chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Coughing; Fever; Body aches; I still have body aches; Chills; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal and COVID-19 from Jun2020 and was hospitalized, and double pneumonia. Concomitant medications included trandolapril for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol, and tadalafil (CIALIS). The patient stated, "I experienced fever, body ache and chills in the evening, which I took some Tylenol (treatment) for and then this morning when I woke up my lymph nodes under my arm on the injection site were swollen so bad that's I could barely lift my arm up it was so painful and I have body aches and the cough I have been coughing quite this morning too, which some slightly concerned what the looks swollen lymph nodes." Clinical outcome of event body aches was not recovered, while for the rest of the events was unknown.  Information on the lot/batch number has been requested.
Bruise around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported). Concomitant products included CENTRUM SILVER +50, VITAMIN 15, CALCIUM and FISH OIL for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE BRUISING (Bruise around the injection site). On 31-Jan-2021, INJECTION SITE BRUISING (Bruise around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were multivitamin with minerals, vitamin, calcium, supplement (fish oil) of drug use for unknown indication. No treatment information provided.
Information has been received from a medical assistant referring to a 7 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1901USA008772: US-009507513-1902USA007550: US-009507513-1902USA007549: US-009507513-1902USA007548: US-009507513-1902USA007547: US-009507513-1902USA007546.
3 days after vaccination, patient fell and needed to be taken to ER for potential leg and/or head injury
A 7 year old male received an injection of Prevnar into his left thigh on 4/19/00. Approximately 48 hours later, the pt developed swelling, redness and tenderness at the injection site. Additional info recieved on 6/8/00, from the reporter indicated that the child had a chronic allergy/asthma hisotry, and that the child recovered from the events.
Fever; Body pain; Vomiting; Chills; Headache; Hot flashes; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 21Apr2021 at 12:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, hypermobility, major depression and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included armodafinil (NUVIGIL), vortioxetine hydrobromide (TRINTELLIX), estradiol (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and midodrine (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 12:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation and previously received gabapentin (NEURONTIN) and dimenhydrinate (DRAMAMINE); both for an unknown indication from unknown date and experienced drug allergy. On 22Apr2021 at 04:30, the patient experienced fever, body pain, vomiting, chills, headache, hot flashes and injection site pain. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event fever, body pain, vomiting, chills, headache, hot flashes and injection site pain was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
had shoulder pain moved into left neck\pain in neck (both sides) nearly unbearable with movement of neck/head; shoulder pain moved into left neck; minor shoulder discomfort; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on left arm on 27Jan2021 15:30 as SINGLE DOSE for covid-19 immunisation. Medical history was None. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. If covid prior vaccination: No. If covid tested post vaccination: No. There was no Allergies to medications, food, or other products. The patient experienced minor shoulder discomfort (musculoskeletal discomfort) on 29Jan2021 16:00, had shoulder pain moved into left neck\pain in neck (both sides) nearly unbearable with movement of neck/head (neck pain) (non-serious) on 30Jan2021, shoulder pain moved into left neck and (arthralgia) (non-serious) on 30Jan2021. It was reported that injection received on 27Jan2021. felt minor shoulder discomfort evening of 29Jan2021. Morning of 30Jan2021 had shoulder pain moved into left neck. pain in neck increased during 30Jan2021. Pain progressed/increase on 31Jan2021 and contacted Pfizer manufacturing site. morning of 01Feb2021 pain in neck (both sides) nearly unbearable with movement of neck/head and contacted Pfizer manufacturing site. recommended alternating heating/cooling to neck and use Advil. By afternoon pain reduced from 10 to 4 with described methods. Contacted Pfizer manufacturing site to report progress and recommended this be reported as side affect to vaccine received. The outcome of events was recovering.  Information on the lot/batch number has been requested
Immun. given Mon., 7/6/09 at 3:30 pm. 7/7/09-around 4 am headache started; by 4 pm vomiting and hot. 5:30 pm fever 104°. Took to ER at 6 pm. Tx with Benedryl, Tylenol, and cool compress.  Blood was drawn; no results at this time. Mother states temp. controlled with Tylenol.
24hr p/vax rt arm edema & erythema & was noted extending from 2cm below DTAP site to superior portion of rt shoulder;swelling resolved w/in 5 days;child vomited once 48hr p/vax;tx w/cool compresses & DPH;hives;
Redness (9" diameter around injection site), warmth to area. Tx "advised cold compresses at 20 min intervals, 600mg MOTRIN every 8 hours as needed for pain for the next 3 days. Ok to also take 10mg ZYRTEC once daily to help with itching. Advised to follow up if child develops a fever, reaction gets significantly worse in size and color and for any drainage from site."
16Aug95 pt recv 1 dose vax. 28Jan98 pt devel 103-104 fever & "full blown chickenpox".Pt tx w/Zovirax & recovered 13Feb98.
Edema, Erythema, warm to touch, tenderness to palp. Numbness at injection site, pain to upper right arm and back. In conjunction with Lymphadenitis.
Injection Thursday PM. Friday AM-"fever and red bump on arm 2" x1" per mother. Took to urgent care Friday pm due to "increased redness and large red streak up arm". Started Benadryl and Tylenol. Took child to Urgent care again Saturday. Temp 101F. Started on Cephalexin for 10 days.
Pt. with fainting-like episode following vaccine. Approx. 3 mins after receiving vaccine, pt. stood up and then fell to the floor. Pt. hit posterior head on tile floor, +LOC, seizure-like movements for approx. 5-10 secs following fall. Pt. very pale appearing for several minutes approx. 2-3 minutes after LOC. VS@1400 : HR 100, RR 16, BP 102/56 RUA. Pt. able to eat and drink after event. Unable to visualize trauma to posterior head. Pt. with GCS 15. Mother informed to seek follow up care for any change in mental status.
Fatigue the day after, itchy 2-inch round rash/lesion at the injection site that showed up 7 days after
Vaccine administered after 9 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial). On 11-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
15 mins post-vaccination: patient developed superficial numbness on skin R side of face, eyes, nose, mouth & chin. Sensation spread to R side forehead, mouth, tongue & back of throat. Stayed on R side. No dysphagia, no SOB, no HA or visual changes, no chest pain, no notable muscle weakness, no facial paralysis, no rash, no tongue swelling, VS stable, talking clearly, sipping water & complaining of numbness on tongue. Patient suddenly grabbed lower neck & throat c/o pain & feeling of tightness & pressure. Felt nauseous, like vomiting. Became apprehensive and at first was alert & oriented but then had difficulty answering questions & speaking.  BP declined to 100/50, O2 decreased to 90%, lungs had decreased breath sounds with no wheezes.  Epipen administered at 1000. VS stabilized: BP 130/60, P 100, R18, O2 sat returned to 98%. Pt was apprehensive, drowsy, confused and had difficulty answering questions.  Transport to ER via EMS. Mental status deteriorated en route, 50mg diphenhydramine administered. Abnormal clenching/tension of hands & lower extremities. Arrived at ER 1040; did not respond to triage nurse. Pulse 114.  EKG scan performed on arrival. CMP, CBC, HCG drawn. Dexamethasone 10mg & lorazepam 1mg administered. EKG, tox screen & MRI performed; all unremarkable. Patient became able to ambulate and use bathroom with minimal assistance. Became awake and oriented and could answer questions, but felt groggy. Discharged at 1446. ER visit 3 hours.
Redness/pain/swelling/itching at injection site 5 days after injection. Instructed to take Benadryl, apply cool compress & see PCP in am if no improvement. Manufacturer (Aventis)unable to enter in section 13.
received 3rd full dose instead of booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose). On 22-Oct-2021, EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose) had resolved.  No concomitant medication was reported.  No treatment medication use was reported. Reporter did not allow further contact
LOCALIZED ENLARGED LYMPH NODES, STARTED 6 DAYS AFTER MODERNA COVID VACCINE, EITHER POSTERIOR SUPERFICIAL CERVICAL CHAIN OR SUPRACLAVICULAR NODES, ONLY ON LEFT SIDE, HAD VACCINE AT LEFT DELTOID, ALSO ASSOCIATED LEFT AXILLARY TENDERNESS BUT SHE DID NOT PALPATE ENLARGED NODES THERE. IS IMPROVING.
cough, runny nose, bilateral ear pain, body aches, generalized rash, sore throat
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose).    The case contains the information regarding patient 13 of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
FEVER AND CHILLS OVERNIGHT. GENERALIZED BODY ACHES AND FATIGUE
shortness of breath; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (shortness of breath) and HEADACHE (headache) 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 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The patient had booster shot on tuesday (01-Feb-2022).  Treatment information was not provided.
High fever 103-104 with tylenol/ibprofen for 3 days. Large welt at injection site for 3 days, lump in leg going on 2 weeks. Vomitting, diahrea, refusal to eat for 3 days. Persistant choking cough. Rash on face, back of neck, and lower back. Periods of lethargy where she would stare for long periods of time, other periods where she would not cease to cry and could not be comforted. After the first 2 days of high fever she would sleep for abnormal amounts of time, going to sleep several times during the day.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:31, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified). There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Havrix was administered today on June 22 2023. Havrix expired on June 17th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 22-JUN-2023, the patient received Havrix. On 22-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix was administered today on June 22 2023. Havrix expired on June 17th 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter consented to follow up. Preferred follow up via email.      On the day of reporting, the patient received an expired dose of Havrix, which led to expired vaccine used.
Began feeling numbess of tongue within 10 minutes of receiving and then felt that lips were numb and that lips were swelling.  Received 25mg of Benadryl, orally, and then repeated Benadryl 25mg, orally, 10 minutes later.  Within one hour began feeling chest tightness, lip and tongue numbness was unchanged at this time.  SpO2 at this time was 97%.  Referred to Dr.  Full examine provided and no further treatment was felt to be needed, unless patient had increasing or new symptoms.
10/26 left arm swelling, pain, hot, red, fever - 5 days later. Decreased ROM on left arm. Continued with severe pain 3 weeks later. Annual followup 01/4/2010 There is still a loss of range of motion in shoulder flexion in my left arm. I continue to have increased muscle fatigued when using my arm and some pain. My left arm has these residual problems and is not normal. It is not like my right arm. It has been over a year since the vaccination and I continue to live with these "adverse events", will I ever recover?
Sharp chest pain 7 hours after receiving the vaccine along with numbness in both legs. The numbness lasted for a few minutes and went away, but I am still experiencing chest pain and an elevated heart rate (around 100-130bpm) even when I'm not moving much. I also experienced extreme pain in my arm that received the vaccine to the point that I couldn't move my arm at all. This lasted almost three weeks. I am currently in the process of getting help for my heart. I will be getting an ultrasound tomorrow morning 7/15 to see what is going on.
The vaccine was ordered wrongly as Hep A Adult, and administered as it was ordered. The patient was 2yrs and 7 months at the time of vaccination. The patient has not presented any complaints, it was only a clinical error without consequence until now notified. The medical director is in the process of notifying the patient guardian. Today was the day the incident was found.
Menveo was given to patient on 4/5/22 , expired 3/31/22; This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 5th April 2022, the patient received Menveo. On 5th April 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comment: The NDC number was provided 58160-955-09. The nurse reported that, Menveo was given to a patient after the expiry date of 31st March 2022. The reporter wanted to have recommendation of the expired dose of Menveo given to the patient. Additional Supportive Information: The nurse reported use of Menveo dose to a patient and the vaccine was already expired on 31st March 2022, which led to expired vaccine used.