chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching (moderate) total all body; lump in throat; slight tightness in throat; This is a spontaneous report from a contactable nurse, the patient. A 62-year-old non-pregnant female patient received the unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 14:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included mad deaf, seizures-simple partial from head trauma, migraines. The patient was allergic to eggs, pesticides, sulfa and ampicillin. Concomitant medications included valproate semisodium (DEPAKOTE), levetiracetam (KEPPRA), topiramate (QUDEXY) and duloxetine hydrochloride (CYMBALTA) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 14:30, the patient experienced Itching (moderate) total all body with lump in throat and slight tightness in throat. Therapeutic measures were taken as a result of the Itching (moderate) total all body with lump in throat and slight tightness in throat included treatment with 50 mg of Benadryl, when she went home. The clinical outcome of the events Itching (moderate) total all body with lump in throat and slight tightness in throat was recovered on an unknown date in April2021.   No follow-up attempts are needed. information about the lot number cannot be obtained.
Fever <104F X 24 hours. Gave Tylenol X 24 hours.
her husband tested and he was also positive; her husband tested and he was also positive; cold; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8731), on 04May2021 as dose 2, single (Lot number: EW0167) and on 11Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 Kidney Disease has had for years" (ongoing), notes: Continuing: True, Comments: Stage 4 Kidney Disease has had for years; "Diabetes has had for years" (ongoing), notes: Continuing: True, Comments: Diabetes has had for years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her husband tested and he was also positive"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive, notes: tested positive for Covid.  Clinical Course: Caller states that she and her husband are in their 80s, states they had Covid at the same time and they took the Paxlovid at the same time and after a couple weeks after that we both started getting severe muscle aches at the same time. Caller wants to know if this from the medication. Caller states the she thinks it is so odd that they both got the muscle aches at exactly the same time. Started Paxlovid on 09Apr2022, ended the treatment on 13Apr2022. States she documented the muscle aches began on 29Apr2022. States they started in the lower back and now they are down into her legs, states it even hurts to get out of bed and getting into the bed is severe and to stand and try to take the first step when she gets out of bed it is severe, states she did get a muscle relaxer prescribed by Dr. (Name withheld) called for a muscle relaxer, states that has not worked, manufacturer is unknown, product was dispensed in a pharmacy vial from pharmacy, NDC LOT and expiration date are unknown, dosage: 500mg tablets, 1 tablet by mouth every six hours as needed, has been trying this since 06May2022 until now and it has not worked. Caller states she has issues with her back, has had them for years and these muscle aches have exacerbated her back issues, this patient is confirmed a female, as documented correctly by the call handler. A clone case was filed for the husband.
sore arm, even more today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, even more today) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and . Concomitant products included NICOTINIC ACID for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm, even more today). At the time of the report, PAIN IN EXTREMITY (sore arm, even more today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: not provided Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Other Concomitant medications included Thyroid medicine and Cholesterol medicine.
Extreme soreness at injection site. Beginning within 1 day after injections, developed extreme weakness, fatigue, severe chills. Unable to get of out bed for two day. Took extreme effort just to stand up. Today is day 4 post injection. Symptoms are beginning to resolve.
Pt. vomited after receiving rotavirus vaccine, then vomited again 2 hrs. later, and didn't want to eat. When pt. woke up from his nap at 4pm, his eyes were swollen shut, his face was swollen, he had a temp of 100.5, & he vomited again. Mom took him to the ER where he received Benadryl & IV fluids, & had blood & urine tests.
Numbness/tingling in left pink and ring finger within 5 minutes after injection; Numbness/tingling in left pink and ring finger within 5 minutes after injection; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 10:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any other concomitant medications and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021 at 10:00, within 5 minutes after injection, the patient experienced numbness/ tingling in the left pink and ring finger. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of numbness/ tingling in the left pink and ring finger. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness/ tingling in the left pink and ring finger was not recovered at the time of this report.  No follow-up attempts are required. Information about lot number cannot be obtained. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (arm is swollen), feeling hot (arm is hot), erythema (arm is red) and pain in extremity (arm hurts) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 19, 2021, patient experienced peripheral swelling (arm is swollen), feeling hot (arm is hot), erythema (arm is red) and pain in extremity (arm hurts). At the time of the report, peripheral swelling (arm is swollen), feeling hot (arm is hot), erythema (arm is red) and pain in extremity (arm hurts) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medicines and treatment information also not provided.
Site: Swelling at Injection Site-Severe, Additional Details: pt reported could not work, dizzy, nauseous, weak. took 4 days.
Long and erratic menstrual cycles for multiple months now. 2 yeast infections between the first 2 cycles after the vaccine. Yeast infection has not returned on 3rd or 4th. Prior to vaccine my birth control pill had almost eliminated my cycle and I only spotted 2 days if one appeared. My entire life my cycles lasted 4 days they are now over a week long 7 to 12 days.
Developed rash concsistent with measels, starting 9 days after receiving first does of MMR vaccine.
Felt ill; flu-like symptoms; low grade fever; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced feeling unwell, influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, fever and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, influenza-like symptoms, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced flu-like symptoms, a low-grade fever, and body aches. The reporter did not consent to follow up. The health care professional closed chat before more information could be obtained. The patient was asking if he did not get the 2nd Shingrix vaccine would he be protected from the shingles. The reporter going to be calling the patient and need any information you can offer to encourage him to get his 2nd vaccine. This case is linked with case US2020AMR048457, reported by same reporter.
mild pain at injection site; fever; mild shivering; lethargy; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date the patient received 1st dose of Shingrix. Refer case US2022AMR156166).   On 25th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, shivering, lethargy and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, shivering, lethargy and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, lethargy and nausea to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR156166   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter was the patient, who received her second dose of SHINGRIX 2 days ago.  The reporter stated that she states that since her 2nd dose, she has experienced a fever, shivering, lethargy, pain at the injection site and nausea.  The reporter also stated that states that these symptoms are worse than her first dose.  The symptoms after her second dose have not yet resolved. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR156166:Same reporter
Woke up the Morning of 3/25/2021 with a bad rash on my arms chest back and legs and slight shortness of breath. Treated with Benadryl and Prednisone. Shortness of breath gone, rash diminishing.
15 min after vac pt c/o dizziness, stated I feel like heart is  racing,  shaky,  sweating .  EMS wheeled  to recovery booth. Assess: no LOC, no N/V, Rt deltoid site benign.  VS 148/88, HR 91 reg strong, resp 18 reg non-labored, SpO2 99%. .  BS taken by ems 106,  cold pack placed to back and front of neck pt stated she did not eat or drink today. Checked left port site for CLL benign.  Monitored for 40 min,   gave water for hydration. dizziness & diaphorsis subsided.  10:10 VS  132/86, HR 85, Resp 12, SpO2  98%. No further complaints.  After 40 minutes  pt stated I feel ok to leave and  walked out.   Ok'd to exit.   S Reagan RN
aches and pains; hard time standing straight, maintaining balance; maybe he was dehydrated; pain in his leg, stated it almost feels like a blood clot/ pain in his right leg; knees were out of whack, there was a pain there and he could not rub it out; knees were out of whack, there was a pain there and he could not rub it out; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 27Jan2021 (Lot number: EL9261) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Batch/Lot number: EK4176), administration date: 06Jan2021, when the patient was 75 years old, for COVID-19 immunisation, reaction: "aches and pains". The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "aches and pains"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "hard time standing straight, maintaining balance"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "maybe he was dehydrated "; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his leg, stated it almost feels like a blood clot/ pain in his right leg"; ARTHROPATHY (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "knees were out of whack, there was a pain there and he could not rub it out".  Additional information: The clinical course of event was as follows: After the second shot, he had aches and pains, but within a week or two he went from being a 75-year-old active dude to someone who could barely get out of his chair. The patient stated that he was having real bad pains, persisting since he received the second vaccine. If he was driving a car he was fine, but when he was going to get out of the car he almost stumbled out of the car, hard time standing straight, maintaining balance, stated maybe he was dehydrated from the medication and didn't know what it was. He was concerned about a pain in his leg, stated it almost felt like a blood clot, pain in his right leg, knees were out of whack, there was a pain there and he could not rub it out. He did not want it to be a blood clot.   No follow-up attempts are possible. No further information is expected.
Received vaccine at 9am 12/30 and felt fine until about 4pm that day. Woke up from a nap and felt chills, headache, body aches. Overnight chills become worse and constant throughout the night. Woke up with sweat on chest and arm pits. Off and on low grade fever. Through out today, more off and on chills, headache, nausea, and low grade fever. Also experiencing burning sensation of eyes off and on along with fatigue.
It was like a bad flu, with fever, chills and intense fatigue.  The symptoms were bad the first day and worse on the second day.  Symptoms started abating on the third day and are now resolved.
Developed rash on face and upper body.  Over in 3 days.  Terribly itchy, hives, swelling right side eye-chin-collar bone.  lethargic.  Took benadryl on 13th;  next day took prednisone which brought down symptoms.  Today, see that is ending.  According to literature reviewed...had light case of typhoid.  Put warning that patient with gastrointestinal conditions should not take this vaccine.
Mild fever, dry cough forceful went to PCP doctor he prescription Albuterol inhaler, Zithromax for 5 days.
Patient received vaccine on 12/10/2020 and started having a fever for 3 days. Fever resolved, then started again accompanied by a rash. Rash started on leg and is now all over the body and face.
dying; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (dying) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 002B21C) for COVID-19 prophylaxis.     The patient never tested positive for COVID.  Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN for Type 1 diabetes mellitus.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (dying). The patient was treated with EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (dying) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased blood sugar stays at 600 every bite of food/blood sugars began to increase/H on her meter was over 600 constantly/Every bite of food makes it go up crazy high.         Concomitant medication included all types of vitamin (unspecified).  The patient was dying, blood sugar stays at 600 every bite of food, water makes it go to 400. The patient had high blood sugars 2 weeks after the first dose and sugars began to increase, H on patient meter was over 600 constantly. Every bite of food makes it go up crazy high.  The patient was given some type 2 diabetes medicine to take Jardiance and the patient been taking it for the past two weeks and it was not doing anything.
Information has been received from a physician concerning a 72 female who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) at her pharmacy. On 05-JUN-2008 the patient went to see physician and was found there were 2 zoster-like blisters at the injection site with erythema, but the physician was not interested in VZV analysis by Polymerases Chain Reaction. At the time of report, the patient's 2 zoster-like blisters at the injection with erythema persisted. Additional information has been requested.
The patient expressed a metalic taste in her mouth in observation. Vitals were taken, an created by agency. A form was signed, the patient refused transport or treatment. Her husband was with her and said he would take her to the ED if anything changed.
I STARTED TO NOTICE LITTLE INDENTIONS IN MY SHIN, THAT CONTINULLY STARTED GETTING DEEPER AND WIDER ON THE INJECTION SITE.
3/29/21 VACCINATION 4/2/21 Nausea 4/3/21 Nausea, Vomiting and Hospitalization
1 month old received Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 322CM, expiry date 15th February 2024) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 8th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 8th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's comment: The certified Medical Assistant reported that the patient received a dose of Pediarix and Rotarix.   The reporter consented to follow up by postal. Additional Supportive Information: The one month old patient received a dose of Pediarix and Rotarix, which led to inappropriate age at vaccine administration.
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.