chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low back pain; it feels like her kidneys are affected; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) received via a Pfizer sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:01), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "low back pain"; RENAL DISORDER (non-serious), outcome "unknown", described as "it feels like her kidneys are affected". Additional information: low back pain approximately one week post dose. She states that it feels like her kidneys are affected and she will follow up with her physician. She states she is not sure if it is related to the vaccine however she was curious if it was a reported side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following the COVID-19 Pfizer vaccine I experienced some joint pain, random arm muscle spasms lasting minor joint pain and discomfort in the upper forearm cubical fossa area.  After the symptoms failed to subside after a couple of months I sought medical attention from my local provider.  The doctor prescribed a physical therapy regime that lasted several months after multiple visits.   During this time an audiologist also diagnosed me with significant hearing loss on my left side.  I still experience discomfort in my upper left forearm, muscle spasms and hearing loss/tinnitus on my left side.
Parent signed form and put DOB as 2/2/2003. Client would have been 18 and qualified for Moderna. However, DOB was found to be incorrect. Client actually born 2004. Parent also wrote in the age as 18 and not 17.
Extreme cold, severe nausea, tachycardia, elevated blood pressure, high fever,
A few hours within receiving second dose of SHINGRIX, pt developed flu like symptoms-body aches, muscle aches, fatigue and generalized not feeling well. Extensive evaluation including labs, cardiac work-up, hospital stay, and neurology evaluation were all unrevealing. Her symptoms have persisted and continue to be ongoing almost 2 months after 2nd vaccine. She is still having significant fatigue, muscle and joint aching, neck pain and upper shoulder pain. Has tried multiple medications including chronic narcotics, prednisone, muscle relaxers, Neurontin and Cymbalta all without improvement. She is awaiting evaluation by both rheumatology and immunology. However, no other obvious cause for her symptoms has been found and myself and her neurologist suspect that this is adverse reaction to SHINGRIX vaccine.
Rash on face, errythmic flat red wheals < 1/4cm round.
IN SHINGRIX ARM (RIGHT) PATIENT REVEALED HER SHOULDER TO BE INFLAMED, RED, WARM TO THE TOUCH, SWOLLEN, SORE AND TENDER.  IN FLUZONE HIGH DOSE ARM (LEFT) PATIENT REVEALED SHOULDER TO BE ONLY SLIGHTLY INFLAMED AND SWOLLEN WHILE STILL SORE AND TENDER.
Dizziness and chills, weakness, headache. Acetaminophen PRN, Bag PRN.
Period started on 12Apr2021 and did not stop until 15May2021; This is a spontaneous report from a contactable consumer(patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration in Arm Right on 07Apr2021 08:30 (Age at the time of vaccination: 47-years-old) (Batch/Lot Number: ER8729) as single for covid-19 immunization. Medical history included Cervical radiculopathy, perimemopausal, and GERD (Gastroesophageal reflux disease). Concomitant medications included Gabapentin 100 mg and multivitamin. The patient had allergic to drugs included amoxicillin and azithromycin. The patient had no other vaccines in four weeks before vaccination. As per the adverse event, it was reported that period started on 12Apr2021 and did not stop until 15May2021. Event was resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for event. The covid prior vaccination and post vaccination was mentioned as no. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Pt described a welt at the shot area & a little itching. Pt was OK otherwise.
Child began screeching, crying, inconsolable at 12:30 pm on day of vaccine administered. Vaccines admin at 10 am. Continued to cry until after 4 pm. Tylenol was given at 1:30 without cessation of symptoms. Warm bath to soothe minimally effective.
Patient stated that she experienced burning sensation after vaccination and symptoms continue.  Patient visited her physician and physician  said administration of the vaccine had hit one of her nerves therefore causing the burning sensation. Patient was prescribed gabapentin to help with pain.
Shoulder to elbow swollen to 3 times size of arm to elbow. Took steroid shots next day. Went down in 2 days. Elbow to lower arm swollen 2 times bigger than arm had cellulitis in arm from shot.
Information has been received from a registered nurse concerning a 5 year old female who on 8/27/02 was vaccinated with a second dose of MMR II (640635/1480L). Concomitant vaccination in the left arm included a dose of IPOL and a dose of DTaP. The pt "pulled away" during administration of the MMR II and the dose was inadvertently injected intradermally. A wheal formed in the skin. Itching and discomfort were also reported and there were no other complaints. Unspecified medical attention was sought and Benadryl cream was prescribed. Additional info has been requested.
The nurse drawing up the vaccine only drew up half a dose so patient had to come back to get the other half
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780 with expiration date of 15-APR-2019, for prophylaxis (dose, route and frequency were not reported).  No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000698: US-009507513-1707USA000699.
feels like dog crap; arm felt real heavy and hurt real bad; sweats; very tired; nauseous; body aches; felt horrible; chills; fever, still running fever of 100; one episode of puking, vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches) and MALAISE (felt horrible) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (survivor of long-haul COVID). Concurrent medical conditions included Asthma and Bronchiectasis NOS.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100) and VOMITING (one episode of puking, vomiting). On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), FATIGUE (very tired) and NAUSEA (nauseous). On an unknown date, the patient experienced LIMB DISCOMFORT (arm felt real heavy and hurt real bad) and FEELING ABNORMAL (feels like dog crap). At the time of the report, LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100), VOMITING (one episode of puking, vomiting), FATIGUE (very tired) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment information reported   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021 contains non-significant information. Email id of the reporter added
Experienced diarrhea later on Saturday and also later on Sunday. Slight soreness at injection site.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included difficulty sleeping. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, urinary frequency and difficulty sleeping. On 21st March 2019, the patient experienced feeling unwell. On 21st March 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm and feeling unwell were not recovered/not resolved and the outcome of the urinary frequency and difficulty sleeping were unknown. The reporter considered the pain in arm and chills to be related to SHINGRIX. It was unknown if the reporter considered the urinary frequency, difficulty sleeping and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and about two hours later, his right arm became sore. About eight hours after the injection, he developed chills and had difficulty sleeping through the night. The patient had to get up to urinate often during the night. On the day of reporting the chills were gone but the patient felts cruddy. The reporter gave consent to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (armpit caused a lot of discomfort) and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DISCOMFORT (armpit caused a lot of discomfort) and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen). The patient was treated with Surgery for Lymphadenopathy. On 09-Nov-2021, DISCOMFORT (armpit caused a lot of discomfort) had resolved and LYMPHADENOPATHY (developed auxiliary node in her armpits and armpit was swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) auxiliary node in her armpits it is not cancerous but it is benign. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The concomitant history was not reported. The treatment history was not provided. Patient had auxiliary node in her armpits surgically removed on the 9 Nov 2021. This case was linked to MOD-2021-396147 (Patient Link).
This spontaneous report as received by an office manager and a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 26-JUL-2012, the patient received the first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On 25-APR-2014, was administered a second dose of GARDASIL (dose, route, lot and expiration date were not provided). The office manager reported a pre-filled GARDASIL syringe (lot # J012438, expiration date 05-OCT-2015) which leaked out from around the base during attempted administration after the syringe needle had already been injected into the patient's skin. The GARDASIL was being administered as "one shot intramuscularly" for the patients second dose in the GARDASIL series the medical assistant confirmed that none of the product contacted her skin or the patient's skin when the leaking occurred. The patient was able to receive a GARDASIL dose from another pre-filled syringe during the same clinic visit. No adverse effect were reported. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 10/1.0 mcrg/ml injection, lot # M043422 with expiration date on 07-JUL-2019 (dose, route and site of administration were not provided). No adverse effects were reported. The vaccine experienced temperature excursion of 47-77 degrees Fahrenheit for 23 hours. There were no previous temperature excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014492.
pt recvd vax 4NOV91 & w/in 24 hrs devel red blotches on both arms & @ inject site, t103, sore throat, h/a, chills, itching, cough, insomnia & diarrhea; presented to MD & was treated w/Xanax; exp blurred vision;
arm pain; Felling achy and her body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felling achy and her body aches) and VACCINATION SITE PAIN (arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS, PLAIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN (Felling achy and her body aches). On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, PAIN (Felling achy and her body aches) and VACCINATION SITE PAIN (arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reported skin rash with bloody/scabbed appearance around the injection site that started after receiving vaccination. He was seen by MD who is treating and following reaction.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20210625000138 (Sanofi).A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization.The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; ARTHRALGIA (non-serious), outcome "recovered", described as "joint pain". Therapeutic measures were taken as a result of pain, fatigue, pyrexia, headache, arthralgia.Additional Information: Events lasted about 24-36 hours. Took Tylenol and hydrated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 2 hours, noted itching at the vaccination site. Within 12 hours, noted redness and warmth about the site. The next day there was a large area of inflammation (mostly triceps area). No decreased ROM, no fever and no rash. Treated with ice and Tylenol. Symptoms totally resolved in 72 hours.
Administered expired vaccine to client; client's mother was notified that this dose would not count and client would need to return for another dose
Patient received her Covid 19 Vaccination on 2-11-21.  I counselled her about side effects and asked her to wait 15 minutes.  She waited and as she was leaving she fell to the floor and hit her head.  The other patients around her said it looked like she slipped, but when speaking to her it seemed that she had become dizzy and fell.  I spoke with her after she fell, she did not loose conscienceness, but was disoriented.  She did know what day it was, who she was and where she was.  She said her head hurt and she could move all her limbs.  I asked the store director, to call for an ambulance.  I sit with her for a few minutes and talked to her, then asked store director to stay with her until the ambulance arrived.  They arrived and spoke with her and decided to transport her to the hospital.  Later that day, her sister in law came by and said she was doing fine and had been released.  The doctors indicated they thought she because dizzy due to dehydration
Product temperature excursion issue; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medications were reported.  It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. There was low power the next day in the middle of the day at 12:00 PM. Had placed all the vaccines into a frozen bag, booster vaccines then transported to another clinic. On 2-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 patients. No symptoms were reported. No treatment details were reported. This case was reported for patient 14 out of 26 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Patient came in to pharmacy today (3/24) complaining of reaction to the SHINGRIX vaccine she received on 3/18/2018. She said she had noticeable pain in her arm immediately following the injection. The following day, her entire torso was sore and she noticed considerable swelling around the site of injection. The body soreness only lasted about one day. The area affected is a 4" x 2" on the upper left arm, likely where the vaccine was administered.  It is warm to touch, very red, itchy, painful and slightly swollen; the patient reported that it was more swollen earlier in the week but seems to be improving. There was no exudate or visible wound/scars. Patient was self-treating with hydrocortisone cream and BENADRYL cream but was still having discomfort and came back to the pharmacy to report the adverse event. Since it has been improving over the past week (although the area is still very red and irritated a week later), she will be following up with her doctor on Monday and if it worsens, she is instructed to go to urgent care to be evaluated. No fever, difficulty swallowing or breathing. Reaction was localized to the area around vaccination site (with upper body/torso soreness for one day after).
fever; she got a cold pretty much; they did the PCR test and the patients came back as positive; had a sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 21Jul2021 as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. Her daughter and herself had an appointment to get the first shot of the Pfizer COVID-19 vaccine at 13:00. Patient stated that on 26Jul2021, five days after receiving the vaccine the caller tested positive for Covid. She stated she got a few symptoms nothing drastic. She stated she got a cold pretty much. She stated that the day of reporting was the first day that she was fever free. She stated that she can pretty much state that she will be fine in the next couple of days. On 22Jul2021, patient had a sore arm the other than that she was fine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.