chrisvoncsefalvay/vaers-outcomes huggingface dataset:
running nightly fevers; Body became very rigid; Walking with a walker; small intestine removal; Aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running nightly fevers) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ATORVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), GABAPENTIN, LAMOTRIGINE (LAMICTAL), LOSARTAN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), TIMOLOL, FLUTICASONE PROPIONATE (XHANCE) and THIAMAZOLE (METHIMAZOLE) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced PYREXIA (running nightly fevers) (seriousness criterion hospitalization). On an unknown date, the patient experienced MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain). On 12-May-2021, PYREXIA (running nightly fevers) had resolved. At the time of the report, MUSCLE RIGIDITY (Body became very rigid), GAIT DISTURBANCE (Walking with a walker), SURGERY (small intestine removal) and MYALGIA (Aches and pain) outcome was unknown.            Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, causality in relation to the vaccine can not be excluded however the event of fever for 2 months is unlikely related to the vaccine.
Vaginal bleeding started around 7/23/21, which was 1.5 weeks after taking prednisone for a rash and 3.5 months after receiving Janssen vaccine.
On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced EYE SWELLING (Swelling of right eye), ERYTHEMA (Redness) and PAIN (Pain). At the time of the report, EYE SWELLING (Swelling of right eye), ERYTHEMA (Redness) and PAIN (Pain) outcome was unknown.            No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-157104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information included no new information. On 25-Jun-2021: Non-significant follow up appended
She stated she got so sick after the 2nd shot; Felt like a truck ran her over; Headache; Fever; Achy; This is a spontaneous report from a contactable consumer (reporting on herself). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration on 03Feb2021  as 2nd dose, single dose for COVID-19 immunization. Medical history included allergic to sulfa. The patient is not diabetic, overweight or have any heart disease. The patient concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FL0140 or EL0140and Expiration date was not reported), via an unspecified route of administration on 06Jan2021, as 1st dose, single dose for COVID-19 immunization. It was reported that the patient had first dose COVID-19 vaccine 06Jan2021 and second dose on 03Feb2021. She was really sick after the second COVID-19 vaccine and was in bed for two and a half days. She had a headache, fever, and was achy and felt like a truck ran her over on 04Feb2021. Symptoms began on Thursday morning at 03:00. She reported that she was in bed all Thursday, Friday, and half of Saturday. She didn't work out or do anything strenuous until Monday. At the appointment for her second COVID-19 vaccine, the nurse looked at it and stated that is not enough. It was confirmed that she did not receive that COVID-19 Vaccine and the nurse went and gathered another COVID-19 Vaccine that was the appropriate dose. Also stated that it looked like the nurse knew what she was doing and everything was very organized. She went to doctor last week on 04Mar2021, because she wanted to make sure that she had the antibodies and her doctor just called and stated that she does not have antibodies for COVID-19 Virus and Antibody test taken on 04Mar2021. Her doctor is going to talk with an infectious disease doctor. She was concerned because she was a dental hygienist, and her husband was a Periodontist, and both are in patient's mouths and also babysitting her granddaughter. Laboratory tests included antibodies test for COVID-19 Virus and result was negative. Outcome of the events headache, fever, achy, she got so sick after the 2nd shot, felt like truck ran her over and does not have antibodies for covid-19 virus was reported as unknown.  No follow up attempts are possible. No further information is expected.
Information has been received from a Pharmacy student, concerning a 51  year old female patient. On an unspecified date, the patient was supposed to receive a dose of live (Merck) VARIVAX and received a dose of live ZOSTAVAX instead. (Dose and route were not reported) (lot # and expiration date were not reported). It was reported that the patient was not experiencing any known symptoms. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The physician reported that the day after vaccination, the patient experienced an area of redness around the area where the vaccine was given. The physician also described that the area as slightly above the elbow but did not know where the injection was given because the pharmacist administered the vaccine. The redness subsided after 2 a couple of day. The reporter did not agree to be contacted on follow up.
Initial physician report was received on 23 Dec 2009: This patient was vaccinated with FLUVIRIN, batch number 103136P1, intramuscular on an unknown date. On 19 Dec 2009, this patient experienced redness, developed above the elbow not below the injection site. The redness was treated with TYLENOL on an unknown date. The outcome of patient's condition was reported as disappeared. The seriousness criteria of the patient was not reported.
Patient tested positive for COVID and received monoclonal antibody infusion after receiving the first dose of COVID-19 (Pfizer) vaccine
No adverse reaction however, Dad filled out documentation for the child. He put the wrong DOB of the child which makes the child 12 years old . Patient did received the 12 plus dosing on Pfizer. We had double check at drop off and also at the time of vaccination and dad had verified the DOB is correct. Then on 3/12/22 patient came in to get 2 nd shot with Mom, and said that the Dob was wrong which would make him 11 years old. The tech came to staff  member and told him that this is what happened. So staff member went to dig up old documentation and saw that was the case. Patient and parents are ok with what had happened and wants to know the next step will be. They understand that it was not our fault.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:12 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Nov-2021 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Excursion duration 1 month was reported by reporter. The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight.   This case was linked to MOD-2021-402935 (Patient Link).
Client BP went up, she had palpitations with warm clammy skin BP went from 136/80 to 170/98.
Everyday it was something different. The first three days I had diarrhea, stomach pain, nauseated and exhibited flu symptoms. Aches and pains throughout my body, sore throat, swollen glands, headache, eyes hurt to move, wheezing. The 5th day I became week in my arms and had pain in my elbow which moved into the arm muscle, wrist and fingers. I was unable to lift without pain and my muscles giving out. The sixth day it presented in the left elbow as well same symptoms...Weak, painful from elbow through arm muscle, wrist and fingers. It has been over 2 months and I still have these symptoms with the right side  being more affected than the left. I was put on naproxen for 2 weeks to no avail. I'm hoping I will get better rather than this turning into a permanent disability but it's been over 2 months!
The patient had pain at the injection site, joint pain and hives. The patient was treated with Atarax, ice to the site and Tylenol.
experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; throat feels very tight; she feels itchiness in different parts of her body; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (Patient herself) reported that a female of an unspecified age received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced throat feels very tight, experiencing itchy throat, eyes and tongue, she feels itchiness in different parts of her body. She stated received her first dose today and she is experiencing itchy throat, eyes and tongue. She said that her throat feels very tight and she feels itchiness in different parts of her body. She was asking if she can take Benadryl. The outcome of events was unknown.  No follow-up attempts are possible. Information related to batch/Lot number could not be requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: The patient received Dose 1 and 2 of Covid-19 immunization (unknown manufacturer). The patient received BNT162B2 as Dose 3 on 28Apr2022. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has tested positive for COVID-19. No known allergies. The patient was given COVID 19 treatment, Paxlovid, from12Jul2022 to16Jul2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One week later it started itching and the next day it was red and hard. i was hurting on my neck and felt bad and couldn't stay away. I think I had a fever because I was sweating but started feeling better by Sunday
Information has been received from a medical assistant referring to patient of unknown age and gender. The patient's concomitant medications, medical history and drug reactions was not provided. On an unspecified date, the patient received an intramuscular dose of VARIVAX (lot# reported as R008197 and expiration date 16-SEP-2019) for prophylaxis instead of subcutaneous(incorrect route of product administration). No adverse effects were reported. Lot number R008197 is an invalid lot number for VARIVAX.
Patient presented with puffy, inflamed eyes and hives forming on left arm. Dosed patient with 25mg of IM Benadryl and symptoms were reducing. After 15 minutes hives were almost gone and eye inflammation was completely gone.
0751:pt c/o itching on left arm where injection site was within 10 mins of observation. pt denied of itching or tingling in the throat. redness spots noted on pt's left arm and around abdomen.  unlabored breathing. VS 165/96 HR 85 O2 99. called Dr. and received verbal ordered for Benadryl 25mg PO and per md to observed pt for 30 mins and advised pt to get a driver to drive him home. 0816: BP 155/94 HR 74 O2 98%. pt stated itchiness has subsided; no redness spots noted on pt's abdomen and left arm. unlabored breathing 0823: confirmed with another two RNs advised pt to take Benadryl at home if itchiness continue also advised pt to contact his PCP for following up. pt verbalized understanding. pt's wife is here to pick up pt to go home.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
On December 15, 2022, I woke up extremely fatigued with a sore throat, headache, cough and severe diarrhea.  I tested positive for COVID-19 with a home test.  These symptoms lasted for 4 days.  My cough was productive with a lot of phlegm; however, it was intermittent.  I took Theraflu, Mucinex and Robitussin.  On day 5 my symptoms seemed to lesson quite a bit.  As of today, I am still fatigued and have a slight, intermittent cough.
Fever, hot arm, uncontrollable shaking, severe headache, nausea, fatigue, vaginal bleeding (not as thick as period blood)
Admitted to hospital 1/6/2022, Moved to ICU 1/15, Intubated 1/15. Ended up with trach.
No additional adverse event; inadvertently administering less fuan a full recommended dose of GARDASIL 9.; fuat is was due to user error, she had removed fue syringe before fue entire amount was injected; This spontaneous report was received from a medical assistant referring to a 27 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 28-MAY-2020, the patient was inadvertently vaccinated with less than a full recommended dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R023609, expiration date 30-APR-2021; strength, dose, frequency and route were not reported) for prophylaxis (accidental underdose and wrong technique in product usage process). It was due to user error, the medical assistant had removed the syringe before the entire amount was injected. No additional adverse event was reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R023609; expirationdate: 30-APR-2021; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient reported arm soreness at injection site; Feeling weak and tired; Feeling weak and tired; The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported; The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported; This is a spontaneous report from a contactable reporter (pharmacist).   A 15-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 at 16:45 (Lot number: FK9729) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Neurological disorder NOS" (unspecified if ongoing), notes: Neurological disorder. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8734; Anatomical location: Left arm; Route of administration: Intramuscular), administration date: 01Jun2021, when the patient was 14 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8734; Anatomical location: Left arm; Route of administration: Intramuscular), administration date: 22Jun2021, when the patient was 14 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 12Feb2022, outcome "unknown", described as "The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), with onset 12Feb2022, outcome "unknown", described as "The vial used for this vaccine was at room temperature for about 31 hours when they received it which is why this is being reported"; VACCINATION SITE PAIN (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Patient reported arm soreness at injection site"; ASTHENIA (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Feeling weak and tired". FATIGUE (non-serious) with onset 12Feb2022, outcome "recovered" (12Feb2022), described as "Feeling weak and tired". Therapeutic measures were taken as a result of vaccination site pain, asthenia and fatigue.  Additional information: Therapeutic measures included treatment with TYLENOL to help with the symptoms. It was reported that the vial was still within recommended 36 hour window. The patient had no known allergies. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care.
11 x 10 cm area of erythema upper left arm - area is swollen w/redness and itches.
Pt began to have chest tightness about 5 minutes after receiving COVID-19 vaccine. Denies shortness of breath or difficulty breathing. States she recently found out her daughter has cancer and has a lot of stress in her life so chest tightness may be related to this. Reports she also feels like she may be having heart burn. EKG reviewed by Dr. Pt taken to APRN for exam. APRN findings noted below: Panic attack as reaction to stress (F41.0). Note: EKG and labs unremarkable. Pt. feeling better now. Has a lot of stress at home with her chronically ill daughter. Discussed coping mechanisms and good nutrition today.
Information has been received from a literature article concerning a 17 year old female patient developed uveitis, corneal deposits, choroidal nevus and macula edema following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
Inconsolable crying for 8 hrs. Mom gave Tylenol as RX every 4 hrs. Didn't sleep that noc. By next day better, whole body seemed sore, like she didn't want to be touch.  Mom did not note high pitched cry.