chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at vaccination site; Hive-like raised area at injection site; Swelling at vaccination site; Mild myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 26-Mar-2015 and Osteoporosis since 08-May-2017. Concomitant products included MIRTAZAPINE (REMERON) from 30-Mar-2021 to an unknown date, TELMISARTAN from 30-Mar-2021 to an unknown date, AZELASTINE from 22-Oct-2020 to an unknown date, COLECALCIFEROL (VITAMIN D3 1000) from 30-Sep-2020 to an unknown date, CICLOSPORIN (RESTASIS) from 26-Mar-2015 to an unknown date, CALCIUM from 26-Mar-2015 to an unknown date, MULTIVITAMIN [VITAMINS NOS] from 09-Feb-2012 to an unknown date, MAGNESIUM, OMEGA-3 NOS, CURCUMIN (TURMERIC MERIVA), ASCORBIC ACID, BIOTIN, COPPER, RETINOL, ZINC (HAIR SKIN NAILS) and ZINC for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia). On 30-Jan-2021, VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE URTICARIA (Hive-like raised area at injection site), VACCINATION SITE SWELLING (Swelling at vaccination site) and MYALGIA (Mild myalgia) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list also include tums extra strength smoothies 300 mg (750 mg) chewable tablet. Treatment information was not provided.
C/O Left arm hurts. H1N1 given in left deltoid 01/08/2010. Worse at night. Continues to hurt. No external swelling or bruising noted. States felt like muscle hurt. Encouraged to see MD. States doesn't hurt bad enough for pain medicine. Encouraged to see MD for eval. and recommendations. Client to notify Health Dept. if sees MD and any findings. Has not seen MD for concerns at this time.
NOT FEELING WELL; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (dose number in series 2). 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 was not feeling well and took Tylenol and that gave a good response (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from not feeling well, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Nausea, Diarrhea, Sneezing, Fever, Chills, Arm Pain, Chest Pain, Extreme Fatigue, Lethargy - all symptoms began the day after my vaccine (1/25) and are still persisting now (1/27)
Fever, body aches, sweating, tiredness, light headed, dizzy, swollen glands, fast heart beat.
Patient came to our pharmacy as a walk in appointment for his COVID vaccine. When asked if this was his first COVID shot, he stated yes and filled out the necessary paperwork, his ID and insurance card was copied and a vaccination record card was given to him. The vaccine was confirmed with him before being  given and was administered without incident. Upon processing the vaccines a few hours later, his insurance company rejected on the basis that the manufacturer was different than the previous dose, so we checked the vaccination registry online and discovered he had received two doses of the Pfizer vaccine at a local Pharmacy. The first was on 04/01/2021 and the second was on 04/25/2021. One of the questions on our consent for vaccination form asks : "Have you every received a dose of the COVID-19 vaccine?" When asked why he had answered "no" to that question despite having already received two doses, he informed us he thought the question was specific to our pharmacy.
Abnormal breathing patterns,lightheaded, cold, clammy, primary impressions: respiratory/acute distress/breathing difficulty Secondary: Allergic reaction (ht:86, BP: 148/92, R: 20, T: 99.0) Hx of first inoculation included mild respiratory reaction, treated with Benedryl.  EMT arrived post swelling of entire face and sinuses.   Post vaccination patient experienced increased sensitivity to known food sensitivities' and airborne allergens.  Patient was diagnosed with asthma as dry cough was continuous. Patient was proscribed asthma medication: Symbicort, Losartan-HVTZ, Nasacort and Zertec.  Cont.
Information has been received from a registered nurse concerning a 21-week-old patient who on 08-DEC-2006 was vaccinated PO with the first dose of Rotateq. On 08-FEB-2007, the patient was vaccinated PO with the second dose of Rotateq. Additional information has been requested.
Arm swelling increased, Do I have cellulitis; Arm hotter; arm redder/redness; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, erythema of extremities and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, erythema of extremities and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's comment:  The patient received dose of Shingrix vaccine 5 days ago from the date of reporting and experienced all the common side effects.  After a couple days from the vaccination his/her arm started feeling better but today (on the day of reporting) the swelling increased, and it was hotter and redder than it was before. The patient asked did he/she have cellulitis. The patient also asked how long did arm pain, redness and heat last. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Dose 1: soreness in arm Dose 2: soreness in arm starting a couple hours after shot.  Headache, fever 100.6 and body aches starting day after the shot and lasting 24 hours
"Moderna COVID-19 Vaccine "  pt received vaccine to his left arm. 10 min later (1335) he reported feeling dizzy. allergy tech and i evaluated pt. pt clammy with sweat noted to the back of his neck. pt speaking in full complete sentences. no increased WOB. left radial pulse regular and not elevated, not thready. no hives found. denied itchiness. asked pt if he felt anything stuck in his throat, he swallowed a few times and said "yes". asked if he had much water today, he said no. pt reported it felt a little hard to breathe in his throat. i had him remove his mask. pt reported nausea. denied abdominal pain. had him take a few sips of water. reported he no longer felt anything stuck in his throat, no longer hard to breathe in his throat. pt reported tingling in his left arm. pt worked the night shift. went to work at 1600 on 2/11. ate at 2000, beef and potatoes. had snacks. ate chicken and rice at 0300. usually has a full gallon of water on shift but only had a half gallon. got off at 0400. went to sleep at 0530. usually wakes at 1445-1500 but woke up earlier for this appt. appt was at 1330 but he was here early. had a protein shake 30 min before arrival but has not had much water. thinking the protein shake was causing his symptoms. denies working out today, denied energy drink intake, denied any coffee. pt took a large amount of water and then threw up. pt reported he felt much better. nausea resolved. still no itchiness. no hives. no clamminess. no trouble breathing. no globus. no dizziness. no tingling in his left arm. resolved by 1340. held Epi given he reported complete resolution of his symptoms. seemed likely the combination of being underhydrated, having slept less than usual, facility being a little warm and him wearing a mask and possibly his protein shake contributed. had patient wait 30 minutes (1410). allergy tech sat with patient who continued to speak in full sentences, tell stories, etc. had him stand up slowly. denied dizziness. still no hives, no itchiness, no globus, no trouble breathing, no nausea, no abdominal pain. advised pt of reasons to call 911 (he lives on base where we have ambulance services). advised i would be placing a VAERS report.
mild body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild body aches) and FATIGUE (fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (mild body aches) and FATIGUE (fatigue). On 16-Mar-2021, PAIN (mild body aches) and FATIGUE (fatigue) had resolved.            No concomitant products were reported.  Treatment medication included Tylenol once in a day.
Patient received outdated COVID-19 vaccine, patient was contacted and returned to clinic a couple of days later for re-vaccination.
Information has been received from a female health professional who was vaccinated with a series of hep B virus vaccine rHBsAg (yeast). She was tested after completing the series and was immune. Last year, in 2004, she had her titers checked and they came back not immune to Hep B. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Information received on 16Nov05 contained the following adverse event: breast cancer (approx 1996; chemotherapy). Additional information has been requested.
her jaw got really tight described as "TMJ"; Information has been received from a female medical assistant of unknown age via a field representative, referring to herself. Information about concurrent condition, concomitant medication and medical history was not provided.     On an unknown date (reported as a couple months ago), the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot# and expiration date were unknown) intramuscularly for prophylaxis.         On the same day, a couple hours after vaccination, the patient's jaw got really tight described as temporomandibular joint (TMJ). It persisted for three days and then resolved without treatment on an unspecified date. The patient talked to her dentist about it but didn't see anyone. The causality assessment was not provided by reporter.
Swollen lymph nodes in left armpit, some injection site soreness.  Lymph node swelling occurred approx 1 day after vaccine
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 3rd of 15 reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
pt recv vax 6OCT97 & 13OCT97 pt devel a rash w/red small raised areas on the chin & cheek consisting of less than ten lesions;
vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but didn't arrive to them until around 11 am/No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267336, 2019SA267342, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 73 years old male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Approximately 5 minutes after receiving vaccination, patient reportedly became dizzy and stumbled into a floor display in the waiting area. Mother, who was with patient, states there was no loss of consciousness. Patient then sat in chair and after a few minutes stated symptoms began to resolve. Patient stated having a brief period of fuzzy vision. No signs of an allergic reaction were noted. Patient stayed in waiting area for approximately 1/2 and during that time stated symptoms had completed resolved. Patient then left the store.
date started  3/17/21 fever, chills, shortness of breath, fatigue, body aches, lots of coughing,  Dr. visit 3/23/21 treatment-1 st  Dr visit albuterol,   rapid covid test given  negative    low  o2  SATS  80 2nd dr visit Friday 3/26/21 stronger albuterol , prednisone medication for 5 days,  steroid injection,   low  o2 SATS  87 ANOTHER COVID TEST GIVEN WAITING FOR RESULTS
Nausea; Anxiety Attacks; Pulse rate goes up; Blood pressure goes up; Whole body shaky; Weak; This spontaneous case was reported by a reporter of unknown type and describes the occurrence of ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency. At the time of the report, ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment with CBD oil, Beta blocker and pertained to the symptoms were provided.
I had both vaccines, the second exacerbated the shingles/suspected vaccination failure; shingles exacerbated; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date refer case US2021AMR178108).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles vaccines. The patient stated the first vaccine gave him/her shingles and the second vaccine exacerbated them. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178108:same patient/ reporter
Ten days post vax, the patient experienced multiple pox lesions on her face and 2 pox lesions on her chest. Medical attention was sought. On 1/21/2001, the patient recovered. No further information is available.
Recombinant Zoster Shingles vaccine. Arm was slightly sore on the day of and day after the vaccine. By about the 3rd day arm was getting more sore. Today is a week later and I can't lift my arm at all more than maybe several inches at the most. Was experiencing pain in my shoulder blade, neck and down my arm. Lying down makes it worse, better to prop my elbow on a pillow. Vaccine site is very sore to touch even with the slightest touch. Terrible headaches which I think might be due to the neck soreness. I would rate the pain at constantly an 8-10 on a scale of 1-10 with 10 being the worst. Very debilitating on my right side.
Extremely fatigue-7-14 days. Injection site swollen- 4 days. Mouth, throat and tongue swollen- 2 days. Injection site pain and left side muscle pain and numbness at times-7 days. Fever- 2 days. Headache- 2 days. Nausea- 5 days. Dizziness- 2 days. Treatment- Bed rest, took time off work.
Pt developed a large, raised, red rash around the injection site. She noticed it upon waking up the morning after the vaccine was administered. The rash is inflamed and painful to the touch. No treatment has been prescribed as of yet and we will continue to monitor the rash to determine the next course of action.
This case was reported by a consumer via call center representative and described the occurrence of abdominal bloating in a adult male patient who received HAVRIX. Co-suspect products included ENGERIX B. On 7th June 2015, the patient received HAVRIX (intramuscular) and ENGERIX B. On 7th June 2015, less than a day after receiving HAVRIX and ENGERIX B, the patient experienced abdominal bloating. On an unknown date, the outcome of the abdominal bloating was unknown. It was unknown if the reporter considered the abdominal bloating to be related to HAVRIX and ENGERIX B. Additional information received: Patient received HAVRIX on 07 June 2015 but unable to confirm specific admin date for ENGERIX B. Implied by patient that ENGERIX B administered on the same day as HAVRIX. For the previous 3 days, stomach bloated was 'on and off', and the bloating is typically worse after eating. After asking Safety question for HAVRIX product, patient then decided that he did not want to answer additional questions on Safety form. Patient denied contact for follow-up.
flu like symptoms x 2 days. Patient states that he got his first covid vaccine 3 days ago. States that since yesterday he has had bilateral eye redness, congestion, sneezing, sore throat, and diarrhea.
report side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment medications were provided by the Reporter. Med Info Agent: Nensi pandya caller wants to report the side effects.
Nov 11, 2015, Hours after Flu vaccine- Nausea/vomting/diarrhea and fever. 3 days later- cough with wheezing- Following day to ER- Discharged on albuterol Neb Tx. Nov 21-22- another bout of N/V/D adn fever Nov 23- fine today.
Vaccine was given 3 days early due to upcoming surgery on next appointment date. Patient was supposed to receive dose #2 of Moderna on 4/19/21; received it instead on 4/16/21.
Arm swelled around shot area, couldn't move arm, as days went by feet and lower legs went numb, went to doctor the next week because not improving. He said it is Guillain-Barre Syndrome reaction to Pneumovax 23 vaccine. He gave me steroids for two weeks and it did seem to help. Going 6 weeks now. Improving but very weak and some numbness comes and goes. Dr said it will take time.
Patient had facial swelling, lip swelling, and tongue heaviness two days after recieving the second dose of vaccine. She took Benadryl 25 mg every six hours and this resolved in three days.