chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Greater than 35 days since the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine) in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received  contains Reporter information  updated address, city, postal code, phone number and fax number. Patient information updated DOB, age at time of reaction. Vaccine information updated batch number, route of administration.
After receiving the vaccine approximately 10-12 days later , site of injection got red and slightly itchy. By day 16 the area measured 6? x 8?, very red and itchy. Went to my primary care giver and she ordered kelflex.  Said to go to the emergency room if it get down to my elbow. Since taking the antibiotic it stopped growing.
It was brought to our attention that a 17 year old went through our vaccination event on 3/11/2021 and received the Moderna Vaccine, she had a prescription from her primary physician to receive a COVID vaccine due to her asthma. No adverse events have been noted and she will be receiving her second dose per CDC guidelines next week.
Patient felt weak and anxious as the vaccine was given, asked to lay down, and we helped her onto a mat, gave a bottle of water and in 5 minutes patient was back in chair, waited 30 minutes, felt ok and left
pt recvd vax 21JUL92 devel severe swelling of the rt quadricep muscle @ the injec site; t102.5; rt knee & rt hip were swollen & tender; lab eval revealed a WBC of 15.7 w/ 59 PMNs, 16 bands, 17 lymphs, 8 monos, hemoglobin 11.6; periostitis;
Severe adverse reaction; This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional information was provided as follows: The office manager reported this case on behalf of physician. The age at vaccination was not reported. No patient identifiable information provided in the e-mail. The age group was captured as an adult as per vaccine indication. The patient complained of unspecified severe adverse reaction which was lasted for all day. This case had been linked with US2020041827, reported by same reporter.
Patient presented to our facility complaining of shortness of breath.  A CTA of the chest revealed bilateral pulmonary emboli.
Information has been received from a registered nurse concerning a patient who in approximately 1994 was vaccinated with Hepatitis B vaccine recombinant. Subsequent laboratory evaluation revealed positive Hepatitis B core antigen. Medical attention was sought. No further information is available.
Have a fever of 100.7; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 12Apr2021 at 14:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and formoterol fumarate, mometasone furoate (DULERA) from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 11:00, the patient experienced fever of 100.7 (unspecified units). On 22Apr2021 at 11:00, the patient checked his body temperature measured and it was 100.7(unspecified units).The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had a fever of 100.7 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
According to the patient, a few hours following vaccination (on the same day), she started to experience swelling first in the feet, then in the face. In addition, she complains of increased thirst that emerged following vaccination. She came into the pharmacy today 4/14/22 (8 days after her vaccination). She says that swelling in her feet has resolved, but she's still a bit swollen in the face (though it was not clinically apparent upon staff observation). Her increased thirst remains. We advised her to see her doctor for further evaluation and to determine whether she may be suffering from allergic reaction and to seek prompt care/treatment as appropriate. Also, advised her to ask her doctor to see whether or not she's a candidate for receiving a 2nd dose of COVID vaccine to complete initial series or whether it's advisable to not get it.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 13-JAN-2014 the patient was vaccinated with one dose of ROTATEQ (dose not reported, lot # J003813, expired date: 10-AUG-2014) (unspecified in series) that were improperly stored with exposure to 9C for up to 64 hours. They were not standard doses. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Asthma flare-ups. Increased from a few times per year to daily, including an attack that put me in the ER for the first time.  Have occurred daily ever since. Now on daily singulair and Flovent. Together, they have partially mitigated the flare ups.
Headaches started at 6am 1/20/2021 patient took Ibuprofen 800mg at 7am and 1pm. patient reports slight headache on 1/21/2021 at 7am. she took Ibuprofen 800mg. still had a slight headache on 1/22/21 at 7am and took more Ibuprofen 800mg.
Following 3rd dose of vax Hep screening panel revealed pt had not sero-converted; revaccinated on 16NOV89 & 19DEC89 following 5th inject arm noted to be sl swollen w/redness @ inject site; 30JAN90 test revealed pt had sero-converted;
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age. The patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L022262, expiry date 05-NOV-2016, L027732, expiry date 23-FEB-2017 on multiple unspecified dates following an excursion that occurred on 13-JAN-2016. No adverse effects were reported. The temperature was 50.7 with a time frame of 1 hour and 30 minutes. This is one of the several reports received from the same reporter. Additional information has been requested.
t100, diarrhea, shakes, pain & joint aches, 1 day abdominal cramps;
At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F. The pain in my left arm was so severe I could barely move it. This all persisted to the morning of 1/18/2021 after which it resolved. I was unable to sleep at all the nights of 1/16/2021 or 1/18/2021.
Fever, chills, body ache, severe headache/earache, patient was unable to wear clothing for several hours because the feeling of clothes cause painful sensation on her skin.
TESTICULAR SWELLING; TESTICULAR PAIN; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced testicular swelling. On 2021, the subject experienced testicular pain. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.3 Unit not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, testicular swelling, and testicular pain. This report was non-serious.
lips swollen; tongue itchy; throat sore; Sleepy; arm pain; head hurt; joints hurt; chills; throat scratchy; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153), via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included long QT Syndrome, asthma, Attention-Deficit and Hyperactivity Disorder (ADHD), anorexia, sensory processing, misophonia and sensitive to some products and chemicals. Concomitant medications included ethinylestradiol, levonorgestrel (LARISSIA), lorazepam MANUFACTURER UNKNOWN), nadoloL MANUFACTURER UNKNOWN), Melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient was allergic to sensitive to - Dodecyl Gallate, Formaldehyde, Fragrance Mix I or II (most botanicals REMOVED), Fragrance STRICTLY AVOIDED (Products will be free of B Peru, Benzoic acid, Benzaldehyde, Benzyl Alcohol, Sodium Benzoate, Cinnamates, Octocrylene), Hydroperoxides of Limonene, Limonene, MCI / MI, Oil Free (Oil containing products will be removed from list but list WILL contain Petrolatum and Paran), Propolis, Propyl Gallate, Thiuram mix, Tixocortol-21-Pivalate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  On 08Mar2021, the patient received first dose of Diphtheria, tetanus, Pertussis - Tdap via left arm, four weeks prior to the vaccination. On 09Apr2021 at 16:15, the patient experienced arm pain right away and her head hurt and was sleepy, friday night her joints hurt and wasn't hungry but did eat some toast. The patient also reported that she had chills and throat was scratchy. She had been drinking water and Gatorade, Overnight she threw up after taking Tylenol but did ok. On Sunday, she woke up and her lips were swollen, but the tip of her tongue was itchy but hadn't gotten worse and her throat hurts. Monday lips are still swollen, tongue still itchy throat still sore. On an unspecified date, the patient received TYLENOL as a treatment for the adverse events. The clinical outcomes of the events arm pain right, head hurt sleepy, joints hurt, chills throat scratchy, lips were swollen, tongue was itchy and tongue, itchy and throat sore were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Patient reported nausea for 2 days beginning immediately after dose and feeling of lack of circulation in her right hand beginning day after vaccine and lasting 2-3 hours.  Patient described right hand/ finger felt numb and exhibited bruising on her right middle finger and below her fingernail.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two vaccination sites.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to HCF, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Received Td on 5/7/02 in left deltoid, vaccine lot U0376A, expiration date 2/5/03. Three days later, stated "had no strength, muscles hurt and ached in both arms and legs," also reported weight loss. Did not contact health dept until late June, had been to two doctors for the muscle weakness and pain, was told at that time felt to be arthritic in nature. Pt was started on Cataflam and given a steroid injection which made his sugars become elevated. Was switched to ibuprofen at that time with no resolution of symptoms. On 7/16/02, pt again contacted health dept with continuation of symptoms and was encouraged to contact his physician for an appointment. On 7/27/02, pt had an appointment with MD and was given a tentative diagnosis of Guillain-Barré syndrome.
Herpes Simplex 1 outbreak on corner of lip and center of upper lip, spread to tip of nose and inside of left and right nostrils. Lasted 7 days.
24 hours vomiting diarrhea.  Light headed lower BP from normal for week after.
Fever, 100F, started at 11:00 pm, 5/1. Self recovery at 06:00pm, 5/2. Sores in the injection region, self recovery at 5/3.
febrile episodes ranging from 101-104 for 48hr;taken to MD pt given APAP & advil for temp;
Today his is showing flu-like symptoms; the patient received his first dose of VARIVAX on 08/14/2019 and subsequently experienced injection site pain that evening; the patient used VARIVAX for prevention of shingles; Information has been received from a physician who wished to remain anonymous, referring to a 61 years old male patient. The patient's concurrent condition was not reported; pertinent medical history and drug reactions/allergies were unknown and his concomitant medication included atorvastatin calcium (LIPITOR).  On 14-AUG-2019, the patient was vaccinated with the first dose ofvaricella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not provided; route of administration, lot number and expiration date were unknown by the reporter) for prevention of shingles (product use in unapproved indication).    On 14-AUG-2019 in the evening, the patient experienced injection site pain. On 15-AUG-2019 (reported as today), the patient is showing flu-like symptoms. It was confirmed with the reporter that no rash was present. It was unknown if treatment was given or if lab diagnostics/labs were done for the events. The patient did not seek medical attention. No product quality issue was present. At the reporting time, the outcome of injection site pain and flu-like symptoms was not resolved.   The causality between atorvastatin calcium (LIPITOR) and the events was not provided.
Pain in arm, swollen lymph node, generalized muscle pain, headache, nausea, vertigo, fever of 100.4 F. Treated by patient with Benadryl and rest.  symptoms resolved after 48 hours except for the swollen lymph node and arm pain which are still present.
A physician reported that a 40 year old female received an injection of Tetanus Toxoid Adsorbed Purogenated on 3/10/2000. On 3/13/2000 pt developed intermittent pain at the injection site which would shoot into her neck and down her arm. Pt treated self with advil. This is 1 of 3 pt from this facility who developed an injection site reaction following receipt of tetanus Toxoid Adsorbed, Purogenated lot 462-809.
INDIGESTION; UPSET STOMACH; This spontaneous report received from a patient concerned a 62 year old male. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced indigestion. On 05-JUN-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from indigestion, and upset stomach. This report was non-serious.
A couple of days after my vaccine, I noticed a severe itch on my right arm that I received the vaccine. I noticed a red bumps that looked like they were filled with pus in it coming from my shoulder down to my elbow. It became not to bother me as much to do anything about and I let it go away on its own as it got scaly and dried up.
Stroke/left side of the body; Can't talk; can't walk; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke/left side of the body) (seriousness criteria disability and medically significant), APHASIA (Can't talk) and GAIT INABILITY (can't walk). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke/left side of the body), APHASIA (Can't talk) and GAIT INABILITY (can't walk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       There was no concomitant medications reported.  No treatment medications were provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
"I had a very sore, swollen, and bruised right arm from my RSV vaccination back on September 20, 2023.  I also experienced allergy symptoms for two days (runny nose and sneezing) and then they were gone. "
Hearing loss; Severe tinnitus; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (solution for injection, lot number: EK5730, Expiry Date: 31Mar2021, NDC number: 59267-1000-01), intramuscularly on 16Dec2020 at 0.3 mg, single in deltoid for prevention of COVID viral infection. The patient's medical history and concomitant medications were not reported.  The patient's wife is COVID positive, but he has not been tested and has no other symptoms. On 17Dec2020, the patient experienced hearing loss, and severe tinnitus. There is no additional vaccines administered on same date of the Pfizer suspect. The outcome of both events was not resolved.; Sender's Comments: The reported information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1 day post vax, deltoid L arm sore. Following day red spot occured. 3rd day blistered. 10x10 cm area of erythema. Blister below and medial to inject site.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009c21a and 46017821a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) had resolved.            Blood thinners and blood pressure were used as concomitant medications. No treatment medication details was reported.   This case was linked to MOD-2021-231073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up document received on 19-JUL-2021.Updated event outcome( Difficulty breathing)
PATIENT HAS SWOLLEN LYMPH NODES UNDER THE ARMS AND IN THE COLLARBONE AREA.  IT STARTED THE DAY FOLLOWING THE SHOT AND HAS BECOME PROGRESSIVELY MORE SWOLLEN AND PAINFUL.  PATIENT WILL CONTACT THEIR PRIMARY CARE DR FOR AN OFFICE VISIT.
Pt developed fever, chest pain and vomiting. Pt was seen in the ER, treated with PHENERGAN.
Whole body inflammation; Major fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A adult non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left (reported as left arm) on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left (reported as left arm) on an unspecified date as dose 2, single both for covid-19 immunization. Patient's relevant medical history included allergy to bee venom, from an unknown date and unknown if ongoing. The patient did not receive any concomitant medications. The patient previously received naproxen (MANUFACTURER UNKNOWN) and cefalexin (KEFLEX) on an unspecified date and experienced drug allergy. Prior to vaccination, it was unknown if the patient was 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 an unspecified date, the patient experienced whole body inflammation. and major fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Shortness of breath, had to increase to non-rebreather mask.  Restlessness and 2 seizures. The hospital discharge summary received on 2/3/04 states seizure, tachycardia, respiratory failure, and dehydration.
Initially had myalgias - bilateral neck and shoulders and generalized myalgias - now with crown area headache, dizziness, and perceived unsteady gait - neuro exam WNL.
Developed severe pain @ site of injection, large swelling & redness approx. 7 hrs after administration.