chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme Fatigue). At the time of the report, FATIGUE (Extreme Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.   This case was linked to MOD-2021-079043 (E2B Linked Report).; Sender's Comments:  MOD-2021-079043:2nd dose
Redness on my vaccinated hands occurred  first 4- 5 days after shot and a week  later I felt like  a needle  poking me on the inside  and eventually I  broke out with a painful rash all over my body.
3 x 3 inch redness and swelling at inj site. Slightly warm to touch. Cool compress/BENADRYL Q6-8 hours PRN.
Injection site has large red circle , itchy and tender if lay on arm, and a little stingy at times. It was tender for 1st night, Wed then unremarkable until 4th day after shot, Sun and continues thru today 6th day after shot Tues I used calendula gel to lessen the itching, and cold compress to help the redness, no change on the redness yet
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On an unknown date the patient did not receive ZOSTAVAX vaccination due to product quality complaint (PQC). No adverse effect was reported. Additional information has been requested.
PATIENT RECIEVED HIS MODERNA VACCINATION FIRST DOSE ON FEBRUARY 1ST 2021 AND 2ND DOSE MARCH 1ST 2021 PATIENT DEVELOPED FEVER AND CHILLS AS WELL AS LOW O2 STAT, AND HE ADDRESSED HIS CONCERN WITHT HE PROVIDER HERE IN THE HOSPITAL THAT HIS HOSPITAL ADMISSION IS DUE TO THE MODERNA VACCINE HE RECEIVED
This spontaneous report has been received from the medical assistant refers to a 12 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK INJ) used to reconstitute the VARIVAX was properly stored. On 16-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degree F) to 14 degree F (also reported as "9F") for a time frame of 10 minutes; and of 15 degree F to 46 degree F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
The pt developed chicken pox. The pt had the vax on 1/12/1998.
COVID-19; COVID-19; chills; fever; ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426070-00 (Agency).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "ache". The action taken for adalimumab was unknown. Clinical information: It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter considered "covid-19", "chills", "fever" and "ache" related to BNT162b2. The reporter's causality for the event(s) covid-19", "chills", "fever" and "ache" with the suspect product(s) adalimumab (HUMIRA) was not provided at the time of this report. The reporter's causality for the event(s) covid-19", "chills", "fever" and "ache" with the suspect product(s) MODERNA COVID-19 VACCINE was possible at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial and follow up information has been received from a licensed practical nurse concerning a 60 yr old white female restauranteer who on 06Feb06, at 9:00AM was vaccinated IM, into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot651322/1044P). On 06Feb06, in the evening, it was noted that her arm was red, hot, swollen and hard from the injection site to elbow and halfway around her arm. The pt was able to use arm but hurt. Medical attention was sought and the pt was advised treated with ice and ibuprofen (Advil). On 11Feb06, the pt recovered. The office is concerned and reluctant to administer the remaining 3 doses from this vial. The doctor would like a lot investigation. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
PNEUMOVAX given 12-18-08.  Patient became ill 2-20-08 with symptoms, fever, chills, sweating, cough, fatigue and weakness.  Office visit 12-22-08 CXR showed extensive left lower lobe Pneumonia treated in office 1000mg ROCEPHIN IM, nebulizer treatment and Rx's for AVELOX 400mg 8d and ROBITUSSIN AC after 4 hrs PRN.
Injection site developed large (2" x 3" oval) red spot, red and itchy superficially and painful to the touch below the skin.  Persisted 7-10 days.  One month later a brown stain remains of the same dimensions (2" x 3" oval).  Slight surface itching remains as well as slight pain on applying pressure to the oval.
There was a syringe malfunction and the vaccination did not make it into the arm.  Another dose was successfully given.
11/18 Extreme Itching in the middle of night. Hives on neck and face in the morning. 11/19 Hives over several different parts of body. Visit with the Urgent Care. Was informed to take Zyrtec and use steroid cream on hives. 11/20 Swelling of the right ear, lips, forehead, scalp, hands, feet. 11/21 Zyrtec keeping most symptoms away. Ear, lip, scalp swelling go away. Hand and Feet swelling remain. Develop symptoms of Dermatographia.  11/24 Hand and Feet swelling cease. 11/25-Today (12/6)  Occasional Hives that come and go. Dermatographia remains.
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2022, SARS-CoV-2 test: (Positive) Positive. On 25-Jun-2022, SARS-CoV-2 test: (Negative) Negative.         No Concomitant medication reported.  It had been reported that Symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain.  It was reported that They started feeling better around the 24th or 25th of June.  No Treatment medication reported.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 6 to 7 months after the first booster dose of mRNA-1273 vaccine administration with positive Covid-19 test result. It was reported that after 6 to 7 days, patient felt better and tested negative for Covid-19 at the same time. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-600557 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 6 to 7 months after the first booster dose of mRNA-1273 vaccine administration with positive Covid-19 test result. It was reported that after 6 to 7 days, patient felt better and tested negative for Covid-19 at the same time. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-600557:MOD22-017743
Per mother's report, son had about 6 hours of inconsolable crying, starting a few hours, post vax, at his 4 month well child check. He was not examined at the time of his reaction. He fully recovered by the next morning.
This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed a skin disorder (weird circle on arm), with outcome of unknown. Additional information: Patient and spouse got the Pfizer shot couple of months ago and now have a weird circle on their arms. Follow-up (Nov 17, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101512002 (same product and event, different patients).
I spoke to patient today, 9/20, and she explained that immediately after receiving the vaccine, roughly 30 minutes after, she started getting tingling. She said when she got him her arm was red from her shoulder down to her elbow. She said that she felt a lump in her arm and it hurt to touch.
Presented to ED w/neck pain; pt hemodynamically unstable and admitted; COVID+ on 1/10; tx w/remdesivir, steroids, zinc, O2; weaned to RA for d/c.
dizziness, confusion, difficulty forming sentences, headaches, forgetting processes (work) that she has known how to do for years
My left underarm lymph nodes swelled noticeably (same arm as injection site) and felt sore for 3-4 days.  My left arm had occasional soreness during that time also, all the way down to the wrist.
Fever of 103. Vomiting.  Headache.  Soreness and redness at injection site.  Went to emergency room. Diagnosed with cellulitis. Admitted to hospital for IV antibiotic treatments on 11/16/2013. Discharged on 11/18/2013 to continue oral antibiotic course.
Patient was administered flu shot at the time of the rash on Monday  (10/7/2019) Denies any new medicines. No recent Abx or supplements Denies chemical exposures or irritants. She was outdoors with her husband, who did not have a rash  Denies tongue swelling, lip swelling, throat closing, dyspnea or wheezing   Feels well otherwise No other bleeding, painful or concerning skin lesions
atopic dermatitis on the face, neck, and hands which became moderate to severe; red patches; bruised-around my face and neck; flared up eczema; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 13Apr2021 at 17:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, type 2 diabetes mellitus, urticaria, atopic dermatitis and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), vitamin b12 nos (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN) all from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 23Mar2021 at 18:15 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 12:00, the patient had reported an underlying condition of atopic dermatitis on the face, neck, and hands which became moderate to severe in the morning after the second dose of vaccination. The patient had red patches that almost look bruised around the face and neck which were extremely dry, tight, and flaky, and dried up after minutes of applying thick lotion/cream. It flared up eczema and the patient had not experienced this severe reaction in over one year. There was with no changes in any products used or the diet of the patient. Therapeutic measures included treatment with unknown lotion/cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events atopic dermatitis on the face, neck and hands which became moderate to severe, red patches almost look bruised and flared up eczema was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
High fever for three days. After couple months started flutter eyelid, pain and swollen jaw and behind ear - left side.
Pfizer vaccine second dose: chills, fatigue and swollen lymph node R collarbone
lt leg had 12xm of induration/warmth, & swollen from groin to ankle;pt had a high pitched persistent cry for 6hr;@ time of exam no fever noted;
Severe uncontrollable shaking 12:15-8 am 04/03/2021 (no fever), fatigue, mild headache Resting heart rate measured with pulse oximeter at about 6:30 pm 04/03/2021:  127 (about 2X  normal)  Info sheet said that was a reason to go to an emergency room.  Went to ER and admitted for overnight observation at about 8:00 pm.  EKG, chest x-ray and cardiac enzymes normal. Released morning of  04/04/2021 with recommendation for echocardiogram and nuclear stress test. [red, swollen band across injection site on left arm appeared 04/04/2021]
My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that lasted all day and next day was a fine. No medication needed. I also noticed knee pain in both knees mainly when I am moving around. I was not having that problem before the vaccine.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 year old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 04-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
I had bleeding for my period 5 days earlier the month of my second vaccine. I subsequently got pregnant that month and miscarried at 5 weeks.
After getting my Moderna covid 19 injections in January and February I began losing skin pigment all over my body.
Med/tx BENADRYL 12.5mg/5ml 5ml PO Q6 hours x 24 hours - f/u 8/6/11. (mild rash at site of injection local erythema/warmth no induration).
received a dose of expired Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number T2472, expiry date 26th November 2021) and (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 7th December 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 7th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharma intern reported that, the patient received expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252431:same reporter US-GLAXOSMITHKLINE-US2021AMR252432:same reporter
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042265, expiration date: 26-OCT-2017, (administration, route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient became unresponsive in chair color poor, skin cool and dry. Faint pulse and low BP. S/sx lasted 90 seconds. Patient lethargic and weak. EMS called. Color remained poor patient gradually became more alert. Patient returned to baseline after 45mins. Color good VSS.  Declined transport to ER and went home with mother.
Patient reported blindness  for 12 hours starting at 1:00am the following  morning along with a "bad headache".
Bruising and soreness noted by patient around injection site in left deltoid area 2 days after injection was received. Today patient reported soreness continued with sharp shooting pain "like fire" down left arm from injection site to left wrist. Patient took Ibuprofen 600mg which "dulled" the pain but did not relieve it. Patient applied ice which increased the pain. Pain increased when arm was bent at the elbow or twisted toward chest, when lifting or pulling things.
Patient exhibited muscle spasms and pain in middle of lower back. Pain and muscle spasms in right leg with some weakness. This occurred about 5 minutes after injection. After about 30 minutes patient was able to stand and walk with some soreness. EMS checked her vital signs and patient was able to go home by herself.
stinging around the chest; whelps/hives around the chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) 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 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest). At the time of the report, PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) 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 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest). At the time of the report, PAIN (stinging around the chest) and URTICARIA (whelps/hives around the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported.  No treatment information was provided.
Day 0 (4/1/21) had mild arm soreness.  On day 1 (4/2/21), she had chills and sweats and body aches.  Took Tylenol and improved her symptoms.  On day 2 (4/3/21) in the morning she felt well, but later that afternoon she had severe abdominal pain. She had worsening symptoms over the next few hours, with recurrence of sweats, nausea and then vomiting.  She had resolution of symptoms after 15 minutes, but recurred about 1-2 hours later with vomiting and abdominal pain.  Mom reports her pain was crippling, doubled over and on the floor due to pain.  Took to urgent care for evaluation.  UA and UPT negative.  ED records show abdominal exam was normal except for "increased peristalsis". Treated with Zofran with resolution of vomiting.  discharged home.  Abdominal pain self-limited and resolved without further intervention within a few hours.
No signs of flu or any other infection. Urine and mucus test did not show anything. Only had very high fever which went from 100.2 to 105 F in a period of two hours even when Motrin was administered at first onset. High fever culminated in febrile seizure which lasted around 2 minutes.
PARTIAL EPILEPSY, INTRACTABLE 8/21/2021 PALLIATIVE CARE  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/21/2021 PALLIATIVE CARE