chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got tremendous energy (cooking 3 dishes)/fibromyalgia suddenly disappeared ( patient got this for 13 years); This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (got tremendous energy (cooking 3 dishes)/fibromyalgia suddenly disappeared ( patient got this for 13 years)) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (got tremendous energy (cooking 3 dishes)/fibromyalgia suddenly disappeared ( patient got this for 13 years)). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (got tremendous energy (cooking 3 dishes)/fibromyalgia suddenly disappeared ( patient got this for 13 years)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Patient returned to pharmacy 15 days post immunization stating redness and itching at injection site that spread to elbow. She said she would take BENADRYL every now and then. Reaction is subsiding. Not itching today and redness is fading.
FLUABV+SARS-CoV-2+RSV RNA Pnl Resp NAA+p~FLU/RSV/Covid-19 by PCR performed on 7/13/2021 at 18:55. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 21-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degree for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
severe shoulder pain; shoulder injury related to vaccine administration; limited range of motion; limitations with activity of daily living; This is a spontaneous report received from a contactable Pharmacist via Medical Information Team. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/Batch number: Unknown), on an unspecified date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient had concern about shoulder injury related to vaccine administration. On an unknown date the patient had severe shoulder pain, limited range of motion, and limitations with activity of daily living. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Patient has a red sore arm and loss of appetite still on 7/14/21 since the date of vaccinations. Patient was vomiting on 7/10/21 but has stopped
Started with headache 15 min after shot.  That was on Thursday afternoon the 8th of April.  We are already the 14th of April and headache has not gone away once.  Body aches and joint pain are still present.  Snapping my fingers hurts the joints in my hand.  Walking hurts my knees.  Fatigue has set in and is still present.  VERY tired all the time.  All I want to do is sleep.  Dizziness all morning.  Taking about 2 to 3 hours for dizziness to go away.  But present again at intervals during the day then again the next day.  This has gone on since day two of shot.  Dry mouth.  I am drinking LOTS of water.
Arm pain at site of injection; Flu like symptoms; Nausea; This non-serious case was reported by a lawyer and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-JUL-2023, the patient received the 1st dose of Shingrix (left arm). On 01-AUG-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm pain at site of injection), influenza-like symptoms (Verbatim: Flu like symptoms) and nausea (Verbatim: Nausea). The outcome of the injection site pain, influenza-like symptoms and nausea were not reported.   The reporter considered the injection site pain, influenza-like symptoms and nausea to be related to Shingrix.     The company considered the injection site pain, influenza-like symptoms and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 The patient age was reported as 6 decades. The patient reported that after received Shingrix vaccine he experienced flu like symptoms, arm pain at the site of injection and nausea.
Information has been received from a 59 year old female registered nurse with diabetes who on 14-OCT-2009 was vaccinated intramuscularly with her first dose of PNEUMOVAX 23. The registered nurse reported that on 14-OCT-2009, she withdrew PNEUMOVAX 23 from a multidose vial and she had another nurse give her the dose. The registered nurse could not recall if she withdrew 0.5mL or 1mL and had not way to tell. Subsequently the nurse experienced pain and swelling at the injection site that get worse at night. The swelling extends down to the registered nurse elbow. No lab tests were performed. The registered nurse sought medical attention by consulting a pharmacist. At the time of the report the patient had not recovered from pain and swelling. Additional information has been requested.
The pt experienced pruritus and erythema lasting only the day of vaccination. Treated with Benadryl.
Testes for Covid and flu, showed that he was positive for Covid; Testes for Covid and flu, showed that he was positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 17Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing), notes: Gout Recently started medication for that; "high blood pressure" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "low potassium" (unspecified if ongoing); "diuretic" (unspecified if ongoing). Concomitant medication(s) included: LEVEMIR taken for diabetes mellitus (ongoing); NOVOLIN R taken for diabetes mellitus (ongoing); METFORMIN taken for diabetes mellitus (ongoing); CHLORPHENIRAMINE [CHLORPHENAMINE] (ongoing); TYLENOL (ongoing); LABETALOL taken for blood pressure measurement, start date: Nov2022 (ongoing); PIOGLITAZONE HCL taken for diabetes mellitus (ongoing); LOSARTAN POTASSIUM taken for hypokalaemic syndrome (ongoing); HYDROCHLOROTHIAZIDE taken for polyuria (ongoing); ALLOPURINOL taken for gout (ongoing); ASPIRIN (E.C.) taken for blood disorder (ongoing); GUANFACINE HCL taken for blood pressure measurement (ongoing); ATORVASTATIN CALCIUM (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2023, outcome "unknown" and all described as "Testes for Covid and flu, showed that he was positive for Covid". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5, 11 or 5, 10; Flu test: (unspecified date) Unknown results; SARS-CoV-2 test: (16Aug2023) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
about 7PM 4OCT96 pt devel febrile sz;was seen in ER prescribed for pink ear drum;about 24hr later pt again seizured in spite of being on regular doses APAP;was sen @ hosp ER;t104.5;pt refused to eat during these 2 days;
About 4 months after my 1st Covid Vaccination, and 3 months after my 2nd Vaccine, I developed "Frozen Shoulder" in my left arm.  I had both Covid vaccines in my upper left arm.  I am a Type 1 Diabetic, and I know that Diabetics are more likely to develop "Frozen Shoulder" but I thought I should report this to the CDC because I've read online that those infected with Covid also appear to be more likely to develop "Frozen Shoulder"
Patient tested positive for Covid 7/19/21. Hospitalized with COVID, pneumonia, NSTEMI
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 1:46 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 1:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.45 for dose administered on 03-Mar-2021   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 09:00 AM, 34 degrees Fahrenheit at 10:00 AM and 35 degrees Fahrenheit at  01:00 PM. This vial was moved to fridge on 24-Feb-2021. vial was moved to clinic on 03-Mar-2021. BUD for the vial was reported as 26-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
metallic taste in the back of my throat; arm got sore a little bit; she felt almost like a pins and needles sensation in her lower legs; little tired; my lower extremities had pins and needles; I felt like a rush of adrenaline; heart was beating a little faster; stress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste in the back of my throat"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm got sore a little bit"; PARAESTHESIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "my lower extremities had pins and needles"; EPINEPHRINE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "I felt like a rush of adrenaline"; HEART RATE INCREASED (non-serious) with onset 09Mar2021, outcome "unknown", described as "heart was beating a little faster"; STRESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "stress"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she felt almost like a pins and needles sensation in her lower legs"; FATIGUE (non-serious), outcome "unknown", described as "little tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient stated that, her arm is a little sore and she was a little tired afterwards but that is it and she says her friends down the street complained of the same thing. But 5 to 10 minutes after she received her vaccine, she was sitting in the chair, and she felt almost like a pins and needles sensation in her lower legs and flushing like a rush of adrenaline. Her heart was then beating fast, but that she chalked up to stress. She also had a metallic taste in her mouth and the back of her throat. The taste only lasted a couple of hours and she knows that certain medications and antibiotics can do that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable other health professional reported for herself. A 31-year-old female patient (not pregnant at time of the report) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), intramuscularly on left arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. Facility type Vaccine was reported as Doctor's office/urgent care. Medical history included SVT, neurocardiogenicy syncope, PVCS, known allergies: PCN. Concomitant medications were not reported. The patient experienced arm soreness, headache, shakiness, nausea, diarrhea on 31Dec2020. No treatment was received for the events. The outcome of the events were not resolved.
Drug effect incomplete; the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK). At the time of the report, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Daily dose was reported as CF for Humira and 1 in 1 once for Moderna. On unknown dates, the patient experienced HUMIRA has worked 90 percent and Sick. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  The reporter's causality for the event(s) of HUMIRA HAS WORKED 90 PERCENT and SICK was not provided. No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of Chronic plaque psoriasis, who experienced unexpected, non-serious event of Ilness. Therapeutic product effect incomplete was reported as an additional event. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of Chronic plaque psoriasis, who experienced unexpected, non-serious event of Ilness. Therapeutic product effect incomplete was reported as an additional event. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Chills. Low grade fever, severe headache, shooting joint pain. Took Tylenol. No treatment necessary.  Symptoms gone in less than 24 hours.
My Child started throwing up at least 10 times 45 mins after the vaccine. He was not even able to consume the water. Water was also coming out. I had to rush to medical Centre emergency ward. Hospital staff has admitted (Patient) and put him on observation in emergency room for a few hours.  A Glucose POCT lab test was taken for patient.  One half of the  tablet named 'Zofran' has given to him and 30 mins after that he consumer Apple Juice and didn't throw up and after 30 mins patient was discharged from the hospital.
Pain in both knees, weakness in legs pain in the shoulder, just one the right one. Pain in the back. Some times its hard to lie down. Don't have a primary right now. She left the network. In the process off choosing one. I take pain relievers just over the counter. It does ease the pain.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at injection site for 3 to 4 days and redness for another 5 days. The patient was upset because of availability of the product and was unable to find pharmacy with product in stock, which led to incomplete course of vaccination. The patient did not provide further details.
nausea, vomiting, diarrhea, sleepiness & extreme fatigue, starting 45min p/vax & lasting around 2-3 days;
pt states about 2 weeks after her 3rd dose of booster vax she became very weak and she started loosing weight.  She has burn like marks on her lower legs.   She has brown spots on the bottom of her feet.  She also had itchy rash on her legs, belly and neck.  She had pain in all her joints.  The pain was so severe she went to ER.  She had XRAYS, lab test,  was given steroid shots and was referred to a sports medicine for her joint pain.   She went to her PCP and he sent her to take several test.  She has strange sensations in within her body.  If she touches her buttock she feels the sensation in her feet.  If she touches her feet then she feels the sensation somewhere else.  She cant explain since these sensations move within her body.  She stated she started planning her funeral since she doesn't not what is going on and she has never had these symptoms before and she has had them for so long.  She says the spots on her feet are still there but they are getting some better.  She still has the spots on her legs that are not as dark but they still give her a strange painful sensation when she touches them.  When she sits down it feels like her bones are moving but she knows they are not.  She is drinking Ensure to help build back up her strength.  She feels like the vaccine affected her muscles within her body.  She has a FU appt an ortho doctor this Friday.
On 9/27/10 GARDASIL # 1 given. On 10/20/10 Pt immunized with another dose of GARDASIL -mom noted H/A on 10/20/10 given Ibuprofen no vomiting pt is currently fine.
Fainting after vaccine, patient had not eaten breakfast, no chronic diseases reported, blood pressure at onset of episode 110/60, heart rate 62, pale, clammy, after approximately 10 seconds patient responded to verbal commands, cool clothes to forehead and back of neck, gave patient coke and peanut butter crackers and monitored 30 minutes after episode, patient did not change planes or fall, moved to sitting position with assistance at onset of episode, niece with patient and drove patient home. Patient left clinic in no distress.
I have been having localized heat right in my butt area. Every time I move around its like a spot of heat that just kind of moves around; When I get up; when I walk around I can feel the heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: EW0179) at the age of 54 years 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: FEELING HOT (non-serious) with onset 06Aug2021, outcome "not recovered", described as "I have been having localized heat right in my butt area. Every time I move around its like a spot of heat that just kind of moves around; When I get up; when I walk around I can feel the heat". Therapeutic measures were not taken as a result of feeling hot. Additional information: The patient stated that, she received the Covid vaccine on yesterday, Saturday, Friday, Thursday (not further clarified) and she have been having localized heat right in her butt area. Every time she move around its like a spot of heat that just kind of moves around. The patient thought it was a reaction to shot. When the patient got up she can feel the heat, when she walk around she can feel the heat. It was a kind of sitting there and she did not have this kind of problem before she got this shot. Its like right under her skin. The patient stated that she had no prior vaccination. The patient did not had any treatment and stated that no, nothing she can do. It was just there. It started the day before reporting. No follow-up attempts are possible. No further information is expected.