chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore lt arm, stiff neck, h/a, nauseated, achy stomach, fever -didn't check, felt hot.
Permanent lip damage. Burning. Discolored. Enlarged. Constant canker sore on tip of tongue.
This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 3rd of four reports. A patient of unspecified age and gender received PREVNAR 13 at single dose for immunization on unknown date. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced pneumococcal infection and then a hemolytic uremic syndrome. The outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2018410904 Same reporter/drug/event, different patient.
Itching at site, swelling, muscle pains, headache, fatigue, nausea, diarrhea, fever, joint pain, neck pain. I have been taking Tylenol.
Tongue became swollen and painful, heart raced, reports fever - but did not take temperature. Did not seek medical treatment.
A NP reported that a 50 year old male inadvertently received DT for wound on 1/14/00. Pt developed an injection site reaction characterized by erythema and soreness, malaise and flu like symptoms. His symptoms were reportedly "resolving" as of 1/18/00.
Rash at site of injection, tingling, burning began the day after vaccine given. Then vesicular rash, spreading. Seen in office 12/10/12. Dx with Herpes Zoster, Tx with VALTREX 1 gm tid x 10 days.
mom phoned pt had a high fever following 3rd vax; MD said it was a nl reaction;
A phone call was made to the patient a couple days after her second vaccination and she reported that she had experienced fatigue, upset stomach and soreness in her arm starting the night of her vaccination.
Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on arm). At the time of the report, VACCINATION SITE RASH (Rash on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Patient reports that at 9:00 pm on the evening of her covid vaccination her right arm was sore, it was a numbness/tingling feeling that went to her face and leg.  Patient went to bed that evening with the numbness/tingling and when she woke in the morning the numbness/tingling had increased.  4/22 Patient reported this reaction to the LHD and was advised to see her PCP.  Patient visited her PCP that day and reports that everything checked out and she was instructed to go to the hospital should the numbness/tingling  increase.  Patient denies any weakness or facial drooping.    Patient reports that the numbness/tingling in her face is from her ear/cheek bone to her jaw/lip area.  Patient reports that when she had COVID in November of 2020 her cheek bones felt like someone was pinching them.  She indicated that where her numbness and tingling was occuring was the same place she felt like she had been get pinched by someone.
Severe vertigo that kept me bedridden for two days after vaccine, with symptoms of severe dizziness that lasted on and off for three weeks
I received the flu vaccine at my workplace clinic. I don't know which one it was. About one day after, the injection site was red and itchy and raised. About a week later, I got a patch of dry, scaly skin around the area, about a quarter in size. There is no pain or discomfort, it's just really dry and scaly. I hope it goes away.
Moderna 3/19/21, 4/16/21. Positive on 2/1/22
This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the right arm on 17Sep2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 24Aug2021 at 15:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient experienced migraine headache on 17Sep2021 at 15:00 (also reported as "from one hour after dose"). First two weeks it was so bad that she could not work. The patient has had a headache every day since second dose always at least a severe headache, most of the time migraine. The patient stated that nothing took away the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified pain injection and unspecified migraine medication. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021 post vaccination, the patient underwent test for COVID-19 via nasal swab and the result was unknown. The clinical outcome of the event migraine headache from one hour after dose; has had a headache every day since second dose always at least a severe headache, most of the time migraine was not resolved at the time of this report.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 9/2/2022 Discharge Date: 09/11/2022  HOSPITAL COURSE: Patient is a 75 y.o. female who presented from rehab, admitted with AKI. Outpatient provider noticed a slight increasing trend of her creatinine so sent her to the ED. Patient remains overall remains deconditioned due to previous prolonged hospital stay at Hospital from 08/2-8/18, where patient was treated for hypovolemia induced prerenal azotemia following radiation and chemo treatment for her uterine carcinoma.    ER Course: Vitals all stable, COVID-19 positive. Labs:Hgb 10.8. Bicarb 39, BUN 105, Creat 3.42, GFR 13, alk phos 170. Chest xray unremarkable.  Consults: nephrology recommended gentle fluid hydration.   AKI: creatinine upon discharge to hospital from hospital (8/2-8/18) was 2.9. Patient's AKI improved with fluid hydration, and holding her home torsemide. Cr 2.6 at discharge.    Anemia: Patient continued to have a normocytic normochromic anemia, HgB was 10 on admission.  Patient did not complain of bloody stool, no other active signs of bleeding.  Her anemia was also present at hospital stay and was believed to be secondary to chronic inflammation or low EPO from kidney injury. However starting on 09/04, patient's hemoglobin dropped to 9, followed by a 8.6 on 9/5, 7.6 on 9/6.  On 9/7 hemoglobin dropped to 6.9 and patient was given 1 unit RBCs.  Labs: Occult blood was negative.  Iron studies normal, ferritin and reticulocyte count were elevated.  Blood smear showed no evidence of hemolysis.   Imaging: CT abdomen/pelvis showed no definite evidence of intra-abdominal hemorrhage but GI bleed could not be fully evaluated due to lack of IV contrast.  Patient's hemoglobin continued to drop and she received 1 additional unit of RBCs on 09/08.  Patient had 1 episode of coffee-ground emesis morning of 9/8, IV Protonix 40 mg added daily. GI completed EGD on 9/9 with no evidence of acute bleeding.  Patient's hemoglobin continued to decrease with no clear source for her bleeding, and 1 unit RBCs given 9/10.  In total, she has received 3 units RBCs.  GI was consulted, and they were agreeable to transferring her to hospital for further workup of this bleeding and anemia.    Atrial fibrillation:  On admission patient was started on lower home dose of metoprolol due to initial hypotension.  Patient later developed AFib with RVR which was able to be rate controlled on her home Cardizem 120 mg daily and metoprolol 100 mg BID.  Her home Eliquis was held due to concern for bleeding.   Patient also continues to suffer from severe malnutrition persistent difficulty with intake, possible benefit from palliative paracentesis was mentioned at last hospital stay.    Due to patient's continued decline and unclear source of bleeding, patient was transferred to hospital for further evaluation and treatment. Patient transferred in stable condition.
On 6/30/21 required ICU stay for fever and status epilepticus with associated acute respiratory failure requiring intubation and hypotension requiring Norepi in the setting of AED administration. PICU Course by system: Resp: Arrived on AVAPS, continued to have decreasing mental status and ultimately intubated for airway protection. Easy mask, grade 1, mac 3, ketamine and roc used. Remained on low vent settings.  Extubated to RA on 7/5. CV: Additional 40/kg given for soft BPs around intubation and AEDs and ultimately low dose infusion of norepi given AED administration-related hypotension. Stress dose hydrocort Q6h - wean started 7/5.  FEN/GI: Initially NPO on MIVF. GT feeds started on 7/1. Continued home vitamins.  Free water added back on 7/3. Renal: Urinary rentention requiring foley cath, removed 7/6. Neuro: Continue home AEDs enterally (cannibidoil, clobazam, fenfluramine, stiripentol, valproic acid). Received additional AED loads for continued seizures including depakote and fospheny 7/1, fosphey 7/2. Arrived on versed drip which was titrated for seizure suppression (max 0.5mg/kg/hr).  Began wean of Versed on 7/4, off that night. ID: Given known trigger for fevers, did not start antibiotics on arrival. Low-grade fevers (true fevers for Brionna) on 7/2 and cultures obtained showing E.coli in the urine.  Ampicillin started on 7/2, transitioned to Unasyn on 7/3, then amoxicillin on 7/4. Heme: SCDs, enoxaparin for VTE ppx 7/2 - 7/5. Endo: Hydrocort as above.  Discharged on 7/6/21  Following continued to have ataxia, L sided weakness requiring assistance for all transfers, ambulation and standing, when previously was able to walk and run without assistance.  This continues until today 7/31/21.  Has had additional complication of nausea, vomiting, diarrhea in setting of  positive C diff + Salmonella in stool, with now improving GI symptoms.
Patient was feeling dizzy. Patient was put on the floor with there feet up in the and then the patient was feeling better so the patient was on the chair when we went out to get him. Patient was given water and a snack. We took the patients vitals at 8:40 am heart rate 61, resp 18, Blood pressure 84/46 and o2 99%, 8:56 heart rate 66, resp 17, Blood pressure 94/58, o2 98%, and again at 9:07 am heart rate 67, resp 18, Blood pressure 91/52 o2 100 %. Mother stated that he has low heart rate. Patient was feeling better so we released the home with his mother at 9:16 am.
c/o severe stomach cramps, diarrhea, vomiting approx 10min p/vax;pt was instructed to stay in lobby p/vax (from time of vax);pt left lobby afterwards did not stay;
Pt received GARDASIL - dose #3 on 8-13-08. Pt to ER 10-15-08 - passed out, lower extremity weakness, no fever, has had headache - lower extremity weakness had been present x 2 wks. Also decreased sensation in lower extremities.  12/5/08 Reviewed hosptial medical records of 10/16-10/24/2008. FINAL DX: Conversion disorder; history of abuse. Records reveal patient experienced LE weakness, numbness x 2-3 wks, difficulty walking, syncopal episode w/fall.  Admitted to outlying hospital for neuro w/u which was completely WNL.  Referred for psych & transferred for inpatient rehab.  Progressed well & d/c to home w/continued outpatient PT & counseling.
My arm hurt more when I took the bandage off.; This is a spontaneous report from a contactable other hcp (patient). A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Dec2020 08:00 (at the age of 57 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Dec2020, the patient experienced arm hurt more when she took the bandage off. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Patient called stating he has experienced retrograde ejaculation, was extremely dehydrated all day after the vaccine.
This spontaneous report was received from a physician via company representative and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 24-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
HOT FLASHES; NUMBNESS MOUTH; NUMBNESS OF TONGUE; SORENESS IN THE BASE OF NECK; TINGLY TONGUE; RASH ON TORSO; HEADACHES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, sulfa allergy, neuropathy in the face, and chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced numbness mouth. On 12-APR-2021, the subject experienced numbness of tongue. On 12-APR-2021, the subject experienced soreness in the base of neck. On 12-APR-2021, the subject experienced tingly tongue. On 12-APR-2021, the subject experienced rash on torso. On 12-APR-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, numbness of tongue, tingly tongue, and rash on torso on 12-APR-2021, was recovering from numbness mouth, and had not recovered from headaches, and soreness in the base of neck. This report was non-serious.
Became light headed, dizzy, and severe headache 2 hrs post-immunization. Severe headache lasted 18 hrs. Ataxic gait developed next morning, c/o twitching legs. Dizziness and ataxia gradually improved, but persisted x several days. See at ER 9-18-15. Neuro exam normal.
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 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
on Feb 4, 2021 my lip swelled and then had severe hives requiring medical treatment for the last 4 months, improving now and reducing medication dosage gradually, have not quit medication yet due to concern of hives coming back,  had hives on all extremities, trunk, head and neck
Child and mother were in school health office with FNP for CHDP physical exam. At conclusion of complete exam Hep A 1 was given and about 2 min later provider pricked child's finger with lancet and collected a drop of blood in microcervette a moment later child slumped to floor bumping back of head, c/o pain back of head, knee pain and nausea, no vomiting. 20 min later child said he felt fine, ice pack to back of head, written head cautions and referred to PMD.
Angioedema & SkinRash Narrative: mild reaction for which she will self monitor and medicate.
On January 20th my left deltoid had a well-defined red, hot horseshoe-shaped area (seemed to follow the outline of my deltoid) that was very warm to touch and also very itchy.
Myocarditis with troponinemia to 4, no volume overload/heart failure. Presented with chest pain the day after vaccination, did not abate, associated with palpitations, went to the ED and found to have troponinemia. Treated conservatively. Left heart cath showed non obstructive CAD, preserved LVEF 55%, discharged home on colchicine.
1st dose in 2019. /would like their second dose; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date in 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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional enquired if they could administer 2nd dose or needed to restart the series.
pt recv vax 27JAN98 & that same day pt exp sleepiness;mom couldn't keep pt awake;
Pfizer-BioNTech COVID-19 Vaccine EUA  25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
After hours call cyanotic episode 04/08/2014 at 9:52 pm. Admitted to hospital 4/11/2015 to 4/14/2015 DX seizures then admitted to hospital on 4/24/2015 to 4/27/2015 fever T105 and rash, hyper sensitivity reaction to phenobarbital.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 1st October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site wheal. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site wheal were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site wheal to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX was EH927, which was changed to EH9Z7, as per sales data sheet. After receiving SHINGRIX, the patient experienced two large red welts near the injection site along with pain. The reporter asked does GSK have recommendations on what to do. No additional information was provided.
No adverse event until Day 9 post-vaccination, when patient reported the appearance of a flat,  pink-reddish  rash 1" in diameter with an irregular border surrounding the injection site (L deltoid). Patient reports that the area grew to about 4-5" in diameter over the course of the next 7 days, some swelling noted,  and that the top area of the rash had faded while the bottom area  was travelling down her arm. Reports the affected area feeling warm and tender upon touch. Denies pruritis, fever, axillary swelling, or any systemic reactions. Denies any unusual pain.
Patient received SHINGRIX vaccine, first dose to the left tricep. The location of the vaccine was not on the deltoid, but the middle back portion of the left arm. Patient supplied picture, displaying erythema, slight swelling, and round reaction site on left tricep. Patient reported painful arm, with swelling that eventually resolved after 3 days.
~20 hours after the 2nd vaccine I had muscle and joint aches which increased in pain until I took Tylenol (recommended by person who gave me the vaccine).  Symptoms lasted about 48 hours. Feeling better today (Mon 5/3/21). Also having hot flashes, but may be contributed to my age.