chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme pain in legs, hamstrings, shoulders and hands; extreme pain in legs, hamstrings, shoulders and hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031M02A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) (seriousness criterion hospitalization) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) (seriousness criterion hospitalization). The patient was hospitalized from 06-May-2021 to 09-May-2021 due to ARTHRALGIA and PAIN IN EXTREMITY. The patient was treated with PREDNISONE on 06-May-2021 for Adverse event, at an unspecified dose and frequency; GABAPENTIN on 26-May-2021 for Adverse event, at an unspecified dose and frequency and MELOXICAM on 26-May-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) had not resolved.            No relevant concomitant medications were provided.  On 06 May 2021, patient underwent X-rays, magnetic resonance imaging (MRI) and blood work but results were not provided. He was hooked up to intravenous steroids for 3 days in hospital. On 24 May 2021, patient went to PA due to severe pain in both hands and was given a steroid shot. On 26 May 2021, he went to neurology due to severe pain in both hands.  Company Comment: 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.; 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.
p/vax that evening pt c/o T100 & muscle ache/joint pain in hands, joint pain lasted approx 2wk;
Woke up with nausea. Dizziness and vertigo upon rising. No other symptoms.
The arm muscle that received the shot became quite sore overnight, and lasted throughout the next day.  The rest of me felt like I had a mild case of the flu.  Aches and fatigue all over, with some chills.   I have been training for a half marathon, and this through off my training due to knee pain.    I also had diarrhea that has lasted through Saturday.   The first day after was the worst, and things have improved each day since.
No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-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. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.).    Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case belong to 4 th patient  out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master Case ( Patient 4 )
Tinnitus; The initial safety information received was reporting only a non-serious adverse drug reaction, upon receipt of follow-up information on 13Aug2021, this case now contains a serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm (also reported as 'left upper arm) on 03Mar2021 at 12:00 (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. Medical history included high BP from an unknown date, ongoing Lichen sclerosis from 1987, cholesterol (as reported) from an unknown date, Differentiated VIN- 3 from 01Jan2017 to 20Jan2018 (wide excision vulva), hormone replacement from an unknown date and herpes from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient has not been tested for COVID-19 prior to vaccination. Concomitant medications included atorvastatin (manufacturer unknown) taken for cholesterol abnormal from 2009 and ongoing; metoprolol (manufacturer unknown) taken for blood pressure from 2009 and ongoing; zolpidem (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; estradiol (manufacturer unknown) taken for hormone replacement from 2016 and ongoing; aciclovir (manufacturer unknown) taken for herpes from 2009 and ongoing and clobetasol (manufacturer unknown) taken for lichen sclerosis from 2000 and ongoing.  The patient previously received simvastatin and experienced deep muscular pain and topical Retin A and experienced allergy. The patient previously received the first dose of BNT162B2 on 08Feb2021 at 03:00 (lot number: EL9269) in the left upper arm for COVID-19 immunization. The patient experienced sudden onset of tinnitus on 05Mar2021 at 08:00. The event required a visit to the Physician's office and did not receive treatment for the event. The outcome of the event was not recovered. The event was considered as serious (important medical event).
Almost immediately felt flushy  and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.
Given PEDIARIX, MMR, Chickenpox, PCV7.  Inappropriately wrong sister, wrong age appropriate vaccine.  9/15/09 Called mom, states no unusual reaction.  No temp.  No redness, hardness at site.
He notes acute onset of right antecubital supervicial thrombophlebits 4 days after his second Moderna Covid vaccine. He has not previous SVT/DVT history and no Family History of SVT/DVT.
Apr 11, I felt dizzy, then you felt tired and a headache. I tested positive for three home tests. I called the doctor on Apr 12. I was fine in one week.
Rash on chest. Swollen lymph nodes. Swollen lymp nodes particularly worse on injection side and still persistent. Periods of hot and cold chills
Generalized rash; "some blisters" throughout; This case was reported by a nurse via call center representative and described the occurrence of rash in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2021, the patient received the 1st dose of SHINGRIX. On 6th October 2021, 1 days after receiving SHINGRIX, the patient experienced rash and blister. On 20th October 2021, the outcome of the rash and blister were recovered/resolved. It was unknown if the reporter considered the rash and blister to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX and next day experienced generalized rash on both arms. The patient described some blisters throughout. The patient was not evaluated by a health care professional for the reaction at the time and was back on the office for dose two. The nurse wanted to know if it was safe for her to get the second dose after this reaction. The reporter was provided medical advise disclaimer and was provided information on adverse event reports on clinical trials per (package insert) PI. HCP requested more information, provided warm transfer to (medical information) MI for further assistance. Consent to follow up was denied.
the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as "either 22Jan2021 or 23Jan202"), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event "dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side" was not recovered; "the room was spinning/whole room was spinning" was recovered on 26Jan2021 (reported as "went away after a few seconds"); and "her scalp was itching and her back and stomach was itching" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021).  Information on lot/batch number has been requested.
For 48 hours after the vaccine I had very pronounced flu like symptoms; chills, fever, body ache, headache, diarrhea.  After the flu like symptoms went away and a few days passed I developed a headache right side of head only with intermittent piercing pain above my right ear this headache lasted about three days.  I do not suffer with headaches except when sick. I then developed joint stiffness and pain that continued to get worse during March - April.  My knees were the most affected, but my hips, shoulders and jaw/ mandibular joint were affected.  I reached a point where it was difficult to walk.  I then began to improve but the knee pain was persistent so I got some physical therapy.  The therapy made small improvement but the knee pain is persistent and is still present in December.
Fainted the morning following the vaccine.  Weakness followed.  The feeling of being so weak that I would eat yet I wouldn't gain any energy back.  Tried to hydrate and eat nutritious food for the first few days.  However, strange feeling of being lightheaded, dizzy, wobbly on my feet, almost feeling faint, continued for a full 2+ weeks after the 2nd vaccine on May 15th.. I went to the ER on May 22nd since that was 1 week past the vaccine and I wasn't feeling any better.  I was getting nervous.  I had this "out of body" feeling, like the pressure in my head wasn't right.  I had blood work and was recommended to see a cardiologist.  I wore a heart monitor for 2 weeks, all while my symptoms started to slowly improve.  I feel mostly completely recovered now.
Regained total feeling of lip and chin (L); Diminished Taste; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine and regained sensation in lower lip and chin and diminished taste.   The patient's medical history included cancer, Meniere, tinnitus and vertigo. No relevant concomitant medications were reported.   On 15-Feb-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:023M20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 15-Feb-2021, after injection, patient experienced symptoms included regaining sensation in the lower lip and chin and diminished taste. Patient mentioned about previous history of cancer and chemotherapy treatment had affected lip nerve. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event, regained sensation in lower lip and chin and diminished taste were considered unknown.; Reporter's Comments: This case concerns a 76-year-old male with PMH of cancer, Meniere, tinnitus, vertigo, who had NS unexpected events of "regaining sensation in the lower lip and diminished taste". Events occurred 2 days after first dose of mRNA-1273. Very limited information on the events has been provided at this time. Further information requested. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
our refrigerator was not up to standard for vaccine storage; have already given all the doses and did not know at the time; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time). At the time of the report, PRODUCT STORAGE ERROR (our refrigerator was not up to standard for vaccine storage) and EXPIRED PRODUCT ADMINISTERED (have already given all the doses and did not know at the time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
soreness in my right arm - I could not lift up my arm Back-right shoulder blade muscle Under arm was sore Severe headache Pain my right breast Inflamed lymph's node Numbness in my arm Corded veins the right arm  Bed restrictions since 04/2021
I had a rash about the size of a baseball at the injection site. It was noticed 8 days after the injection but I am not sure if it had been present prior to that.  Just redness. No swelling or pain with it. By the evening of 1/9/2021 it had disappeared.
Rednesss and swelling like a local reaction to a vaccine; Rednesss and swelling like a local reaction to a vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine). At the time of the report, VACCINATION SITE SWELLING (Rednesss and swelling like a local reaction to a vaccine) and VACCINATION SITE ERYTHEMA (Rednesss and swelling like a local reaction to a vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  No treatment information was provided.; 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.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug were reported.  No concomitant medication were reported.  The vaccines was stored in freezer, then one to two vials were took out and placed in fridge each day as needed.  Patient was given expired booster Moderna vaccine.
No adverse effects reported.; TE with PROQUAD.; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.   On 03-AUG-2023, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 milliliters (ml) (route of administration and anatomical site of vaccination were not reported; lot number W023865 has been verified to be valid, expiration date reported and established as 29-OCT-2023) for prophylaxis (product storage error).  No adverse effects were reported (no adverse event).
I had eye pain and drainage, body aches, abdominal pain, headache and joint pain.
Rectal bleeding; Anal incontinence; Vaccination site pain; This is a non-interventional solicited report based on information received by Pfizer from Regulatory Authority (Mfr Control no.: 21K-163-4053241-00) from contactable physician and a non-contactable consumer reported for a 65-Year-Old female patient.   A 65-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 11May2021 as dose 2, single (age at vaccination: 65 years) for COVID-19 immunisation; adalimumab (HUMIRA Solution for injection Lot number was not reported) via subcutaneously from an unspecified date to an unspecified date for colitis ulcerative. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly on 16Apr2021 as dose 1, single for COVID-19 immunisation. On an unspecified date 2021, the patient experienced anal incontinence, rectal bleeding, vaccination site pain. It was reported that the patient had leakage and bleeding out the rectum and pain in the arm after covid vaccine with humira. It was unknown if patient was enrolled in a covid-19 vaccine trial. The clinical outcome of the events was not resolved. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of leakage and bleeding out the rectum unknown onset, leakage and bleeding out the rectum unknown onset and pain in the arm after covid vaccine with humira (adalimumab) was no reasonable possibility. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) (TOZINAMERAN), UNKNOWN, UNKNOWN Daily Dose: The reporters causality for the events anal incontinence, rectal bleeding, vaccination site pain was not related.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available in the case , the association between reported Event rectal bleeding is unrelated to the suspect drug. The contribution of patient's age cannot be completely ruled out in the occurrence of the events.    The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.