chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 99.5; Chills; Vomiting; Nausea; Pain at injection site; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 04Apr2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease stage 3 (Ckd stage 3), non-alcoholic fatty liver, tachycardia, adrenal insufficiency from unilateral adrenalectomy. The patient had previously taken penicillin and experienced penicillin allergy. Concomitant medications taken within two weeks prior to vaccination included lisinopril (MANUFACTURER UNKNOWN), carvedilol (COREG), montelukast sodium (SINGULAIR), hydrochlorothiazide (MANUFACTURER UNKNOWN), omeprazole (PROZA), all for unknown indication from unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 14Mar2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:00, the patient experienced fever 99.5 (unspecified units), chills, vomiting, nausea, pain at injection site and body aches. Therapeutic measures were taken as a result of nausea for which the doctor called in antinausea medication. The adverse events fever 99.5 (unspecified units), chills, vomiting, pain at injection site and body aches did not result in doctor or other healthcare professional office/clinic visit/emergency visit. The clinical outcome of the events fever 99.5, chills, vomiting, nausea, pain at injection site and body aches was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Date of delivery 7/14/2021 and weight is 6 pounds 9 ounces, Nothing during pregnancy. I had chills and fatigue for half a day and soreness at the injection site. I had preeclampsia and now on BP medication and pulmonary edema. Acute cardiac stress, Blood test  Doctor - 7/19/2021
At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility. She developed a headache, along with dizziness and pain at the injection site. She also reports that her arm began tingling and felt heavy. She waited for an hour without resolution to her symptoms. Around 5:30 PM, she began having intermittent episodes of shaking her limbs. There was no seizure activity. She reports that she has had these episodes since the beginning of the school year, but hadn't told her Mom. She reports that it mostly happens when taking a test at school. The episodes are worse today since taking the vaccine. Vitals: HR 110 BP 134/75 Sat 99% on RA. An RRT was called and she was taken to the ED.
Received MMR vaccine on 1/16/12.  Next morning, 1/17, had stiffness and swelling in (L) ring finger.  Swelling and stiffness progressed through day 12-14 until all fingers and both wrists were swollen and stiff.  On day 15 swelling and stiffness gradually subsided and was all gone by day 18.
Dizzy, fell to ground from chair.  BP 128/68 at 12:05.  BP repeat at 12:10 is 122/70. Recovered and Father came to pick her up from school.
Unexplained, nontraumatic severe peripheral neuropathy primarily of sciatic nerve and branches with accompanying non-related dermatomal patterns of RLE and paresthesia. No assoc weakness noted as yet.  Started dexamethasone oral, ibuprofen at onset of symptoms with minimal improvement noted (day 2-3).  Raising dexamethasone dosage and adding antihistamine and pepcid to treatment. Will continue to treat and monitor.
I've had fiibromyalgia since I was a teenager.  I have more fatigue than pain now.  Starting the next morning after the vaccines, I had a horrible headache especially in my forehead and upper neck.  I very achy, much more than normal, my arm was very sore.  My temperature usually runs about 97.1 and during the night it spiked to 99.1.  I also had no appetite.  It takes a lot for me to realize I don't feel well because I don't feel that great anyway, but I definitely did not feel well.  I slept very little that night. By the next morning I felt much better and was back to "normal" by midafternoon.
Sore lymph nodes in injection arm started 6 days after injection, injection site reaction started almost a full week after injection. Swelling, itching, redness, warmth, soreness. Symptoms are still present 48 hours after they began
Within 1 day. Lt arm small red rash - spread making it difficult to move arm. Became swollen, red, hot, tender, 10/17/12 to PCP Dx cellulitis - rec. antibiotics. 10/23/12 Still has hard knot at injection site.
p/vax pt devel a really bad rash & a high fever;the rash was red & looked liked hives; This is in follow-up to report(s) previously submitted on 05/21/99. Information has been received from a physician concerning a 1-year-old White female patient who on 07-JAN-1999 was vaccinated with a first dose of MMRII IM in the right thigh. Concomitant vaccinations that same day included VARIVAX and haemophiilus B conjugate vaccine. On 18-JAN-1999 the patient developed a "really bad rash and a high fever (102F). The rash was red and looked like hives." The patient was prescribed hydrocortisone and told to follow-up if the rash persists. Follow-up was received which indicated the patient had not seen in the clinic since 18-JAN-1999. The responsible physician was no longer in practice at the clinic. No further information is expected.
Reaction to Dtap given 4/26/05. 2 days later area red and swollen, hot to touch, measures 10cm across. Advised to ice pack area and use Benadryl, oral or topical, should respond in 2-3 days.
Shot 1, next period cycle, irregular.  Menstrual pain coming and going.  On day 8 now.  Spotting, then flow, repeat.   This has never happened during my menstrual cycle, even when stressed.
Pt experienced syncope in waiting room and recovered without complication on 9/24/13. Returned on 9/26/13 with local reaction to (R) upper arm. Assessed and advised to see MD; referral given.
sl leakage of blood from lt nipple for 4 days; same thing happened last year; This nipple is inverted & often has a sl clear discharge which gets crusty; It was biopsied once but nothing found;
Rapid onset of infection in lower right jaw where tooth was loose but not infected.   tooth was removed on 03/22/2021 but Infection resisted multiple antibiotics for 10 days,  but there was no fever.   Infection and swelling finally subsided after 21 days of treatment.
Vaccine was given early by error. First dose was given 11/21/21 and second dose was given 12/6/21. Patient has had fever of 101 and body aches since receiveing vaccine
3:30pm flushed face (for about an hour) 5:30pm pain at injection site (continued through 5:00pm 3/11/21) 9:30pm muscle aches (continued through 5:00pm 3/11/21) 12:15am 3/11/21 chills and low grade fever 99.9*F (continued through about 10am)
Headache, Arthralgia, Fever Chills, Cough, Lower Back Pain Narrative: Fever 100.5 @3:20AM morning following injection. Took Tylenol.
FEVER OF 101.6; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever of 101.6. Laboratory data (dates unspecified) included: Body temperature 101.6 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.6. This report was non-serious.
Information has been received from a pharmacist concerning a 27 year old female who on 10/25/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot number 654981/0674F). On 10/25/06 within one hour of vaccination, the pt experienced pain in injection arm and headache. The pain worsened and the pt woke up in the morning of 10/26/06 with chills and shivering, nausea without vomiting and generalized pain in the back. The pt was hospitalized for observation on 10/26/06. Subsequently the same day, the pt was discharged with unspecified pain and nausea medication. When the pt was discharged, she was judged to be recovering. A follow up visit was scheduled for one week. Additional information has been requested.
10 cm area edema & redness surrounding inject site; 24 hrs p/inject x 5-6 days duration;
This spontaneous report as received from a nurse via physician refers to a 18 year old female pregnant patient. No medical history nor concomitant therapy was reported. On an unknown date in 2016, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular (lot# and expiration date were not reported). After a few days after being vaccinated with GARDASIL 9 the patient found out that she was 13 weeks pregnant. Last Menstrual Period (LMP) was calculated on 05-JUL-2016 and Estimated Due Date (EDD) on 11-APR-2017. The patient was exposure to GARDASIL 9 during the first trimester of pregnancy. The pregnancy outcome was pending. Additional information has been requested.
Chills, fever, muscle aches, sweating spells, redness traveling down my arm under the injection site, severe arm pain, runny nose , increasing redness and swelling down  anterior tricep under injection site
Left arm is red below injection site. Hot to touch and pt is c/o a lot of pain in entire arm. Advised warm compress and alternate TYLENOL and ibuprofen. Go to ER if has any drainage, develops fever or red streaks.
head hurts; fluctuating fever; Nauseous; extremely tired ; Fatigue; her whole body hurt; Feeling bad; Groggy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was reported as ER8733; Expiration Date was reported as 31Jul2021) via an unspecified route of administration on 03Apr2021 09:15 (at the age of 23 years old) as dose 1, single for covid-19 immunisation. Medical history included haematoma from Feb2021 to an unknown date she had donated plasma and got a hematoma in her right arm at location where her blood was taken. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The reporter reported that, she got her first COVID-19 Vaccine dose on Saturday, 03Apr2021, at 9:15AM. She said she had bad symptoms the day of the COVID-19 Vaccine. She said she was nauseous, felt extremely tired: Fatigue, her whole body hurt, she felt bad, and was really groggy. She said she had a fluctuating fever on Saturday (03Apr2021), and that was to be expected. She said she still had the fever today (06Apr2021) and was unable to break the fever. She clarified she had a fever Saturday night (03Apr2021) that was 102-degrees. She said she did not check her temperature on Sunday (04Apr2021), but on Monday (05Apr2021) she had a 100-degree temperature that increased to 102 degrees. She said today (06Apr2021) she had a 100-degree temperature. She said her symptoms had improved. She said she still felt a bit like she was fatigued, had the fever, and her head hurts. She said her head started to hurt on Sunday morning (04Apr2021) when she woke up. She said she was not sure if her head hurting was caused by the fever, or if she had a headache. The patient reported that, she started taking the Tylenol on Saturday night (03Apr2021) and was taking 2 Tylenol tablets every 6 hours. She said she did not take any Tylenol on Sunday (04Apr2021). She said she took the Tylenol on Monday and was planning to take a dose of Tylenol when she got home today (06Apr2021). The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: 102 degrees on 03Apr2021, body temperature: 100 degrees temperature that increased to 102 degrees on 05Apr2021, body temperature: 100 degrees on 06Apr2021. The outcome for the events nauseous, extremely tired; fatigue, her whole body hurt, feeling bad, groggy was recovering and for the events fluctuating fever and head hurts was not recovered.   No follow-up attempts are possible. No further information is expected.
Deceased/wrongful death; This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2022, the patient received Shingrix (intravenous). On 3rd August 2022, 4 days after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 3rd August 2022. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingrix.  Additional Information: GSK Receipt Date: 22 Feb 2023 Reporter's Comments:The patient allegedly passed away from complications after receiving a shingrix vial kit vaccine.The patient death case arising out of complications from an intravenous vaccine administration which occurred on 30 Jul 2022. The patient was deceased ( date of loss) on 3 Aug 2022 or wrongful . The autopsy was unknown. The patient cause of death was unknown cause of death.; Reported Cause(s) of Death: Deceased
In EC 05/24/2021 "Patient is a 17 yo female with a history of McArdle's disease, Asthma, GERD and colitis (recent admission in 2/2021) who is presenting with lower abdominal pain, nausea, vomiting and diarrhea".
I developed an excruciating headache and stiff neck that persisted for 4 weeks. It did not recur when I got my second vaccination
No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.  No Medical History information was reported.    On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). No concomitant medications were reported. It was unknown if patient had allergies to medication, foods and other products.  It was unknown if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
2 cases of apnea in 1 day following a stuffy cold;pt was taken to ER & put in the hosp for observation;
red ness to injection side area , primarily below site, 4inches x 5 inches; soreness, fatigue, fever
We inadvertently administered doses from a vial that was in our refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-037831 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded.; Sender's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknown  with no associated AEs.
-6 days after injection - noticed discomfort under left arm pit extending across mid back thoracic region ack at same level.  ( previous soreness at injection site was minimal soreness and resolved by day 3).   -7 days after injection  site on left  arm became red , swollen, warm and painful.  Symptoms also included a burning and pulling under left arm extending across right breast area and back at level of arm pit and soreness /discomfort down left arm into fingers, also felt discomfort across chest area.  8  days after injection symptoms continued - contacted Geisinger Covid-19 hotline - referred to primary physician. -Primary Physician visit on this date 01-28-2021 - Physician also noted lymph nodes under right arm enlarged - prescribed Bactrim DS dosage 2x daily for seven days. -8 days after injection - swelling decreased at injection site, other symptoms persist -11 days after injection - symptoms of redness and occasional burning/ discomfort persist with decreased severity
approx 72 hrs p/vax pt lt arm swollen from elbow to p/shoullder sl redness, heat w/palpation; mom states pt had hives on back & stomach last nite called MD who ordered DPH;
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/9/2021 and 4/6/2021. Presented to ED on 9/20/2021 after being found down in barn where he was working. The fall was not witnessed, and family does not believe he hit his head as only abrasions noted are on elbows. Patient found to be COVID positive and treatment with Dexamethasone, remdesivir, and baricitinib, HFNC oxygen started. Patient developed confusion and agitation on 9/25/2021. Patient began to experience SOB on 10/1/2021, and enterococcus bacteremia noted. On 10/5/2021 patient developed tachycardia and worsening hypoxia. Patient condition continued to deteriorate and family decided comfort measures on 10/11/2021. Patient expired on 10/15/2021.
Narrative: She received Moderna vaccines 02/25/2021 and 03/25/2021, both in the left arm. On 9/28/2021 she had a biopsy of left breast lesion positive for infiltrating mammary carcinoma. She is 78 yo no history of abnormal mammogram nor a biopsy. No family history of breast cancer.
Pt rec'd FLUZONE at approximately 3:40 pm 9/20. Husband called 9/21 to report that pt had fever, vomiting, nausea, low BP unsteadiness. I called pt approximately 2 pm and she said she was feeling much better. The most severe symptoms were through the night.
Agitation, accelerated heart rate, and increased respirations. States "skin hurt". Patient states lasted 48 hrs. Saw PMD and given medication.
Fever, coarsed voice. Positive 7-8 vesicular scattered on face/torsol/leg.
passed out; being cold; shivering; fell and hit her head; fell and hit her head; stiffness; extreme muscular pain not sure If that is AE or from the fall; This case was reported by a other health professional via sales rep and described the occurrence of passed out in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received Shingrix. On 28th October 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling cold, shivering, fall, head injury, stiffness and muscle pain. On an unknown date, the outcome of the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain were unknown.   It was unknown if the reporter considered the passed out, feeling cold, shivering, fall, head injury, stiffness and muscle pain to be related to Shingrix.  Additional case details were reported as follows: Several hours later patient complained of being cold and shivering. During the night, she went downstairs and passed out. She felt and hit her head. She was now experiencing stiffness and extreme muscular pain, reporter not sure If that was adverse event or from the fall. The patient taking rest and being monitored. She would proceed to the hospital if conditions worsen. The reporter consented to follow up.
Oral intake reduced; Diarrhea; Vomiting; Sickness; Speech disorder; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), HYPOPHAGIA (Oral intake reduced), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced HYPOPHAGIA (Oral intake reduced). At the time of the report, ILLNESS (Sickness), SPEECH DISORDER (Speech disorder), HYPOPHAGIA (Oral intake reduced), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.            No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
FEVER, SWELLING, REDNESS. 3 DAYS AFTER VACCINATION, THE PATIENT PRESENTED TO PHARMACY WITH REACTION. PATIENT STATED THAT SYMPTOMS HAVE IMPROVED SINCE VACCINATION DATE. TREATMENT: TYLENOL, COLD PACK.
This serious spontaneous case, initially received on 28-Feb-2018, reported by other non-health professional and concerns a 68-year-old, elderly, male patient. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient had flu (reported as: three times this year) [considered as vaccination failure]. At the time of this report, the outcome of the event- flu was not reported.
Erythema, warmth, increase in arm circumference (upper right)  area of erythema : 14 cm x 16 cm