chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; headache; nausea; dizziness; extreme fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30155BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "AFib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: oseltamivir, notes: known allergies Oseltamivir. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. RN copied the same Lot number as shot #1, Location of injection: Arm Left), administration date: 20Jan2021, for Covid-19 immunization, reaction(s): "fever", "chills", "Sore arm", "muscle aches", "headache behind my eyes", "fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: 30155BA, Location of injection: Arm Left), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "fever"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "chills"; HEADACHE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "headache"; NAUSEA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "nausea"; DIZZINESS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "dizziness"; FATIGUE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, nausea, dizziness, fatigue, pain in extremity.  Additional information: It was reported that the patient had fever, chills, sore arm, headache, nausea, dizziness, extreme fatigue (7days). Patient received COVID-19 vaccine at Public Health Clinic/ facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
64 year old female pt present today due to a bad reaction to the covid 19 vaccination. Pt stated that she got the first shot on 03/17/2021 moderna and has developed ongoing  chills ,lost all her energy, denies fever, some headache , some nausea, middle of the night has severe chills and temperature 96 but boiling skin temperature.  Patient states she is very active and not used to feeling like car ran her over and it is not getting better ; approx  2 days ago chills have decreased on episode and length of it but severe limb fatigue.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant products were not reported.  It was reported that primary reporter did not have the lot number information, because the packing was discarded. The causality for Humira was reported as not related.  Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 52-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after a dose of mRNA-1273 COVID-19 vaccine, dose number unknown. On an unknown date, COVID-19 TEST was positive. There is no available information regarding clinical course and treatment medication. Outcome of COVID-19 was reported as not recovered. Use of non-company co-suspect drug Humira was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after a dose of mRNA-1273 COVID-19 vaccine, dose number unknown. On an unknown date, COVID-19 TEST was positive. There is no available information regarding clinical course and treatment medication. Outcome of COVID-19 was reported as not recovered. Use of non-company co-suspect drug Humira was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Administered vaccine after 12 hrs of 1st puncture of vial; Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Administered vaccine after 12 hrs of 1st puncture of vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) and PRODUCT STORAGE ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant Products use was not provided by the reporter. Action taken for the suspect drug mRNA-1273 for the events is not applicable.
Red and swollen on left upper arm at injection site. Both arms reddened and itching. Itching on arms, head and trunk of body. Throat felt funny and scratchy. Took Benadryl 50 mg po with good results at home. (Both arms looked sun burned, red and blotchy).
Returned to office 1 hour after vaccine, with complaint of facial swelling and tongue swelling, face neck upper chest both ears red and warm patient had difficulty talking  At 2:59 pm Patient given Benadryl 12.5mg/5ml -12.5ml & Epi Pen @ 3:02 pm given albuterol inhalation solution 1ml with 2 ml saline @ 3:12 pm Prednisolone 15ml was given@ 3:16 pm Benadryl 12.5ml given.
she had covid-19 vaccine 1st then tired; This is a spontaneous report received from a contactable consumer (patient) based on the information received by Pfizer for BNT162B2. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she had covid-19 vaccine 1st then tired on an unspecified date with outcome of unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I am in so much pain, with aches and joints/ Every joint is killing me.; My legs are throbbing; I am in so much pain, with aches and joints/ Every joint is killing me.; My back, I can't get comfortable; The arm that I got the shot is so sore; The arm that I got the shot is so sore; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported, Age at vaccination: 51-year-old) via an unspecified route of administration in left arm on 11Mar2021 01:00 PM as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was included overweight, borderline diabetic. Concomitant medications included Clodian, omeprazole, venlafaxine. Historical vaccine included bnt162b2 via an unspecified route of administration in left arm on 19Feb2021 as Dose 1, SINGLE for COVID-19 immunization. On 12Mar2021 02:00 AM, patient experienced i am in so much pain, with aches and joints/ Every joint is killing me (joint pain and pain), my legs are throbbing, my back, I can't get comfortable, the arm that I got the shot is so sore (vaccination site pain and pain in arm). Facility type vaccine was workplace clinic. Treatment was received for the adverse event as Aleve. No covid prior vaccination. Covid was not tested post vaccination. No known allergies. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Expired Moderna vaccine administered to patient; Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and was stored in refrigerator on 05 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 01 Dec 2021 Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue. No treatment drug information was reported.   This case was linked to MOD-2022-538614, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538688, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-537580, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701 (Patient Link).
I was asked to prep the covid 6mo- 4yr bivalent for a patient coming in at 950am.  i prepped the 5-11yr bivalent instead of the 6mo-4yr, it was labeled with its corresponding colors (we use a color based system)  This child was administered a 5-11yr bivalent vs the 6mo- 4yr bivalent
Spots started to be itchy and now they are spreading to the wrists; Patient started seeing red spots on his both hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Patient started seeing red spots on his both hands) and PRURITUS (Spots started to be itchy and now they are spreading to the wrists) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced RASH MACULAR (Patient started seeing red spots on his both hands). On 16-Mar-2021, the patient experienced PRURITUS (Spots started to be itchy and now they are spreading to the wrists). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Patient started seeing red spots on his both hands) and PRURITUS (Spots started to be itchy and now they are spreading to the wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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, a causal relationship cannot be excluded.
Patient became light headed and fainted after immunization. EMS evaluated the patient and he no further complaints. He did not experience any other episodes of syncope and reported no other side effects at the time and at 3 hour follow up.
She complained of arm and shoulder pain and stiffness on day vaccine was given. The following morning she woke up with chills, fever (101.9), and joint pain and stiffness which worsened throughout the day. She took Excedrin and Motrin which relieved some of the pain and fever. She took Nyquil at bedtime. On day 2 she continued to have fever(100.9) and body ache but the joint pain and stiffness was improved. On day 3 the fever subsided.
This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. the patients were vaccinated with ZOSTAVAX (lot number unknown) and experienced injection site reactions with reactions affecting the whole arm which subsided in about 5 days at an unspecified time. Pharmacist stated that he reported this a number of years ago to VAERS. Additional information is not expected.
arm that ached several days/ Arm being little sore; neck pain; low grade fever; chills; fatigue; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date, it was good). Concurrent medical conditions included immunocompromised (the patient had low immune system).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, neck pain, low grade fever, chills and fatigue. On an unknown date, the outcome of the pain in arm, neck pain, low grade fever, chills and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, neck pain, low grade fever, chills and fatigue to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient said his/her insurance paid for both 100 percents. His/her first injection was all good.  The patient received second injection was arm that ached for several days and into his/her neck on that side.  The patient had low grade fever and chills and fatigue but not bad enough to keep from working.  Besides the arm being a little sore. All symptoms were gone within 36 hours including the neck pain.  The patient was low immune system and his/her doctor recommended it.  The patient was said glad did it.  The patient said had several patients with shingles and they were in so much pain. Additional supportive information: Follow up would not possible, as no contact details were available.
Fatigue; Chills; Throbbing headache; Muscle aches; Nausea; Inappetence; Unable to work and do normal daily; This is a spontaneous report from a contactable consumer. A 45-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 16Feb2021 10:45 (at 45-years age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in left arm on 26Jan2021 10:30 AM (at 45-years age) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); atorvastatin (LIPITOR [ATORVASTATIN]); fish oil (FISH OIL); meloxicam (MELOXICAM). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced fatigue, chills, throbbing headache, muscle aches, nausea, inappetence, unable to work and do normal daily activities on 17Feb2021 10:00. Patient not tested for COVID-19 after the vaccination.  No treatment received for reported adverse event. The outcome of the events was resolving.  Follow-up (04Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Apologies for the typo. patient became aware of my clinical signs on 17Feb2021.
Joints ache/more soreness with weather change; Arm sore with fourth Moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine) and ARTHRALGIA (Joints ache/more soreness with weather change) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis).   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2022, the patient experienced VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine). On an unknown date, the patient experienced ARTHRALGIA (Joints ache/more soreness with weather change). In 2022, VACCINATION SITE PAIN (Arm sore with fourth Moderna covid 19 vaccine) had resolved. At the time of the report, ARTHRALGIA (Joints ache/more soreness with weather change) had not resolved.            Concomitant medications were not reported. Patient received Dose 1 and Dose 2 of vaccine on unspecified dates (Intramuscular). Patient received Dose 3/booster of Moderna COVID-19 vaccine on 2022 (Intramuscular). It was unknown if patient was enrolled in covid-19-vaccine trial. The reporter's causality for the event(s) of arm sore with fourth Moderna COVID-19 vaccine and joints ache/more soreness with weather change with Adalimumab Solution for Injection was No Reasonable Possibility                       No treatment information was provided by the reporter.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 025B21A and 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications include anti-rejection medication for dermatomyositis called Cellcept No treatment reported.   This case was linked to MOD-2021-310491, MOD-2021-310516 (Patient Link).
8.5 cm x 7 cm Erythema with 5.5 cm x 5 cm induration to the right thigh.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions). At the time of the report, HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter.