known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included statin. On 09 Feb2021, at 8:00pm the patient had experienced Severe chills, muscle ache, extreme sweating, and ear ache. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the events were resolved.  Information on the lot/batch number has been requested.
low testosterone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD TESTOSTERONE DECREASED (non-serious), outcome "unknown", described as "low testosterone". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller also notes that his son also experienced the same "low testosterone" and he questions it possibly be due to them being "out of shape" or possibly "not eating the right things." Caller states that he is "older" and he knows why his is lower. He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards. He notes that "COVID19 can lower testosterone" and he is "wondering if in the form of the medication to fight it off has the same stuff as COVID 19 to build immunity." He states that maybe it lowers testosterone as COVID 19 can lower testosterone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.