chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in muscles and body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in muscles and body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in muscles and body). At the time of the report, MYALGIA (pain in muscles and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Soreness and stiffness in neck and arm on right side (same as inj site). Achiness in upper body. No meds or Tx
Kinrix administered to infant less than 1 YO; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe 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: 29-Jul-2022 Reporter's Comments: The pharmacist reported a Kinrix might had been administered to an infant less than one year of age. Healthcare professional unsure if this happened but they were investigating, he was anonymous in the original case but agreed to follow up via email. Additional Supportive Information: The infant patient was administered with Kinrix vaccine, which led to inappropriate age at vaccine administration.
swelling in area 6/27/21 itching later that day 6/20/21 told mom felt difficulty breathing and breathing was ok so mom didn't question she gave him Benadryl
she reported that the syringe broke in her arm and got medicine on arm; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of SYRINGE ISSUE (she reported that the syringe broke in her arm and got medicine on arm) and MYALGIA (muscle soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SYRINGE ISSUE (she reported that the syringe broke in her arm and got medicine on arm) and MYALGIA (muscle soreness). On 21-Apr-2021, MYALGIA (muscle soreness) had resolved. At the time of the report, SYRINGE ISSUE (she reported that the syringe broke in her arm and got medicine on arm) outcome was unknown.            No concomitant medication were reported.  No treatment medication was reported.
The first week I had difficulty sleeping, intense pain in my left ear, and strong tinnitus. When I managed to fall asleep I was waking every 30-60 minutes with very bad nightmares and anxiety. I also felt that my ears had high pressure and some fullness. It felt like they were popping almost continuously.
This spontaneous report as received from a nurse refers to an approximately 25 years old female patient with a history of genital warts. In February, 2012, the patient was vaccinated with IM with the first 0.5 ml dose of GARDASIL at a health department. On 03-AUG-2012, the patient was vaccinated IM with the second dose 0.5 ml dose of GARDASIL (lot # reported as 0459AE, exp. date: 13-DEC-2014). It was reported that the patient presented to her practice on 02-AUG-2012 to be examined for genital warts. The doctor examined and treated for her genital warts, type unspecified. The patient was not pregnant. The outcome of genital warts was unknown. Additional information has been requested.
Fever, headache, Chill, and Malaise; Treated with tylenol; fever lasted for one day. Chill, headache and malaise lasted for three days
PT RECEIVED VACCINE ON 1/25/21. UPON COMPLETION OF HER ADMINISTRATION FORM, SHE HAD NOTED THAT SHE CONTRACTED COVID OVER THANKSGIVING. I HAD WARNED HER THAT SHE MAY STILL HAVE ANTIBODIES WITHIN THE 90 DAY TIMEFRAME AND SHE MAY POSSIBLY HAVE A STRONGER RESPONSE TO THE VACCINE, HENCE MORE REACTION TO IT. SHE CALLED THE PHARMACY ON 1/28/21 STATING SHE HAD STARTED PRESENTING SYMPTOMS OF A REACTION 24 HOURS LATER ON 1/26/21. SHE COMPLAINS OF SWOLLEN AND ITCHY ARM AND GENERAL BODY ACHINESS. SHE TOOK ACETAMINOPHEN TO RELIEVE ANY PAIN EVEN THOUGH HER SYMPTOMS STILL PERSIST. I SAID SHE COULD US COLD COMPRESSES AND BENADRYL TO FACILITATE. I TOLD HER TO CALL HER PHYSICIAN AND TO ALSO CALL US BACK IF NO BETTER.
Tremendous back pain; Swollen Injection site; Red injection site; Painful injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Tremendous back pain), INJECTION SITE SWELLING (Swollen Injection site), INJECTION SITE ERYTHEMA (Red injection site) and INJECTION SITE PAIN (Painful injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced BACK PAIN (Tremendous back pain), INJECTION SITE SWELLING (Swollen Injection site), INJECTION SITE ERYTHEMA (Red injection site) and INJECTION SITE PAIN (Painful injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 12-Feb-2021, BACK PAIN (Tremendous back pain), INJECTION SITE SWELLING (Swollen Injection site), INJECTION SITE ERYTHEMA (Red injection site) and INJECTION SITE PAIN (Painful injection site) had resolved.            No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up received and outcome of events updated to recovered.
Myalgia, Arthralgia, Fever, fatigue, chills Narrative:  The morning after the vaccine, the patient experienced fatigue, generalized body aches, and alternating between having the chills and feeling warm. He took 650mg acetaminophen once.
disoriented gait; balance problems going up stairs; dizziness when turning head side to side; brain fog; This case was reported by a physician via call center representative and described the occurrence of unsteady gait in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2020, 7 days after receiving Shingrix, the patient experienced unsteady gait, balance difficulty, dizziness and foggy feeling in head. On an unknown date, the outcome of the unsteady gait, balance difficulty, dizziness and foggy feeling in head were recovering/resolving.   It was unknown if the reporter considered the unsteady gait, balance difficulty, dizziness and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient began to experience dizziness when turning head side to side, disoriented gait, balance problems going up stairs, and brain fog. The patient was examined by a neurologist and had an MRI (magnetic resonance imaging) and bloodwork, but there were no abnormal findings.  The patient had a follow visit with primary care physician on 1st February 2021, and the physician reported there were some slight improvements in the patient's adverse events. The reporter consented to follow-up.
Diffuse papular rash to abdomen and right forearm, itchy non-painful, showed up 7 days after administration of vaccine. No new contacts, detergents, exposures, or food. Benadryl helps alleviate symptoms but does not go away. Going on day 4 of rash presence.
Redness, swelling around injection site within 24 hours with general malaise, aching, swollen glands and mild fever followed by itchy, red eruptions beginning in area surrounding site (24 - 36 hrs) then spreading increasingly to both arms and legs over 5-6 days.  Still in progress.  Also, both siblings in home exhibiting mild fever and vomiting without any apparant reason.
All joint bother; Shingles; COVID-19; Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), MUSCULOSKELETAL DISCOMFORT (All joint bother), HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 01-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF (40 mg,1 in 2 M). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF (40 mg,1 in 2 M). In January 2021, the patient experienced ILLNESS (Sick). On 26-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (All joint bother) and HERPES ZOSTER (Shingles). At the time of the report, ILLNESS (Sick) and COVID-19 (COVID-19) was resolving and MUSCULOSKELETAL DISCOMFORT (All joint bother) and HERPES ZOSTER (Shingles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter.  The patient was sick after second Covid vaccine dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with Humira for the events of sick , all joint bother, Covid-19 and shingles was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Additional follow-up received, added event of Shingles.
Pt rcv'd first inject, at an uspecified subsequent date, the pt lost her eyesight in one eye.  Litigation pending. Pt also experienced pain in both ankles following Lymerix vaccine, rash and flu-like sxs.
In day following administration developed redness and pain near site. Treating with cool compress right arm. 10 x 13.
high blood pressure/blood pressure was very high at 217/got it down a little to 200; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization.  Medical history included heart surgery.  The patient's concomitant medications were not reported. The patient received the first shot of the vaccine on 13Jan2021. On 14Jan2021, the patient experienced high blood pressure and was taken to the hospital. The patient would like to know if the COVID vaccine contain any substance that can trigger the blood pressure to go higher. The patient used to get iron bags for years injected and has not had any for a while and they said she needed some. The blood work showed that her iron was down. Patient's blood pressure has to be checked before giving it to the patient, and blood pressure was very high at 217. They waited a little bit for and got it down a little to 200 and gave her the iron (Jan2021). The patient was suggested to go over to a hospital. They were just concerned that it took a 12-hour process. The patient was then given different medications. Second shot of COVID vaccine is due in 3 weeks. She was just wondering would that have anything to do with her blood pressure going up and should she have the second dose.  Her doctor did not think it had anything to do with it, but she said they only know so much.  The patient was recovering from the event high blood pressure.   Information on the lot/batch number has been requested.
Pain in sinuses and temples; Sore arm at injection site; Headache; Headache in back of head; Fever; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN, PYREXIA, CHILLS, MYALGIA, and VACCINATION SITE PAIN in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No allergies were reported.  Patient has never been diagnosed with COVID-19.  Concurrent medical conditions included Psoriatic arthritis since 04-Jan-2012, Cholesterol and Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure, CRESTOR for Cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced Fever. 01-Apr-2021, the patient experienced CHILLS and MYALGIA. On an unknown date, the patient experienced SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE. The patient was treated with IBUPROFEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA, CHILLS, and MYALGIA had resolved. At the time of the report, SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE had resolved.            Most recent FOLLOW-UP information incorporated above On 24-May-2021: No specific follow-up information recorded.
Multiple ulcerations/spots on tongue.  Sensation of difficulty in swallowing although no swelling of lips/tongue noted by patient.  Pt. did not take any medications/interventions.  Pt. felt better next day and spots were gone.  Also had large area of swelling, redness, tenderness at injection site.  This continues as of this date, 1/13/21.  Pt. has no other issues/complaints.
feel bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter that his/her sisters took the shot and it made them feel bad for 2 days. The reporter said 2 days was better than 2 months. The follow up would not possible as no contact details were available.
Received vaccine Nov. 21 at 4:00. At 6:30 symptoms arose of coughing, gagging, heaviness on chest, wheezing, difficulty breathing - went to hospital emergency after calling doctor on call. Was treated with I.V.
Extreme fatigue beginning at 5AM day after vaccine injection, resolving the following morning (total of ~24 hours) Arm twitching at vaccination site beginning day after vaccine injection - ongoing (now 48 hours)  I also had a major headache after the first dose (6 weeks ago) that resolved within 24 hours
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30May2022 at 16:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 65 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.   Additional information: Patient didn't receive any other medication in 2 weeks. Patient had no known allergies.
Chest hurt evening that #2 H1N1 nasal vaccine given.  Child developed fever to 102F the next day.
My first Pfizer vaccine did not cause any adverse side effects.   My second Pfizer vaccine which I received around 11:30 AM on 4/24/24, caused mild symptoms. The day of the vaccine I had an ache in my arm at the site of the shot. For roughly 2 days I had mild cold symptoms?phlegm and a scratchy throat.   Between the hours of 7:00-8:00 PM on 01/05/2022, after receiving my booster vaccine shot I began feeling an ache where my booster shot was given, as expected. Roughly 12 hours (2:00AM, 01/06/2022)  after receiving my booster shot (2:30PM, 01/05/2022), I woke up freezing with a massive headache. Roughly 30 minutes after that I woke up drenched in sweat. This cycle of freezing/hot happened about 4 times during my sleep, until waking up at around 11 AM on the 6th of January. I woke up with a massive headache again, along with pain in my arm. I did not wake up drenched in sweat, however I was wet from it as a result of soaking my sheets and blankets from the events that occurred during my sleep. I took some ibuprofen to help my headache, but it did not really help. The headache lasted all day. Around an hour and a half after waking up, I again started to feel freezing. I took my temperature which was 99.5 degrees. Soon after this I began to sweat again. Around 4 PM I got another fever, which was 100.6 degrees. That was my last one. For the next two days, I had cold symptoms such as a scratchy throat, cough, fatigue, headaches, and phlegm in my throat.
Patient age 5 came into the Public Health Center with his mother and twin brother on April 29th 2022 for his second dose of the Pfizer COVID Vaccine for 5 - <12 yrs. Due to oversight, Pharmacist inadvertently administered patient 0.2ml of undiluted vaccine. This error was discovered later when it was realized sufficient additional doses could not be drawn from the vial. Upon realization of the error, Pharmacist alerted administration staff, Pfizer via telephone, and the parent. Mother was informed of the error, increased risk of adverse reactions due to elevated immune response. Mother was offered additional resources from the CDC and the opportunity to talk with Pfizer staff. Mother was made aware that Pharmacist would call again on 04/20/2022 to follow-up on the condition of patient.
achy neck; Red oval circle at injection site; Itchy circle at the injection site; swollen lymph nodes in the left side; soreness in her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (soreness in her left armpit), NECK PAIN (achy neck), LYMPHADENOPATHY (swollen lymph nodes in the left side), VACCINATION SITE ERYTHEMA (Red oval circle at injection site) and VACCINATION SITE PRURITUS (Itchy circle at the injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced AXILLARY PAIN (soreness in her left armpit) and LYMPHADENOPATHY (swollen lymph nodes in the left side). On 19-Apr-2021, the patient experienced NECK PAIN (achy neck), VACCINATION SITE ERYTHEMA (Red oval circle at injection site) and VACCINATION SITE PRURITUS (Itchy circle at the injection site). At the time of the report, AXILLARY PAIN (soreness in her left armpit), NECK PAIN (achy neck), LYMPHADENOPATHY (swollen lymph nodes in the left side), VACCINATION SITE ERYTHEMA (Red oval circle at injection site) and VACCINATION SITE PRURITUS (Itchy circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
She was limp and unresponsive and I called EMS and she was taken to facility were we found out that she had permanent brain damage and was having seizures.
GARDASIL 9 given at 1:50 pm, blood drawn at 1:55. Patient complained to lab that arm where shot was given felt numb. 2:00 patient passed out in subwait area. Oxygen placed, nausea and vomited. Vitals stable, had some chest tightness. EKG done, results normal. Went home with mother.
Second dose Moderna patient received a Pfizer vaccine for his second dose, instead of receiving a second dose Moderna.
shingles; This is a spontaneous report received from a contactable consumer (friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was reported that it was full blown shingles. The patient took the covid vaccine and had shingles about a week later. Reporter stated that it might be on his back. The patient didn't realize it until he took the second shot and 3 or 4 weeks later it was bad on his back and chest. The patient had really bad shingles. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515262 same reporter/drug/AE, different patient;US-PFIZER INC-2021503505 same reporter/drug/AE, different patient
he was bleeding profusely; fell; hurt his hand; This is a spontaneous report from a Pfizer-sponsored program. A male patient (caller's husband) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on 24Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got his Covid vaccine on 24Jan2021 and today (26Jan2021) he fell and hurt his hand and he was bleeding profusely. They want to give him a tetanus shot, but caller was not sure if he can get it or not. The outcome of the events was unknown.  Information on the lot/batch number has been requested.