chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Taste buds have been altered; Arms of smell have been altered; Losing weight; Couldn't eat savory foods; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), buspirone hydrochloride (BUSPAR), levonorgestrel (MIRENA) and clonazepam (KLONOPIN); all from an unknown start date for an unknown indication and unknown if ongoing. On 01Mar2021, the patient's taste buds and arms of smell had been altered. Things that used to smell pleasant repulsed the patient. This happened after the 2nd dose of the vaccine. The patient lost weight and couldn't eat savory foods. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events taste buds have been altered, arms of smell have been altered, losing weight and couldn't eat savory foods were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
21SEP96 pt woke up w/several itching hives on chest & back of lt leg;mom gave DPH p/hives had spread to body & soles of feet;contacted MD who advised to cont DPh & use Caladryl lotion;hives returned 3hr p/DPH for 2 days;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: el3248), on 01Feb2021 as dose 2, single (Lot number: el9269) and on 12Oct2021 as dose 3 (booster), single (Lot number: ff2587) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Hypertension" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Chronic sinus problems" (unspecified if ongoing), notes: Chronic sinus problems; "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL; METFORMIN; ROSUVASTATIN; OZEMPIC; FAMOTIDINE; LEXAPRO; WELLBUTRIN; HYDROCHLOROTHIAZIDE; CALCIUM + VIT D; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril; Dilaudid, reaction(s): "Known allergies: Dilaudid", notes: Known allergies: Dilaudid; Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Paxlovid, from 31May2022 to 05Jun2022, Adverse event: Stopped Paxlovid 05Jun2022. COVID test had light line by 08Jun, then darker line 09Jun. Some symptoms resolved - low fever, productive cough, extreme fatigue. But sinus congestion symptoms continued and worsened a bit. Still positive with sinus symptoms as of 13Jun2022; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
This spontaneous report as received from a nurse via a company representative refers to a 14-year-old female patient. The patient had citrus allergy. The patient had no concomitant medications. On 25-NOV-2014, the patient received the first shot of GARDASIL (lot number K006191; expiration date was not reported) and on 02-FEB-2015 she received second shot (lot number K006191; expiration date was not reported), both intramuscularly for human papillomavirus prevention. The patient had never received a third dose of GARDASIL. On an unspecified date in March 2017, reported also as after receiving GARDASIL, the patient experienced pain and generalized bruising. The patient sought a medical attention by seeing the physician due to the adverse effects. She was not given any medical treatment for the events but was referred to unspecified rheumatologist for her symptoms. The outcome and causality assessment of the events to GARDASIL were not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA010353.
went back to ER twice. Arm with Shingles; numbness n hand; pain n hand; I've lost 50 % use n my hand; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles, numbness in hand, pain in hand and injected limb mobility decreased. On an unknown date, the outcome of the shingles and injected limb mobility decreased were unknown and the outcome of the numbness in hand and pain in hand were not recovered/not resolved.   It was unknown if the reporter considered the shingles, numbness in hand, pain in hand and injected limb mobility decreased to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took shingles shot and went back to emergency department twice with her arm end up with shingles two weeks later. The patient had numbness and pain in hand now and had lost 50 percent use and her hand this all on the one side, where took shot in. The reporter denied to follow-up.
requested medical records, but never received them; pt had a positive COVID test on 7/26/21; per death certificate, pt died in the hospice facility with the cause of death being Pneumonia due to COVID
Syncope, dizziness.  Called 911, paramedics arrived.  Pt's color returned and felt better and refused paramedics service.
Pelvic pain; Sore arm; Achy on shoulders and back; Achy on shoulders and back; Feeling like needles were poking her in the left side of her head; This spontaneous case was received on 02-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01919) and concerned a 66-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 31-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 01-Sep-2021, one day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient did not receive any corrective treatment for the events.  At the time of initial reporting on 02-Sep-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   Company comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.; Sender's Comments: ompany comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.
Itching and slight burning sesnation 2-3 inches around injection site. Subsided w/in 20 minutes.
Pt recvd vax & exp paresthesia of both arms; No further details were provided;
pt recv vax 24OCT96 reddened area  w/o rash to upper lt arm;warm & soft to palpation;c/o tenderness-no swelling;appt w/MD 20NOV96;
Right after injection 2 inch band of redness around site, pharmacist said it was from rubbing borders too define and distinct according to pt thought. He asked to stay a few minutes and then he left. Then told them they could stay longer outside of office. His shift was up at 6:00 and pt was sitting there in pain she feels in joint. He gave it with a springloaded syringe and she asked before how to aspirate with that , He didn't seem to understand how that was accomplished, why you would need to do that. Pain during the injection during the night, pain kept increasing all night. And so much muscle weakness that she couldn't lift it without assistance. Muscle would tremor because it was weak. In the morning saw DR. He did A X ray, said it wasn't an allergic reaction but inflammation. He ordered Vicodin 500 Tablets, she only took 2 the 1st day and then no more. A steroid Etodolac 400mg 2x day generic Lodine. It has improved, your shoulder, but it clicks at is painful. And plan to go back to Dr today 10/24/06. Pt started going to physical therapy a week ago for right arm & shoulder where vaccine was given. Three times a week for 1 month.
I was taking a bath a week later and my back was inching real bad and discovered I had Shingles after going to the doctor, I was also extremely tired. Dr  prescribed anti fungal cream
On July 12 began seeing starbursts in vision. This progressed to distorted colors. Eventually Went to eye doctor on July 13 2021 and was diagnosed with a detaching retina. Had surgery to repair on July 19, 2021.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Right arm pain.  The knuckles in my hand, my wrist, my bicep, my shoulder, my clavicle and my scapula.  These effects vary and do not always occur at the same times.  Some days there is no pain, somedays it all hurts.  I have also suffered from a yeast infection that did not occur until March 30
PATIENT STATED SHE HAD HIVES ALL OVER HER BODY STARTING ON 10/11/19 AFTER THE SHOT AND IT CONTINUED FOR SEVERAL DAYS.
feel bad; she was wearing a 300 lb suit and was exhausted; headache; slept and rested a lot the following day; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Feb2021 (at the age of 40-years-old) at 2nd dose, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included known allergies to gluten and single kidney. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on an unspecified date for COVID-19 immunisation.  The patient did not have significant side effects after her 2nd dose but felt bad the day after, in Feb2021. She said she felt like she was wearing a 300 lb suit and was exhausted and headache. She did not take her temperature but slept and rested a lot the following day, in Feb2021. Felt better 2 days after vaccination. She did not contact her doctor and did not need follow ups. No treatment was received for the events. The patient had recovered from the events in 2021.   No follow-up attempts are possible. Information about lot/batch cannot be obtained.
moderate pain in arm; general unwell feeling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 14:15 (Lot number: EW0150) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD; "IBS" (unspecified if ongoing), notes: Verbatim: IBS; "Mildly lactose intolerant" (unspecified if ongoing), notes: Mildly lactose intolerant; "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE taken for attention deficit hyperactivity disorder; BUSPIRONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "moderate pain in arm"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "general unwell feeling". Therapeutic measures were not taken as a result of pain in extremity, malaise.  Additional information: The Facility where patient administered the most recent COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt turned pale white, a second later she turned blue and fell limp in my husband's arms.  Pt stopped breathing.  I, called 911.  My husband, attempted CPR.  I also ask the 911 operator for advise.  She was not responding to CPR.  We lifed her off the floor and she opened her eyes.  She remained pale and lethargic.  Police and EMT arrived in approximately 5 minutes.  Pt was taken to the Emergency Room at the Hospital by ambulance.  We informed the ER doctor she had received several immunizations that afternoon at her 2-month doctor appointment.  While waiting in the exam room, pt lapsed into a state of shallow breathing and nearly passed out.  The ER personnel witnessed it and rushed into the room.  Medical procedures performed during the investigation for a cause: Invasive spinal tap, invasive urine draw, sleep apnea test, and IV antibiotics for 4-days in-patient at the hospital.  It wasn't until a few months later we learned that what the pt had experienced was an H.H.E. (Hypotonic-Hyporesponsive Episode) as a result of her MULTIPLE immunizations early that day. Future affects unknown.
Paralyzed from waist down-over course of approx. 2 1/2 hrs. 8:30AM began w/(R) foot tingling then (R) leg became weak and wouldn't hold up body. Progressed to spastic muscles, then (L) Leg then complete numbness. Body temp normal. Diagnosis: Transverse myelitis. Treatment: IV Steroids 5 days; rehab.
Left deltoid with circular 6.5 cm x 7 cm area of erythema around Dtap site.
When he was receiving his second dose of  Shingrix, patient claimed that his entire left arm has been sore since the day he received his first dose, which was March 1, 2023. He said that he has not been able to sleep on that side since March 1.
Information has been received from a registered nurse concerning a 19 year old female with unknown medical history who on 10-JUN-2005 was vaccinated with a 1 mL first dose of hepatitis A virus vaccine inactivated (Lot# 648526/0859P) (reported as the pediatric formulation). Concomitant therapy was reported as "other medications exact names unknown". On 10-JUN-2005, about 2 hours after receiving the vaccination, the patient developed hives, shortness of breath and a feeling that she was going to pass out. The patient sought unspecified medical attention. The symptoms resolved spontaneously the same day. There was no product quality complaint involved. Additional information has been requested.
-Itching and hives on left arm. no SOB. Prednisone & monitor. Started 8 hours or after administration. Mom reports similar reaction last year to flu shot but only 1 red mark.
p/ pt recv vax approx 10 days later devel macular-papular rash in groin & throat & exp a sore throat. sought MD attention
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021 at 12:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 12:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient 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. The age of patient was provided as 72.91 On 5-Jan-2021, vaccine moved to fridge. Condition of vaccine prior to administration was reported Not frozen.  On 11-Jan-2021,vaccine excursion time at 9am and 10 am was 34 degree F temperature and vaccine BUD date was reported as 27-Jan-2021. Vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
I contracted COVID-19 on 06/27/2022. I tested on Wednesday 06/29/2022 and was taken by ambulance to the ER because I was unable to breathe. I was given oxygen and steroids to open up my throat. I finished a prescription of Paxlovid. I haven't fully recovered and have still tested positive with a home test. Today is 07/06/2022 and had a telephone call with my doctor because I'm not over this yet.
Itchy rash on left arm around vaccination area, appeared a few days after the injection, lasted a few days.
After administration, patient reports feeling dizzy and flushed. On exam, patient was diaphoretic, and mild shortness of breath. BP 128/110, repeat x 3 and consistently elevated. Patient was sent to the emergency department at 13:27. Patient reported pressure in the head on the right side, some flashing yellow lights and symptoms resolved before ED visit. Patient reported headaches, dizziness, vertigo and right sided neck pain. Medications given: 0.9% NaCl 1000ml IV infusion at 1545; ketorolac 15mg IV push at 1638, lidocaine 4% patch 2 patches applied to right and left neck for stiffness at 1547; meclizine 25mg po at 1547 and 1637, ondansetron 4mg IV push 1638.
A lot of hives on both arms, belly, back, shoulders, and upper thigh of left and right leg.
This spontaneous report was received from a back office lead and refers to a 36 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Felt soreness immediately after at injection site. Woke up this morning, face seemed swollen, particularly on cheeks. Felt dizzy and light-headed. No syncope. Standing up made it worse. Denies blurred vision, shortness of breath, itchy or tightening sensation in throat. No hives. Reports that his face feels warm, no fever.
Patient is experiencing sore throat, cough, nausea, diarrhea, and headache. Patient will be treated with acetaminophen, ondasetron, and Imodium.
pt given shot 7/20/19,  on 7/23/19, pt said arm swollen/pain at injection site. On 7/25/19 patient says feels better now,  just a little bit of itch at the area and site pain
got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose). On 17-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (got the Pfizer vaccine first dose 21 days ago and today, 17Aug2021, got a dose of the Moderna vaccine as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient takes some medication but nothing long term.