chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain.; Tiredness; Chills; Joint pain; Feeling unwell; Muscle pain; This is a spontaneous report received from a consumer, the patient. A 18-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 1230 (at the age of 18-years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was allergic to bactrim. The patient concomitant medications was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 1600 the patient experienced injection site pain (vaccination site pain), tiredness, muscle pain, chills, joint pain and myalgia. The patient did not receive any treatment for the events and 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 vaccination site pain, tiredness, muscle pain, chills, joint pain and myalgia was recovering at the time of this report.    Information about lot/batch number cannot be obtained. No further information is expected.
The pt felt weak, hot and short of breath, numbness in the hands and feet. Shallow breathing, O2 given. Pt cold and shaking. Epipen given IM. Paramedics came at 11:00 am. EKG normal, pt calming down. 12:00 pt was relaxed and asleep.
patient was administered with a DTap/IPV injection from a Vial instead of mixing it with the Hib to form a Pentacel, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which only DTap/IPV injection was given from a Vial instead of mixing it with the Hib component (Pentacel lot: UJ015AAA, Expiration Date: 26Oct2020, Lot U6218AA, Expiration Date: 26Oct2020, and Lot UJ015AA, Expiration Date: 26Oct2020on 30-Sep-2019.  It is an actual medication error case due to Inappropriate reconstitution technique.  It was reported that the patient had no adverse event.  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.
0.3 ml was given to patient. Dose for pfizer for age range is 0.2 mL
Information has been received from a pharmacist concerning a 77 yr old male pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine while he was a hospital inpatient. Subsequently, the pt developed a localized cellulitis. He was treated with an antibiotic for his cellulitis. It was noted that the pt improved after antibiotic therapy and had recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
3cm firm nodule lt thigh w/erythemia; Keflex x 10 days;
Arm pain; lightheaded; Fatigue; Headache; I had fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F2117, 028A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 101 (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The symptoms are ongoing but have mostly resolved.    This case was linked to MOD-2021-395827 (Patient Link).
May 1, 2021 around 2:30 in the morning I started feeling itchy and when I checked my body there' a lot of rashes appear on both arms, legs and in my butt. The one on my left arm who got shot was worst , big round rashes occurred.
Patient was adminstered Fluzone intradermal vaccine in error. Patient is over age 65 and vaccine is only indicated for that age group.
My daughter is exactly 2 weeks out from administration. She called me today, stating her heart was intermittently racing.  Felt like she has a fever, but none registered on the thermometer. Body aches, malaise present. No chest pain, shortness of breath, headache, or vertigo. She does have diarrhea x1 today. I am calling her often, to find out any other sx. I will take her for a covid test when I get off of work, if she still feels poorly.
PATIENT STATED HIS ARM FEELS  FINE FOR MOST OF THE DAY--HE TOLD ME EVER SINCE THE SECOND COVID SHOT HE CAN NO LONGER ROLL OVER ONTO HIS ARM WHILE SLEEPING. HE STATED THAT WHEN HE ROLLS OVER HE FEELS A THROBBING PAIN AND IT ALSO FEELS LIKE IT IS A SHOOTING PAIN ALL THE WAY DOWN. HE CONTINUED TO MENTION THAT THE PAIN IS ONLY RELIEVED WHEN HE SITS ON HIS CHAIR AND RESTS IT/PUTS SLIGHT PRESSURE ON IT FOR A LITTLE BIT.
10/14/06 1pm started to develop rash of red, not raised dots, to torso and face and down arms to elbows. Mom reported fever 101-102 F Sat 1pm through Sunday. Tylenol given PRN Friday through Sunday. Redness decreased on Monday am. Mother referred to her HCP Dr to be advised if pt should be seen by MD.
A report has been received from a Health Professional concerning a 50 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 02-Oct-2013. The patient received FLUMIST which started on 02-Oct-2013. The outcome of the event of received FLUMIST over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from Health professional: reporters tab updated.
Red rash-face, chest, arms. Cough/wheezing began approx 2hrs after injection. Took BENADRYL @ S/S onset with some relief. Denied difficulty breathing/swallowing. Tx with MEDROL dose pack + instructed to go to ER for any increase in S/S + continued BENADRYL.
reported approx 12 hours post vaccination felt swelling on left side of tongue with tingling sensation; sensation similar to that when exposed to shellfish or ibuprofen - denies having had either these or any new foods or medication  at time reporting reaction to clinic the sensation was almost completely subsided; just a slight sensation of tingling on left side of tongue
flu-like symptoms; weakness; A spontaneous report  was received from a consumer concerning a 60-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced influenza-like illness and asthenia.  The patient has a history of hypertension. No relevant concomitant medications were reported. Other medications included HCTZ, Prevacid, Adderall, Cerezyme.  The patient received their first of two planned doses of mRNA-1273 on 24-Dec-2020. On 18-Jan-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 02620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 24-Dec-2020, the patient experienced influenza-like illness and asthenia.  Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (influenza-like illness and asthenia) was unknown.
LUE erythema, warmth, swelling that began 1 hour after injection. Redness up to shoulder and over left side of chest that resolved before morning of 3/7/17. At time of visit on 3/7/17 patient presents with LUE erythema, warmth, swelling around entire prox UE, just distal to elbow and several cm inf to axilla.
This case was received form a health professional on 05 October 2007.  An eight-year-old male patient with an allergy to penicillin received an intramuscular injection of FLUZONE (lot number U2461BA) on 22 September 2007.  Within two days he developed redness at the site, which subsequently turned into a " 15 cm brown spot".  The patient had not been seen by a physician.  Per the reporter, the patient had received FLUZONE in 2006, and had not experienced any adverse events following vaccination.  At the time of report, the events remained ongoing.  Follow-up information received on 08 January 2008 from a physician.  Per the reporter, the patient suffered no ill effect from the adverse events, and was subsequently re-evaluated by a physician and found to have no symptoms.  The date of re-evaluation was not reported.  It was not reported whether the patient received any other treatments.  The patient recovered.  No further information is expected.
This spontaneous report was received from a pharmacist via a company representative and refers to a 72 year old female patient. The patient's relevant medical history and concomitant medications were not reported. On 22-SEP-2015, the patient received a dose of PNEUMOVAX 23 injection in the arm (dose, route, lot # and expiration date were not reported). It was reported, that on the same day and on the same arm, the patient "high dose" of influenza (FLUZONE HT) injection (dose, route, lot # and expiration date were not reported). On 22-SEP-2015, the patient developed an unspecified reaction from shoulder to elbow on the vaccination arm. The patient sought medical attention by visiting an unspecified urgent clinic on an unknown date, in 2015. The patient was treated with unspecified steroids for the event. The outcome of the event of unspecified reaction from shoulder to elbow was unknown. The relatedness between the event and PNEUMOVAX 23 and FLUZONE HT was not reported. Additional information is not expected, as no pharmacist's contact details were provided.
Pt with complaints of nausea, sweating, and feeling BP low. Vitals: BP 123/69 HR 82 RR 18 SpO2 100% on RA. Pt given water and rested for 15 minutes. Patient verbalized symptoms improved and released from vaccination site.
Reduced pain in knee left; Pain at injection site left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site left) and ARTHRALGIA (Reduced pain in knee left) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 044B21A) for COVID-19 vaccination.     The patient's past medical history included Knee arthritis (Prior to vaccine 2 month).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site left). On 22-Mar-2021, the patient experienced ARTHRALGIA (Reduced pain in knee left). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain at injection site left) and ARTHRALGIA (Reduced pain in knee left) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
sore arm; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (very fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient goes for Chemotherapy every 27 or 28 days, also takes a chemo pill daily. ).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (very fatigued). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. The medical assistant reported for temperature excursion and that on unknown dates some improperly stored ROTATEQ ("suspension 2", oral, lot#, dose and frequency were not provided) had been administered to patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; Pediatric dose was given to adults mistakenly; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    No concomitant information was reported. 051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use. Pediatric dose was given to adults mistakenly and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. No treatment information was reported.
Suspect COVID breakthrough case presented 1/24 with SOB s/p COVID dx 1/6/22
"About 5 min after injection, she came to me asking for Benadryl because her mouth was starting to itch.  So I inject Diphenhydramine 50mg/ml 1ml IM right deltoid and she sat next to me.  After a few minutes, she thought she was feeling better. Then about 5 minutes later she said she could feel her tongue swelling and throat starting to burn, so I called 911 and administered one dose of epi-pen 0.3mg in her right thigh.  She was still able to breathe, talk, and swallow a few sips of water.  Approximately 8 minutes later EMS arrived.  I heard EMS tell her that her blood pressure was good while I was talking to another EMS personnel reporting everything I had done, her husband was there and gave her medical history and other medications she takes (methotrexate, Pristiq, and Renvoq for rheumatoid arthritis and fibromyalgia).  She was taken to the hospital for further examination.  Before hand, she reported no drug allergies and never having any type of allergic reaction to medications, food, or having any adverse reaction to injectable medications.  However, her daughter has many allergies and has used epipens frequently in the past."--Per Immunizing pharmacist.
was administrated with the powder component of Menveo with sterile water; was administrated with the powder component of Menveo with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo with sterile water, which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
TWO RAISED BUMPS (RASH LIKE) ON BACK OF NECK; This spontaneous report received from a consumer concerned a female 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced two raised bumps (rash like) on back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two raised bumps (rash like) on back of neck. This report was non-serious.
Patient got the vaccine and within minutes she became gray in color, limp, and her head went down. she then started to take deep breathes and her body stiffened right up and she stopped breathing for a second. we called 911 as soon as we noticed something was off with her. When she came to a few minutes later she knew she passed out but that was it. she did not go with the EMS, another staff member took her to the ER.
Pt developed induration on right deltoid with a 3x5 area of tenderness.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:23 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.44.  Concomitant medication of the patient was not reported.  On 11-Jan-2021, excursion time was 9 AM with temperature of 34 degree Fahrenheit and excursion time was 2 PM with temperature of 35 degree Fahrenheit. Total doses given for the day was 98, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. 9 vials were sent to clinic on 11-Jan-2021.  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 traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment information was provided by the reporter.
Pulling sensation left deltoid where infection was given. Had some reaction 2 years ago in right deltoid.
He received the Flu Shot on 10-17-06.  That evening, he complained of some pain and the injection area appeared okay.  The following morning, his upper thigh had a large red circle around the sight, he complained of pain, and he was limping after getting out of bed.  We contacted his PCP who advised us to continue to monitor the area, which now appears okay.  They also suggested we complete this online form to report the incident.