chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a physician concerning a 66 year old female with a hypersensitivity to ezetimibe (MSD) who on 19-OCT-2007 was vaccinated into the left arm with a single dose of zoster vaccine live (Oka/Merck) (Lot # 658602/1080U). Concomitant therapy included Ambien, potassium chloride, Nexium, Lisinopril Comp, Norvasc, Toprol XL, Benicar HCT and Tekturna. Five days post vaccination, on 25-OCT-2007, the patient developed a vesicular rash, with 10 to 11 lesions, on the right side of her mid back. The patient was diagnosed with herpes zoster. The patient reported pain at a level of five on a scale of one to ten. The patient denied any any history of chickenpox or recent exposure of chickenpox. There was no lab diagnostic studies performed, and no lesion specimens submitted for analysis. The physicians reported that the patient was not immunocompromised in any way. At the time of reporting the patient "still had a rash." Unspecified medical attention was sought. There was no product quality complaint. It has been determined that WAES0710USA5849 is a duplicate of WAES710USA05579. Therefore, WAES # 0710USA05849 is being deleted from our files and the reports consolidated into WAES # 0710USA05579. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain. The PCR results for the specimen from vesicular rash identified the presence of WT VZV.
Pain on site for 3 days (till 11/23) Fatigue/ache till Saturday 7pm
Experiencing vertigo mainly when laying down and turning over to my side. I get dizzy when leaning my head to the side while looking at something, pickup something.  Also experience numbness in the left side of my jaw and below my nose.   No treatment. It happens for a few seconds at a time.
Four hours after vaccine, patient noted pain surrounding injection site.  By 8 hours after vaccine, patient noted pain  had spread and extended from shoulder to elbow. By 18 hours after vaccine, the patient noted moderate muscle pain (myalgia) and joint pain (arthralgia) limiting ADL unrelieved by over-the-counter agents (ibuprofen, acetaminophen). These symptoms persisted through the second day and the patient noted new neck pain and headache, again unrelieved by over-the-counter agents.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of ROTATEQ (orally, lot # M012495, expiration date 09-OCT-2017; dose was not reported) for prophylaxis. No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005657: US-009507513-1610USA005658: US-009507513-1610USA005157: MERCK 1610USA005656:Mfr number.
Patient complained of increased heart rate and trouble breathing right after getting the vaccine she was unable to speak. Team called 911 & administered epipen. Pt was checked out and sent home.
This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 51-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced varicella-like rash and pain. On an unknown date, the outcome of the varicella-like rash and pain were unknown. It was unknown if the reporter considered the varicella-like rash and pain to be related to SHINGRIX. Additional details were reported as follows: The reporter was not a healthcare professional. The patient received 1st dose of the new vaccine a little over 2 months ago. The patient's 1st injection was very little pain. Over a month after receiving the 1st dose the patient got a rash with chicken pox looking sores over part of his chest and one large chicken pox like mark on the waist. This case has been linked with case, reported by the same reporter for 2nd dose.
6 days after shots high fever 102-104 developed a rash all over. Rx rest lethargic. Had a local redness in right arm the day of shot, then ok by the next day.
FEELS GENERALLY UNWELL; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feels generally unwell, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and feels generally unwell. This report was non-serious. This case, from the same reporter is linked to 20210644172 and 20210642487.
For two days after the shot I was nauseous  and had a terrible headache, even when I slept. I was also running a low fever the day after. Four days after the shot, I developed a hard itching lump about two inches around the injection site. It?s stayed itchy and swollen since then.
approx 12hrs p/shot devel red bumps on arms, stomach, buttocks & fever of 104, vomiting (had hx of vomiting x 1wk-formula switched);no tx received
Cellulitis like crash with demarcated border and warm to the touch. Beginning evening of 6-17-2020 and persistent through 6-21-2020
Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in hip (Hip soreness), Hypothyroidism (low thyroid) since 1995, Drug allergy (Statins), Allergy to antibiotic (Arythamyacin) and Grass allergy (Fresh cut grass). Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). At the time of the report, VACCINATION SITE PAIN (Injection arm soreness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was allergic to super glue.  Treatment information was not provided.   This case was linked to MOD-2021-250499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information included patient's demographics, allergy details, concomitant medications and medical history.
Upon arriving a line was already forming for workers to get the Pfizer vaccine(some first dosers, some second dosers). I completed Registration, scheduled the appt, check-in, inserted vaccine order in Athena, filled out vaccine card, and risked informed consent. Worker reconstituted and administered the Pfizer vaccine. Since there was a line, he drew up each vaccine 1 by 1. After completing the 4th vaccine, he informed me that he only was able to draw up 4 vaccines, and there was none left in the vial. I instructed him to reconstitute the new vial and draw up all 6 before administering. Once again, he only was able to have enough mixture to draw up 4. We clarified that 1.8ml of diluent needed to be added to the vial. Worker stated that he only added 0.8 to the last batch (as well as this one). We reinserted all 4 of the drawn up syringes back into he vial and added 1ml of additional diluent (totaling 1.8 ml of diluent) and then we were able to draw up 6, syringes of the Pfizer vaccine. No more issues were noted. Follow up phone call: Pt has had head aches for 2 weeks post vaccination. Patient has seen his PCP and was given Ibuprofen for the HA and has a return appointment on Oct. 22, 2021. Pt was tested for both Flu and Covid because of the HA. Both test came back negative. Pt said he appreciated the update.
+headache, numbness, shacks, weak, vomited,meakness, dizziness, felt very  weird all over all night,  weak for 2 days
Healthy athletic male, symptoms(HA, mayalgias, fatigue) developed 09/12/21. syncopal episode at home. ER Hospital, cardiac symptoms. myocarditis with acute heart failure.  Hospitalized from 09/17-09/24/21. Responded well to milrinone and IVIG.   Was discharged to home on lisinopril.  EF 40-45% at discharge.  Not sure if fully recovered but not strenuous exercise for 6 months
feeling weak; sleeping a lot; no appetite; chills; headache; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt). At the time of the report, ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication were not provided.
I developed a rash like chicken pox or shingles around my waist, my sides and the back of my neck. The spots looked like ant bites, some had white centers. They were painful and somewhat itchy. They started to dry up by Tuesday-4 days after they appeared. I also had a really intense headache the evening after getting the shot, and the headache returned the night the rash appeared.
Adverse reaction that started Saturday evening with redness and swelling at the injection site. Doxycycline started Sunday morning, two doses taken Sunday. Injection site was red, swollen, itchy and hot to touch. Size of inflammation was 4 centimeters circular area. Monday 9/11/17 MD reevaluation and Doxycycline stopped, started Loratadine and topical Triamcinolone along with BENADRYL at night. Redness and swelling continued to diminish and as of 9/13/2017 there is complete resolution.
Pt received FLUZONE HD in left arm IM delt and is now having pain in Rt arm and spine.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 25Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Kidney disease" (unspecified if ongoing), notes: Mild to moderate Kidney disease.Diagnosed about 3 years ago, caused by high blood pressure.; "high blood pressure" (unspecified if ongoing), notes: Mild to moderate Kidney disease. Diagnosed about 3 years ago, caused by high blood pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: She tested positive for Covid twice. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course information: She does not know if she should stop taking the medication or not. She's gotten the Covid vaccines and has been vaccinated and boosted twice and has taken two days worth of medication. She plans on taking it at least one more day because she knows it has good results.
This spontaneous report was received from an office manager and refers to 5 patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 16-JUN-2017, 04-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M011117, expiration date 12-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 207 hours and 47 to 77 degrees Fahrenheit for 207 hours. Data logger was involved in recording of the temperature excursions. There was a previous temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours reported. This is one of two reports received from the same reporter.
Fever of 103 approximately 6 hours after vaccine. Experienced fast heartbeat, weakness and felt helpless and was crying - very unusual for me. Symptoms lasted for approx. 2 hours.
ACHES; CHILLS; 101 FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, chills, and 101 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101 fever, chills and aches was not reported. This report was non-serious.
Patient presented with three weeks of progressive back pain and bilateral lower extremity radiculopathy, associated with night sweats (no fevers, no leukocytosis), found to have extensive T9-S1 spinal epidural abscess due to MSSA. Symptoms started at around the time the patient received her first COVID-19 vaccination on 1/26/2021. No other obvious source of infection (she does have an ear wound but this did not appear infected). She was admitted to the Hospital on 2/17/2021. Adverse event reported on 2/23/2021. She remains hospitalized as of this report.
Hospitalization for COPD exacerbation and COVID-19 on dates 1/19/2023- 1/26/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
3 weeks prior to 08/16/2021- I had a migraine headache that was continuous for 3 weeks and a sinus infection. On 08/11/2021-I went in for the visit and my sinuses and ear were full of fluid. Dr. assistant prescribed my antibiotic- z-pack. My symptoms resolved after the antibiotics.  On 08/16/2021, Monday, I did not feel right. I did not have  a fever, or a cough. I could still taste, smell and and I still had my appetite. I did not have any of the classic symptoms. That night I got up to go to the bathroom and vomited, and had diarrhea (and I normally do not vomit)  and I passed out afterwards. It was only a one shot of vomiting and diarrhea.  I did not know I passed out. My husband found me on the floor.  The next morning, Tuesday, 08/17/2021, I didn't feel well. I had a low grade fever and chills. I went and bought an over-the-counter COVID-19 test and the results were negative.  That same day, I went to the clinic, and they administered a COVID-19 test and it was positive.  For 2 days after, I had  fever,  chills , heavy chest, massive headache. I felt like someone was sitting on my chest and head. The headache was worse than a migraine. The pain felt different than a migraine, a pain I had never felt before. I took Tylenol and it broke my fever, but it was no match for my headache.   By Friday my symptoms, began to resolve. I did have a little congestion .  A week after my Pfizer 2nd dose - I developed COVID arm. It felt like a bee sting, hot to the touch, swollen and really itched. And went away after a week on it's own.
Altered perception of temperature. No fever but increased feeling of warmth that persisted more than 3 weeks. Possible increase of metabolism. Not confirmed but measurable weight loss.
Itchiness around neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness around neck) 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 (No reported medical history).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itchiness around neck). At the time of the report, PRURITUS (Itchiness around neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  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.
lower back hurt; pain in legs; muscle ache; pain in arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), PAIN IN EXTREMITY (pain in legs), MYALGIA (muscle ache) and BACK PAIN (lower back hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in legs) and MYALGIA (muscle ache). On 03-Feb-2021, the patient experienced BACK PAIN (lower back hurt). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), PAIN IN EXTREMITY (pain in legs), MYALGIA (muscle ache) and BACK PAIN (lower back hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Client received booster dose of pfizer at the age of 15, sooner than agency recommendation. No symptoms or adverse reactions observed or reported at this time. Pfizer notified.
PT STATES SHE STILL HAS LINGERING SORENESS IN DELTOID AREA OF ARM SINCE VACCINATION. SHE REPORTS NO REDNESS OR SWELLING ASSOCIATED WITH THE PAIN. REFERRED TO PRIMARY CARE PHYSICIAN FOR FURTHER EVALUATION.
itchy sensation near the injection site; swelling area was larger; Arm soreness; redness near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy sensation near the injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (redness near the injection site) and VACCINATION SITE SWELLING (swelling area was larger) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (redness near the injection site).   On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy sensation near the injection site) and VACCINATION SITE SWELLING (swelling area was larger).   At the time of the report, VACCINATION SITE PRURITUS (itchy sensation near the injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (redness near the injection site) and VACCINATION SITE SWELLING (swelling area was larger) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
swelling of tongue; swelling of roof of mouth; This is a spontaneous report from a contactable pharmacist, the patient. A 62-years-old adult non-pregnant female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) via an unspecified route of administration in the left arm on 17Mar2021 at 09:45 (at the age 62-years-old) as single dose for COVID-19 immunisation. Medical history included back surgery and chronic pain. The patient was allergic to latex, papaya, trees, grasses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem (AMBIEN), pravastatin (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), vitamins, bupropion (MANUFACTURER UNKNOWN). Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient experienced swelling of roof of the mouth and tongue. Therapeutic measures included self-treatment with diphenhydramine (Benadryl). The patient felt much better 8 hours after taking the diphenhydramine. The clinical outcome of the events swelling of roof of the mouth and tongue was reported as recovering.   No follow-up attempts are needed. No further information is expected.
on day after vaccination developed R forearm, wrist, and hand swelling. Also developed tenderness over dorsal aspect of R mid forewarm, and pain at L foot arch. On 2nd day after vaccination, R arm symptoms improved slightly. L foot pain completely resolved. On 3rd day after vaccination, R arm symptoms slightly more improved.
Could not move arm the next day, it was swollen, red, hot to the touch. Patient also had chills and headache.