chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body pain; Headache; Fever; Chills; Mild nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included pain (patient had severe pain from other medical conditions).  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Body pain), headache (Verbatim: Headache), fever (Verbatim: Fever), chills (Verbatim: Chills) and nausea (Verbatim: Mild nausea). The patient was treated with paracetamol (Tylenol) and mylanta (nos) (Mylanta). The outcome of the general body pain and headache were resolved and the outcome of the fever, chills and nausea were not reported.  It was unknown if the reporter considered the general body pain, headache, fever, chills and nausea to be related to Shingles vaccine.  It was unknown if the company considered the general body pain, headache, fever, chills and nausea to be related to Shingles vaccine.  Additional Information: GSK receipt date 31-MAR-2023 This case was reported by the patient via interactive digital media.  He/She was under the weather for a few days and had body pain, headaches.  The reporter stated that, he/she would rather be uncomfortable for a few days, than have shingles.  He/she had experienced more severe pain from other medical conditions and would get the 2nd shot in 4 months.  The reporter had stated that, yes, as a matter of fact he/she did get fever and chills and mild nausea and had taken some Tylenol and Mylanta. The reporter had asked that, just do it and get it behind you.  Follow-up would not possible as no contact details were available.
10/23/2006 10am pt called informed about nausea, vomiting. Slightly fever, diarrhea, black stool, started dose of Typhoid 10/20/06, get worse with 3rd dose and stopped with Pepto Bismol but still feels little weak. Suggest discontinued to take 4th dose and see PMD if get worse and reported to us.
Within 2 hours, the injection site was very sore. The pain was on the upper back on the left side. Then it was in the left shoulder blade. Felt tired, went to bed early and woke up next morning with soreness and limping in the left leg. Had problems walking and afraid of falling because of the pain. Went to urgent care, the doctor looked at it to find the soreness. Continued to be sored. Best way to treat it is to stay off of it and take Naproxen. Took Naproxen. Keep taking it as along as there was soreness. Feeling ok now.
The pt experienced pain and swelling of arm on the same day as vax. The next day the pt experienced increased pain and swelling, Redness began to occur and extended down to the elbow.
temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient; moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient) and PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 11:32 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021 at 3:30 PM, the patient experienced PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins). On 14-Oct-2021 at 11:32 AM, the patient experienced PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient). On 06-Oct-2021 at 4:50 PM, PRODUCT STORAGE ERROR (moderna vial in refrigerator was discovered that refrigerator door was ajar and temperature logger was out of range at 10C for 1 hour 20 mins) had resolved. On 14-Oct-2021 at 11:32 AM, PRODUCT ADMINISTRATION ERROR (temperature logger was out of range at 10C for 1 hour 20 mins and returned to normal and 6 vials of this moderna was administered to patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported. The temperature logger was out of range at 10C for 1 hour 20 mins and Door was closed immediately and temperature returned to normal.  No side effects reported to patient.
Information has been received from a medical assistant concerning a 13 month old male patient with no pertinent medical history or drug reactions/allergies who on 12-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 661555/1175Z, expiry date 10-FEB-2012) subcutaneously in the right arm. There was no concomitant medication. On 02-FEB-2011 the patient began to have a fever and loss of appetite. The patient reported to the physician's office on 04-FEB-2011 with a fever of 101.5F. The physician noted "anterior cervical lymph nodes" on the neck were swollen. Also, he noted "4 red popular lesions on the back and that one was vesicular." There were no lab diagnostics studies performed. The patient was treated with TYLENOL. At the time of report the patient's status was not recovered. Additional information has been requested.
Post vax, the pt developed leg swelling with erythema around site (1/2 diameter of thigh). Pt was treated with Motrin and Prelone.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. There was no information about patient's concomitant medications or pertinent medical history. On 21-NOV-2017, the patient was vaccinated with a dose of ROTATEQ orally,  lot # M006112, expiration date 16-NOV-2017 (strength and dose were not reported) for prophylaxis.  The nurse stated that the expired vaccine did not have any temperature excursions prior to administration. No adverse symptoms were reported.
COVID Vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (COVID Vaccine while pregnant) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (COVID Vaccine while pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (COVID Vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medication was not reported. No treatment medication was reported.
2nd dose a year after his first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Shingrix 1 year after received 1st dose of Shingrix, which led to lengthening of vaccination schedule. The reporter asked if the patient should get a 3rd dose 2 to 6 months after 2nd dose.
I am a 38 year old female with a Mirena IUD. Prior to receiving my first covid vaccine, I did not get my period due to my IUD. Following the first covid vaccine, I started getting my period again. It came at somewhat irregular intervals, lasted for around a week or longer, and had accompanying symptoms of cramps and headaches. The intensity of my period has increased with each subsequent vaccine and over time. I received my booster on 10/12/21 and the periods I have had since have been the heaviest flow I have ever had, including clots and massive release of blood at once. Cramping pain has been high and duration long as well.
A pharmacist reported via a nurse that a patient received an injection of Flu Shield (2001-2002 Formula). Subsequently, the patient experienced throat constriction, flushing, and sweating. The patient also developed an injection site reaction characterized by "extreme" pain and bruising. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that "several" patients experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
No adverse symptoms from the shots given on 1/28/03.  However patient died from probable SIDS while @ daycare.  County investigating.
Reported being light headed exit monitor walking client to the cot. Client fainted assisted to the floor.  Client quickly came responsive and  was assisted to get in wheelchair.  Taken to a private monitoring room.  b/p 118/50  PSO2 100%  pulse 84.  Respirations even and unlabored. Skin pink warm and dry.    3:53 Given water and a snack.  Stated she felt 80% better.  3:57 stated she  was ready to go, no further symptoms.  informed to seek medical attention with any further problems.
swelling @ inj site immed p/needle withdrawn;diameter approx 50mm, raised approx 20mm;ice applied immed thereafter area reddened & unable to determine if site warm;no s/s systemic or local allergic rxn;swelling to be hematoma;
Itching, broke out, swelling at site. TYLENOL at home. Steroids given at ER. (Prednisone, BENADRYL, PEPCID in ER)
Had a small rash on arm for a couple of days after the vaccine but now I am having severe allergic reactions to mosquito bites.   Eyes swell shut if bitten on face, large (4 inches on top and bottom, 3 inches on sides) red raised bumps if on body.  I have never had reactions like this pre-vaccine.
Redness on neck; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and lymph node excision (Left side lymph node removed).   On 19th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 20th August 2019, the patient experienced red neck. On 20th August 2019, the outcome of the injection site pain was recovered/resolved. On 22nd August 2019, the outcome of the red neck was recovered/resolved.   It was unknown if the reporter considered the injection site pain and red neck to be related to Shingrix.  Additional Deatils were provided as follows: The patient received dose of Shingrix in the right arm. The patient palnned to follow up with physician on an unknown date. The reporter consented to follow up.
Patient indicated mild tingling of the lips during her first 15 minutes wait after the Covid vaccine. She said on a scale of 1 to 10 with 10 being the most severe , her lip tingling was a 2. I stayed with her and kept monitoring her and continued to communicate with her. I informed her that she will have to stay for another 15 minutes due to the tingling of her lips. She consented to stay. A few minutes later, she stated that her throat felt as if it was closing. I informed her that due to her symptoms i will have to administer Epipen with her consent. She consented to the use of Epipen Auto injection. I asked the technician to call 911 immediately while I administered Epipen Auto Injection 0.3mg/0.3ml. The EMS team arrived a few minutes after that and took her via ambulance to the hospital. I called her today 4/4/21 and she said she felt much butter and was fine. She said she did not receive any treatment while at the hospital and was discharged on the same day 4/3/21
Information has been received from a nurse practitioner concerning a male patient who in December 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included MEDROL DOSEPAK. On approximately 05-JAN-2009, "one week ago", the patient experienced dissemination of the herpes virus. "It is not known if he is speaking about herpes zoster or a different strain of the herpes virus". Patient sought unspecified medical assistance. At the time of the report the patient had not recovered. Additional information has been requested.
Rapid heart rate, 103.7 temp, dizziness, weakness in both legs, numbing of arms/hands, heaviness in chest and nausea.  Went to hospital emergency 5:00 am.  Treated w/fluids and medication to lower temp and reduce nausea.  EKG, chest x-rays and CT scan were normal.  All blood work came back normal.  Sent home at noon.  2:00 PM:  Honeycomb rash developed on arm shot was administered.  Rash and fever gone by 11:00 pm 11/21/09. Fever (101) came back 11/22/09 5:00 pm.  Fever responded to Motrin for 24 hrs.  By 1:00 am 11/22/09 fever slowly rose to 104.5.  Went back to hospital.  More fluids administered to lower fever.  Advised to alternate Motrin and Tylenol every 3 hours.  Again, all blood work and x-rays were normal.  "Fever of unknown origin" was the final diagnosis.
Lack of efficacy; diagnosed with COVID about a month ago; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (diagnosed with COVID about a month ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (diagnosed with COVID about a month ago). In 2021, COVID-19 (diagnosed with COVID about a month ago) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The patient was having symptoms of COVID prior to the diagnosis date, and had not realized that it was COVID. The patient was sick and isolated on the patient's birthday due to COVID. The patient has antibodies, but had not taken any treatment. The patient asked whether the patient should receive Moderna booster dose vaccine or not. It was reported as a breakthrough case. This case concerns a 69-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. Drug ineffective was considered an additionally event. The events occurred approximately six months after the first dose of Moderna COVID-19 vaccine (exact date unknown). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: The follow-up information contains updated suspect vaccine dose dates and addition of new event; Sender's Comments: This case concerns a 69-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. Drug ineffective was considered an additionally event. The events occurred approximately six months after the first dose of Moderna COVID-19 vaccine (exact date unknown). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
I received my first moderna vaccine on Friday 01/22/21 at 1:20 pm. I woke up at 12:00 a.m. on 01/23/21 with nausea, vomiting, fever, chills, myalgias, severe back pain, and RUQ abdominal pain. I attempted to sleep until 3:00 a.m. but with the nausea and vomiting worsening I decided to go to the emergency room. I received 2 L of LR, IV zofran, IV morphine, and 1g IV ceftriaxone for an asymptomatic UTI. The doctor stated she believed my symptoms to be the result of acute gastritis secondary to the vaccine I received the afternoon before. I was sent home with 500 mg TID PO keflex x 10 days and 4 mg PO Zofran .
Patient contacted the pharmacy on October 1st, 2021 complaining of redness and swelling at the injection site.  We counseled patient to ice the area and massage.  Also recommended using acetaminophen for pain relief.
Red blister rash all over body and head, bleeding on scalp and gums, and extremely easy bruising.  Period longer and heavier bleeding.   When symptoms had not resolved one week after appearing,  went  in-person to GP.   Blood test revealed  extremely low platelet count.  Hematologist consulted diagnosed Immune Thrombocytopenia (Immunte Thrombocytopenic Purpura) or ITP.
Evening that I received the shot, became extremely light headed and diaphoretic (outcome resolved). The next day, temperature rose to 103 F (treated with acetaminophen, outcome resolved) .  The following day had chest pains which continue to persist. Saw Family Physician on 4/26.  (ECG, Pulse Ox done,  Dx Costochondritis most likely related to the vaccine, outcome not resolved).
right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247, expiry date not reported), via an unspecified route of administration on the right arm on 28Jan2021 13:00 at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported experiencing right arm which the vaccine was injected into became extremely sore and was unable to move it without feeling pain on 29Jan2021 05:00. No treatment was received for the event. The patient recovered from the event on an unspecified date.  No follow up attempts are possible. No further information is expected.
pt recvd vax & exp soreness @ site, myalgia, arthritic sx & difficulty concentrating; pt seen by MD; reporter indicated pt's sx progressed w/2nd dose;
red-itching hard knot(large) w/skin redness from shoulder to elbow; hot compresses placed improved by 50% per mom; pt not brought back to clinic; all tx @ home 24 hrs;
46 year old female presented with focal neurologic symptoms, including right sided facial droop. She underwent imaging of the head (given concern for CVA) and neck (because of complaints consistent with radiculopathy). Ultimately she was diagnosed with Bell's Palsy.
rapid heart rate became apparent after arriving home and resting at about 2 pm, four hours after vaccination. My resting heart rate is typically around 70 bpm. My bpm during this period of time was around 105 bpm. Walking across the room took it to around 120. My bp was normal during this time. This continued until approximately 10 pm, a duration of about 4 hours.  I rested, performed some deep breathing exercises, and pushed fluids
patient complained of swelling, heat, and redness at injection site, along with swelling from shoulder to elbow
On 10/11/2006 at approximately 08:30 a.m, the above named employee received the Inactivated Influenza Vaccine (Right Deltoid) and a PPD SKIN Test (Left Arm).  She states that approx. 1 hour post vaccination she developed on LUE fine raised red rash on the LUE spreading to BUE's and back. Other symptoms include generalized pruritis.  Denies respiratory symptoms, Chest pains, or SOB at time of report.   10/11/06 Approx.12:00 Noon:  The employee  report that she recieved a Cortisone Injection from her treating physician for a plantar fascitis problem.  10/11/06 @ 16:30:  The employee presented to the Employee Health Office to report a possible vaccine adverse reaction to the flu shot based on the above symptomology reported.   - Employee self medicated with 2 Benadryl   (50mg total) with little relief at time of report.   -Employeee reports a history of multiple medical conditions.   -Denies adverse reactions with previous Flu vaccine given in 2005. - Employee was referred for further medial evaluation.
Nausea come and go.; Running 100+ fever; Bad head ache; This is a spontaneous report received from a non-contactable consumer, the patient. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208, dose number: 2) via an unspecified route of administration in the right arm on 16Mar2021 at 15:30 as single dose for COVID-19 immunisation (at the age of 65). The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no; EN6198; dose number:1) via an unspecified route of administration in the right arm on 22Feb2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included allergic to statins. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 16Mar2021 at 16:00, the patient experienced nausea which was come and go, running 100+ (units unspecified) fever and bad headache. No therapeutic measures were taken for the event. The clinical outcome of the events fever, headache and nausea were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Headache injection site pain, swelling redness , headache, shills, fatigue Narrative: started 1/21 and resolved by 1/23- lost days of work  Other Relevant History:
c/o itching, hives, strange feeling since 1hr p/vax;given DPH;
NO REACTION. MODERNA VACCINE EXPIRED 10-29-2022. VACCINE WAS GIVEN ON 11-01-2022.
fever, sore throat, truncal rash, abd, chest neck 14 days p/vax;
Tdap administered on 7/5/11. Seen on 7/6/11 for 2-3cm area of swelling. Mildly tender to palpation.
Fever, headache, aches & pains - took Advil and rested.  I felt much better the next day.