chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted to ICU from ER. Ntg drip relived C/P. Stress test-negative. Lovenox. Admitted on 3/31/03. DC 4/2/03. C/O CP at stenum that radiates into L shoulder and L side of neck approximately 2 hr PTA. Pt states it feels like pressure, and a sensation that she "couldn't get enough air." She is a 55 year old female. The pt has been under a little bit more stress than usual today. She worked a 24-hour shift the day before she got ill. Yesterday while she was walking around the hospital she had chest pain, it bothered her, made her a little bit dizzy and she got diaphoretic with it. It was midsternal, progressive and associated with some shortness of breath and some aching in her shoulder and neck. She got to thinking about all the people she had seen with chest pain that she had warned to come to the hospital because of it and finally went to the ER. They did EKGs and started a nitrodrip on her and she got almost immediate relief of the chest pain with the nitro drip. The heaviness and shortness of breath were also resolved. She became hypotensive and they had to drop her off of the nitrates and the chest pain returned. They started the nitrates and the chest pain was resolved again.
No adverse event; received possibly improperly stored vaccine due to lack of temperature readings; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. On 10-FEB-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin-rHA) subcutaneous injection, valid lot # U015476, valid expiration date: 13-NOV-2022, administered for prophylaxis (strength, dose, and route of administration were not provided). The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   Causal assessment between measles, mumps, rubella and varicella (Oka Merck) virus vaccine live (PROQUAD) regarding the events was not provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000564: US-009507513-2205USA000560:
This case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to BEXSERO. Additional details were reported as follows: This case was reported via email. The age at vaccination was not reported. The patient experienced a very large erythema.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-OCT-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Dose of MENACTRA given on 7-31-08 at approx 1630.  Patient had dose of MENACTRA on 7-22-08.  Pt. complained of pain at injection site.
Patient became pale, weak, slightly warm. Advised rest + fluids, light snack + ER if symptoms became worse. After eating dinner, patient improved greatly
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. The subject also experienced left arm pain which radiated down the arm. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A through A0809361A.
"Delayed menstruation. I have a prettyregular cycle, and I am now 6 dayslate on my period"; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 29Mar2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included loratadine (CLARITIN) and ibuprofen (ADVIL), Prenatal vitamins ; all from unknown dates for unspecified indication. The patient previously took Fluconazole and experienced drug allergy. 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, the patient experienced delayed menstruation. She had a pretty regular cycle, and she was six days late on her period. She had taken two negative pregnancy tests. The patient was planning to try to get pregnant later this spring, but now  she was very concerned the shot will negatively impact her fertility and menstruation cycle. 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 events. The clinical outcome of the event delayed menstruation was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Cellulitis and wheal and flare. Levaquin 500 mg PO q day started 10/016/07. Benadryl 25mg PO q 6 hr started 10/17/07.
an unspecified 15 year old female patient was administered a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 15 year old female patient. No information was provided regarding the patient's medical history, previous drug reactions, allergies, and concurrent conditions.  On an usnpecified date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002924 with expiration date on 28-JUL-2020 for prophylaxis (strength, dose, anatomical location, and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age).
Patient tested positive for COVID 19 by PCR on 4/15/21; >2 weeks after 2nd dose Symptoms started 4/3/21; now w/ SOB w/ exertion, cough, chills, diarrhea, fatigue, chest pain/tightness, fever.
Right deltoid area red, warm and painful to touch.  Mother gave Tylenol, applied cool compresses.  Area of redness measured 8 x 11 cm wide.  Parent would schedule follow up appointment  (if condition not improving) to be scheduled.  Patient doing well, no redness or soreness of arm 05/21/2003.
Fever onset (101 F) on Sunday (09/17/17) around 18:00. Low grade fever (100 F) all day Monday followed by mild rash all over the body on Tuesday.
Itching; Aches and pains; Pins and needles; This is a spontaneous report from a contactable consumer (reporting for herself).  A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation  (85-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. Patient states he has a pacemaker and has a stent in his heart. Both have been there for over 10 years. The patient's concomitant medications include carvedilol (COREG) at 25 mg, twice a day taken for cardiac disorder (He has been taking this for years). It was reported that patient previously took first dose of bnt162b2 (Lot number: EM9809, Expiry date: 30Jun2021) 04Feb2021 11:00. It was reported that during that night he was getting aches and pains, he took Tylenol and was fine for a while week. The week after that, he started to get pins and needles all over his body, and itching. He states it did not want to go away. Sometimes it was better, sometimes it was worse. The doctor gave him antihistamines, but it did not go away. All the doctor's say they have never heard of it, no one knows what it was. He read some place that they have few cases like this. He was just trying to find out what he should do. He was itching all the time and got pins and needles. The antihistamine helps, but it comes back. It has been over a month now, almost 2 months. He asks what he should do. He had seen a cardiologist, urologist, and his regular doctor. In the beginning he had itchiness and pins and needles all the time, but now it was on and off. For example right now he did not have it but when he woke up this morning it was there. He tried different soaps and different shampoos, just in case that was it. He even took off some of the medications for a couple days to be sure it was one of them but no. He was almost 100% sure it was it, he never had this before. Started the night of the shot. It got a little better in the night. The next morning he took Tylenol and felt better and thought it was all over. It was then explained that it started again about a week or so later and now he has it all the time. Itchiness began a week or a week or a half. Then says it could have been 2 weeks later. The symptoms are on and off. For the aches and pains he took Tylenol and it went away. The doctor that prescribed Coreg said he never had anyone having trouble taking this medication with the vaccine. He never heard of that. That was the first thing he asked. Outcome of the event Aches and pains was recovered on 26Feb2021. Outcome of the other events was not recovered.     No follow-up attempts are needed. No further information is expected
Patient experienced mild urticaria and pruritis at injection site within a minute of vaccine delivery.  Patient was monitored for 10 minutes before guardian had to leave clinic to attend to an emergency.  Patient was given 25mg of Benadryl for the pruritis.  No other symptoms observed.  Signs and symptoms of anaphylaxis provided.
Papular rash noticed 24 hours after shot. Rash located on same area where vaccine was given.
Got my 2nd booster on 6/10/22; got Covid on 9/1/22 (E=Day 0); got on Paxlovid 9/2/22. Covid symptoms were "mild" - no fever but intense headache and congestion and feeling crummy. Paxlovid course made my skin itch (especially arms and scalp) but no rash or hives. Something to put up with if it makes this be over faster, but I got Covid after 4 shots anyway.
Temperature of 103 degrees F, weakness, joint pain, diaphoretic for 2 days, treatment was rest and administration of 800 mg Ibuprofen every 6 hours.
Patient received two vaccines on the left arm as requested by the patient while patient's mom is next to her at 11am.  patient started feeling nauseated and feeling faint but didn't end up fainting but threw up in the garbage can. mom reported to intern that patient often vomits after all vaccinations and is fine after 15 minutes of resting. Mom and patient said it is not necessary to call their doctor or go to call paramedics. They both walked out fine after 30 minutes
Patient was administered a Boostrix on 8/29/2022 that had expired on 8/19/2022.  Patient was immediately informed and was held for observation.  He had no adverse events and was offered a return visit for a fresh Tdap.
Left eardrum burst 2 days later. There were no symptoms on Friday, there were few symptoms on Saturday. On Sunday it burst I went to the otologist on Monday. I took 2 doses of 10 days each of antibiotics. Increasing tiredness after shot. Sometime in January, I began feeling tired and it got worse to a point where I could not do as much. I am now attending physical therapy to strengthen. I was unable to get up from the floor if I kneeled which was not an issue for me before. This was around February.
Unable to stand up straight or ambulate without help; Unable to stand up straight or ambulate without help; 102 temp; Nausea; Lethargy; Vertigo; Brain fog; Lack of visual field; Posterior mid back pain; Spent 3 days in bed with these symptoms; Hot to touch at injection site and very painful; Hot to touch at injection site and very painful; This is a spontaneous report from a contactable nurse (patient). This nurse reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot Number: EM9809, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation at a doctor's office/urgent care. Medical history included hypertension, hypercholesterolemia, hypothyroid, chronic lumber pain and glaucoma. Known allergies include statins. Historical vaccination information included the patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 28Jan2021 at 4pm (Batch/Lot Number: EL9261, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation. On an unspecified date in 2021 (after the second vaccine dose), the patient experienced 102 temperature, nausea, lethargy, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain. She spent 3 days in bed with these symptoms. The morning lethargy lasts till around noon then subsides. She also reported it was hot to the touch at injection site and very painful. The clinical outcome of the events 102 (unspecified units) temperature, nausea, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain, spent 3 days in bed with these symptoms, injection site was hot to touch and very painful was unknown.   Follow-up (12Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101487756 Same reporter/SD, potential/AE
Heart palpitations; Chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort). At the time of the report, PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: No abnormal findings. On an unknown date, Electrocardiogram: No abnormal findings.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient visited the local emergency department on 07-Sep-2022 due to chest discomfort and heart palpitations. Her ED physician mentioned that it might be related to COVID.  No treatment information was provided.
This spontaneous report was received from a pharmacist via a company representative regarding an unknown number of patients (also reported as one or two patients) of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and dosing regimen unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, Pharmacist mentioned to representative that an unknown umber of patients may have received less than the recommended dose of ZOSTAVAX because the pharmacist was not able to withdraw the complete amount of the reconstituted ZOSTAVAX from the vial. When the pharmacist worked at other pharmacies about a month ago (names not provided), she stated she may have had one or two patients (names not provided) that may have received ZOSTAVAX vaccine that was slightly underfilled. A PQC (product quality complaint) was filed. No Adverse events symptoms were reported. The outcome of the underdose was unknown. Additional information has been requested.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 11-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Moderna COVID-19 Vaccine EUA:      Chills, headache, neck pain, back ache, fatique, bloody nose, high BP (154/110), injection site pain.   No history of bloody noses and history of  taking BP.  Have not taken BP pills last 3 years because pressure has been stable.    Symptoms disappeared after 48 hours with exception of slight headache on day 2 and injection site pain.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 67-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.  On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.
It was reported that a male pt received a TD vaccine on 4/13/99 and reportedly, 2 days later, the pt experienced "swelling, redness and warm to the touch at the site of the injection". The pt went to the doctor and from additional information received on 5/17/99, it was reported that the pt recovered from this experience.