chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A female consumer of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. In Feb2021, the patient experienced fever and she took Ibuprofen. The patient did not recover from the event. Information on the Lot/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Right upper arm red, swollen, itchy.  Vaccine reaction vs. early cellulitis.  Treated with Loratidine and Augmentin.
Pain in hands and knee joints, headache, itching in different parts of the body and dizziness.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th September 2018, 1 days after receiving SHINGRIX, the patient experienced tingling. In September 2018, the patient experienced influenza-like symptoms and numbness in fingers. On an unknown date, the outcome of the influenza-like symptoms, tingling and numbness in fingers were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, tingling and numbness in fingers to be related to SHINGRIX. Additional information was reported as follows: The pharmacist reported the case on behalf of the patient. On the date of reporting, the patient reported to the pharmacist that she was experiencing the events flu-like symptoms, numbness in her fingers and her face had started to tingle. The reporter was unsure when the symptoms had started. The patient had to leave the work early on the date of reporting due to the symptoms.
Chills, fever up to 102.3, headaches, body aches, nausea. Lasted about 24 hours, treated with Tylenol, Advil and zofran.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient was a friend of a friend of reporter. The age at vaccination was not reported. The fever and shivering lasted for approximately 4 to 5 days. Limited information was reported.
I noticed that my arthritis in my spine was bothering me more than usual, as well as my hips. I went to physical therapy because my neck was bothering me as well, but that was more muscular, I think. I went to the doctor, who sent me to physical therapy. There was a pinched nerve in my spine. If that did not work, he said, "I'd be sent for an MRI". They PT did help a little, but I still have issues. I don't have nerve pain anymore, but my back still bothers me. When the pain got bothersome, I would take Motrin. As of right now, things have been about the same as it was initially. I had painted the whole side of my house with no issues, and after the 2nd dose, I noticed pain all of a sudden and was limited in how much I could work which was strange.
Diarrhea; Pain from injection site up to her neck; Neck feels stiff; Body chills; Pain at the injection site; Nausea; Vomiting; Feels like she's running a fever temperature; A spontaneous report was received from a consumer, who was also a 34-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020 at 6:00 am, the patient began to experience body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature. Patient reported that symptoms are ongoing and progressing.  Treatment for the event included ondansetron for nausea.   Action taken with mRNA-1273 in response to the events was not reported.   The events, body chills, pain at the injection site, pain from the injection site up to her neck, neck stiffness, nausea, vomiting, diarrhea, and feeling like she's running a temperature, were considered not recovered/not resolved.; Reporter's Comments: This case concerns a 34-years-old, female subject, who experienced a non-serious unexpected event of diarrhea, and non-serious expected events of neck pain, musculoskeletal stiffness, chills, injection site pain, nausea, vomiting, and pyrexia. The events occurred one day after first dose of mRNA-1273. The treatment medication included ondansetron. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom; rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer since an unknown date and Lobectomy (thyroid) since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form once a day; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form once a day; PREDNISONE on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form, for 4 days and DOXEPIN for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) had resolved and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) had not resolved.            Patient was not taking any concomitant medications.  Patient's experienced rash and itching again on 07-MAR-2021.   This case was linked to MOD-2021-037221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Outcome of events and treatment medication updated
Confusion, Headache, Myalgia, Fever, Awoke with fever, chilly, fogginess, myalgias, fatigue, and soreness of arm days after injection of 2nd COVID 19 vaccine. Narrative:  Awoke with fever, chilly, fogginess, myalgias, fatigue, and soreness of arm days after injection of 2nd COVID 19 vaccine.Missed 1 day of work.
Redness at site; Redness at site turned into burning; at site turned into burning then black with fluid filled blisters; fluid filled blisters which has now turned black; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for injection site erythema, injection site pain, injection site blisters and injection site discoloration.   On 3rd April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th April 2021, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site burning, injection site blisters and injection site discoloration. The patient was treated with cefalexin (Cephalexin) and steroid shot (nos). On an unknown date, the outcome of the injection site erythema, injection site burning, injection site blisters and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site burning, injection site blisters and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter reported that patient received 1st dose of Shingrix by which patient experienced redness at site which turned into burning then black with fluid filled blisters,which are not resolved. The patient went to urgent care and emergency room and now has appointment with wound care specialist on 19-April-2021.  ER visit required. The HCP consented to followup.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy (WAES 1110USA00578). On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Additional information has been requested.
Developed diarrhea and stomach pain issues that were not previously present.   Seen my pediatrician for gastrointestinal issues.   Referred to pediatric gastroenterologist.   Diagnosed with lactose intolerance
12 year old received Moderna dose for her 1st covid vaccine. This was per the parent's request. Patient should have received Pfizer vaccine based on her age. We have spoken with her mother and explained she will receive Pfizer to complete the series. No adverse reaction to the vaccine.
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 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:36 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 72.98.   No concomitant medications were reported.  Batch number 019B21A administered on 27-Mar-2021 with temperature 35 degrees at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-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 using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012501, expiration date 08-JAN-2020 (dose and route of administration were not reported). The details (temperature and time frame) of temperature excursion were not reported. Data logger was not involved. There were no previous excursions reported. There were no adverse effects.
Sudden onset of Fever of 101, Chills, neck pain headache, nausea, and dizziness, the evening of 9/27. Unable to get out of bed. Patient contacted PCP following day and was prescribed ZOFRAN for the nausea and Ibuprofen for fever/pain. Symptoms improved the following day and resolved by 9/29/2018. No emergent care was required/reported by patient.
Headache, Myalgia, bone and muscle pain, nausea, sore throat, general weakness, chills
Pt was given DTaP in LD IM on 5/22/2006 and IPV SQ in left arm on 5/22/2006. Seen by nurse 5/24/06 at 11:25. Left deltoid red and swollen area measures 8cm x 9cm.
Approximately 15 minutes after the injection, patient reported chest tightness and rapid heart rate. This did not resolve, so EMS was contacted. Patient was evaluated by paramedic who found her blood pressure was very high and he advised that she be transported to the ER for evaluation. She was transported to the ER by the ambulance.
her eyesight has deteriorated since 09 Jan 2021 from 20/80 to 20/200; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number unknown) as single dose, dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number unknown) as single dose for covid-19 immunisation. Medical history included (Uveitis) pre-existing condition with her left eye (Fuch's Heterochromic Iritis Cyclitis) for 20 years.  Concomitant medication(s) included Humira (The patient received 3 doses of Humira on 25Feb2021, 11Mar2021, and 25Mar2021). She went to the doctor to have surgery on her eye and her eyesight has deteriorated since 09Jan2021 from 20/80 to 20/200. She asked if her deterioration in her eye sight was related to the COVID vaccine. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
felt unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization; Bnt162b2 (2nd dose of covid vaccine), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fully vaccinated (Moderna) but not boosted admitted to the hospital on 02/13/22 with COVID-19 and associated hypoxia. Patient expired on 02/20/22.
pt recvd vax & c/o weak, listless x 5 hrs; poor suck on bottle; sent to ER;
pt recvd vax; pt cont to cry & will not eat; apap given; T 101; sl nasal congest;mom has cold & cough;
pt recvd vax & 2 days p/inject pt had a couple of drinks of alcohol & exp flushing & vision disturbances lasting approx 15 mins; No further details were provided;
APPROXIMATELY 2 WEEKS AFTER VACCINATION, PATIENT NOTICED PALPITATIONS OFF AND ON FOR 4-5 MONTHS.
patient received vaccine on the left arm on 9/25/19 she came back on 9/27/19 to the pharmacy with rash and liquid filled blisters on the right arm and trunk no local reaction at injection site she was questioning if she got shingles from vaccine ,patient was advised to go urgent care or contact pcp and then was contacted for follow up by pharmacy team left multiple messages and no response so no updates on case as of 10/8/19
pain in leg went back; she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in leg went back) and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Osteopenia ((arthritis in her bones)). Previously administered products included for COVID-19 vaccination: Pfizer (First Pfizer shot on 25May2021, given in left non-dominant arm. Lot number: EW00170. Expiration date: 31Aug2021.) on 25-May-2021, Pfizer (Second Pfizer shot on 15Jun2021 and given in left non-dominant arm. Lot number: EW0217. Expiration date: 30Sep2021.) on 15-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, ATORVASTATIN, VITAMIN D3, PANTOPRAZOLE, CARVEDILOL, RIVAROXABAN (XARELTO) and POLYVINYL ALCOHOL (LIQUID TEARS) for an unknown indication.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in leg went back) and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg). At the time of the report, PAIN IN EXTREMITY (pain in leg went back) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were reported.  The patient said that that she has osteopenia (arthritis in her bones). She sleeps on her right side and takes 2 Tylenol before going to sleep. Around 1:30 to 2:30 am she wakes up because of pain in her right leg, which is very painful. Sometimes, she needs to get up and sleep in the recliner because she doesn't deal well with pain.  However, after getting the Moderna booster shot on Monday afternoon, she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg. She slept all night with no pain whatsoever in her leg. It felt like she could do a cartwheel and felt so good. Last night, around 3:30 am the pain went back in her leg. She said that maybe the Moderna vaccine made her pain go away and after 63 hours the pain was back.
On 02/18/2022 I left work early because I had a sore throat. I was running a fever of 101. I did a rapid test in the same day and it came back positive. I started to feel better after about 3 days. I contact my primary care physician and he prescribed a stronger version of Mucinex. I felt at least 95% better after a week. I still suffer from a cough every now and then.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (one episode of sleep walking 40 years ago, but had no history of sleep walking since then).    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The patient was on concomitant medication, but the reporter did not specify the names.  After the second dose, the patient did not experience any unusual side effects.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-535830, MOD-2022-535842, MOD-2022-535849 (Patient Link).