chrisvoncsefalvay/vaers-outcomes huggingface dataset:
32 y.o. female with no significant PMH presenting with chest pain, lightheadedness, dyspnea on exertion..   Patient reports that a month ago she started experiencing a headache around the time of her first COVID vaccination (~7/11/21). She then visited her doctor Wednesday 07/28. She was started on fioricet for headache treatment. She got her last dose of the vaccination, Sunday 08/01, and on Monday (8/2/21) started to experience facial numbness, left arm and hand numbness.   She went to hospital and was diagnosed with Bell's Palsy and started on prednisone. The next day she started to have chest pain. She described the chest pain as a pressure, as if someone was sitting on her chest, substernal in location without any radiation or alleviating/exacerbating factors. The chest pain persisted over the next two days which prompted her to come to the ER on 8/5/21.   In addition to the chest pain she endorses significant lightheadedness. She stated that it happens whenever she gets up to move, example going to the bathroom). No syncopal events. She denies any nausea, vomiting, melena, BRBPR, or hematemesis. She is on her menstrual cycle currently and says that she is not having heavier vaginal bleeding. Also having shortness of breath which is mild at rest but also worsened with exertion. Lastly did started to notice spontaneous bruising on her arms over the past two weeks without clear trauma.   Denies fevers, chills, dysuria, urinary urgency, cough, abdominal pain, diarrhea, rashes.   She is undergoing diagnosis with a presumptive diagnosis of Microangiopathic hemolytic anemia likely 2/2 to TTP, with PLASMIC score of 6.
Red bumps, pt thinks it looks like case of chickenpox, not itchy, scarred areas from prior outbreaks.
horrible pains in both shoulders; Pain spreaded to other joints; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 74-years-old female patient (who was not pregnant at the time of vaccination), received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in arm left on 18Feb2021 as 2nd dose, single; dose 1 (Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 21Jan2021 10:00AM, as 1st dose, single for COVID-19 immunization. Medical history included arthritis, high blood pressure and chronic boreliosis. The patient had known allergies to NSAIDs, Levaquin and latex. Concomitant medications included Oxycodone (OXYCODONE)7.5 mg; carvedidol (CARVEDILOL) 20 mg; gabapentin (GABAPENTIN) 300. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient stated that, No adverse effects first 4 days. Then a horrible pain in both shoulders, samnitska m up dcery houf. Could not lift a cup od water, pull my pants up or shirt on. Because I heard from a friend in a state that hers lasted a month I was waiting. After three weeks, Eben Pain spreaded to other joints I visited my family doctor. He prescribed Medrol- steroid pack.and to stop Simvastatin. Pains subsided after 24 hours. On 23Feb2021 06:00AM, the patient experienced horrible pains in both shoulders and pain spreaded to other joints. Therapeutic measures (Medrol) were taken as a result of horrible pains in both shoulders and pain spreaded to other joints. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected
6/1/06 Axillary temperature 103 F 6/8/06 Pinpoint rash on tummy 4-5 spots 5/26/06 to 5/29/06 Around someone who just received vaccinia vaccination.   6/2/06 Pt. went to Dr. office
Patient reports regular stinging, then joint pain from shoulder down to fingertips and the swelling at the injection site and to the right there was one "giant hive". Patient also reports body aches and mild fatigue but she has recovered from that.
During the 15 minute observation period after a patient had received her second dose of Moderna COVID-19 vaccine she began breaking into a rash and stated she had trouble breathing. The doctor onsite the vaccine clinic  recommended the administration 25 mg of benadryl on the patient's gluteal site which was administered by an LVN using a vial pharmacy provided. The patient was kept in observation until her symptoms subsided.
Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Hot, red, burning, itchy rash spread from vaccination site over shoulder and onto neck and face. Not relieved by topical Benadryl.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an 8 month old patient. On 22-APR-2014 (at the reporting day) the patient was vaccinated with the first dose of ROTATEQ, 2 ml, (lot #, expiration date and dose unspecified). No adverse effect reported. Additional information has been requested.
Pt. states after receiving the Moderna 2nd dose 07/16/2021, 07/17/2021 experienced swelling under the arm of the right side and soreness. Currently no visible swelling or soreness visible/detectable.  07/19/2021 Physician visit Dr. suggested just observation.
Product temperature excursion issue/patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue/patients were given shots during excursions) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue/patients were given shots during excursions). On 28-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue/patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
rt arm where Td given became sore & swollen in 24 hrs; remained for 72 hrs then blistered around site (1"-2" diam); pain down arm; swollen from 2" above elbow to shoulder, red, hot blisters white & yellow; swelling moved to joint & muscle;
very sore left arm, achy body,  weakness, 12 hours + after vaccination.
This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 15 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-FEB-2014 the pregnant patient was administered with a dose of 0.5 ml GARDASIL, (lot # J012212, expiration date 18-FEB-2014), intramuscular and a dose of influenza virus vaccine (manufacturer unknown) (lot #, expiration date and dose unspecified). Concomitant therapies included CLARITIN. The patient became pregnant with LMP of 17-DEC-2013 and EDD of 23-SEP-2014. Initial exposure to GARDASIL was at 9 week(s). The pregnancy outcome was outcome pending. No adverse effects reported. The patient underwent unspecified pregnancy test and unspecified "flu and strep screening test". Additional information has been requested.
Rash on both legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both legs) 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 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on both legs). At the time of the report, RASH (Rash on both legs) had not resolved. Not Provided          Patient stated has taken allergy medication and no relief yet.  Patient stated has been visiting HCP.
administered an expired vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old male patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 5th July 2022, the patient received the 1st dose of Havrix. On 5th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: The patient received an expired dose of Havrix vaccine. The reporter asked was it still effective. The reporter consented to follow up. Additional Supportive Information:  The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used
Fatigue, headaches, decreased appetite, SOB, body aches about 2 days after vaccine administration that has lasted 10 days
Subsequent to receiving the first and second doses of varicella virus vaccine live, laboratory evaluation revealed a lack of response.
Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 18Feb2021 12:30 (at the age of 57-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Neuropathy in legs from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 28Jan2021 13:00 (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chills on 18Feb2021 23:30 and headache on 19Feb2021 07:00. Patient did not receive treatment for adverse events. The outcome of chills was recovered, and headache was recovering.  No follow up attempts are possible. No further information is expected.
Pt. complained of dizziness, vision change.  Pt. became diaphoretic.  Blood Pressure was 99/68, Heart Rate was 68, SpO2 98% Respirations 16.  Pt. given ice pack to place under arm pit.  Pt. monitored for an additional 20-30 minutes and he left the clinic in stable condition with all signs and symptoms described above resolved.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient, after immunization, experienced shallow breathing, turned blue around his mouth, flaccid, non-responsive, total blank look and pale. At months of age, the patient received the first dose on 1/31/05. The patient also received the second dose of Recombivax on the same day. The patient had no relevant medical history. The child received several childhood vaccines ten days earlier. Indication for Prevnar was immunization. Product was administered on 1/31/05. Dose regimen was 1 dose. Additional suspect medication included Polio Vaccine, Hib-Titer vaccine, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant therapy included Advil given to the infant 30 to 45 minutes before Prevnar. After immunization, the child became non-responsive, turned blue around his mouth, flaccid, total blank look and pale on 1/31/05. The nurse laid the child on the table, thumped his chest slightly and rolled him onto his side. She worked on him for 35 to 45 seconds and he became responsive but his breathing remained shallow. Later, he was seen by the family physician. A complete blood count was performed and the results were normal. The mother of the infant did say that the child holds his breath when receiving injections, he never had a reaction like this one. As of the 2/1/05, the reporter indicated that the child is fine. A copy of this information has been forwarded to the manufacturers of the concomitantly administered vaccines.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. On unknown dates since 03-APR-2015, the patients were vaccinated with doses of ZOSTAVAX (lot # K016320 with expiration date: 24-DEC-2015 or lot # K016318 with expiration date: 24-DEC-2015), which were exposed to temperatures outside of the recommended range. The reporter was not aware of any adverse effects. Additional information has been requested.
headaches; The injection on Day 7 was not injected into the deltoid muscle. It was injected lower; muscle aches; Initial information received on 05-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced headaches, muscle aches while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received post exposure immunization, injection of doses on Day 0, 3, 7, and 14 of suspect RABIES (HDC) VACCINE lot number, expiry date not reported via unknown route in unknown administration site. (Day 7 injection was given in lower deltoid muscle NOS)  On an unknown date, the patient developed a non-serious headaches (headache) with unknown latency following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious muscle aches (myalgia) with unknown latency following the administration of RABIES (HDC) VACCINE.  It was an actual medication error due vaccine administered at inappropriate site as the injection on Day 7 was not injected into the deltoid muscle. It was injected lower.  Lab data was not provided.  Final diagnosis was muscle aches and headaches.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved for headaches, as Recovered / Resolved for muscle aches (duration 3 days).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Information on lot number was requested for this case.
Full body rash; WBC drastically dropped to almost zero; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) in a male 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 medical history provided.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Full body rash) (seriousness criterion hospitalization) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) (seriousness criteria hospitalization and medically significant). At the time of the report, RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) 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 medications were not provided.  Physician called to report adverse reaction for her husband's co-worker who received the vaccine ten days back and developed full body rash and was hospitalized. Patient's WBC count drastically dropped(Almost zero). They were not sure if the vaccine was Moderna.  Treatment details were not 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.
Patient received COVID vaccine (Pfizer) dose 1 and afterwards experienced heartburn, tingling in both arms, and developed tongue/hard palate discomfort immediately following the vaccination and states BP was elevated. Patient had vitals taken and noted systolic BP 205, then RRT called and taken to the ED for further monitoring. In the ED patient had CBC, CMP, and Troponin drawn and no abnormalities seen and EKG was normal. Patient was monitored and then discharged home from the ED.
No fever. Leg became "itchy" and red day after immunizations given about the size of a quarter continue to increase in size approximately size of baseball - given Clarinex syrup recommended Motrin post ice to site.
Normal side effects to expect with the exception of after the third day of the second dose my lymph nodes are swollen and tender in my right armpit and right neck which I have not read about any reports of this reaction. My lymph nodes are only on the same side as where the second dose Pfizer injection was administered.
Patient reported development of rash on right arm 1 day after vaccine. Described as raised, erythematous, pruritic. Rash then spread to left arm and left leg and neck. Rash is still present.  Also endorsed 3 weeks of night sweats following vaccination. Also endorsed 1 day of chest discomfort, globus sensation, and difficulty breathing- resolved with albuterol inhaler.   Had telephone visit with PCP office- on 3/25/22 for her symptoms.  Treatment: 7-10 day course of hydroxyzine 25 mg for rash.
Arm was typically sore after a vaccine, but I am still sore and have now developed a redness area that is moving down my arm and up to my shoulder.  Erythema is approximately 5.5 inches in length from top of my shoulder extending towards the medial side of my right arm.  Width is approximately 6 inches extending across my arm.  The tenderness has also moved with the redness and is now the most tender on the medial side in the middle of my arm.
excruciating pain; 5 bad disks; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-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 SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks). At the time of the report, SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported. No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains non-significant information.
No symptoms reported./ No additional AE; were given an extra dose of MMR-II and VARIVAX; This spontaneous report has been received from a registered nurse referring to a child patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 28-JUN-2023, the patient was vaccinated with an extra third dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W039697, expiration date: 13-DEC-2024, administered subcutaneously (SQ) for prophylaxis (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (extra dose administered). The reporter was looking for further guidance. No symptoms reported. No additional AE or PQC (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013345:
I began experiencing cramps and pains in my right leg, especially behind my knee and calf. There is also a lump behind my knee that I never noticed before. It was very painful to walk and to stand for long periods of time, I somewhat limped. But there was no swelling or redness. After about 2 weeks of this pain, I went to urgent care, City MD. They were worried that it was a cyst or a DVT, so the doctor prescribed sonograms of the veins and tissue. The lump was a normal vein (possible varicose vein), but there were no signs of DVT or abnormal blood flow. The doctors concluded that it must be a muscular strain. I was told to rest and take ibuprofen. I exercise frequently, but had never had something like this happen to me. The pain persisted for about 4 more weeks. I did not fully recover my leg until mid-July. I sometimes get a little pain in the morning, but the pain is mostly gone.