chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient told me that they had a reaction after receiving a vaccine.   Patient went to urgent care with vomiting/nausea, generalized unwell feeling, and rash on arm near injection site for Tdap.
soreness and Body pain; joint pain; headache; muscle pain; experiencing more pain ever since he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness and Body pain), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and VACCINATION SITE PAIN (experiencing more pain ever since he received the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Peripheral neuropathy.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness and Body pain), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and VACCINATION SITE PAIN (experiencing more pain ever since he received the vaccine). At the time of the report, PAIN (soreness and Body pain), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and VACCINATION SITE PAIN (experiencing more pain ever since he received the vaccine) 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.   Reporter did not allow further contact
Immediately after administration of HD Flu vaccine pt's injection site swelled to about the size of a golf ball. Pt went to urgent care and was told it was nothing to worry about, a nerve was possibly hit. Swelling decreased and pt was fine.
Aches; Chills; Discomfort; L lymph node swelling under arm and L side of neck; This is a spontaneous report from a contactable pharmacist, the patient. A 50-year-old, female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route in the left arm on 21Apr2021 (at an age of 50-year-old) as single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received oral contraceptives (OC) (MANUFACTURER UNKNOWN), calcium sodium lactate, calcium phosphate and ergocalciferol (CALCIUM WITH VITAMIN D) and AREDS with 2 weeks of COVID-19 vaccination for unknown indications. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route in the left arm on 31Mar2021 as single dose for COVID-19 immunisation. On 23Apr2021, after 8 hours of vaccination, post the second dose, the patient developed chills and aches, resolving in 24 hours. Following, she developed L lymph node swelling under arm and L side of neck, resulting in discomfort on an unknown date in Apr2021. The patient was able to do most activities except normal exercise. These resolved with any interventions after 5 days. Since the vaccination, the patient had not been tested for COVID-19. 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, and emergency room/department or urgent care. The clinical outcome of the events of aches, discomfort, L lymph node swelling under arm and L side of neck and chills were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 32°F for 45 days. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006132: US-009507513-1702USA009042: US-009507513-1702USA009043: US-009507513-1702USA009040: US-009507513-1702USA009041.
Patient woke up on Oct 26th am with pins-and-needles sensation and numbness initially started in her feet and progressed to her both legs.  Patient complains of having similar sensations in both hands.  Patient got flu shot 10/25.  Admits to have tinnitus since morning.   She was admitted to the hospital and diagnosed with Guillain-Barré  and started on plasma exchange.
Intense diffuse pruritus occurred primarily in the arms and legs.  Itching the affected areas resulted in more severe symptoms frequently leading to bleeding.  The itchiness was spread over a broad area (no hives were observed at any of these locations).  Exposure to hot water (bathing) intensified the symptoms.  Treatment included antihistamines (Zyrtec and Loratadine; 1 each daily) with minimal efficacy.  Symptoms were reduced by application of topical lotion to the affected areas.  Symptoms persisted for 8-9 weeks and then subsided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.86.  Concomitant products were not provided.  On 15 Apr 2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06 Apr 2021, vial was moved to clinic on 15 Apr 2021. 18 vials were sent to clinic. Vaccine BUD date was 09 May 2021.  On 15 Apr 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer or refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Initial report received from a nurse on 10 Mar 2011: This patient was vaccinated with MENVEO (batch number X10030) on 04 Mar 2011. The patient was inadvertently administered 0.5 ml IM dose of only the MenCWY liquid conjugate component of 04 Mar 2011. No adverse event was reported since administration.
Entire body aches that has not subsided. Joint pain throughout my body that has continued since the vaccine was administered. These symptoms did not exist prior to the vaccine. I hurt everyday and I am at a loss as to what to do.
pt devel fever, stridor, cough on evening of having been given vax; clinical dx was croup;
Initial report was received 29 October 2010 from a health care professional. A 38-year-old male patient who had a history of morphine allergy, had received a first dose intramuscular right deltoid injection of ADACEL, lot number C3516AA and an intramuscular left deltoid injection of FLUZONE, lot number U3A655AA (invalid sanofi pasteur lot number) on 04 October 2010 and an unspecified amount of time later on the day of vaccination, the patient developed a cough, chest congestion and slight shortness of breath. The event required a doctor's visit, and the patient began taking a Z Pak and PREDNISONE on 29 October 2010. The patient had no concurrent illness and he had been taking ALTACE and NEXIUM concomitantly at the time of vaccination. At the time of the report, symptoms remained ongoing and the patient had not recovered. Documents held by sender: None
Fri 04-16-2021  10:00 pm  Bad Chills start. Sat  1:30 am woke with 100.6 fever.  3:30 am woke with 101.8 fever.  8:30 am 101.8 fever.   11:30 am 101.6 fever.  4:00 pm 103.3 fever, took 2 Excedrin.   5:00 pm  101.7 fever.  6:00 pm  99.6 fever. 9:00  pm 97.6 temp.  10:00 pm 99.0 fever.  10:45 pm 100.5 fever took 2 aspirin.  11:45 pm  101.7 fever. Sun  1:00 am 98.5 temp. 4:30 am 98.9 fever.  8:00 am 98.8 fever.  12 noon 99.5 fever took 2 aspirin.   2;00 pm temp normal.   Felt 100 % OK from then on.  No more problems
Symptoms: extreme chills to the point where I could not sleep and could not get warm.  Fever 101-102.  Body aches and extreme exhaustion to the point I could barely move.  Symptoms were much worse than the second Moderna vaccine.  It finally started to get better about 48 hours after injection.  I still have some lingering musculoskeletal aches.
Acute Pericarditis, approx onset of symptoms 9/18  seen at urgent care on 9/23 Stat Labs results showed elevated Troponin Levels, sent to ER. Went to Hospital ER where he was admitted into observation on 9/23/2021 discharged 9/25 to follow up with cardiologist on 10/12
COLD SWEATS; FEVER; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced cold sweats. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold sweats and fever was not reported. This report was non-serious.
Patient developed mild rash to right leg near the site of the varicella vaccine and also 2 small raised spots noted to posterior thigh.
Pfizer-BioNTech COVID-19 Vaccine EUA Heat flash in chest and throat, blurry vision, nausea
Patient was given Pediarix vs. Kinrix; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient was given Pediarix instead of Kinrix because she needed a 3rd dose of Hepatitis. The patient did not experience any adverse reaction to the dose. Additional Supportive Information: The patient was given Pediarix instead of Kinrix because she needed a 3rd dose of Hepatitis, which led to Wrong vaccine administered.
pt recv vax 13NOV97 & mom reported pt devel h/a & nausea 30min p/vax;APAP given;father reported pt slept & w/in 24hr was feeling fine;pt also exp swelling of hands, feet & face;
This spontaneous report as received from a consumer via Clinic refers to a currently 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-OCT-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (Lot # M044350, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
general malaise at 12 hours later, got into bed and immediately developed body aches 6/10 and chills 5/10; did not fall asleep until 3:30 am
Two hours after receiving Td vaccine, redness and pruritus of skin, hives, some swelling of ears and scalp. Patient took Benadryl.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX vial (strength, dose were not reported) (lot # M042850, expiry date: 18-JAN-2018) subcutaneously for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved.
PT FELT LOW BLOOD PRESSURE APPROX 1 HOUR (3.40P) AFTER THE IMZ, OVER THE COURSE OF AN HOUR WHILE WAITING TO RECOVER AND HER HUSBAND TO PICK HER UP SHE FELT WOOZY (4.00PM) THEN SAID SHE FELT LIKE A SEIZURE WAS COMING ON , SHE EVENTUALLY SLID TO FLOOR  AT 4.20PM; BP TAKEN AT 4.26  73/58 PULSE=121 ; PARAMEDICS ARRIVED  4.36PM AND RESUMED CARE AND ADMITTED HER TO HOSPITAL ; I  FOLLOWED UP WITH THE PATIENT THE EVENING OF 9/26/19, SHE WAS FEELING BETTER BUT WAS STILL TRYING TO RECOVER HER SPEACH FROM THE SEIZURE
approx 1mo p/vax pt exp rash which was dx as mild case of chickenpox.
This spontaneous report as received from an unspecified healthcare worker refers to a 10 year old patient of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot # L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported, This is one of the several reports from the same source. Additional information has been requested.
By 3/20/03, left leg was red and swollen to an area 14" X 16" from hip to knee and extends to back of thigh and warm to touch. Treat with ice packs and Tylenol.
Case number PHHY2012US051498 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with trivalent inactivated influenza vaccine (seasonal influenza vaccine, manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unknown date after vaccination, the patient had intrauterine fetal death. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among present women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
TOOK VIVOTIF AND VOMITED 2 HOURS LATER; This spontaneous case report (PVX2019-1627) was received from a pharmacist on 22-Jun-2019. It describes a 17-year-old male consumer who "took Vivotif and vomited 2 hours later". He was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif on 22-Jun-2019 and vomited 2 hours later.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer "took Vivotif and vomited 2 hours later". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "took Vivotif and vomited 2 hours later". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Left arm has been aching; pain in the left arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Left arm has been aching; pain in the left arm". The event "left arm has been aching; pain in the left arm" required physician office visit. The patient underwent the following laboratory tests and procedures: X-ray: There is no problem there. Therapeutic measures were taken as a result of pain in extremity. Per clinical course, the patient and his wife had Pfizer shot for the COVID-19 two years ago and they were happier and had the shot in the right arm. Now, the left arm has been aching ever since the shot, they never had anything in the left arm, and they have pain now in the left arm. They had a reverse shoulder in the left arm (as reported) number one, and they had no trouble with the reverse shoulder. It has been fine, they had X-rays and everything else and there was no problem there. They have had pain in the left arm, and they believed it is the result of the Pfizer vaccine shot. The patient was calling, and his wife is right beside him wondering if there is anything they can take that Pfizer would recommend because none of their doctors know what to do with it. They had the booster shot also.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050924 Same reporter, product, and event; different patient;
16 hours after injection: Facial swelling around right eye for 18 hours.  Hives (raised bumps) along left side of body and upper back area.  Hives lasted about 6 hours, or about 3 hours after taking diphenhydramine 50mg.  12 hours after injection for about 8 hours:  insomnia, tingling in lower legs, mild pain around injection site,  stomach pain/nausea, headache, cough, stuffy nose, confusion/anxiety.
FEVER; EXHAUSTION; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and exhaustion. This report was non-serious. This case, from the same reporter is linked to 20210331202, 20210332072, 20210331262, 20210331801 and 20210331104.
APPROXIMATELY ONE WEEK AFTER RECEIVING VACCINE BEGAN HAVING PAIN AND FLU-LIKE SYMPTOMS.  WAS DIAGNOSED WITH GUILLIAN BARRE SYNDROME WITH A LUMBAR PUNCTURE.
Reaction/Event: limited arm movement with the flu shot; Case Narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer, reference number 2016108259) on 26 February 2016. This case involves a (age and gender not reporter) patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had limited arm movement. Laboratory investigation and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
All of my lymph nodes are swollen, very painful and felt I couldn't move. I couldn't pick anything up. I was drained, tired, and had a racing heart. I just rested. All of this lasted about a week and a half.
awoke feeling sweaty became very diaphoretic, hears flutters, collapsed, ? faint or sz-became incontinent;30sec duration pt feels probably loss of consciousness; & not sz;5-10min felt nl;lightheaded-cold sx;
Severe arm swelling/pain reported the morning after the injection.  Patient self reported taking ibuprofen.  Patient advised to continue with ibuprofen, add diphenhydramine and contact medical provider/urgent care.  Patient responded that they would seek attention at an Urgent care facility.
(L) Deltoid - very red from (L) deltoid to axillary area lump - 32" c/o pain, red streaks - over area. Medically permanent due to reaction to Anthrax.
Congestion, runny nose, cough, fever, aches. Home test for Covid 19 positive on 11/22.