chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to touch; her arm started to get swollen; A spontaneous report was received from a consumer (United States) concerning a 61-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced her arm started to get swollen and was warm to touch.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately ten days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient's husband reported that she received her Moderna vaccine on 28-Dec-2020.  He stated that on day 10, 07-Jan-2021, her arm started to swell and was warm to the touch. He wished to know if that was normal.    There was no treatment for the event per report.  Action taken with mRNA-1273 in response to the events, her arm started to get swollen and was warm to touch, was not provided.   The outcome of the events, her arm started to get swollen and was warm to touch, was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Awoke with joint pain in knees lasting through the night. Unable to work the next day and eventually subsided.
This spontaneous report as received from a healthcare worker refers to a 12 year old female patient with no pertinent medical history or drug reactions/allergies. On 15-APR-2013 the patient was vaccinated with first dose of GARDASIL (lot number reported as H01555, expire date: 13-APR-2015). Concomitant therapies included HAVRIX on 15-APR-2013. On 15-APR-2013, the patient experienced fainted in the office after the vaccine was administered. The healthcare worker reported the patient did not hit the ground, however she presented in the office 2 days later with a swollen and bruised wrist and hand. The healthcare worker stated the patient reported that her hand felt very weak. The healthcare worker stated "the patient did not eat much prior to her appointment". At the time of the report, the patient was not recovered from the events. The causality was not provided. H01555 is not a valid lot number for GARDASIL. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months from the date of reporting, refer case US2018GSK194788). On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the sweating, general body pain, influenza like illness, shivering and hallucination were recovered/resolved and the outcome of the exhaustion was recovering/resolving and the outcome of the feeling bad, neck pain and lacrimation were unknown. It was unknown if the reporter considered the pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation to be related to SHINGRIX. Additional details were reported as follows: The patient's arm hurt right after the injection. By 11 PM in the evening of vaccination day, the patient was almost in tears because she felt so bad. The patient was shivering so much her teeth were chattering, she had neck pain, body pain and was almost hallucinating. The patient sweated the symptoms out overnight and was felt a lot better the day of reporting, thought the patient was still wiped out. The patient provided details of physician.
HAD LOSS OF 80 PERCENT RANGE OF MOTION; AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's.    No Medical History information was reported.   In April 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 week. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM). At the time of the report, JOINT RANGE OF MOTION DECREASED (HAD LOSS OF 80 PERCENT RANGE OF MOTION) and PAIN IN EXTREMITY (AFTER COVID VACCINE RECEIVED EXPERIENCED PAIN IN SORE ARM) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Joint range of motion measurement: Loss of 80 percent range of motion.. On 01-Jun-2022, Blood triglycerides: Elevated triglyceride level was 317.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Patient received moderna third dose as a booster dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events with HUMIRA (ADALIMUMAB) was reported as not related.   Treatment information was not provided by the reporter.
On 10/11/2018 at 5:48PM, Mr. and Mrs. contacted the pharmacy via telephone stating that Mr. had a reaction on his left arm after getting his vaccination. Mrs. stated that Mr.'s pain and irritation began early 10/11/18, but did not recall the exact time. Mr. stated that his left arm, where the PNEUMOVAX 23 vaccine was given, was a bright pink color from his shoulder down to his elbow. He stated that his arm was hot in one spot where the shot was injected. Mrs. stated that Mr. has never had a reaction to an influenza vaccination. The influenza vaccination was given on the right arm, which is doing well. The immunizer advised the patient to make sure he kept both arms mobilized to prevent any arm pain that may be resulted from the vaccine. Mrs. stated that Mr. had not moved his arm since getting both vaccines due to him staying the sofa to watch television for an extended period of time, and only the left arm had became irritated. Mr. received both vaccines on 10/10/18 and the irritation from the PNEUMOVAX began the next day. The immunizer advised giving Mr. BENADRYL.
Approx 2-5 minutes after receiving vaccines patient passed out while getting dressed. There was no witness to the event. Patient lost consciousness and fell from the seated position hitting head in 3 places. Blood pressure had dropped. Patient had a short episode of tremors during the recovery phase. Patient was allowed to rest and rehydrate until blood pressure returned to normal (100/80) 30 minutes later.
Myalgia, fever, nausea, vomiting, diarrhoea, extreme fatigue, insomnia, loss of appetite. Duration: 7 days Odanestron prescribed for nausea, paracetamol recommended for pain,
On 4/10/18 patient received three vaccines in our pharmacy. In her right arm (lower) she received HAVRIX (NDC 58160-0826-43), and upper she got SHINGRIX (NDC 58160-0829-03). In her left arm she got ADACEL (NDC 49281-0400-88). On Friday 4/13/18 patient called and spoke with pharmacist. She was complaining that her right arm is raised and swollen since receiving the vaccines on 4/10/18. Our pharmacists told her that these types of skin reactions are normal as part of the vaccination process. He recommended she try OTC TYLENOL and it should go away within a few days. Patient was satisfied with this information.
Moderna COVID-19 Vaccine EUA swelling arm, aching joints, muscle aches, fever, rolling headaches, terrible fatigue, no appetite, couldn't do anything except lie in bed
Patient fainted, was brought to emergency room due to severe hypotension but has since been released and is fully recovered per patient's mother.
pt rpt moderate systemic react; dizziness;lightheadedness;disturbed vision;pruritic;erythematous wheals devel entire body;most sx resolved w/DPH;still has some discoloration areas;lump inj site;allerg react to vax;urticaria;
Temp 102, chills LL NIGHT, BODY ACHES, Headache
Patient developed cellulitus in left upper arm at the site of the sub-Q injection after having varicella booster.
About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body aches, head ache, and eyes hurt. This is a similar reaction to what I have with the flu vaccine. I no longer get the flu vaccine because of this.
myocarditis; This is a spontaneous report from a contactable physician (pediatrician).  A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported ) via an unspecified route of administration on 18May2021 (at 14 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The pediatrician reported that the patient had a mild case of myocarditis on an unspecified date in 2021, was not hospitalized for it; event lasted 2 days and patient recovered fine from it on an unknown date in 2021.  Patient mother was concerned about him getting second dose, but wanted him to for school.  Physician wanted to know if there were additional recommendations for getting the second dose.  In addition to myocarditis, patient was also greater than 42 days past the date of the first dose. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and myocarditis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Received an expired vaccine dose; A spontaneous report was received from a Consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received an expired vaccine dose.  The patient had no adverse event in the medical history. No relevant concomitant medications were reported.  On 13 Feb, 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient was acknowledged by her neighbor that her neighbor received expired vaccine dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, received an expired vaccine dose, was resolved on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 043L20A)  with no associated AEs reported.
Next day injection sight red, itchy, bumpy, hot to touch. Used cortizone then went to PA. Antibiotic given, using BENADRYL.
Dizziness, near syncope, nausea, headache, lightheadedness, neck pain, fatigue, malaise
there were a few cases with the moderna vaccine with bell´s palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (there were a few cases with the moderna vaccine with bell´s palsy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. Treatment medication not 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 event, a causal relationship cannot be excluded. However, Further information is requested.
After the vaccine everything was fine. Taking precautions. On January, I was exposed to my grandson, at Christmas time, he got sick, my daughter took it for urgent care, and then she was negative. We were going north to my daughter's place, my daughter on Dec 31st she tested positive. I went home on Jan 1st and on Jan 2nd, I woke with fever (102.1), I called my primary doctor and she transferred to the COVID clinic unit, and because of my medications and did give me PAXLOVID, they gave me another similar medication. I remain sick, after my days of medication, I called my doctor (Jan 11) because I had a shortness of breath, they gave me steroids and the last dose was on Jan 16th.
Strep throat; This is a spontaneous report received from a Pfizer Program. A contactable consumer or other non hcp (parent) reported. A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 (Age at vaccination was 17 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On unspecified date in 2021 the reporter said that her children received the 1st dose of the vaccine and they are scheduled to get the 2nd dose on 05May2021, however, they developed strep throat. She would like to know if they can still go and get the 2nd dose as scheduled. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Vaccine administered at annual mass influenza clinic setting. Patient notified HD on 12/16/2008 that he received flu vaccine and has had sore Left arm. Arm was a little sore prior to vaccination date, was a little more sore for a few days after the vaccine, but when the increased soreness did not abate, patient noticed. Reports decreased ROM: can assist left with right to reach full ROM. Mentioned to occasional provider, but has not informed "regular MD". Reports no problems with prior influenza vaccine. Education to notify HCP re evaluation.
Skin 6 x 9 1/2 cm mild erythematous warm area (L) arm around site of injection. Left axilla no lymph nodes palpated but axilla entire area increased tissue area swollen, nontender. Axilla swelling, erythema resolved by 7/15/13.
Everything was fine after vaccine; I had no reaction. On Feb 10, I had a COVID-19 home test and it was positive, I had high fever, body ache, cough, the day after the test I called the doctor, he prescribed Paxlovid, and he said I had to suspend certain medications because conflict with Paxlovid.
Bell's Palsy; Tongue started tingling; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy and tongue started tingling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, within two days after injection, the patient's tongue started tingling.  On 23 Jan 2021, the patient spent 18 hours in the emergency room. Two MRIs (magnetic resonance imaging) and bloodwork were conducted, they confirmed the patient had Bell's Palsy on the left side of the face.  On 27 Jan 2021, the patient's tongue began tingling again and had not resolved at the time of reporting. Treatment for the events was not provided.  Action taken the second dose of mRNA-1273 in response to the events was not reported.  The event, tongue started tingling, was reported as not resolved. The outcome for the event, Bell's Palsy, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
I got my first dose of the vaccine on the advice of my Rheumatologist. I have not been able to see him yet. Two days after the first dose my left arm was really bothering me. My arm was red below the injection site and it was hot, raised up and painful. I couldn?t sleep on that side. I was very tired that week. I used antibiotic ointment and alcohol pads with a cold washcloth. I went back to the pharmacy. It looks better now after eight days. It is a little splotchy now, but the pain has gone down. I have also had more joint pain since I got the vaccine but that may be because I have not had any Embrel for two weeks. It feels like my Rheumatoid Arthritis is flared up.
Injection site soreness, early the next morning had intense flu-like symptoms. Can't stay still, legs cramping, muscle spasms, hard breathing, stuffed nose, chills/extreme heat with body
Full body w/Torso Anterior & Posterior focus - raised, red, rash, mildly itchy.  NO blistering.  This rash is lingering still.  I have worked diligently to rule out causes and the vaccine is the only thing left that I can think of that may be causing the rash.  The rash is not on my face, hands or feet, is on my arms, legs, and torso.  ALSO after the second vaccine within the first 24 hours, I had an acute chest pain reaction, it felt like I imagine a directing aneurysm or heart attack would feel like.  It woke me up it was so bad.  It resolved on it's own and there have been no additional symptoms.  No prior symptoms have been experienced along either of these lines before.
he was in hospital at the intensive care for 3 weeks and he is still ill; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Mar2021 (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 wants to cancel his 2nd dose appointment because was hospitalized and stayed 3 weeks in intensive care. Cannot take the 2nd shot because still ill. The patient was hospitalized for the event for 21 days. The outcome of the event was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021421729 similar report from same reporter
Sore arm near and around injection site. almost immediately after shot. Paint went away after about 36 hours later.  Sever diarrhea starting about 2 hours after Injection, lasting about 36 hours.  Back and shoulder aches and pains,  still in pain 36+ hours after injection. Chills, sensation of cold but skin is warm, no fever. Lasted about 24 hours after injection.
Undergoing treatment for Vertigo.  Mezlicline prescribed.  MRI to be scheduled.
fever, h/a, diarrhea w/in 24hr p/vax;went on & devel chest congestion;
Initial slight arm soreness and redness at injection sight.  Disappeared with 3 days.  On eighth day following injection, red patch about 2? in diameter appeared around injection sight with slight swelling and slight itching. Redness and welling disappeared within 3 days.  Slight itching occurs occasionally.
6 hours of vomiting, headache, numbness & pain in my hand ( to the point I was unable to hold my coffee cup) which in hours radiating up my arm, to shoulder,  and slowly down my back. Pain and numbness slowly after 48 to 72 hours dissipated.  I was extremely tired / exhausted.   I still have extreme fatigue and the headaches have not stopped. I?ve reached out to my primary physician and not heard back. After my first Moderna shot, I did NOT take the second.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had the shingles 6 times since 2011 in 6 different places). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blood immunoglobulin g decreased. The patient was treated with intravenous fluid (nos) (Infusion). On an unknown date, the outcome of the vaccination failure, shingles and blood immunoglobulin g decreased were unknown. It was unknown if the reporter considered the vaccination failure, shingles and blood immunoglobulin g decreased to be related to Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had vaccine yearly and had the shingles 6 times since 2011 in 6 different places. The doctor had confirmed every time and given him/her medicine three times daily for 7 days, now he/she took a low dose of the shingles medication daily for a year to see if it would prevent them. The patient had low IGG (immunoglobulin G) and had 5-hour infusions monthly. The follow up would not be possible as no contact information was available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Started having vaginal bleeding 4 days after getting vaccine. Scheduled to see an genecologist.
On 6/25/18, 4 yo ordered was for vaccinations at his well child visit. CMA pulled the VARIVAX vaccine from the freezer from a box of VARIVAX vials, whose box indicated were not expired. CMA prepared and administered varicella vaccine (VARIVAX) without double checking the expiration date on the vial itself. The VARIVAX vaccine had expired 6/7/18. Investigated the remaining VARIVAX vaccines, and all the remaining vials' expiration dates matched that of the expiration date noted on the box that housed the VARIVAX vaccines - and all of which were not expired. Patient did not have any side effects noted at the time.
I had severe pain in the entire both legs and pain in the trochanteric bursa at 4:00 AM with a fever.  It resolved quickly with over-the-counter naproxen 440 mg
Oral ulcer of unknown etiology occurring within 10 days of ROTATEQ, however also a/w fever. Pt referred to local pediatric emergency dept due to associated fever and elevated WBC. Pt made full recovery. Oral ulcer resolved without obvious sequelae.