chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer (the subject's mother) and described the occurrence of rash all over body in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), Rotavirus vaccine, Hepatitis B vaccine, Hib and (non-gsk) PREVNAR. A physician or other health care professional has not verified this report. On an unspecified date in November 2009 the subject received 1st dose of INFANRIX (unknown route, unknown thigh). It was unknown whether the subject received concurrent vaccinations. One day after vaccination with INFANRIX, the subject experienced rash all over body. After the next vaccination with INFANRIX the event recurred. On an unspecified date the subject received unspecified dose of Rotavirus vaccine. At an unspecified time after vaccination with Rotavirus vaccine, the subject experienced unspecified food allergies. On an unspecified date at 4-months-old, the subject received 2nd dose of INFANRIX (details unknown) unspecified dose of Hepatitis B vaccine (details unknown), unspecified dose of Hib (details unknown), and unspecified dose of PREVNAR (details unknown). One day after vaccination with INFANRIX, Hepatitis B vaccine, Hib, and PREVNAR, the subject experienced rash all over body, and at an unspecified time after vaccination with INFANRIX, Hepatitis B vaccine, Hib, and PREVNAR, the subject experienced food allergies. The consumer reported that the events were worse after the vaccinations received at 4-months-old. At the time of reporting the rash all over body was resolved and the food allergies were unresolved.
47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021); This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 17NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Vaccine expiration date was mentioned as 07-NOV-2021.
Information has been received from a health care professional concerning a patient who on 11-MAY-2010 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (lot # not reported). No other details provided. It was not specified if the patient sought medical attention. Additional information has been requested.
Went to gym was doing stuff in water,working on bar bells, started rt shoulder pain soerness. Rt shoulder not able to lift, swelling deltoid area, triceps demarcation, no neusens deficit, elbow, hand rom nl 10/01/2018 11:47:22 AM PDT > rt shoulder/upper arm pain r/o hematoma, muscle repture Ordered CT scan and labs, recommended to keep arm in sling
Patient with history of Alzheimer's dementia, diabetes.   She was brought to the ED by EMS on 11/16/22 for evaluation of weakness and cough. Her son was concerned about the patient's ability to care for herself at home. COVID-19 PCR test was done in the ED which resulted positive. Ultimately patient was admitted to the hospital 11/16/22 - 12/2/22 for evaluation of her weakness. Discharge diagnosis included generalized weakness and agitation in the setting of COVID-19 infection, COVID-19 infection has resolved.
An 18-year-old male patient (WA) experienced lethargy after receiving RabAvert therapy. The patient received the first three doses of RabAvert, 1 ml intramuscularly on days zero, three and seven with the third dose given on 22 Jul 03.   The patient received the first three doses of RabAvert and became lethargic after the injections. He skipped the fourth and fifth doses due to the lethargy. The patient had returned to the hospital in Sep 03 complaining of a sore throat and vomiting, treated with amoxicillin. The reported stated these events were unrelated to RabAvert. No further details are available at this time.  Follow-up received 08 Dec 03: The patient sustained a coyote bite on 06 Jul 03 and experienced lethargy, weakness, tiredness and flu-like symptoms while receiving RabAvert. He received 5 injections of RabAvert from 08 Jul 03 to 07 Oct 03 (first dose 08 Jul 03, second dose 11 Jul 03 and third dose 15 Jul 03). He also experienced and episode of pharyngitis, gastroenteritis and vomiting on 17 Sep 03 during the RabAvert series, treated with Amoxicillin. Other concomitant medications included a diphtheria tetanus (DT) vaccination on 07 Jul 03 and a 10 day course of Augmentin beginning 07 Jul 03.  On 11 Jul 03 the patient complained of tiredness and flu-like symptoms (described as severe after the first injection on 08 Jul 03). On 15 Jul 03 he still had flu symptoms, tiredness and lack of energy that lasted for three days. On 22 Jul 03 the patient did not present to the clinic to take the RabAvert injection #4 because he was feeling so lethargic, so it was administered on 22 Sep 03. He received the 5th injection on 07 Oct 03. After the fourth and fifth doses the patient experienced weaknesss, lethargy and flu-like symptoms, lasting three to four days post injection. The symptoms were more noticeable after the fifth dose. He had a complete recovery by 04 Dec 03.
After initially receiving my first Moderna shot, only issue was sore arm.  Less than 4 days after received shot, woke up with vertigo.  This led to vomiting for 14 hours before I could keep anything in my stomach. Dizziness, nausea, diarrhea throughout the day.  Chills for about 3 hours at onset.  Slight dizziness, nausea and headache next day.  Continued slight dizziness and nausea 3 days later.
Fever as high as 104.7 Body Aches Chills Tired Sore at injection site
On 2/13/02, the vaccinee received her 1st injection of Engerix-B. On 2/15/02, she developed a red, papular rash on her left lateral flank. The rash resolved on 2/20/02. The reporter stated that the rash was possibly related to Engerix-B.
Dizziness, Headache, Myalgia, Fever &  NauseaVomiting Narrative:  Headache, myalgia, fever, nausea,  vomiting, dizzy, resolved in 30 hours.
10/30/22 presents to ED for "chest pain, syncope". PMHx of "COPD"
27yo male received YF-Vax and JE-VC on 14 Jul 2018. Approximately 45m later, he began to feel hot, broke out in hives (neck, chest, and RUE), felt like his throat was closing, experienced tongue tingling, had red watery eyes. He went to the ED, where he reported dyspnea, and had audible wheezing (noted as both inspiratory and expiratory), although respirations even/unlabored, able to speak in complete sentences. Per available notes he was treated with epipen at 13:41 & arrived in ER at 14:10. Initial O2 sat is documented at 94% and exam notes describe urticaria to lateral upper extremities, chest, back and abdomen,, neck swelling and non-productive cough. Patient denies any other known adverse events following immunizations. Patient states he tolerates ingestion of eggs and gelatin and denies any known adverse reactions to latex, neomycin, polymixin, sreptomycin, thimerosal, yeast, or formaldehyde.
blacked out intermittently without loss of consciousness; Dizziness/felt verylightheaded; This case was reported by a nurse via sales rep and described the occurrence of blackout in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced blackout (serious criteria GSK medically significant) and light headedness. On an unknown date, the outcome of the blackout and light headedness were unknown.   It was unknown if the reporter considered the blackout and light headedness to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported.  After receiving 1st dose of Bexsero, the patient experienced dizziness, felt very lightheaded and blacked out intermittently without loss of consciousness. The HCP said patient denied any fainting or syncopal episodes. The MSL called HCP back and left message since HCP was with patients. The reporter consented to follow up. This case has been linked with US2020AMR182434 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR182434:same reporter
When given the first dose I had slight pricking when the needle went in and when they removed the needle. Otherwise no pain.  Later that night my arm started hurting and I felt a sharp pain in my forearm, my fingers felt like millions of needles were picking them in both hands, and I had severe abdominal pain just below the belly button. The abdominal pain was so severe that I was screaming out in pain and my wife had to hold me. I took three ibuprofen, still have the pain, but fell asleep. The abdominal pain went away the next day. The other symptoms took a few days to get rid of.
12yo with varicella immunization on 4/8/2021. Mother reports swelling and pain in left arm for over 2 months. Mom did not want to give her ibuprofen for pain.  On exam arm sizes were found to be symmetric.  Full range of motion of both arms.  Normal strength and sensation.  Ultrasound ordered per mother's request.
Case number PHEH2013US025478 is an initial spontaneous report received from a nurse on 09 Dec 2013 and a follow up report from the nurse received on 09 Jan 2014: This report refers to a 56-year-old male patient. She was allergic to crabs. Concomitant vaccines included TYPHIM VI (batch number: J12011) and TWINRIX (batch number: MF3X3) intramuscularly on 09 Dec 2013. The patient was inadvertently vaccinated with 0.5 ml of MENVEO (batch number: M12100) intramuscularly in the left deltoid on 09 Dec 2013 (09:30 am). No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow up report from the nurse received on 09 Jan 2014: medical history, concomitant vaccines, MENVEO vaccination site, date and dose were updated.
chickenpox like rash with pustules on her arms and legs; chickenpox like rash; This case was reported by a consumer via call center representative and described the occurrence of pustular rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix. On 19th April 2022, 4 days after receiving Shingrix, the patient experienced pustular rash and vesicular rash. On an unknown date, the outcome of the pustular rash and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the pustular rash and vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: This case was self reported by patient. The patient reported that she received dose of Shingrix and after 4 days she developed a chickenpox like rash with pustules on her arms and legs. AE (Adverse Event) filed. The reporter was given medical disclaimer. Referred to HCP (Heath Care Professional). Spoked per package insert and content. The reporter provided MI (medical information) phone number for HCP (Health care professional) reference. Offered after call survey. The reporter consent to follow up.
Left upper arm cellulitis at injection site. Treatment started 7/16/07 with Augmentin 875 mg BID x 10 days
Patient reported dizziness, fast heartbeat, weakness, and pain and swelling in left arm.
Large local reaction to DTAP injection. Given 4-17-10- Lt thigh.
headache, nausea, extreme joint pain (beyond what is normal for me for my osteoarthritis) - joint pain in knees, hips, ankles, feet, wrists, fingers, neck;
This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician and received via a Pfizer sales representative. A 16-year-old male patient of other race received TRUMENBA at 0.5 ml single, in right arm and MENACTRA at 1 DF single, in left arm, both on 26Jun2017, for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced fatigue and headache, both on 26Jun2017, with unknown outcome. The doctor recommended ibuprofen and taking a nap. There was no local aggravation of injection site prior to injection.
Tightening of throat, difficulty swallowing. 50 mg Benadryl
Patient husband called and described his wife as having chills, nausea, vomiting.  I recommended the patient call PCP and get further advise for treatment
Mother phoned Dept of Health on 5/11/11 to report that patient had a red sore (L) upper arm. The redness continued to the (L) scapula. Also she developed a blister at injection site. Saw family doctor who advised her to avoid this vaccine in the future.
This spontaneous report was received from a pharmacist concerning a 65 year old female patient with high cholesterol and no drug reactions/allergies. The patient's medical history included pain. In 2008, at the age of 60 years, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, and lot # not provided). On 06-OCT-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot # J006242; expiration date 03-AUG-2014), 0.5 ml, intramuscular. Concomitant therapy included FLUVIRIN, SKELAXIN, ZETIA, TOPROL XL tablets, AMBIEN, PRAVACHOL, rizatriptan benzoate (manufacturer unknown), PLAVIX, lisinopril (manufacturer unknown), PROMETRIUM, XANAX, oxycodone (manufacturer unknown), NEXIUM and tramadol hydrochloride (manufacturer unknown). On unknown date after first dose of PNEUMOVAX23, the patient experienced redness at the injection site. On 06-OCT-2013, the patient at the time of the injection felt injection site warm and had pain at the injection site. On 07-OCT-2013, the pain went up to the elbow. On 08-OCT-2013, the pain was in the middle of the arm. The patient took TYLENOL the last 2 days and it had not help. At the time of the report, patients outcome was not recovered. No laboratory tests were performed. The patient sought medical attention by calling the pharmacist. This is one of several reports from the same source. Additional information has been requested.
Cellulitis-like redness and swelling and pain from site of injection to elbow joint lasting 2 days and starting to abate on the third day.
Seizure; Broke her teeth; 1st dose 15-May-2021 and then the second dose on 30-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Root canal procedure (Root canal). Previously administered products included for Product used for unknown indication: Restylane kysse in November 2020. Concurrent medical conditions included Seizure (Seizure disorder) since November 2020.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, 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 experienced SEIZURE (Seizure) (seriousness criterion medically significant), TOOTH FRACTURE (Broke her teeth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021). The patient was treated with TOPIRAMATE (TOPAMAX) in July 2021 for Seizure, at a dose of 50 milligram. At the time of the report, SEIZURE (Seizure) and TOOTH FRACTURE (Broke her teeth) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021) had resolved.            Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No symptoms being reported.; Patient who is 21 years old, inadvertently received a (second) dose of PROQUAD/patient also received first dose of PROQUAD on 08/07/2019 (21 years old); This spontaneous report was received from a nurse, referring to a 20-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On 07-AUG-2019, at the age of 20, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form, for prophylaxis (product use issue) (albumin status, concentration, frequency of vaccination scheme, route and anatomical location of vaccination, lot number and expiry date were not reported).   On 10-FEB-2020, at the age of 21, the patient was inadvertently vaccinated with a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (lot number S012534 had been verified to be a valid number; expiration date reported and validated as 20-OCT-2020) (product use issue) ( concentration, frequency of vaccination scheme, route and anatomical location of vaccination, were not reported).  No symptoms were reported (no adverse event).  The reporter did not have available information about the diluent used.
Narrative:  Patient presented to primary care clinic with complaints of warm, tender, painful arm where he had received the flu shot the previous day. Skin around injection site was slightly edematous, warm and painful. Patient was evaluated by a nurse and provider ordered prednisone dose-pack and Augmentin. Symptoms resolved and required no further care.
The week after receiving my vaccine, I felt very fatigued. I would have to come home from work and lay down for some rest. I was also having heart palpitations. I would go for weekly testing for COVID. My blood pressure was checked and it was high. I was told to go to the local ER. My BP was elevated and they kept me overnight for monitoring. I was told to monitor my BP, daily, for two weeks. My PCP, did an EKG, which came back normal. The elevated BP lasted for about two weeks and has been normal every time it has been checked.
Pt received influenza vaccine injection on 9/22/2003. The following morning, 9/24/03 pt noted raised wheal with erythema, urticaria and warmth at the injection site. Reaction subsided as the day progressed and no other problems noted.
ITCHING TO HEAD AND BACK LIKE BAD ALLERGIES; EYES FELT SWOLLEN; FEELING OF HAVING FLU; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-AUG-2021, the patient experienced itching to head and back like bad allergies. On 28-AUG-2021, the patient experienced eyes felt swollen. On 28-AUG-2021, the patient experienced feeling of having flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching to head and back like bad allergies, eyes felt swollen, and feeling of having flu. This report was non-serious.
Initial report received on 19 Jun 2008 from a nurse. A 12-year-old male patient who had a concurrent illnesses, pre-existing medical conditions or use of other medication, and who had no known allergies, had received a first intramuscular left deltoid injection of MENACTRA (Lot # U2635AA) on 16 June 2008 in the am. The vaccine was administered in a 1cc tuberculin syringe. Approximately 24 hours post-vaccination, on 17 June 2008 in the am, the patient reported lymph node swelling of 2 x 3 cm under the left arm. The left arm was not swollen, but was sore to touch. The patient was evaluated by a physician the following day and prescribed Keflex. The patient was scheduled to have a flu culture dose on 19 June 2008. At the time of this report, the patient had not recovered.
Swelling at injection site, sever pain in the left arm, low grade fever during the day and elevated at night.
(1)Starting next day, severe pain, stiffness of entire right shoulder, no focal, decreased movement (2) Right suboccipital lymph node enlargement (3) No reaction over injection site.
Headache, Myalgia, Arthralgia, CoughWheeze, Diarrhea, NauseaVomiting, injection site pain day 1- Narrative:  Day 1-injection site soreness & insomnia, day 3-7, fatigue, chills, cough, & headache, day 6: added symptoms of nausea with diarrhea along with chills, night sweats.
HCP called in to report patient received only 2 doses instead of the 3 doses of ROTATEQ and the dose was given outside of the 8 month range and patient is currently 12 months old. Patient missed second dose. Precautionary AE/No PQC.; HCP called in to report patient received only 2 doses instead of the 3 doses of ROTATEQ and the dose was given outside of the 8 month range and patient is currently 12 months old. Patient missed second dose. Precautionary AE/No PQC.; the dose was given outside of the 8 month range; This spontaneous report was received from a nurse refers to a 12-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first and the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  The reporter stated that the patient received only two doses instead of the three doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the dose was given outside of the 8-month-old (inappropriate schedule of product administration, product administered to a patient of inappropriate age). Patient missed second dose (product dose omission issue).
The patient developed redness and rash like bumps.  No burning but itching. She was instructed to take benadryl 25mg tablets. She was also instructed two days later to apply hydrocortisone cream 1% to stop the itching and redness not resolved by the benadryl tablets. But she was feeling better and not in any pain.
dizziness and concern for elevated blood pressure reading. This afternoon at around 12:00, the patient received her second dose of the Moderna COVID-19 vaccine at the clinic. She had no apparent complications with her first dose of the COVID vaccine. However, about 10 minutes post second vaccination, she suddenly began to feel dizzy, described as lightheadedness, with associated nausea, all of which were rated a 4/10 in severity. Staff there took her blood pressure, which was noted to be elevated, reportedly at 220/104. EMS was activated, and en route to the ED, the patient was given Zofran by paramedics. Currently the patient no longer has nausea and has not had any vomiting. She does have chills, but no measured fever.