chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis; Arm was sore; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis and arm was sore/limb discomfort.  The patient's medical history was not provided.  Concomitant medication included an unspecified low dose blood pressure medication.  On 18Jann2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan2021, the patient experienced sore arm.  On 24Jan2021, the patient experienced itching, swelling and feeling hot at the injection site.  The patient was diagnosed with cellulitis and was treated with unspecified antibiotics for 10 days.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of cellulitis (itching, swelling, hot at the injection site) and limb discomfort was considered resolved.; Reporter'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.
lack of drug effect; diarrhea; fever; Inappropriate age at vaccine administration; wrong vaccine administered; This spontaneous report was received from a consumer, concerning a 7-month-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 23-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once in the left thigh by subcutaneous route (lot number, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 29-MAR-2023) (product administered to patient of inappropriate age) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1863317 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Lot number 1863317 does not match any Company product as confirmed by Lot Verification team. Furthermore, it was reported the patient was supposed to be vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), but he received diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), at a dose of 0.5 ml, once in the left vastus lateralis by intramuscular route (lot number: C5970AA, expiration date not reported) instead (wrong product administered). All the vaccines were administered as prophylaxis.  On an unknown date, the patient experienced mild fever (pyrexia), diarrhea and lack of drug effect.  At the time of the report, the outcome of the events was unknown.  The causality between the events and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) was not related. The causal relationship between events and the remaining suspect vaccines was related, further described as "expected side effects of given vaccines".  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006736:
Joint pain all over my body. No energy. Bad headaches. Shooting pains across shoulder blades and up the back of my neck. My neck is also stiff. Middle and lower back pain. Middle back stiffness. Dizzy spells. GI discomfort. On day 2, I could hear my heart beating in my ears. Injection site very sore and has heat in it. It is also swollen. I am not able to lay on that side in bed at all. Lifting that arm also causes pain at the injection site.
Delirium; Swelling tonsils; Vomiting; Chills; Body ache; On and off fever (98 to 101 degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)). At the time of the report, DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)) outcome was unknown.            No concomitant medications provided. Treatment of these events were not reported. 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.
49 year old patient received expired Moderna COVID-19 vaccine for his second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs are provided and treatment drugs are also not provided.
Initial case received 15 January 2010 from a healthcare professional. A 48 year old female patient received a right deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3224BB) on 14 January 2010. On 15 January 2010 the patient was seen by a nurse due to a large bump at the right deltoid (approximately the size of a golf ball). She had shoulder and axillary pain. There was swelling from the axillary area, down the arm to the wrist. She could lift her arm, but it caused pain in the shoulder. The patient had a medical history of hypertension. Concomitant medications included NORVASC and HTCZ. She had no illnesses at the time of the vaccination. At the time of the report the patient had not recovered. Follow up information was received on 12 February 2010 from a health care professional. The patient was started on methylprednisone 4 mg dose pack for 6 days on 16 January 2010. The patient recovered as a result. Based upon new information received, this case meets seriousness criteria and has been upgraded to serious. Documents held by sender: None.
ALLERGIC REACTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, unknown, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
I had pain in my left arm after my vaccine, also diarrhea. I went to the hospital partially for anxiety, pain in her heart and chest.  I feel so tired and fatigued had 2 doctors' appointment earlier today.  I lost my appetite.  I still have these symptoms today.  I want these pandemics to be over.
Saddle pulmonary embolus diagnosed 5/12/21 with unilateral leg swelling starting over one month prior.
The patient was here for her 4th dose of Moderna. The patient stated she was immunocompromised. The nurse was unsure if the patient should receive an additional full dose 0.5mL or the booster dose of 0.25mL of Moderna. It was determined from the charge nurse and other nurse present that the dose should be a full dose instead of a booster dose. I was in a meeting on-site still but no one asked me for what the appropriate dose was. The incorrect dose was given to the patient, but she was aware that she received a full dose.
This case was reported by a pharmacist via sale rep and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the pain in arm and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that he had a number of patients who had complained about being sick for a week after vaccination with SHINGRIX. The patients were also reporting arm pain. The pharmacist was questioning about whether these patients would return for a second dose.
I was positive for Covid-19; I was feeling bad for 2 days and I was prescribed PAXLOVID then 5 days later I was negative.
On 1/8/2021 patient called stating her right knee was swollen and painful, an 8/10 on pain scale, she iced it and took Tylenol now 5/10 pain scale.  Patient received 1st dose of Moderna on 1/7/2021.Patient stated that she thought  she remembered joint pain was a side effect of vaccine.  Provider spoke with patient and stated more than likely knee pain due to far driving distance and walking more than usual.  Continue topical and OTC treatment.
I noticed a large red, raised, very itchy, blotch on my left arm right at the vaccination site. This appeared exactly 7 days after my vaccine.
Had high fever of 104 for 6 consecutive days. Then the fever subsided followed by head banging, ear and neck pain, heavily bleeding gums, cold sores and mouth ulcers. Crankiness and fussiness with hitting her head on the floor.
Facial tics on right side of face  Started day after shot & continued daily for about a week.  Then became less frequent.  After about one month still happens but infrequently.
Only powder portion given with other diluent; Only powder portion given with other diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only powder portion given with other diluent) and inappropriate dose of vaccine administered (Verbatim: Only powder portion given with other diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 The medical assistant reported that the patient received only the powder portion of Menveo might have been given to a patient. The healthcare professional reported that she found that only one diluent left in the box so a powder with other diluent might had been given but was unsure of vaccination date or patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. The patient received only the powder portion of Menveo with other diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Whole body is inflamed with arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Whole body is inflamed with arthritis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Whole body is inflamed with arthritis). At the time of the report, ARTHRITIS (Whole body is inflamed with arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sore at site the day after vaccination. X2 days had itchiness, redness, swelling 2 inches below vacc. site with warmth to touch. No blister. Sts entire arm was painful on 8-28-12. States it was a local reaction only - no fever or other generalized symptoms reported.
No adverse event.; a patient was administered improperly stored PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information about medical history, concurrent conditions and drug allergies was not provided.      On 18-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S013715, expiration date: 01-NOV-2020, therapy type: recombinant Human albumin (rHA); dose, frequency and route were unknown) for prophylaxis (product storage error). The sterile diluent was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.   The vaccine was stored between 5 degrees Fahrenheit to 46 degrees Fahrenheit (17.6 degrees Fahrenheit) for 6 hours and 15 minutes. There were no previous temperature excursions. The digital data logger was not involved. No adverse event.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with high blood pressure and no known allergies. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # H011052; Ex date: 05-SEP-2013). Concomitant therapies included ADACEL and NORVASC. On 23-JUL-2013 the patient experienced a red, inflamed 2x3 inch rash, hot and sensitive to touch at the injection site. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. No treatment was given. Additional information has been requested.
Tested positive for COVID 11/13/2021 with symptom onset 11/10/2021. Received monoclonal antibody treatment 11/15/2021. Started feeling better evening of 11/15/2021. Got progressively better. Around 11/22/2021 felt tightness in my chest, reminiscent of previous asthma flare-ups. Pain/discomfort got progressively worse on 11/23/2021. Evening of 11/23/2021 I went to my local ER. Ultimately prescribed steroids.
Swollen, bright red, itchy, hot rash began January 15 covering 3x4 inch area expanding to 3x5 inches.  Improved somewhat on January 18.  January 21, area above and below original area broke out in same manner.  No fever.  Wearing long sleeves irritates the rash and causes more itching.  Using Cortaid, Benedryl cream, and Benedryl tablets (25mg), cold packs, aspirin.  As of January 23, have treated for 8 days and still treating.
Information has been received from a company representative via a letter from a female consumer (age not reported) concerning an adverse reaction with 1 PNEUMOVAX (lot # J-04887). On an unspecified date, the patient was injected with 1 PNEUMOVAX (lot # J-04887) on the right arm. On 04-OCT-2013, the patient experienced "a sustained fever, swelling and red hot to the touch at injection site." No further AE information was provided. Follow up information has been received in a letter from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on an unspecified date was vaccinated with PNEUMOVAX (lot # J-04887) in the right arm. On 04-OCT-2013, the patient sustained "fever, swelling and hot to touch on area where shot was administered." Treatment and outcome of the adverse event were unspecified by the reporter. Additional information has been requested.
830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.
Report minor chest pain after receiving both first and second dose x 1 week later. Treatment: Visit to Cardiologist with stress test and EKG being unchanged from previous. Outcome: Continue to monitor. Employee continues to work
Pt. had runny nose, sneezing, cough that started aprox. 11-7-14. Cough got so bad he would vomit. Dx: on 11-14-14 and 11-16-14 with pertussis. Treated with Z-PAK, treatment started 11-14-14. (Not healed).
Tested (+) for Covid after returning from fishing trip  Had nasal congestion & cough & urinary frequency
Temperature: 51.4 F; This solicited report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, Intramuscularly (IM), lot # T007024 was confirmed to be valid, expiration date 23-APR-2022, (site of administration was not provided) for prophylaxis. The administered dose was exposed to the temperature of 51.4 degrees Fahrenheit (F) for 2 hours. There was no previous temperature excursion. The call was because of a digital data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a registered nurse concerning female patient with no pertinent medical history who on approximately 22-JUN-2007 was vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the dizziness, nausea and diaphoresis on the same day she received the Gardasil. This report is one of several reports received from the same source. Additional information has been requested.
This is my first time to experience the following after flu vaccination:1.  Body Aches 2. Fever 3. Sore Throat 4. Cough. This is the worst side effects.
Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 173 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up was received with non-significant information.
Pt had several life threatening blood clots in his veins and arteries in his legs, and blood clots in his lungs.
This is a spontaneous report from a contactable nurse reported for herself. This 79-year-old female patient received PREVNAR 13, intramuscular at single dose on 20Jan2016. The patient medical history was not reported. Concomitant medication included metformin and HYDRODIURIL. On 27Jan2016, the patient woke up completely deaf/totally deaf. Nurse mentioned that she had a hearing test under the other doctor and added that it was 30 something, she did not know and then she went back, it was 80 and 70. Therapeutic measures were taken as a result of deaf/totally deaf included prednisone taper. The outcome of the event was recovered.
Nauseous; This is a spontaneous report from a contactable consumer (patient).  A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at an unspecified dose via an unspecified route of administration, on 19Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient reported she got the vaccine yesterday (19Dec2020) and she is really nauseous right now (Dec2020). It was unknown if a treatment was received. Outcome was unknown. Information for Lot/Batch number has been requested.
1/2 hour after receiving pneumonia shot, right arm swollen, hot, and hurt. Couldn't lift over head. Went to M.D. On antibiotics and had Cortisone shot 11/22/2002. Stated arm doing alot better. Case closed.