chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red knot at the site of injection; Itchy knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red knot at the site of injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). On an unknown date, the patient experienced VACCINATION SITE MASS (Red knot at the site of injection). At the time of the report, VACCINATION SITE MASS (Red knot at the site of injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
stomach cramps; Diarrhea; Nausea; chills; sore left arm; I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills) and MYALGIA (sore left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired). On 08-Aug-2021, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (chills), MYALGIA (sore left arm) and FATIGUE (I felt tired) had resolved.        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.   Concomitant medication use was unknown Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 13-09-2021 contains age height weight and batch number updated
NO ADVERSE EVENTS MOM STATES" HE HAS HAD NO FEVER NO VOMITING NO SHORTNESS OF BREATH. SITE IS ERYTHEMATOUS ABOUT 2 INCHES, WARM TO TOUCH WITH SLIGHT EDEMA.
On 09/08/2021 I received my Covid-19 vaccine. On 02/10/2022 I was told I had tested positive for Covid 19 but was not experiencing any symptoms. After being told I was positive I started driving toward home and passed out while driving. After reaching out to cardiologist I was sent to the hospital for heart rate complications. I had to have a pace maker implanted on 02/28/2022.
Developed malaise on 10/24/10 & on 10/25/10 in the afternoon developed fever - 101.7 with severe pain in all joints. Did not see PMD treated self with TYLENOL and rest.
Within 15-minutes of vaccination, the patient reported pruritus at the site of injection. Patient was monitored and managed on-site.
pt recv vax 5JUN97 & 830PM onset hoarseness, raspy voice;7JUN same;7JUN fretful, dec appetite 2PM APAP;8&9JUN same;
1/8/22 pt admitted to Hospital with SOB, CP, O2 saturation 56% on RA; found to be positive for COVID; given Baricitinib, Dexamethasone; A Fib with RVR, treated with medication; respiratory decline; intubated; blood culture positive for MRSA; given ABX; tracheostomy and PICC line placed; 2/15/22 pt admitted to Hospital; 2/17/22 moderate amount of blood in tracheostomy; bronchoscopy performed, no source of bleeding found; respiratory distress; agonal; pulse lost; CPR and ACLS with medications; intubated orally; removed large blood clot from tracheostomy; tracheostomy tube removed; 29 minutes of CPR; family opted to stop CPR and pt expired in the hospital
Rash on her face, neck and chest/spot on her neck and chest are again red; Itchy/spot on her neck and chest are again itchy; raised red, hot area about 4x2 inches on the arm; hot area on the arm; Flu like symptoms; Sore arm; Headache; Body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, headache and general body pain. On 13th September 2019, the patient experienced erythema of extremities and skin warm. On 14th September 2019, the patient experienced red rash and itchy rash. On 14th September 2019, the outcome of the skin warm, red rash and itchy rash were not recovered/not resolved and the outcome of the pain in arm, headache and general body pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities, skin warm, red rash, pain in arm, headache, general body pain and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and developed flu like symptoms including headache and body aches. These symptoms were resolved. The patient had sore arms but that resolved. 24 hours after the vaccination the patient experienced a raised red, hot area about 4x2 inches on the arm in which she got the vaccine but closer to her body than the injection site. She started getting a rash on her face, neck and chest.  This continued and then the rash on the face was pretty much gone.  It had settled down to redness and wasn't itchy or hot. After work out the patient noticed the spot on her neck and chest are again red and itchy and feels like the symptoms are returning. The reporter consented to follow up. This case linked with US2019169081, reported by same reporter.
Entire thigh was swollen with some localized erythema, not warm to touch; resolved in one day after shot.
1/6 a rash developed at the injection site and by 1/7 it had spread to the belly and chest.
3 months after the shot I have been experiencing increasing pain in the injection spot. It hurts to lift my arm. If I pick something up I get sharp muscle pain at the site.  It feels sore and like someone keeps punching my arm
Initial case received from a consumer, who is also the patient's parent, on 13 November 2009. A five-year-old male patient received an intramuscular right thigh injection of H1N1 (lot number UP006AA) on 11 November 2009. The patient had a history of asthma and a cardiac valve defect, and had been ill with cold symptoms including nasal drainage and cough for 10 days prior to vaccination. Concomitant medications included FLOVENT and Enalapril. On 12 November 2009, one day post-vaccination, the patient developed a fever of 103 degrees Fahrenheit, body aches, chills, nausea, and stomach pain. His cold symptoms also became worse. His parent noted that his fever reduced with alternating use of MOTRIN and TYLENOL. At the time of the report, the event had not yet recovered. Follow-up information received 28 December 2009 from a health care professional. Additional corrective treatments included ZITHROMAX. According to the reporter, the events lasted for five days and the patient recovered.
pt fainted then threw up, felt better, gave water and made her stay in pharmacy area for 30 more minutes
c/o headache w/ slight nausea the night of injection given felt ok the next day.
noticed blood in the syringe; plunger would not progress / next syringe she tried, she noticed the needle appeared bent; This case was reported by a nurse via sales rep and described the occurrence of injection site hemorrhage in a 55-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number P7HK7, expiry date 30th June 2021) for prophylaxis. This case was associated with a product complaint.   On 17th September 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular). On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site hemorrhage and pharmaceutical product complaint. On an unknown date, the outcome of the injection site hemorrhage and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The Health case professional, who was the nurse attempted to give the injection, stated that she followed the procedure for administering an intramuscular injection for Flulaval. However, when she started to push the injection into the patient's arm, the plunger would not progress, she noticed blood in the syringe and pulled out the needle. The caller stated that the patient did not get any of the medication and she threw the needle and syringe away and did not have the LOT No. or the product to return. The next syringe she tried, she noticed the needle appeared bent, so she did not inject the patient.  The reporter did not consent to follow up.
Headaches, chills, fever, running nose, cough, sneezing, severe sweating, 104 fever, sore throat, muscle aches, fatigue, ear ache, very tired, chest pain, diarrhea
frozen product was accidently administered with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via a physician under Medical Information Inquiry Number: 00814948.  This case is linked to cluster case 2021SA345065.  This case involves an 88 years old male patient who was accidently administered a frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 21-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen, that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  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 the 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.
I administered wrong vaccine to the patient, he was due for the tdap vaccine and accidently gave dtap.
extreme fatigue; This is a spontaneous report from a contactable consumer reporting for her mother. A 90-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that her mother (female, 90 years old) received the first dose of the COVID vaccine and after 2 days she had been needing or requesting oxygen and she hadn't needed it for a long time so the consumer was wondering if that could be related to having gotten the vaccine, and if so, would it go away. The patient had extreme fatigue on an unspecified date then requested oxygen. The event outcome was unknown.  Information on the Lot/batch number has been requested.
A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 15-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Moderna COVID-19 Vaccine EUA shortness of breath, dizziness/weakness, nausea, vomiting
generalized urticaria, appeared within 48 hrs of receicing vaccine.  Slight fever 100.2.  Treated with Prednisolone 5mL
nerve damage; shingles; Information has been received from a lawyer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. In or around June 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Reaction to flu shot. Flu shot given in left arm 10-5-18 at 06:35. At 0500 on 10-6-18, reddened bump over injection site with itching and reddened rash across right upper chest, arm, abdomen, back and legs. PO BENADRYL at HS on 10-6-18. On 10-7-18, reddened itchy rash cont'd. PO BENADRYL on 10-7-18 at HS. On 10-8-18, rash less red, still itching, bump decreased.
Information has been received from an office manager concerning a 67 year old female with type II diabetes mellitus, neuropathy peripheral, allergies to penicillin, LEVAQUIN, "adhesives from tape" and history of right hip fracture and past breast cancer who on 23-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 651357/0391F) (0.5 ml), intramuscularly in the left deltoid.  Concomitant therapy included a dose of influenza virus vaccine (unspecified), in the same arm but different area.  On 25-OCT-2006 the patient experienced cellulitis.  It started below the Pneumovax 23 injection site and spread to her elbow.  The reaction consisted of a red, hot, swollen area.  Redness and induration down left arm were also reported at 8:00 AM.  The patient was given KEFLEX, BENADRYL and KENALOG for the treatment.  On 08-NOV-2006 the patient recovered.  Additional information is not expected.
10 days after pt received her vaccines, she started getting what looked like a rash on her abdomen and thighs. As the day went on is started spreading until it eventually covered her whole body. In the emergency room she was diagnosed with Erythema Multiforme. For the next 9 days she had huge spots on her that itched and were painful to the touch. She ran a fever with this as well.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 504 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
70 yo male with h/o of HTN and diabetes who had a flu vaccine and shingles vaccine two weeks prior to admission. Approximately ten days ago, he developed an orolabial herpes outbreak and some numbness of the bilateral hands, which over time progressed to generalized weakness, difficulty walking, and UE weakness LUE>RUE. On 10/2 he developed slurred speech, dysphasia and facial weakness. Patient was tranferred to Clinic for further workup and management.  Clinical picture most c/w GBS. Patient got his vaccines at the pharmacy. Admitted to hospital on 10/2/2010. Currently in ICU. Contact Dr for any additional information.
Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine). The patient was treated with CORTISONE on 22-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHROPATHY (Cortisone shot in knee after both doses of the Moderna COVID-19 vaccine) outcome was unknown.            Concomitant medications were not provided.   Reporter did not allow further contact
Still quite lame; Now Have a cold; Sore throat; sneezing; Neck hurts; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ILLNESS (Still quite lame), NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts). At the time of the report, ILLNESS (Still quite lame) had not resolved and NASOPHARYNGITIS (Now Have a cold), OROPHARYNGEAL PAIN (Sore throat), SNEEZING (sneezing) and NECK PAIN (Neck hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for Covid..         no concomitant medication were reported  no treatment medication were reported
10APR97 parent states pt recv vax 7APR97 & since then has broken out in rash over trunk area & today is having difficulty breathing-referred to ER;
Normal labor and delivery on (Privacy). Hospital admission within 6 weeks of receiving the COVID vaccine.
Fever and vomiting, persisting into the following day (3/15/2012); 1-minute seizure, afternoon of 3/15/2012; rectal temp 106.7.
Severe chills, shivering, fever, sweats, exhaustion, headache, nausea, dizziness, fast heartbeat, weakness, difficulty walking, dehydrated, and passed out.  Severe symptoms began 1:00 A.M. on 1/8/2020 and lasted until 9:00 A.M. Still was weak and had headache until 5:00 P.M. on 1/8/2020.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient was COVID positive and had symptoms and started Paxlovid. He was better and tested negative but is now sick with fever and congestion. The reporter thought this rebound COVID is much more prevalent than they initially thought.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291370 Same reporter/ drug/ event, different patient;
MMR given on 2/21/02 to L arm. Call received 10:45am, 3/4/02 that she had developed a fever of 101.4, 3/3/02, she took tylenol now temp 99.9. Pt states red, raised rash noted to arms, more on L than R. Rash extends form elbows down to her arms, states rash is size of pin head. DPH called and info given to pt. Pt to call PCP.
Second dose was given too early. First dose was given on 12/27/2022.  Patient was called and advised to return on or after Jan. 24  to receive dose.